549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 549300LLEO25ZJJ3NT91 2020-12-31 549300LLEO25ZJJ3NT91 2021-12-31 549300LLEO25ZJJ3NT91 2019-12-31 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 ifrs-full:ReserveOfChangeInFairValueOfFinancialLiabilityAttributableToChangeInCreditRiskOfLiabilityMember 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2020-01-01 2020-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2021-01-01 2021-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:ReserveOfChangeInFairValueOfFinancialLiabilityAttributableToChangeInCreditRiskOfLiabilityMember 549300LLEO25ZJJ3NT91 2019-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2020-12-31 ifrs-full:RetainedEarningsMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:IssuedCapitalMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:SharePremiumMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:TreasurySharesMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember 549300LLEO25ZJJ3NT91 2021-12-31 ifrs-full:RetainedEarningsMember iso4217:SEK xbrli:shares iso4217:SEK xbrli:shares
Cha
ngin
g
soc
i
et
y
wit
h
sci
enc
e
Annual Repor
t 20
2
1
®
2
6
10
3
7
11
12
4
8
1
5
9
Strat
e
gy
The
share
Go
v
ernance
M
a
r
ke
t
Dir
ector
’
s
re
por
t
Remuner
ation
Glo
ssar
y
T
ech
nology
ESG
Ov
er
view
G
r
ow
t
h
Financials
Content
s
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Hansa Biopharma
Annual Report 202
1
2
Ove
rv
iew
Our vision
W
e e
n
vision a w
orld
where al
l pat
ie
n
t
s with
rare immunologic
dis
eases can lea
d long
and healt
hy l
iv
es
.
Hansa Biopharma is a pioneering commercial-stag
e
bio
phar
mac
euti
cal co
mpa
ny on a mis
sion to
dev
elop and commercialize inno
vativ
e, life-saving
an
d life
-alte
rin
g trea
tmen
ts for pa
tien
ts wit
h rar
e
immunological conditions.
We have develo
ped a r
st-in
-cl
ass i
mmun
oglob
ulin
G (IgG) antibody clea
ving enzyme therapy
, which
ca
n enab
le ki
dney tr
ansp
lant
atio
n in hig
hly
se
nsit
ized pat
ient
s. We have a ric
h and exp
andi
ng
re
sea
rch a
nd develo
pmen
t pipel
ine, ba
sed o
n our
proprieta
ry IgG
-cleaving
enzyme technology
platform, to address serious unmet medical
needs
in transpla
ntation, autoimmune
disea
ses, gene
the
ra
py and ca
ncer.
Ha
nsa is b
ase
d in Lun
d, Swede
n and h
as
operations in Europe and
the U.S.
Hansa
Biopharma
in brief
Strateg
y
T
echnology
Grow
th
Ma
rket
Hansa Biopharma
Annual Report 202
1
3
Remuneration
Directors
’
repo
rt
ESG
Financials
Governance
The share
Ove
rv
iew
1
Ov
er
vie
w
Cha
irm
an’
s let
ter
5
2021 highlights
6
CEO st
atem
ent
7
Impact from the CO
VID-
1
9 pandemic
1
0
Hansa Biopharma
Annual Report 202
1
4
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Strateg
y
Ma
rket
Overview
Hansa Biopharma
Annual Report 202
1
4
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Dear Shareholders,
Du
ring 20
2
1
, we too
k anoth
er ma
jor ste
p in this d
irec
tion,
adv
anci
ng to bec
ome a f
ully i
ntegr
ated com
merc
ial st
age
biopharmaceutical com
pany t
hrough t
he Eur
opean launch o
f
Iderix
®
in kidney
transplant
ation.
This prod
uct launch
is not
Ha
nsa’s lo
ng-te
rm go
al is t
o bec
ome a
re
cog
nize
d glo
bal l
ead
er in r
ar
e dis
eas
es
ac
ros
s mul
tip
le t
her
ap
eut
ic ar
ea
s thr
oug
h th
e
dev
elopment o
f new
, transformative
drugs
th
at c
oul
d be bot
h li
fesa
vin
g and l
ife a
lte
rin
g
for p
at
ien
ts su
f
fer
ing f
rom r
ar
e imm
uno
logi
c
diseases
and conditions.
Given the
versatility
an
d flex
ib
ili
ty o
f the s
cie
nt
ifi
c tec
hno
log
y
pl
at
for
m, it
s val
uab
le p
ipe
lin
e of dr
ug
candidates, and
its talented
and dedicated
te
am of em
ploy
ees
, we bel
ieve H
ans
a has
wh
at it t
akes t
o bec
ome a l
ead
ing p
laye
r in
rare immunologic diseases.
onl
y a lan
dma
rk mil
eston
e for Ha
nsa Bi
opha
rma
, but, mor
e
imp
or
tant
ly
, grea
t news for h
ighl
y sen
siti
zed pati
ents in n
eed
of a ki
dney tr
ansp
lant.
From a st
rategi
c poin
t of view, the Boa
rd and I h
ave bee
n ver
y
encouraged by
our team
’
s abilit
y
to
secure a number
of
important partnerships acro
ss both
research
and dev
elopment
and commercial
operation
s. During
the last
1
2 months
alone,
Ha
nsa has en
tered into thre
e new col
labo
ratio
ns with ar
gen
x,
Me
diso
n Phar
ma an
d AskB
io. The
se ag
reem
ents a
nd the
co
ntinu
ed level of inte
rest we are expe
rie
nci
ng ser
ve as fur
th
er
val
idati
on of the p
otentia
l of the Co
mpany
’
s u
niqu
e IgG
-cle
avin
g
enzyme technology
platform.
Th
e
ye
ar ahe
ad promi
ses to be as excitin
g
as 2021 as we plan
to expan
d activ
itie
s
ac
ross ou
r
bu
sine
ss and R&
D
ac
tivi
ties.
Nota
bly
, I am v
er
y enc
oura
ged by th
e addi
tiona
l prog
ress i
n our
cli
nic
al deve
lop
ment p
roje
cts, wit
h fur
the
r adva
nce
s in the
imp
or
tant U.S. pi
votal C
onfI
deS st
udy in k
idn
ey tran
spla
ntati
on,
which could
lead t
o submission
of a
Biologics License
Ap
plic
atio
n (BL
A) to the U.S. Foo
d and D
rug Ad
mini
strati
on
(FDA) u
nde
r the acc
ele
rated a
pprova
l pathway in 2024. Also, I
am eq
uall
y ex
ci
ted abo
ut the prog
ress we have se
en in
ant
i-GB
M, a ser
ious d
isea
se wi
th hig
h unmet m
edi
cal n
eed. A
nti-
GBM is th
e
r
st indi
cati
on outs
ide of trans
pla
ntatio
n, where
iml
id
ase has sh
own proof-of-
conc
ept and I am pl
ease
d that we
have b
een a
ble to al
ign on th
e des
ign of a p
ivotal t
rial of
iml
id
ase in anti
-GBM di
sea
se with both th
e
U.S. FDA
an
d
EM
A.
La
stly
, we als
o
lo
ok for
ward to follow
ing the Co
mpan
y’
s eo
rt
s
to explo
re the potenti
al deve
lopm
ent of imli
da
se as a
dr
ug
candidat
e in al
logeneic hemat
opoietic s
tem cell
transplanta
tion
(HSC
T
)
, also known
as “bone-marro
w” tr
ansplantation
. St
em
cell tr
ansplantation
is a lar
ge indicat
ion, s
imilar t
o kidney
transplant
ation,
where t
here is
a high un
met medical need
for
pati
ents wi
th high leve
ls of dono
r
sp
eci
c anti
bodi
es, as cur
rent
desensitization met
hods remain inadequat
e.
Wh
ile Ha
nsa s
aw soli
d prog
ress d
urin
g 202
1
, with f
ur
the
r
validation
of its
business model and t
echnology platform and
sol
id execu
tion on its str
ategi
c
pr
ior
itie
s,
th
e
op
erati
ng
environment and
capital market
have bo
th been challenging
.
Fr
om a capital marke
t perspective,
the bio
technology industry
as a w
hole h
as had i
ts wors
t per
iod in m
ore tha
n a dec
ade.
The direct and
indirect impacts
from the
COVID-
1
9 pandemic,
increasing int
erest rat
es, sect
or ro
tation and
geopolitical
unc
er
tai
ntie
s are ju
st som
e of the dy
nami
cs tha
t have cau
sed
an
d conti
nue to ca
use wea
kne
ss to the va
luati
ons i
n the se
ctor
.
Th
e fun
dame
ntal d
rive
rs be
hind t
he suc
ces
s of the bi
otech
ind
ustr
y as a ver
y sign
ic
ant valu
e
cr
eator over the pa
st dec
ades
are, howeve
r
, int
act, and we rm
ly bel
ieve that Ha
nsa
Bi
opha
rma, a
s a com
merc
ial st
age co
mpany w
ith a va
lidate
d
tec
hnol
ogy pl
atfo
rm, an excitin
g
pi
pel
ine of late-s
tage val
uab
le
drug candidat
es,
and a s
trong or
ganization
is well
-positioned t
o
suc
cee
d in de
live
rin
g on its st
rategi
c pri
orit
ies eve
n in suc
h a
volat
ile and ch
allenging envir
onment.
On b
eha
lf of the B
oard of Di
recto
rs,
Ulf Wii
nberg
Chairman,
Hansa Bioph
arma
Lu
nd Swe
den
, Apr
il 2022
Chairman
’
s le
t
ter
W
e
ar
e building Hansa int
o a
global lea
der in rar
e diseases
.
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Hansa Biopharma
Annual Report 202
1
5
Overview
2
02
1 highlight
s
Hansa Biopharma enters
pre-clinical
research
collaboration
with argenx
BV to exp
lore p
otenti
al co
mbi
natio
n
the
rap
ies w
ith im
li
dase a
nd
efgartigimod
Pos
itive 3
-yea
r foll
ow-up da
ta
pu
blis
hed i
n Ame
ric
an Jo
urn
al of
T
r
ansplant
ation demonstr
ating graft
su
rv
ival o
f 84
% af
ter im
li
dase
treatme
nt
and tra
nsplantati
on
Ha
nsa B
ioph
arm
a AB ce
rt
ie
d as a
Gre
at Pla
ce to Wor
k
®
for second
con
secuti
ve year
New mu
ltiregional commer
cialization
partner
ship
with Medison Pharma
for i
mli
das
e in ki
dney t
rans
pla
nt in
Ce
ntra
l Easte
rn Eu
rope a
nd Is
rael
Agreement
with AskBio
to e
valuat
e
fea
sib
ili
ty of im
li
dase a
hea
d of gen
e
therapy in
Pompe disease
Healthcare T
echnology Assessment
pu
blis
hed by S
wedi
sh “T
L
V”
, wi
th a
favor
able conclusion for
using
Iderix
®
in highly sensitiz
ed patients
incompatible
with a
deceased donor
Ha
nsa B
ioph
arm
a rec
ords 
rst
co
mme
rcia
l sal
e of Ide
rix
®
First national
market access
ag
reem
ent ac
hie
ved for I
der
ix
®
in
Sweden and Finland
(hospital basis)
Full
national reimbursement
ag
reem
ent ac
hie
ved for I
der
ix
®
in the
Netherlands
Ma
rket ac
ces
s agr
eem
ent
ac
hieve
d in Gr
eec
e on a
hospital basis
Fi
rst pa
tien
t enro
lle
d in the U.S.
pivotal
randomized
controlled
study
”ConfIdeS” in
highly sensitized
kidn
ey transplant pati
ents
Januar
y
February
March
April
May
June
July
August
September
October
November
December
January
20
21
2022
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Hansa Biopharma
Annual Report 202
1
6
Overview
Despite a
challenging operating en
vironment,
we wer
e able t
o
sol
idl
y ex
e
cute on ou
r key prio
rit
ies for t
he year
, wh
ich we
re to
:
1.
Ensure a s
ucc
essf
ul lau
nch of Id
eri
x
®
in leading
transplantation
centres in
select European mark
ets
;
2.
Ini
tiate a pi
votal st
udy in t
he U.S. t
o su
ppor
t a f
uture B
L
A
for im
li
dase i
n high
ly sen
siti
zed pati
ents wai
ting fo
r a
kidney transplant
; and
3.
Cont
inue to
build on t
he strong
momentum behind our
eor
ts to ad
vanc
e our pip
eli
ne of dru
g can
didate
s with
in
autoi
mmune diseases
and gene therap
y
.
As fa
r
as th
e Europe
an lau
nch of Ide
ri
x
®
is c
once
rne
d, we saw
sol
id execu
tion in ex
pand
ing our m
arket ac
ces
s
fo
otprin
t.
During 202
1
, pricing
and reimbursement wer
e secured in
Sweden and
the Ne
therlands as
well as
on an individu
al hospital
bas
is in F
inla
nd and G
ree
ce, whi
le Ge
rma
ny and Fra
nce (ea
rly
acc
ess p
rogr
am) were ad
ded to the l
ist of co
untr
ies w
ith
co
mmerc
ial ac
ces
s on neg
otiated ter
ms dur
ing the r
st qua
rte
r
of
2022
. Notably
, a
health-economic assessment
conducted
by
the Swe
dis
h Dent
al and Pha
rma
ceut
ica
l
Be
net
s Agenc
y (T
L
V
)
co
nclu
ded tha
t
Id
eri
x
®
treatme
nt in appropr
iate highly
sensitiz
ed pat
ients on
dialysis w
aiting f
or a kidne
y transplan
t
wou
ld be cost e
ecti
ve and potent
iall
y even le
ad t
o co
st
sav
ings, w
hic
h is rare
ly se
en for o
rph
an dr
ugs.
Ma
rket acc
ess p
roce
dure
s are now o
ngo
ing in 10 count
rie
s incl.
HT
A dos
sie
rs su
bmit
ted in th
e UK, It
aly a
nd Spa
in. Thi
s is a
gre
at achi
eveme
nt by our expe
rie
nce
d marke
t
ac
ces
s t
ea
m and
an im
por
ta
nt mile
stone as we bu
ild the fou
ndati
on for Ide
ri
x
®
as a p
otentia
lly tra
nsfo
rmati
ve ther
apy that i
s bri
ngin
g hope to
the th
ous
ands of h
ighl
y sen
siti
zed pati
ents ac
ross th
e cont
inen
t
who are
currently wait
ing for a
compatible kidney
transplant.
Loo
kin
g beyond t
he ea
rly l
aunc
h hosp
ital
s and c
ountr
ies, I a
m
also pleased
with our
new mult
iregional commer
cialization
pa
rtn
ers
hip wi
th Med
ison Ph
arm
a for Ide
ri
x
®
in C
entra
l
Ea
stern Eu
rope a
nd Isr
ael. Me
diso
n is a rec
ogn
ized
internat
ional pharmaceutical company f
ocused on pro
viding
acc
ess to h
ighl
y innov
ative th
erap
ies to pat
ients i
n inter
natio
nal
ma
rkets. Th
is co
mmer
cial p
ar
tner
shi
p repre
sent
s an imp
or
tant
mil
eston
e for Ha
nsa as we ex
pand a
cce
ss to Ide
rix
®
beyond
initial
markets
for
highly sensitiz
ed pat
ients a
waiting
kidney
transplant
s.
In th
e U
.S., we initi
ated ou
r pivota
l Conf
Ide
S tria
l in ki
dney
tra
nspl
antat
ion. Th
e Conf
Ide
S study i
s evalu
ating i
mli
dase a
s
a po
tential
desensitizat
ion therap
y t
o enable kidne
y transplan
ts
in hi
ghl
y sens
itize
d patie
nts wai
ting fo
r a dec
ease
d don
or
ki
dney th
rough t
he U.S. kidn
ey all
ocati
on syste
m. W
e exp
ect to
enro
ll
1
patien
ts at
1
2-
1
5 leading t
ransplantation
centers
across
the U.S. an
d aim to co
mple
te enrol
lme
nt by the en
d of this
yea
r
. In ad
diti
on to gen
erati
ng im
por
tan
t new dat
a, the
ConfIdeS t
rial will als
o enable t
he participating
key
transplant
ce
nters to ga
in imp
or
tant ex
per
ien
ce with t
he use of im
lid
ase
as a
desensitization
treat
ment ahead
of a
pot
ential commer
cial
lau
nch i
n the U.S.
CE
O s
tatement
Despite a challenging op
era
ting
envi
ron
ment
, we w
ere ab
le t
o
solid
ly e
x
ecut
e on o
ur k
e
y
priorities f
or the y
ear
.
Søren T
uls
trup
Pre
side
nt and CEO,
Hansa Biop
harma
2021 w
as, overall, a transformative and
successful year for Hansa a
s w
e
advanced into a fu
lly integrated,
commercial
-stage biopharmace
utical
company fol
lowing the commercial
launch in
Europe of
Iderix
®
(imlidase)
,
for desensitization of highly sensitized
kidney transplant patients incompatible
to a deceased donor
.
1
Enr
oll
ment i
n the U.S. C
onf
Ide
S tria
l is de
ne
d by pati
ent c
onse
nt an
d
wai
tin
g for a su
ita
ble or
gan o
er
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7
ESG
Financials
Governance
Remuneration
Overview
On th
e rese
arch s
ide, Ha
nsa h
as ente
red into t
wo new
co
llab
orati
ons du
ring t
he las
t 1
2 mo
nths. Th
e rst, a
nnou
nce
d
at the e
nd of Ma
rch 2021
, is a p
re-
clin
ical r
ese
arch
co
llab
orati
on wit
h arge
nx BV
, a le
ade
r in the e
ld of FcR
n-
inhibition
, t
o ev
aluate
the t
herapeutic po
tent
ial of
combining
Hansa
’
s IgG ant
ibody
-cleaving
enzyme, an
d efg
ar
t
igimod,
arg
enx’s FcRn an
tago
nist. A co
mbin
ation of i
mli
dase a
nd
efga
r
tigim
od co
uld pote
ntial
ly be u
sed in b
oth the ac
ute and
chronic
setting o
f aut
oimmune diseases
and tran
splantation
.
In th
e area of ge
ne the
rapy
, we wer
e also exci
ted to anno
unc
e
an ag
ree
ment i
n ear
ly 2022 wi
th Ask
Bio, a su
bsid
iar
y of Baye
r
AG, to evalu
ate imli
das
e in a pre-
cli
nica
l and cl
ini
cal fe
asib
ilit
y
pro
gram a
s pre-tre
atme
nt ahe
ad of ge
ne the
rapy in Po
mpe
dis
eas
e in patie
nts wi
th pre-
exist
ing ne
utra
lizin
g anti
bodi
es
(NA
bs). NAbs a
gain
st ade
no-a
sso
ciated v
iru
s use
d in gen
e
the
rapi
es re
main a ma
jor c
hall
eng
e and we se
e sign
ic
ant
pot
ential f
or our
antibody
-cleaving enzyme t
echnology t
o
en
able g
ene th
era
py also i
n NAb
s posi
tive pat
ients
. The n
ew
collaboration
with AskBio
marks ano
ther k
ey s
tep in
the
implementat
ion of
our partnership st
rategy
in the
gene
therapy
space.
In anti
-GBM disease, f
ollowing a
successful pre-IND meeting
wi
th the U.S. FDA, we re
cent
ly ann
oun
ced pl
ans to in
itiate a
pha
se 3 stu
dy of imli
da
se. Thi
s pivota
l stud
y
, ou
r rst p
hase 3
stu
dy in th
e area of a
utoimm
une di
sea
ses, m
arks a
n impo
r
tant
mil
eston
e for Ha
nsa Bi
opha
rma’
s exp
ansi
on beyo
nd
tra
nspl
antat
ion. Th
e stud
y aims at e
nrol
ling a
pproxi
matel
y 50
pati
ents w
ith ant
i-GB
M dise
ase ac
ross th
e U.S. and Euro
pe,
wi
th the r
st patie
nt expe
cted to be e
nroll
ed in 2022.
As pa
r
t of Hans
a
’
s pl
atfo
rm str
ategy a
nd obj
ecti
ve to broad
en
the u
se of imli
da
se as a pote
ntial th
era
py t
o ch
ange t
he
course of
IgG-mediated immunological diseases and
co
nditi
ons, th
e Comp
any is exp
lor
ing ne
w indi
catio
ns wit
h a
high unme
t need.
One such ind
ication is
allogeneic
hemat
opoietic s
tem cell
transplanta
tion (H
SCT),
also known
as
“bone-marro
w” transplan
tation
is a chal
lenge and ther
e are
cur
rentl
y no ap
proved d
rug
s availa
ble to fa
cili
tate
tra
nspl
antat
ion in th
ese pa
tient
s. W
e be
lieve th
at imli
da
se may
have th
e potenti
al to trans
form th
is e
ld by ena
blin
g clin
icia
ns
to inactivate DSAs pr
ior to transpla
ntation, there
by creating the
basis for
enabling engraftment.
Ha
nsa’
s mis
sion i
s to lever
age ou
r uniq
ue Ig
G-cl
eavi
ng en
zym
e
technology platform t
o dev
elop innova
tive
, lifesaving and
life-altering
immunomodulating therapies,
bring these t
o the
patien
ts with
rare d
iseases and condit
ions who
need them,
an
d gene
rate val
ue to soc
iet
y at larg
e. T
o he
lp de
live
r on this
mis
sio
n, we are bu
ildi
ng a hig
h-pe
rfo
rma
nce tea
m by attr
actin
g
an
d integr
ating th
e most ta
len
ted and ex
per
ienc
ed ca
ndi
dates
whil
e creating a rewardin
g,
prod
uctive and stim
ulating
wor
kpl
ace for o
ur em
ploye
es. Th
e prog
ress we a
re mak
ing in
thi
s eor
t was il
lustr
ated aga
in in 2021 as we rec
eive
d
ce
rti
ca
tion as a “G
reat Pl
ace to Work
” for the s
econ
d
co
nsec
utive ye
ar by the G
PT
W Ins
titute.
At Ha
nsa, su
stai
nab
ilit
y is at th
e core of a
ll we do, an
d we have
dur
ing 2021 for
mal
ized ou
r ESG app
roach. Em
bar
kin
g on this
jo
urne
y
, we have i
denti
ed key e
nviro
nmen
tal, so
cial a
nd
governance
priorities,
which need t
o be
addressed and
used
to deve
lop the C
ompa
ny’
s rs
t sust
aina
bili
ty st
rategy.
CEO stat
ement
cont
inued
In 2
0
2
1 w
e receiv
ed
cer
tica
tion
as a “
Grea
t
Pla
ce t
o W
or
k” f
or the
second consecut
iv
e y
ear
b
y the GPT
W In
st
itut
e.
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y
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Annual Report 202
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8
Overview
CEO stat
ement
cont
inued
GBS Phase
2 complete
enrollment* (Timeline
guidance under r
eview)
2022
2023
2024
AMR Phase
2
complete
enrollment
(
H1 20
2
2)
NiceR comple
te
to
xicology study
(20
22)
Anti-
GBM Initiatio
n o
f
Pha
se 3 stu
dy
(20
22)
Kidney tr
ansplantation
U.
S.
complet
e 1
2m f
ollow-
up
(H2 2023)
Kidney tr
ansplantation
U.
S. complet
e
en
roll
ment (
H2 2022)
AM
R Phas
e 2 rst
dat
a read o
ut
(H
2 202
2)
GB
S Phas
e 2 rst d
ata
rea
d out* (
T
ime
line
guidance under r
eview)
Kidney tr
ansplantation
,
U.
S. BLA submission
(
H1 2
0
24)
Long-
term follo
w-up da
ta
5-ye
ars o
ut in k
idn
ey
transplanta
tion (
2023
)
Guid
anc
e ass
ume
s no pe
rsi
stent i
mpa
ct or f
ur
ther e
sc
alat
ion of th
e COVI
D-
1
9 pa
nde
mic p
otent
iall
y forc
ing t
ria
l cente
rs to re
pri
ori
tize p
atie
nt rec
rui
tme
nt or eve
n shu
t down a
gai
n
*
G
BS: Gi
ven th
e curr
ent d
icu
lt
y of pre
dict
ing e
nrol
lme
nt due to t
he di
rect a
nd in
dire
ct ee
cts of t
he pe
rsi
stent a
nd eve
n esc
ala
ting p
and
emi
c, Han
sa exp
ect
s to upd
ate its g
uida
nce f
or co
mple
tion
of enr
ollment in GBS
in April 202
2
Upcoming milestones
Milest
ones subject t
o po
tent
ial CO
VID-
1
9 impact
We have an
other exci
ting ye
ar ahe
ad of us wi
th seve
ral
important milest
ones t
o be ach
ieved a
cross our
platform and
fr
anch
ise
s. Our key pr
ior
itie
s for the ye
ar are to:
1.
Co
ntinu
e the suc
ces
sfu
l ex
e
cutio
n of our co
mme
rcia
l
lau
nch st
rategy fo
r Ide
rix
®
through
obtaining pricing
and reimbursement agr
eements in new
key
markets
in E
urope,
making addit
ional prioritiz
ed transp
lant
centers
clinically rea
dy for
initiation
, and
generating
growi
ng commercial
sales.
2.
Co
mplete e
nrol
lmen
t in the U.S. Co
nfId
eS tri
al.
3.
F
ur
t
her advance our
pipeline of drug
candidates for
autoi
mmune diseases an
d post t
ransplant m
anagement
by ini
tiati
ng a pivot
al tri
al of imli
da
se in ant
i-GB
M dise
ase
and advancing
our ongoing phase 2
trials in Ant
ibody-
Mediated Rejection (AMR)
and Guillian-Barré syndrome
(GBS) towa
rd rst d
ata read
-ou
ts.
I am p
rofound
ly gr
ateful to ou
r empl
oyee
s for the
ir
co
mmitm
ent, pa
ssio
n and h
ard wor
k in the p
ast yea
r and I l
ook
for
war
d t
o ma
kin
g fur
the
r prog
ress i
n the yea
r ahe
ad towards
the v
isio
n that we ar
e purs
uing w
ith sin
gle
-mind
ed foc
us: A
world
where pat
ients wit
h rare
immunologic d
iseases can lead
long and
healthy l
ives.
Søren T
uls
trup
President
and CE
O, H
ansa Biopharma
Lu
nd Swe
den
, Apr
il 2022
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Annual Report 202
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9
Overview
Impact fr
om the
CO
V
ID-
1
9 pand
emic
The CO
VID
-
1
9 pande
mic
is the dening
global health cr
isis of o
ur time. With
the emerg
ence of ne
w variants, the
Company continues t
o take measures
to prot
ect e
mplo
y
ees a
nd t
o be socially
responsible, while working to l
imit the
potential negativ
e eects of the
pandemic on its busines
s.
Th
ere ar
e still u
ncer
ta
inti
es wit
h rega
rd to the co
ntinu
ed spr
ead
of COVI
D-
1
9 an
d its im
plic
atio
ns, and we w
ill co
ntinu
e to
as
ses
s the sit
uatio
n and s
eek to pu
t in pla
ce rel
evant m
itiga
ting
measures wher
e necessar
y
.
Although w
e believ
e we
hav
e implement
ed stra
tegies designed
to man
age th
e impac
t of the COV
ID-
19 pand
emi
c t
o ou
r
bus
ine
ss, we have exp
eri
enc
ed, are ex
per
ienc
ing a
nd may
co
ntinu
e t
o exp
eri
enc
e, adver
se eec
ts to our bu
sine
ss,
including
delays wit
h respect t
o enr
olling pa
tients
, the
initiation
of ce
rt
ain ad
diti
onal s
tudi
es and r
ece
ipt of any g
overn
ment
al or
reg
ulator
y a
pprova
ls. For exa
mple, re
cru
itme
nt of patie
nts in
our p
has
e 2 clin
ical s
tudi
es in GB
S and A
MR was tem
pora
ril
y
ha
lted du
ring 20
20
.
Aga
in in the fo
ur
th qua
rte
r of 202
1
, we ex
per
ien
ced ho
w the
dir
ect an
d indi
rect e
ects of th
e conti
nue
d pand
emic a
nd the
em
erge
nce of th
e Omic
ron var
iant a
ecte
d a
nu
mbe
r of our
trial cent
ers in our GBS
phase 2 pr
ogram including the
sh
or
tage of I
VIg an
d availa
ble tr
ial st
a
. Thi
s, in tur
n, aecte
d
the e
nrol
lmen
t rate in the G
BS pro
gram at a s
ubse
t of
participating
hospitals.
T
o mitigat
e t
hese hurdles
, Hansa has
ini
tiated m
eas
ures to si
mpli
f
y the stu
dy protoc
ol, acti
vely
sup
por
t the h
irin
g of addi
tion
al sta at th
e clin
ics a
nd add
ed
tw
o new site
s for the r
ecr
uitm
ent of pati
ents i
n the U.K. an
d
the Ne
therlands.
We may exp
erie
nce a
dditi
ona
l delay
s to
ou
r ongo
ing st
udie
s,
as w
ell as dela
ys t
o the
planned initia
tion o
f our po
st
-appro
val
stu
dy of iml
ida
se in ki
dney tr
ansp
lant
ation i
n Europ
e and ou
r
pl
anne
d phas
e 3 stud
y of imli
das
e in anti-
GBM. A
lso, our
co
mmerc
ial l
aunc
h acti
viti
es in Eur
ope wer
e, are and m
ay
co
ntinu
e t
o be, n
egat
ivel
y impac
ted du
e t
o li
mited a
cce
ss to,
and r
educed decision-m
aking ability o
f
, marke
t access
aut
hori
tie
s, potenti
ally c
aus
ing de
lays in t
he gra
nting of
rei
mbur
sem
ent sta
tus to Ide
rix
®
by
authorities in
tradit
ional
early launch
countries.
Further
, our new phase
3 study
in anti-GBM an
tibody disease
in ap
proxi
matel
y 50 patie
nts whi
ch is exp
ecte
d t
o co
mme
nce
in 2022 i
n the EU an
d U
.S may b
e del
ayed du
e to reduc
ed
de
cisi
on-m
aki
ng or rep
rio
riti
zatio
ns by reg
ulator
s. The ex
tent to
wh
ich the C
OVID
-
19 pand
emic i
mpac
ts the tim
ing of th
ese
matters
will depend on
future
developments
, which
are highly
unc
er
tai
n and c
annot b
e pred
icted w
ith con
de
nce, suc
h as
the
ultimat
e geographic
spread
of
the
disease,
the
identication
of new va
ria
nts of the v
iru
s, the du
ration o
f the pan
dem
ic, any
restrict
ions on t
he ability o
f hospitals
and study
sites t
o
co
nduc
t studi
es tha
t are not d
esig
ned to ad
dres
s the
COVI
D-
1
9 pandemic
or pr
ocedures such
as transplan
tations
that
are elective in
nature
, including r
estrictions due t
o
sh
or
ta
ge
s in sup
pl
ies
a
nd st
a
, an
d the p
erc
ei
ved e
ect
ive
ne
ss
of act
ions t
aken in t
he U.S.
, Europ
e and oth
er co
untri
es to
co
ntain a
nd tre
at the di
sea
se. We will c
ontin
ue to evalu
ate the
imp
act of th
e COVID
-
19 pand
emi
c on our b
usin
ess.
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Hansa Biopharma
Annual Report 202
1
10
Overview
2
Stra
t
e
gy
Potential indication univ
er
se
1
2
Business model
1
4
Our strategic priorities
1
5
Mid
-term 
nan
cial p
rior
iti
es
1
7
Our Environmental, Social and
Gover
nan
ce (ESG
) str
ategy
1
8
Hansa Biopharma
Annual Report 202
1
11
T
echnology
Grow
th
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rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
P
oten
tial indication
univ
erse
*
T
he EU C
omm
iss
ion h
as gra
nted c
ond
itio
nal a
ppro
val fo
r imli
da
se in h
ighl
y sen
sit
ized k
idn
ey tra
nsp
lant p
atie
nts
**
In th
e U.S. a new s
tudy h
as co
mme
nce
d targ
eti
ng a BL
A li
ng by H1 2024
First generat
ion antibody
cleaving enzyme t
echnology
Opportunities
Obtained
EU condit
ional appro
val
Partnership Preclinical program
(Sarep
ta Therapeut
ics Inc
. and
AskBio)
Clinical
program
Research/Preclinical pr
ogram
New enz
ym
es
for r
epeat
dosing “NiceR”
…
Lung
Hear
t
...
Lung
AMR
Kid
ney*
,
**
Pompe
disease
Limble
Girdle
(LG
MD)
He
ar
t
AMR
Kid
ney
AMR
Duchenne
(DMD)
…
HCST
(Bone
Mar
row)
First generation
antibody-clea
ving
enz
yme technology
…
…
…
…
Guillain
Barre
Syndrome
Anti-
GBM
…
…
T
ransplant
ation
and p
ost transplantation
(Own
commercial infrast
ructure in
EU
/U.
S.
)
Other areas
Acute
autoimmune diseases
(Own
commercial infrast
ructure in
EU
/U.
S.
)
Gene therapy
Gene therapy
pre-treatment
(Partnership opportunities
)
T
ransplant
ation
and po
st
transplantation
New
therapies and on
cology
Oncology (EnzE)
Relapsing
IgG-related
autoimmune
diseases
Hansa Biopharma
Annual Report 202
1
12
T
echnology
Grow
th
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repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
P
otential
indication univ
erse
cont
inued
Our rst-gener
ation
antibody-cleaving
enzyme, imlidase, is
a protein
with
proper
ties that ena
ble it t
o quickly and
eectively
inactivate
IgG antibodies.
Imlidase is derived
from the human
pathogen,
Streptococcus pyo
gen
es
.
It is b
ein
g devel
ope
d for the tre
atme
nt and p
reventi
on of
diseases and
conditions caus
ed by
IgG anti
bodies in t
he acut
e
phase,
such as
to
enable transplan
tation
for highly
sensitiz
ed
pati
ents. T
here a
re a lar
ge num
ber of re
leva
nt indi
cati
ons an
d
sp
eci
c dise
ase a
reas th
at can b
e targ
eted wit
hin thi
s unive
rse.
In add
ition t
o desensitiza
tion prior
to
kidney tr
ansplantation
,
which has
received condit
ional appro
val f
or mark
eting
in
Euro
pe, we are al
so inves
tigat
ing im
lid
ase as a p
otentia
l drug
ca
ndid
ate for tre
atmen
t of active A
MR ep
isod
es in k
idn
ey
transplant
ation.
In ad
dition,
there ar
e ot
her solid
organ
tra
nspl
ants wh
ich may b
e rele
vant for i
mli
dase, bot
h pre-
and post
-transplan
tation (
e
.g
. heart and lung
)
.
Loo
kin
g beyond t
rans
pla
ntatio
n, there a
re a num
ber of oth
er
grow
th ve
ctors an
d area
s, whe
re imli
da
se may play a ro
le,
such as
in acut
e aut
oimmune di
seases, gene t
herapy
as well
as on
col
ogy
. Mo
re spe
ci
call
y
, we a
re curr
ently i
nvesti
gatin
g
rare
life-t
hreat
ening conditions
such as
anti-GBM
antibody
disease and Guillain-Barré
Syndrome (GBS
)
, which are
both
two ongoing clinical pr
ograms.
In ad
ditio
n, Hans
a, wit
h its par
tn
ers, i
s investi
gatin
g imli
da
se
as a p
re-treat
ment to pote
ntia
lly en
abl
e gen
e thera
py in
pati
ents w
ith pre
-exi
sting N
Abs. T
hroug
h the pa
rtn
ers
hip wi
th
Sa
repta T
hera
peu
tics, i
mli
dase i
s curr
ently b
ein
g investi
gated
in Limb-Girdle Muscular Dystroph
y (L
GMD) and
Duche
nne
Mus
cula
r Dys
trophy (
DMD); and th
rough t
he par
tn
ers
hip wi
th
As
kBio, a su
bsid
iar
y of Baye
r AG, in Pomp
e Dis
ease.
Fur
the
r
, Ha
nsa ha
s star
ted to exp
lore p
otentia
l indi
cati
ons
wi
thin on
col
ogy
. Ini
tial
ly the C
ompa
ny will l
ook in
t
o exp
lor
ing
the p
otentia
l devel
opm
ent of iml
ida
se in al
log
ene
ic HSCT
.
Stem c
ell tr
ansp
lant
ation i
s a sign
ic
ant ind
icat
ion, wh
ere the
re
is a hi
gh un
met me
dica
l nee
d for pat
ients w
ith hi
gh leve
ls of
donor specic
antibodies
, as c
urrent desensit
ization
methods
remain inadequat
e.
Beyo
nd iml
ida
se for th
e acute tre
atme
nt in IgG m
edi
ated
conditions
and diseases,
we ar
e also
developing
new
Ig
G-cl
eavi
ng en
zym
es un
der th
e prog
am “Ni
ceR” (
Novel
Immunoglobulin Cleaving
Enzyme
s
for Repeat
Dosing)
. These
“nex
t-gen
erati
on” enz
ym
es fro
m the Nic
eR pro
gram w
ill be
de
sign
ed to have a l
ower pro
pens
it
y t
o in
duc
e immu
nit
y
, in
order t
o incr
ease the
therapeutic
window
. The new
enzyme
s
are b
ein
g devel
ope
d t
o be u
tili
zed in a nu
mber o
f IgG-
dri
ven
auto
immu
ne dis
ease
s whe
re patie
nts exp
eri
enc
e are
s or in
tra
nspl
antat
ion, wh
ere rep
eat do
sing wo
uld be b
ene
cia
l and
add further v
alue, p
ar
tic
ularly post
-
transplant
.
La
stly
, Ha
nsa a
nd arge
nx BV ar
e evalua
ting th
e thera
peu
tic
poten
tial of c
ombi
ning i
mli
dase, a
nd efga
rti
gim
od, arge
nx’
s
FcR
n antag
oni
st. A comb
inati
on of imli
da
se and ef
gar
tig
imod
co
uld pote
ntial
ly be us
ed in b
oth the ac
ute and c
hroni
c set
ting
of
autoimmune
diseases and
transplanta
tion.
Hansa Biopharma
Annual Report 202
1
13
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Busin
ess model
Lev
eraging our technology plat
form t
o dev
elop new therapies t
argeting
rar
e diseases with unmet medical need acr
oss a range of indications
Reve
nue / sa
les
Upfront
payments
Milestone
payments
Roya
ltie
s
T
ransplantation
Autoimmune diseases
Gene therapy
New t
herapies and oncology
Growth engine
Lev
eraging pr
oprietar
y
antibody clea
ving
enzyme technology
V
alue chain
Commercia
lization
Ev
olut
ion into a full
y integr
ated bioph
armace
utica
l Company
Own commercial
infrastructure
Par
tn
ers
hip
strategy
Dr
ug
di
scove
r
y
Dr
ug
dev
elopment
Supply
operations
Distribution
Controlling t
he full value chain
Build-up o
f franchises
Indications
and therapies
Multiple income s
treams
F(ab’)2
Fc
In oth
er are
as, wh
ere the t
arge
t audi
ence
s and m
arkets a
re
mo
re comp
lex and f
ragm
ented, o
r wher
e acce
ss to gen
e
the
rapi
es or o
nco
logy c
omp
ound
s is req
uire
d, we will c
onsi
der
di
eren
t appro
ache
s. Amo
ng the
m, Hans
a may emp
loy a
pa
rtn
eri
ng strate
gy si
mila
r to the agr
eem
ents the C
omp
any
has wit
h Sarept
a Therapeutics and
AskBio in gene
therapy
or
the commer
cial partnership with
Medison Pharma
covering
se
lect c
ount
rie
s in Cen
tral Ea
ster
n Europe a
nd Is
rael i
n
kidney t
ransplantat
ion.
As Ha
nsa a
dvan
ces th
e devel
opm
ent of new t
hera
pie
s
ta
rgetin
g rare d
isea
ses w
ith a hi
gh unm
et med
ica
l nee
d and
transforms
into
a fully int
egrated
biopharmaceutical
co
mpany
, a wel
l-de
ne
d busin
ess m
ode
l supp
or
ts the
Company
’
s plans
to
leverage
its t
echnology platform
across
the en
tire v
alue chain
.
At the c
ore of the b
usin
ess m
ode
l is our “g
rowth e
ngi
ne” –
our pr
oprietary antibody-clea
ving enzyme t
echnology platform
.
As n
ew dru
g cand
idate
s advan
ce fro
m disc
over
y thro
ugh
development
to
regulat
ory approv
al and commer
cialization
,
it is ou
r intenti
on to retain st
rategi
c contro
l at the die
rent sta
ges
to capt
ure the m
ajor
it
y of the ec
ono
mic up
side g
ene
rated.
As new
products
approach
commercializat
ion, w
e ha
ve t
he
ex
ibil
ity to pu
rsu
e market e
ntr
y via t
wo die
rent p
athways.
In t
ransplantation
and aut
oimmune
diseases, wher
e target
aud
ien
ces a
re rela
tivel
y con
centr
ated, we inte
nd to pri
mari
ly
utiliz
e our o
wn commerc
ial and medical
infrastructu
re,
inc
lud
ing an ex
per
ienc
ed an
d ski
lled c
ustome
r faci
ng team,
to sec
ure su
cce
ssfu
l laun
che
s in the
se mar
kets.
Hansa Biopharma
Annual Report 202
1
14
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Our s
tr
ategic priorit
ies
Hansa is emba
rking on a mission to
become a global leader in r
are
diseases thr
ough the de
velopment o
f
inno
vativ
e, lif
e
-savi
ng and life-a
lt
ering
treatments for patients with ra
re
immunological conditions.
2
Enr
oll
ment i
n the U.S. C
onf
Ide
S tria
l is de
ne
d by pati
ent c
onse
nt an
d
wai
tin
g for a su
ita
ble or
gan o
er
Our stra
tegy builds
upon our proprietary enzyme technology
platform wit
h the
goal of
developing
and commerc
ializing
imm
uno
modu
lator
y rs
t
-in
-cla
ss or be
st-in-c
las
s treatm
ents fo
r
organ t
ransplants
, rare
IgG-mediat
ed aut
oimmune condit
ions
an
d gene t
hera
py
, as we
ll as ex
plor
ing th
e potenti
al for ou
r
tec
hnol
ogy in o
nco
logy. In execut
ing up
on our st
rategy, we
inte
nd to purs
ue the fo
llowi
ng ne
ar and m
id-term g
oals:
1.
Successf
ully
commercialize Iderix
®
in
kidney transplantation
in Europe
, the U
.S.
and selected
international
markets
In Au
gus
t 2020, Han
sa re
cei
ved co
ndi
tion
al ap
prova
l from t
he
Euro
pea
n Com
mis
sio
n for Id
eri
x
®
(i
mli
das
e) for the
de
sen
siti
zati
on tre
atme
nt of hi
ghly s
ens
itize
d adu
lt ki
dney
transplant
patients
with po
sitive cr
ossmatch
against an
available
deceased donor
.
We are p
ursu
ing th
e lau
nch of Id
er
ix
®
in sev
eral major
European
countries by
seeking pricing and r
eimbursement
approval
, raising
awareness and
working closely wit
h leading
cl
inic
al exp
er
ts. Fo
llow
ing co
mpl
etio
n of our p
ost-ap
prova
l
co
mmit
men
ts, we pla
n to see
k ful
l app
roval fo
r thi
s indi
cati
on
from t
he Eur
opean Commission.
In th
e U.S.
, we al
so pl
an to se
ek FDA ap
prova
l. T
o s
upp
or
t the
su
bmis
sio
n of a BL
A in th
e U.S.
, Ha
nsa h
as ini
tiate
d a pha
se 3
cl
inic
al st
udy (th
e Con
fId
eS stu
dy). If su
cce
ssf
ul, we ai
m to
su
bmit a B
LA s
eek
ing a
cce
ler
ated ap
prova
l in the 
rst ha
lf
o
f 2
024
.
By th
e tim
e of this a
nnu
al rep
or
t, we have o
btai
ned p
ric
ing an
d
rei
mbu
rse
ment f
or Ide
ri
x
®
in kidney
transplanta
tion in
Ge
rma
ny
, Fran
ce (ea
rly a
cce
ss), Swed
en, th
e Neth
erl
and
s as
wel
l as in F
inla
nd an
d Gre
ece o
n a hos
pita
l bas
is; we have
ma
rket ac
ces
s pro
ced
ures o
ngo
ing in 10 co
untr
ies, w
ith He
alt
h
T
ech
nol
ogy A
sse
ssm
ent (H
T
A
) dos
sie
rs l
ed in al
l of the v
e
la
rge
st mar
kets in Eu
rop
e.
Ou
r U
.S. C
onf
IdeS s
tud
y has e
nrol
led
2
1
3 of th
e targ
ette
d
64 p
atie
nts at 9 ce
nter
s acro
ss the U.S. b
y the tim
e of the
annual report.
2
.
Advance
our ongoin
g clinical
programs
in AMR
and rare
autoimmune
diseases
to regulatory approval
We have a
n ong
oin
g clin
ica
l prog
ram i
n AMR, f
or whi
ch we a
re
cu
rren
tly co
ndu
ctin
g a clin
ica
l pha
se 2 stud
y
. We expe
ct to
co
mpl
ete enro
llm
ent in t
he rs
t hal
f of 2022 an
d t
o re
por
t in
itia
l
dat
a by the e
nd of 2022. By t
he tim
e of this a
nnu
al re
por
t, 28 of
the t
arg
eted 30 p
atie
nts have b
ee
n enro
lle
d at 1
4 c
ente
rs ac
ross
the U.S., Eur
ope an
d Aust
rali
a.
We als
o have t
wo ong
oin
g cli
nic
al-st
age p
rogr
ams in r
are ac
ute
autoimmune
diseases – anti-GBM
antibody disease and GBS
.
In ant
i-GBM, a
phase 2
invest
igator
-initiat
ed study
was complet
ed
in S
eptem
ber 20
20 in wh
ich 10 out of 15 patie
nts ha
d a
fu
ncti
oni
ng kid
ney at six mo
nths, ve of wh
om requ
ired di
aly
sis at
stu
dy en
tr
y
. We b
eli
eve thi
s outco
me de
mon
strate
d pro
of-of-
co
nce
pt
by sh
owin
g
tha
t
th
e
us
e
of iml
id
ase was as
soc
iated wi
th
a subst
antially bett
er renal
outcome,
as compar
ed with h
istorical
co
ntrol
s. In Nov
emb
er 2021
, H
ans
a ann
oun
ced p
lans to i
niti
ate a
ph
ase 3 stud
y
of iml
id
ase fol
lowi
ng a
su
cce
ssf
ul pre
-IND me
etin
g
wi
th the U.S.
FDA
.
In ad
diti
on Han
sa com
plete
d
a sci
enti
c adv
ice
pro
ces
s wit
h EMA an
d rec
eive
d the
ir po
siti
ve fee
dbac
k on th
e
pl
ann
ed pha
se 3 stu
dy. The n
ew pivo
tal ph
ase 3 s
tudy a
ims to
en
roll a
pprox
imate
ly 50 pat
ient
s
wi
th ant
i-GB
M dise
ase a
cros
s
the U.S. and Eu
rope, wi
th the rs
t
pat
ient ex
pec
ted to
be en
roll
ed
i
n 20
22.
We are a
lso de
velo
pin
g imli
da
se for th
e trea
tmen
t of GBS fo
r
wh
ich we h
ave an on
goi
ng cl
inic
al pr
ogra
m, and f
or whi
ch we
are c
urr
entl
y con
duct
ing a cl
ini
cal p
has
e 2 stud
y
. B
y the ti
me of
thi
s ann
ual re
por
t, 16 of targ
eted 30 p
atie
nts hav
e bee
n enro
lle
d
at 10 cente
rs ac
ross t
he U.K., Neth
erl
and
s and Fr
anc
e.
Hansa Biopharma
Annual Report 202
1
15
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
3.
Deve
lop i
mli
da
se as p
re-t
re
atm
ent to g
ene
therap
y
,
starting with
our
coll
aborati
ons w
ith
Sa
re
pta a
nd As
kBi
o
In Ju
ly 2020, H
ans
a ann
ounc
ed a pa
rt
ner
shi
p with S
are
pta to
dev
elo
p imli
da
se as a pote
ntia
l pre
-treat
ment to g
ene th
era
py
in D
MD and LG
MD for p
atie
nts tha
t car
ry n
eut
rali
zing a
nti-A
AV
antibodies which w
ould otherwise make
them ineligible t
o
re
cei
ve trea
tmen
t. The p
rogr
am is be
ing l
ed by Sa
rept
a, whi
ch
in
itiate
d pre
-cl
inic
al stu
die
s in 2020. We exp
ect S
are
pta to
ad
vanc
e the pr
ogra
m into th
e clin
ic an
d, if su
cce
ssf
ul, to
es
tabl
ish i
mli
das
e as a pre
-trea
tmen
t in DMD a
nd LGMD.
In January 2
022
, Hansa
announced a collabora
tion with
AskBio
to eval
uate im
li
das
e in a pre
-cli
nic
al an
d clin
ica
l fea
sibi
lit
y
pro
gra
m as pre
-trea
tmen
t ahe
ad of ge
ne the
rapy i
n Pomp
e
di
sea
se in pat
ient
s with p
re-
exist
ing Na
bs. Na
bs ag
ains
t
ad
eno
-ass
oci
ated vi
rus u
sed i
n gen
e ther
api
es re
main a
ma
jor ch
all
eng
e and we s
ee si
gni
can
t poten
tial fo
r our
antibody
-cleaving enzyme t
echnology to
help o
vercome
this
barrier
.
4.
Dev
elop o
ur ne
x
t
generation IgG-clea
ving
en
zy
mes t
o allow f
or re
cur
ri
ng tr
eat
me
nt
We are p
urs
uing o
ur Ni
ceR p
rogr
am, ai
med at d
evel
opi
ng a
nex
t ge
ner
atio
n IgG-
cle
avi
ng enz
ym
e that co
uld a
llow fo
r
rep
eat d
osi
ng and, t
hus, re
cur
rin
g trea
tmen
t in auto
imm
une
di
sea
ses, tr
ans
pla
ntati
on an
d onco
log
y
. We have now i
den
tie
d
a le
ad mol
ecu
le an
d toxico
log
y stud
ies i
n non
clin
ica
l mod
els
are c
urr
entl
y ong
oing i
n pre
para
tion fo
r a cli
nic
al ph
ase 1 st
udy.
We exp
ect th
e toxic
olog
y stu
dies to b
e com
plete
d in 2022.
5.
Successf
ully mark
et our
product
s
by
pursuing a
hybrid comm
ercialization model
In transplanta
tion and aut
oimmune disease indications
, we
aim
to ma
xi
mize va
lue by co
mme
rcia
liz
ing ou
r ass
ets thr
ough o
ur
own c
omm
erci
al tea
m for ma
jor m
arke
ts in Eur
ope a
nd the U.S.
Du
rin
g 2021 we cont
inue
d to suc
ces
sfu
lly p
rogre
ss th
e lau
nch
of Id
eri
x
®
in E
urope.
In oth
er ma
rkets
, our go
al is to l
evera
ge th
e mar
ket poten
tial
through
commercial partnerships i
n the
form of
distribution
or
license agr
eements, depending
on the
partner
, t
he territ
or
y
an
d the sp
eci
c ind
ica
tion. F
or that p
urp
ose, in 20
2
1 we
en
tered i
nto our 
rst co
mme
rcia
l dis
trib
utio
n agre
eme
nt wi
th
Medison Pharma.
In o
ther disease
areas such
as gene t
herapy or
oncology
, w
e
may re
ly o
n our pa
rt
ner
s for co
mme
rcia
liz
atio
n, whi
le aim
ing to
se
cure c
er
tai
n rig
hts to co
-pro
mote or c
o-ma
rket, d
epe
ndin
g
on the
partner
, t
he territ
or
y
and the
indication
.
Our strate
gic pri
orities
cont
inued
Hansa Biopharma
Annual Report 202
1
16
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Mid-
ter
m nancial priori
ties
W
e expec
t to use our cu
rrent c
ash posit
ion to:
Fund the la
unch an
d commer
cial exp
ansio
n of Ider
ix
®
in kidney transpla
ntation in Europe
Init
iate our EU pos
t
-ap
proval com
mitme
nts and c
omplete th
e ve-year da
ta rea
d-
out in o
ur long
-
ter
m follow-up s
tudy an
d advance p
atient e
nroll
ment in our
Conf
IdeS s
tudy in ki
dney tra
nspla
ntati
on in the U.S.
Comp
lete enr
ollment o
f our ongo
ing pha
se 2 prog
ram
s in AMR an
d GBS an
d
init
iate a phas
e 3 clinic
al pro
gra
m in anti-
GB
M
Comp
lete the pr
eclini
cal pr
ogra
m for our le
ad mole
cule fr
om our nex
t gener
atio
n
enz
ymes fo
r repe
at dosing (
“Nice
R”) a
nd advanc
e our init
iatives in ou
r other
indications such as gene therapy and oncology
Fund work
ing cap
ital a
nd gene
ral c
orpo
rate pur
poses
As of December 31
, 2021 Hansa h
ad
cash, cas
h equiv
alents and s
hor
t
-term
inv
estments of SEK 88
9m,
corre
sponding t
o approximat
ely
USD 98m, which is expected to fund
Hans
a
’
s oper
ations into 2023.
Ou
r k
ey n
anc
ial pr
ior
itie
s over the c
omin
g year
s will b
e
foc
used o
n ensu
rin
g a
su
cce
ssf
ul Europ
ean l
aunc
h of Ider
ix
®
,
wh
ile ta
rgetin
g mid-ter
m prod
uct pro
tab
ilit
y
. In tan
dem, we
exp
ect to mai
ntai
n invest
ments to f
ur
ther st
reng
then o
ur
position
in kidney
transplantat
ion thr
ough the
completion
of
en
rollm
ent in o
ur U.S. Conf
Ide
S study. In add
ition, H
ans
a will
continue t
o maintain
its focus
on advancing
its ongoing clinical
pro
gram
s in AMR a
nd rar
e autoim
mun
e dise
ase
s throu
gh to
regulat
or
y
approv
al.
Lastly
, the Compan
y will cont
inue t
o support promising
partnership structur
es, such
as tho
se already
established with
Sa
repta, M
edis
on, arg
enx a
nd Ask
Bio, in a
reas su
ch as g
ene
therapy
, transplanta
tion,
oncology
, and ot
her stra
tegic
therapeutic
areas.
Building upon
the nancing
mandate
approved
by
the last
AGM
in M
ay 202
1
, we h
ave als
o star
ted to eva
luate opt
ions to se
cure
na
nci
ng Han
sa’
s o
pera
tions b
eyond 2023.
Hansa Biopharma
Annual Report 202
1
17
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Our En
viron
mental, So
cial and
Go
v
er
nanc
e (ESG) st
ra
tegy
Our approa
ch to
sustainability
By dev
eloping and delivering life-alt
ering treatment
s for
those
with r
are immunological
conditions
, Hansa posit
ions
sus
tain
abi
lit
y at the co
re of its bu
sin
ess a
nd stri
ves to cre
ate
val
ue to soc
iety a
t larg
e. Stake
hold
ers s
uch a
s empl
oyees
,
healthcare
professionals
, pat
ient adv
ocacy gr
oups and
inve
stors hav
e high a
nd ever
-r
isi
ng expe
ctati
ons for h
ow
pharmaceutical companies should int
egrate
and work wit
h
environmen
tal, s
ocial and go
vernance issues
. Therefor
e,
we
be
lieve i
t is es
senti
al to form
alize o
ur ap
proac
h to susta
ina
bili
ty
and communicat
e our work
and progress t
o our
stakeholders.
Du
ring 20
2
1
, we h
ave emba
rked o
n this j
ourn
ey
. We have
id
enti
ed the a
reas m
ost cr
ucia
l to our sta
keho
lder
s and
aligned with
the U
N Sustainable
Development
Goals t
o ident
if
y
which act
ions are
needed to
address
toda
y’
s challenges, and
tho
se we wil
l face i
n the fu
ture. Ou
r patie
nt
-
centr
ic ap
proac
h
aims t
o mak
e new
, lifesa
ving and l
ife-altering
medicines
avai
labl
e to those w
ho ne
ed the
m most, w
hile we m
inim
ize
our i
mpac
t on the e
nviro
nme
nt as we grow. Base
d on ou
r
mate
rial
it
y anal
ysis, s
usta
inab
ili
ty str
ategy
, an
d now our r
st
sus
tain
abi
lit
y repo
rt, we w
ill co
ntinu
e to evolve, mo
nitor
, an
d
rep
or
t on ou
r progr
ess.
Material aspects
and stak
eholder dialo
gue
Material aspects
Ha
nsa ca
rri
ed ou
t a mater
iali
ty a
naly
sis in 20
2
1 to ide
ntif
y the
ke
y sustainabil
ity priorities which need
to
be addressed
.
In-
depth i
nter
vie
ws with key re
pre
sent
atives f
rom Ha
nsa’
s
stakeholders w
ere carried out,
addressing sustainability within
the pharma
ceutical indust
r
y
, po
tential
opportunities and
ch
alle
nge
s for Ha
nsa an
d our im
pact o
n this a
rea.
Ou
r stake
hold
ers c
lari
ed th
eir ex
pec
tatio
ns for Ha
nsa’
s
sustainability initiatives
, including which
areas are the
most mater
ially re
levant.
By analyzing this f
eedback and sustainability trends
and issues
wi
thin ou
r indu
str
y
, we id
enti
ed th
e most i
mpor
ta
nt are
as for
Han
sa’
s foc
us, goin
g for
ward.
Social
Foundations
Environment
Economy
Third
p
arty
risk
Acc
ess
to
medicines
Health equity
& un
met
needs
Safety
,
ecacy
& et
hic
s
Environmental
footpr
int
Employ
ee
wellbeing,
diversity &
inclusion
Pricing
Retu
rn
to
inve
stor
s
Hansa’
s hi
gh-priorit
y
areas within sustainability
Hansa Biopharma
Annual Report 202
1
18
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Hansa’
s stakeholders and stak
eholder dialogue
Among Hansa
’
s stak
eholders are our emplo
yees, in
vestors,
pati
ents a
nd pati
ent ad
vocac
y group
s, gover
nme
nt age
ncie
s,
exp
er
ts in pha
rma
ceu
tica
l susta
ina
bili
ty an
d the in
dustr
y
, as
well
as healthcare
prof
essionals at
specialised transplan
tation
cli
nic
s and the s
cie
ntic c
ommm
unit
y at la
rge.
In add
ition t
o the
stakeholder
dialogue undertaken in
conjunction
with t
he mat
eriality analysis and
this r
epor
ti
ng
cycle
, Hansa engages with
its stak
eholders throughout the
year thr
ough formal and
informal meetings
and contact poin
ts.
Th
is inc
lude
s in-
depth d
ialo
gue
s with th
e lea
ding ~4
0-6
0
tra
nspl
ant ce
nters i
n Europ
e, and gl
obal
ly
, thro
ugh
collaboration
s with
patient
organization
s and adv
ocacy gr
oups
in k
ey Eur
opean countries, and
by serving our inv
estor
co
mmun
ity i
n approx
imate
ly 1
50 mee
tings a
nd inve
stor even
ts.
Additionally
, we conduct
a yearly survey among
our employees
to mea
sure wo
rkp
lace ex
per
ien
ce and s
atisf
actio
n.
Sustainabili
t
y
strategy
In 2021
, H
ansa fo
rma
lized i
ts sus
tain
abil
it
y appro
ach by
deve
lop
ing a str
ategy b
ased o
n a mater
iali
ty a
nal
ysis. T
he
stra
tegy is d
esi
gne
d t
o co
ntri
bute to Han
sa’
s v
isi
on – a wor
ld
where all
patien
ts with
rare i
mmunologic diseases
can lead long
an
d heal
thy liv
es. Th
is doe
s als
o unde
rpi
n Hans
a
’s busin
ess
Company
vision
ESG priorities
Focus
areas
strategy
, guid
e prior
ities an
d
ini
tiatives, fur
the
r strengthe
n our
co
mmitm
ent to patie
nts and m
eet sta
kehol
der exp
ect
ation
s.
The strat
egy is comprised o
f three
pillars encompassing our
ma
in pri
ori
ties: pati
ent c
entri
cit
y – we cal
l it
Healthy
patients,
responsible
business – w
e call it
Healthy
business
, and
env
iron
ment
al protec
tion – we c
all i
t
Health
y planet
.
Go
ing for
wa
rd, Hans
a pla
ns to fur
the
r sol
idif
y th
is strate
gy by
setting target
s and contin
uously providing
progress updat
es in
each annual
report.
Healthy
patients
We want to ma
ke new
, li
fe
changing trea
tments a
vailable
to thos
e who n
eed th
em mos
t
Healthy
business
We
conduct our business
responsibly throughout
our
entire
value chain
Healthy
planet
We
minimize our
impact
on the
environmen
t
>
Unmet
medical needs
>
Patie
nt safe
ty
>
Patie
nt acc
ess
>
Health equity
>
Et
hical business
>
Happy
and skilled people
>
Impact
on the
environment
A wor
ld whe
re all
pat
ient
s with r
are
immunologic diseases
ca
n lead l
ong an
d
healthy liv
es
Our En
vironmental, So
cial and Go
vernance
(ESG) st
rateg
y
con
ti
nued
Hansa Biopharma
Annual Report 202
1
19
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
Contribution to the UN
Sust
ainable De
velopment
Goals (SDGs)
Hansa supports t
he SDGs,
which call
for concr
ete
actions
to ach
ieve a bet
ter an
d more s
usta
inab
le fu
ture for a
ll. Ou
r
stra
tegy is a
lig
ned wi
th the SD
Gs, an
d incl
ude
s key goal
s
an
d targ
ets to whic
h Han
sa is ab
le to con
tribu
te.
Sustainabili
t
y
Go
vernance
The governance st
ructure surrounding
Hansa’
s sustainability
work ensures
that sustainability is
fully integra
ted int
o its
bus
ine
ss mo
del an
d ope
ratio
ns. Th
e Boar
d of Dire
ctors
ap
proves th
e overa
ll bus
ines
s strate
gy an
d Comp
any po
lici
es
– suc
h as the C
ode of Co
nduc
t – and id
enti
es how
sustainability issues impact Hansa
’
s business. In 2
02
1
, the
Board also appro
ved Hansa
’
s sustainability strat
egy
. The
execu
tive ma
nag
emen
t team, le
d by the Chi
ef Exe
cuti
ve
O
cer
, is ul
timate
ly res
pon
sibl
e for its im
ple
ment
ation i
nclu
ding
target
-setting
and investmen
t in the
initiatives
and activities
associat
ed with
achieving t
his str
ategy
.
Our En
vironmental, So
cial and Go
vernance
(ESG) st
rateg
y
con
ti
nued
Hansa Biopharma
Annual Report 202
1
20
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Strategy
M
a
r
k
e
t
Helping highly sensitiz
ed patients who
ca
nnot ac
cess a k
idn
ey
22
Con
diti
onal a
ppr
ov
a
l in Euro
pe for Id
er
ix
®
in highly sensitiz
ed kidney transplant patients
25
Hig
hly foc
use
d and se
que
nced l
aunch s
tra
tegy
26
Our center
focused and sequenced
launch process
27
Ongoing market
access processes
28
European guidelines for
the management of
kidney transplant patients with
HL
A antibodies
29
Medison Pharma-par
tnership expands access
to Ide
ri
x
®
31
21
Hansa Biopharma
Annual Report 202
1
3
Hansa Biopharma
Annual Report 202
1
21
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
≥90%
Ki
dney d
ama
ge wi
th
normal
kidney function
89% to 60%
Ki
dney d
ama
ge wi
th
mild
loss
of kidney
function
59% to 45%
Mi
ld to
moderate
loss of
kidney function
44% to 30%
Moderate
to se
vere
loss
of kidney
function
29% to 15%
Seve
re
loss
of kidney
function
<15%
Kidney failure
End Stage
Renal Dise
ase
ESR
D occu
rs wh
en th
e kid
neys h
ave rea
che
d the la
st sta
ges of
CK
D
, wh
ere th
ey los
e ≥85% of thei
r nor
mal f
unc
tion a
nd are u
nab
le
to fu
ncti
on on th
eir o
wn.
Helping highly sensitized p
ati
ents
who can
no
t access a k
idney
An introduction
to chronic
kidney
disease (
CKD)
Chronic kidney
disease is a pr
ogressive disorder
characterized
by the g
radua
l los
s of kid
ney fu
ncti
on over ti
me. As CK
D
wor
sens, i
t can p
rogre
ss to ki
dney fa
ilur
e, also ref
erre
d to as
en
d stage r
enal d
isea
se, or ESR
D
, whi
ch is th
e nal a
nd most
critical st
age of
CKD
, where
the kidney
s can no
longer function
wi
thout s
uppo
r
t
. ESR
D is a sig
nic
ant gl
obal h
eal
th burd
en,
wi
th almo
st 2.5 milli
on pati
ents tr
eated fo
r the di
seas
e glob
all
y
,
inc
lud
ing 7
1
0,00
0 patie
nts in th
e U
.S., 5
70,
0
00 pat
ients i
n
Euro
pe, 328,000 p
atien
ts in Jap
an an
d 1
8
0
,00
0 pati
ents i
n
Bra
zil
4
.
Peo
ple wh
o prog
ress to ESR
D will r
equi
re rena
l repl
ace
ment
therapy
, which in
volves eit
her dialysis
or kidney t
ransplantat
ion.
Patie
nts de
pen
dent o
n dial
ysis n
eed fo
ur to six ho
urs of
tre
atment t
hree to fou
r time
s per we
ek, w
hich, fo
r most
pati
ents, re
sult
s in sig
nic
antl
y impa
ired qu
ali
ty of li
fe.
Long-
term
dialysis is
also associat
ed with
cardiov
ascular
co
mpli
catio
ns an
d prema
ture de
ath. Acc
ordin
g to the Uni
ted
Sta
tes Ren
al Dat
a Syste
m, in 20
1
6, the a
djus
ted mor
ta
lit
y
rate
s per 1
,00
0 patie
nt
-yea
rs were 164 for d
ialy
sis pat
ients,
an
d 29 for tra
nspl
ant pat
ients
5
. Kidney
transplanta
tion
repre
sents a life-s
aving treatme
nt for patients wit
h
ESRD
wh
ich, in m
ost ca
ses, e
nabl
es pat
ients to ret
urn to a no
rmal
li
fe at a sign
ic
antly l
ower co
st.
4
https:/
/w
ww.
kid
ney
.org/
5
Un
ited S
tates R
ena
l Data S
yste
m, 201
8 USR
DS An
nua
l Data
Re
por
t, Volu
me 2: ESRD i
n the Un
ited S
tate
s (p. 4
1
1)
. Ava
ilab
le at:
https:/
/ww
w
.usr
ds.org/
media
/
1
730/v2_c05_mor
tality
_
1
8_usrds.pdf
Th
e 5 st
ages o
f CKD
Based on an individual’
s eGFR [mL/min/1.73m
2
])
Bet
ter
outcomes for
transplantation patients
8
-year
survival
1
77%
4
4%
5
-yea
r cos
t
2,3
USD
1
80-
200k
5
USD 450-50
0k
Employment
4
6
1%
18%
T
ransplantation
Dialysis
1
Or
and
i
et al. N Eng
l
J Me
d
201
6:37
4:940
-50
2
ww
w
.usrds.org
3
Sh
ehat
a et al, T
ran
sfu
s Med Re
v
201
, 24
Su
ppl 1
: S7
-
S27
4
Ja
rl et al. T
ra
nsp
lant
atio
n, 201
8, 1
02:
13
75-
1
381
5
Co
st of Ki
dne
y tran
spl
anta
tion a
nd 5 ye
ars of i
mmun
o-s
upp
ress
ion t
reat
ment
Hansa Biopharma
Annual Report 202
1
22
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
The kidne
y transplantation landscape
Acc
ordi
ng to the Un
ited Net
wor
k for Org
an Sh
arin
g, ther
e are
ap
proxim
ately 10
7
,00
0 patie
nts wai
ting for a
n orga
n trans
pla
nt
in the U.S.
,
ap
proxi
mately 90,0
00 of
wh
ich are wait
ing for a
kidney transplant
6
. Wi
thin the E
U
, app
roxim
ately 80,0
00
pati
ents a
re waiti
ng for a k
idn
ey trans
pla
nt
7
. Bet
wee
n 1
0% a
nd
1
5
% of pat
ients wa
itin
g for ki
dney tr
ansp
lant
s are hi
ghly
se
nsiti
zed aga
inst p
otenti
al don
or tis
sue
s
8
. Y
e
arl
y
, 3% to 4
%
of pati
ents wa
itin
g for a tra
nspl
ant di
e before t
hey are a
ble to
receive
a t
ransplant
9
.
Gl
obal
ly
, app
roximate
ly 1
00,0
00 ki
dney tr
ansp
lant
s were
pe
rfo
rme
d in 201
9, wi
th 63% of kid
neys re
cei
ved fr
om
deceased donors
10
. In 2020, tra
nsp
lanta
tion a
nd org
an
do
natio
n rates exp
eri
enc
ed a sha
rp dro
p due to the Cov
id-
19
pandemic.
In E
urope,
the n
umber of
kidney tr
ansplantation
s fell
fro
m 28,
0
00 in 201
9 to app
roximate
ly 22,000. T
ran
spl
antati
ons
fro
m dec
eas
ed don
ors we
re down by 19% from th
e previ
ous
yea
r
, wh
ile li
vin
g dono
r tran
spla
ntati
ons fe
ll by 25
% vers
us
the ye
ar bef
ore
11
.
In th
e U
.S., dec
ease
d don
or tran
spl
antati
ons ro
se to an all
-time
rec
ord in 2020, w
ith 1
8,4
1
0 k
idney t
rans
plan
tatio
ns car
rie
d out,
despite
an initial
dip in
organ dona
tion when t
he pandemic
brok
e out
12
. Mu
ch of the in
crea
se in d
ece
ased d
ono
r
transplant
ations i
n the U
.S. w
as made
possible as
donors
represent
ing less t
raditional
medical criteria
were
accepted
for donat
ion, including
those from
a higher age gr
oup than
previously included and
individuals who died o
f
card
iorespi
ratory fa
ilure.
Th
at sai
d, livi
ng do
nor tra
nspl
anta
tions s
till dr
oppe
d by 2
4
%
in 2020 c
ompa
red to 201
9, pre
dom
inan
tly du
e t
o mo
re
res
tric
tive proto
cols a
mon
g reci
pien
ts and d
onor
s, as wel
l as
priorities and resources
at the
hospitals treating
Covid-
1
9
related pati
ents
13
.
Se
nsiti
zed pati
ents re
pre
sent m
ore tha
n one
-
thi
rd of thos
e
waiting
for
kidney tran
splantation
14
. Th
is grou
p of patie
nts are
se
nsiti
zed aga
inst pote
ntia
l
do
nor ti
ssue
s due to pri
or expo
sure
to fore
ign an
tige
ns dur
ing p
regn
ancy
, af
ter bl
ood tr
ansf
usi
ons,
fro
m previ
ous o
rgan tr
ansp
lant
ation
s, or
, i
n rare c
ase
s,
infe
ctio
ns. Th
e pres
enc
e of DSA is e
ithe
r an ab
solu
te or rela
tive
contraind
ication,
depending on
the br
eadth and
strength
of
the
ant
ibod
y resp
onse. Fo
r patie
nts wi
th a wid
e rang
e of anti-
HL
A
ant
ibod
ies, it i
s extre
mel
y di
cult to n
d a comp
atibl
e dono
r
.
Wh
ile rec
ent mo
di
catio
ns to the K
idney A
llo
catio
n Syste
m in
the U.S. have i
ncre
ase
d the num
ber of o
rgan
s availa
ble fo
r
hi
ghly s
ensi
tized p
atien
ts, ther
e rema
ins a la
rge po
ol of hig
hly
se
nsiti
zed pati
ents u
nlikel
y to ever rec
eive a
n orga
n oer an
d
wh
o
, the
refore, re
mai
n at ris
k, not on
ly for wa
itlis
t remova
l, but
al
so dea
th on dia
lys
is. For th
ese pa
tient
s, acce
ss to
tra
nspl
antat
ion is a s
igni
ca
nt unme
t medi
cal n
eed a
nd
iml
id
ase ha
s the poten
tial to me
et this n
eed v
ia a
sta
nda
rdized, e
ecti
ve, and pre
dic
tabl
e inac
tivatio
n of HL
A
antibodies
within t
he time
constrain
ts inheren
t in or
gan
allocation
and deceased donor
transplanta
tion.
Helping highly sensitized patients
who ca
nnot acces
s a kidn
e
y
cont
inued
T
otal number
of patients
waitlisted
1
7
0
,
000
ACROSS U
.S./EU
T
ra
ns
pla
nt
s per
f
orm
ed g
lob
all
y in 2
019
~
1
00 ,
000
63% OF K
IDN
EYS FR
OM DEC
EAS
ED DON
ORS
Highly sensitized
patients a
waiting kidne
y transplant
1
0
-1
5
%
6
United
Network for
Organ Sharing
7
New
sle
tter Trans
pla
nt 2021
. pg 62-
64. Avai
lab
le at: ht
tps://w
ww.edq
m.eu/
en/news/
newsletter
-transplant
-202
1
-now-av
ailable
8
EDQ
M. (2020). In
tern
atio
nal 
gure
s on d
onati
on an
d T
ran
spl
anta
tion 2
0
19
and SRTR
Database and individual assessments
of allocation
systems
9
https:/
/w
ww.
kid
ney
.org/
10
https:/
/w
ww.
kid
ney
.org/
11
Gl
oba
l Obe
ser
vato
ry o
n Don
atio
n and Trans
pla
ntat
ion. Ava
ila
ble at:
http:/
/ww
w
.transpla
nt
-obse
rvator
y
.org/data-ch
arts-an
d-
tab
les/
12
Gl
oba
l Obe
ser
vato
ry o
n Don
atio
n and Trans
pla
ntat
ion. Ava
ila
ble at:
http:/
/ww
w
.transpla
nt
-obse
rvator
y
.org/data-ch
arts-an
d-
tab
les/
13
Gl
oba
l Obe
ser
vato
ry o
n Don
atio
n and Trans
pla
ntat
ion. Ava
ila
ble at:
http:/
/ww
w
.transpla
nt
-obse
rvator
y
.org/data-ch
arts-an
d-
tab
les/
14
EDQ
M. (2020). In
tern
atio
nal 
gure
s on d
onati
on an
d T
ran
spl
anta
tion 2
0
19
Hansa Biopharma
Annual Report 202
1
23
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
2
02
0
2
0
19
2
018
2
0
17
5,234
18,410
6,867
17,406
6,442
15,561
5,811
14,827
5,629
14,229
2
0
16
23
,64
4
24,
273
22
,00
3
20,
638
19,858
3%
*
1
0%
7%
4
%
7%
5Y avg 22,083
Up to 1
5% of the pat
ient
s waiti
ng for a new k
idne
y are hi
ghly s
ensi
tized
~50
,00
0 tra
nspl
ants a
re do
ne ann
uall
y acro
ss the U.
S. an
d Europ
e
Helping highly sensitized patients
who ca
nnot acces
s a kidn
e
y
cont
inued
The kidne
y transplantation landscape
in Europe
and the U
.S.
Breakd
own o
f the kidne
y transplant w
aitlist in
U.S. and
EU
U.S.
annual kidney
transplants
To
t
a
l
5Y avg 2
2
,08
3
5Y avg 26,
27
5
To
t
a
l
YoY
YoY
Europe annual
kidney
transplants
So
urce: T
he U.S. De
par
tm
ent of H
eal
th and H
uma
n Ser
vi
ce
s and .i
rodat.o
rg
So
urce: G
lob
al Obs
er
vato
ry o
n Don
atio
n and T
ra
nsp
lan
tatio
n,
http:/
/ww
w
.transpla
nt
-obse
rvator
y
.org/
~
1
70,00
0 kidne
y patients
waiting for a transplant
~50,00
0 sensitiz
ed patients
(cPRA a
bo
ve 20%
)
~25,000 highly sensitiz
ed patients
(cPR
A above 8
0
%
)
5,824
15,999
7,766
20,287
7,820
20,097
7,565
19,510
7,524
18,979
2
02
0
2
0
19
2
018
2
0
17
2
0
16
21
,
826
5Y avg 26,275
28
,
05
3
27
,
91
7
27
,075
26
,50
3
22%
*
1
%
3%
2%
3%
Deceased Donor
T
ransplants
Living Donor T
ransplants
Hansa Biopharma
Annual Report 202
1
24
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
*
Rep
or
ted to be i
mpa
cted by th
e COVI
D-
1
9 pa
nde
mic
Condit
i
onal ap
pro
v
al in E
urop
e
* for
Ider
ix
®
in hig
hly sensitized kidne
y t
ransplant patients
Th
e devel
opm
ent of iml
ida
se for k
idne
y
transplant
ation is
supported b
y two
complet
ed phase 1
studies
in health
y
subjects,
three complet
ed phase 2 s
tudies
in k
idne
y patie
nts and o
ne inve
stig
ator
-
initiat
ed st
udy also in
kidney t
ransplant
pati
ents. I
n t
ota
l, 35 hea
lthy su
bje
cts have
be
en exp
osed to im
lid
ase an
d 46 pati
ents
have be
en tra
nsp
lante
d afte
r imli
das
e
tre
atment. Po
st
-h
oc ana
lyse
s of the da
ta
po
oled f
rom al
l stud
ies sh
owed tha
t 43 out
of a total of 4
6 patie
nts had a f
uncti
oni
ng
ki
dney si
x mont
hs af
ter tran
spl
antati
on.
On th
e bas
is of the
se stud
ies, i
n Augus
t
2020, the Eu
rope
an Com
mis
sion g
rante
d
a condit
ional appro
val in
the E
uropean
Uni
on for Id
er
ix
®
(imlidase)
, representing
the 
rst co
ndit
iona
lly ap
proved t
reatme
nt
for ad
ult pa
tient
s waiti
ng for a k
idney
tra
nspl
ant wh
o are hi
ghly s
ens
itize
d
aga
inst t
issu
e from th
e don
or and w
ho
have a p
ositi
ve cros
smatc
h t
e
st aga
inst a
n
avai
lable kidney
from a deceased
donor
.
A pos
t appr
oval stud
y in app
roxim
ately
50 hi
ghly s
ens
itize
d patie
nts in Euro
pe
is ex
pecte
d to
be i
niti
ated in 2022 in
parallel wit
h the
commercial launch
an
d will b
e key in integ
ratin
g the
co
mmerc
ial a
nd sci
enti
c app
roach
an
d t
o bro
ade
ning th
e clin
ica
l
experience wit
h imlidase
.
Iderix
®
label
Low c
ompl
exit
y tra
nsp
lant
s
Hi
gh com
plex
it
y tran
spl
ants
~70%
1,
2
No
n or le
ss
sensitized
(cPR
A < 20%)
15-20%
1,
2
Moderately
sensitized
(20% < cPR
A < 80%)
10-15%
1,
2
Highly
sensitized
(cPR
A > 80%)
Highly sensitiz
ed
patients unli
kely t
o
be transplanted
under av
ailable
K
AS,
including
prioritizat
ion
programs
Highly sensitiz
ed
patients that are
like
ly to be
trans
planted with a
compatible donor
Iderix
®
label
Desensitization trea
tment of
highly sensitized
adult
kidney t
ransplant pa
tients wit
h positiv
e crossmat
ch
ag
ains
t an ava
ilab
le de
ce
ased d
ono
r
. T
he us
e of
Iderix
®
sh
ould b
e res
er
ved fo
r pati
ents u
nlike
ly to be
transplant
ed under t
he av
ailable kidney
allocation
syst
em including prioritizat
ion programs
for highly
sensitized patient
s.
Potential Patients
1
EDQM. (2020). International gures on donation and T
ransplantation 2019
2
SRTR Database and individual assessments of allocation systems
Stock image
Hansa Biopharma
Annual Report 202
1
25
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
FDA ap
proval. Lo
nge
r t
e
rm it is t
he Com
pany’s intenti
on to
poten
tial
ly expa
nd the l
abe
l into new are
as su
ch as AM
R post
kidney t
ransplantat
ion, living
donor t
ransplantation
, as
well as
hear
t
and lung
pre- and
post
-t
ransplantat
ion.
Operationally
, we measure
our launch pr
ogress using a se
t of
ke
y commercializa
tion met
rics, which
directly
impact fut
ure
ado
ption a
nd sal
es of Id
eri
x
®
as a n
ew tran
sform
ative th
erapy.
Those metrics
include:
>
Pricing and r
eimbursement agreements
>
Market
access procedures
(HT
A processes)
>
Clinical and
commercial r
eadiness
>
Increasing aw
areness
During 202
1
, Hansa
secured positive
pricing and
reimbursement
decisions in
Sweden and
the Net
herlands, as
wel
l as on a ho
spi
tal ba
sis in F
inla
nd an
d Gree
ce. In ad
diti
on
pricing and reimbursement w
as obtained
in France
(early
acc
ess) a
nd Ger
many d
urin
g the r
st qua
rte
r 2022
. Ma
rket
Access procedures ar
e ongoing in 1
0 countries including
HT
A
dos
sie
rs in U.K., Ital
y and Sp
ain. Th
e ve la
rges
t market
s
rep
rese
nt a total of 1
5,00
0 kid
ney tra
nspl
anta
tions, a
nnu
ally
15
.
In De
ce
mber 20
2
1
, H
ansa a
nno
unce
d a new
, mu
ltire
gio
nal
commercializat
ion partnership with
Medison Pharma
for
Iderix
®
in Is
rael a
nd se
lec
t Centr
al Ea
stern Eu
rope
an cou
ntri
es
including Croa
tia, Hungary
, P
oland and Slov
enia. Medison is a
recognized in
ternational pharmaceutical compan
y focused on
prov
idin
g acce
ss to hi
ghly i
nnovati
ve the
rapi
es to pati
ents in
int
ernational mark
ets
. This commer
cial partnership repr
esents
an i
mpor
ta
nt mil
eston
e for Han
sa an
d will p
rovid
e acce
ss to
Iderix
®
in n
ew mar
kets beyon
d the ea
rly l
aunc
h cou
ntrie
s.
Ha
nsa an
d Med
ison w
ill be wo
rki
ng toge
ther to obt
ain p
rici
ng
and reimbursement as
required,
depending on the coun
tr
y
.
On th
e clin
ica
l sid
e
, Ha
nsa c
ontin
ues to wor
k with a n
umb
er of
pr
ior
ity c
enter
s to ensu
re and o
ptimize c
lini
cal re
adin
ess, a
s
inc
omp
atibl
e patie
nts are be
ing id
enti
ed a
nd pri
ori
tized fo
r
ki
dney tr
ansp
lant
s. End of De
cem
ber
, 2021
, 1
0 cl
inic
al ce
nters
have qu
ali
ed as c
lini
cal
ly read
y to take on hi
ghl
y sens
itize
d
patients
for incompat
ible kidney tr
ansplant and we
continue t
o
work clo
sely with a
dditional cen
ters acr
oss Eu
rope on
their
preparedness through
training,
Key
Opinion Leader (K
OL)
engagement and logis
tics.
As far a
s
awar
ene
ss is conc
er
ned, Han
sa has exp
eri
ence
d
ex
tensi
ve intere
st and eng
age
ment, wit
h
mo
re than 30 exp
er
ts in
kidney t
ransplantat
ion who ar
e committed
to
operationalizi
ng
HL
A
-incompatible kidney
transplants
in highly sensitized
pati
ents. T
he grow
ing le
vel of inte
rest f
rom KOLs wa
s also
exemp
li
ed at the Ide
rix
®
launch s
ymposium sponsor
ed in June
2021 with at
tend
anc
e from m
ore tha
n 1
20 tr
ansp
lant p
hysic
ian
s
rep
rese
nting 8
0 cli
nica
l cen
t
e
rs in Euro
pe fro
m 1
3 c
ountr
ies
.
In add
ition t
o the
launch e
vent
, Hansa also
sponsored
a
wel
l-at
t
e
nded s
ympo
sium t
itle
d, “
A Roa
dmap to T
ran
spla
nt for
the H
ighl
y Sen
sitize
d Patie
nts” at the Eu
rope
an Soc
iet
y for
Organ T
ransplantation
Congress (E
SO
T
)
, which was
held in
Mil
an, Ita
ly in Au
gust 20
2
1
. B
eyond th
e symp
osiu
m Hans
a
hosted
more than
30 K
OL meetings
with our combined
co
mmerc
ial a
nd me
dica
l team
s
; an
d had t
wo oral
pre
sent
ation
s in sup
por
t of Ide
rix
®
.
On
e of the key ou
tcome
s from ESOT wa
s the for
matio
n of a
new wo
rkstr
eam w
ith le
ading t
rans
pla
ntatio
n K
OL
s to advan
ce
clinical guidelines t
o include incompatible
kidney transplant
pati
ents. T
he new ESOT gu
ide
line i
s expec
ted to be a key
dr
iver fo
r har
moni
zatio
n in the a
pproa
ch to tran
spl
antin
g high
ly
se
nsiti
zed pati
ents. T
he rs
t phas
e of the gui
del
ine is a
ime
d at
prov
idin
g an evi
den
ce revi
ew of the l
iteratu
re, with c
lea
rly
ar
tic
ulate
d reco
mme
ndati
ons an
d statem
ents of th
e iss
ues fo
r
incompatible kidney
transplant pa
tients.
The second phase will
foc
us on use a
nd pati
ent ou
tcome
s, as the ex
per
ien
ce with
iml
id
ase grow
s withi
n the tra
nspl
ant co
mmun
ity.
Ha
nsa’
s goa
l in ki
dney tra
nsp
lant
ation i
s to have a pos
itive
imp
act on p
atie
nts as we wor
k clo
sely w
ith th
e trans
pla
nt
co
mmun
ity to re
sha
pe the a
rea of de
sen
sitiz
atio
n and in
t
e
grate
Iderix
®
into cl
inic
al pr
actic
e as a new s
tand
ard-
of
-c
are.
Iderix
®
is th
e rst a
nd onl
y treatm
ent ap
proved i
n Europe fo
r
des
ensitiz
ation treatme
nt of
hig
hly sens
itized patients. T
he
intr
oduc
tion of th
is poten
tial tr
ansfo
rmati
ve dru
g is vi
ewed by
ma
ny lead
ing exp
er
ts, cli
nici
ans a
nd thos
e in the paye
r
co
mmun
ity a
s ena
blin
g a para
digm s
hif
t towards e
qui
ty of
acc
ess f
or hig
hly se
nsi
tized pa
tient
s t
o pote
ntia
lly li
fesav
ing
and life
altering kidney t
ransplants.
At tra
nspl
antat
ion ce
nters, p
roce
dure
s are ma
nage
d by a
highly specializ
ed t
eam of
clinicians includ
ing nephrologist
s,
transplant surgeons,
immunologists, tissue typists,
transplant
co
ordin
ators a
nd nur
se pra
ctiti
oner
s, as wel
l as po
ssib
ly othe
r
specialty physicians
such as
psychologis
ts, car
diologists
and
ne
urolo
gist
s, who al
l work ti
ghtl
y togeth
er befo
re, duri
ng an
d
after a
transplanta
tion.
As pa
r
t of its lau
nch s
trateg
y
, Ha
nsa w
ill in
itial
ly be fo
cuse
d on
ta
rgetin
g lead
ing c
enter
s with th
e potenti
al to be
come e
arl
y
ado
pters a
nd cen
t
e
rs of excel
lenc
e. The l
ong-ter
m mar
ket
upta
ke of this i
nnovati
on is hi
ghl
y dep
ende
nt on su
cce
ssf
ul
ea
rly ex
per
ienc
es in key e
arl
y adopte
r center
s. It is cr
itic
al for a
suc
ces
sfu
l laun
ch of Ide
rix
®
, that p
osi
tive ou
t
co
mes a
re
ge
nera
ted in the 
rst pati
ents a
nd for cl
inic
al ce
nters to bu
ild
the fo
unda
tion ne
ces
sar
y fo
r expan
ded u
se of Ide
rix
®
as a
pot
ential ne
w Gold St
andard in
desensitization
prot
ocols.
Ou
r antic
ipated “
S”
-sha
ped l
aunc
h cur
ve re
ects th
is car
eful
approach
in the
initial y
ears of
commercializat
ion, u
ntil mor
e
exp
one
ntial g
rowth o
ccur
s, whi
ch is an
ticip
ated mid
-t
er
m, as
Ha
nsa exp
ands b
eyond th
e rst wave of e
arl
y-lau
nch
co
untri
es, leve
rage t
he ful
l potenti
al in the 
ve larg
est Eu
rope
an
ma
rkets as we
ll as a
ntici
pate lau
nchi
ng in th
e U
.S. fol
lowi
ng
High
ly fo
cused and sequenced
lau
nch s
tr
ateg
y
Our European launch str
at
egy
15
Gl
oba
l Obe
ser
vato
ry o
n Don
atio
n and Trans
pla
ntat
ion. Ava
ila
ble at: h
ttp://ww
w.tran
spla
nt-ob
ser
vato
ry.org
/
da
ta-c
har
ts-
and
-tabl
es/
26
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
Hansa Biopharma
Annual Report 202
1
Initial years of
commercialization
Illus
trative
Mi
d term
Longer term
1.
Bu
ild t
he fou
nd
ati
on for I
de
ri
x
®
in E
U to
be
com
e a new St
an
dar
d of Ca
re
>
Commercialize in
early-launch count
ries focusing on leading
cli
nic
s and e
arl
y adopte
rs
>
Secure Pricing
and Reimbursement agreements
>
Ensure
clinical readiness and K
OL engagement
>
Implement ne
w medical gu
idelines throug
h ESO
T
>
Inc
reas
e aware
nes
s on unm
et nee
d throu
gh KOL
engagemen
t,
pati
ent or
ganizat
ions and
medical
confer
ences
>
Ini
tiate po
st app
roval stu
dy in Eu
rope to su
ppor
t fu
ll
approv
al and
establish long-
term
outcomes
Commercial sales
uptake
2.
Expan
ding
internat
ionally will
lead to
more
accelerated gro
wth mid term
>
Leve
rage ex
per
ien
ce to sca
le Idef
ir
ix
®
in Eur
ope wi
th
ea
rly-l
aunc
h cente
rs an
d in the f
ive la
rges
t mar
kets af
ter
completing mark
et access
>
La
unch i
n the U.S. foll
owin
g comp
letio
n of the Co
nfId
eS
stu
dy and F
DA approva
l
>
E
xpan
d to sele
ct ma
rkets an
d regi
ons b
eyond c
ore
ma
rkets in EU a
nd the U.S. thro
ugh p
ar
tner
ship
s
>
Full
marketing
authorization in
Europe
>
Sup
por
t pati
ent a
nd org
an acc
ess fo
r high
ly
se
nsiti
zed pati
ents
3.
Po
tential label
expansion
will enable
new g
row
th p
ocket
s lon
ger t
er
m
>
Co
mmer
cial
ize in AM
R in ki
dney up
on pote
ntial a
pprova
l
>
Potenti
all
y expan
d into liv
ing d
onor t
rans
plan
tatio
n
>
Potenti
all
y expan
d into othe
r soli
d orga
n
transplant
ations s
uch as heart and
lun
g pre- a
nd po
st
transplant
ation (AM
R)
“Low init
ial upt
ak
e and gr
o
w
th”
Sl
ow grow
th a
nd lum
py sal
es be
twe
en qu
ar
ter
s dur
ing th
e
ini
tia
l laun
ch yea
rs u
ntil e
arl
y pos
itive ex
per
ien
ces a
re
ge
ner
ated fo
r Ide
ri
x
®
to be
com
e a new So
C
“
Accelerated gro
w
th
”
Expanding internationally w
ill lead t
o more
ac
cel
era
ted gr
owt
h mid te
rm
“Grow
th fr
om pur
suing
new oppor
tunities”
Pot
entially enable label
expansions
Our center
-
foc
used and sequenced laun
ch process wi
ll help
build th
e
foundat
ion
for
Id
erix
®
to become a ne
w St
anda
rd
of
Care i
n transplantation
Iderix
®
is th
e rs
t
and only approv
ed treatment in E
urope for desensitization t
reatment of highly sensitiz
ed kidney transplant patients.
The long-term market uptak
e is highly dependent on succe
ssful early experiences in key early adopter centers
Hansa Biopharma
Annual Report 202
1
27
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
EU4+
UK represe
nt ~
1
5,00
0 annual kidney transplants
Pricing and reimbursement obtained in
Germa
n
y
, F
rance, Sweden, Netherlands
as we
ll as Fin
land a
nd Gr
eec
e on a
hospital basis.
Unit
ed Kingdom
3,6
4
9
T
ransplants
1
Germany
2
,1
3
2
T
ransplants
1,
2
Fr
an
c
e
3,6
4
3
T
ransplants
1,
2
Spain
3,
423
T
ransplants
1
Ital
y
2
,1
3
9
T
ransplants
1
Ongoing mark
et
ac
cess pr
oce
sses
1
Annual kidney
transplantat
ions 20
1
9
(pre COVI
D-
19
)
T
ransplantation da
ta is fr
om Global Observat
ory on Donation
and T
ransplantation
, 20
1
9
2
Pr
icin
g and R
eim
bur
sem
ent ob
tain
ed in Fr
anc
e (Ea
rly A
cce
ss) an
d
Ge
rma
ny in Fe
bru
ar
y and M
arc
h 2022
Health T
echnology Assessments (
HT
A)
dossiers
led
Market
ing Aut
horization Applica
tion subm
itted
Pri
cin
g &
re
imbu
rse
ment o
btain
ed
Medison Pharma distribution partnership
Israel
Hansa Biopharma
Annual Report 202
1
28
Strateg
y
T
echnology
Grow
th
The share
Governance
Remuneration
Ove
rv
iew
Directors
’
repo
rt
Financials
ESG
Ma
rke
t
Europea
n guidelines for th
e
manag
ement o
f kidne
y transplant
pat
ients wi
th HL
A ant
ibodies
:
Q.
Th
is ye
ar
, H
ans
a sp
ons
ore
d a new wo
rks
tr
eam
by ES
OT on d
ese
ns
iti
za
tio
n – why i
s th
is wor
kst
re
am
so important
?
A.
Ha
nsa wa
s del
ighted to b
e asked to su
ppo
rt th
e hum
an
le
ukocy
te anti
gen (
HL
A) De
sens
itiz
ation wo
rkstr
eam a
s par
t of
ESO
T’
s education
al T
ransplant
Learning Journey
(
TLJ)
2
.0
se
rie
s, led by T
ran
spla
nt Surg
eon, Pr
ofess
or Niz
am Ma
mode,
an
d supp
or
ted by other l
eadi
ng expe
r
ts. This wo
rki
ng gro
up
foc
used o
n strate
gies fo
r the ma
nag
emen
t of thos
e potenti
al
kidney t
ransplant r
ecipients wit
h HLA sensitizat
ion who ha
ve
antibodies
direct
ed against
poten
tial donor
organs –
termed
do
nor
-sp
eci
c anti
bodi
es (HL
A DS
As)
. Al
thou
gh kid
ney
transplantation
rates
have
increased in many
countries in
recent y
ears, high
ly sensitiz
ed pat
ients typically spend
longer
wai
ting fo
r a trans
pla
nt or may n
ever rec
eive o
ne.
ESOT has a tr
ack rec
ord in c
reatin
g exte
nsive e
duc
ation
al and
training pr
ogrammes, promo
ting changes in E
uropean policy
,
an
d is com
mit
ted to imp
roving t
rans
plan
t patie
nt outc
omes
. At
Ha
nsa, we a
re focu
sed on t
he big
ger p
ictur
e and wa
nt to be
pa
rt of th
e solu
tion a
t many le
vels fo
r high
ly se
nsiti
zed pati
ents.
Q.
What have
been the
insights and
results of
the
ESOT
workstream, so far?
A.
Th
is gui
del
ine rep
rese
nts the r
st inte
rnati
ona
l
co
nse
nsus
on a m
anag
eme
nt pathway fo
r high
ly se
nsiti
zed pati
ents a
nd
ar
tic
ulate
s the var
iabi
lit
y in de
nitio
ns, ap
proac
hes, ou
tcome
s
as we
ll as the p
erce
ived su
cce
ss of HL
Ai T
x. Th
e guid
elin
e is
aimed at
healthcare
professionals
who are
faced wit
h a pa
tient
wi
th HL
A DSA , to prov
ide a roa
dmap r
ega
rding th
e most
ap
propr
iate pat
h t
o ac
hieve a s
ucce
ssf
ul tra
nspl
ant. As th
e
num
ber
s of imli
das
e-e
nabl
ed tra
nspl
ant re
cipi
ents re
main l
ow
,
thi
s guid
eli
ne is an i
mpor
ta
nt mil
eston
e on that j
our
ney to
ach
ievi
ng eq
uita
ble ac
ces
s for the
se di
sadva
ntag
ed pati
ents.
Q.
Regarding the group
of
highly sensitized
kidney
tr
an
sp
lan
t pat
ie
nt
s – why h
ave th
ey en
de
d up as
highly-sensitiz
ed and
how
many are
there?
A.
Hi
ghl
y sens
itize
d patie
nts ca
n be des
cri
bed a
s the mos
t
imm
uno
logi
cal
ly com
plex on th
e trans
pla
nt waiti
ng list
s. Due
the pa
tient’
s pref
ormed HLA antibodies (
HL
A
sensitization
)
through
pregnancy
, transfusions or pre
vious transplants
, these
pati
ents a
re dic
ult to match wi
th a com
patibl
e dec
eas
ed
do
nor an
d,
co
nse
que
ntly
, end u
p waitin
g inde
nite
ly on th
e
transplant
list wit
hout access t
o a
kidney t
ransplantat
ion.
by the E
uropea
n Society for Org
an T
ransplantation (ESOT
) w
orking gr
oup
W
e are f
ocused on t
he bigger
pict
ure an
d wan
t t
o be par
t of t
he
solut
ion at man
y lev
e
ls f
or highly
se
ns
itize
d pati
en
ts.
Vincenz
a
Nigro
VP
, Glo
bal Fra
nchi
se Lead,
Ki
dney tr
anspl
antati
on and He
ad of Med
ica
l Aair
s
ESG
Financials
Governance
Remuneration
Interview
Vincenz
a
Nigro
VP
, Glo
bal Fra
nchi
se Lead,
Ki
dney tr
anspl
antati
on and He
ad of Med
ica
l Aair
s
Hansa Biopharma
Annual Report 202
1
29
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Ove
rv
iew
Ma
rke
t
Hig
hly s
ensi
tized p
atien
ts are gi
ven pr
ior
ity w
ithi
n kid
ney
allocation
syst
ems, b
ut despite
a rise
in transplan
t rat
es,
as m
any as 35% of the m
ost hig
hly s
ensi
tized p
atien
ts
(≥98% cPRA
)
in the EU an
d
th
ose with
in the wit
hin the U.S.
Ki
dney
Allo
cati
on Sy
stems,
with c
PRA
≥ 99.9%, a co
mpati
ble
donor is
rarely found
16
. Although
allocation
syst
ems and
pr
ior
itiza
tion p
rogra
ms have im
proved a
cce
ss to
tra
nspl
antat
ion for h
igh
ly sen
siti
zed ki
dney pa
tient
s, there i
s still
a po
pulati
on of pat
ients t
hat rem
ains u
nde
rser
ve
d and in
urg
ent ne
ed of mo
re optio
ns.
Q.
Wh
at i
s Han
sa’s ro
le i
n adv
anc
ing t
he s
cie
nc
e for
highly sensitized
patients in
kidney transplantation
?
A.
As a
n amb
itio
us glo
bal co
mpa
ny
, we a
re focus
ed on th
e
bi
gger p
ictu
re and wa
nt to be par
t of th
e solu
tion a
t many
levels
. This means
helping pat
ients alon
g their
journey and
en
gagi
ng wit
h heal
thca
re com
muni
ties i
n Europ
e, the U.S. and
gl
obal
ly
. We use thi
s opp
or
tuni
ty to, not onl
y rai
se aware
nes
s
ab
out th
e unmet n
eed
s of the pat
ients we a
im to hel
p but, al
so
to adva
nce the u
nde
rsta
ndin
g of thes
e comp
lex el
ds. Ever
y
pati
ent is u
niqu
e, and th
is is eve
n more tr
ue in ra
re co
nditi
ons.
We have an o
ppor
tu
nit
y to set new S
tand
ards of C
are de
eme
d
imp
oss
ible u
ntil now. Thi
s mea
ns we are a
ble to prov
ide
imp
act
ful c
olla
borat
ions w
ith the sc
ien
tic an
d medi
cal
community
, pat
ient organizations
and research gr
oups, and
use t
he sci
enc
e to shap
e a bet
t
e
r futu
re, have a pos
itive i
mpac
t
an
d create va
lue ac
ross th
e enti
re system. We wan
t to do this
on
e patie
nt at a time.
Ha
nsa’
s role i
s to provid
e the too
ls to supp
or
t spe
cia
list
tra
nspl
ant tea
ms and c
enter
s in ens
uri
ng that Id
eri
x
®
(i
mli
dase) is ava
ila
ble an
d use
d in a safe an
d appr
opri
ate way
for th
ose pati
ents w
ho nee
d it. By le
verag
ing ou
r scie
ntic
exp
er
tise a
nd, as exp
eri
ence w
ith im
lid
ase grow
s in the
ma
rket, we expe
ct it to be
come th
e trus
ted gol
d stan
dard
the
rapy fo
r high
ly se
nsiti
zed pati
ents w
hose o
nly tra
nsp
lant
opti
on is a
n HL
A-inc
ompat
ible k
idn
ey
. W
hat we do h
ere at
Ha
nsa is i
mpac
tfu
l for pati
ents a
nd the tr
ansp
lant c
omm
unit
y
an
d I am ver
y pro
ud to be pa
rt of t
hat.
Vincenz
a
Nigro
VP
, Glo
bal Fra
nchi
se Lead,
Ki
dney tr
anspl
antati
on and He
ad of Med
ica
l Aair
s
European g
uidelines f
or the manage
ment
of kidne
y transplant patients with
HL
A ant
ibodies:
cont
inued
16
Kj
ell
man e
t al. 2021
, AJ
T
Hansa Biopharma
Annual Report 202
1
30
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ove
rv
iew
Ma
rke
t
Q.
In D
ec
emb
er 2
021, Ha
nsa a
nd M
edi
so
n Pha
rma
an
nou
nc
ed a pa
r
tn
er
shi
p – wh
at is t
he p
urp
os
e of
this agreement?
A.
We are ex
trem
ely pl
eas
ed and exci
ted ab
out thi
s new
commercial p
ar
tnership
with Medis
on Pharma.
The partnership
covers
Israel and
the f
ollowing
countries wit
hin Centr
al East
ern
Euro
pe: Polan
d, Croatia
, Hung
ar
y and Sl
oveni
a. The m
ain
obj
ecti
ve is to expa
nd acc
ess to iml
id
ase an
d acce
lera
te
it
s
reach f
or highly
sensitized
patient
s aw
aiting kidne
y transplan
ts
in these coun
tries.
Q.
What is the
situation for
highly sensitiz
ed
kidney transplant
patients in
Central Eastern
Europe
and Israel
?
A.
Th
ere is a
n unmet m
edi
cal ne
ed id
enti
ed in al
l coun
trie
s
cove
red by the M
edis
on Pha
rma ag
reem
ent. Patie
nts su
erin
g
fro
m this ra
re con
diti
on cur
rentl
y face v
er
y lon
g wait ti
mes or
are u
nabl
e to
n
d a suita
ble d
onor m
atch due to hig
h level
s of
pref
ormed antibodies
, elev
ating t
he risk o
f organ
rejection
.
Th
ank
fu
lly
, man
y count
rie
s have rec
ogni
zed the u
nmet n
eed
s
of
patients
with r
are diseases
. The P
olish Health
Authority
, for
exam
ple, ha
s listed i
mli
dase w
ithi
n its new ad
vanc
ed
the
rapi
es pro
gram, w
hich oe
rs a pote
ntial
ly acc
ele
rated
acc
ess p
athway for h
ighl
y inno
vative me
dic
ines
. As Pola
nd is
the l
arge
st ma
rket in th
e regi
on, we are th
rill
ed to wor
k t
owa
rds
exp
andi
ng acc
ess to Poli
sh pati
ents th
rough th
is pathway fo
r
highly innov
ative
therapies.
Q.
How d
o Ha
nsa a
nd M
edi
son P
har
ma wo
rk to
get
he
r?
A.
O
ne of the gr
eat el
eme
nts of the p
ar
tner
shi
p is the tr
ue
collaboration
between our
two companies
and t
eams. The
medical and
commercial organi
zations o
f bo
th companies
are
wor
kin
g hand i
n hand to b
etter s
er
ve pati
ents e
ligi
ble fo
r this
muc
h nee
ded th
erapy. Whil
e Hans
a brin
gs its u
niqu
e exper
ti
se
in a r
st
-i
n-cl
ass im
muno
glo
bulin G (I
gG) ant
ibod
y clea
ving
en
zym
e ther
apy
, Med
ison P
har
ma bri
ngs it
s dee
p know
led
ge
an
d exper
ien
ce in la
unch
ing hi
ghly i
nnovati
ve med
icin
es in
these countries,
well demonstr
ated t
hrough various s
ucces
sful
partnerships with
leading biopharmaceut
ical companies in
Central
Eastern
Europe
and Israel
.
Q.
Is
ra
el is t
he r
st c
ou
ntr
y o
ut
sid
e Eur
op
e to ga
in
ma
rket
in
g aut
hor
iz
at
ion fo
r Id
er
ix
®
– wh
y is th
is
important to
Hansa?
A.
Gi
ven th
at high
ly se
nsit
ized k
idney p
atien
ts are un
ser
ved i
n
the h
eal
th care s
ystem tod
ay
, Ha
nsa i
s stri
ving to g
ain pat
ient
access in k
ey marke
ts thr
oughout the w
orld. With
marketing
aut
hori
zati
on in the EU a
nd UK, Is
rael i
s the rs
t market o
utsi
de
of Euro
pe to give h
ope to tho
se prev
ious
ly un
ser
ved p
atien
ts.
Mediso
n P
harma-par
tner
ship
e
x
pands access to Ideri
x
®
This new commer
cial par
tnership
with Med
ison Ph
arma is an
impor
tant m
ilest
one f
or Hansa as
it e
xpands a
ccess t
o iml
idase f
or
hi
ghl
y s
en
si
tized
patie
nts
aw
a
itin
g
kidney transplant
s.
Pierre-Henri P
atin
Vice President
Commercial Operations
®
Interview
Pierre-Henri P
atin
Vice President
Commercial Operations
Hansa Biopharma
Annual Report 202
1
31
Strateg
y
T
echnology
Grow
th
The share
Ove
rv
iew
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rke
t
T
ec
h
nolog
y
The role of immunoglobulin antibodies
33
Iml
ida
se – a novel a
ppro
ach to el
imina
ting
pat
hoge
nic Ig
G
34
Our unique antibody
cleaving enzyme
tec
hnolo
gy may h
av
e re
levan
ce acr
oss
a ra
nge of i
ndic
ation
s
35
Intellectual propert
y rights
and orphan
dr
ug des
igna
tion
s
37
4
Hansa Biopharma
Annual Report 202
1
32
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
The role of immunoglobulin ant
ibodies
An immune respons
e begins with the recognition of a pathogen
or foreign molecule, follo
wed b
y a reaction to eliminate it
IgM
IgG
IgA
IgE
IgD
0.00
2%
Antibody
of allergy
and ant
i-parasitic
activity
1%
B Ce
ll Rec
eptor
13%
Secreted
into
mucus
, t
ears, sal
iva
8
0%
Main blood
antibody
,
ne
utral
izes toxi
ns,
opsonzation
6%
% of to
tal
antibody
in serum
Function
Primary responese,
xes
complemen
t.
Monomer serves as
B-cell recept
or
A wi
de var
iet
y of immu
ne cel
ls an
d mole
cul
es are i
nvolve
d in
the de
velopment o
f immune
responses.
Antibodies,
also
kn
own as i
mmun
oglo
buli
ns (Ig), are prote
ins pr
oduc
ed an
d
use
d by the im
mune s
ystem to re
cogn
ize and e
limi
nate
path
oge
ns or oth
er fore
ign ma
teria
l. Each a
ntib
ody bi
nds
to
one of
many
molecules on t
he microor
ganism’
s surface
an
d henc
e, there m
ay be seve
ral di
erent a
ntib
odie
s for a
given
pat
hogen.
Through this
binding mechanism, one
or more an
tibodies can
tag a p
athog
en or i
nfecte
d cel
l. This t
aggi
ng the
n resu
lts in o
ne
or se
veral d
iere
nt so-
cal
led “ee
ctor fu
ncti
ons,
” in wh
ich
othe
r par
ts of th
e immu
ne syste
m are act
ivated in o
rder to
inh
ibi
t and
/
o
r eli
minate th
e patho
gen o
r forei
gn mate
ria
l. The
hum
an imm
une sys
tem use
s die
rent cl
ass
es of anti
bod
ies
ca
lled i
sot
ype
s, know
n as Ig
A, IgD, IgE, I
gG, an
d IgM. T
he
isot
yp
es have sl
ight
ly die
rent st
ruct
ures a
nd they pl
ay die
rent
rol
es in th
e immu
ne syste
m. Immu
nogl
obul
in G (Ig
G)
, is th
e
mos
t comm
on t
ype fo
und in th
e blo
od and t
issu
e and
provides
the majority o
f ant
ibody-based
immunity against
invading
pathogens.
In v
arious aut
oimmune diseases
, the
immune sy
stem
mis
taken
ly mo
unts a re
spon
se toward th
e body
’
s ow
n cel
ls
and tissues. This misguided a
ttack results in various clinical
sym
ptoms de
pen
ding o
n whic
h cel
ls or ti
ssue
s are su
bje
ct to
the a
ttack. In
several
autoim
mune diseases,
antibodies
ca
pabl
e of bind
ing to se
lf-anti
gen
s play a
n impo
rt
ant rol
e in the
attack.
These are called
autoan
tibodies.
In t
ransplantation
, b
y design
, foreign
mat
erial is in
troduced t
o
an i
ndiv
idua
l’
s imm
une sys
tem. In ord
er to preve
nt the bo
dy’s
imm
une sy
stem fro
m reje
ctin
g the tra
nspl
anted o
rgan, a
ll
trans
planted patie
nts are treated with imm
unosupp
ressa
nt
drugs. Don
ors and po
tent
ial recipient
s also need
to
be
match
ed wi
th res
pect to b
lood t
yp
e and ti
ssue t
yp
e prio
r to
transplant
ation t
o min
imize t
he risk o
f tr
ansplant reject
ion.
As pa
r
t of a natur
al imm
une re
spon
se aga
inst th
e tran
spla
nted
organ,
the i
mmune sys
tem can
develop
antibodies,
which then
co
ntrib
ute to a reje
ctio
n. Thi
s proce
ss is r
eferr
ed to as AM
R
and these
patient
s usually
have
developed
antibodies t
o t
he
do
nors H
L
A (Huma
n Leu
k
oc
yte A
ntig
en)
.
Patie
nts in n
eed of a n
ew orga
n, such a
s kid
ney
, lun
g or he
ar
t,
may a
lso have d
evelo
ped a
nti-HL
A (
Huma
n Leuko
cyte A
ntig
en)
antibodies
prior t
o the
transplanta
tion.
T
ypically
, t
hese
pre-
formed ant
i-HLA antibodies w
ere dev
eloped earlier in
life
,
wh
en pati
ents wer
e expos
ed to forei
gn HL
A du
e t
o
pregnancies,
blood tr
ansfusions or
previous t
ransplantat
ions.
Th
ese i
ndiv
idua
ls are r
eferr
ed to as HL
A-s
ensi
tized o
r
HL
A-im
muni
zed pati
ents. I
n gene
ral, it i
s more di
cul
t to nd a
compatible
donor organ
for HLA–
sensitiz
ed patien
ts.
Pat
ients on
transplant
waitlis
ts are
screened wit
h respect t
o
the
ir anti
-HL
A anti
bod
y prol
es and a
re care
full
y tested w
ith
res
pec
t t
o do
nor
-s
pec
ic ant
ibod
ies (D
SA) pr
ior to an ac
tual
tra
nspl
antat
ion. Hi
ghly s
ens
itized p
atie
nts have a wi
de
sp
ectr
um and of
ten h
igh l
evels of a
nti-H
LA a
ntib
odie
s and a
re,
the
refore, l
ikely to have D
SAs. Si
nce DS
As are l
ikely to ta
rget
an
d sign
ica
ntly c
ompro
mis
e a trans
plan
ted orga
n, thes
e
pati
ents a
re ofte
n preve
nted fro
m rece
ivi
ng a tra
nspl
ant.
The broa
der reactivity o
f the
antibodies
, the
lower
the lik
elihood
of nd
ing a do
nor or
gan tha
t will b
e a
ma
t
ch. A
s a resul
t, many
of the
se hig
hly se
nsi
tized pa
tient
s remai
n, for an in
den
ite
period,
in a debilit
ating d
isease stat
e on
long-t
erm dialysis
treat
ment,
which is
associated
with hig
h cost
, a poor
quality of
li
fe and an i
ncre
ase
d mor
tal
it
y rate.
Hansa Biopharma
Annual Report 202
1
33
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
Imlid
ase –
a no
v
el app
roa
ch to
eliminat
ing pat
h
ogenic IgG
Ha
nsa’
s rs
t gene
ratio
n enz
yme, i
mli
dase, o
rigi
nates f
rom a
hum
an path
oge
n – a bacte
ria c
alle
d
Strept
ococcus p
yogenes
– which
is a species
of Gram
-positive
, spherical b
acteria i
n the
ge
nus
Streptococcus
an
d is usu
ally k
nown f
or cau
sing a s
trep
throat
infection
.
Imlidase’
s
Mod
e of Action
i
s that it ve
r
y quic
kly a
nd eec
tivel
y
cleav
es
Immunoglobolin G
(Ig
G) with
in 2
-
6 hour
s from a 15- to
30-minut
e infusion
. The IgG
is cleav
ed below
the so-called
‘hin
ge reg
ion,
’ cre
ating a
n F(
a
b
’)2 and a
n Fc com
pone
nt.
Af
ter tre
atmen
t, intac
t IgG le
vels wi
ll dro
p t
o be
low de
tecta
ble
leve
ls an
d stay sup
ress
ed for a
pproxi
matel
y 5-
7 days,
creati
ng a windo
w for
transplant
ation be
fore
it gradually
retu
rns ba
ck to nor
mal le
vels du
rin
g the wee
ks foll
owin
g
tre
atment. T
he iml
id
ase en
zym
e is hig
hly s
peci
c to IgG
an
d all su
bcla
sse
s of IgG, a
nd has b
een d
emo
nstra
t
e
d t
o
not ae
ct othe
r Ig-is
oty
pes.
IgG (mg/mL)
0.5h
0
1h
2h
4h
6h
8h
1d
2d
3d
7d
14d
21d
28d
64d
10
8
6
4
2
0
F(ab’)
2
Fc
Anti-GBM Ab
Imlifidase
IgG
>
Species of
Gram-positiv
e,
spherical bact
eria in the
ge
nus
Streptococcus
>
Usu
all
y know
n from c
ausi
ng a stre
p throat i
nfect
ion
>
Rapid onset
of action
that ina
ctivat
es IgG below de
tectable
leve
l in 2-6 hou
rs
f
rom a 1
5-mi
nute in
fusi
on
>
Ig
G antib
ody-fre
e win
dow for ap
proxim
ately o
ne wee
k
>
Inte
racts w
ith Fc-p
ar
t of IgG wi
th extr
eme
ly hig
h spe
cif
icit
y
>
Cl
eaves Ig
G at the hi
nge re
gion, g
ene
ratin
g one F(ab’)₂
fragment
and one homo-dimeric
Fc-
fragment
Or
igi
ns fr
om a ba
cte
ri
a
Streptococcus
pyog
enes
Im
li
das
e, a uni
qu
e IgG an
ti
bod
y-cl
eav
ing
enzyme to
eliminate
pathogenic IgG
Im
li
das
e ina
ct
ivat
es Ig
G in 2-6 h
our
s
from i
nfusion
F(ab’)
2
Fc
Anti-GBM Ab
Imlifidase
IgG
Hansa Biopharma
Annual Report 202
1
34
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
A
u
t
o
i
m
m
u
n
e
d
i
s
e
a
s
e
s
N
e
w
t
h
e
r
a
p
i
e
s
a
n
d
o
n
c
o
l
o
g
y
G
e
n
e
t
h
e
r
a
p
y
T
r
a
n
s
p
l
a
n
t
a
t
i
o
n
I
m
l
i
f
i
d
a
s
e
+
c
o
m
b
i
n
a
t
i
o
n
I
m
l
i
f
i
d
a
s
e
N
i
c
e
R
GBS
Anti-
GBM
Kidney
Trans-
plantation
EU
AMR
Kidney
Trans-
plantation
U.S.
Duchenne
Limb-
Girdle
Pompe
EnzE
Our vision
T
oday
T
argeting r
are IgG mediated diseases
Expanding our
commercial
franchises
Regulatory approv
al (conditional)
Clinical dev
elopment
Partnership
(
preclinical
development
)
Preclinical de
velopment
Opportunities
currently
not p
ursued
Our u
nique a
ntibody cl
ea
v
ing enz
yme
tech
nology may hav
e r
ele
vance ac
ross
a ra
nge of indicat
i
ons
An
ti
-G
BM pav
es th
e way fo
r
devel
opment in
other
autoimmune
diseases
>
Rapidly progressive
glomerulonephritis
>
Neurological d
isorders
>
Skin and blood
disorders
Shaping a
new
standard for
desensitization will
help enable
new
indications in
transplantations
>
Antibody
mediated
rejection (AMR
)
in kidney
transplanta
tion
>
Other tr
ansplantation
types
IgG-cleaving
enzymes to
enable or
ev
en poten
tiate cancer
therapy
>
Al
loge
nic s
tem cel
l (bo
ne mar
row)
transplant
ation (H
SCT)
>
Enzyme-based ant
ibody
Enhancement (EnzE)
Exploring opportunities in
gene therap
y
>
Encouraging pr
eclinical data
published in Na
ture
>
V
alidation
through
collaboration
s
wi
th Sare
pta and A
skB
io
>
Wide indica
tion landscape
beyond
Hansa Biopharma
Annual Report 202
1
35
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
Ig
G leve
ls af
t
er im
li
da
se tr
ea
tme
nt in h
uma
ns
Fir
st 30 day
s
0
20
30
10
0
Time (days)
IgG
Our prop
rietar
y
antibody
-cleaving enzyme t
echnology
pl
atfor
m to targ
et patho
gen
ic ant
ibod
ies is a
t the co
re of
our business. T
o sharpen our focus
and commitment t
ow
ard
advancing Hansa
’
s platform beyond
kidney transplantat
ion,
we ha
ve established f
our distinct
franchises in
transplant
ation,
aut
oimmune diseases
, gene therap
y
and oncology
/
new therap
ies.
Ha
nsa’
s rs
t
-ge
ner
ation I
gG-
cle
aving e
nzy
me, iml
id
ase, is
de
sign
ed to ina
ctivate I
gG anti
bod
ies in b
oth pla
sma a
nd
tis
sue, wi
th a sin
gle in
traveno
us tre
atmen
t
. T
hroug
h the Ni
ceR
pro
gram, we a
re als
o devel
opin
g a sec
ond ge
ner
ation of
Ig
G-cl
eavi
ng en
zym
es de
sig
ned to have l
ower
immunogenicity
, thereb
y enabling multiple
administrations
.
Sp
eci
cal
ly
, with N
ice
R, we are wor
kin
g on gen
etic
ally
mo
dif
yin
g our e
nzy
mes to re
duce t
he imm
unog
eni
cit
y and th
e
imm
une re
spo
nse, so th
at we can u
se the
m for rep
eated
dos
ing. T
his co
uld p
ot
e
ntial
ly ope
n a new tre
atme
nt para
digm
in a br
oad ran
ge of in
dica
tions
.
In ad
diti
on to ide
ntif
yin
g the mo
st rel
evant in
dic
ation
s for our
en
zym
es, we ar
e also l
ook
ing at h
ow our un
ique a
ntibo
dy-
cleaving
enzyme technology can
be used in
pot
ential
combination
with o
ther t
echnologies tar
geting I
gG antibodies
.
For exa
mpl
e,
Fc
Rn inhi
bitor
s, whi
ch do not gi
ve the sa
me ra
pid
an
d eecti
ve res
pons
e as imli
da
se, but c
an be us
eful fo
r
lo
ng-term m
anag
eme
nt in in
dic
ation
s know
n t
o be d
rive
n by
dis
eas
e-c
ausi
ng IgG
s. In li
ne with t
his id
ea, we e
ntered i
nto a
pre
-cl
inic
al res
earc
h coll
abo
ratio
n with ar
gen
x BV in Marc
h
2021 to
exp
lore th
e potenti
al of co
mbin
ing im
lid
ase an
d
efga
r
tigim
od, arg
enx’s FcRn an
tago
nist. If th
e data be
ars o
ut, a
co
mbin
ation of i
mli
dase a
nd efga
rt
igim
od cou
ld poten
tiall
y be
use
d in both t
he acu
te and ch
roni
c sett
ing of au
t
oi
mmun
e
diseases and
transplanta
tion.
I
m
l
i
f
i
d
a
s
e
+
c
o
m
b
i
n
a
t
i
o
n
I
m
l
i
f
i
d
a
s
e
N
i
c
e
R
Our unique antibody cleaving
enzy
me
tech
nology may have relevance acros
s
a ra
nge of indic
ations
conti
nued
Ke
y opportu
nities:
>
Expanding into
new indications
>
Reduce immune
response
to I
gG-cleaving enzyme,
i.e. al
low
repeated trea
tment
>
Combination
therapy
, i.e. in
ducti
on an
d
maintenance t
herapy
The technology platfor
m is the
primar
y ba
sis for ach
ieving
our vision
T
argeting rare
IgG mediated
diseases
and conditions
Hansa Biopharma
Annual Report 202
1
36
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
Intellec
tual prope
r
t
y right
s and
orp
han dr
ug designat
ions
Hansa aims at se
curing broad patent
and related IP protection for our
curre
nt and future products and
treatments dev
eloped within our
technology plat
form.
In ad
ditio
n to this, excl
usiv
it
y for our p
roduc
ts and tre
atme
nts
is se
eked v
ia or
pha
n drug d
esi
gnati
ons.
Th
e Comp
any’
s pa
t
e
nt and re
lated I
P posi
tion i
s glob
al, and
cove
rs ma
rkets de
eme
d to be of cri
tica
l cli
nica
l, manu
fact
urin
g
and commercial
relev
ance for
the pr
oduct pipeline
. As ou
r
tec
hnol
ogy p
latfo
rm fu
r
ther d
evelo
ps, we wil
l purs
ue new
pate
nt and re
lated IP 
ling
s.
Ou
r IP por
t
foli
o curre
ntly i
nclu
des p
atent fa
mili
es rel
ated to
iml
id
ase an
d its use, w
ith cove
rage o
ut to 2035, in key
ma
rkets. Ge
ogr
aphi
cal
ly
, t
hese p
atent fa
mili
es cove
r a larg
e
number of
jurisdictions, including
the U
.S
.
, Europe
and Japan.
Ou
r lead p
roduc
t, imli
das
e, is protecte
d by six pa
t
e
nt fami
lies
including bot
h grant
ed pat
ents and pending
applications and
cove
r the use of i
sola
ted imli
da
se. The m
ost si
gni
cant p
atent
fam
ilie
s protec
ting im
li
dase a
nd its us
e provi
des ba
sis fo
r
ex
tende
d patent te
rm ex
t
e
nsio
ns (PT
Es)
, whi
ch are ava
ila
ble in
ce
rt
ain ma
jor m
arkets, i
nclu
ding t
he U.S. and th
e EU (as
sup
ple
ment
ar
y protec
tion c
er
tic
ate, SPC). The ter
m of the
PT
E/S
PC can va
ry f
rom zero to ma
x
imum 
ve year
s,
de
pend
ing o
n the tim
e taken to o
btain m
arketi
ng app
roval.
Patent
s with exp
irati
ons up to 203
5 can be ex
ten
ded up to
ve ye
ars v
ia avail
abl
e patent ter
m exte
nsio
ns.
In ad
diti
on to patent a
nd IP re
lated pr
otectio
n, the Co
mpany
co
ntinu
ousl
y evalu
ates the o
ppor
tu
nitie
s for ma
rket exclu
siv
ity
for drug
candidates thr
ough orphan drug designations
and
data
exclusivity
.
Or
pha
n drug d
esi
gnati
on is g
ranted to th
erap
ies a
ime
d at
treating
life-t
hreatening
or chronically debilitating
rare diseases
where no
therapeutic
options
are either
authoriz
ed, or
where
the d
rugs w
ill be of s
igni
ca
nt ben
et to thos
e aecte
d by the
co
nditi
on. Rar
e dise
ase
s are thos
e den
ed as hav
ing a
preva
len
ce of no mo
re than 
ve in 1
0,000 p
ers
ons in Eu
rope or
ae
cting l
ess th
an 200,0
00 pati
ents in t
he U
.S. T
he des
ign
ation
provides de
velopment and commercial incent
ives, including
ten ye
ars of ma
rket exclu
siv
ity i
n the EU an
d seven ye
ars in th
e
U.S.
, protoc
ol as
sist
ance o
n the de
velo
pmen
t of the dr
ug,
inc
lud
ing cli
nic
al stud
ies a
nd cer
t
ain exempt
ions f
rom or
redu
ctions in reg
ulatory fe
es.
Sin
ce 201
7
, Ha
nsa ha
s bee
n grante
d ve or
phan
s drug
designations
by
EMA and
the FD
A acr
oss transp
lantation
,
anti-GBM ant
ibody disease and GBS
(only F
DA)
.
EMA Orphan
drug designation
>
Imlifidase f
or the
prev
ention o
f graft reject
ion follo
wing
solid or
gan transplan
tation
(20
1
7)
>
Iml
ifi
dase fo
r the tre
atme
nt of the ra
re and a
cute
disease anti-GBM
(20
1
8)
FDA Or
pha
n dr
ug de
sig
nat
io
n
>
Imlifidase f
or the
prev
ention o
f anti
body-mediat
ed org
an
rejection
in solid
organ tr
ansplantation
(2
01
5)
>
Imlifidase f
or the
treat
ment of
Guillain-Barr
e Syndrome
(
2
018
)
>
Iml
ifi
dase fo
r the tre
atme
nt of the ra
re and a
cute dis
eas
e
ant
i-GB
M (20
1
8)
Hansa Biopharma
Annual Report 202
1
37
Strateg
y
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
T
echnology
5
G
r
ow
t
h
Our dev
elopment programs
39
Ongoing clinical programs
40
U.S. randomized control trial “ConfIdeS”
41
Oppor
tunities be
yond kidney
transplant
ation
42
Acut
e Anti-GBM antibody
disease
(Goodpasture’
s disease)
43
Adva
ncin
g imli
das
e in anti
-G
BM dis
esa
se
44
Active
kidney transpla
nt
AMR
45
Guillai
n-Barré syndrome (
GBS)
46
Iml
ida
se in ge
ne the
ra
py
– an emerging opportunit
y
47
Explor
ation
of HSCT as
an oppor
tunity
for im
lid
ase
52
Research and preclinical
dev
elopment projects
54
Hansa Biopharma
Annual Report 202
1
38
Hansa Biopharma
Annual Report 202
1
38
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Broad clinical pipeline in transpla
ntation and auto-immune diseases
Candidate/
Projec
t
Indication
Research/
Preclinical
Phase
1
Potentially
Pivo
tal/Phase 2
Phase
3
Marketing
Authorization
Market
ed
Next Anticipated
Milestone
Imlidase
EU: Ki
dney t
rans
pla
ntati
on in h
ighl
y
sensitized pat
ients
1.
2
*)
EU: Add
itio
nal a
gree
men
ts aro
und
reimbursement from H
2’2
1
U.S.: Kid
ney tra
nsp
lant
atio
n in hig
hly
sensitized patient
s
1.
2
Completion o
f enrollment
(64 patients) H2’22
Anti-GBM antibody
disease
3
Piv
otal Ph
ase 3 st
udy ex
pec
ted to
co
mme
nce i
n 2022 (50 pa
tien
ts)
Antibody media
ted kidne
y transplant
reje
ction (AMR)
Completion o
f enrollment
(30 p
atie
nts) H1
’22
Gullain-Barre syndrome
(GBS)
Timeline guidance under re
view
Pre
-treat
ment a
he
ad of ge
ne the
rapy i
n
Limb-Girdle (P
artnered with Sar
epta)
Preclinical phase
Pre
-treat
ment a
he
ad of ge
ne the
rapy i
n
Duchenne (P
ar
tner
ed with
Sarepta)
Preclinical phase
Pre
-treat
ment a
he
ad of ge
ne the
rapy i
n
Pompe
disease (Partnered
with AskBio
)
Preclinical phase
NiceR
Recurring treatment
in aut
oimmune diseases,
transplanta
tion and
oncology
Co
mpl
etion o
f GLP toxi
col
ogy
stu
die
s in 2022
EnzE
Cancer immunot
herapy
Research phase
1
R
esu
lts fr
om the P
has
e 1 stud
y have b
een p
ubli
she
d, Win
sted
t el al. (2
0
15) PLOS ONE 10(
7)
2
Lor
ant et a
l Am
eri
can J
our
nal of Trans
pla
ntat
ion a
nd 03+
04 stu
die
s (Jorda
n et al N
ew Eng
lan
d Jou
rna
l of Med
ici
ne)
3
Investigat
or
-initiat
ed study b
y Mårten Segelmark, Pro
fessor at t
he universities in
Linköping and Lund
*)
Th
e EU Com
mis
sio
n has g
rante
d con
dit
iona
l app
roval f
or im
lid
ase i
n hig
hly s
ens
itize
d kid
ney tr
ans
pla
nt pati
ent
s.
A po
st-app
roval s
tud
y will c
omm
enc
e in pa
ral
lel w
ith th
e laun
ch
Our dev
elopment programs
Completed
Ongoing
Planned
Conditional
approval
ba
sed o
n Phas
e 2 data
Hansa Biopharma
Annual Report 202
1
39
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Ongoing clinica
l programs
>
28/30 pat
ients e
nrol
led i
n the AM
R
pha
se 2 stu
dy
>
Co
mplet
ion of e
nroll
ment ex
pec
ted
H1 2022* as prev
iou
sly gu
ide
d
>
Fir
st dat
a read ou
t expe
cted in
H2 2022*
Antibody Mediated
Rejection
phase 2
>
Al
ignm
ent wi
th FDA on a pi
votal
Pha
se 3 stud
y of iml
ifi
dase i
n
anti-
GBM patients
>
Th
e pla
nned s
tudy w
ill ta
rget
ap
proxim
ately 50 p
atie
nts with
ant
i-GB
M dise
ase ac
ross th
e U.S.
an
d Europe
>
Th
e fir
st pati
ent is ex
pec
ted to be
en
rolle
d in 2022*
An
ti
-G
BM ph
ase 3
>
1
6/30 pa
tient
s enro
lled i
n the GB
S
pha
se 2 stu
dy
>
GBS enrollment
timeline under
revi
ew giv
en the d
if
fic
ult
y of
pre
dict
ing en
roll
ment d
ue to the
dir
ect an
d indi
rect e
ffe
cts of th
e
escalating pandemic
>
Hansa e
xpects to
updat
e its
guidance
for c
ompl
etion o
f enrol
lme
nt in GBS
in A
pril 20
22
Guillain-Barré Syndrome
phase 2
>
1
3/64 pat
ients e
nrol
led in t
he pha
se 3
“ConfI
deS” st
udy
>
First pat
ients enrolled a
t Columbia
Uni
vers
it
y (NY
) at th
e end of De
c 2021
>
Nin
e cen
t
e
rs are ac
tive a
nd ope
n for
enrollment
>
Co
mplet
ion of e
nroll
ment ex
pec
ted
H2 2022*
>
Completion
of 1
2 months
follow
-up
exp
ected H
2 2023*
U.S.
ConfIdeS trial
phase 3
*
G
uid
anc
e ass
ume
s no fu
rth
er e
sca
lati
on of the C
OVID
-
19 pan
dem
ic pote
nti
ally f
orci
ng tr
ial c
ente
rs to rep
rio
rit
ize pat
ient
recruitment
or even
shut down
again
Hansa Biopharma
Annual Report 202
1
40
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Enr
ollment s
tatus A
pr 6, 2
022
2
28
14
16
51
13
Patients
e
nrolled
Patients
remaining
Not s
ta
r
ted ye
t
U
.
S. ra
ndomiz
ed
cont
rol tr
ial “ConfIde
S”
In December 2021 Hansa a
nnounced
that the
r
st pa
tient in its U
.S. open-
label, ran
domi
zed, controlled pivo
tal
trial (“ConfIdeS”) h
ad been enrolled at
the Columbia Univ
er
sity Medica
l Cent
er
,
Ne
w Y
ork.
Th
e Conf
Ide
S tria
l is evalu
ating i
mli
dase a
s a potenti
al
desensitizat
ion therap
y t
o enable kidne
y transplan
ts in
highly
se
nsiti
zed pati
ents wa
itin
g for a de
cea
sed do
nor k
idne
y
through
the U
.S. kidney
allocation
syst
em.
Th
e tria
l is expe
cted to ra
ndom
ize 64 hi
ghly s
ensi
tized k
idn
ey
tra
nspl
ant p
atien
ts wit
h a cPR
A of ≥9
9
.9%, re
pres
entin
g a
sub
set of ver
y h
ighl
y sens
itize
d patie
nts that c
onti
nue to be
disadvant
aged despite
prioritization
under the
U
.S.
kidney
allocation
syst
em. When
a donor
organ becomes a
vailable and
a posit
ive cro
ssmatch
with t
he int
ended recipient
indicat
es tha
t
the o
rgan i
s not com
patib
le, the pa
tient w
ill b
e rand
omize
d to
ei
ther i
mli
dase d
ese
nsit
izati
on treat
ment o
r t
o a co
ntrol ar
m
that w
ill re
cei
ve stan
dard of c
are (i.e. wai
ting fo
r a more
co
mpatib
le ki
dney oe
r or rec
eiv
ing an ex
per
ime
ntal
des
ensitiz
ation treatme
nt)
. The stud
y’
s pr
imar
y endpo
int for
iml
id
ase to eval
uate ben
et in tr
ansp
lant
ing hi
ghly s
ensi
tized
pati
ents i
s kidn
ey graf
t f
uncti
on at 1
2 mon
ths, me
asure
d by
eGFR (esti
mated Glome
rular Fi
ltration Rate)
.
Rob
er
t A. M
ontgom
er
y
, M.
D
.
, Profe
sso
r of Surg
er
y and
Direct
or
, NYU Langone T
ransplant Instit
ute
in New
Y
ork City
,
has been appoi
nted
National
Coordinati
ng Inv
estigat
or f
or the
Co
nfId
eS tri
al. Th
e tria
l will e
nrol
l patie
nts at 1
2 to 1
5 l
eadi
ng
tra
nspl
antat
ion ce
nters i
n the U.S.
End of D
ece
mbe
r
, 2021
, 2 of th
e targ
eted 64 p
atien
ts have
been enrolled
17
at 5 ce
nters a
cros
s the U.S. (
1
3 of the ta
rgete
d
64 p
atient
s were en
roll
ed by Ap
ril 6, 2022). Comp
leti
on of
en
rollm
ent in th
e tria
l is expe
cted i
n the sec
ond h
alf of 2022,
wi
th a 1
2-mont
h follow-
up stud
y per
iod exp
ecte
d t
o be
co
mplete
d in the s
eco
nd hal
f of 2023. Res
ults f
rom thi
s pivota
l
tri
al are ex
pec
ted to supp
or
t a potenti
al BL
A sub
mis
sion to th
e
FDA und
er the a
cce
lerate
d app
roval pathway i
n the rs
t half of
202
4. Th
e guid
anc
e assu
mes n
o fur
the
r esc
alati
on or
sus
tain
ed ne
gati
ve impa
ct of the COV
ID-
19 pand
emi
c
poten
tial
ly forc
ing tr
ial ce
nters to to ha
lt or d
elay pa
tient
recruitment
or ev
en shut do
wn again
.
Iml
ida
se ha
s alrea
dy rec
eive
d con
ditio
nal ma
rketi
ng app
roval
in Eur
ope for t
he de
sens
itiz
ation tr
eatme
nt of hig
hly s
ensi
tized
adult kidne
y transplan
t pat
ients wit
h positiv
e crossma
tch
against
an av
ailable deceased donor
.
Complete
enrolment
(H
2 202
2)
2022
20
21
2023
2024
First pat
ient enrolled
(
H
2
20
2
1)
1
2m fol
low-u
p eGFR
(H2 2023)
BLA submission
(
H1 2
0
24)
Timeline
17
G
uid
anc
e ass
ume
s no fu
rth
er e
sca
lati
on of the C
OVID
-
19 pan
dem
ic pote
nti
ally f
orci
ng tr
ial c
ente
rs to rep
rio
rit
ize pat
ient
recruitment
or even
shut down
again
Hansa Biopharma
Annual Report 202
1
41
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Hansa’
s unique antibody-cleaving platform may hav
e relev
ance in numerous
autoimmune d
iseas
es, where IgG autoantibodies play an import
ant role
Op
por
tun
ities bey
on
d kidney tr
anspl
anta
tion
1
DeVri
eze, B.W
. an
d Hur
ley
, J.
A.
Goodpasture
Syndrome.
StatP
earls
Publishing,
Jan 2
02
1
.
https:/
/w
ww
.ncbi.
nlm.
nih.
gov/books/NBK
45929
1
/ [
accessed
2
02
1-
0
3
-2
9
]
2
Pate
l, M et al. T
he Pre
vale
nce a
nd In
cid
enc
e
of Bi
ops
y-Prove
n Lup
us Ne
phr
itis i
n the UK
.
Ar
th
riti
s &
Rh
eum
atis
m, 200
6
3
Be
rt
i A, Co
rne
c D, Crows
on CS, S
pec
ks U,
Mat
tes
on EL. T
he Ep
ide
mio
log
y of ANCA
As
soc
iated Vas
culi
tis in th
e U
.S.: A 20
Y
ea
r
Populat
ion Based St
udy
. Arthritis
Rheumatol
. 2
01
7
;69
4
Myasthenia
Gravis.
National Or
ganization
for R
are Dis
ord
ers, ht
tps://rar
edi
sea
ses.o
rg/
rare-diseases/myasthenia-gra
vis/ [accessed
2
02
1-
0
3
-2
9
]
5
Guillain-Barré s
yndrome.
Orpha.net,
https:/
/
ww
w
.orpha.net/consor
/
cgi-bin/OC_Exp.
php
?Lng=GB
&Exper
t
=2
1
03 [a
ccessed
2
02
1-
0
3
-2
9
]
6
Chronic
Inammatory Demyelina
ting
Polyneuropat
hy:
Considerations
for
Diagnosis,
Management,
and Popula
tion
He
alt
h. The A
mer
ica
n Jou
rna
l of Man
age
d
Care, https:/
/ww
w
.ajmc.com/v
iew/
chronic-infammat
or
y
-demyelinating-
polyneuropath
y-considerations
-for
-
diagnosis-management-
and-population-
he
alt
h [acce
sse
d 2021
-
03-29]
7
Ma
rri
e, R.A
. Th
e Inci
den
ce an
d Preva
len
ce
of Neur
omyelitis
Optica.
Internat
ional
Jo
urn
al of MS Care, 2013
Fal
l: 1
13-
1
18
8
Me
hre
n, C.R. and G
nia
dec
ki, R.
Epidermolysis bullosa
acquisita:
current
diagnosis and
therapy
. Dermatol
Reports,
20
1
1
-
1
0-05
9
Wer
ten
teil, S. e
t al. Pre
vale
nce E
stim
ates fo
r
Pemphigus in
the United
States.
JAMA
De
rma
tol, May 2
0
19: 627
-6
29
10
Immune Thr
ombocytopenia. Nat
ional
Or
gani
zati
on for Ra
re Dis
ord
ers, ht
tps://
rarediseases.org/
rare-diseases/
immune-th
rombocytopenia//
[accessed
2
02
1-
0
3
-2
9
]
11
Warm
Autoimmune
Hemolytic Anemia.
National
Organization
for Rare
Disorders,
https:/
/rarediseases.
org/rare-diseases/
warm-aut
oimmune-hemolytic-anemia/
[access
ed 20
21
-03-2
9]
12
Li
tv
inova
, E. et al. Pr
eval
enc
e and
Signicance
of
Non-convent
ional
Antiphospholipid Antibodies in
Patients
Wi
th Cli
nic
al AP
S Cri
teri
a. Fron
tier
s in
Immunology
, 2
01
8-
12
-
1
4
An
ti-
GBM
~
1,00
0 pa
tie
nts*
1
GBS
~
10,00
0 p
ati
en
ts*
5
EBA
<1
,0
0
0 pat
ie
nts*
8
Rapidly progressiv
e
glomerulonephritis
Neurological
disorders
Sk
in
disorders
Blo
od
disorders
Myasthenia
gravis
~
21
0,
000
*4
NMO
~
20,
000
*7
Pemphigus
vulgaris
~40
,000
*9
CIDP
~5
5,
000
*6
Lupus
nephritis
~35
,
000
*2
ITP
~
7
5,000
*
10
WA
H
A
~
95,
000
*
11
ANCA-
associated
vasculitis
~
90,
000
*3
APS
~350,
000
*
12
Clinical programs
Pote
ntia
l ind
ica
tion
s (cur
rentl
y not pu
rsu
ed)
Hansa Biopharma
Annual Report 202
1
42
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
*
T
ota
l dis
eas
e popu
lati
ons i
n EU & US, ba
sed
on pre
valence and
population da
ta
CIDP:
Chronic
inammatory demyelina
ting
polyradiculoneuropat
hy
NM
O:
Neuromyelit
is opt
ica
EB
A:
Epidermolysis bullosa acquisita
ITP:
Immune
thrombocytopenia
W
AHA:
W
arm antibody
hemoly
tic
anemia
APS:
Antiphospholipid s
yndrome
Glomerulonephritis is
a lea
ding cause
for kidne
y disease
GNN
Glomerulonephritis
(GNN
)
Diabetic neuropa
th
Adult
polycytic kidney
disease
Hypertonicity
Pyelonephritis
Uremi
a
Othe
rs
In Se
ptemb
er 2020, pos
itive h
igh-
level d
ata were p
rese
nted
fro
m an inve
stiga
t
or-ini
tiated p
hase 2 tr
ial of im
lid
ase to tre
at
ant
i-GB
M dise
ase. T
he stud
y
, l
ed by Pri
nci
pal Inve
stig
ator
Mår
t
en Segelmark, Pro
fessor at
the Universities in
Linköping
an
d Lund, s
howed th
at two
-
th
irds of pat
ients a
chie
ved dia
lys
is
ind
epe
nde
nce si
x mont
hs af
ter treat
ment a
s comp
ared to
typica
lly
two-thir
ds of p
atients losing
their kidney funct
ion and
en
ding u
p on dia
lysi
s afte
r six mo
nths.
Th
e posi
tive ou
tcome f
rom th
e phas
e 2 tria
l mar
ked an
imp
or
tant m
iles
tone for the ex
pans
ion of iml
ida
se out
side
transplantation
and int
o aut
o-immune diseases. Hansa plans
to
ini
tiate a Phas
e 3
stu
dy of imli
da
se to
tre
at anti-
GBM di
seas
e
fol
lowin
g a suc
ces
sful p
re-IN
D meet
ing wi
th the U.S. FDA. T
he
pl
anne
d pivota
l phas
e
3 cl
inic
al stud
y will en
roll ap
proxi
mately
50 pat
ients w
ith an
ti-GB
M dis
ease a
cros
s the U.S. and Eur
ope
wi
th the rst p
atien
t
exp
ecte
d
to be en
rolle
d in 2022.
A
cute A
nti-
GBM antibod
y disease
(
Goodpastu
re
’
s di
sease
)
Anti-
GBM, a rare acute
autoimmune
disease aecting kidneys
and lungs
Anti-GBM
(ant
i-glomerular basement
membrane disease
)
,
al
so know
n as “Go
odpa
sture´s dis
eas
e,
” is a
n acute a
nd ver
y
seve
re ina
mmator
y di
sea
se imp
actin
g the ki
dneys. Fo
r larg
ely
unk
now
n reaso
ns, the i
mmun
e system d
evel
ops Ig
G-
ant
ibod
ies th
at reco
gnize a m
emb
rane a
sso
ciated a
ntig
en in
the k
idn
ey and so
meti
mes, in t
he lun
gs. Ant
i-GB
M is on
e form
of
glomerulonephritis (
GNN)
, which
comprises a number
in
amma
t
or
y di
sea
ses in th
e kid
ney an
d is a lea
ding c
ause of
ki
dney di
sea
se. In glo
mer
ulo
neph
riti
s, the in
amm
ation st
ar
ts
in th
e glom
eru
li (lte
ring u
nit of th
e kidn
eys) and th
e smal
l
bl
ood ves
sel
s. The r
esul
t is an ac
ute imm
une at
tac
k on the
se
org
ans. In m
ost ca
ses, a
nti-
GBM ant
ibod
y dise
ase l
eads to
si
gni
cant l
oss of k
idney f
unc
tion, re
quir
ing ch
roni
c dial
ysis o
r
res
ults i
n death.
Pat
ients with
glomerulo
nephritis
, including those
diagnosed
wi
th anti-
GBM di
sea
se, usua
lly ex
per
ienc
e ver
y few sym
ptoms
initially
, which
is why
many p
atients
are dia
gnosed lat
e in
dis
eas
e progr
ess
ion. T
o
day
, dia
gnos
tic tests c
an de
termi
ne if a
pati
ent ha
s anti-
GBM a
utoanti
bod
ies bu
t, sinc
e this d
isea
se is
rar
e, knowl
edg
e of the di
sea
se and w
hen to us
e the di
agno
stic
test i
s not wid
esp
read th
roug
hout t
he hea
lthc
are sys
tem.
Ea
rly di
agn
osis a
nd trea
tment i
s, howeve
r
, cr
ucia
l for th
ese
patients
, as det
erioration o
f kidney function
progresses rapidly
into th
e acute st
age. T
he onl
y way to halt a
n immu
nol
ogic
attack is
through
elimination
of
the ant
ibodies as early
as
pos
sib
le. T
o
day’
s sta
ndar
d of care i
n anti-
GBM di
sea
se
invo
lves m
edic
atio
ns suc
h as cy
tot
oxi
c drug
s
(e
.g
. corticosteroids
and cyclophosphamide)
and plasma
excha
nge, bu
t thes
e treatm
ents ar
e seen a
s inad
equ
ate as
it can t
ake se
veral mon
ths f
or the
autoan
tibody pr
oduction
to hal
t and t
ypi
cal
ly onl
y a fra
ction of t
he total Ig
G anti
bodi
es
are re
moved th
roug
h plas
ma excha
nge.
An
ti-GB
M is an ultr
a
ra
re dise
ase tha
t
ae
cts ap
proxim
ately
1
.6
per million
people globally
, ev
er
y
year
18
,1
9
(e.g. 1
,0
00 c
ase
s
acr
oss EU and th
e U
.S. ann
uall
y).
For o
ne out of six p
atient
s,
ant
i-GB
M can b
ecom
e fata
l duri
ng the a
cute ph
ase of the
dis
eas
e, whil
e the ma
jori
ty of p
atient
s will e
nd up o
n chron
ic
dialysis
20
. On
ly one i
n thre
e anti-
GBM pa
tient
s will h
ave a
pre
ser
ved re
nal fun
ctio
n
af
ter six mo
nths with cu
rren
t
tre
atment
21
.
Wi
th imli
das
e, the anti
-GB
M antib
odie
s in cir
culati
on, as we
ll
as th
e IgG b
ound to th
e GBM, ar
e cleave
d by the e
nzy
me
wi
thin a few h
ours a
nd may p
revent f
ur
ther r
enal d
amag
e.
Pot
ent
ia
l of us
ing i
mli
d
ase v
s
PL
EX in a
nt
i-G
BM
Illus
trative
G
raf
t los
s if un
treate
d
PLEX (Multiple rounds
)
Imlidase
Days
0
2
3
4
5
6
7
8
9
1
Anti-GBM antibodies
Renal injury
Start of treatment
So
urce Th
e Immu
nog
lob
ulin G De
grad
ing Enz
ym
e imli
da
se for the T
re
atme
nt
of An
ti-
GBM Di
sea
se – th
e Goo
d-ID
ES 01 T
r
ial
M
år
ten Se
gel
mar
k 1
,
2, Fredr
ik
Uh
lin 2, Eli
sab
eth So
nes
son 3 o
n beh
alf o
f the Go
od-I
DES – 1
.0 stu
dy te
am
18
Kl
uth et al. J Am Soc Ne
phro
l.
1999 Nov;1
0
(
1
1):
2446
-53
19
He
llm
ark e
t al. J Au
toimm
un. 201
4 Fe
b-M
ar;48-
49:
1
08
-
12
20
Co
hor
t of 13 stud
ies (6
61 patie
nts i
n anti-
GBM 199
3-201
7) Treat
ing a
nti-
GBM
di
sea
se wit
h iml
ida
se Må
rt
en Se
gel
mar
k, Profe
sso
r OF Ne
phr
olog
y
21
Kl
uth et al. J Am Soc Ne
phro
l.
1999 Nov;1
0
(
1
1):
2446
-53 an
d
He
llm
ark e
t al. J Au
toimm
un. 201
4 Fe
b-M
ar;48-
49:
1
08
-
12
Hansa Biopharma
Annual Report 202
1
43
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Q.
Wh
at i
s ant
i-
GBM d
ise
as
e and w
ho is a
ec
te
d?
A.
Anti-GBM disease,
also known as
Goodpasture
’
s disease
,
is a
n ultra-
rare, sev
ere ki
dney d
isea
se whi
ch ca
uses
in
amma
tion of the g
lom
erul
i. It aect
s approx
imatel
y 1
.6 in a
million people annually
23
. The cond
ition causes
the immune
syste
m to
mi
stake
nly at
tack a s
pec
ic pa
rt of th
e kidn
eys
called the
glomerular basement
membrane (
GBM) with
IgG-antibodies,
severely damaging
the kidneys and
, in s
ome
cases, the
lungs. Many
patients
with anti
-GBM disease lose
kidney function and
require chr
onic dialysis and kidney
transplant
ation
24
. In
severe cases
, anti-GBM disease
may
le
ad to deat
h.
Q.
Wh
at a
re t
he re
ce
nt de
velo
pme
nt
s in Ha
ns
a’s
anti-GBM product program?
A.
I am exci
ted to see tha
t our eor
ts in a
nti-
GBM dis
eas
e is
pro
gres
sing towa
rd late sta
ge deve
lop
ment. We ai
m t
o have a
gl
obal p
rotocol fo
r our p
hase 3 st
udy
, an
d have rec
entl
y
co
mplete
d a ser
ies of s
ucce
ssf
ul inte
racti
ons wi
th var
ious
reg
ulator
y au
thor
itie
s, inc
ludi
ng the FDA a
nd EMA
. The g
oal i
s
to have th
e tria
l up and r
unn
ing du
ring 20
22
, wi
th patie
nt
rec
rui
tment i
n the U.S. and E
U
.
Q.
Wh
at h
ave tr
ia
ls sh
own s
o far
?
A.
Th
e recentl
y
co
mpleted investi
gator
-in
itiated phas
e 2
study
26
, be
ing le
d by Profes
sor M
år
ten Seg
elm
ark, s
howed t
hat
tw
o thirds (67%
) of pat
ients (1
0 ou
t of 1
5) ac
hieve
d dia
lysi
s
ind
epe
nde
nce at si
x month
s af
t
e
r imli
das
e treatm
ent. As a
co
mpar
ison, t
he overa
ll ren
al sur
v
ival ove
r 1
2 tr
ial
s has be
en
rep
or
ted to be 26% wit
h curr
ent St
anda
rd of Care (S
oC)
22
. Th
is
pos
itiv
e outcom
e ser
ve
d as Proof of C
onc
ept (PoC) fo
r the
poten
tial of im
lid
ase to trea
t IgG-
medi
ated se
riou
s
autoi
mmune diseases.
Q.
How i
s Ha
nsa a
dva
nci
ng t
he sc
ie
nce f
or
anti-GBM disease
?
A.
There hav
e been no
randomized
control
led trials performed
within ant
i-GBM since 1
985
25
. Ha
nsa pl
ans to in
itiate a
ran
dom
ised c
ontrol
led tr
ial c
ompa
ring i
mli
dase o
n top of SOC,
or to SOC, al
one, i
n 50 patie
nts. Th
e resu
lts of thi
s tria
l may
le
ad to a new
, li
fe savi
ng trea
tment fo
r patie
nts di
agno
sed wi
th
this v
er
y serious d
isease.
Adv
ancing imlid
ase
in ant
i-GBM dis
esase
Hansa w
ant
s t
o bring hope t
o
pat
ients with ant
i-GBM disease,
which is a de
v
asta
tin
g
aut
oimmune condit
ion
, sev
erely
damaging the kidney’
s a
nd in
some case
s t
he lungs.
Elisabeth
Sonesson
Global F
ranchise lead
Autoimm
unity
22
Se
gel
mar
k M et al. A
nti-
glo
mer
ula
r bas
eme
nt mem
bra
ne di
sea
se: an up
date o
n subg
rou
ps, pat
hoge
ne
sis a
nd the
rap
ies. N
eph
rol
Di
al T
ra
nspl
ant. 2019;34:
1
826-
32
23
Ca
nney, M., O
’H
ara, P
. V.
, Mc
Evoy
, C. M., Me
dan
i, S.
, Co
nna
ughto
n, D. M.
, A
bda
lla, A
. A., . . . Li
ttl
e, M. A. (2016). Spati
al an
d
T
em
pora
l Clu
ster
ing o
f Anti
-Gl
ome
rul
ar Ba
sem
ent M
emb
ran
e Dis
eas
e Cli
n J Am S
oc Ne
phr
ol, 1
1(8), 1
392-
1
39
9. doi:1
0.221
5/
C
J
N
.1
3
5
9
1
2
15
24
Mc
Adoo S e
t al. An
ti-G
BM di
sea
se. Cli
n J Am S
oc Ne
phro
l 201
7
. 12
: 1
162–1
17
25
25
Jo
hnso
n et
al. M
edi
cine (B
alt
imor
e)
1985 Jul; 64
(
4):2
19-27
26
GO
OD-
IDES-
01 Cli
nic
alT
r
ial
s.gov Id
enti
er
: NCT031
57037
Interview
Elisabeth
Sonesson
Gl
obal Fr
anchi
se Lead A
utoim
muni
ty
Hansa Biopharma
Annual Report 202
1
44
Strateg
y
T
echnology
The share
Ma
rket
Ove
rv
iew
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Gr
owt
h
Pot
ent
ia
l of us
ing i
mli
d
ase v
s. PLE
X in AM
R
Illus
trative
G
raf
t los
s if un
treate
d
PLEX (Multiple rounds
)
Imlidase
Days
0
Clinical symptoms
2
3
4
5
6
7
8
9
1
Start of treatment
PLEX
Imlifidase
Level of Donor Specific Antibodies (DSAs)
A
ctiv
e kidne
y tr
ansplant
AMR
Long-term graf
t sur
vival is challenged by AMR post transpla
ntation
Acti
ve anti
body m
edi
ated rej
ecti
on, or A
MR, is a se
rio
us
condition
after transplan
tation
that occ
urs in r
oughly 1
0% o
f
ki
dney tr
ansp
lants a
nd is a si
gni
can
t chal
len
ge to long
-
ter
m
gra
ft s
ur
viva
l. AMR, i
s the ma
in cau
se for gr
af
t dysf
uncti
on an
d
lo
ss af
ter ki
dney tr
ansp
lant
ation. I
n the U.S. and Eu
rope, the
re
are a
pproxi
matel
y 45,000 p
atien
ts who re
cei
ve kid
ney
tra
nspl
ants, a
nnua
lly
, and a
pprox
imatel
y 400,00
0, who
cur
rentl
y live w
ith a k
idney t
rans
plan
t
27
. AM
R is one of t
he most
challenging adverse e
vents a
f
t
er kidney tr
ansplantation,
oc
curr
ing in a
pprox
imatel
y 1
0% of p
atien
ts
28
, an
d there i
s no
approv
ed therapy
.
T
o
day’
s sta
nda
rd of care f
or AMR tr
eatme
nt inc
lude
s pla
sma
excha
nge a
nd treat
ment w
ith stero
ids an
d IVIg. A
MR pati
ents
not tre
ated su
cce
ssf
ully r
isk gr
af
t fail
ure, dia
lysi
s and ret
urn to
the w
aitlist
.
29
Gi
ven that t
here a
re no ap
proved th
era
pies f
or AMR
, the abi
lit
y
of iml
id
ase to dire
ctly i
nter
vene w
ith the p
athop
hysio
log
y of
AM
R is potenti
all
y a sign
ic
ant new ad
vanc
eme
nt in the
treatme
nt of
AM
R.
Ha
nsa’s p
has
e 2 pro
gra
m in AM
R
Iml
ida
se is cu
rren
tly be
ing inve
stig
ated in a ph
ase 2,
randomiz
ed, open-
label, mult
i-center
, control
led trial,
which is
exp
ected to e
nroll 3
0 AMR pati
ents ac
ross c
enter
s in Fran
ce,
Ge
rma
ny
, Au
stri
a, Austr
alia a
nd the U.S. Th
e stud
y is de
sign
ed
to evalu
ate the saf
ety a
nd ec
acy of iml
ida
se in el
imin
ating
do
nor sp
eci
c anti
bodi
es (DS
As) in acu
t
e AM
R patie
nts, pos
t
tra
nspl
antat
ion. T
we
nt
y subj
ects w
ill be r
ando
mized to re
cei
ve
iml
id
ase tre
atmen
t comp
rise
d of one i
ntraven
ous do
se of
0.25mg
/kg, whi
le 1
0 sub
jec
ts in the a
ctive c
ontrol a
rm wi
ll
rec
eive 5
-
10 ses
sion
s of plas
ma excha
nge. Ec
acy an
d safet
y
will be
monitor
ed ov
er a 6-mon
th period
, post
treatmen
t.
End of D
ece
mbe
r
, 2021
, 23 of th
e targ
eted 30 pa
tient
s have
be
en en
rolle
d at 1
4 c
enter
s acro
ss the U.S.
, Eur
ope an
d
Aus
trali
a. 28 of the ta
rgeted 3
0 patie
nts were e
nrol
led by A
pri
l
6, 2022) Enro
llme
nt is exp
ected to be c
omp
leted in th
e rst h
alf
of 2022 wi
th the r
st data re
ad out ex
pec
ted in the s
eco
nd hal
f
of 2022, as pre
viou
sly g
uide
d. Thi
s guid
ance a
ssu
mes n
o
further escalation or
sustained
negative
impact o
f the
COVI
D-
1
9 pa
nde
mic, pote
ntial
ly forc
ing tr
ial ce
nters to
reprioritiz
e pat
ient recruitmen
t or e
ven shut
down a
gain.
A lo
ng-term, 3 ye
ar fol
low-up s
tudy w
ith pati
ents f
rom the
co
mplete
d AMR p
hase 2 tr
ial, h
as be
en ini
tiated. T
he pr
imar
y
endpoint is gr
af
t
sur
vival
. Five
patients
have comple
ted the
one-y
ear visit.
More i
nformation
about the
trial is
avai
lable at
ClinicalT
rials.
gov
und
er NCT0
3897
205 (201
9).
27
Gl
oba
l Obs
er
vator
y on d
onat
ion & tr
ans
pla
nt
28
Put
ta
raja
ppa e
t al., Jou
rna
l of T
r
ans
pla
ntati
on, 201
2, Ar
ti
cle ID 19372
4
29
Put
ta
raja
ppa e
t al., 201
2; Jo
rda
n et al., 201
5
Hansa Biopharma
Annual Report 202
1
45
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Guilla
in-Barr
é synd
rome (
G
BS)
Guillain-Ba
rré syndrome is an acute autoimmune attack on the per
i
pher
al ner
v
ous system
GBS is
an aggressiv
e neurological
disease o
f the
peripheral
ne
rvo
us syste
m that ae
cts 1
-2
in 100,00
0 peo
ple, ann
ual
ly
,
rep
rese
nting a
n addr
ess
able p
opu
latio
n of ~
1
1
,00
0 pe
r year in
the s
even ma
jor ma
rkets.
30
GBS i
s the mo
st fre
que
nt caus
e of
acu
te neur
omus
cula
r weak
nes
s in the we
ster
n worl
d and ca
n
ae
ct anyon
e at any ag
e and ma
ny patie
nts deter
ior
ate,
des
pite standa
rd o
f ca
re
treatm
ent.
T
wo th
irds of G
BS pati
ents have s
evere sy
mptoms, re
sul
ting in
an i
nabi
lit
y to walk un
aid
ed, and 20
-30% re
quire m
ech
ani
cal
vent
ilati
on for we
eks or m
onths
31
. Wh
ile pat
ients a
re ty
pic
ally
tre
ated with e
ithe
r IVI
g or pla
smap
here
sis, a s
igni
ca
nt unme
t
me
dica
l nee
d rema
ins, a
s not all p
atien
ts ful
ly rec
over fro
m
GBS
. Up to 40% of patie
nts wi
ll los
e stren
gth an
d have
ongoing pain
. Mortality is est
imated
at be
tween 3-5
%.
32,3
3
Ha
nsa’s p
has
e 2 pro
gra
m in GB
S
Iml
ida
se is cu
rren
tly be
ing inve
stig
ated in a ph
ase 2 tri
al
ta
rgeted to en
roll 3
0 GBS pat
ients a
cros
s clin
ics in Fr
ance, th
e
UK a
nd the Ne
ther
lan
ds. It is a
n ope
n-lab
el, si
ngle a
rm,
mul
tice
nter stu
dy eval
uatin
g the saf
ety
, tole
rabi
lit
y and e
cacy
of iml
id
ase in GB
S patie
nts, in co
mbin
atio
n with st
anda
rd of
care int
ravenous immunoglobulin
(IVIg)
. GBS patients
enrolled
in th
e stud
y will re
cei
ve a sin
gle do
se of 0.25 mg/
kg of
iml
id
ase. Th
e patie
nts wil
l be com
pare
d with a ma
t
ch
ed
co
ntrol gro
up of GB
S patie
nts trea
t
e
d with IV
Ig, fro
m the
Int
ernational G
BS Outcome
Study (
IGOS)
database
.
End of D
ece
mbe
r
, 2022, 1
5 of the ta
rgete
d 30 pati
ents have
be
en en
rolle
d acro
ss ce
nters i
n Franc
e, the U.K. and th
e
Neth
erl
and
s. (
1
6 of the t
argete
d 30 pati
ents we
re enro
lled by
Ap
ril 6, 2022).
The widespread impact
of the
COVID-
1
9 pandemic including
the e
merg
enc
e of new var
ian
ts have imp
acted t
he avail
abi
lit
y of
sta
 acros
s a numb
er of tri
al cen
ters. Ad
ditio
nal
ly
, a s
hor
tag
e
of IVI
g has ae
cted th
e enrol
lme
nt rate at a sub
set of
par
t
icipating hospitals
in our GBS
program. Giv
en the current
di
cul
ty of pre
dic
ting en
roll
ment du
e to the dire
ct an
d indi
rect
ee
cts of the c
ontin
ued pa
nde
mic an
d incre
ase
d infe
ction
rate
s due to omi
cron, Ha
nsa Bi
oph
arm
a expec
ts to update i
ts
gui
dan
ce rel
ated to the GB
S stud
y time
line
s on Ap
ril 21
, 202
2
,
in connection
with t
he publicat
ion of
its Q
1 report. In
the
me
antim
e, in orde
r to hel
p mitig
ate the
se hurd
les, th
e
Co
mpany h
as sim
pli
ed the s
tudy pr
ot
oc
ol an
d is acti
vely
sup
por
tin
g the hir
ing of ad
diti
onal s
ta at the a
ected c
lini
cs.
In ad
diti
on, two s
ites we
re adde
d dur
ing Ja
nuar
y a
nd
Feb
rua
ry 20
22
, for th
e recr
uitm
ent of pa
tient
s in the U.K.
and the
Netherlands.
In 201
8
, the U.S. FDA gran
t
e
d Orp
han Dr
ug De
sig
natio
n
to imli
da
se for the t
reatme
nt of GBS. M
ore info
rmat
ion
about the
study
is av
ailable at
ClinicalT
rials.
gov under
NCT03
94358
9 (20
1
9).
30
Sev
en Ma
jor M
arket
s Seve
n maj
or ma
rkets i
ncl
ude US
, Ger
many, UK,
France
, Spai
n, I
taly
, and
Japan
31
Fl
etche
r DD, Law
n ND, Wolte
r TD, et al. L
ong
-term o
utco
me in pa
tien
ts
with GuillainBarré
syndrome requiring mechanical v
entilation.
Neurology
20
00;5
4
:231
1–5
32
McGrogan et
al.
,
” The Epidemiology o
f Guillain-Barré Syndrome
Worldwide
“
, Neuroepidemiology;
2009
, 32
(2
):
1
50-63
33
van d
en B
erg et a
l.
, 201
4
Poten
tial with
imlidase
Illus
trative
-4
4
8
12
0
Paralysis
No weakness
Time from onset of weakness (weeks)
Infection
Course of GBS
Antibodies
T
o
day
’s St
and
ar
d of Ca
re IV
Ig or PL
EX
Illus
trative
-4
4
8
12
0
Paralysis
No weakness
Time from onset of weakness (weeks)
Infection
Course of GBS
Antibodies
Hansa Biopharma
Annual Report 202
1
46
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Imlid
ase in
gen
e
t
herapy –
an emer
ging oppor
tun
it
y
Neutra
li
zing antibodies (NAbs) are immunological bar
rier
s in gene therapy
Ge
netic d
isor
der
s are ca
used by d
efect
ive ge
nes w
hich f
ail to
pro
duce a f
unc
tioni
ng prote
in. Gen
e the
rapy tre
atmen
ts are
designed t
o int
roduce genet
ic mat
erial int
o cells
to
compensate
for th
ese n
on-fu
nctio
ning g
ene
s Thu
s, if a mu
tated ge
ne
ca
uses a
n ess
enti
al protei
n to be faul
ty o
r miss
ing, ge
ne
the
rapy may b
e abl
e to introd
uce a no
rma
l copy of th
e gen
e
to resto
re the ge
ne fu
ncti
on to prod
uce th
e desi
red pr
ot
e
in.
In or
der to tra
nsfer a h
eal
thy and f
unc
tioni
ng ge
ne into a c
ell,
non-replicating
and non-disease causing viruses,
usually
ade
no as
soci
ated vi
rus ve
ctors (
A
A
Vs), are uti
lized. T
he tra
nsfe
r
an
d inse
rt
ion of th
e heal
thy ge
ne and i
ts vecto
r into a cel
l is
called tr
ansduction.
Th
ere ar
e vector
s that ca
n be adm
inis
tered l
oca
lly to se
lecte
d
ta
rget tis
sue
s incl
udin
g spe
cic c
ell
s in the eye an
d the bra
in.
Th
ere ar
e also ve
ctors t
hat ca
n be dis
tribu
ted syste
mic
ally,
ta
rgetin
g live
r or mus
cle c
ells. S
inc
e most pe
opl
e have be
en
exp
osed to ad
enov
irus
es at so
me poi
nt in the
ir live
s, the
re is a
relativ
ely high p
revalence
of pr
eformed an
tibodies again
st
A
A
Vs. The p
revale
nce of th
ose an
tibo
dies va
rie
s sig
nic
antl
y
bet
wee
n the di
erent t
yp
e of vector
s and ca
n be as hi
gh as up
to 70
% in t
he gen
era
l popu
latio
n (e.
g. A
A
V 1
)
34
. Th
e pres
enc
e
of
antibodies a
gainst AA
V blocks
the tran
sduction,
thus
preventin
g succe
ssful ge
ne therapy treatm
ent in those
pati
ents. T
his m
eans t
hat a sub
stan
tial pr
opor
ti
on of pati
ents
are excl
ude
d from th
e poss
ibil
it
y of havin
g a potenti
ally
disease-curing gene therapy
treatment
.
We bel
ieve that o
ur anti
bod
y cleav
ing e
nzy
me, iml
ida
se, has
the po
tent
ial t
o eliminat
e an
tibodies which
can bind an
d inhibit
ge
ne the
rapy
, the
reby en
abli
ng eec
tive tra
nsfe
r of a heal
thy
ge
ne seq
uen
ce into th
ese pa
tient
s. The c
once
pt of usi
ng
iml
id
ase as a pote
ntia
l pre-tre
atmen
t t
o ove
rcome p
re-ex
isti
ng
antibodies
to
A
A
V based gene t
herapy w
as highligh
ted in
“
Na
ture M
edicine
,
” in 2020
35
. In particular
, highly encouraging
results from
preclinical studies were published
, illustrating
that
iml
id
ase co
uld el
imin
ate the blo
cki
ng ee
ct of NAb
s towards
A
A
Vs in
a mouse model
, in non-h
uman primates,
as well
as in
human plasma
samples from
patient
s with
antibodies
against
A
AVs
.
Our collabora
tions wit
h Sarept
a Therapeutics in
L
GMD and
DMD, an
noun
ced i
n 2020, and th
e coll
abo
ratio
n with As
kBi
o in
Pompe disease
, announced in
the beginning o
f this y
ear
, are
evi
den
ce of an in
teres
t amon
gst ge
ne the
rapy c
ompa
nie
s t
o
use i
mli
das
e t
o pote
ntial
ly pre
-treat ge
ne the
rapy pa
tients w
ith
pre
-exi
sting a
nti-A
A
V an
tibod
ies.
34
Bo
utin et a
l (201
0), Gri
n et al (201
9), Wan
g et al (201
8), Calc
edo & W
ilso
n
(201
3), Fal
ese et a
l (201
7
), Haiy
an et al (2
0
1
7), El
lswor
th e
t al (201
8), Gre
ig
et al (2
0
1
7)
35
Le
borg
ne, C., Bar
bon, E., Al
exan
der, J.M. et al. I
gG-
cle
avi
ng
en
dop
epti
dase e
nab
le
s in vi
vo gen
e the
rapy i
n the pr
ese
nce of a
nti-A
AV
ne
utra
liz
ing anti
bod
ies
.
Nat Me
d
26, 1
09
6
–
1
101
(2020). htt
ps:/
/doi.
o
r
g
/10
.
10
3
8
/s
4159
1-
0
20
-
0
911-7
Hansa Biopharma
Annual Report 202
1
47
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Rare mon
ogenic disea
ses
Fr
om hundreds o
f patient
s to
thousands of
patients
D
M
-1
1
00,
000
Astellas
Hemoph
illa
+5
5,
000
Spark, BioMarin
, uniQure,
T
a
keda, P
zer
, Free
lin
e
Duchenne
20
,000
Sa
repta, P
zer
,
Astellas
OTC
-
deciency
20
,000
Ult
rage
nyx
SMA
+30
,
000
Novartis
Wilson
40
,000
Vi
viet, Ul
trag
eny
x
Limb-
Girdle
20
,000
Sarep
ta,
Genethon
,
AskBio
Fa
br
y
-
9
,000
Fre
eli
ne,
UniQure
Pompe
1
0,
000
Spark, AskBio
,
Astellas
HAE
8,
000
BioMarin,
REGEN
XBIO
PKU
25,000
BioMarin
Late Preclinical
Clinical
Ma
rke
t
Pr
ecl
inic
al pr
ogra
ms wi
th Sa
rept
a and As
kBi
o
Po
tential
gene therapy
indications
(current
ly not
pursued)
Si
ze of idi
cati
on (U.S. & E
U)
Systemic
gene therapy is
an emer
ging oppor
tun
it
y
With a focus on the pot
ential to corre
ct issues causing genes in r
are monogenic disease
s
Hansa Biopharma
Annual Report 202
1
48
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Pr
evela
nce o
f Nab
s in A
AV
s
A
AV
1
A
AV
2
A
AV
8
A
AV
6
A
AV
7
A
AV
9
A
AV
5
Up to 10%
Up to 30%
Up to 20%
Up to 30%
A
A
V-
r
h
74
Up to 70%
Up to 60%
Up to 60%
Up to 45%
A
AV
4
CNS,
Eye
,Sk
eletal m
uscle
CNS, Eye,K
idne
y
Lung,
Skeletal
muscle
Liver
, Sk
eletal muscle
Hear
t
,Liv
er
, Lung,
Skeletal
muscle
CNS,
Eye
,Sk
eletal m
uscle
CNS, Liver
,
Lun
g Eye
Li
ver
, CNS, He
ar
t, Eye,
Pancreas
, Sk
eletal muscle
Up to 2%
CNS,
Lun
g, Eye
Source: Boutin et al (2010), Grin et al (2019), W
ang et al (2018), Calcedo & Wilson (2013),
Falese et al (2017), Haiyan et al (2017), Ellsworth et al (2018), Greig et al (2017)
Eye (
loca
l ta
rge
t)
~1
x
1
0
11
vg
Live
r (syst
emic)
~1
x
1
0
14
vg
Brain (local target)
~1
x
1
0
12
vg
Muscle (systemic)
~1
x
1
0
15
vg
A
A
V 4 & 8
A
A
V 1
, 2 & 5
A
A
V 6, 7
, rh7
4
A
A
V 3,7 & 8
Th
e prev
ale
nce of N
abs va
ri
es sig
ni
ca
ntl
y an
d
i
s a
ba
rr
ier t
hat p
re
clu
des
ge
ne th
er
api
es f
rom wor
ki
ng in a l
arg
e gro
up of p
at
ien
ts
T
ropism and
target tissue
Systemic gene
therapy is an
emergi
ng oppor
tunit
y
cont
inued
Hansa Biopharma
Annual Report 202
1
49
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Colla
borat
ion wi
th Ask
Bio to e
v
alu
ate
feasibilit
y of imlidase as pre
-
t
reatme
nt
ahead
of g
ene ther
ap
y in P
ompe disease
Potential
milestone
payments
Phase
1/
2
study
Preclinical
Devel
opmen
t
Antibody cleaving
enzyme technology
Current a
greement sco
ped around
a fea
sibility program
wh
ic
h cover
s pr
ec
lin
ic
al wor
k an
d a Pha
se 1/2 stu
dy
Commerciali-
zation
Regula
tory
approval
Hansa’
s k
ey resources
and deliverables
>
Imlifidase v
alidat
ed with
positive
clinical efficacy and
safe
ty da
ta as wel
l as Euro
pea
n appr
oval
>
Significant know-ho
w around an
tibody cleaving enzymes
>
Cle
ar pat
h to U
.S. ap
proval (
kidn
ey tran
spl
ant)
>
Hansa supplies mat
erial and pro
vides additional support
AskBio’
s key
resources and deliv
erables
>
Ea
rly in
novator i
n the Ge
ne Th
era
py spac
e with A
AV
platform and ongoing
clinical stage P
ompe disease program
>
Conducts
pre-clinical and
clinical trials
according
to
agreed plan
Antibody cleaving
enzyme technology
E
xclu
siv
e opt
ion f
or As
kBi
o to ne
got
ia
te a po
ten
ti
al fu
ll
development
and commercialization agreement
Potential structure
Poten
tial roy
alties
and sales
Up
fr
ont fe
e of U
SD 5m
®
Feasibil
it
y progra
m to
evaluate imli
dase as
pre
-
treatm
ent ahead of
gene therapy in
Po
mpe
disease f
or patients
with pre-
e
xisting
neutr
alizing antibodies
(NA
bs) t
o ade
no-
assoc
iated vir
us (A
A
V
)
Hansa Biopharma
Annual Report 202
1
50
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Collaboration Agreement
On J
anua
ry 3, 20
22
, Ha
nsa an
nou
nced a c
oll
abor
ation
agr
eem
ent wi
th Ask
Bio (su
bsidi
ar
y of Baye
r A
G), a ful
ly
inte
grated A
AV gen
e ther
apy com
pany d
edic
ated to
deve
lop
ing me
dic
ines t
hat imp
rove the qu
ali
ty of li
fe for
patien
ts with
genetic
diseases.
Th
e coll
abo
ratio
n will eva
luate th
e potenti
al use of im
li
dase a
s
a pre
-treatm
ent pr
ior to th
e admin
istra
tion of A
skBi
o
’
s ge
ne
the
rapy in Po
mpe di
sea
se in a pr
e-cl
inic
al an
d clin
ica
l feas
ibil
ity
pro
gram fo
r patie
nts wit
h pre-
existi
ng NA
bs to the ade
no-
as
soci
ated vi
ral vec
tor use
d in As
kBio’
s ge
ne the
rapy
.
Und
er th
e t
e
rms of th
e agree
men
t
, Ha
nsa re
cei
ved a US
D
5 mil
lion p
ayme
nt upo
n ex
ec
utio
n of the agr
eem
ent an
d
As
kBio h
as the excl
usi
ve option to ne
goti
ate a
f
ull deve
lop
ment
and commercial
ization a
greement,
follo
wing ev
aluation o
f the
res
ults f
rom an i
niti
al pha
se 1
/2 stud
y
.
As
kBio’
s ge
ne the
rapy c
andi
date, A
A
V2/8
-LSPh
GA
A, i
s bei
ng
inve
stig
ated for th
e treatm
ent of Pom
pe Di
seas
e. Thi
s gene
the
rapy c
andi
date com
bin
es A
A
V2 an
d AAV8 ca
psid
s, t
o
de
live
r a liver-spe
cic p
romote
r t
o exp
ress t
he GA
A en
zy
me.
It is c
urre
ntly b
eing i
nvesti
gated by A
skBi
o in an o
pen-
labe
l,
pha
se 1
/2 stud
y (Clin
ica
lT
r
ial
s.
gov: N
CT03533
6
73)
, in w
hich
8 pati
ents w
ith La
te-O
nset Pom
pe Di
sea
se wil
l be enro
lle
d.
For further in
formation
regarding
AskBio
’
s gene
therapy
program in
Pompe disease
, please re
fer t
o ww
w
.askbio.com
.
Pompe
Disease
Pomp
e dise
ase i
s a rare g
eneti
c, ofte
n fatal, d
isor
der c
ause
d
by a defe
ct in a g
ene m
aki
ng an en
zy
me ca
lled a
cid al
pha-
glu
cos
idas
e (GA
A). GA
A is u
sed to bre
ak dow
n glyc
oge
n
(a sug
ar use
d to store en
ergy i
n cel
ls) and a d
efect G
A
A
en
zym
e lea
ds to accu
mula
tion of gl
ycog
en in th
e bod
y’
s cel
ls.
Th
e glyc
oge
n accu
mulati
on in c
er
tai
n orga
ns and ti
ssu
es,
es
pec
iall
y musc
les, l
iver a
nd he
ar
t, severe
ly imp
act no
rma
l
organ function
.
Up to 30
0 die
rent mu
tatio
ns res
ultin
g in Pomp
e dise
ase
have be
en id
enti
ed an
d the seve
rit
y an
d age of ons
et is
rel
ated to the sp
eci
c mut
ation
s. The m
ost seve
re form
s (
e
arly
ons
et or inf
antil
e form) re
sult i
n, for examp
le, an en
larg
ed he
ar
t,
mus
cle we
akn
ess a
nd res
pirator
y di
cu
ltie
s and mo
st patie
nts
wi
th the inf
antil
e form d
ie fro
m card
iac or re
spi
rator
y fai
lure
befo
re the
ir rst b
ir
thday. The late o
nset or j
uven
ile/adul
t form
ini
tial
ly pre
sent
s as mus
cle we
akn
ess, p
rogre
ssin
g to
res
pira
t
or
y we
akn
ess a
nd de
ath from r
espi
rator
y fai
lure af
ter
sev
eral y
ears.
While en
zyme replac
ement t
herapy
(ER
T
)
has
sh
own prom
ise in p
atie
nts with Po
mpe d
isea
se, no cu
rative
therapy
is a
vailable.
Pomp
e dise
ase i
s estim
ated to aec
t 1 in 40,000 b
ir
ths in
the U.S.
36
, an
d equa
t
e
s t
o an i
nci
denc
e of ~
200 p
er yea
r in
the U.S an
d Europ
e. Additi
ona
lly
, dat
a indi
cates th
at the
preva
len
ce of Pom
pe dis
ease i
n the U.S. and Eu
rope,
co
mbin
ed, is ap
proxim
ately 10
,00
0
37
. Th
e perc
enta
ge
of pati
ents th
at are exp
ected to have N
Abs ag
ain
st the
A
A
V8-ve
ctor co
mpon
ents u
sed in A
skB
io’
s g
ene th
era
py
is 4
0-
60%
38
.
36
Pompe Disease
, https:
/
/rarediseases.
org/rare-diseases/pompe-disease/
37
Ca
lcul
ated by H
ans
a on th
e basi
s of inc
ide
nce n
umb
ers f
rom ht
tps://rar
edi
seas
es.o
rg/ra
re-
dise
ase
s/po
mpe
-di
sea
se/ a
nd li
fe expe
cta
ncy e
stim
ates f
rom
https:
/
/pompediseasene
ws.com/lat
e-onset
-pompe-disease/
, as well
as population
statis
tics for
the Unit
ed Stat
es and E
uropean Union/Eur
ope
38
ESGC
T 2
7th A
nnua
l Con
gre
ss Ab
stra
cts, Se
nsi
tiv
ity o
f die
rent A
AV se
roty
pes to p
re-
exis
ting N
Abs, h
ttp
s:/
/w
ww.es
gct.eu
/h
ome
/Ba
rcel
ona%202
0
19/
NE
W_
All%20
Barc
elo
na%20Ab
stra
cts.p
df & Bo
utin e
t al. Prev
ale
nce of s
eru
m IgG a
nd ne
utra
liz
ing fa
ctor
s aga
inst a
den
o-a
ssoc
iate
d vir
us (A
AV) t
yp
es 1
, 2, 5,
6, 8, an
d 9 in th
e hea
lthy p
opul
atio
n: imp
lic
atio
ns for g
ene t
hera
py us
ing A
AV vecto
rs. Hu
m Gen
e Th
er
. 201
0. ht
tps://pubm
ed.n
cbi.n
lm.ni
h.gov/200
95819/
Hansa Biopharma
Annual Report 202
1
51
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
Collabor
ation wit
h AskBio to
ev
alu
ate feasibili
t
y of
imli
dase as
pre-treatment
ahead of
gene therapy
in Pompe dis
ease
cont
inued
E
xplor
ation of HSCT as an
oppor
tu
nit
y f
or imlidas
e
As par
t of the Company’
s platfor
m
strategy a
nd objectiv
e to broaden the
application of
imlidase as a po
tential
therapy to change the cours
e o
f IgG
-
mediated immunological diseases and
conditions, we are e
xploring new
indications with high unmet need.
One such
indication
is allogeneic HS
CT
, also kno
wn as
“bonemarrow
” transplan
tation
. Desensitizat
ion trea
tment o
f
pati
ents wi
th elevate
d
le
vels of don
or spec
ic an
tibod
ies (DS
A)
pr
ior to al
loge
nei
c HSCT tra
nspl
ant is a c
hal
leng
e, and cu
rre
ntly
the
re are no a
pprove
d dru
gs to man
age th
ese pat
ients
. It is
Ha
nsa Bio
pha
rma’
s beli
ef that iml
ida
se may have the poten
tial
to tran
sfor
m the sta
nda
rd of care by e
nab
ling c
lini
cian
s to
ina
ctiva
t
e DS
As pri
or to tran
spl
antati
on so a
s t
o cr
eate the b
asis
for
successful transplant
ation.
Al
loge
nei
c HSCT is a key
, pote
ntia
lly cu
rative tr
eatme
nt
int
er
ven
tion f
or patien
ts with
high-risk
hematolog
ic malignancies,
wi
th over 50,00
0 HSCT tra
nspl
ants p
er
form
ed an
nual
ly
,
wor
ldwi
de with ap
proxi
matel
y
ha
lf bei
ng allo
gen
eic
39
. Th
e
pref
erre
d don
or for pat
ients i
s a huma
n leu
kocy
te antig
en, or
HL
A, ma
tched individual
. In the
absence of
HL
A-ma
tched
donors,
or when an
urgent t
ransplant is
needed, haploiden
tical
donors (
siblings, parent
s, children
) are
now increasingly
considered f
or tran
splantation
. Overall
, in
haploidentical
HSCT
,
the pre
vale
nce of dono
r
-spe
ci
c
an
ti-HL
A anti
bod
ies var
ies
acc
ordi
ng to publ
ish
ed dat
a and may r
ange b
etwe
en 1
0% an
d
2
1%
40
. Th
is prop
or
tio
n is hig
hly de
pen
dent o
n the re
cipi
ent’s
39
https:
/
/
ashpublications
.org/blood/
article/1
34/Supplement_
1
/2035
/
42
7
903/
One-and-Half-Million-Hemat
opoietic-Stem-Cell
40
Ci
urea e
t al. Th
e Euro
pea
n Soc
iet
y for Bl
ood a
nd Ma
rrow Trans
pla
ntat
ion (E
BMT
) Co
nse
nsu
s Guid
eli
nes f
or the D
etec
tion a
nd
T
rea
tme
nt of Don
or-spe
ci
c Ant
i-HL
A A
ntib
odie
s (DS
A) in Ha
plo
ide
ntic
al He
mato
poi
etic C
ell Trans
pla
ntati
on. Bo
ne Ma
rrow
T
ra
nspl
ant. 2018;
53
(5):52
1-534. Ava
ila
ble at: ht
tps:
/
/
ww
w.ncb
i.nlm.n
ih.gov/pm
c/ar
tic
les
/PMC723277
4
/
ge
nde
r
, wi
th low prev
alen
ce in m
ale re
cipi
ents c
ompa
red to
female recipients
, as a
result of
sensitization during
pregnancies.
DSA h
ave bee
n reco
gnize
d as an i
mpor
ta
nt bar
rie
r aga
inst
suc
ces
sfu
l
en
graf
tme
nt of dono
r
ce
lls. Pre
-exi
sting DSA in
crea
se
the risk
of p
rimar
y
failure o
f engra
f
tmen
t of
donor hemat
opoietic
pro
geni
tor ce
lls, le
avin
g the pati
ent in a s
tate of mar
row ap
lasi
a
af
ter tran
spl
antati
on and exp
osin
g the patie
nt t
o a high r
isk of
non-relapse
mortalit
y
.
According t
o consensus
guidelines from the E
uropean Society
for B
lood a
nd Ma
rrow T
rans
pla
ntatio
n, if DSA l
evels h
ave a
Me
an Flu
ores
cen
ce Inte
nsit
y (MF
I) above 100
0
,
desensitizat
ion therap
y is r
ecommended, especially
in pat
ients
wi
th high D
SA leve
ls (>500
0 MFI), wh
ich po
ses a ve
ry h
igh r
isk
of ne
utrop
hil en
graf
tme
nt fai
lure. It i
s, ther
efore, al
so
rec
omm
ende
d that eo
rt
s be made to sc
ree
n all pati
ents
befo
re tran
spla
nt, and d
ese
nsit
ize patie
nts wi
th DSA pr
ior to
transplant
to
avoi
d the
negative
outcomes on
neutrophi
l
engraftment and pat
ient surv
iv
al.
Des
ensitiz
ation treatme
nt of
patie
nts with high leve
ls of DSA
prior t
o allogeneic H
SCT
transplant
remains a
challenge,
and
cur
rentl
y the
re are no a
pprove
d dru
gs to mana
ge the
se
pati
ents. D
iere
nt strate
gie
s, mostl
y adopte
d from so
lid o
rgan
tra
nspl
antat
ion ap
proac
hes, h
ave bee
n explo
red to red
uce th
e
antibody
titer
or desensitiz
e such
patient
s, includ
ing anti
body
remov
al (plasmapheresis
)
, inhibit
ion of
antibody
production
(rit
uxi
mab, bor
tezom
ib)
, an
d incre
asi
ng anti
body tu
rnove
r (e.
g.
IV
Ig)
, amo
ng othe
rs. Dat
a for the e
ecti
vene
ss of the
se
desensit
ization
met
hods ar
e deriv
ed fro
m case
reports and
sm
all ca
se ser
ies. T
hes
e app
roach
es yi
eld mi
xed res
ults,
wh
ereby a si
gni
ca
nt prop
or
tion of pat
ients w
ill co
mpl
ete the
tra
nspl
ant proto
col wi
th con
tinue
d pre
senc
e of DSA an
d ris
k t
o
the a
llog
raf
t. Imli
das
e may have the p
otentia
l to trans
form th
e
sta
nda
rd of care by e
nab
ling c
lini
cia
ns to inac
tivate DSA w
ith a
sin
gle ad
mini
strati
on pr
ior to tran
spl
antati
on. Iml
ida
se ca
n be
rea
dily i
ntegra
ted and o
per
ation
alize
d with
in cur
rent p
racti
ce at
the t
ime of
transplant
.
Bo
ne mar
row ce
lls fr
om pati
ent
s
’
own bo
dy (no i
ssue
s)
HL
A
-identical
sibling
HL
A-matched
unrelated donor
Autologous HSCT
Haploidentical
donor
Pr
e-
exi
sti
ng DS
As m
ay re
sul
t in p
rim
ar
y gr
af
t f
ail
ur
e and p
oor
survival after allogenic
hematopoie
tic stem
cell transplantation
Allogenic HSCT
Hansa Biopharma
Annual Report 202
1
52
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
ESG
Financials
Governance
Remuneration
Q.
Ha
ns
a wan
ts to b
roa
de
n int
o a new di
se
ase
ar
ea – w
hy is t
hat
?
A.
The technology
we ha
ve de
veloped has
great
poten
tial in
ma
ny dise
ase a
reas; on
colo
gy is j
ust on
e we are now
exp
lori
ng. We are spe
ci
cal
ly focu
sed on n
umer
ous ind
icat
ions
within
the rare
disease spa
ce, wher
e our t
echnology appears
to
be mo
st app
lica
ble, so ex
pand
ing th
e numbe
r of indi
cati
ons we
exp
lore is a na
tural s
tep for us.
Q.
Wh
y is th
e th
er
ap
eut
ic a
rea o
f all
oge
nei
c
HSCT so
interest
ing?
A.
Matc
hing of re
cipi
ent an
d dono
r is a com
plex act
ivi
ty an
d as
the ave
rage f
amil
y size c
ontin
ues to de
cli
ne, the li
kelih
ood of
nd
ing a matc
hed, rel
ated do
nor
, cont
inue
s to
de
cre
ase. Even
tho
ugh th
ere are p
rogra
ms an
d regi
sters i
n plac
e to incre
ase
the c
hanc
e of ndi
ng a per
fe
ct match for ev
er
yone, thi
s
som
etim
es fai
ls and i
s a muc
h long
er pro
ces
s than w
hen th
ere
is a re
lated d
onor ava
ila
ble. T
his is p
ar
ticu
larl
y trou
bles
ome fo
r
pati
ents w
ith mo
re advan
ced d
ise
ase in ra
pid n
eed of a
tra
nspl
ant. Don
or spe
ci
c antib
odi
es are a ma
jor co
nce
rn in
al
loge
nei
c HSCT an
d are lin
ked to pri
mar
y gr
aft f
ailu
re and
po
or sur
vi
val af
ter HS
CT
. O
ur tech
nol
ogy ha
s the pote
ntial to
rem
ove dono
r spe
cic a
ntibo
die
s, provi
ding an o
ppo
rtu
nit
y to
increase b
oth t
he pool
of a
vailable donors
and number
of
pati
ents w
ho have ac
ces
s to a potenti
ally l
ife-
savin
g ther
apy
.
Interview
So
a Jä
rnu
m
Global F
ranchise lead
New Therapies
Q.
Wh
o ar
e ae
cte
d, an
d why
?
A.
A
llog
ene
ic HSCT i
s used a
s a treatm
ent fo
r many no
n-
ma
lign
ant an
d mali
gna
nt dise
ase
s and i
s a treatm
ent wi
th a
curat
ive po
tential
for
many indica
tions.
Acut
e my
eloid
le
ukae
mia (A
ML), acute l
ymp
hoid l
euk
aemi
a (ALL
) and
myelody
splastic s
yndrome (MD
S) ar
e the
main indicat
ions for
wh
ich al
log
ene
ic HSCT is u
sed. T
he maj
or ca
use of
se
nsiti
zati
on to HL
A anti
gens a
nd dev
elop
ment o
f dono
r
sp
eci
c antib
odi
es are tra
nsf
usio
ns, prev
ious tr
ans
plan
t and
pre
gna
ncie
s. Patie
nts in ne
ed of al
log
ene
ic HSCT have of
te
n
rec
eive
d tran
sfus
ion s
uppo
rt a
nd are m
ulti
parou
s wome
n, so
the r
isk of b
eing s
ens
itized i
s hig
her a
mong p
atien
ts in ne
ed of
an allogeneic H
SCT
compared t
o the
aver
age populat
ion.
Q.
How i
s Ha
nsa a
dva
nci
ng t
he sc
ie
nce
for allogeneic HSCT?
A.
Desensitization
within allogeneic
HSCT
is buildi
ng on t
he
exp
eri
ence f
rom de
sen
sitiz
atio
n
str
ategi
es use
d with
in the
ki
dney tra
nsp
lant 
eld. Howeve
r
, th
e eld i
s young, a
nd no
sta
nda
rd of care h
as be
en deve
lop
ed to man
age pat
ients w
ith
hi
gh level
s of dono
r spe
cic a
ntibo
die
s. W
e have th
e potenti
al
to imp
act sta
nda
rd of care fo
r des
ens
itiza
tion p
rior to
al
loge
nei
c HSCT an
d our go
al is to ma
ke our tec
hnol
ogy a
ga
me-
chan
ger fo
r acce
ss to a pote
ntial
ly lif
e-sav
ing tre
atme
nt.
Allogeneic HSC
T is the only
cu
rative
treatm
ent
inter
ve
ntio
n
fo
r most pa
tien
ts wit
h high-risk
hemat
ologic malignancies
, and
presence o
f donor
-specic
ant
ibodies is a cont
raindica
tion
t
o
suc
ce
s
sfu
l tre
atme
nt
.
So
a Jä
rnu
m
Global F
ranchise lead
New Therapies
E
xplor
ation of HSCT as a
n oppor
tu
nit
y
for imli
dase
cont
inued
Hansa Biopharma
Annual Report 202
1
53
Strateg
y
T
echnology
The share
Directors
’
repo
rt
Ma
rket
Ove
rv
iew
Gr
owt
h
Research an
d preclinic
al
de
v
elopmen
t pro
jects
Ni
ceR c
an po
ten
ti
all
y in
act
iva
te a
re
s
Illus
trative
flare 1
flare 2
flare 3
flare (n)
Time
Level of Pathogenic IgG
Imlidase
Mi
ce wi
th h
uma
n Ig
G (~9m
g/m
L)
500
1000
1500
10
20
25
15
Days after innoculation
0
RTX Start
No
tre
atment
Rituximab
Imlidase +
Rituximab
So
urce: 1
Jär
num e
t al. M
ol Ca
nce
r Th
er 201
7
;
16
:1
887
-1
8
97
Ni
ceR – N
ew set o
f enz
ym
es for r
ep
eat
dosing; potentially enabling treatment of
relapsing disea
ses
Hansa is dev
eloping novel
IgG-degrading enzyme
s
under the
program name,
“NiceR” (Novel Immunoglobulin Cleaving
Enz
ym
es for Re
pea
t dosi
ng)
. T
he obj
ecti
ve of the en
zy
mes
deve
lop
ed fro
m the Ni
ceR pr
ogra
m is to ena
ble re
peat
dos
ing in a b
road ar
ray of ind
icati
ons wi
th sig
nic
ant un
met
medical need including reoccurring tr
ansplantation,
relapsing
autoimmune
diseases and
oncology
, where
pati
ents may b
ene
t from m
ore tha
n one do
se of an
IgG-modulating enzyme.
A bro
ad repe
r
t
oi
re of novel i
mmun
ogl
obul
in cyste
ine
endopeptidases
has been de
veloped and
paten
ted wit
hin the
pro
gram a
nd a le
ad can
dida
te was sel
ecte
d in 20
1
9 for
cli
nic
al deve
lop
ment. T
he sel
ecte
d can
didate i
s an IgG
-
cleaving
enzyme (cys
teine pep
tidase
) with
characteris
tics
bas
ed on a ho
mol
og to imli
das
e, but wi
th potenti
al for
lower
ed immunogenicity
.
Development o
f a GMP
-manufacturing pr
ocess is ongoing and
IND
-en
abl
ing toxic
olo
gy stud
ies fo
r the le
ad Nice
R can
dida
te
were i
niti
ated dur
ing th
e sec
ond qu
ar
ter of 2021 in pre
para
tion
for a cl
ini
cal ph
ase 1 stu
dy
. T
oxi
col
ogy stu
die
s are exp
ected to
be c
ompl
eted in 2022 a
nd, upo
n com
pleti
on of the
se stu
dies
,
Ha
nsa exp
ects to ad
vanc
e the Nic
eR pro
gram i
nto the cli
nic.
EnzE – Enzyme-base
d
antibod
y
Enhance
ment
Ha
nsa is c
urre
ntly in
vestig
ating E
nzE as a p
otentia
l
therapeutic
intervention
in oncology
, in which
imlidase
administ
ration
prior t
o therapeutic
antibody
treat
ment may
lead
to a more e
cie
nt anti-tu
mor th
erapy th
roug
h cleav
ing th
e
abundance of
normal IgG in blood
.
EnzE i
s cur
rentl
y a proje
ct in th
e rese
arch p
has
e, whil
e the
proof
-
o
f-
mechanism is being
inves
tigat
ed. The
concept is
being evalua
ted in
a B-cell lymphoma mouse model
to
de
mons
trate how pre
-treatm
ent wi
th imli
da
se in tum
or
pati
ents may p
otentia
lly i
ncre
ase the e
cac
y of curre
ntly
avai
lable antibody
-based
cancer therapies.
Hig
h leve
ls of pla
sma Ig
G in ca
nce
r patie
nts have b
een s
hown
to limi
t the e
cacy of th
erap
euti
c antib
odi
es, as pl
asma I
gG
ca
n satur
ate the ant
ibod
y rec
eptors of th
e patie
nt’
s im
mune
ce
lls, pre
ventin
g them f
rom ec
ient
ly kil
ling t
he tumo
r cel
ls.
Re
movin
g plas
ma Ig
G with im
lid
ase or n
ovel Ig
G-cl
ear
ing
en
zym
es fr
om the Ni
ceR p
rogra
m pri
or to dos
ing the p
atie
nt
with a
therapeutic
antibody
may po
tent
ially increase
the
ec
acy of a gi
ven ca
ncer t
hera
py
.
Hansa Biopharma
Annual Report 202
1
54
Strateg
y
T
echnology
The share
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Gr
owt
h
6
The
shar
e
Shar
eholder information
56
Own
er
ship a
nd ana
lys
t covera
ge
57
Hansa Biopharma
Annual Report 202
1
55
Strateg
y
T
echnology
Grow
th
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
The share
Shar
eh
older inf
ormatio
n
Hansa
share price
dev
elopment
versus
peer group
1
during
2021
50
100
200
150
250
0
1/21
2/21
3/21
4/21
5/21
6/21
7/21
8/21
9/21
10/21
11/21
12/21
300
XBI
Peer group
HANSA
1
Peer gr
oup consist o
f Scandinavian bio
tech/
ph
arm
a com
pani
es w
ith ne
gati
ve EBI
T and
1
-ye
ar ave
rage m
arke
t cap
ita
lis
atio
n of
ab
ove 2 00
0m SE
K (2022-02-
1
4)
Ha
nsa Bi
oph
arma’
s sh
ares a
re lis
ted on Na
sdaq O
MX
Stoc
kho
lm, und
er the ti
cker H
NSA an
d are inc
lud
ed in
seve
ral in
dexes in
clud
ing, bu
t not lim
ited to:
>
OM
X Nordi
c Mid Ca
p
>
OM
X Nordi
c Hea
lth Ca
re Index
>
OM
X Stock
hol
m Benc
hma
rk Ind
ex
>
OMX St
ockholm Health
Care
>
OM
X Stock
hol
m Mid Ca
p
>
OM
X Stock
hol
m Phar
mace
utic
als & B
iotech
nol
ogy
>
MSCI G
lob
al Sma
ll Cap
>
STOX
X Europe T
ota
l Marke
t Smal
l Index
Br
ief fa
cts
Listing
Nasdaq OMX
Stockholm
Nu
mber o
f sha
res
46,335
,36
1 (
44,
4
7
3,45
2 ordinary
shares and 1
,861
,909 C-shares
)
Ma
rket Ca
p Dec
emb
er 31
, 2
02
1
SE
K ~4bn (U
SD ~440
m)
Ti
cker
HNSA
ISIN
SE00
02
1
48
8
1
7
Brief facts,
the Hansa B
iopharma-share
According t
o t
he shareholder regist
er maintained by
Euroclear
Swe
den A
B, as of 3
1 De
cem
ber 2021
, H
ans
a Bio
phar
ma had
ap
proxim
ately 1
8,00
0 sha
reho
lde
rs, co
mpare
d to
ap
proxim
ately 1
7
,00
0 shar
ehol
der
s as of 3
1 De
cem
ber 2020.
Informat
ion regarding shareholders and
shareholdings is
upd
ated ea
ch qua
r
ter on the C
omp
any’
s web
site, w
ww.
hansabiopharma.com.
Share capital
T
ot
al sha
res is
sue
d as of 31 Dec
embe
r 202
1 a
mounte
d to
44,
4
73
,45
2 ordinary shares outstanding
and 1
,86
1
,909
C-s
hare
s. At year e
nd 2021
, th
e shar
e capi
tal a
mounte
d to
SEK 46,3
35,361
. At the g
ene
ral me
etin
g, each o
rdina
r
y shar
e
ent
itle
s the ho
lder to o
ne vote and e
ach s
hare
hold
er may vote
the f
ull nu
mbe
r of shar
es he
ld by him o
r her
. All o
utst
andi
ng
sh
ares a
re ful
ly pai
d up. The C
ompa
ny’
s sha
re ca
pita
l is
denominated
in Swedish kronor
(SEK) and divided among t
he
Co
mpany’s sha
res wi
th a quoti
ent va
lue of SEK 1 p
er sh
are.
Pr
ice d
evel
op
men
t for t
he HN
SA s
har
e in 2
02
0 an
d 20
21
20
21
2020
SEK
High
Low
High
L
ow
1s
t
q
ua
r
t
e
r
24
5.6
14
4
.5
89.0
63.6
2nd
quar
t
er
18
0.
9
13
2
.2
17
7.
2
78.2
3rd q
uar
te
r
151.
6
105.9
276
.0
16
4.
9
4th q
ua
r
ter
120
.
5
80.6
272.0
220.0
Hansa Biopharma
Annual Report 202
1
56
Strateg
y
T
echnology
Grow
th
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
The share
Owners
hip
and analyst co
v
erage
T
o
p 10 lar
ge
st sh
ar
eho
ld
er
s, 31 De
cem
be
r 20
21
Owners
Number of
shares
HNSA
Cap
it
al (%)
Redmile Group
5
,76
8
,6
19
13
Handelsbanken Asset Management
1
2,2
66,350
5
.1
Fourth Swedish
National P
ension Fund
2
,
2
0
7,
3
9
7
4.9
NX
T2B
2
,1
5
5
,
3
7
9
4.
8
Inve
sco A
dvi
ser
s, Inc.
1,
9
73
,
2
0
0
4.4
Thomas Olausson
1
,820,500
4
.1
Th
ird Swe
dis
h Nati
ona
l Pens
ion Fu
nd
1,
3
8
9
,
6
5
0
3
.1
För
säk
ri
ngs AB Avan
za Pen
sio
n
1,
2
3
2
,0
8
1
2.8
Schroder I
nvestment
Management,
L
TD
1
,16
0
,
9
0
0
2.
6
Th
e V
a
ngua
rd Gro
up, Inc.
1,1
5
8
,
2
0
0
2.
6
Othe
r
2
3
,
3
41,1
7
6
52.
6
Outstanding ordinary shares in
total
44,473,452
10
0
1
Handelsbanken Asset Management
decreased their ownership t
o under
5% dur
ing Ja
nua
r
y 2022
Hansa Bi
opharma shareholders
~
1
8
,
000
AS OF 31 DE
CEMBE
R 2021
So
urce: IH
S Mar
ki
t/I
PREO c
omp
ile
d and pr
oce
sse
d data f
rom va
rio
us
sources, including
Euroclear
, Morningstar
, Fact
set and t
he Swedish
Fi
nan
cial S
upe
rv
iso
ry Authority (Finansinspektionen)
An
al
ys
t cover
ag
e 20
21 an
d 20
22
An
alys
t
Ba
nk / Re
se
arc
h in
st
itu
ti
on
(year of
initiation)
Loc
ati
on
Email
Phone
Christopher Uhde
S
E
B
(2
016
)
Stockholm
christ
opher
.
[email protected]
+46 (
0) 87
6-
385 53
Adam
Karlsson
ABG
Sundal Coll
ier (2
01
8)
Stockholm
adam.karlsson@
abgsc.se
+4
6 (0) 8 566 28
6 9
1
Zoe
Karamanoli
R
B
C
(
2
0
17
)
London
zoe.k
aram
anol
i@rb
ccm.co
m
+44 783
4 7
651
19
Naresh Chouhan
Intr
on Health Resear
ch (2
020
)
London
naresh@in
tronhealthresearch
.com
+4
4 7
93
9 22
4 322
Douglas T
s
ao
H.C. W
a
inwr
ight (20
2
1
)
New Y
ork City
dtsao
@hcwresearch
.com
+
1 212-916
-3
9
68
Erik Hult
gård
C
a
r
n
e
g
i
e (
2
019
)
Stockholm
erik
.hultgar
d@carnegie.
com
+46 (0) 8
58-8
69 237
Johan Unnerus
Red
eye (2008)
Stockholm
johan.unner
[email protected]
+
46 (0) 724 023 385
Ludvig
Svensson
Erik Penser Bank
(202
1
)
Stockholm
ludvig.sv
ensson@penser
.com
+46 (
0) 704 962 5
35
Lar
s Hatholt
Ökonomisk
Ugebrev (
2020
)
Copenhagen
ha
tholt@outlook
.com
+45 2
2 23 78 1
5
Ingrid Gafanhão
K
e
m
pe
n
(
20
19
)
Ams
terd
am
Ingrid.
Gafanhao@k
empen.com
+31 689 9
37 5
25
Caroline
Banér
Da
nske Ba
nk (2021
)
Stockholm
[email protected]
+46 76 721 66 94
Ow
ne
rs
hip by t
y
pe a
nd lo
ca
tio
n, 31 De
ce
mbe
r 20
21
Ownership b
y type
Ownership b
y country
13%
4%
23%
60%
35%
10%
5%
50%
Inves
tor typ
e
Institu
tions
VC
High net
-w
or
th
Retail
Sp
li
t by re
gio
n
Swe
den
Un
ited S
tates
Europe
United Kingdom
Hansa Biopharma
Annual Report 202
1
57
Strateg
y
T
echnology
Grow
th
Directors
’
repo
rt
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
The share
7
D
i
r
e
c
t
o
r
s’
r
e
por
t
Di
rec
tors’ R
epor
t
59
Hansa Biopharma
Annual Report 202
1
58
Strateg
y
T
echnology
Grow
th
The share
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Directo
rs’
repor
t
1
Hansa Biopharma Annual Report 2021
Operations
Hansa is a commercial
-
stage biopharmaceutical company pioneering the devel
opment and
commercialization of innovati
ve, life
-
saving and life
-
altering t
reatments for patients with rare
immunological conditions.
The Company has developed a proprietary antibod
y-
cleaving enzyme technology platform to
target pathogenic or disease
causi
ng antibodies. Hansa’s first
-
generation I
gG
-
cleaving enzyme,
imlifidase, is designed to inactivat
e IgG
antibodies in the plasma and tissue through a single
intravenous treatment. Id
efirix (imlifidase) recently
received conditional approval from the
European Commission for desensitization t
reatment of highly
sensitized adult
kidney transplant
patients, who may not otherwise be able to recei
ve a new kidney.
Additionally, t
he Company
ha
s initiated a Phase 3 study to support
the approval of imlifidase in the U.S. for
the same
indication.
Hansa is also currently evaluating imlifidase across a wide
spectrum of both potential disease
areas and
indications in an effort to addr
ess significant
unmet medical needs. Its broad pipeline
spans pre
-
kidney
transplantation desensi
tization and post
-
transplantation ant
ibody
-
mediated
organ rejection, or AMR, and
rare IgG
-
mediated autoimmune conditions such as anti
-
glomerular basement membrane, or anti
-
GBM,
antibody
disease and Guillain
-
Barre Syndrome,
or GBS, as well as cancer.
Through collaborations with Sarept
a Therapeutics, Inc. and Asklepios BioPharmaceutical
, Inc.
(AskBio)
Hansa is also
evaluating imlifidase as a pre
-
tr
eatment prior to gene therapy to
potentially allow the treat
ment of patients
with pre
-
existing neutrali
zing antibodies against gene
therapy vectors. In additi
on, Hansa entered a preclinical research coll
aboration with argenx BV
to evaluate the therapeutic pot
ential of combining the two c
ompanies
’
IgG
-
modulating
technologies.
Beyond imlifidase, the Company's second
-
generation IgG
-
cleaving enzyme program, NiceR, is
in preclinical development and is designed to enable
expansion into a large spectrum of
potential indications, i
ncluding relaps
ing autoimmune diseases and gene therapy, as well as
oncology indications. Through it
s preclinical EnzE program, Hansa is exploring the combined
use of approved antibody
-
based cancer treatment
s with IgG
-
modulating enzymes. Hansa
Biopharma is headquartered
in Lund, Sweden and also has operat
ions in other European
countries and in the U.S.
2021 Business review
2021 was, overall, a transformativ
e and successful year for Hansa as the Company advanced
into a fully integrated, commercial
-
stage biopharmaceutical
company following the commercial
launch in Europe of Idefirix
®
(imlifidase). Hansa executed throughout the year on key pri
orities,
including R&D, commercial and organizational objectives:
The Company progressed the launch of and market access effor
ts for I
defirix
®
in Europe,
securing reimbursement in Sweden and the Netherlands
as well as on a hospital basis in
Finland and Greece while having market access pr
ocedures ongoing in 13 European countries,
including key 5 markets. Also, Hansa recorded its fir
st comm
ercial sal
es in 2021.
Further, i
n December 2021, Hansa and Medison Pharma announced a multiregional
commercialization partnershi
p for
Idefirix
®
covering Israel and key countries i
n the Central
Eastern European region, i.e. Croati
a, Hungary, Poland and Slovenia.
Hansa also progressed its pipeline activiti
es by initiating the pivotal U.S. ConfideS phase 3
study in kidney transplantat
ion and enrolled
the first patients
during December 2021 into the
study. Also, the Company reported three
-
year follow
-
up data in crossmatch positive pati
ents
who received imlifidase prior to kidney transpl
antation demonstrating 3
-
year graft survival of
84%, confirming that imlif
idase is a potent option to enable transplantat
ion among patients who
have a significant immunologic barri
er to successful kidney transplantation.
Following the positive resul
ts from the completed investigator
-
ini
tiated Phase 2 study and a
successfu
l pre
-
IND meeting with the U.S. FDA in fourth quarter 2021, the Company announced
its intend to commence a Phase 3 study in 2022 marking an important milestone i
n the
expansion of imlifidase into aut
oimmune diseases.
Recruitment into the ongoing phase 2 studies in AMR and GBS was continued progressing
enrolment to 23 out of targeted 30 patient
s in the AMR trial and 15 out of targeted 30 patients in
the GBS study as of December 31, 2021
.
Beyond the collaboration with Medi
son on the commercial front, Hansa also entered a
preclinical research coll
aboration with argenx BV (Argenx) to evaluate the therapeuti
c potential
of combining the two companies’ IgG
-
modulating t
echnologies, imlifidase and efgartigimod, as
well as an agr
eement with AskBio, a subsidiary
of Bay
er AG, to evaluate imlifidase in a pre
-
clinical and clinic
al feasibility program as pre
-
treatment ahead of
gene therapy in Pompe
disease in patients with pre
-
existing neutralizing antibodies (Nabs)
.
And finally, Hansa continued to bui
ld
a high
-
performance team by attracting and integrati
ng the
most talented and experienced candidates, while creati
ng a rewarding, productive and
stimulating workplace for
its
employees. The progress the Company is making
was again
eviden
ced in 2021 as
it
received certificati
on as a “Great Place to Work” for the second
consecutive year by the GPTW Institute.
However, beyond the significant achievements during 202
1
, the Company has also seen its
commercialization and
pipeline activities, sp
ecifically related to the recrui
tment of patients in the
ongoing GBS phase 2 stud
y,
significantly i
mpacted by the COVID
-
19 pandemic
and the
emergence of the Omicron variant
.
2021 Directors’ report
Dir
ectors’ R
epor
t
Hansa Biopharma
Annual Report 202
1
59
Strateg
y
T
echnology
Grow
th
The share
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Directo
rs’
repor
t
2
Hansa Biopharma Annual Report 2021
Given the current status and uncertai
nties around the COVID
-
19 pandemic, the Company may
continue to see negative impact on its
operational business and clinical tri
al activities, including
potentially related to
r
ecruitment timelines for ongoing and planned clinical s
tudies
as well as
the commercial launch of imlifidase i
n Europe.
Han
sa will continue to monitor the si
tuation very closely and diligently
and
implement further
measures as required and keep the markets informed should the assessment of any potenti
al
impact change substantially.
Risk management
Hansa is committed to effecti
ve risk management. Risk management is recogni
zed as an
integral part of good management practice and is a basis f
or the Company to achieve its
objectives and strategies. Hansa´
s risk management policy was launched in 2015 and reviewed
and revised in 2020.
It provides management wit
h a facilitating framework providing gui
dance
when dealing with risks inherent in achieving the organi
zation’s objectives and to:
>
Establi
sh a common organizational approach to risk management to ensure consist
ent and
efficient ri
sk identification,
assessment,
and control
>
Raise awareness of the need f
or risk management
>
Integr
ate risk management into the Company culture and processes
>
Establish
defined roles,
responsibi
lities,
and reporting structures for risk management
Hansa’s exec
utive management and the Board of Directors regular
ly discuss the Company’s
key risks and respective risk
management.
Risk factors
Hansa’s business is influenced by several factors, the
effects of which on the Company’s
earnings and financial position,
in certain respects, cannot be contr
olled by the Company at all
or in part. In an assessment of the Company’s f
uture development and business prospects, it is
important, alongside the possibiliti
es for growth in earnings, to also consider these risks.
Set for
th below is a description, without any i
nternal order of priority, of the r
isks which are
considered to have the highest level
of significance on the Company’s future development. For
natural reasons, not all the ri
sk factors can be described. Instead, the
risks which are specific to
the
Company,
or the industry are set forth here. It
is important to also note that the signif
icance
of risks may change over time
–
risks which are not considered si
gnificant may become
significant over time despi
te not being l
isted below. An overall assessment must also include
other information contained in t
he annual report as well as an overall assessment of extraneous
factors in general.
Risks related to COVID
-
19 and public health crisi
s
The global outbreak of COVID
-
19 continues to r
apidly evolve. While the extent of the impact
of
the current COVID
-
19 pandemic on the Company’s business and financi
al results is uncertain,
a continued and prolonged public health cri
sis such as the COVID
-
19 pandemic could have a
material negative impact on the Company’s business, financial
condition,
and operating r
esults.
To the extent the COVID
-
19 pandemic or any other potenti
al future public health crisis
adversely affects the Company’s business
and financial results, it may also have the ef
fect of
heightening many of the other risks descr
ibed in this “Risk Factors” section, suc
h as those
relating to the Company’s clinical development operat
ions, the supply chain for the Company’s
ongoing and planned clinical studies,
the availability of gove
r
nmental and regulatory authorities
to conduct inspections of the Company’
s clinical study sites, review mater
ials submitted in
support of the Company’s applications
for regulatory approval and grant approval for
product
candidates, and the success of the
Company’s commercial launch in Europe and potential
other territories.
Due to the continued evolution and uncertain global i
mpact of the COVID
-
19 pandemic, Hansa
cannot precisely determine or quant
ify the impact this pandemic (or any potential
future publi
c
health crisis) will have on t
he Company’s business, results of operations and financi
al condition.
The potential
impact
on
the Company will depend on a variety of
factors and future
developments, which are highly uncertain and c
annot be predicted with confidence, including
the duration, scope and severity
of the pandemic and the effectiveness of actions t
aken to
contain and t
reat COVID
-
19, including global vaccination effort
s.
The Company has experienced and may continue to experience delays
in the initiation and
completion of clinical s
tudies, patient selection and enrollment
or in the progression of the
Company’s activities related to its clinical
studies and commercial launch activities, and the
Company may encounter other negative impacts to its business due to the eff
ects of the
COVID
-
19 pandemic or any potential future publi
c health crisis.
Product development, regulatory
approval,
and com
mercialization
The Company operates procedures to secure the integr
ity and protection of its R&D and
commercial activities and dat
a, and to optimize allocation of budgets and resour
ces.
Nevertheless, due to limited resources and access to
capital, the Company must and have in
the past decided to prioriti
ze development of certain product candidates; t
hese decisions may
prove to have been wrong and may adversely affect Hansa’s busi
ness. The Company is heavily
dependent on the success of its product
candidate imlifidase. Hansa is also dependent on the
success of its other product candi
dates, for example in the NiceR program.
The Company cannot give any assurance that any product candi
date will successfully complete
clinical trial
s or receive regulatory approval, which is
necessary before it can be
commercialized. Hansa’s business and fut
ure success is substantially dependent o
n its ability
to develop successfully, obt
ain regulatory approval for, and then success
fully commercialize its
product candidate imlifidase and i
ts other product candidates. Hansa is not permitted t
o market
or promote any of its product candidates
before it receives regulator
y approval from the FDA,
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the EMA or any other comparable regulatory author
ity, and Hansa may never receive such
regulatory approval for any of its product
candidates, or, if approved, such approval may be
revoked if an approved product is later found to be unsafe or lack eff
icacy.
The Company cannot give any assurances that its cl
inical trials for imlif
idase or its other product
candidates will be completed in a ti
mely manner, or at all. If imlifi
dase or any other product
candidate is not approved and/or commerci
alized, Hansa will not be able to generate any
revenues for that product candidate.
The regulatory approval processes of
the FDA, the EMA and other comparable regulatory
authorities are lengthy, t
ime consuming and inherently unpredictable,
and if the Company is
ultimately unable to obtain (f
ull) regulatory approval for its product
candidates, Hansa’s
business will be substantiall
y harmed.
Clinical testing is expensive and does take many years to complete,
and its outcome is
inheren
tly uncertain. Results of
earlier studies and trials as well as
data from any interim
analysis of ongoing clinical
trials may not be predictive of future tr
ial results and failure can
occur at any time during the clini
cal trial process. If Hansa experience
s delays in the completion
of any clinical trial of
its product candidates, the commercial prospect
s of the product
candidates may be significantly har
med, and Hansa’s ability to generate revenues from any of
these product candidates will be del
ayed and/or
significantly reduced. I
f imlifidase or any other
product candidate is found to be unsafe or
lack efficacy, Hansa will not be able to obtain
regulatory approval for it and its busi
ness will be materially harmed.
The rates at which Hansa completes its sci
entific studies and clinical t
rials depend on many
factors, including, but
not limited to, patient enrolment. Pat
ient enrolment is a significant fact
or
in the timing of clinical tri
als and is affected by many factors including competing clinical t
rials,
cli
nicians’,
and patients’ perceptions as to the potential advant
ages of the drug being studied in
relation to other available therapi
es and the relatively limited number of patients. Any of these
factors may harm Hansa’s clinical
trials and by extension, Hansa’s business,
financial
condition,
and prospects.
The Company’s product candidates may cause undesirable s
ide effects or have other
properties that could delay or prev
ent their regulatory approval, limit t
he commercial profile of
an approved label, or result i
n significant negative consequences following pot
ential marketing
approval. Undesirable side effect
s caused by our product candidates could cause Hansa or
regulatory authorities to inter
rupt, delay or halt clinical trials and could r
esult in a more
re
strictive label or the del
ay or denial of regulatory approval, or i
f approved, market withdrawals,
by the FDA, the
EMA,
or other comparable regulator
y authorities. The drug
-
related side ef
fects
could negatively affect pati
ent recruitment or the ability of
enrolled patients to complete a trial
,
the commercial prospects or result
in potential product liabilit
y claims. Any of these occurrences
may harm Hansa’s business, financial
condition,
and prospects signif
icantly. Box warnings,
labelling restrictions, dos
e limitat
ions and similar restrictions on use could have a materi
al
adverse effect on Hansa’s abilit
y to commercialize imlifidase or any other
product
candidate, if
approved, in those jurisdicti
ons where such restrictions apply.
If the Company is not able to maintai
n orphan product exclusivity for imli
fidase or obtain such
status for other or for f
uture product candidates for which it seeks thi
s status, or if the
Company’s competitors are able to obtain orphan product exclusivit
y before the Company does,
it
may not be able to obtain approval for Its competing products
for a significant period of time.
Hansa’s commercial success depends upon attaining significant market acceptance of
its
product candidates, if approved,
among physicians, healthcare payers,
pa
tients,
and the
medical community. Coverage and reimbursement decisions by third
-
party payers may have an
adverse effect on pricing and market accept
ance. Legislative and regulatory activi
ty may exert
downward pressure on potential pricing and rei
mbursement for any of Hansa’s commercial
products and/or product candidates,
if approved, that could materially affect
the
commercial
opportunity.
Collaboration and partners
hips
The Company
has entered and may in
the
future enter into agreements with 3r
d party part
ners
related to the research, development and/or commercializat
ion of Hansa’s product candidates
and/or commercial products, such as
with
argenix BV,
Sarepta Therapeutics, Inc., Medison
Pharma and Asklepios BioPharmaceutical, Inc.
Such partnerships and agreements may be
terminated, unsuccessful, not
achieve the intended results and outcomes, not met Hansa’
s
objectives or
expectations,
and therefore materially negatively impact Hansa’s
business, its
financial position,
and earnings
prospects.
Reliance on Con
tract Manufacturing Organisati
ons (CMO
s)
The manufacturing and packaging process for i
mlifidase is made in collaboration wit
h contract
manufacturers/packagers in Europe.
Hansa is dependent on the quality of the manufacturing and packaging pr
ocesses, as wel
l as
the availability and maintenanc
e of the production facilities. Regul
atory authorities require that
all manufacturing processes and methods, as well
as all equipment, comply with current
requirements of Good Manufacturing Practice (GMP) and consequence
s for the Company in
the event of deficiencies i
n GMP requirements, and potential withdrawal of approval f
rom the
regulatory authorities, in the r
espective territories, for those facilit
ies providing the services, may
lead to delays in or the inability
to
supply the product for clinical trials or commerci
alization
which will negatively affect the Company’s earnings and fut
ure prospects. In addition to the
compliance risk of our coll
aborators, the Company is exposed to business continuity
risk as our
collabo
rator’s faciliti
es might be damaged, destroyed or not have sufficient capacity for other
reasons. This may lead to the Company not being able to continue cli
nical trials or sell its
products which
will
negatively affect the Company’s earni
ngs and future pr
ospects.
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Reliance on Contract Research Organisati
ons (CROs)
The Company has relied upon and will conti
nue to rely upon third
-
party contract research
organizations, or CROs, to conduct, monitor and manage its precli
nical and clinical programs. The
Company
relies on these parti
es for execution of its preclinical studies, anal
ytical and laboratory work,
data management and analysis, and clinical trials and cont
rols only certain, limited aspects of the
CRO’s activities. Nevertheless, the Company is responsible
for ensuring that each of its trials
is
conducted in accordance with the appli
cable protocol, legal and regulator
y requirements and
scientific standards and i
ts reliance on a CRO or any other vendor does not reli
eve Hansa of its
regulatory responsibilitie
s. If
Hansa or any of its CROs or vendors fail to comply wi
th applicable
regulations, the data generated in Hansa’s precl
inical studies, analytical and laboratory work and/or
clinical trial
s may be deemed unreliable, and the EMA, FDA or other regulatory
au
thorities may
require Hansa to perform additional preclini
cal studies, analytical and laboratory work and/or clini
cal
trials before approving Hansa’s marketing appli
cations.
If any of the relationships with t
hese third
-
party CROs terminates, the Company ma
y not be able to
enter into arrangements with alternative CROs or do so on commercially reasonabl
e terms.
If CROs do not successfully carr
y out their contractual duties or obli
gations or meet expected
deadlines, if they need to be replaced or
if the quality or accuracy of
the data, they obtain is
compromised due to the failure to adhere t
o Hansa’s protocols, regulatory requirements or
for
other reasons, Hansa’s pre
-
clini
cal and/or clinical trials may be ext
ended, delayed, or
terminated, and the Company may not be able to obtai
n regulatory approval for or successfully
commercialize its product candi
dates. CROs may also generate higher costs than anticipated.
As a result, the Company’s results of
operations and the commercial prospects for its pr
oduct
candidat
es would be harmed, Hansa’s costs could i
ncrease, and the Company’s ability to
generate revenue could be delayed.
Intellectual propert
y
The value of Hansa is largely dependent on it
s ability to obtain and defend patents and it
s
ability to protect specific
know
-
how. Patent protection for biomedical and biotech companies
may be uncertain and involve complicated legal and technical quest
ions. There is significant
risk that a patent sought will not be gr
anted for an invention, that the patent granted will
not
p
rovide sufficient protection, or that
the patent granted will be circumvented or revoked.
If the Company fail
s
to obtain and/or maint
ain patent protection and trade secret prot
ection of
its product candidates and/or commercial products, i
t could lose its competitive advantage and
the competition the Company faces would incre
ase, reducing or eliminating any potenti
al
revenues and adversely affecting its abili
ty to attain or maintain profitability,
impacting the
Company’s future prospects and valuation significantl
y.
Dependence on key product
The Company has a thin and concentrated pipeline. The v
alue of the Company
is primarily
dependent on success in the Company’s leading development product
candidate, imlifidase.
The market value of the Company, and thus the Company’s share pr
ice, would be significantly
negatively impacted or entirely
lost by setbacks related to im
li
fidase.
Market and competition
The product candidates Hansa has under development and any commercial
product, risk being
exposed to competition from new pharmaceuticals and/
or diagnostic methods. Developing a
new pharmaceutical from invention to fi
nished
product requires a long time. Not the l
east for
this reason, when development is underway it
is uncertain whether there will be any market for
the product when it is finall
y developed and, in such case, how large this market wil
l be, as well
as which competing products the Company’s products wil
l encounter when they reach the
market. To the extent competition consists of exi
sting preparations or methods, Hansa’s
success is dependent on its abili
ty to induce potential customers to replace k
nown products or
methods with those of Hansa.
Another risk is that competit
ors, who in many cases have greater resources than the Company,
will develop alternative preparations t
hat are more effective, more secure, or cheaper than
those offered by Hans
a
. This may lead to the Company fac
ing limited sales or not being able to
sell its products at al
l which may negatively affect the Company’s earnings.
Pricing and reimbursement
On many markets, purchases of pharmaceuticals of
the type being developed or
commercialized by the Company are financed, in whol
e or in part, by a party other than the
patient, for example, caregiver
s, insurance companies or governmental authorities subsi
dizing
pharmaceuticals. If the Company does not achiev
e acceptance for its commercial products and
pr
icing and reimbursement of the products by such financi
ers, this may make it more difficult or
impossible for the products to reach the market and may prejudi
ce their commercial potential,
which may negatively affect the Company’s earnings and financial po
sition.
Dependence on key persons
Hansa is, to a high degree, dependent on key persons, both employees as well as di
rectors.
The Company’s future earnings are affect
ed by its ability to attract and ret
ain qualified key
persons. In cases where one or more key persons leave the Company and t
he Company is not
successful in replacing such per
son(s), this might harm the Company’s business, fi
nancial
position and earnings.
Financial risks
Hansa carries out capital
-
intensive and value generating pharmaceuticals devel
opment and
commercialization. Future f
inancing of its operations is expected to t
ake place either through
new issues of shares, loans, struct
ured financing, convertible bonds, licens
ing revenue,
cooperation with other parti
es, the sales of rights and/or patents or a combi
nation of any t
he
above. The Company has, since the start of it
s operations, incurred net losses and cash flow is
expected to remain negative until t
he Company generates substantial revenues from any
marketed product. The Company has historically financed its oper
ations
primaril
y through
equity financings. The Company has devoted substant
ially all of its resources on, int
er alia,
raising capital, organizing and staf
fing the company, business planning, development,
regulatory approval and commercialization of imlif
idase an
d other candidates and protecting the
Company’s intellectual property portfolio.
The Company expects that it will be several years, if
ever, before the Company has commercialized imlif
idase in any jurisdictions other than Europe
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Hansa Biopharma Annual Report 2021
or any other product candidates.
The Company expects to continue to incur significant
expenses and increasing operating losses f
or the foreseeable future.
If the Company is not able to continue t
o finance its operations this may result
in the Company
being unable to continue operati
ons and as a result significantly harm the value of
the Company
and thus the share price of the Company. For furt
her description of the Company’s financial
risks, see Note 20 to the Consolidated Financial Stat
ements.
Sustainability and social responsibili
t
y
Hansa leverages its unique enzyme technology platform to develop innovati
ve, lifesaving and
life altering immunomodulating therapies, bri
ng these to the patients with rare diseases who
need them, and generate value to society at l
arge.
By developing therapies that seek t
o prolong and significantly enhance the lives of
people
around the world, sustainabilit
y is why Hansa exists and works tirelessly to bri
ng pioneering and
life changing treatments to those who need them most. Hansa’s visi
on is simple yet co
mpelling,
and whilst not easy to achieve is somethi
ng that unites everybody associated with Hansa:
A
world where patients with rare immunologic diseases can lead long and healt
hy lives
.
To read more on Hansa’s approach to sustainabil
ity, please refer to
ou
r ESG strategy on
page
18
-
20
and
the
“ESG”
section
on page
68
-
75
of
this annual report for more details.
Employees
–
Personal development
–
Equality
& Inclusi
on
–
Work environment
At Hansa, employees are the most valuable asset
. They play a key role in reaching the
Company’s vision. Hansa strives to attract and keep the best t
alent. It values and promotes
equality and inclusion in it
s workforce and across its global leadership. Hansa of
fers a range of
personal and professional development
opportunities such as, for example, career changes
within Hansa, new project management roles, trainings and Hansa Academy. Hansa takes
responsibility by ensuring good working conditi
ons in a healthy and sustainable work
environment.
Please refe
r to the section “
Sustainability
–
our employees
”
on page
71
of this annual report for
more details.
Revenue and financial result
Revenue for 2021 amounted to SEK 33.9 million (2020: SEK 6.1m) and comprises of product sales
in the amount of SEK 15.0 millio
n, revenue recognition from the upfront payment t
he Company
received under the Sarepta agreement in the amount of SEK 15.7 million,
and royalty income and
cost reimbursements from Axis
-
Shield Diagnostics (Abbott group) in
an amount of SEK 3.2 million.
The
loss from operation for t
he year
2021 amounted to SEK 547.0 million (2020: SEK 422.8m).
Compared to the year
2020
,
2021 expenses have increased primaril
y in line with the strategic
objective to grow Hansa into a fully int
egrated commercial stage biopharmaceutical company and,
as such, the increase reflects Hansa’s expandi
ng commercial footprint and increased activities
including investments in key European markets, marketi
ng, market access and supply chain
activities related to the l
aunch of Idefirix
®
. The result for 2021 includes non
-
c
ash expenses related
to the Company’s long
-
term incentive pr
ograms (LTIP) amounting to SEK 56.6 million
(2020: SEK 43.3m).
Loss for the year
2021 amounted to SEK 548.3 million (
2020: SEK 420.9m).
Cash flow and financial posi
t
ion
Net cash used in operating activities amounted to SEK 481.2 milli
on in 2021
(2020: SEK
290.3m)
.
The
increase in
cash
consumption is in line with the continued gr
owth
of the commercial footprint in Europe and t
he
non
-
recurring 10 million U.S. dollar (SEK 81.9m)
Sarepta upfront payment received in Jul
y of 2020
.
Five
-
year summary
KSEK, unless other stated
2021
2020
2019
2018
2017
Revenue
33,
878
6,098
3,364
3,358
3,442
Sales, general and administration
expenses
(
327,269
)
(
202,987
)
(
167,310
)
(
90,387
)
(
43,723
)
Research and development
expenses
(
230,764
)
(
227,191
)
(
192,949
)
(
154,558
)
(
137,060
)
Other operating
(
expense
)
/income
(
7,398
)
2,270
(
1,907
)
(
3,995
)
1,479
Loss from operations
(
546,978
)
(
422,807
)
(
359,668
)
(
246,498
)
(
176,083
)
Loss for the year
(
548,282
)
(
420,853
)
(
360,009
)
(
247,974
)
(
176,660
)
Net cash used in operating
activities
(
481,168
)
(
290,274
)
(
334,775
)
(
204,560
)
(
150,105
)
Cash and cash
equivalents,
including short
-
term investments
888,961
1,377,506
601,094
858,187
616,061
Shareholder’s equity
757,573
1,242,124
562,815
859,876
630,661
Loss
per share before and after
the dilution (SEK)
(
12.33
)
(
9.98
)
(
9.00
)
(
6.47
)
(
4.97
)
Number of outstanding shares at
the end of the
year
44,473,452
44,473,452
40,026,107
39,959,890
37,087,386
Weighted average number of
shares before and after dilution
44,473,452
42,176,872
40,020,429
38,326,098
35,519,029
Number of FTE’
s
at the end of
the
year
13
1
87
74
52
33
In July 2020, Hansa successfully c
ompleted the placement of 4.4 million ordinary shar
es raising
net proceeds of SEK 1,071 million.
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Hansa Biopharma Annual Report 2021
Cash and cash equivalents including short term investments amounted to SEK 889.0 milli
on as
of
December 31, 2021 (SEK 1,377.5m as of December 31, 2020), which is expected to finance
Hansa’s operations into 2023
.
Building upon the financing mandate approved by t
he last AGM in June 2021, the Company
has also started to evaluate opti
ons to secure financing Hansa’s operations
beyond 2023.
Capital expenditures
Capital expenditures during 202
1
amounted to SEK
2.
6 m
illion
(20
20
: SEK
0.3m
).
Shareholders’ equity
On December 31,
2021,
shareholders equity amounted to SEK
757.6 million
compared to SEK
1,242.1
m
illion
at the end of the financial year 2020.
Parent Company
The Parent Company’s revenue for 202
1
amounted to SEK
33.9
m
illion
(20
20
: SEK
6.1
m). The
net loss for the Parent Company amounted to SEK
549.
1
m
illion
for 202
1
(20
20
: SE
K
421.6
m).
On December 31, 202
1
, cash and cash equivalents includi
ng short
-
term investments amounted
to SEK
882.6 million compared to SEK 1,371.
8
m
illion
at the end of the year 20
20
.
The Parent Company’s shareholders equity amounted to SEK
755.9
m
illion
as
per December
31, 202
1
, compared to SEK 1,241.6
m
illion
at the end of 20
20
.
The Group consists of the parent company, Hansa Biophar
ma AB and the subsidiaries Cartela
R&D AB, Hansa Biopharma Ltd, Hansa Biopharma Inc. and Hansa Bipharma Australia PTY
LTD. Hansa Biopharma Inc
.
had four employees at the end of December 2021. Hansa
Biopharma Ltd owns patent rights to the EnzE concept
and had four employees at the end of
December 2021
.
Share capital and ownership
The Company is authorized to issue 80,000,000 shar
es. Two classes of shares may be issued,
ordinary shares (Class A) and Class C shares and toget
her they may not exceed 80,000,000.
Total shares issued as of 31 December 202
1
comprised of 44,473,
452 ordinary shares and
1,861
,457 C
-
shares held by the Company
as treasury shares
. Each share has a nominal value
of SEK 1 resulting in SEK 4
6,334
,909 shar
e capital and SEK 44,473,452 in outstanding share
capital as of 31 December 202
1.
At the general meeting, each ordinary shar
e entitles the holder to one vote
and C
-
shares to one
tenth of a vote each. C shares are not ent
itled to dividends. Each shareholder may vote th
e full
number of shares held by him or her. The Company’s share capit
al is denominated in Swedish
kronor (SEK) and divided amongst the Company’s o
utstanding shares with a quotient value of
SEK 1 per share. As per December 31, 202
1
, the single l
argest shareholder in Hansa was
Redmile Group LLC, with a total of
5,768,619
shares, representing
13.0
percent of the voting
rights and the
outstanding share
capital
.
Share
-
based compensation programs
Hansa uses
share
-
based long
-
term compensation programs to create conditi
ons for motivating
and retaining key employees and to align int
erests and long
-
term objectives between t
he
shareholders and the Company, as well as to i
ncentivise meeting and exceeding the
Company’s business and financial targets.
As in certain previous years, and upon t
he proposal of Hansa Biopharma’s Board of Directors,
the AGM resolved to adopt a long
-
term, share
-
based
compensati
on program in 202
1.
In 2021 the Board of Directors have decided t
o make certain amendments to LTIP2019 and
LTIP2020 in order to account for the impact
of the COVID
-
19 pandemic and changes to its
operating environment as further outl
ined in Note 14 to the Group Financial Stat
ements
elsewhere in this Annual Report.
2021 Long
-
term incentive program
Hansa Annual General Meeting (the “AGM”) on May 12, 2021 resolved to adopt a long
-
term incentive
program, LTIP2021, based on (a) performance
-
based share r
i
ghts and (b) employee stock options.
LTIP2021 based on performance
-
based share rights
Under the terms of LTIP2021 key employees may participate in the program and may receive so
-
called performance
-
based share awards free
-
of charge (a “Share Right
”) which,
provided certain pre
-
defined Performance Conditions (as briefly summarized below) and other cri
teria are met, give the
participants the right to acquire or
dinary shares in Hansa Biopharma AB at no cost. Each Share Right
represents the right to acquire one
share in Hansa Biopharma AB and shall carry a vesting per
iod of
three years commencing on the day of its allotment to a par
ticipant (the “Vesting Period”).
The final number of shares a partici
pant is entitled to receive is, amongst
other terms,
conditiona
l upon if or to what extend
the following performance conditions are met during the
Vesting Period (the” Performance Conditi
ons”):
>
Condition 1: U.S. FDA has accepted a BLA filing for approval of imlifidase in the U.S.
>
Condition 2: A phase 3 study in either
AMR or GBS is initiated or
a filing for regulatory approval is
accepted by either the FDA or EMA for one of these indic
ations or anti
-
GBM
>
Condition 3: At least 80 per cent of the targeted transplantation centers in Europe have been initiated
>
Condition 4:
Total shareholder return of at least 25%
A maximum of 624,615 Share Rights may be allotted to parti
cipants under the LTIP 2021 from
the day following the 2021 AGM up and until the day pr
ior to the AGM in 2022.
As of December 31, 2021, 557,000 Share Rights have been allot
ted to plan participants.
LTIP2021 based on stock options
The 2021 AGM also resolved to adopt an employee stock option pr
ogram under the terms of
LTIP2021. Senior executives may partici
pate in the program and receive employee stock
options f
ree
-
of
-
charge.
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Remuneration
Ma
rket
Ove
rv
iew
Directo
rs’
repor
t
Di
rec
tor
s
’ Re
por
t
conti
nued
7
Hansa Biopharma Annual Report 2021
Each employee stock option entitles t
he holder to receive one new ordinary share in Hansa
Biopharma AB at an exercise price of SEK 192.20 corres
ponding to 125 per cent of the volume
weighted average share price during the 30 trading days imm
ediately prior to the offer
to
subscribe for the employee stock opti
ons.
A maximum of 452,307 employee stock options may be allotted t
o participants under the
LTIP2021 from the day following the 2021 AGM up and until the day
prior to the AGM in 2022.
As of
December 31, 2021, 430,000 employee stock options have been allotted to the plan
participants under the LTIP2021.
Expenses related to share rights and employee s
tock options are reported in accordance with
IFRS 2. The total expenses including s
ocial secur
ity contributions (based on social
security tax
of 31.4 percent) for the share ri
ghts and options under LTIP2021 allotted as of December 31,
2021, is expected to amount to approximately SEK 79.
5 million, of which SEK 15.5m is included
in the results for th
e Parent Company and the Group for the year 2021.
Please refer to Notes 2 and 14 for furt
her information and previously adopted share
-
based
compensation programs.
2021 Guidelines for remuneration to senior executives
A prerequisite for the successf
ul imple
mentation of the Company’s business strategy and
safeguarding of its long
-
ter
m interests, including its sustai
nability, is that the Company is able to
recruit and retain qualified personnel
, consequently, it is necessary that the Company offers
market comp
etitive remuneration.
The guidelines adopted by the 2021 annual general meet
ing entail that senior executives
, i.e.
the CEO and members of the executive committee, will
be offered remuneration which is
competitive and on market terms. The level
of the remuneration for the individual
senior
executive
shall be based on factors such as complexit
y and responsibility of the posit
ion,
expertise, experience,
and performance.
The remuneration consists of a fixed base salary and
pension benefits and, in addition,
may consist of a variable cash remuneration, performance
-
based short
-
term incentive (STI),
share based long
-
ter
m incentive programs (LTIP) as resolved
by a general meeting, severance remuneration, and ot
her benefits. The STI shall be based on
the achievement of quantitativ
e and qualitative performance targets and shall not
exceed 75
percent of the annual fixed base
salary. The variable cash remuneration is intended t
o support
recruitment or retention of key personnel or t
o reward extraordinary performance beyond the
individual’s ordinary responsibili
ties and shall not exceed 30% of the annual fixed base salary.
Cont
ributions to pension plans shall not exceed 30% of the annual
fixed base salary. Salary
during the notice of terminati
on period and severance remuneration shall be possible in a total
maximum amount of 18 monthly base salaries.
Ultimate responsibility for
the remunerat
ion to senior executives as well as setti
ng the
respective performance targets lies with the Board of
Directors who is supported by the
Remuneration Committee and the CEO.
Please refer to the Remuneration Report elsewher
e in this Annual Report
for further
information
on remuneration to senior executives.
2022 proposed changes to remuneration guidelines for senior executives
The changes to the guidelines proposed by the Board of
Directors stipulate that in order
to drive
the business outcomes th
rough a tailor
ed employee incentive program that balances individual
achievement and organisational contri
bution it
i
s proposed that the performance cr
iteria for the
“Annual Short
-
Term Incentive (“STI”) shall
include both corporate and individual object
ive
s.
Furthermore, it is proposed t
hat the performance criteria, weighting and t
argets for the
individual objectives under the STI are to be pr
oposed, evaluated and approved annually CEO
as manager for members of the executive committee or, i
f it is not the CEO, then the r
espective
manager for such members of the executive committee, and for the CEO the Remuneration
Committee. The proposed adjustments have been reflected in these guidelines which wi
ll be
subject to the shareholders’ appr
oval at the annual gene
ral meeting 2022 and are appended to
this document as an appendix to the Corporate Gover
nance Section.
During 2021, neither the Remuneration Committee nor the Board of Directors recei
ved any
comments or questions from the
shareholder
s
on the remuneration guidelines adopted at the
2021 AGM
.
Dividend
The Board proposes that no dividend will
be paid for the financial year 2021. For more
information about Hansa dividend policy, please ref
er to the Hansa Corporate Governance
Report available on the Company’s website at https://hansabiopharma.com/this
-
is
-
hansa/corporate
-
governance/
Other information
For additional informati
on, please see the Corporate governance report and the Remuneration
report.
Annual general meeting 2022
The annual general meeting
of Hansa Biopharma AB (publ) will
take place on June 16, 2022.
Notice to attend the annual general meeting will be publ
ished on Hansa website at:
www.hansabiopharma.com.
Financial calendar 2022
April 7, 2022
Annual Report 2021
April 21, 2022
Interim report for January
-
March 2022
June 16, 2022
Annual General Meeting 2022
July 21, 2022
Half year 2022 report
October 20, 2022
Interim Report for January
-
September 2022
Hansa Biopharma
Annual Report 202
1
65
Strateg
y
T
echnology
Grow
th
The share
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Directo
rs’
repor
t
Di
rec
tor
s
’ Re
por
t
conti
nued
8
Hansa Biopharma Annual Report 2021
Appropriation of loss
carried forward
Unrestricted shareholders
’ equity in the Pa
rent Company
SEK
Share premium reserve
2,572,925,209
Treasury shares
(
1,861,909
)
Loss carried forward
(
1,312,352,987
)
Result for the year
(
549,097,916
)
Total
709,612,397
The Board of Directors proposes that the l
oss carried forward and
unrestricted
reserves to be all
ocated as follows
SEK
Share premium reserve
2,5
72
,
925
,
209
Treasury shares
(
1,861
,
909
)
L
oss carried forward
(
1,861
,
450
,9
03)
Total
709,612,397
The Group’s and the Parent Company’s results and fi
nancial position are shown in the sect
ion
“Financials”
: further below
in thi
s Annual Report
, which includes the
statement of financial
position, statement of profi
t or loss, statement of cash flow and statement of
changes in equity
as well as
accompanying notes and supplementa
ry inf
ormation, which are an integral part of
the financial statements.
Address
Hansa Biopharma AB (publ)
Scheelevägen 22, SE
-
223 63 Lund, Sweden
Postal addres
s
P.O. Box 785, SE
-
220 07 Lund, Sweden
Registration number
556734
-
5359
Hansa Biopharma
Annual Report 202
1
66
Strateg
y
T
echnology
Grow
th
The share
ESG
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
Directo
rs’
repor
t
Di
rec
tor
s
’ Re
por
t
conti
nued
8
ESG
Sust
ainabilit
y 68
GRI
73
Hansa Biopharma
Annual Report 202
1
67
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
Su
sta
inabilit
y
W
e are ful
ly committed t
o bringing
new lif
e-changing tr
eat
ments t
o
thos
e who need them most
.
At Hansa, we hav
e put sustainabilit
y at
the core of our business, aiming to
create value t
o societ
y at large.
Th
erefo
re, in 2021 we bega
n to form
alize o
ur app
roac
h t
o
sustainability
, bo
th by
advancing our
ambitions and ensuring
tra
nspa
renc
y in our ac
tivi
ties. T
he r
st step in th
is pro
ces
s was
a mate
rial
it
y anal
ysis, w
hic
h iden
tie
d the mos
t impo
rt
ant
aspects of
sustainability for our
stakeholders.
We
aligned th
ose mat
erial aspects
with t
he UN Sus
tainable
Deve
lop
ment G
oal
s, and us
ed the
m to form th
e basi
s of our
sustainability strat
egy
, out
lined in the
strat
egy section of
this
rep
or
t, page
s 1
8
-
20. Ou
r core fo
cus is to pro
mote He
althy
patien
ts, a
Healthy
planet and
Healthy
business, and
hav
e
the
se le
ad us for
wa
rd.
Patient cen
tricit
y
At Ha
nsa, we wa
nt ever
yon
e to be abl
e to live the
ir li
fe to the
fu
lles
t and we a
re ded
icate
d t
o he
lpi
ng pati
ents in n
eed, s
etti
ng
pati
ent ce
ntri
cit
y at the c
ore of ou
r busi
nes
s.
On
e such g
roup a
re hig
hly se
nsit
ized pat
ients i
n nee
d of a
ki
dney tr
ansp
lant, w
ho cur
rentl
y are aro
und 10 t
o 1
5% of
patients
on transplant
waiting list
s. Finding
a donor mat
ch is
pa
rti
cula
rly d
icu
lt for th
is pati
ent gro
up
, an
d we work to
nd s
olu
tions to me
et the
se unm
et nee
ds, as we
ll as rai
sin
g
awar
eness of
the condit
ion to
impro
ve t
reatment
options
and management.
Patient
access
We
are fully committed
to bringing
new
, life-changing
tre
atment
s to those w
ho ne
ed the
m most. We be
lieve ac
ces
s
to med
icin
es is a key p
ar
t of patie
nt ce
ntric
it
y and re
cog
nize
the chal
lenges this can
pose.
As such
, we
support sustainable
acc
ess to o
ur trea
tments f
or all p
atien
ts who n
eed th
em.
T
o e
nha
nce ac
ces
s, we eng
age wi
th hea
lth au
thor
itie
s, payer
s
an
d patie
nt orga
niz
ation
s. W
e str
ive to en
sure pr
ici
ng and
rei
mbur
sem
ent on a p
er
-pat
ient p
ric
e, maki
ng acc
ess to
tre
atment a
s cost-e
ecti
ve as pos
sibl
e for hos
pit
als.
Add
itio
nall
y
, we c
ondu
ct adv
isor
y bo
ards w
ith key expe
r
ts in
the tr
ansp
lant 
eld to id
entif
y a
ny ineq
uiti
es in ac
ces
s or
fu
ndin
g. W
e al
so sup
por
t ea
rly a
cce
ss and h
ave a bri
dgin
g-
access solution
in place
on a
case-by
-case basis.
Collaborations
with transplantation centers
In or
der to have a p
atien
t focus th
roug
hout o
ur val
ue cha
in, we
collaborat
e with
transplanta
tion cent
ers.
During 20
21
, we
collaborat
ed with
~60 specialist
transplanta
tion cent
res in
Euro
pe as pa
rt of o
ur imli
da
se lau
nch ac
tivi
ties.
Advancing
the science
As a
n ambi
tiou
s glob
al co
mpany
, we a
re focus
ed on th
e big
ger
pi
cture a
nd want to be p
ar
t of the so
luti
on at ma
ny level
s. Thi
s
means helping pat
ients along their
journey and engaging
with
the h
eal
thca
re com
muni
ties b
oth in Euro
pe and t
he U.S. W
e
use t
his op
por
tun
ity to n
ot only r
aise a
waren
ess a
bout t
he
unm
et ne
eds of th
e patie
nts we aim to h
elp bu
t als
o advan
ce
the u
nder
sta
ndin
g in thes
e com
plex e
lds.
Our t
echnology platform
has a uni
que mechanism o
f action
that
makes
it po
tentially
suitable
for man
y dier
ent applica
tions.
By rapidly inact
ivating
potent
ially pathogenic ant
ibodies, we
may
be able
to
impact a
number o
f aut
oimmune condit
ions as w
ell as
pre
-treatm
ent in g
ene th
era
py
. Eve
ry p
atie
nt is uni
que, an
d this i
s
even m
ore tr
ue in ra
re con
ditio
ns. We have an o
ppo
rtu
nit
y to set
new s
tand
ards of c
are de
eme
d impo
ssi
ble un
til now. This m
ean
s
we
are in
a position
to
provide
impactful collaborat
ions with
the
sci
enti
c and me
dica
l comm
unit
y
, patie
nt organ
izati
ons, an
d
research group
s and use t
he science t
o shape a be
tter future
,
have p
ositi
ve imp
act an
d create va
lue ac
ross th
e enti
re system.
An
d we want to do i
t one pat
ient at a t
ime.
E
xpa
nd
ing a
cce
ss to n
ew ma
rket
s
Iml
ida
se is a
pprove
d in the EU an
d the U.K. and ex
pans
ion i
s
pl
anne
d to the U.S. and to inte
rnat
iona
l mar
kets. Eac
h mar
k
et
rep
rese
nts its ow
n cha
llen
ges w
ith re
gards to ac
ces
s to
medicines,
sometimes meaning
new appr
oaches will
be
req
uire
d t
o su
ppor
t th
e expan
sion of a n
ovel me
dici
ne. Thu
s,
we str
ive to provi
de pati
ents wi
th ear
ly ac
ces
s t
o im
lid
ase wi
th
co
mpas
sio
nate use an
d bri
dge
-nan
cing a
pproa
che
s on a
case-by
-case basis
.
Health equity
Our ambition
is t
o incr
ease equity in healt
hcare for
patien
ts
with r
are immunological
conditions
and t
o support and amplify
the pa
tient’
s voice
. By w
orking closely wit
h healthcare
prof
essionals and p
atient
organizations
we
hope t
o facilita
te
bet
ter tre
atme
nt outco
mes fo
r our pat
ients
. One fo
cal po
int for
us in t
his re
gard i
s rais
ing awar
ene
ss of ca
re disp
ari
ties by
ge
nde
r and ethn
ici
ty exp
eri
enc
ed by hig
hly se
nsi
tized k
idney
pati
ents. We have a
lso us
ed ou
r soci
al me
dia ch
ann
els to
amplify and raise
awareness
of t
he health
inequities faced
by
hi
ghly s
ensi
tized p
atien
ts.
T
raining programs
As th
e deci
sio
n t
o tre
at a patie
nt wit
h imli
das
e is a com
plex
on
e, made by ma
ny mem
ber
s in a spe
cia
list te
am of
transplant
ation ph
ysicians and
nurses,
we ha
ve de
veloped an
onboarding
program
for health
care personnel
and transp
lant
ce
nters, w
hich h
as be
en rol
led ou
t dur
ing 2020 a
nd 2021
.
Hansa Biopharma
Annual Report 202
1
68
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
Collaborations
with patient
advocacy
groups
and
healthcare pro
fessional
Ha
nsa wor
ks clo
sel
y with p
atien
t orga
nizat
ions a
nd sup
por
ts
sever
al initiat
ives tar
geting
health inequities
. W
e support the
Euro
pea
n Soci
ety fo
r Orga
n T
ra
nspl
anta
tion (ES
O
T
) to keep
evol
vin
g thei
r reco
mme
ndati
ons on s
tand
ard of ca
re for
desensitizat
ion of
highly sensiti
zed kidney
transplant
patien
ts,
wh
ich se
eks to kee
p guid
eli
nes up to d
ate with th
e lates
t
inn
ovative tr
eatme
nts. Th
is yea
r
, Ha
nsa s
pons
ored a n
ew
wor
kstre
am by ESOT on de
sens
itiz
ation t
hroug
h an
unrestricted
educational grant
. Their workst
ream, in
volving
leading t
ransplantat
ion specialists
, aims
to
update
Eur
opean
clinical guideli
nes for
desensitization
practices i
n highly
sensitiz
ed kidney t
ransplant
patients
.
As pa
r
t of our am
biti
ons to in
crea
se hea
lth eq
uit
y and
aware
nes
s of hig
hly se
nsi
tized pa
tient
s, we are al
so inter
actin
g
wi
th Europ
e- and U.S.-wide p
atie
nt advoc
acy gr
oups, s
uch as
the E
uropean Kidne
y Pa
tient F
ederation
, Eur
opean Kidney
Health Alliance
, American Associa
tion o
f Kidney P
atient
s,
American Kidney F
und,
American Society of
T
ransplantat
ions,
the American Soc
iety of T
ransplantat
ion and The
Dutch Kidne
y
Fou
ndati
on whi
ch have a wo
rld-w
ide re
ach. ln-
cou
ntr
y patie
nt
advocacy gr
oups include Njurförbundet in
Sweden, Kidney
Car
e in U.K. and R
enal
oo in Fra
nce. T
hrou
gh col
lab
orati
on with
sever
al patien
t organiza
tions,
we aim
to
fur
t
her strengt
hen the
voice
of the
patien
t.
Unmet
medical
needs
Th
e patie
nts we he
lp are o
ur key focu
s, and g
ive us th
e
motiv
ation
to
continue de
veloping
life-altering
therapies t
o
address the
unmet needs tha
t remain amongst
those living
wi
th rare c
ondi
tion
s. W
e ar
e there
fore pl
ease
d that in l
ate 2020,
iml
id
ase rec
eiv
ed con
diti
onal a
pprova
l in the EU fo
r high
ly
se
nsiti
zed adu
lt ki
dney tr
ansp
lant p
atien
ts. We are al
so in
dialogue wit
h the
FDA
concerning future
marke
t authorizat
ion
in th
e U
.S. Add
itio
nal
ly
, we h
ave ini
tiated t
wo Phas
e 2 cli
nica
l
studies
in addition
al aut
oimmune indica
tions,
and we
are
pl
anni
ng to cond
uct a fu
r
ther ph
ase 3 stu
dy
, to fur
the
r expa
nd
our port
f
olio and address
unmet needs.
We are pa
rtn
eri
ng wi
th Sare
pta to potenti
ally ex
pan
d the use of
iml
id
ase in th
e eld of g
ene th
era
py as a pre-tre
atme
nt in
cli
nic
al stud
ies. T
he pa
rt
ner
ship w
ith Sa
repta i
s progr
essi
ng as
pl
anne
d with p
re-c
lini
cal in
vesti
gatio
ns usi
ng imli
da
se bei
ng
cur
rentl
y ong
oing. F
irst f
ew days in 202
2
, Han
sa al
so reac
hed
an ag
ree
ment w
ith Ask
Bio to fu
rt
her pa
rt
ner in t
he el
d of gen
e
the
rapy
, to evalu
ate feas
ibil
it
y of imli
das
e as pre-tr
eatme
nt
ah
ead of ge
ne the
rapy fo
r Pompe D
ise
ase.
An
other key p
ar
tner
shi
p Hans
a emb
arked o
n in 2021 was wi
th
arg
enx. O
ur pre-
cli
nica
l rese
arch co
lla
borati
on agre
eme
nt wil
l
exp
lore the p
otentia
l of
co
mbin
ing iml
id
ase, Han
sa’
s I
gG
ant
ibod
y-cle
avin
g enz
yme, an
d
efg
ar
tigi
mod, arg
enx’s FcRn
antagonist
, t
o po
tent
ially unlock a
dditional t
herapeutic v
alue in
both th
e acute a
nd ch
ronic s
etti
ng of auto
immu
ne dis
eas
es and
transplant
ation.
Se
cond we
ek of 2022, Ha
nsa al
so an
noun
ced i
ts intenti
on to
exp
lore th
e poss
ibil
ity of ex
pan
ding i
ts pipe
lin
e into allo
gen
eic
hemat
opoietic s
tem cell
transplanta
tion (H
SCT),
also known
as
“bone-marro
w transplan
tation
”
. Anti-
HL
A
antibodies a
gainst
the d
onor m
ay preve
nt the su
cce
ssf
ul eng
raf
tmen
t of dono
r
ce
lls in a p
atien
t requ
irin
g allo
gen
ic HSCT
. A
llo
gen
eic HS
CT is
the onl
y curative treatme
nt interve
ntion for most pati
ents with
high-risk
hematologic
malignancies,
with o
ver 5
0,
000
transplants
per
f
ormed annually worldwide
.
Des
ensitiz
ation treatme
nt of
patie
nts with high leve
ls of donor
sp
eci
c antib
odi
es (DSA
) pri
or to allo
gen
eic HS
CT trans
plan
t is
a ch
alle
nge, an
d cur
rentl
y there a
re no ap
proved d
rug
s for
ma
nagin
g thes
e patie
nts. Iml
id
ase may have t
he potent
ial to
tra
nsfor
m the st
anda
rd of car
e by enab
ling c
lini
cia
ns to
ina
ctiva
t
e DS
As pri
or to tran
spl
antati
on an
d has thu
s the
pot
ential t
o enable
successful tr
ansplantation
. T
reatment wit
h
iml
id
ase wou
ld potent
iall
y be a maj
or adva
nce
ment to
cur
rently availab
le treatments.
Patient
safety
In ou
r end
eavor to prov
ide l
ife-a
lter
ing th
erap
ies fo
r peo
ple
with r
are immunological
conditions
, the
safety o
f our p
atients
is
at the c
ente
r of all of ou
r work. We va
lue both t
he safe
ty an
d
ca
re of our pa
tient
s and have s
ystems i
n plac
e to guar
antee
patie
nt safety
.
We aim to go b
eyond j
ust co
mpli
anc
e with a
ppli
cab
le laws a
nd
regulations
in our pre-clinical and
clinical studies t
o ensure our
therapies mee
t the
highest pharmaceutical
standards
. All
stu
dies d
uri
ng the d
evelo
pmen
t phas
e of a treatm
ent a
sses
s
the e
cacy a
nd safe
ty of the t
reatme
nt. We always c
ondu
ct
our r
esea
rch wi
th the up
most s
cien
tic in
tegri
ty a
nd edu
cate
our employ
ees continuously on pa
tient saf
ety
.
Hansa main
tains a c
lose dialogue w
ith rele
vant aut
horities t
o
en
sure th
e safet
y of our p
roduc
ts. In 2021
, Ha
nsa wo
rked w
ith
EU a
uthorities on
the condit
ional mark
eting appr
oval
for
iml
id
ase an
d post-e
cacy st
udy
, an
d with the F
DA
in th
e
Uni
ted Sta
tes on the re
gul
ator
y path for
war
d for imli
da
se in
kidney transplanta
tion (Phase
3 study design
) and ant
i-GBM
(Ph
ase 3 stu
dy de
sig
n
). The re
gul
ator
y auth
orit
ies c
arr
y ou
t
regular inspections o
f our fa
cilities. Besides that
, Hansa
per
forms
due diligence of our
suppliers.
T
o e
nsur
e produ
ct qua
lit
y
, H
ans
a has a qu
alit
y ma
nage
men
t
syst
em in
place,
which conti
nuously perform
pha
rma
covi
gila
nce ac
tivi
ties a
nd have a r
mly in
tegrate
d
syste
m for ad
verse e
vents re
por
tin
g, whic
h ensu
res ti
mel
y and
transp
arent
analysis.
Sust
ainabilit
y
cont
inued
Hansa Biopharma
Annual Report 202
1
69
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
Sust
ainabilit
y
cont
inued
Ha
nsa is a
lso co
mmi
tted to su
ppor
t o
ptimal p
atie
nt care.
Therefor
e,
we onboar
d health
care pro
fessionals and
work
cl
osel
y with p
atien
t orga
nizat
ions to u
nder
stan
d patie
nts
unique perspectiv
es, aim
ing t
o achiev
e bett
er trea
tment
outcomes
for all
.
Ethic
al busin
ess pr
actice
s
Co
de of c
ond
uc
t and s
up
pli
er c
ode
The pharmaceutical industry is a s
trongly regulat
ed sect
or with
global supply chains
and many or
ganizations working t
ogether
.
Al
l new em
ploye
es take p
ar
t in Co
mpany l
ega
l and co
mpl
ianc
e
onboarding meetings
, which int
roduce the
company’
s most
relev
ant legal and
compliance policies
, including
the code
of
co
nduc
t.
D
urin
g 202
1
, s
ix Co
mpany l
ega
l and co
mpli
anc
e
onboardings ha
ve tak
en place thr
oughout the y
ear
. Our code
of co
nduc
t reec
ts our va
lue
s, provid
ing ou
r empl
oyee
s with
gui
dan
ce on how to d
o the ri
ght thi
ng in th
eir eve
ryd
ay role.
The code o
f conduct
covers
topics
such as an
ti-corruption
,
medical et
hics, div
ersity and inclusion
, supplier
selection
and sustainability
.
Our responsible business pra
ctices concern our entir
e value
chain.
Just as
Hansa holds
itself t
o the
highest e
thical
sta
nda
rds, we expe
ct the s
ame l
evel of inte
grit
y fro
m our
suppliers. Therefor
e, Hansa
selects its suppliers and
enters
new partnerships carefully
. W
e ensure t
hat our direct
suppliers and partners maintain the
high standards in
regards
to soc
ial, n
anci
al an
d enviro
nme
ntal i
ssue
s that we se
t
ourselves through
our supplier code.
The supplier code is
therefor
e implemented
into
Hansas contract
templates
.
Sup
pli
ers ar
e also r
isk a
sse
ssed a
nd au
dited i
n acco
rdan
ce
with our
quality procedures.
Anti-cor
ruption
Ha
nsa ha
s a zero tole
ran
ce to cor
rupti
on, an
d our ant
i-
co
rru
ption a
nd anti
-bri
ber
y co
mmitm
ent is m
ani
fested i
n our
co
de of con
duc
t
. Si
nce th
e ris
k for cor
rupt
ion is l
arge
st in
relation
to
healthcare
professionals
, our
policies are
carefully
considered t
o provide
guidance on all k
ey risk
areas, including
contrac
tual arrangements
with healt
hcare pr
ofessionals
;
grants
, sponsorships
, and
donations
; as
well as
a compliant
communication
s with
healthcare pr
ofessionals.
Hansa encourages the
repor
ting
of an
y suspected une
thical
be
havio
r and h
ave ensu
red ap
prop
riate c
hann
els to ma
ke this
ea
sy to do. If emp
loyee
s feel u
nab
le to disc
uss c
once
rns w
ith
the
ir dire
ct ma
nage
r
, th
e Comp
lian
ce O
cer o
r Huma
n
Re
sourc
es, a thi
rd-pa
rt
y wh
istle
blow
ing se
r
vice i
s als
o
avai
labl
e to them, to re
move any ba
rri
ers t
hat may pr
event
reporting.
Informat
ion on t
he whistleblo
wing pr
ocess is
avai
labl
e in the c
ode of c
ondu
ct an
d on Han
sa’
s i
ntran
et.
Du
ring 20
2
1
, n
o repo
rts w
ere mad
e and i
nvesti
gated.
Data privacy
Dat
a pri
vacy an
d protecti
on pl
ays a pivot
al rol
e in Han
sa’
s way
of wor
kin
g, so that d
ata fro
m our pat
ients, c
lini
cal s
tudie
s,
em
ploye
es and ot
her bu
sin
ess pa
r
tner
s are prote
cted. Dat
a
pr
ivacy i
s par
t of Ha
nsa’
s cod
e of con
duct to e
nsure th
at all
em
ploye
es are e
duca
ted on how to h
andl
e per
sona
l data.
Du
ring 20
2
1
, we hav
e worked to exp
and th
e resou
rces
available
to emplo
yees on data
privacy
, including int
ernal
pre
sent
ation
s and th
ree on
line c
our
ses on d
ata pr
ivacy f
or all
em
ploye
es. Th
ese re
sour
ces a
re des
igne
d to enab
le
em
ploye
es to uph
old Ha
nsa’
s str
inge
nt pol
ici
es on da
ta
pr
ivacy a
nd dat
a subj
ect r
ights. T
he gu
idel
ine
s and p
olic
ies a
re
ins
trum
enta
l for Ha
nsa to co
mply w
ith al
l appl
ica
ble l
aws and
reg
ulati
ons th
at protect t
he pri
vacy of pe
rso
nall
y ide
ntia
ble
informa
tion and
prot
ected
health inf
ormation
such as t
he
General Data
Pro
tection
Regulation
(GDP
R) in
the E
uropean
Uni
on. Wi
th our IT I
ncid
ent H
andl
ing Pol
icy
, we have a pr
oces
s
in pl
ace to de
tect, rep
or
t and m
anag
e data br
each
es of both
dat
a pri
vacy an
d cybe
r sec
urit
y
. Du
ring 2021
, n
o repo
r
ts of
suspected
personal data
breaches w
ere issued
.
Just as Hansa hol
ds itself t
o the
highest et
hical standar
ds
, we
e
xpect the same lev
el of in
t
egrit
y
from our suppliers.
Hansa Biopharma
Annual Report 202
1
70
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
Our emplo
yees
At
Hansa, our employ
ees are our mo
st valuable asset
. They
pl
ay a k
ey ro
le in re
achi
ng our v
isi
on. We stri
ve to attra
ct and
kee
p the be
st tal
ent an
d want to en
cour
age a di
vers
e and
inclusive w
orkplace.
Ha
nsa ha
s system
atic an
d preve
ntive wor
k env
ironm
ent sa
fety
pro
ces
ses in p
lac
e
, to saf
egua
rd emp
loyee
s, esp
eci
all
y in our
laborat
ories. W
e also
place gr
eat importance on t
he
psyc
holo
gic
al safe
ty an
d well
bein
g of our te
ams, ma
ny of
wh
om work r
emotel
y
.
By pr
oviding a
range o
f personal and
prof
essional dev
elopment
opportunities such
as career changes
within Hansa
, new
project management r
oles, trainings
and Hansa Academy
, we
ai
m t
o str
engt
hen th
e ski
ll sets of a
ll our e
mploy
ees, e
nabl
ing
the
m to ex
ce
l in the
ir rol
es. Th
ese ca
ree
r devel
opme
nt
oppor
t
unities are individually planned during
each employee
’
s
continuous performance reviews
. Hansa also
conducts an
an
nual e
mpl
oyee sati
sfac
tion su
r
vey
, to ge
t feed
back o
n how
Ha
nsa ca
n fur
th
er imp
rove. The r
esul
ts of our 2021 su
rvey l
ed
to Han
sa bei
ng ce
rti
ed a G
reat Pl
ace to Work
®
for th
e sec
ond
con
secu
tive yea
r
.
We have al
so imp
lem
ented a li
vin
g don
or pol
icy in l
ine wi
th the
li
ving D
onor C
ircl
e of
E
xcel
len
ce, ens
urin
g no emp
loyee at th
e
co
mpany wo
uld fac
e neg
ative n
anc
ial co
nseq
uen
ces s
houl
d
they w
ish to be
com
e a liv
ing org
an do
nor
. No em
ploye
e had
the n
eed to us
e this po
licy
, bu
t we beli
eve it re
ects w
ho we
are a
nd wh
at we do.
We
value and pr
omote
equality and inclusion in our
workforce
an
d acros
s our gl
oba
l lead
ers
hip. T
o e
nsure o
ur Co
mpany i
s
inclusive,
we ha
ve implement
ed a diversity and inclusion
policy
,
wh
ich pro
motes a fa
ntas
tic bl
end of ge
nde
r
, ag
e, ethni
cit
y
,
cul
tura
l backgro
und a
nd sexua
l ori
entat
ion – wh
ether we h
ave
a dis
abi
lit
y
, g
ende
r ide
ntit
y and g
ende
r expre
ssi
on, leve
l of
ed
ucati
on, fam
ily si
tuati
on, val
ues, a
nd so for
th. In 20
2
1
, we
were p
roud to co
unt pe
ople f
rom mo
re than 30 d
iere
nt
nationalit
ies among ou
r workforce
, and t
o onbo
ard 46
new
co
llea
gue
s from ma
ny new ter
ritor
ies. H
avin
g iden
tie
d
standout candidat
es in these locat
ions, Hansa is
attracting
le
adin
g tale
nt fro
m acros
s the wor
ld. Th
is equ
ated to a glo
bal
grow
th for H
ans
a of 56%, all wh
ile ma
inta
inin
g a low em
ployee
tur
nover of 8.7
%.
T
o s
peci
ca
lly e
nsure g
end
er equ
ali
ty at Ha
nsa, we c
ondu
ct
yea
rly s
ala
ry s
ur
veys to ens
ure tha
t men an
d wome
n rece
ive
eq
ual pay fo
r equ
ival
ent wor
k. It se
rve
s as a tool fo
r Han
sa
to avoid s
ala
ry d
rif
t an
d to disc
over any u
ncon
scio
us
dis
cri
minat
ion. In 2021
, n
o dier
ence
s due to ge
nde
r
were fou
nd.
We cont
inue to mo
nitor th
e diver
sit
y at di
erent l
evel
s of
ou
r
co
mpany
, wi
th the g
oal of id
enti
fy
ing a
reas fo
r improve
men
t
an
d addre
ssi
ng the
m over tim
e. In 2021
, t
he boa
rd
co
mpos
itio
n is 33% (2020: 33%
) wo
men a
nd 67
% (2020: 67
%)
me
n. On man
age
ment l
evel, th
e gend
er di
strib
utio
n was 45%
(2020: 50%
) wom
en an
d 55
% (2020: 50%
) me
n.
T
his co
mpar
es
to the co
mpan
y as a whol
e of 6
1
% (2020: 57%
) wome
n and
39% (2020: 43%) men.
Ha
nsa ha
s bee
n
ce
rti
ed a G
reat
Pla
ce to Work for
the second
con
secu
tive yea
r
.
Sust
ainabilit
y
cont
inued
Diversity lev
els of
Hansa (F2021
)
Company
as a whole
Management le
vel
45%
55%
61%
39%
Split b
y gender
Me
n
Women
5
6% emp
loye
e grow
t
h
46
NEW COLLEAGUES
FROM
MANY NEW TERRIT
ORIES
30
DIFFERENT
NA
TIONA
LITIE
S
8
.7
%
LOW E
MPLOY
EE
TURNOVER
RA
TE
Hansa Biopharma
Annual Report 202
1
71
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
Sust
ainabilit
y
cont
inued
Environment
al protection
While Hansa
’s
product
ion operation
s are
small in s
cope, w
e
are ne
vertheless committed t
o monit
oring our
environmen
tal
imp
act so we c
an re
duce i
t whe
re we can. En
viron
ment
al
imp
acts c
an be bot
h dire
ct and i
ndire
ct, stem
ming n
ot onl
y
from in
ternal oper
ations
but the
entire
value chain
. During
2021
, we be
gan to c
ondu
ct com
preh
ens
ive me
asure
men
ts of
our foo
tprint t
o better
understand and minimize
our impact
.
Du
ring 20
2
1
, 6
3
% of th
e ene
rgy (i
nclu
ding 75
% of th
e
electricity) used
in our oper
ations w
as rene
wable,
a pr
opor
tion
we hope
to
increase in coming
years.
Energy consumption
du
ri
ng 2
021 (
in kW
h)
Electricity
207
36
0
Of which
renew
able
11
5
5
2
0
Distr
ict heating
1
20 420
Of which
renew
able
1
20 420
Cooling
47
10
0
To
t
a
l
37
4 88
0 kWh
In thi
s rst r
epor
t of it
s gree
nhou
se gas e
miss
ion
s, the
emissions stemming
from Hansa
’
s act
ivities in 20
2
1
, including
indirect emissions from
purchased electricity
, dist
rict heating
an
d cool
ing (sc
ope 2); as well a
s other i
ndir
ect em
iss
ions f
rom
ups
trea
m activ
itie
s (scop
e 3) can b
e see
n in the b
elow ta
ble.
Ha
nsa fol
lows th
e Gree
nho
use Ga
s (GHG) protoc
ol for
calculating
CO
2
emissions.
Em
is
sio
ns (
in to
n CO
2
-eq)
Scope 2
23
Scope 3
4 86
9
Of t
he mea
sure
d emi
ssio
ns for 2021
, p
urch
ased g
ood
s and
se
rv
ice
s were th
e main s
ource o
f emis
sio
ns, foll
owed by
upstr
eam transportation
and distrib
ution,
and capital goods
.
Go
ing for
wa
rd, Hans
a plan
s to
ex
tend i
ts emis
sio
ns rep
or
ting
to ide
ntif
y fu
rt
her e
miss
ion so
urce
s and t
ake steps to m
inim
ize
emissions from
its v
alue chain
.
In ou
r prod
uctio
n, we als
o want to co
ntinu
e t
o re
duce b
oth the
use of
environmentally hazardous substances and
the
product
ion of
hazardous wast
e,
as much
as possible
. Our
cur
rent p
rodu
ct is an o
rgan
ic mol
ecu
le, an en
zy
me de
rive
d
fro
m a liv
ing ba
cteri
a, and th
erefo
re is co
mple
tely de
grad
ed by
the b
ody o
n use. Th
e limi
ted dis
cha
rges m
ade fro
m our
laborat
ories consist
of common
salts and
biodegradable
org
anic s
ubst
anc
es. For m
ore ha
rmfu
l bypro
ducts a
nd
substances, st
rict handling and disposal r
outines are
in place
an
d are be
ing se
nt to a recyc
ling c
enter fo
r recyc
ling a
nd was
te
tre
atment. H
ansa’
s op
erati
ons ar
e subj
ect to a noti
cati
on
obligation
under the
Swedish
Environmen
tal Code wit
h a
reporting obligat
ion t
o the
municipality of
Lund.
Br
eakd
own o
f sco
pe 3 em
is
sio
ns by c
ate
gor
y
2%
9%
89%
Purchased goods
and
services
Upstream
transpor
ta
tion
and distribution
Capital goods
Hansa Biopharma
Annual Report 202
1
72
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
Financials
Governance
Remuneration
Ma
rket
Ove
rv
iew
ESG
GRI
GRI Standard
Disclosure
GRI Standard Disclosure
description
Page
Comment
General disclosures
–
GRI
102
Organisational
Prole
10
2
-1
Name o
f the
organization
66
10
2-
2
Activities,
brands, products
, and services
3, 1
4, 59
10
2-
3
Location
of hea
dquar
t
ers
66
10
2-
4
Location
of oper
ations
3, 82
10
2-
5
Ownership and
legal form
64, 81
, 128-
130
10
2-
6
Ma
rkets s
er
ved
15
, 2
5
-2
6
10
2-7
Scale of
the or
ganization
6
3
-
6
4
,
11
7
10
2-
8
Inf
orma
tion o
n emp
loye
es an
d othe
r worke
rs
7
1,
11
7
10
2-
9
Supply chain
70
10
2-10
Si
gni
ca
nt cha
nge
s to the org
ani
zati
on and i
ts sup
ply c
hai
n
6, 59
-60
1
0
2
-11
Precautionary Principle or approach
6
8
-70
10
2
-12
Ex
t
ernal initiatives
20
10
2
-13
Membership of
associations
Hansa Biopharma is a
member of se
veral industry associations.
Strategy and
analysis
10
2
-14
Statemen
t from
senior decision-mak
er
5
,
7-
9
10
2
-15
Key
impacts,
risks, and opportunities
18
, 6
0
-
6
3
Ethics and
integrity
10
2
-16
V
alues, principles, standards
, and norms o
f behavior
70
Gov
ernance
10
2
-18
Governan
ce struct
ure
2
0,
12
8
-12
9
Stakeholder
engagement
10
2-
4
0
List of
stakeholder gr
oups
19,
5
7
10
2
-
41
Collective bargaining
agreements
Emp
loye
es ar
e not cove
red by c
oll
ecti
ve bar
gai
ning a
gre
eme
nts.
10
2-
4
2
Identifying and selecting stakeholders
18
-1
9
10
2-
4
3
Approach t
o stak
eholder engagement
1
8
-1
9
10
2-
4
4
Key top
ics a
nd co
nce
rns r
aise
d
18
Hansa Biopharma
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ESG
GRI
cont
inued
GRI Standard
Disclosure
GRI Standard Disclosure
description
Page
Comment
General disclosures
–
GRI
102
Reporting
practice
10
2-
4
5
Ent
itie
s inc
lude
d in th
e cons
oli
dated 
nan
cial s
tatem
ents
81-
8
9
10
2-
4
6
De
nin
g repo
r
t conte
nt and to
pic B
ound
ari
es
18-
1
9,
8
1
-89
10
2-
47
Li
st of mate
ria
l topi
cs
18
10
2-
4
8
Restatem
ents of information
Not a
ppl
ica
ble. T
his is t
he rs
t repo
rt.
10
2-
4
9
Changes in reporting
Not a
ppl
ica
ble. T
his is t
he rs
t repo
rt.
10
2-
5
0
Reporting period
20
21
10
2-
51
Date of m
ost re
ce
nt rep
or
t
Not a
ppl
ica
ble. T
his is t
he rs
t repo
rt.
10
2-
52
Reporting cycle
Y
early
10
2-
5
3
Contact
point for
questions
regarding t
he report
Katja
Margell, Hea
d of
Corporate
Communications
,
katja.
[email protected]
10
2-
5
4
Cl
aims o
f repo
rt
ing in a
cco
rdan
ce wi
th the G
RI Sta
nda
rds
Th
is rep
or
t has b
ee
n prep
ared i
n acc
orda
nce w
ith th
e GRI
St
anda
rds: Co
re leve
l
10
2-
5
5
GR
I conte
nt ind
ex
73
-75
10
2-
5
6
E
xte
rna
l assu
ran
ce
Th
is Sus
tai
nab
ilit
y Re
por
t has n
ot bee
n exte
rna
lly ve
ri
ed.
Management
approach
– GR
I 103
10
3
-1
E
xpl
anat
ion of th
e mater
ial to
pic a
nd its B
ound
ar
y
18
10
3
-2
The management
approach and
its componen
ts
18
-
2
0,
6
8
-72
10
3
-3
Evalua
tion of
the m
anagement approach
18
-2
0
, 6
8
-7
2
T
opic-speci
c
disclosures
– GR
I 20
0
: Econ
omi
c
2
0
1-1
Direct economic value
generated and dis
tributed
7
7-
8
0
203
-2
Signicant indirect
economic impacts
68-69
2
0
5
-1
Operations
assess for
risks of
anti-corrupt
ion
70
205
-2
Communicatio
n and t
raining about
anti-corrup
tion policies
and pr
ocedures
70
205-3
Co
nrm
ed in
cid
ents of c
orr
upti
on and a
ctio
ns ta
ken
70
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ESG
GRI
cont
inued
GRI Standard
Disclosure
GRI Standard Disclosure
description
Page
Comment
T
opic-S
pecic
Disclosures
– GR
I 30
0
:
Environmental
302-
1
Energy consu
mption wit
hin the
organization
72
30
5-2
Energy indirect
(Scope 2
) GHG emissions
72
305-3
Other indirect (
Scope 3)
GHG emissions
72
30
6-2
Ma
nage
me
nt of sig
ni
cant w
aste-
rel
ated im
pact
72
T
opic-speci
c
disclosures
– GR
I 40
0
: Soc
ial
4
0
1-1
New employ
ee hires and
employee turnov
er
7
1
,
117
404
-2
Programs
for upgrading
employee
skills and transit
ion assistance pr
ograms
71
404-3
Perc
ent
age of e
mpl
oyee
s rece
ivi
ng re
gul
ar pe
rfo
rma
nce a
nd ca
ree
r deve
lop
ment
reviews
71
4
0
5
-1
Di
ver
sit
y of gove
rna
nce b
odi
es an
d empl
oyee
s
71
413
-1
Operations
with local
community engagement,
impact assessment
s, and
development pr
ograms
68-69
414
-1
New sup
pliers that
were
screened using
social criteria
70
416
-1
As
ses
sme
nt of the h
eal
th an
d safet
y im
pact
s of prod
uct a
nd se
rv
ice c
ateg
ori
es
69
417-1
Requirements f
or product and
ser
vice inf
ormation and labeling
6
9
-70
418
-1
Su
bsta
ntiate
d com
pla
ints c
onc
ern
ing br
eac
hes of c
ustom
er pr
ivac
y and l
oss
es
of cu
stome
r dat
a
70
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ESG
9
F
inancials
The Group Financial Statements
77
Note
s to the Gr
oup Fi
nanc
ial S
tatem
ents
81
Parent Company
Financial Statements
1
08
Note
s to the Par
ent C
ompa
ny
Financial Statements
1
1
2
Signatures 1
22
Aud
itor’s Re
por
t
1
2
3
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Hansa Biopharma
Annual Report 202
1
1
Hansa Biopharma Annual Report 2021
 
 
Consolidated statement
of
financial
p
osition
 
 
As of December 31,
(in thousands of SEK)
Note
2021
2020
ASSETS
 
 
Non
-
current
 
assets:
Intangible assets
4
28,761
31,410
Property and equipment
5
6,432
5,206
Right
-
of
-
use assets
6
35,273
4,493
Total non
-
current assets
70,466
41,109
Current assets:
Inventories
7
242
98
Trade receivables
8
9,712
110
Prepaid expenses and accrued income
9
20,889
5,716
Other receivables
10
22,538
9,957
Short
-
term investments
20
237,619
238,144
Cash and cash equivalents
20
651,342
1,139,362
Total current assets
942,342
1,393,387
TOTAL ASSETS
1,012,808
1,434,496
EQUITY
Share capital
22
46,335
45,895
Share premium
23
2,572,925
2,509,458
Treasury share reserve
24,25
(1,862)
(1,421)
Other reserves
25
127
(137)
Accumulated deficit
(1,859,953)
(1,311,671)
Total equity attributable to owners of the parent
company
 
757,573
1,242,124
 
 
 
 
 
As of December 31,
(in thousands of SEK)
Note
2021
2020
LIABILITIES
Non
-
current liabilities:
Lease liabilities
6
28,491
630
Deferred revenue
13
47,020
62,026
Contingent consideration
18
722
663
Provisions
15
7,357
14,426
Deferred tax liabilities
16
426
424
Total non
-
current liabilities
84,016
78,169
Current liabilities:
Lease liabilities
6
6,888
4,415
Trade payables
20
53,360
26,669
Other liabilities
12
13,548
9,588
Deferred revenue
13
24,961
17,406
Accrued expenses
11
72,462
56,125
Total current liabilities
 
171,219
114,203
Total liabilities
255,235
192,372
TOTAL EQUITY AND LIABILITIES
 
1,012,808
1,434,496
 
The accompanying notes are an integral part of these Consolidat
ed Financial Statements.
The Group F
inanc
ial St
at
ements
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Hansa Biopharma Annual Report 2021
 
 
Consolidated income
statement
Years Ended December 31,
(in thousands of SEK, except for shares and per share data)
Note
2021
2020
Revenue
13
33,878
6,098
Cost of revenue
(15,425)
(997)
Other operating income
27
—
2,270
Sales, general and administrative expenses
28
(327,269)
(202,987)
Research and development expenses
28
(230,764)
(227,191)
Other operating expenses
27
(7,398)
—
Loss from operations
(546,978)
(422,807)
Finance income
21
67
2,170
Finance expenses
21
(1,219)
(257)
Loss before tax
(548,130)
(420,893)
Income tax benefit (expense)
16
(152)
40
Loss for the year
(548,282)
(420,853)
Loss for the year attributable to owners of the parent
(548,282)
(420,853)
Loss per share, basic and diluted
17
SEK
(12.33)
SEK (9.98)
Weighted
-
average number of ordinary shares outstanding,
basic,
and diluted
44,473,452
42,176,872
 
 
 
 
S
tatement
of other
comprehensive income
Years Ended December 31,
(in thousands of SEK, except for shares and per share data)
Note
2021
2020
Loss for the year
(548,282)
(420,853)
Other comprehensive income (loss):
Items that are or may be reclassified subsequently to
profit or loss, net of tax:
 
Exchange differences on translating foreign operations
264
(297)
Other comprehensive income (loss) for the year
264
(297)
Total comprehensive loss for the year
(548,018)
(421,150)
Total comprehensive loss for the year attributable to
owners of the parent
 
(548,018)
(421,150)
 
The accompanying notes are an integral part of these Consolidated Financ
ial Statements.
 
The Group F
inancial Statements
con
ti
nued
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Hansa Biopharma Annual Report 2021
 
 
Consolidated statement of cash flow
Years Ended December 31,
(in thousands of SEK, except for shares and per share data)
Note
2021
2020
Cash Flows from Operating Activities
 
 
Loss for the year
(548,282)
(420,853)
Adjustments to reconcile net loss to net cash flows:
Depreciation and amortization expenses
8,606
7,666
Expenses related to incentive programs
56,624
43,348
Costs related to pension plan
(226)
141
Unrealized currency differences
(6)
275
(483,284)
(369,423)
Changes:
(
Increase
)
decrease of trade receivables
8
(9,602)
412
Increase of other operating receivables
(29,756)
(3,885)
Increase (decrease) trade payables
28,577
(23,897)
Increase of other operating liabilities
13,668
106,693
Total changes
2,887
79,323
Interest paid, net
(627)
(68)
Income taxes paid
(143)
(105)
Net cash used in operating activities
(481,168)
(290,274)
Cash Flows from Investing Activities
 
 
Proceeds from sale of short
-
term investments
—
182,828
Acquisition of property and equipment
5
(2,399)
(294)
Net cash
(used in)
from investing activities
(2,399)
182,534
 
 
 
 
 
 
 
Years Ended December 31,
Note
2021
2020
Cash Flows from Financing Activities
 
 
 
Proceeds from issue of ordinary shares, net of
transaction costs
(1)
 
—
1,070,581
Payment of lease liabilities
6
(4,857)
(4,674)
Net cash (used in)
from
financing activities
 
(4,857)
1,065,906
Net change in cash and cash equivalents
 
(488,424)
958,166
Cash and cash equivalents at beginning of year
 
1,139,362
181,697
Effects of movements in exchange rate on cash held
 
403
(501)
Cash and cash equivalents at end of year
 
651,342
1,139,362
(1)
Total share issue cost amounted to SEK 41,255k
in the year 2020
.
 
The accompanying notes are an integral part of these Consolidated Financi
al Statements.
The Group F
inancial Statements
con
ti
nued
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Hansa Biopharma Annual Report 2021
 
 
Consolidated statement of
changes in equity
 
 
 
 
 
 
 
 
(in thousands of SEK)
Note
Share
Capital
Share
Premium
Treasury
Share
Reserve
Translation
Reserve
Fair
Value
Reserve
Accumulated
deficit
Total equity
attributable to
owners of the
parent company
Balance at January 1, 20
20
41,448
1,413,447
(1,421)
160
81,003
(971,821)
562,815
Consolidated statement of profit or loss and other comprehensive income (loss):
 
 
Loss for the year
—
—
—
—
—
(420,853)
(420,853)
Other comprehensive
loss
for the year
—
—
—
(297)
—
—
(297)
Total comprehensive loss for the year
—
—
—
(297)
—
(420,853)
(421,150)
Reclassification of fair value reserve
—
—
—
—
(81,003)
81,003
—
Issue of ordinary shares
(1)
4,447
1,066,133
—
—
—
—
1,070,581
Long term incentive program
—
29,878
—
—
—
—
29,878
Balance at December 31, 20
20
22,23,24,25
45,895
2,509,458
(1,421)
(137)
—
(1,311,671)
1,242,124
Consolidated statement of profit or loss and other comprehensive income (loss):
Loss for the year
—
—
—
—
—
(548,282)
(548,282)
Other comprehensive
income
for the year
—
—
—
264
—
—
264
Total comprehensive loss for the
year
—
—
—
264
—
(548,282)
(548,018)
Issue
of
Class
C
shares
(2)
440
—
(440)
—
—
—
—
Long term incentive program
—
63,467
—
—
—
—
63,467
Balance at December 31, 202
1
22,23,24,25
46,335
2,572,925
(1,862)
127
—
(1,859,953)
757,573
(1)
Total share issue cost amounted to SEK 41,255
in the year 2020.
(2)
The year 2021 additions of Class C shares refer to the new issue and subsequent repurchase of Cl
ass C shares that have taken
place in accordance with the respective long term incentive plan (LTIP) program
.
 
The accompanying notes are an integral part of these Consolidated Financ
ial Statements.
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The Group F
inancial Statements
con
ti
nued
5
Hansa Biopharma Annual Report 2021
 
 
Note 1
General Information
Hansa Biopharma AB (Hansa, the Company; and together with its
subsidiaries, the Group) is a
pioneering commercial
-
stage biopharmaceuti
cal corporation on a mission to develop and
commercialize innovative, l
ifesaving and life altering treat
ments for patients with rare
immunological conditions. The Company has developed
an immunoglobulin
G (IgG) antibody
cleaving enzyme therapy
, imlifidase
, which can enable kidney transplantati
on in highly
sensitized patients and
is
also
being de
veloped
as a pot
ential treatment in different autoimmune
indications.
Hansa
has received conditional approval of I
defirix
(imlifidase)
by the European
Commission for desensitization treatment of highly sensit
ized kidney transplant patients. Hansa
is a public limited liabilit
y company under the laws of Sweden, based in Lund,
Sweden
, and has
operations in
Europe
and the United States
.
The Group consists of the parent company, Hansa
Biopharma AB and the subsidiaries Cartela R&D AB, Hansa Biopharma Ltd,
Hansa Biopharma
Inc. and Hansa Bi
o
pharma Australia PTY LTD
.
Note 2
Basis of Prese
ntation and Summary of Signi
ficant Accounting Policies
Basis of ac
coun
ting
The consolidated financial st
atements are reported in Swedish Krona, Hansa Biopharma AB’s
functional currency, and prepar
ed in accordance with the International Financi
al Reporting
Standards (IFRS), issued by the Int
ernational Accounting Standards Board (I
ASB) and the
interpretations issued by the IASB’s Inter
national Financial Reporting Interpretation Committee.
The consolidated financial st
atements provide a general overview of the Group’s acti
vities and
the results achieved. They present
fairly the entity’s fi
nancial position, its financial
performance,
and cash flows, on a going concern basis. The account
ing policies described in Note 2 and 3 of
the Group’s consolidated financi
al statements have been applied in preparing the consoli
dated
financial statements as of and f
or the year ended December 31,
2021
,
and for the comparative
information as of and for the year ended December 31, 20
20
.The significant accounting pol
icies
applied in the preparation of the above c
onsolidated financial statements are set ou
t below.
The preparation of consolidated f
inancial statements requires management to exercise i
ts
judgment in the process of applying the Group’s accounting
policies. The areas involving a
higher degree of judgment or complexity, or
areas where assumptions
and estimates that are
significant to the consoli
dated financial statements are disclosed i
n Note 3.
These consolidated financial st
atements of the Group as of December 31,
2021,
and for the
year then ended were approved by the Board of Director
s of the G
roup and authorized for issue
on
April
6
, 202
2.
 
 
Ch
ange
s in Accounting Poli
cies and Disclosures
Several amendments to and interpretations of
IFRS applied for the first time in 202
1
, which has
not had an impact on the accounting policies
applied by the Group. Thus, the accounti
ng
policies applied when preparing these consol
idated financial statements have been applied
consistently to all t
he periods presented, unless otherwise stated
.
Basis of Consolidation
The consolidated financial st
atements include Hansa Biopharma AB, Lund Sweden, and
subsidiaries over which the Group has cont
rol. Control is achieved when the Group:
>
has power over t
he investee;
>
is exposed, or
has rights, to variable returns from its involvement with t
he investee; and
>
has the abil
ity to use its power to affect i
ts returns.
The Group reassesses whether it controls
an investee if facts and circumstances indic
ate that
there are changes to one or more of the three el
ements of control listed above. If the Group
does not have a majority of the vot
ing rights of an investee, it has power over t
he investee when
the voting rights are suff
icient to give it the practical
ability to direct the relevant act
ivities of the
investee unilaterally
.
The Group considers all relevant f
acts and circumstances in assessing whether the Group’
s
voting rights in an invest
ee are sufficient to give it power, inc
luding:
>
the si
ze of the Group’s holding of voting rights r
elative to the size and dispersion of holdi
ngs
of the other vote holders;
>
potenti
al voting rights
held by the Group;
>
rights ar
ising from other contractual arrangements; and
>
any additi
onal facts and circumstances that indicate t
hat the Group has, or does not have, the
current ability to di
rect the relevant activities at
the time that decisions need to be made,
including voting patterns at previous sharehol
ders’ meetings.
Consolidation of a subsidiary begins when the Group obtains contr
ol over the subsidiary and
ceases when the Group loses control of the subsi
diary. Specifically, income and expenses of
a
subsidiary acquired or disposed of
during the year are included in the consoli
dated statement of
profit or loss and other comprehensive i
ncome (loss)from the date the Group gains control until
the date when the Group ceases to control the s
ubsidiary.
Adju
stments are made to the financial statements of
subsidiaries to bring their accounti
ng
policies in line with the Group’
s accounting policies. All intra group t
ransactions, balances,
income and expenses are eliminated in full in consolidat
ion. Unrealized lo
sses are also
eliminated unless the transacti
on provides evidence of an impairment of the transferred as
set.
Notes
 
No
tes to the G
roup Financial S
tateme
nts
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Hansa Biopharma Annual Report 2021
The Group holds investments either dir
ectly or indirectly in the fol
lowing subsidiaries:
Share ownership percentage (%)
Subsidiaries
Registered office/Country
2021
2020
Cartela
R&D AB
Lund, Sweden
100
100
Hansa Biopharma Ltd
Cheltenham, UK
100
100
Hansa Biopharma Inc
Delaware, USA
100
100
*
Hansa Biopharma
Australia
Pty Ltd
Australia
100
—
*Dormant company
Because the functional currency for
Hansa Biopharma Ltd and Hansa Biopharma Inc is the UK
Pound Sterling and the United States Dollar
, respectively, the Group has foreign curr
ency
exposure. See “Functional and Presentati
on Currency” section that follows an
d Note 20,
“Financial Risk and Financial Instruments.”
Functional and Presentation Currency
The presentation currency of the consol
idated financial statements is Swedish Kronor
(SEK).
The functional currency, which i
s the currency that best reflects the ec
onomic environment in
which the subsidiaries of the Group operate and conduct their
transactions, is separately
determined for the Group’s subsidiari
es and is used to measure their financial positi
on and
operating results.
Transactions in currencies ot
her than the functional currency of a subsi
diary are recorded at the
rates of exchange prevailing at the date of t
he transaction. Monetary assets and liabilities in
currencies other than the functi
onal currency are remeasured at the rates of exchange
prevailin
g on the date of the consolidated statements of financ
ial position and the related
translation gains and losses ar
e recognized in the Consolidated statement of profi
t or loss and
other comprehensive income. Non
-
monetary items that are carr
ied at cost are translated using
the rate of exchange prevailing at
the date of the transaction. Non
-
monetary it
ems that are
carried at fair value are t
ranslated using the exchange rate prevailing when the f
air value was
determined
,
and the related translation gai
ns and losses are reported in the Consoli
dated
statement of profit or loss and ot
her comprehensive income
.
Upon consolidation, the results of operations of
subsidiaries whose functional currency is other
than the SEK are translated into SEK at t
he monthly average exchange rates and assets and
liabilities are translated at
the year
-
end exchange rates. Translation adjustments are recognized
directly in other comprehensive i
ncome.
Measurement of Fair Values
The Group’s accounting policies and di
sclosures require the measurement of fair val
ues, for
both financial and non
-
financi
al assets and liabilities. The Group has an est
ablished control
framework with respect to the measurement of f
air values. This includes the use of val
uation
specialists that have responsi
bility fo
r overseeing certain signif
icant fair value measurements,
including Level 3 fair values, and report
s directly to the chief financial officer.
If third party
information, such as broker quotes or pricing servi
ces, is used to measure fair values, then the
Gr
oup assesses the evidence obtained fr
om the valuation specialists to support the concl
usion
that these valuations meet the requi
rements of the Standards, including the level
in the fair
value hierarchy in which the val
uations should be classified. Signifi
cant valuation issues are
reported to the Group’s audit committee.
When measuring the fair value of an asset or a liabil
ity, the Group uses observable market data
as far as possible. Fair values ar
e categorized into different levels i
n a fair value
hierarchy
based on the inputs used in the valuation t
echniques as follows:
>
Level 1: quot
ed prices (unadjusted) in active markets for i
dentical assets or liabilities
.
>
Level 2: i
nputs other than quoted prices included in Level 1 that
are observable for the a
sset
or liability, either directly (i.e
., as prices) or indirectly (i.e., derived from
prices).
>
Level 3: i
nputs for the asset or liability t
hat are not based on observable market data
(unobservable inputs).
If the inputs used to measure the fai
r value of a
n asset or a liability fall into diffe
rent levels of the
fair value hierarchy, t
hen the fair value measurement is categorized in it
s entirety in the same
level of the fair value hierarchy as t
he lowest level input that is significant to the
entire
measurem
ent. The Group recognizes transfers between levels of
the fair value hierarchy at the
end of the reporting period during which t
he change has occurred.
Revenue
Revenue is recognized when control of the promised goods or services is t
ransferred to the
custo
mer, and in an amount that reflects the considerat
ion the Group received or expects to
receive in exchange for those goods or services.
The Group derives its revenues primari
ly from products and contractual arrangements.
The
Group determines revenue recogn
ition through the
following steps:
>
(1) Ident
ification of the contract, or contracts, wit
h a customer.
>
(2)
Identifi
cation of the performance obligation(s) i
n the contract.
>
(3
)
Determination of the transacti
on price.
>
(4
)
Allocation of t
he transaction price to the performance obli
gations in the contract.
>
(5
)
Recognition of revenue when, or as, the Group sat
isfies a performance obligation.
Product revenue
Product revenue is recognized net of any s
ales and value added taxes and sales deductions
based on contractually agreed payment ter
ms. The control passes according to contractual
terms. The amount of
consideration the Group r
eceives and revenue the Group recognizes
varies based on actual or estimated r
ebates, discounts, returns and charge backs. The Group
adjus
ts its estimate of r
evenue at the earlier of when the most likely amount of
consideration the
Group expects to receive changes or when the consi
deration becomes fixed.
Hansa Biopharma
Annual Report 202
1
82
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
7
Hansa Biopharma Annual Report 2021
Sales returns are generally esti
mated and recorded based on historical sales and returns
information. Sales returns allowances represent a r
eserve for products that may be returned
due to expiration, damage or potential
other reasons typically calculated as a percent
of gross
revenues.
For the periods ended December 31, 202
1
, and 20
20
, there have been no sal
es
returns
.
Co
ntract revenue
The Group accounts for a contract when it has appr
oval and commitment from both parties, the
rights of the parties are identif
ied, payment terms are identified, the contract has commercial
substance and collectabili
ty of consideration is probable.
In determining the proper revenue recogni
tion method, the performance obligation(s) under an
agreement is reviewed and evaluated if such obli
gation(s) be accounted for as more than one
performance obligation.
Fo
r certain contracts, a service of combining a l
icense and related tasks into a single
performance obligation may be provided. In suc
h a case, the entire contract is accounted for as
one performance obligation. Certain cont
racts may promise to provide a dist
inct license with
distinct services withi
n a contract, in which case the contract is separ
ated into more than one
performance obligation. If a cont
ract is separated into more than one performance obligati
on,
the total transaction pr
ice is allocated to each performance obligat
ion in an amount based on
the estimated relative standal
one selling price of the promised goods or servi
ces underlying
each performance obligation. Non
-
refundable upf
ront payments and substantive development
and sales milestone payments are typi
cally recognized over the remaining performance period
based on the progress towards satisfyi
ng its identified performance obligation.
Grant revenue
Because the Group carries out extensive r
esearch and development activities, the Group may
benef
it from various grants, research and development i
ncentives and payroll tax rebates from
certain governmental agencies. These grant
s, research and development incentives and payroll
tax rebates generally aim to part
ly reimburse approved expenditures incurr
ed in research and
development efforts of the Group and are credi
ted to the consolidated statement of profit
or loss
and other comprehensive income, under the line other
income, when the relevant expenditure
has been incurred and there is reasonable assura
nce that the grants or research and
development incentives are receivable.
Research and Development Expense
s
Research and development costs are typically expensed as incurred, unless
capitalized. Costs
of research and development equipment with alter
native
future uses are capitali
zed and
depreciated over the equipment’s useful
life.
Research and development expenses primarily include costs for third
-
party services in
connection with clinical
studies and research projects, costs for produc
ing substance to be
used
in such studies and projects, personnel expenses for t
he Group’s research and development
groups, and depreciation of equipment used for
research and development activities. In
addition, research and development expenses cont
ain expenses for producing pharmaceutical
material which may be used for commercialization subject to regul
atory approval, and which
was produced prior to obtaining regulatory approval or
evidence being available that regulatory
approval can reasonably be expected.
Expenditures on
research activities is r
ecognized in the consolidated statement of profit or loss
and other comprehensive income (loss) as incurr
ed. Development expenditures are capitalized
only if the expenditure can be measured reli
ably, the product or process is techn
ically and
commercially feasible, f
uture economic benefits are probable, and the Group int
ends to and has
sufficient resources to c
omplete development and to use or sell the asset. Otherwise,
it is
recognized in the consolidated statement of prof
it or loss
and other comprehensive income
(loss) as incurred. Subsequent to initial
recognition, development expenditure is measured at
cost less accumulated amortizati
on and any accumulated impairment losses.
Generally, expenditures are not capi
talized before the pharmaceutical aut
horities have given
approval due to the level of uncertai
nty associated with the approval process. The Group has
not capitalized any research and development ex
penditure for the periods ended December 31,
202
1,
and 20
20
.
Sales, General and Administrative Expenses
Sales, general and administrativ
e expenses consist primarily of (i) personnel
expenses relating
to salaries and related costs
for personnel, including share
-
based compensation,
of our
employees in executive, commercial, fi
nance, business development and support functions,
(ii)
fees relating to professi
onal services for commercialization, market
ing, selling, medical affairs,
corporate management, legal, finance,
human resources, business development, licensing and
investor relations, (iii) board expenses consi
sting of directors’ fees and travel expenses for
board members, and (iv) other general and administr
ative expenses, including leasing costs,
office expenses, travel cost
s. General and administrative expenses are recognized i
n the
consolidated statement of profi
t or loss and other comprehensive income (loss)i
n the period to
which they relate.
Pensions
Plans where the Group’s obligations are l
imited to the contribution the Group has undertaken t
o
pay are classified as “defined
contribution pension plans”. In such cases,
the size of the
employee’s pension is dependent upon the contribut
ion which the Group pays into the plan, or
to an insurance company, and the return on capi
tal which the contribution generate.
Consequently, it is
the employee who bears the actuarial r
isk (that the benefits will be lower
than anticipated) and the invest
ment risk (that the invested assets wil
l be insufficient to
generate the anticipated benefit
s). The Group’s obligations regarding fees paid to def
in
ed
contribution plans are repor
ted as an expense in the consolidated statement of profi
t or loss
and other comprehensive income (loss) when they are earned by t
he employees performing
their services on behalf of t
he Group during a given period of time.
Hansa Biopharma
Annual Report 202
1
83
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
8
Hansa Biopharma Annual Report 2021
Emp
loyee Benefits
Short
-
term employee benefits
Short
-
term employee benefits are expensed as the r
elated service is provided. A liabil
ity is
recognized for the amount expected to be paid if the
Group has a present legal or constructive
obligation to pay this a
mount as a r
esult of past service provided by the employee and the
obligation can be estimated reliabl
y.
Long
-
term employee benefits
The Group’s net obligation in res
pect of long
-
term employee benefits is the amount of f
uture
benefit that employees have ea
rned in r
eturn for their service in the current and prior peri
ods.
That benefit is discounted to det
ermine its present value. Remeasurements are recognized i
n
profit or loss in the period i
n which they arise.
Termination benefits
Termination benefits are expensed at
the earlier of when the Group can no longer withdraw the
offer of those benefits and when the Group rec
ognizes costs for a restructuring. If
benefits are
not expected to be settled wholly wit
hin 12 months of the reporting date, then they are
dis
counted.
Share
-
based Payments
The Company has provided share
-
based payment awards through long
-
ter
m incentive
programs for certain employees whereby partic
ipants are provided ordinary shares of the
Company after the vesting period, either through share r
ig
hts,
employee stock options or share
warrants, if certain performance conditions are met.
Vesting is based on market or non
-
market
performance conditions. For awards that v
est upon achieving a market condition, the
Company’s share price must achieve certai
n thresholds. For awards that vest upon achi
eving
the non
-
market conditions, the Company must achieve certain pre
-
defined business objectives
related to financial, portfol
io and/or commercial targets.
The awards are classified as equity
-
settled share
-
based
payments since the only settlement
alternative is in shares of t
he Company. For equity
-
settled programs, the fai
r value of the
instruments is determined at the grant date and is
subsequently not remeasured. The share
-
based payment expense is recognized over the ves
ting period with a corresponding entry
recognized directly in equity. Social secur
ity costs relating to share
-
based compensation are
recognized as expense in profit or loss over the same vesti
ng period, based on the fair value of
the equity inst
ruments at each report
ing date. An amount corresponding to the recognized
expense is recognized as a liabili
ty.
The fair value of the options i
s calculated based on the Black
-
Scholes model and expensed
over the vesting period. During the v
esting period, the expense is adjust
ed in order to account
for the number of options that are expec
ted to vest.
For share rights that vest upon achi
eving market conditions, the Company determines the value
of the awards using the Monte Carlo model at the grant
date because
different share price
realizations result in differ
ent values for the award. The effect of a market condition is ref
lected
in the grant
-
date fair value of an award. The share
-
based payment expense is recognized over
the three
-
year vesting period provi
ded that the service is rendered, regardl
ess of when, if ever,
the market condition is sati
sfied.
For share rights with a non
-
market performance condit
ion, the Company valued the awards
using Black
-
Scholes model. The exercise price of
the share rights has been set using a volume
weighted average of the Company’s share price over a certain period befor
e grant date. For the
estimation of expected future vol
atility, the average 90
-
day historical volatility was estimated
for
the Company and nine peers over periods
between one and seven years.
B
y using peer
publicly traded companies which it cons
iders to be as closely comparable in addition to the
Company’s trading activity. The yield curve for Swedish government bonds i
s used to determine
the
risk
-
free
interest rat
e. After the value of the awards were determined, the Company
estimated the probability of ac
hieving the non
-
market conditions and adjusted the number of
awards that would expense over the amortizati
on period. The Company
re
-
evaluates
the
probability of achieving t
he non
-
market conditions each reporting period.
The Company also has a share warrant program in which parti
cipants were given the
opportunity to acquire warrants at
market value calculated based on the Black Scholes model.
The share warrant progra
m was subsidized by the Company and participant
s (except the CEO)
in the share warrant program received a one
-
time subsidy when the warrants were purchased.
The fair value of the subsidy i
s expensed over the vesting period.
Other operating i
ncome and expen
ses
Other income
Other income includes foreign currency
gain on receivables from operating activiti
es
and
gain
from disposal of assets.
Other expenses
Other expenses include foreign currenc
y loss on receivables from operating activit
ies
and
loss
from dispo
sals of assets.
Finance Income and Expenses
Finance income and expenses comprise of interes
t income and expenses, amortization of
securities, and realiz
ed and unrealized exchange rate gains and losses on transacti
ons
denominated in foreign currencies.
Interest income and interest ex
penses are stated on an accrual basis using the princi
pal and
the effective interest
rate. The effective interest rat
e is the discount rate that is used to di
scount
expected future cash payments or receipts
through the expected life of the fi
nancial asset or
financial liabili
ty to the amortized cost (the gross carryi
ng amount), of such asset or liability
.
Income Taxes
Tax for the year, which consists of
current tax for the year and changes in deferred t
ax, is
recognized in the
Consolidated statement of profit or loss and other
comprehensive income
(loss)
by the portion attributabl
e to the profit or loss for the year and recogni
zed directly in
Hansa Biopharma
Annual Report 202
1
84
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
9
Hansa Biopharma Annual Report 2021
equity or other comprehensive income by the port
ion attributable to entries directl
y in equity and
in other comprehensive income. The current tax payable or receivabl
e is recognized in the
consolidated statement of financi
al position, stated as tax computed on this year
’s taxable
income, adjusted for prepaid tax.
When computing the current
tax for the year, the tax rates
and tax rules enacted or substantially
enacted at the reporting date are used. Cur
rent tax payable is based on taxable profit or los
s for
the year. Taxable profit or l
oss differs from net profit or loss
as reported in the co
nsolidated
statement of profit or loss and ot
her comprehensive income (loss)because it excludes i
tems of
income or expense that are taxable or deductible in pr
ior or future years. In addition, taxable
profit or loss excludes it
ems that are never taxable or
deductible.
Deferred tax is recognized according to the balance sheet l
iability method of all temporary
differences between carrying amounts and tax
-
based values of assets and liabilities
, apart from
deferred tax on all temporary diff
erences occurring on
initial recogni
tion of goodwill or on initial
recognition of a transaction which is not a
business combination, and for which the temporary
difference found at the time of i
nitial recognition neither affect
s profit or loss nor taxable income.
Deferred tax liabilities are recognized on all
temporary differences related to investments in
subsidiaries and/or associat
es, unless the Group is able to control when the deferr
ed tax is
realized, and it is probable that t
he deferred tax will not become due and payabl
e as current tax
in the foreseeable future.
Deferred tax assets, including the tax base of t
ax loss carry forwards, are recognized in the
statement of financial posit
ion at their estimated realizable val
ue, either as a set
-
off against
deferred tax liabilit
ies or as net tax assets for offset against futur
e positive taxable income.
Deferred tax assets are only offset against defer
red tax liabilities if the entity has a l
egally
enforceable right to set off
, and the deferred tax assets and deferred tax liabi
lit
ies relate to
income taxes levied by the same tax jurisdiction. Defer
red tax is calculated based on the
planned use of each asset and the settlement of
each liability, respectively.
Deferred tax is measured using the tax rates and tax rules i
n the relevant
countr
ies that, based
on acts in force or acts in real
ity in force at the reporting date are expect
ed to apply when the
deferred tax is expected to cryst
allize as current tax. Changes in deferred tax
resulting from
changed tax rates or tax rules are r
ecognized in the consolidated statement of prof
it or loss and
other comprehensive income (loss)unless t
he deferred tax is attributable to transac
tions
previously recognized directl
y in equity or other comprehensive income. In the
latter case, such
changes are also recognized in equity or
other comprehensive income. On every reporting
date, it is assessed whether suff
icient taxable income is likely to ari
se in the future for the
deferred tax asset to be utili
zed.
Property and Equipment
Property and equipment are measured at cost less acc
umulated depreciation and any
accumulated impairment losses. Cost comprises t
he acquisition price, costs directl
y attributable
to the acquisition and preparati
on costs
of the asset until the time when it i
s ready to be
used in
operation. Subsequent costs are incl
uded in the carrying amount of the asset or recognized as
a separate asset, as appropriate, onl
y when it is probable that future economic benefits
associated with the assets will
flow to the Group and the costs of the it
ems can be measured
reliably. All repair and maintenance costs ar
e charged to the consolidated statement of profit or
loss and other comprehensive income (loss)during the financial
periods in which they are
incurred.
Equipment acquired for research and devel
opment activities with alternative use,
which is
expected to be used for more than one year, is capi
talized and depreciated over the estimated
useful life as research and development cos
ts. Equipment acquired for research and
development activit
ies, which has no al
ternative use, is recognized as research and
development costs when incurred.
If the acquisition or use of
the asset involves an obligation to incur
costs of decommissioning or
restoration of the asset, the esti
mated related costs are r
ecognized as a provision and as part
of the relevant asset’s cost
, respectively.
The basis for depreciation is
cost less estimated residual value. The resi
dual value of an asset
is the estimated amount that an entity would current
ly obtain from disposal of
the asset, after
deducting the estimated costs of di
sposal, if the asset were already of the age and in the
condition expected at the end of it
s useful life. If signifi
cant parts of an item of property and
equipment have different useful li
ves, then they are accounted for as separat
e items (major
components) of property and equipment. Depreci
ation commences when the asset is available
for use, which is when it is i
n the location and condition necessary for it
to be capable of
operating in the manner intend
ed.
Depreciation is calculated on a straight
-
line basis, based on an asset’s expect
ed useful life,
being within the following ranges:
Property and equipment
3
−
10 years
Right
-
of
-
use assets
3
−
5
years
Hansa Biopharma
Annual Report 202
1
85
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
10
Hansa Biopharma Annual Report 2021
Depreciation methods, useful lives and residual values are reviewed at each report
ing date and
adjusted if appropriate.
Depreciation and impairment losses of property and equipment is recogni
zed in the
Consolidated statement of profit or loss and other
comprehensive income (loss)as research and
development costs or as selling, general
and administrative expenses, as appropriate.
Gains and losses on disposal of property
and equipment are recognized in the Consolidated
statement of profit or loss and ot
her comprehensive income (loss)at its net
proceeds, as either
other income or other expenses, as appropriat
e.
Intangible Assets
Acquired intangible assets held by t
he Group consists of patents and in
-
process devel
opment
projects acquired in a business combinat
ion. The intangible assets where origi
nally recognized
at the acquisition date fair
value. Subsequently, they are measured at cost less accumulat
ed
amortization and any impairment. Amortizat
ion is calculated to write off the cost
of development
projects, less their est
imated residual values, using the str
aight
-
line method over their
estimated useful lives and commence when the project
s start to generate revenue, being within
the following range:
Patents
Until expiry date
In
-
process development projects
10
−
15 years
Impairment
If
circumstances or changes in the Group’s operat
ions indicate that the carrying amount of non
-
current assets in a cash
-
generating uni
t may not be recoverable, management reviews the
asset for impairment. An annual impairment t
est is also performed for assets
yet to be brought
into use, i.e. per December 31, 202
1
in
-
process development projects mainly relating to
imlifidase. The basis for the review is the
recoverable amount of the assets, determined as the
greater of the fair value less
costs of disposal or its val
ue in use. Such review uses an analysis
of current market value (market cap of t
he Company) as the fair value less cost of disposal. I
f
the carrying amount of an asset is gr
eater than the recoverable amount, the asset is wri
tten
down to the recoverab
le amount. An impairment loss is r
ecognized in the consolidated
statement of profit or loss and ot
her comprehensive income (loss)when the impairment is
identified. The Group assess at the end of each report
ing period whether there is any indication
that an
asset may be impaired. If any such indi
cation exists, the Group will estimate t
he
recoverable amount of the asset.
Cash and Cash Equivalents
Cash and cash equivalents comprise of on
-
demand deposits with financial institut
ions. Cash
and cash equivalents are measured at amortiz
ed cost.
Shareholders’ Equity
The share premium reserve is comprised of t
he amount received, attributable to shareholder
s’
equity, in excess of the nominal amount of
the shares issued, reduced by any amount allocated
external expenses directly at
tributable to the offerings. The share premium res
erve can be
distributed.
Shareholders are entitled to div
idends which are determined after they become shareholders.
Shareholdings entitle a shareholder
to one vote per share at general meetings.
The year
2021
additions of Class C shares refer t
o the new issue and subsequent repurchase
of Class C shares
related to the fundi
ng of the
long
-
term
incentive plan
(LTIP)
2021
, as
approved at the 2021 AGM
.
The treasury shares reserves compris
e own shares repurchased by the Group.
The translation reserve compri
ses all foreign exchange differences arisi
ng on translation of
financial statements from f
oreign business prepared in currency other than the r
eporting
currency for the financial
statements of the Group.
Retained earnings
/accumulated deficit, i
ncluding profit/loss for the year,
includes profits
earned
/losses incurred
by the Group and it
s subsidiaries. Previous allocations t
o statutory
reserves, excluding transferred share premium reserves, are
i
ncluded i
n this shareholders’
equity item.
No dividend was paid for the periods ended December
3
1, 202
1,
or 20
20
.
Leases
The Group leases various offices, l
aboratory facilities, equipment and v
ehicles. Rental contracts
are typically made for fixed peri
ods of three to four years, but cert
ain contracts may have
extension options.
Contracts may contain both lease and non
-
lease components. The Group allocates the
consideration in the contract
to the lease and non
-
lease components based on their relative
stand
-a
lone prices. For leases of real estate, it
has elected not to separate lease and non
-
lease
components and instead accounts for these as a si
ngle lease component. Lease terms are
negotiated on an individual basis and cont
ain a wide range of different terms
and conditions.
The lease agreements do not impose any covenants other t
han the security interests in the
leased assets that are held by the lessor. Leases are
recognized as right
-
of
-
use asset
s and
corresponding liabili
ties at the date at which the underly
ing asset
s are available for use by the
Group. Leased assets and lease liabili
ties arising from a lease are initial
ly measured at present
value. Lease liabilit
ies include the net present value of the lease payments
, and they are
discounted using the lessee
’s i
ncremental borrowing rate.
Hansa Biopharma
Annual Report 202
1
86
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
11
Hansa Biopharma Annual Report 2021
Subsequent to initial recognit
ion, the right
-
of
-
use is measured at amortized cos
t using the
effective interest method.
Leased assets are generally depreciated over
the shorter of the asset’s useful lif
e and the lease
term on
a straight
-
line basis. If t
he Group is reasonably certain to exercise a purchase option,
the right
-
of
-
use assets are depreciat
ed over the underlying asset’s useful life.
Payments
associated with short
-
term leases of
equipment and all leases of low
-
value a
ssets are
recognized on a straight
-
line basis as an expense in the consolidated stat
ement of profit or loss
and other comprehensive income. Short
-
ter
m leases are leases with a lease term of twelve
months or less. Low
-
value assets comprise mainly of IT equi
pment and small items of office
furniture.
Extension and termination options are i
ncluded in a number of property and equipment leases
across the Group. These are used to maximize operati
onal flexibility in terms of managing the
assets used in the Group’s operations
.
Trade Payables
Trade payables are measured in the consolidat
ed statement of financial position at amor
tized
cost.
Other Liab
ilities
Other liabilities compri
se payables to public authorities, and short
-
term employee benefits.
Other liabi
lities are measured at t
heir either amortized cost or historical cost which is
reasonable approximation of their fair val
ue.
Financial Instruments
Financial instruments which ar
e recognized in the consolidated statement of fi
nancial position
include, on th
e assets side, cash and equivalent
s, short term investments, other receivables
,
accounts receivable and listed shar
es. On the liability side,
trade
payable
s
and contingent
consideration.
Trade
receivables
are initially recognized when t
hey are originated.
Regular
-
way purchases and
sales of financial assets ar
e recognized on the settlement date. Other financial
assets and
financial liabili
ties are recognized when the Group becomes party to the instr
ument’s
contractual terms.
Financial instruments are i
nitial
ly recognized at fair value with the addi
tion/deduction for
transaction expenses, except f
or instruments that are continuously measured at f
air value
through the consolidated statement of
profit or loss and other comprehensive income (los
s) for
which trans
action expenses are instead expensed when they ari
se. Accounts receivable
(without a significant financing component)
are initially valued at the transaction price as
determined in accordance with IFRS 15.
On initial recognition,
a financial asset is classif
ied as measured at: amortized cost, fair value
through other comprehensive income (debt ins
trument investment), fair value through ot
her
comprehensive income (equity investment
), or fair value through the consolidat
ed statement of
profit or loss and other comprehens
ive income (loss).
The following describes how the Group’s var
ious holdings of financial assets have been
classified:
The Group’s holdings of units in interest funds are report
ed at fair value through the
consolidated statement of profi
t or loss and other comprehensive income (loss).
The shares
(seen from the fund’s perspective) constitut
e financial liabilities and as such do not give rise t
o
payments of solely payments of principal
and interest and do therefore not
fulfil
the amorti
zed
cost r
equirements.
Other financial assets are held wi
thin the framework of a business model with a goal to obtain
the contractual cash flows at t
he same time as the cash flows from the assets only consi
sts
solely of payments of principal
and interest (SPPI) and are recognized at amorti
zed cost.
Financial liabili
ties are classified as valued at amorti
zed cost or valued at fair value through the
consolidated statement of profi
t or loss and other comprehensive income (loss).
Financial
liabilities that are measured a
t fair value t
hrough the consolidated statement of profit
or loss and
other comprehensive income (loss) consist
of contingent consideration, not yet paid.
Other
financial liabili
ties are valued at amortized cost.
Financial assets are derecognized when t
he
rights to receive cash flows from the financial
assets have expired or have been transferr
ed and the Group has transferred substantially all
the risks and rewards of ownership.
The Group derecognizes a financial li
ability from the consolidated stat
ement of
financial position
when, and only when, it is extinguished. That is,
when the obligations specified in the contract is
either discharged or cancelled or has ex
pired. The Group also removes a financial liabili
ty from
the statement of financial pos
ition when the contractual terms are modified and t
he cash flows
from the modified debt are signif
icantly different. In that cas
e, a new financial liability is r
eported
at fair value based on the modified ter
ms.
Impairment of financial assets
For financial assets valued at
amortized cost, a reserve must be booked for expected loan
losses according to IFRS 9. The loss reserve for accounts receivabl
e is valued at an amount
corresponding to the expected losses f
or the remaining term. However, no reserve was
recognized
in any period presented due to materiality, as t
he amount of accounts receivable is
insignificant. In addition,
the loss reserve for deposits in banks is insignificant
since the Group’s
deposits are held with Swedish banks with good credi
t rating and the deposits may be
withdrawn upon request.
Hansa Biopharma
Annual Report 202
1
87
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
12
Hansa Biopharma Annual Report 2021
Statement of Cash Flow
The cash flow statement is presented usi
ng the indirect method with basis in the net resul
t.
Cash flow from operating activities is stated as t
he net result adjusted for net financial items,
no
n-
cash operating items such as depreciation, amort
ization, impairment losses, share
-
based
compensation expenses, provisions, and for
changes in working capital, interest pai
d and
received, and corporate taxes paid. Working capital
mainly comprises changes
in receivables,
deferred revenue, provisions paid and ot
her payables excluding the items included in cash and
cash equivalents. Changes in non
-
current
assets and liabilities are included i
n working capital, if
related to the main revenue
-
producing activities of
the Group.
Cash flow from investing activities is comprised of cash f
low from the purchase and sale of
intangible assets and property and equipment and financi
al assets as well as purchase and
sale of marketable securities
.
Cash flow from financing a
ctivities is compri
sed of cash flow from the issuance of shares, if any,
and payment of long
-
term loans including
instalments
on lease lia
bilities.
Cash and cash equivalents, consist of bank deposits. The cash fl
ow statement cannot be
derived solely from the fi
nancial statements.
Segment Reporting
The Group is managed and operated as one operating and reportabl
e segment. No separate
operating segments or reportable segments have been i
dentified in relation to product
candidates or geographical
markets. Accordi
ngly, except for entity wide disclosures, no
segment information on business segments or geographi
cal markets is disclosed.
Earnings per Share
Basic Earnings per Share (EPS) is calculat
ed by dividing profit or loss attri
butable to ordinary
equity holders of the parent enti
ty by the weighted average number of ordinary shares
outstanding during the period. Dil
uted earnings per share is calculated as profit
or loss
attributable to ordinary equi
ty holders of the parent entity divided by t
he weighted average
number of ordinary shares outstanding duri
ng the period, both adjusted for the effects of
all
dilutive potential ordi
nary shares. If the result is a net loss,
no adjustment is made for the
dilutive effect, as such ef
fect would be anti
-
dilutive
.
Treasury Shares
The treasury shares reserves compris
e own shares repurchased by the Group. The total
amount paid to acquire treasury shares inc
luding directly attributable costs
and the proceeds
from the sale of treasury shares ar
e recognized in share premium reserve.
New A
ccou
nting Policies and Disclosur
es
In the year ended December 31, 202
1
, the
Group has applied the below amendments to IFRS
and interpretations issued by the Boar
d. Their adoption has not had any material impact on the
disclosu
re or on the amounts reported in these consolidated
financial statements.
Interest Rate Benchmark Reform
–
Phase 2 (
Amendments
to IFRS 9, IAS 39, IFRS
7,
IFRS 4 and IFRS 16)
The Phase 2 amendments provide practical reli
ef from certain requirements in IFRS St
andards.
These reliefs relate to modif
ications of financial instrument
s and lease contracts triggered by a
replacement of a benchmark interest rate in a contract
with a new alternative benchmark rate.
The amendments are effective for annual peri
ods beg
inning on or after January 1, 2021.
Standards, amendments, and interpretati
ons in issue
but
not yet effective
The adoption of the following mentioned s
tandards, amendments and
interpretations
in future
years are not expected to have a material
impact on the Group’s financial
stat
ements
:
Effective date periods
beginning on or after
IAS 16
Property, Plant and Equipment
: Amendments
in relation
to
proceeds before intended use
January 1, 2022
COVID
-
19
-
Related Rent Concessions beyond 30 June 2021
January 1, 2022
IAS 37
Provision Contingent Liabilit
ies and Contingent Assets:
Amendments in relation to the costs of fulfilling a co
ntract when assessing
onerous contracts
January 1, 2022
IFRS 3:
Business Combinations:
Amendments to update references to
Conceptual Framework
January 1, 2022
Annual Improvements to IFRSs (2018
−
2020 cycle)
January 1, 2022
IAS 1
Presentation of Financial Statements:
Amendments in relation to the
classification of liabilities as curre
nt or
non
-
current
January 1, 2023
Disclosure of Accounting Policies (Amendments to IAS 1 and IFRS
Practice Statement 2).
January 1, 2023
Deferred Tax related to Assets and Liabilities arising from a Single
Transaction (Amendments to IAS 12
)
January 1, 2023
Definition of Accounting Estimates (Amendments to IAS
8)
January 1, 2023
The Group has not elected to early adopt any of t
he above standards, amendments and
interpretations in the years ended December 31, 2021, and 2020.
The Group plans to adopt
these standards on the effectiv
e dates.
Hansa Biopharma
Annual Report 202
1
88
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 2
Ba
si
s of Pre
se
nt
ati
on an
d Su
mma
r
y of Si
gni
c
ant Ac
cou
nt
ing Po
lic
ie
s
con
tinued
13
Hansa Biopharma Annual Report 2021
Note 3
Use of judgements and estimates
In the application of the Group’
s accounting policies, management is required to make
judgements, estimates and assumptions about the carrying amounts of asset
s and liabilities
that
are not readily apparent from other sources. J
udgements and estimates applied are based
on historical experience and other f
actors that are relevant, and which are availabl
e at the
reporting date. Uncertainty concerning judgements and est
imates could resul
t in out
comes, that
require a material adjustment to assets and liabi
lities in future periods.
Estimates and underlying assumptions are r
eviewed on an ongoing basis. Revisions to
accounting estimates are recognized in t
he period in which the estimate is re
vised if the revision
affects only that period, or
in the period of the revision and future periods
if the revision affects
both current and future periods. Whil
e the application of critical accounti
ng estimates is subject
to material estimation uncert
aint
ies, management’s ongoing revisions of critical account
ing
estimates have not revealed any material i
mpact in any of the years ended December 31,
2021,
and 20
20
.
Significant
judgements made in the appli
cation of the Group’s accounting policies
Significant judgements that management has made in t
he process of applying the Group’s
accounting principles are descri
bed below.
Revenue
Revenue is primarily generated
from
product sales and
license agreements, which typically
involve multiple promises, and thus require signi
ficant judgements by the Group on certain
areas including:
>
Determining whether t
he promises in the agreements are distinct performance obligations;
>
Ident
i
fying and constraining variable consideration in the tr
ansaction price including milestone
payments;
>
Allocat
ing transaction price to identifi
ed performance obligations based on their relativ
e stand
-
alone selling prices;
>
Determining whether perf
ormance obligations are satisfied over time, or at a point in time
;
and
>
Classificat
ion of licenses as “Right
-
to
-
Use” or “Right
-
to
-
Access”
.
Regarding the classification of licenses as “Right
-
to
-
Use” or “Right
-
to
-
Access”, the Group
considers whether it is obli
gated or expected to perform research and development activ
ities
that significantly af
fect the licensee’s ability t
o benefit from product candidates. If t
he Group is
contractually obligated or
is expected to perform research and development activi
ties affecting
the
stand
-
alone functionality of the product
candidate, the license is classified as “
right
-
to
-
access”. The licensed products have been consi
dered “rights
-
to
-
access” since the Group is
required to perform activities that
significantly affect the
licensee’s
ab
ility to benefit from the
products.
Pre
-
launch Inventories
In order to accommodate market demands, the Group init
iates manufacturing of inventories for
late
-
stage development product candidates prior to obtai
ning marketing approvals, or pre
-
launch inventor
ies.
In determining the accounting for
pre
-
launch inventories, management considers the probability
of future benefits, and accordi
ngly, whether pre
-
launch inventories qualify as
assets.
Manufacturing of pre
-
launch inventories are initiated for
late
-
stage
product candidates and are
recognized as inventories. However, since pre
-
launch inventories are not realizable
prior to
obtaining marketing approvals, pre
-
launch inventories are immediately written down to zero
through research and development costs. I
f the marketing approval is obtained, writ
e
-
downs of
pre
-
launch inventories will be reversed through research and development cost
s if there is
future benefit.
Share
-
Based Payment
IFRS 2, “Share
-
Based Payment” requires an entity
to reflect in its consolidated stat
ement of
profit or loss and other comprehensive i
ncome (loss) and consolidates statement of financi
al
position, the effects of
share
-
based payment transactions. Share
-
based compensation costs
are recognized as research and development expenses or sel
ling, general and administrativ
e
expenses, as appropriate, over the vest
ing period, based on management’s best estimate of
the number of awards that will ulti
mately vests, which is subject to uncert
ainty. In addition,
share
-
based compensation costs are measu
red according to t
he grant date fair values of the
instruments granted. Estimating fair values r
equires the Group to apply generally accepted
valuation models and apply these models consi
stently according to the terms and conditions
of
the specific share
-b
ased compensation programs. Depending on t
he instrument, the Group
applies the Black Scholes or the Monte Carlo model t
o determine the fair value of the awards
granted. Subjective judgements and assumptions
, which are subject to estimation uncertainti
es,
n
eed to be exercised in determining the appropriat
e input to the valuation model
.
Hansa Biopharma
Annual Report 202
1
89
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
14
Hansa Biopharma Annual Report 2021
Note 4
Intangible Assets
The projects pending in the Group are a combinat
ion of acquired development projects and
continued activities i
n these projects. Of the total acqui
sition cost for acquired in
-
process
development projects, approximately 75% rel
ates to imlifidase and 25% relates to HBP
-
assay.
Capitalized internal development expenditures for i
mlifidase’s previous production process were
completely amortized during the
year 2018.
Acquired in
-
process development projects ar
e assessed for possible impairment at least on an
annual basis and the impairment assessment on December 31, 2021, and 2020 demonstr
ated
that there was no need for impairment. The est
imated recoverable amount supported by
external and internal valuati
on reports by far exceed the assets carrying amount, res
ulting in no
impairment charges for the year 2021 and 2020.
Internally
generated
Capitalized
development
expenditures
Acquired intangible assets
(in thousands of SEK)
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance January 1, 202
1
4,485
12,06
9
25,136
41,
690
Effects of movements in exchange rates
—
270
—
270
Closing balance December 31, 202
1
4,485
12,
339
25,136
41,96
0
Amortization:
Opening balance January 1, 202
1
(4,485)
(
5,794
)
—
(
10
,
280
)
Amortization for the year
—
(
747
)
(2,094)
(2,
841
)
Effects of movements in exchange rates
—
(
78)
—
(78)
Closing balance December 31, 202
1
(4,485)
(6,6
19
)
(2,094)
(1
3,
199
)
Carrying amounts:
At January 1, 202
1
—
6
,2
75
25,136
31,
410
At December 31, 202
1
—
5,
720
23,
042
28
,
761
Internally
generated
Capitalized
development
expenditures
Acquired intangible assets
(in thousands of SEK)
Patents
In-process
development
projects
Total Intangible
Assets
Cost:
Opening balance January 1, 20
20
4,485
12,479
25,136
42,100
Effects of movements in exchange rates
—
(4
10
)
—
(
410
)
Closing balance December 31, 20
20
4,485
12,069
25,136
41,690
Amortization:
Opening balance January 1, 20
20
(4,485)
(4,267)
—
(8,752)
Amortization for the year
—
(1,668)
—
(1,668)
Effects of movements in exchange rates
—
140
—
140
Closing balance December 31, 20
20
(4,485)
(5,794)
—
(10,280)
Carrying amounts:
At January 1, 2020
—
8,213
25,136
33,348
At December 31, 2020
—
6,275
25,136
31,410
The acquired intangible asset rel
ating to imlifidase presented as in
-
process development
projects will be amortized over t
he estimated useful life of the underlying asset
. Following t
he
first commercial sale of i
mlifidase in Q1
-
2021 the Group
started to amortize the SEK 25,136
k
from the period of first sal
e in Q1
-
2021. The estimated useful life is 12 years.
The HBP
-
assay patent cost is amortized over the fi
nite useful life of the underlying pat
ent in the
amount of SEK 559 k for the year 2021
(
2020
: SEK 559 k). The patent
cost is amortized over
sales, general and administrat
ion line item in the consolidated statement of
profit or loss and
other comprehensive income.
HBP
-
assay is a method of analysi
s used to predict severe sepsis in emergency clinics. A first version
has been launched, primarily intended for research purposes and i
nterested specialists. The HBP
-
assay has been licensed to a cooperating partner, Axis
-
Shield Diagnostics Ltd. (Axis
-
Shield), which is
currently developing a ful
ly commercial product. The Company receives mi
lestone compensation and
additional royalty revenue upon the sale of the
sublicensed technology.
Hansa Biopharma
Annual Report 202
1
90
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
15
Hansa Biopharma Annual Report 2021
Note 5
Property and Equipment
As of December 31,
(in thousands of SEK)
2021
2020
Cost:
Opening balance January 1
11,871
11,577
Additions during the year
2,580
294
Closing balance December 31
14,
451
11,871
Accumulated depreciation and impairment losses:
Opening balance January
(6,
665
)
(5,542)
Depreciation during the
period
(1,
354
)
(1,123)
Closing balance December
(8,
019
)
(6,665)
Carrying amounts:
At January 1
5,206
6,035
At December 31
6,432
5,206
Note 6
Right
-
of
-
Use Assets, Lease Liabilities
As of December 31,
(in thousands of SEK)
2021
2020
Leased assets:
Buildings
37,
95
4
3,574
Equipment
673
440
Vehicles
725
480
Total
35,273
4,493
Lease liabilities:
Non
-
current
28,491
630
Current
6,888
4,415
Total
3
5,379
5,045
For the years ended December 31, 202
1,
and 20
20
, there
were
SEK
36
,0
71,000
and SEK
5
40
,000, respectively, in addit
ions of right
-
of
-
use assets.
Depreciation charge
of leased assets
As of December 31,
(in thousands of SEK)
2021
2020
Buildings
(4,
646
)
(4,550)
Equipment
(169)
(169)
Vehicles
(1
74
)
(161)
Total
(4,
989)
(4,880)
Interest expense (included in f
inance cost) amounted to SEK
572
,000. Expenses related t
o low
-
value leases and short
-
term leases amounted t
o
SEK 1,2
98,000
. Total cash outflow of leases
amounted to
SEK 6,
727,000
.
Most of the Group’s operational leasing agreements involve
leases of real property and
premises on which the
business operations are c
onducted. The
initial
duration of the lease for
the Lund, Sweden, offices is three y
ears from January 1, 2019. The agreement is automatically
extended with two years at a time unless cancel
lation is made no later than nine months
before
the end of the contract period. Ther
e are no variable fees included in the leases. The l
ease term
covered by the extension option was not inc
luded in the lease term when the lease was
originally recognized as the Group di
d not consider that the exercise of
the option would be
reasonably certain.
The Group has entered into lease agreements with r
espect to office space, IT and office
equipment. The leases are non
-
cancellable
for various periods up to 2023.
On April 1, 2021, the Company executed a lease
amendment at Scheel
evägen 22, 223 63
Lund, for its headquarters. The leas
e amendment includes both an extension of the existing
space leased by the Company and an agreement to lease additional
space. In addition, the
lessor provided the Company with SEK 1
.0 million of incentives to spend on i
ts leasehold
improvements. The Company determined that the existing space and additional space
represent separate lease components. As the lease term extension f
or the existing space
meets the definition of a lease modification, the Company accounted for the exi
sting space
lease component by allocating the consideration in t
he modified contract, determining the lease
term of the modified lease, and remeasuri
ng the lease liability by discounti
ng the revised lease
payment
s using a revised discount rat
e. The Company accounted for incentives by reducing its
consideration used to determine the r
ight of use asset and liability by t
he amount of the lease
incentive. On November 1, 2021, the Company took control of the addit
ional
leased space
associated with the April 1, 2021
,
lease amendment for the headquarters at Scheelevägen 22,
223 63 Lund. The future minimum lease payments associated with t
he extension of the existing
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Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
16
Hansa Biopharma Annual Report 2021
space lease by the Company from April 1, 2021
,
until th
e estimated end date of
October 31,
2026
,
is SEK 24,065,000 equivalent to approximately SEK 354,000 per month.
The total future
minimum lease payments
associated with the additional leased
space
from
January 1,
2022
until the estimated end date of October
31, 2026
,
is SEK 1
6,
808,000
equivalent to
approximately SEK 290,000 per month.
Note 7
Inventories
Inventories include material
,
labour
and overhead and consisted of the following:
As of December 31,
(in thousands of SEK)
2021
2020
Raw materials and supplies
3,141
2
,078
Work in process
8,
282
3,512
Packaging material
311
212
Finished goods
1,
8
82
380
Total inventories, gross
13
,
616
6,182
Less: provision for excess & obsolete inventories
(
13
,
374
)
(6,084)
Total inventories, net
242
98
See further discussion in Note 3 rel
ated to write
-
down of pre
-
launch inventories.
Note 8
Trade Receivables
As of December 31,
(in thousands of SEK)
2021
2020
Trade receivables
9,712
110
During the
year
ended
December 31,
2021 and 2020, respectively,
there
were no loss
es related
to receivables and the credit r
isk on receivables is considered to be limi
ted. See further
discussions in Note 20 related to cr
edit risk.
Note 9
Prepaid expenses and accrued income
As of December 31,
(in thousands of SEK)
2021
2020
Insurance
s
829
494
Healthcare conference
124
1,664
Software
1,177
1,378
Pension
1,644
—
Rent
2,512
1,161
Legal expenses
8,325
—
License fee
3,999
262
Other
2,279
757
Total
20
,
889
5,716
Note 10
Other receivables
As of December 31,
(in thousands of SEK)
2021
2020
VAT receivables
9,827
3,786
Advance payments to suppliers
11
,
29
2
3,124
Other receivables
1,
419
3,047
Total
22
,
538
9,957
Other receivables are mainly comprised of
VAT receivables, advance payments to suppliers
and other receivables.
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Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
Note
6
Right
-of-Use
Assets, Lea
se Liabilities
continued
17
Hansa Biopharma Annual Report 2021
Note 1
1
Accrued Expenses
As of December 31,
(in thousands of SEK)
2021
2020
Annual leave accrual
15,879
10,775
Accrued social security contribution on salaries
4,395
2,964
Accrued
short term incentives, incl. related social security contri
butions
24,146
13,585
R&D project costs
7,791
13,223
Consulting fees
17,
600
11,269
Other
2,651
4,311
Closing balance December 31
72
,
462
56,125
Note 12
Other lia
bilities
—
Current
As of December 31,
(in thousands of SEK)
2021
2020
Personnel related liabilities
13
,
358
9,454
Current tax
190
134
Closing balance December 31
13
,
548
9,588
Note 13
Revenue
The Group’s revenue from its contract
s with customers is primarily generated fr
om
product
sales and
two license agreements, as furt
her described below, with its customers which were
entered into in 2009 and 2020 with Axis
-
Shield and Sarepta Therapeutics, Inc. (Sarepta),
respectively.
Revenue has been recognized in the consolidated statement of profit
or
loss and other
comprehensive income (loss) with the f
ollowing amounts:
Years Ended December 31,
(in thousands of SEK)
2021
2020
Revenue from contracts with customers:
Product sales
15,017
—
Contract revenue, Axis
-
Shield agreement
2,6
24
2,864
Cost reimbursement, Axis
-
Shield agreement
527
636
Contract revenue, Sarepta agreement
15
,
710
2,599
Total revenue
33
,
878
6,098
Performance Obligations Satisfied Over Time
The
transaction price is all
ocated to each performance obligation according to t
heir stand
-
alone
selling prices and is recogni
zed when control of the goods or services are transf
erred to the
customer, either over time or at
a point in time, depending on the specif
ic terms and conditions
in the contracts.
For the Group’s current licens
ing arrangements, our professionals are requir
ed to be committed
throughout the development period. Theref
ore, promises such as the license, materials or
professional support are one perf
ormance obligation. Accordingly, upfront payments ar
e
recognized over time.
Variable Consideration
In the transaction price,
variable consideration, including mil
estone payments, is only included
to the extent that it i
s highly probable that a significant r
eversal in the amount of cumulative
revenue recognized will not occur when the uncertainty associ
a
ted with t
he variable
consideration is subsequently r
esolved. Therefore, royalties and mil
estone payments from
licensing arrangements are constrained for the peri
ods ended
December 31,
2021
,
and 2020
,
with the exception of the Axis
-
Shield minimum royalty p
ayment.
Product revenue
For the period ended December 31, 2021, the Group recorded pr
oduct revenue of SEK 15
.0
million (2020: nil). Product revenue is r
ecognized net of any sales and value
-
added taxes and
sales deductions based on contractuall
y agreed payment terms.
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rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
18
Hansa Biopharma Annual Report 2021
License Agreement with Sarepta
On July 1, 2020, the Company executed an agreement with Sarepta.
Sarepta was granted an
exclusive, worldwide license to dev
elop and promote imlifidase, in addition to access t
o the
Group’s materials and profession
al support as a pre
-
treatment to enable Sarepta’s gene
therapy treatment in Duchenne muscular dyst
rophy (DMD) and Limb
-
girdle muscular dystrophy
(LGMD). The pre
-
treat
ment is intended for patients with pre
-
existing neutralizing antibodies
(NAb
-
positive patients) to adeno
-
associated vir
us (AAV), the technology that is the basis for
Sarepta’s gene therapy products.
Sarepta
is
responsible for conducting preclinical and cl
inical studies with imlifidase and any
subsequent
potential filings for
regulatory approval
s. Sarepta will also be responsible for
the
promotion of imlifidase as a pre
-
treatment to Sarepta’s gene therapies followi
ng potential
approval.
Under the terms of the agreement, the Company received a $10.0 million (SEK 81.9 milli
on)
non
-
refundable upfron
t payment in July 2020 and is eligibl
e for a total of up to $397.5 million in
development, regulatory and sales milest
one payments. The Company will record all sales of
imlifidase and earn high single
-
digit to mid
-
teens royalties on Sarepta’s incremental
gene
therapy sales when treating NAb
-
positi
ve patients enabled by pre
-
treatment with imli
fidase.
The exclusive worldwide license t
o develop and promote imlifidase was determined to be not
distinct as Sarepta cannot benefi
t from the license without the Group’
s materials and
professional support and therefor
e the license and related support that includes the
requirements to provide the Group’s materials and professi
onal support are one performance
obligation.
The upfront payment will be recognized over
the development period, currently est
imated at 51
months, as the Group fulfils its performance obli
gation under the Agreement. The Company
concluded that labor hours expended by the Group’s
professionals was the appropriate
measure of the transfer of control of
the combined promises of t
he license, Hansa materials and
professional services as it
is the measure that is most indicative of the perf
ormance obligation
satisfied.
For the milestone payments associated wit
h the development and regulatory milestones, the
Group concluded that the successful complet
ion of the development and regulatory activit
ies
are not probable at this time since t
he project is still in preclini
cal stage and therefore will not
recognize any of these milestones for the Group’s December 31,
202
1,
financial reporting
period. Revenue from performance based and sales
-
based milestones and sales
-
based
royalties will be constraint because it
is not probable that a reversal of revenue will not occur if
these were recognized.
For the period ended December
31, 202
1
, the Group recorded cont
ract revenue in the amount
of
SEK 15.7 m
illion
(2020:
SEK 2.6 m
illion
)
related to its agreement with Sarepta in connection
with the upfront payment received in July 2020.
License Agreement with Axis
-
Shield
In 202
1
, the Gro
up recorded contract revenue in the amount of SEK 2.
6
million (2020:
SEK 2.9
million
)
under its agreement with Axis
-
Shield related to a minimum royalty pay
ment of $250,000
and a commercial milestone payment of
$60,000. The agr
eement entails a license to ac
cess
the Group’s intellectual pr
operty regarding HBP analysis during the license per
iod. The
agreement requires the Group to conduct activ
ities that substantially affect
the intellectual
property rights during the li
cense period, which in turn affects Axis
-
Shield as a license holder.
Royalty payments are accrued and recognized as income during the period to which the r
oyalty
refers. The minimum royalty amount was received in
February
202
1
, initially recorded as
a
deferred revenue and recognized
as revenue over
the reporting period on a straight
-
li
ne basis.
The commercial milestone relates t
o achieved sales. Since it is a sales
-
based miles
tone it has
been recognized as revenue when the sales occurred and the Company became entit
led to
receive the milestone pa
yment.
In addition, the Group recorded revenue r
elated to reimbursable costs upon rendering servi
ces
related to maintaining licensed patents i
n an amount of SEK 0.
5 million (
2020:
SEK 0.6 million
).
Deferred revenue (contract bal
ances)
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance January 1
,
79,432
—
Addition under existing contracts
18
,
168
3,500
Addition under new contracts (Sarepta agreement)
—
81,900
Revenue recognized
(33,878)
(6,098)
Adjustments, foreign exchange
8,259
130
Closing balance December 31
,
71,981
79,432
Revenue may vary from period to period as revenue comprises product sales, royalti
es,
milestone payments, deferred revenue
,
and reimbursement of certain expenses.
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Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 13
Reven
ue
continued
19
Hansa Biopharma Annual Report 2021
Note 14
Staff Costs
Total compensation
-
related
expenses
recorded
in the Group broken down to senior
management, which includes the Board of Directors and executive management, and other
employees:
Year Ended December 31, 2021
(in thousands of SEK)
Senior
Management
Other
Employees
Total
Salaries, bonuses
,
and other benefits
32
,
282
122
,
304
154
,
586
Social security contribution
10
,
040
20
,
518
30
,
558
Pension cost, contribution plan
2,
72
3
15,381
18,104
Share
-
based compensation
3
3,8
60
22
,
764
56
,
624
Total
compensation
-
related
expenses
78
,
905
180,967
259,872
Year Ended December 31, 2020
(in thousands of SEK)
Senior
Management
Other
Employees
Total
Salaries, bonuses
,
and other benefits
28,896
67,789
96,685
Social security contribution
8,894
10,185
19,079
Pension cost, contribution plan
1,357
9,330
10,68
8
Share
-
based compensation
23,882
19,466
43,348
Total
compensation
-
related expenses
63,029
106,770
169,800
Share
-
based payments
Long
-
term incentive program 2016 (LTIP 2016)
At Hansa’s Extraordinary General Meeting on November 21,
2016, shareholders resolved to
adopt a long
-
term incentive program (LTIP
2016) in the form of performance
-
based share rights
(share rights) for all employees of the Group.
Each share right provides the right
to acquire one ordinary share in the
Company
free
-
of
-
charge
provided certain conditions are met i
n accordance with the te
rms of LTIP 2016. A share right
may be exercised if the performance condition is met and provided
that the participant, with
certain exceptions, from the dat
e of participation in LTIP 2016 up until and inc
luding the date
three years thereafter (t
he Vesting
Period) maintains his or her employment within t
he Group.
The single performance condition i
s: Total shareholder return (TSR) during the Vest
ing Period
compared to a starting value of SEK 112.51 (al
lotment November 2016) and SEK 142.34
(allotment May 201
7). The performance condition is set at
a “minimum level” of 25% and
“maximum level” of 100%, whereby the number of shares granted to participants
is increased
lineally between the minimum level and maximum level in line with the
TSR appreciation.
A total
of 289,750 share rights were allotted to part
icipants, of which 234,750 were allotted in
November 2016 and 55,000 were
allotted
in May 2019. LTIP 2016 ended in 2020.
The Group used the following inputs when valui
ng the share rights under LTIP 2016 based on
Monte Carlo simulation:
Allotment
Nov 26, 2016
Allotment
May 19, 2017
Starting value (base
-
line share price) for TSR calculation, SEK
112.51
142.34
Risk
-
free interest rate, (%)
(0.52)
(0.51)
Expected volatility, (%)
55
55
Expected
dividend, SEK
—
—
Calculated fair value per
s
hare
r
ight, SEK
62.01
89.30
Years Ended December 31,
2021
2020
Share rights, Opening balance January 1
—
35,000
Allotted share rights during the period
—
—
Share rights expired during the period
—
(35,000)
Rights, Closing balance December 31
—
—
Recorded share
-
based compensation expenses, in thousands of SEK
—
395
Long
-
term incentive program 2018 (LTIP 2018)
At Hansa’s Annual General Meeting (AGM) on May 29, 2018, shareholders
resolved to adopt a
long
-
term incentive program (LTIP 2018). Part
icipants in the program were given the
opportunity to acquire equity
-
based awards (warrants) at market value and/or recei
ve share
rights free of charge which, provided that
certain conditions are met, may give the right to
acquire shares in the
Company
.
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iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
20
Hansa Biopharma Annual Report 2021
Warrants
under LTIP 2018
Each warrant gives the participant
the right to exercise the warrant for subscr
iption of one
ordinary share in the
Company
at a price equal to the mark
et value of the share at the time of
the issuance of the warrants (SEK
223.10)
adjusted upwards in the amount of 7% annually
during the
three
-
year
vesting period,
i.e., SEK 273.31. Provided the participant r
emains an
employee of the Group, subscription for
shares in accordance with the terms of the warrants
may take place during the period from June 12, 2021
through June 12, 2022.
The warrants were sold to the partici
pants on market terms at a price established on the basi
s
of an estimated market value of the warrant
s using the Black Scholes model. In connection with
the warrants program participants
(except the CEO) received a subsidy of maximum 25% of the
purchase price.
Should the participant’s employment ceas
e before the awards are exercised, the Group is
entitled to repurchase the awards at market
value less any subsidy provided to the partici
pant.
A total
of 6,701 warrants were sold under the program in June 2018.
The Group used the following inputs when valui
ng the warrants under LTIP 2018 based on
Black Scholes model:
Issuance June
2018
Underlying volume
-
weighted average share price, SEK
223.10
Risk
-
free interest rate, (%)
(0.178)
Expected volatility, (%)
43
Expected dividend, SEK
—
Calculated fair value per
w
arrant, SEK
53.41
Years Ended December 31,
2021
2020
Warrants, Opening balance January 1
6,701
6,701
Warrants expired or redeemed in advance during the period
—
—
Warrants, Closing balance December 31
6,701
6,701
Recorded share
-
based compensation expenses, in thousands of SEK
5
17
Share rights under LTIP 2018
Each share right provides a partici
pant the right to acquire one ordinary share in t
he
Company
free
-
of
-
charge provided certain
pre
-
defined
conditions are met
in accordance with the terms of
LTIP 2018. A share right may be exercised if t
he performance condition is met and provided
that the participant, wi
th certain exceptions, from the date of t
he start of participation in LTIP
2018 up until and including the date thr
ee years thereafter (the Vesting Period) maintains
his or
her employment within the Group.
The single performance condition i
s: TSR during the Vesting Period compared to a starting
value of SEK 222.10 (allotment June 2018), SEK 278.70 (
allotment November 2018) and
SEK178.60 (allotment May 2019). The performance condit
ion is set at a “minimum level” of
25% and “maximum level” of 100%, whereby the number of shares granted to par
ticipants is
increased lineally between the minimum level and maximum level in line wit
h the TSR
appreciation.
A total of 260,710 share rights were al
lotted to participants,
of which 105,460 were allotted in
June 2018, 72,671 were
allotted
in November 2018 and 82,579 were
allotted
in May 2019.
The Group used the following inputs when valui
ng the share rights under LTIP 2018 based on
Monte Carlo simulation:
Allotment
June 15, 2018
Allotment
Nov 30, 2018
Allotment
May 14, 2019
Starting value (base
-
line share price) for TSR calculation,
SEK
221.10
278.70
178.60
Risk
-
free interest rate, (%)
(0.36)
(0.28)
(0.55)
Expected volatility, (%)
43
43
43
Expected dividend, SEK
—
—
—
Calculated fair value per
s
hare
r
ight, SEK
94.08
117.43
76.02
Years Ended December 31,
2021
2020
Share rights, Opening balance January 1
223,778
238,368
Share rights
expired or
forfeited during the period
(163,
692)
(14,590)
Share rights, Closing balance December 31
60,086
223,778
Recorded share
-
based compensation expenses, in thousands of SEK
9
12
9,213
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rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
4
S
ta
 Cos
ts
continued
21
Hansa Biopharma Annual Report 2021
Long
-
term incentive program 2019 (LTIP 2019)
At Hansa’s AGM on May 22, 2019, shareholders resolved to adopt a l
ong
-
term incentive
program, LTIP 2019. Under the terms of LTIP 2019, part
icipants in the program could receive
performance
-
based share rights (share right
s) free of charge and/or share options, as furt
her
described below.
Share rights under LTIP 2019
Each share right provides a partici
pant the right to acquire one ordinary share in t
he
Company
free
-
of
-
charge provided certain pre
-
defined performance condi
tions are met and provided that
the participant, with
certain exceptions, from the date of the star
t of participation in LTIP 2019
up until and including the date thr
ee years thereafter (the Vesting Period) maintains
his or her
employment within the Group.
The final number of ordinary shares a par
ticipant is entitled to r
eceive is, amongst other terms,
conditional upon meeting the foll
owing performance conditions during the Vesting Peri
od:
>
Condition 1 (account
ing for 22%): Obtain market approval in the EU by the EMA
>
Condition 2 (account
ing for 22%):
At least 1
0 patients enrolled in US RCT (ConfIdes)
>
Condition 3 (account
ing for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
In December 2021,
Hansa’s Board of Directors in line with the ter
ms and conditions of the
LTIP
2019 resolved to adjust Condition 2
from
the
previous condition
“
Imlifidase U.S. approval
“
to
the
new condition „At least 10 pati
ents enrolled in US RCT (ConfIdes)
”.
A total of 306,303 share rights were al
lotted to participants, of which 288,
727 were
allotted in
June 2019, and 17,576 were allotted in October 2019.
The Group used the following inputs when valui
ng the share rights under LTIP 2019 based on
Monte Carlo simulation:
Allotment
June 17, 2019
Allotment
Oct 24, 2019
Starting value
(base
-
line share price) for TSR calculation, SEK
178.38
129.28
Risk
-
free interest rate, (%)
(0.5
9)
(0.
4
1)
Expected volatility, (%)
43
43
Expected dividend, SEK
—
—
Calculated fair value per
s
hare
r
ight, SEK
122.12
89.00
Years Ended December 31,
2021
2020
Share rights, Opening balance January 1
287,555
306,303
Share rights
forfeited
during the period
(9,374)
(18,748)
Share rights, Closing balance December 31
278,181
287,555
Recorded share
-
based compensation expenses, in thousands of SEK
12,906
12,459
Share options under LTIP 2019
The share option program consists of t
wo option series: Series 1
—
Warrants, and Series 2
—
Employee stock options.
Each warrant or employee stock option entit
les the holder to receive one new ordinary share in
the
Company
at an exercise price corresponding to 110% of the volume weighted av
erage
share price during the 10 tradi
ng days immediately prior to the offer to su
bscribe for the
instruments, and provided that the partici
pant, with certain exceptions, from the date of the start
of participation in LTIP 2019 up unti
l and including the date three years thereafter
(the Vesting
Period) maintains his or her employment wi
thin the Group.
LTIP 2019, Warrants
A total of 11,000 warrants were sold t
o participants in June 2019. In connection with t
he
warrants program participants (except the CEO) received a subsidy of up t
o 100% of the
purchase price.
The Group used the following inputs when val
uing the warrants under LTIP 2019 based on
Black Scholes model:
Issuance
June 17, 2019
Underlying volume
-
weighted average share price, SEK
178.38
Exercise price, SEK
196.20
Risk
-
free interest rate, (%)
(0.59)
Warrant term,
years
3
Expected volatility, (%)
43
Expected dividend, SEK
—
Calculated fair value per
w
arrant, SEK
45.54
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Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
4
S
ta
 Cos
ts
continued
22
Hansa Biopharma Annual Report 2021
Years Ended December 31,
2021
2020
Warrants, Opening balance January 1
11,000
11,000
Warrants expired or redeemed in advance during the period
—
—
Warrants, Closing balance December 31
11,000
11,000
Recorded share
-
based compensation expenses, thousands of SEK
97
223
LTIP 2019, Employee Stock Options (ESOs)
A
total of 149,148 ESOs were issued to parti
cipants in June 2019.
The Group used the following inputs when valui
ng the ESOs under LTIP 2019 based on Black
Scholes model:
Issuance
June 17, 2019
Underlying volume
-
weighted average share price, SEK
178.38
Exercise price, SEK
196.20
Risk
-
free interest rate, (%)
(0.59)
ESO term, years
3
Expected volatility, (%)
43
Expected dividend, SEK
—
Calculated fair value per ESO, SEK
45.19
Years Ended December 31,
2021
2020
ESO, Opening balance January 1
149,148
149,148
ESO forfeited or expired during the period
—
—
ESO, Closing balance December 31
149,148
149,148
Recorded share
-
based compensation expenses, thousands of SEK
690
3,776
Long
-
term incentive program 2020 (LTIP 2020)
At Hansa’s AGM on June 23, 2020, shareholders resolved to adopt
a long
-
term incentive
program, LTIP 2020. Under the terms of LTIP 2020 parti
cipants in the program may receive
share rights
free
of charge and/or
ESOs as further described below.
Share rights under LTIP 2020
Each share right entitles a part
icipant to acquire one ordinary share in the
Company
at no cost
provided certain pre
-
defined perf
ormance conditions are met and the employment is maintained
within the Group
during the vesting period. Each sh
are right carries a vesting period of thr
ee
years commencing on the day of its allot
ment to a participant (the Vesting Period).
The final number of ordinary shares a par
ticipant is entitled to recei
ve is, amongst other terms,
conditional upon meeting the fol
lowing performance conditions during the Vesting Period:
>
Condition 1 (acc
ounting for 22%): US RCT study (ConfIdes) fully enrolled
;
>
Condition 2 (acc
ounting for 11%): Top
-
line data read out of the ongoing Phase 2 study in
either AMR or GBS is completed with data provi
ding a solid scientific rational
to continue
either of the two programs;
>
Condition 3 (acc
ounting for 11%): At least 70% of the targeted transplantation centers i
n
Europe have been initiated;
and
>
Condition 4 (acc
ounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
In December 2021, Hansa’s Board of Directors i
n line with the terms and conditions of the LTIP
2020 resolved to adjust Condition 1 fr
om
the
previous condition “The U.S. randomized
controlled trial i
s completed during the Vesting Period
“ to the new condit
ion
“
US RCT study
(ConfIde
S
) fully enrolled
”.
A total of
417,556
share rights were allotted to part
icipants, of which
401,556
were allotted in
July
2020
and 16,000
were allotted in
February
2021
.
The Group used the following inputs when valui
ng the share rights under LTIP 2020 based on
Monte Carlo simulation:
Allotment
July 23,2020
Allotment
Feb 12, 2021
Starting value (base
-
line share price) for TSR calculation, SEK
252.60
252.60
Risk
-
free interest rate, (%)
(0.33)
(0.25)
Expected volatility, (%)
43
43
Expected dividend, SEK
—
—
Calculated fair value per
s
hare
r
ight, SEK
173.26
1
20.07
Hansa Biopharma
Annual Report 202
1
98
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
4
S
ta
 Cos
ts
continued
23
Hansa Biopharma Annual Report 2021
Years Ended December 31,
2021
2020
Share rights, Opening balance January 1
389,556
—
Allotted to participants July 23, 2020
—
401,556
Allotted to participants February 12, 2021
16,000
Share rights forfeited
(
5,000
)
(12,000)
Share Rights, Closing balance December 31
400,556
389,556
Recorded share
-
based compensation expenses, thousands of SEK
21,20
5
12,678
Employee Stock Options under LTIP 2020
Each ESO entitles the holder to receiv
e one new ordinary share in the
Company
at an exercise
price corresponding to 125% of the volume weighted aver
age share price during the 10 trading
days immediately prior to the offer
to subscribe for the instruments,
and provided that the
participant, with certai
n exceptions, from the date of the start of par
ticipation in LTIP 2020 up
until and including the date thr
ee years thereafter (the Vesting Period) maintains
his or her
employment within the Group.
A total of
5
07,520
ESOs
were issued to participants of which
487,520 were issued in July 202
0
and 20,000 were issued in February 2021.
The Group used the following inputs when valui
ng the ESOs under LTIP 2020 based on Black
Scholes model:
Issuance
July 23,2020
Issuance
Feb 12, 2021
Underlying volume
-
weighted average share price, SEK
252.60
185.13
Exercise price, SEK
315.75
315.75
Risk
-
free interest rate, (%)
(0.33)
(
0.25)
ESO term, years
3
3
Expected volatility, (%)
43
43
Expected dividend, SEK
—
—
Calculated
fair
value
per
ESO,
SEK
53.05
27.25
Years Ended December 31,
2021
2020
ESO, Opening balance January 1
477,520
—
ESO allotted to participants July 23, 2020
—
487,520
ESO allotted to participants
February
12, 2021
20,000
—
ESO forfeited
—
(10,000)
ESO, Closing balance December 31
49
7,520
477,520
Recorded share
-
based compensation expenses, thousands of SEK
7,658
4,588
Long
-
term incentive program 202
1
(LTIP 20
2
1)
At Hansa’s AGM on
May 12
, 202
1
, shareholders resolved to adopt a l
ong
-
term incentive
program, LTIP 202
1
. Under the terms of LTIP 202
1
partici
pants in the program may receive
share rights
free
of charge and/or
ESOs as further described below.
S
hare rights under LTIP 202
1
Each share right entitles a part
icipant to acquire one ordinary share in the Company at no cost
provided certain pre
-
defined perf
ormance conditions are met and the employment is maintained
within the Group during the
vesting period. Each share ri
ght carries a vesting period of three
years commencing on the day of its allot
ment to a participant (the Vesting Period).
The final number of ordinary shares a par
ticipant is entitled to recei
ve is, amongst other terms,
conditi
onal upon meeting the followi
ng performance conditions during the Vesting Period:
>
Condition 1 (acc
ounting for 22%): U.S. FDA has accepted a BLA filing for approval of
imlifidase in the U.S.
;
>
Condition 2 (acc
ounting for 11%):
A
phase 3 study in either AMR o
r GBS is initiated or a filing
for regulatory approval is ac
cepted by either the FDA or EMA for one of these indications
or
anti
-
GBM
;
>
Condition 3 (acc
ounting for 11%): At least
8
0% of the targeted transplantation centers in
Europe have been initiated;
and
>
Condition 4 (acc
ounting for 56%): TSR of at least 25% against the baseline share price at the
date of allotment.
A maximum of
624,615
share rights can be allott
ed under LTIP 202
1
. As of December 31,
202
1
, a total of
5
57,000
share rights have initially been allot
ted to participants.
Hansa Biopharma
Annual Report 202
1
99
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
4
S
ta
 Cos
ts
continued
24
Hansa Biopharma Annual Report 2021
The Group used the following inputs when valui
ng the share rights under LTIP 2021 based on
Monte Carlo simulation:
Allotment
June 7, 2021
Starting value (base
-
line share price) for TSR calculation, SEK
153.75
Risk
-
free interest rate, (%)
(0.18
)
Expected volatility, (%)
46.9
Expected dividend, SEK
—
Calculated fair value per
s
hare
r
ight, SEK
98.94
Years Ended December 31,
2021
2020
Share rights, Opening balance January 1
—
—
Allotted to participants
June
7
,
2021,
557,000
—
Share rights forfeited
—
—
Share Rights, Closing balance December 31
557,000
—
Recorded share
-
based compensation expenses, thousands of SEK
11,722
—
Employee Stock Options under LTIP 2021
Each ESO entitles the holder to receiv
e one new ordinary share in the Company at an exercise
price corresponding to 125% of the volume weighted aver
age share price during the
30
tradi
ng
days immediately prior to the offer
to subscribe for the instruments,
and provided that the
participant, with certai
n exceptions, from the date of the start of par
ticipation in LTIP 202
1
up
until and including the date thr
ee years thereafter (the Vesting Period) maintains
his or her
employment within the Group.
A maximum o
f
452,307
ESOs can be allot
ted under LTIP 202
1
. As of December 31, 202
1
, a
total of
430,000
have initially been allotted t
o participants.
The Group used the following inputs when valui
ng the ESOs under
LTIP 202
1
based on Black Scholes model:
Issuance
June 7, 2021
Underlying volume
-
weighted average share price, SEK
153.70
Exercise price, SEK
192.20
Risk
-
free interest rate, (%)
(
0.04)
ESO term, years
4.5
Expected volatility, (%)
46.9
Expected dividend, SEK
—
Calculat
ed
fair
value
per
ESO,
SEK
42.98
Years Ended December 31,
2021
2020
ESO, Opening balance January 1
—
—
ESO allotted to participants
June 7
, 202
1
430,000
—
ESO forfeited
—
—
ESO, Closing balance December 31
430,000
—
Recorded share
-
based compensation expenses, thousands of SEK
3,738
—
Note 15
Provisions
Provisions relate to social
security contributions linked to out
standing share or option rights in
the Group’s ongoing incentive programs.
The social security contributi
ons are expected to be
incurred after vesting if and when plan part
icipants realize value under their specific rights
under the LTIP programs. Please refer to Note 14 r
elated to the Group’s LTIP programs and
respective vesting dates.
The
decrease
in provisions for 202
1
was mainly driven by impact of the
decrease
in the
Company’s share price that resulted in
lower
provision for social sec
urity contributions under
the LTIP programs.
Hansa Biopharma
Annual Report 202
1
10
0
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
4
S
ta
 Cos
ts
continued
25
Hansa Biopharma Annual Report 2021
As of December 31,
2021
2020
Opening balance January 1
14,426
818
Provision related to LTIP 2016
—
1
Provision related to LTIP 2018
(2,9
99
)
2,953
Provision related to LTIP 2019
(4
,
516)
6,778
Provision related to LTIP 2020
(1,
194
)
3,736
Provision related to LTIP 2021
1,866
—
Pension provision
(
226
)
140
Closing balance December 31
7
,
357
14,426
Note 16
Incom
e
Taxes
As of December 31,
(in thousands of SEK)
2021
2020
Deferred Taxes, opening balance January 1
424
507
Tax income in the
consolidated statement of profit or loss and other
comprehensive income
(
39
)
(40)
Currency differences for the year
41
(43
)
Deferred Taxes, closing balance December 31
42
6
424
Losses carried forward
in 2021
Deferred tax assets have not been recognized regarding temporary differences and losses
carried forward since it i
s not probable that such can be set off against taxabl
e profits in the
foreseeable future.
The Group’s losses car
ried forward in
as of December 31, 2021
amounted to
SEK 1,
855
,2
51
,000 (20
20
: SEK
1,369
,
949
,000). The losses
carried forward is, in all
material respects, attributable t
o Swedish companies and therefore has no due date.
A reconciliation of Hansa’s eff
ective tax rate relative to the Swedish s
tatutory tax rate is as
fo
llows:
2021
2020
%
(in thousands
of SEK)
%
(in thousands
of SEK)
Result before tax
—
(548,130)
—
(420,893)
Tax according to current tax rate
20.6
112,915
21.4
90,071
Effect of other tax rates for foreign
subsidiaries
0
(14)
—
—
Non
-
deductible expenses
(2.
4)
(1
3,103
)
(2.2)
(9,119)
Increase in loss carry
-
forwards without
corresponding capitalization of deferred
tax
(
18
.2)
(
99
,
951
)
(19.2)
(80,912)
Reported effective tax
—
(152)
—
40
The corporate tax rate in Sweden
is
20.6%
,
from January 1, 2021.
Note 17
Loss per Share
Years Ended December 31,
(in SEK)
2021
2020
Loss per share, basic and diluted
(
12
.
33
)
(9.98)
Diluted net loss per share is computed using the weighted
-
average number of ordinary shares
outstanding during the period, plus
the dilutive effect of potential or
dinary shares. Diluted net
loss per share does not differ from basic net l
oss per share since
potent
ial ordinary shares from
the conversion of share rights,
stock options and warrants are antidilut
ive for all periods
presented and are, therefore, excl
uded from the calculation. For the year ended December 31,
202
1,
and 20
20
, share rights to receive
1,295
,
823
and
900,889
ordinary shar
es, respectively,
options to purchase
1,076
,668 and
626
,
668
ordinar
y shares, respectively, and warrants to
purchase 17,701 and 17,701 ordinary shares, respec
tively, were not included in t
he
computation of diluted
loss per shar
e since their inclusion would be antidilutive.
The calculation of the numerator and denomi
nator used in the above stated calculations of l
oss
per share are stated below.
Hansa Biopharma
Annual Report 202
1
101
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 15
Prov
is
ion
s
con
tinued
26
Hansa Biopharma Annual Report 2021
Loss attributable to ordinary sharehol
ders, basic and diluted
Years Ended December 31,
(in thousands of SEK)
2021
2020
Loss for the year attributable to owners of the parent
(
548
,
280
)
(420,853)
Loss attributable to ordinary shareholders, basic and diluted
(
548
,
280
)
(420,853)
Weighted average number of
ordinary
shares, basic and diluted
Years Ended December 31,
(in thousands of SEK)
2021
2020
Issued ordinary shares January 1
44,
473
,
452
40,026,107
Effect of issue of ordinary shares in July 2020
—
2,150,765
Weighted average number of ordinary shares, basic and diluted
44,473,452
42,176,872
Note 18
Contingent Consideration
The Group acquired Immago Ltd (today Hansa Biopharma Ltd) on Jul
y 19, 2016. The agreed
upon purchase price was GBP 170,000. An additional
GBP 70,000 milestone payment is to be
paid if a clinical study i
s initiated in Europe or the U.S. The estimated payment dat
e is July 19,
202
3
,
resulting in fair value of contingent li
ability on December 31, 202
1
, amounti
ng to SEK
722
,000 (20
20
:
SEK
663,000
).
The estimated future cash flow is di
scounted using a 10% risk adjusted interest rat
e. See
further discussions in Note 20.
Note 19
Capital Management
The Board of Directors’ policy
is to maintain a strong capital base to maintai
n investor, c
reditor
and market confidence, and a continuous advancement of Hansa’
s product pipeline and
business in general. Hansa has financed it
s operations mostly from shareholders equity through
the issuance of shares. As of December 31, 202
1
, Hansa’s cash position (including short
-
term
investments) amounted to SEK
889
m
illion.
The adequacy of our available funds will
depend on many factors, including growth of Idefi
rix
sales, progress in our research and devel
opment programs, the magnitude of those
programs,
our commitments to existing and new collaborat
ors, our ability to establish commercial and
licensing arrangements, our capital expenditur
es, market developments, and any potential
future acquisitions. Acc
ordingly, we may require additional funds
and may attempt to raise
additional funds through equity or
debt financings, collaborative agreements with par
tners, or
from other sources.
The Board of Directors monitors the shar
e and capital structure to ensure that Hansa’s c
apital
resources support the
strategic goals. Neither t
he Company nor any of its subsidiaries are
subject to externally i
mposed capital requirements. Managed capital is al
l reported equity.
Note 20
Financial Risk and Financial I
nstruments
The Group has exposure to the following ri
sks arising from financial ins
truments:
A. Liquidity risk
B. Market risk
C. Credit risk
Risk management framework
The Group’s board of directors has over
all responsibility for the est
ablishment and oversight of
the Group’s risk management framework. The Gro
up’s risk management policies are
established to identify and anal
yze the risks faced by the Group, to set appropriat
e risk limits
and controls and to monitor risks and adherenc
e to limits. Risk management policies and
systems are reviewed to reflect c
hanges in market conditions and the Group’s activit
ies. The
Group, through its training and management st
andards and procedures, aims to maintain a
disciplined and constructiv
e control environment in which all employees understand their
roles
and obligations. The Group’s audit
committee oversees how management monitors compliance
with the Group’s risk management policies and procedures and reviews the adequacy of t
he
risk management framework in relation to the risks faced by t
he Group. The Group’s audit
commit
tee is assist
ed in its oversight role by corporate f
inance function. Corporate finance
function undertakes both regular
and ad hoc reviews of risk management controls and
procedures, the results of which ar
e reported to the audit committee.
Liquidity Risk
Liquidity risk is the r
isk that the Group will encounter difficul
ty in meeting the obligations
associated with its financi
al liabilities that are settl
ed by delivering cash or another financial
asset. The Group’s approach to managing liquidi
ty is to ensure, as far as possi
ble, that it will
have sufficient liquidi
ty to meet its liabilities when they are due,
under both normal and stressed
conditions, without incur
ring unacceptable losses or risking damage to the Group’
s reputation.
The Board of Directors is
responsibl
e for the long
-
term financing strategy and for the acquisit
ion
of capital. The management of financial
risks in the day
-
to
-
day operations is handled by the
CFO and the corporate finance function.
To secure short
-
term liquidity
, Hansa Biopharma’s AB treasury policy prescribes
that an
appropriate level of liquidi
ty in the form of cash and cash equivalents shall be hel
d in an amount
sufficient to cover the expec
ted Group financial obligations over at l
east the next nine
-
month
period. This principle s
hall be checked and assured every time a new investment decision is
taken. On the reporting date, t
his goal was fulfilled.
Hansa Biopharma
Annual Report 202
1
10
2
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
No
te 1
7
L
oss p
er S
ha
re
continued
27
Hansa Biopharma Annual Report 2021
Cash and cash equivalents on December 31, 202
1
, amounted to SEK
651
million. Cash and
cash equivalents on the reporting dat
e consisted of bank deposits.
Short term investments were mainly invest
ed in interest funds and amounted to SEK 238 million
as of December 31, 202
1.
Set forth below is a term
-
based analysi
s of the Group’s remaining contractual financial
liabilities:
As of December 31, 2021
(in thousands of SEK)
Nominal
Amount
0
−
3
months
3
−
12
months
1
−
5
years
Contingent consideration
846
—
—
846
Non
-
current leasing liabilities
30
,
544
—
—
30
,
544
Current leasing liabilities
7,
929
1,986
5,
943
—
Trade
payable
s
53,
360
53
,360
—
—
Accrued expenses (see note 11)
28,
041
28,
041
—
—
Total
120
,
720
83
,
387
5,
943
31
,
390
As of December 31, 2020
(in thousands of SEK)
Nominal
Amount
0
−
3
months
3
−
12
months
1
−
5
years
Contingent consideration
7
66
—
—
7
76
Non
-
current leasing liabilities
644
—
—
644
Current leasing liabilities
4,497
1,
232
3,265
—
Trade
payable
s
26
,
669
26
,
669
—
—
Accrued expenses (see note 11)
28
,
802
28
,
802
—
—
Total
61
,
387
56
,
703
3,265
1,
420
Market Risk
Market risk is the risk that changes in market pri
ces
,
e.g. foreign exchange rates, interest rates
and equity prices
will affect t
he Group’s income or the value of its holdings of financial
instruments. The objective of market risk management is to manage and control market risk
exposures within acceptable parameters,
while optimizing the return.
Currency risk
The Group is exposed to transactional f
oreign currency risk to the extent that t
here is a
mismatch between the
currencies in which sales, purchases, r
eceivables and borrowings are
denominated and the respective functional
currencies of Group companies. The functional
currencies of Group companies are primar
ily the SEK, GBP and USD. The currencies in which
transacti
ons are primarily
denominated are SEK, EUR, GBP and USD.
To manage the currency risk exposure, the Group may i
n its normal course of business, hold
funds in foreign currency or ent
er into currency forward contracts or si
milar instruments to
manage trends i
n
exchange rates on the basis of a sophisticat
ed analysis considering
exchange rate forecasts published by banks or
other analysts as well as short and mid
-
term
currency needs of the Group.
All cash and investments shall only
be made and held in Swedish Krona. In case of investments
in funds or the like, an investment can only be made if
the currency fluctuation risk is fully
hedged by the fund.
As an exception to the above, the Group may hold cash i
n foreign currency in the normal
course of business to pay
any trade
payable
s
in foreign
currencies. Subsidiaries will hold cash
in their local currency within thei
r normal course of business. The Group also has minimal
amounts in trade and other receivables in f
oreign currencies.
The Group is exposed to translat
i
on risk that arise from consolidation of foreign subsidiar
ies.
The Group net assets on
December 31,
2021,
relating to Hansa Biopharma Inc. amounted to
USD
210
k (full year 20
20
: USD
140
k) and the Group net
assets relating to Hansa Biopharma
Ltd. amounted t
o GBP
50
k (full year
20
20
: GBP
14
k).
Sensitivity analysis
The Company purchases
services
mainly
in USD, GBP, DKK and EUR. A weakening of the
Swedish krona in relation to these cur
rencies therefore leads to increased costs f
or the Group,
all else remaining the same. In addi
tion, the Group receives licensing revenue whi
ch
are paid in
USD and GBP. A strengthening of the Swedish krona in relation to USD and GBP therefore
leads to reduced revenue for the Group expressed in SEK, all else
remaining the same.
A
wea
kening
of the
SEK in relation to EUR by an average of 10% would
have negatively
affect
ed
the Group’s earnings before tax by approximately
SEK
14
,9
80
,000. Correspondingly, a
10%
weakening
of SEK in relation to USD would
have negatively
affect
ed
earnings before tax
by approximately SEK
4,
847
,000, a
weak
ening of SEK in relation to GBP by an aver
age of 10%
would
have negatively
affect
ed
the Group’s
earnings before tax by approximately
SEK
4,
247
,000 and a
strengthening
of SEK in relation to DKK by a
n average of 10 % would
have
negatively
affect
ed
the Group’s earnings before tax by appr
oximately SEK
523
,000. This
analysis assumes that all other var
iables, in particular interest rat
es, remain constant and
ignores any impact of forecast sales and purcha
ses.
Hansa Biopharma
Annual Report 202
1
10
3
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
Note
20
Financial Risk
and Financial
Instruments
cont
inued
28
Hansa Biopharma Annual Report 2021
The sensitivity analysi
s is based on approximated cash flows in foreign currenc
ies. Income and
expenses of foreign operations are tr
anslated into Swedish kronor at an average exchange rate
that approximates the exchange rates pr
esented at each transaction date.
Interest rate risk
The interest rate risk consi
sts of the risk that a change in market int
erest rates will have a
negative effect on earnings. The Group’
s exposure to interest rate risks is consi
dered to be low
as the Group only has very limited
interest
-
bearing liabilities. There is cert
ain exposure to
interest rate risks in cash and cash equivalent
s in the form of bank deposits and holdings of
short
-
term interest fund.
The Group has acquired shares in an interest
fund. Changes in the general interest
rate level
affect the prices of the fund’
s interest investments in the opposite dir
ection. If the
general
interest
rate level drops
1 percentage point, prices wi
ll rise on the investment 0.25
-
0.50% and
vice versa (modified duration 0.
25
-
0.50% in the
normal position). This would lead to impact
on
profit or loss of SEK 59
4
,000 to SEK
(
1,1
88,000
)
, before tax.
Credit risk
Credit risk is the risk of financial
loss to the Group if a customer or counterparty to a financial
instrument fails to meet its
contractual obl
igations and arises principally fr
om the Group’s
receivables from customers and investments in debt securiti
es. The carrying amounts of
financial assets and contract
assets represent the maximum credit exposure.
The Group’s credit risk is pr
imarily related to bank deposits. However, this risk is consi
dered to
be low since the bank deposits are held with t
hree Swedish banks with good credit ratings with
no one bank holding more than 35% of the total amount as of December 31,
2021
. See further
discussions in Note 2. According to t
he Group’s treasury policy, The Company may only hold
bank deposits with, or initi
ate payments through, Swedish and foreign banks under the
supervision of the Swedish Financial
Supervisory Authority or similar f
oreign a
gency.
The Group also has risk related to i
ts trade receivables and other receivables
.
The maximum credit exposure of financial
assets amounted to
SEK
662
,
473
and SEK
1
,142
,
51
9
for the periods ended December 31, 202
1,
and 20
20
, respectively.
Investment pol
icy
The Group may invest a portion of its f
unds in bank deposits, bonds, investment funds and the
like with maturity of more than 35 days, while managing the
interest rate risk exposure, credit
risk exposure as well as
the cluster risk. As a general
principle, the Group may only invest in
investment grade issuers, measured at the day of the invest
ment.
Therefore, the following appl
ies:
1)
Minimum credit rating of one of the following rat
ing agencies (or comparable):
S&P Rating
Moody’s rating
Up to one year
A-2
P2
More than one year
A
A
2)
The maximum amount invested with one counterparty or i
ssuer is limited to 30% of total
funds at the time a new investment decisi
on is taken. This limit might be increased t
o up to 50%
upon prior approval by the Audit Committee.
3)
The duration management within the portfol
io of investments is the responsibili
ty of the CFO.
The maximum maturity of an individual i
nvestment shall not exceed two years.
At year
-
end 202
1
, SEK 198 million of the Group’s
shor
t
-
term investments were invested in an
investment grade fixed income fund denominated in SEK that invests pri
marily in Swedish
interest
-
bearing securities with a remai
ning duration of maximum 360 days. Another SEK 40
million was invested in a housing b
ond fund which invests in invest
ment grade assets
denominated in SEK.
Carrying amounts of financial
assets and financial liabili
ties
The table below shows the carrying amounts for
financial assets and financial li
abilities broken
down by measurement catego
ries under IFRS 9.
Financial assets valued at
amortized cost
Financial assets valued at fair
value through the income
statement
(in thousands of SEK)
2021
2020
2021
2020
Financial assets:
Short term investments
—
—
23
7,
619
238,144
Trade
receivable
s
9,
7
12
110
—
—
Other receivables
1,
419
3,047
—
—
Cash and cash equivalents
651
,3
42
1,139,362
—
—
Total financial assets
662,473
1,142,519
23
7,
619
238,144
Hansa Biopharma
Annual Report 202
1
10
4
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
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Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
Note
20
Financial Risk
and Financial
Instruments
cont
inued
29
Hansa Biopharma Annual Report 2021
Financial liabilities valued at
amortized cost
Financial liabilities valued at fair
value through the consolidated
statement of profit or loss and
other comprehensive income
(in thousands of SEK)
2021
2020
2021
2020
Financial liabilities
:
Contingent consideration
—
—
722
663
Trade
payable
s
53
,
360
26,669
—
—
Accrued expenses (see note 11)
28,
041
28,802
—
—
Total financial liabilities
81
,
401
55,471
722
663
Levels of financial assets and financial
liabilities per valuation hierarchy
Management considers the carrying amounts for all
financial assets and financ
ial liabilities to be
a reasonable approximation of their f
air value.
The table below presents the carryi
ng amount of financial assets and financial l
iabilities per
valuation hierarchy in IFRS 13.
Valuation
Hierarchy
2021
2020
(In thousands of SEK)
Financial asset:
Holdings of short
-
term investments
Level 2
23
7,
619
238,144
Contingent consideration
Level
3
722
663
The table below presents a reconcili
ation between the opening and closing balances for the
contingent consideration valuat
ed in accordance with Level 3.
As of December 31,
2021
2020
Opening balance January 1
663
730
Currency differences
42
(112)
Interest expense
67
45
Closing balance December 31
772
663
The
contingent consideration will
be at minimum 0 and at maximum GBP 70,000.
The Group’s best estimate on December 31, 202
1
, is t
hat the contingent consideration will be
paid in 202
3
. The previous estimate made on December 31,
2020,
was that the contingent
con
sideration would be paid in 202
2
. The fair
value of the contingent consideration is
estimated
based on management assessment when a clinical study is ini
tiated in Europe or the U.S
resulting in a milestone payment under the share purchase agreement.
The es
timated future
cash flow is discounted using a market i
nterest rate.
As of December 31, 202
1
, the maturity profi
le of our marketable securities has maturit
ies of less
than one year. The fair value of the s
ecurities is based on quotes received from the
coun
terparty managing the funds.
Note 21
Finance Income and Expenses
Years Ended December 31,
(in thousands of SEK)
2021
2020
Interest income on bank deposits measured at amortized cost
67
388
Changes in the fair value of interest funds during the year
—
1,782
Finance income
67
2,170
Interest expense
(
69
4)
(257)
Changes in the fair value of interest funds during the year
(
525)
—
Finance costs
(
1,21
9)
(257)
Net finance costs/income
(
1,
152)
1,914
Hansa Biopharma
Annual Report 202
1
10
5
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
Note
20
Financial Risk
and Financial
Instruments
cont
inued
30
Hansa Biopharma Annual Report 2021
Note 2
2
Share capital and number of shares
Years Ended December 31,
Number of shares
2021
2020
Issued as of January 1
44,473,452
40,026,107
Effect of issue of ordinary shares in July 2020
—
4,447,345
Issued as of December 31
44,473,452
44,473,452
The Group’s shares have a par value of SEK 1.
Holders of ordinary shares are entitled to divi
dends which are determined after they become
shareholders. Each ordinary share enti
tles the holder to one vote per share.
Note 2
3
Share Premium
The share premium reserve is comprised of t
he amount received, attributable to shareholder
s’
equity, in excess of the nominal amount of
the shares issued,
reduced by any amount allocated
to deferred income and external expenses di
rectly attributable to the off
erings. The share
premium reserve can be distributed.
Note 24
Treasury shares included in equit
y
Number of Shares
In thousands of SEK
2021
2020
2021
2020
As of January 1
,
1,421,457
1,421,457
1,421
1,421
Additions
440,452
—
440
—
As of December 31
,
1,861
,
909
1,421,457
1,862
1,421
Treasury shares have a par value of SEK 1.
The year 2021 additions of Class C shares ref
er to the new issue and subsequent repurchase
of Class C shares related to the funding of
the
long
-
term
incentive plan (LTIP) 2021, as
approved at the 2021 AGM.
Class C shares
correspond
to treasury shares
held by the
Company
and are reserved to fund the respective LTIP programs. Each Class C shar
e entitles
the holder to 0.1 vote per share.
Note 25
Reserves
Treasury share reserve
The treasury share reserve comprise own shar
es repurchased by the Group.
Translat
ion reserve
The translation reserve compri
ses all foreign exchange differences arisi
ng on translation of
financial statements from f
oreign business prepared in currency other than the r
eporting
currency for the financial
statements of the Group. The Group presents their
financial
statements in Swedish Kronor.
Fair value reserves
Fair value fund includes the accumul
ated change in fair value after tax on the holdi
ng of shares
and shares that the Group has chosen to report at
fair value through other comprehen
si
ve
income according to IFRS 9.
Please refer to Note 14 related to t
he Group’s LTIP programs and respective vesting dates.
Note 26
Royalty Agreements
The Company is party to two separate royalty
agreements (the Royalty Agreements) with
researchers
and an affiliated entity (col
lectively, the Counterparties) of c
ertain patents related to
methods of use of imlifidase. Under each agreement, in considerat
ion of the assignment of
these patents, the Counterparti
es are entitled to receive a low single
-
digit roya
lty percentage of
the Company’s net income related to the expl
oitation of the patents, in each case as defi
ned in
the applicable agreement, and a low double
-
digit percentage of any once
-
only considerations,
milestones, royalties, license income, consider
ation for transfer of patents, patent applications
and other intellectual propert
y rights and other payments received by the Company related to
the exploitation of right
s related to these patents, in each case subj
ect to certain specified
reductions. As the Company has received conditional regulatory approval for
Idefirix (imlifidase)
in the EU for the desensitization treat
ment of highly sensitized adult kidney transplant patients
with a positive crossmatch against an available deceased donor i
n August 2020 a
nd the
Company has initiated the commercial launch of Idefirix i
n the EU, above mentioned
compensation payments
under the Royalty Agreements may become effecti
ve during 202
2.
On April 20, 2021, the Company received a request f
or arbitration from the
Counterpart
ies
claiming they were entitled t
o 10% of the upfront payment the Company received under its 2020
collaboration agreement with Sarept
a as well as entitlement to participat
e in payments the
Company may receive under the Sarepta agreement in the f
uture. The Company believes these
claims are without merit. The ar
bitration proceedings are ongoing at an init
ial stage
.
Hansa Biopharma
Annual Report 202
1
10
6
Strateg
y
T
echnology
Grow
th
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Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
31
Hansa Biopharma Annual Report 2021
Note 27
Other operating income and expenses
Years Ended December 31,
2021
2020
Other operating income
Foreign currency gains on receivables/liabilities fr
om operating activities
—
2,270
Total other operating income
—
2,270
Other operating expenses
Foreign currency losses on receivables/liabilities f
rom operating activities
(7,398)
—
Total other operating expenses
(7,398)
—
Note 28
Operating expenses by nature
The table below presents an analysis of oper
ating expenses presented in profit or loss i
n
classification based on the nat
ure of the expenses
:
Years Ended December 31,
(in
thousands of SEK)
2021
2020
Personnel expenses
(266,611)
(1
80,080
)
Third party expenses
(
283,387
)
(2
42,431
)
Depreciation and amortization expenses
(8
,606
)
(
7,666
)
Other operating expenses
(6,827)
—
Total operating
expenses
(56
5,431
)
(4
30,178
)
Following table summarizes amortiz
ation and depreciation expenses from note 4, 5 and 6
above presented by function in profi
t or loss and other comprehensive income (loss).
Years Ended December 31,
2021
2020
Research and development expenses
5
,
639
3,022
Sales, general and administrative expenses
2,
967
4,644
Total
8,606
7,666
Note 29
Supporting information to the c
ash flows
As of December 31,
(in
thousands of SEK)
2021
2020
Cash and cash
equivalents consist of:
Cash and bank deposits
6
51
,
342
1,1
39,362
Total according to statement of financial position
651,342
1,1
39,362
Total according to cash flow analysis
651,342
1,1
39,362
Reconciliation of liabiliti
es arising from
financing
activities
:
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance
January 1,
5,045
9,458
Termination of lease agreement
(308)
(280)
New lease agreements
35,499
540
Payment of lease liabilities
(4,857)
(4,674)
Closing
balance December 31,
35
,
379
5,
045
Note
30
Subsequent events
On January 3, 2022, Hansa entered into an agreement with AskBi
o to evaluate the potential
use of imlifidase as a pre
-
treat
ment prior to the administration of AskBio’
s
investigational gene
therapy in Pompe disease in a pre
-
clini
cal and clinical feasibilit
y program for patients with pre
-
existing neutralizing anti
bodies (Nabs). Upon execution, Hansa receive
d
a US
D 5 million
payment, while AskBio has an exclusive opti
on to negotiate a full development and
commercialization agreement.
Russian inv
asion of Ukraine
On 24 February, 2022 Russa invaded Ukraine
.
Hansa does not have any own operations i
n nor
collaborates with any thir
d party service provide
r
s from either
Ukraine or Russia. Therefore,
Hansa’s operational activities are not dir
ectly affected by the conflict. However, the conflict does
already have or is expected to have general negat
ive impacts on global economy, stock
markets, energy prices, global supply a
nd free trade, and a
s
such may indirect
ly negatively
impact Hansa’s business. The Company continues to monitor the situation cl
osely and will take
appropriate measures as needed to manage any potential negati
ve impact to its business.
Hansa Biopharma
Annual Report 202
1
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7
Strateg
y
T
echnology
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th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Notes to the G
roup Fina
ncial S
tateme
nts
cont
inued
Hansa Biopharma
Annual Report 202
1
10
8
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
1
Hansa Biopharma Annual Report 2021
S
tatement of financial
p
osition
As of December 31,
(in
thousands of SEK)
Note
2021
2020
ASSETS
Non
-
current
assets:
Intangible assets
2
26,
518
29
,
171
Property and equipment
3
6,
432
5,206
Right
-
of
-
use assets
4
35
,
273
4,493
Financial assets
:
Investment in subsidiaries
5
5,095
5,095
Receivables, group companies
6
2,203
1,972
Total financial assets
7,298
7,067
Total non
-
current assets
75
,
521
45,
937
Current
assets:
Inventories
7
242
98
Trade receivables
8
9,712
110
Prepaid expenses and accrued income
9
20,820
5,394
Other receivables
10
22
,
381
9,763
Short
-
term investments
19
23
7,
619
238,144
Cash and cash equivalents
19
,28
644
,
975
1,13
3,
647
Total current assets
93
5
,749
1,3
87
,
15
7
TOTAL ASSETS
1,011
,
270
1,43
3,09
4
SHAREHOLDERS’ EQUITY AND LIABILITIES
Shareholders’ equity
Restricted shareholders’ equity:
Share capital
21
46,
33
5
45,895
Unrestricted
shareholders’
equity:
Share premium
reserve
22
2,5
72
,
925
2,509,458
Treasury share reserve
23,24
(1,
862
)
(1,421)
Accumulated deficit
(1,312,35
3)
(
890,710
)
Loss for the year
16
(
549
,
098
)
(
421
,6
44
)
Total
shareholders’ equity
755,948
1,24
1,
578
As of December 31,
(in thousands
of SEK)
Note
2021
2020
LIABILITIES
Non
-
current liabilities:
Lease liabilities
4
28,491
630
Deferred revenue
13
47
,02
0
62,026
Contingent consideration
17
722
663
Provisions
15
7,
357
14,426
Total non
-
current liabilities
83
,
590
77,
745
Current liabilities:
Liabilities, group companies
6
3,901
1,613
Lease liabilities
4
6,
888
4,415
Trade payables
19
53
,
240
26,623
Other liabilities
12
13,358
8,
325
Deferred revenue
13
24
,
961
17,406
Accrued expenses
11
69
,
384
55,
387
Total current liabilities
171,732
113,771
Total liabilities
255
,
322
19
1,
516
TOTAL STOCKHOLDERS’ EQUITY AND LIABILITIES
1,011
,
270
1,43
3,
094
Parent
Company
Financial Statement
The accompanying notes are an integral part of these Consolidated Financial Statements.
P
ar
ent Co
mpa
n
y Fina
ncial St
atement
s
Hansa Biopharma
Annual Report 202
1
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Strateg
y
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echnology
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th
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Directors
’
repo
rt
ESG
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Remuneration
Ma
rket
Ove
rv
iew
Financials
2
Hansa Biopharma Annual Report 2021
S
tatement of profit or loss and ot
her comprehensive income (loss)
Years Ended December 31,
(in thousands of SEK)
Note
2021
2020
Revenue
13
33,878
6,098
Cost of revenue
(15,425)
(997)
Other operating income
26
—
2,270
Sales, general and administrative expenses
27
(
327
,
031
)
(20
3,
346
)
Research and development expenses
27
(2
31
,
974
)
(227,531
)
Other operating expenses
26
(7,39
5
)
—
Loss from operations
(547,947)
(423,507)
Finance income (expenses)
Finance income
20
67
2,170
Finance expenses
20
(1,218)
(
307
)
Net finance
(
expenses
)
income
20
(1,151)
1,863
Loss
before tax
(5
4
9,
098
)
(42
1,
644
)
Tax
—
—
Loss for the year
16
(549,098)
(4
21,644)
Years Ended December 31,
(in thousands of SEK)
Note
2021
2020
Loss
for the year
(549,098)
(4
21,644)
Other comprehensive income (loss) for the year
—
—
Total comprehensive loss for the year
(
54
9,0
98
)
(421,
644
)
The accompanying notes are an integral part of these Consolidated Financial Statements.
Paren
t Company Financi
al St
atement
s
con
tin
ued
Hansa Biopharma
Annual Report 202
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Strateg
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echnology
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rv
iew
Financials
3
Hansa Biopharma Annual Report 2021
S
tatement of cash flow
s
Years Ended December 31,
(in thousands of SEK)
Note
2021
2020
Cash Flows from Operating Activities
L
oss for the year
(
54
9,
098
)
(42
1,
644
)
Adjustments to reconcile net loss to net cash flows:
Depreciation and amortization expenses
27
8,
418
6,
350
Expenses related to incentive programs
56
,
624
43,348
Costs related to pension plan
(
226
)
141
Unrealized currency differences
(
231
)
275
(
48
4,
513
)
(3
71,
530
)
Changes:
(
Increase
) d
ecrease of trade receivables
8
(
9,602)
412
(
Increase
)
of other operating receivables
(
30,083
)
(1,
409
)
Increase (decrease) trade payables
28,513
(23,758
)
Increase of other operating liabilities
14
,
895
10
4,
698
Total
changes
3,
723
79
,
943
Interest
(
paid
) re
ceived
, net
(62
5)
79
Income taxes paid
—
—
Net cash used in operating activities
(
481
,4
16
)
(29
1,
509
)
Cash Flows from Investing Activities
Proceeds from sale of short
-
term investments
—
182,828
Acquisition of property and equipment
3
(
2,399
)
(294)
Net cash
(used in)
from investing activities
(2
,
399)
182,534
Years Ended December 31,
(in thousands of SEK)
Note
2021
2020
Cash Flows from Financing Activities
Proceeds from issue of ordinary shares, net of
transaction costs
(1)
—
1,070,581
Payment of lease liabilities
4
,28
(4,
857
)
(4,674)
Net cash (used in)
from
financing activities
(4
,
857
)
1,065,906
Net change in cash and cash equivalents
(488
,
672
)
95
6,
932
Cash and cash equivalents at beginning of year
1,
133,
647
176
,
715
Cash and cash equivalents at end of year
28
6
44
,
975
1,13
3,
647
(1)
Total share issue cost amounted to SEK 41,255k
in the year 2020
.
Parent Company
continued
The accompanying notes are an integral part of these Consolidated Financial Statements.
Paren
t Company Financi
al St
atement
s
con
tin
ued
Hansa Biopharma
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Hansa Biopharma Annual Report 2021
S
tatement of changes in
shareholders’
equity
Restricted
shareholders’
Equity
Unrestricted shareholders’ Equity
(in thousands of SEK)
Note
Share
Capital
Share
Premium
reserve
Treasury
share
reserve
Fair
value
reserve
Accumulated
deficit
Loss
for the year
Total
shareholders’
Equity
Balance at January 1, 20
20
41,448
1,413,447
(1,421)
76,834
(607,146)
(360,398)
562,763
Statement of profit or loss
and other comprehensive income
(loss)
:
Loss for the year
—
—
—
—
—
(42
1,
644
)
(42
1,
644
)
Other comprehensive income
(loss)
for the year
—
—
—
—
—
—
—
Total comprehensive loss for the year
—
—
—
—
—
(42
1,
644
)
(421,
644
)
Reclassification of fair value reserve
—
—
—
(76,834)
(76,834)
—
—
Appropriation of loss of the
year
2019
carried forward
—
—
—
—
(360,398)
360,398
—
Issue of ordinary
shares
(1)
4,447
1,066,133
—
—
—
—
1,070,581
Long term incentive program
—
29,878
—
—
—
—
29,878
Balance at December 31, 20
20
21,22,23,24
45,895
2,509,458
(1,421)
—
(
890,710
)
(
421
,
644
)
1,24
1,
578
S
tatement of profit or loss and other comprehensive income (loss):
Loss for the year
—
—
—
—
—
(
54
9,
098
)
(
54
9,
098
)
Other comprehensive income (
loss
)
for the year
—
—
—
—
—
—
—
Total comprehensive loss for the
year
—
—
—
—
—
(
54
9,
098
)
(54
9
,
098
)
Appropriation of
loss of the
year 2020
carried forward
—
—
—
—
(421,644)
421,644
—
Issue of
Class
-C
shares
(2)
440
—
(440)
—
—
—
—
Long term incentive program
—
63,467
—
—
—
—
63,467
Balance at December 31, 202
1
21,22,23,24
46,
33
5
2,5
72
,
925
(1,
862
)
—
(
1,312,35
3)
(
549
,
098
)
755
,
948
(1)
Total share issue cost amounted to SEK 41,255
in the year 2020
.
(2)
The year 2021 additions of Class C shares refer to the new issue and subsequent repurchase of Cl
ass C shares that have taken
place in accordance with the respective long term incentive plan (LTIP) program.
Parent Company
continued
The accompanying notes are an integral part of these Consolidated Financial
Statements.
Paren
t Company Financi
al St
atement
s
con
tin
ued
Hansa Biopharma
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Hansa Biopharma Annual Report 2021
N
ote
1
Accounting policies
Hansa Biopharma AB
(t
he Parent Company
)
has prepared its annual report in accordance with
the Swedish Annual Accounts Act (SFS 1995:1554) and Recommendation RFR 2 iss
ued by the
Swedish Financial Reporting Board, Report
ing for legal entities. The statements i
ssued by the
Swedish Financial Reporting Board applicabl
e to listed companies have also been applied.
RFR 2 entails that in the annual report for the
legal entity the Parent Company must apply all of
IFRS and the statements adopted by the EU to the extent
possible within the scope of the
Swedish Annual Accounts Act, the Securing of Pens
ion Obligations Act, and taking into
consideration the connection between repor
ting and taxation. The Recommendation sets for
th
which exceptions from, and additions to, IFRS are to be made.
Differences between the Group’s and t
he Parent Company’s accounting principles
The differences between the Group’s and the Parent
Company’s accounting principles are set
forth below. The accounting pri
nciples set forth below for the Parent Company have been
applied consistently to all
periods presented in the Parent Company’s financial stat
ements.
Subsidiaries
Investment
in subsidiaries
is
recognized at cost after deducti
ng for potential impairment. Cost
includes acquisition
-
related expenses and potential additi
onal purchase considerations. When
there is an indication that
investment
in subsidiaries
is
impaired, recoverable amount is
measured. If the recoverable amount is lower than the carrying amount, an impairment is
recognized
. Impairment is recognized in
the
statement of profit or loss.
Presentation
and classificati
on
The differences in the Parent Company’s i
ncome statement and statement of financial positi
on
as compared with the Group’s statements consi
st primarily of the reporting of f
inancial income
and expenses,
non
-
current
assets and shareholders’
equity.
Note
14
employees and
accrued person
nel cost
and note 29
audit fees
includes information
for
the Group and the Parent Company as
required by
the Swedish Annual
Accounts Act.
Note
2
Intangible Assets
The projects pending in the Group are a combinat
ion of acquired development projects and
continued activities i
n these projects. Of the total acquisiti
on cost for acquired
in
-
process
development projects, approximately 75% rel
ates to imlifidase and 25% relates to HBP
-
assay.
Capitalized internal development expenditures for i
mlifidase’s previous production process were
completely amortized during the year
2018.
Acquired in
-
pr
ocess development projects ar
e assessed for possible impairment at least on an
annual basis and the impairment assessment on December 31, 2021
,
and 2020 demonstrated
that there was no need for impairment. The est
imated recoverable amount supported by
exter
nal and internal valuati
on reports by far exceed the assets carrying amount, res
ulting in no
impairment charges for the year 2021 and 2020.
Internally
generated
Capitalized
development
expenditures
Acquired intangible assets
(in thousands of SEK)
Patents
In-process
development
projects
Total
Intangible
Assets
Cost:
Opening balance January 1, 202
1
4,485
8,504
25,136
38,125
Closing balance December 31, 202
1
4,485
8,504
25,136
38,125
Amortization:
Opening balance January 1, 202
1
(4,485)
(4,
469
)
—
(8,
954
)
Amortization for the year
—
(
559
)
(2,094)
(
2,653
)
Closing balance December 31, 202
1
(4,485)
(5,
028
)
(2,094)
(1
1,607
)
Carrying amounts:
At January 1, 2021
—
4,035
25,136
29,171
At
December 31, 2021
—
3,
476
23,
042
26,518
Internally
generated
Capitalized
development
expenditures
Acquired intangible assets
(in thousands of SEK)
Patents
In-process
development
projects
Total
Intangible
Assets
Cost:
Opening balance
January 1, 20
20
4,485
8,504
25,136
38,125
Closing balance December 31, 20
20
4,485
8,504
25,136
38,125
Amortization:
Opening balance January 1, 20
20
(4,485)
(4,
118
)
—
(8,
603
)
Amortization for the year
—
(
351
)
—
(
351
)
Closing balance December 31, 20
20
(4,485)
(
4,469
)
—
(
8,954
)
Carrying amounts:
At January 1, 20
20
—
4,386
25,136
29,522
At December 31, 20
20
—
4,035
25,136
29,171
N
otes
–
Parent Company
No
tes to the Parent Company F
ina
ncial St
atement
s
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Hansa Biopharma Annual Report 2021
The acquired intangible asset rel
ating to imlifidase presented as in
-
process development
projects will be amortized over t
he estimated useful life of the underlying asset
. Following t
he
first commercial sale of i
mlifidase in Q1
-
2021
the Group
started to amortize the SEK 25,136 k
from the period of first sal
e in Q1
-
2021. The estimated useful life is 12 years.
The HBP
-
assay patent cost is amortized over the f
inite useful life of the underlying pat
ent in the
amount of SEK 559 k for the year
202
1 (
full year
20
20
: SEK 559 k). The patent c
ost is
amortized over sales, general and administ
ration line item in the consolidated statement
of
profit or loss and other comprehensive i
ncome.
HBP
-
assay is a method of analysi
s used to predict severe sepsis in emergency clinic
s. A first version
has been launched, primarily intended for research purposes
,
and interested speci
alists. The HBP
-
assay has been licensed to a cooperating partner, Axis
-
Shield Diagnostics Ltd. (Axis
-
Shield), which is
currently developing a ful
ly commerci
al product. The Company receives milestone compensation and
additional royalty revenue upon the sale of the
sublicensed technology.
Note
3
Property and
e
quipment
The
p
roperty and
e
quipment held by the Parent Company
is the same as for the Group, see
note 5 for the Group.
Note
4
Right
-
of
-u
se
a
ssets,
l
ease
l
iabilities
The
r
ight
-
of
-u
se
a
ssets held by the Parent Company
is the same as for the Group, see note 6
for the Group.
Note 5
Investment in
s
ubsidiaries
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance January 1,
5,095
5,095
*
Ad
dition
s
0
0
Closing balance December 31,
5,
095
5,
095
*The paid in capital of
Hansa
Biopharma Pty Ltd amounted to AUD 1
As of December 31,
(in thousands of SEK, except for number of
shares and share percentage)
Number of
shares
Share
%
2021
2020
Cartela R & D AB/556746
-
0083/Lund
1
,000
100
2,
630
2,630
Hansa Biopharma Ltd / 08361712 /
Cheltemham, United Kingdom
100,000
100
2,456
2,4
56
Hansa
Biopharma Inc, 6846164,
Delaware, USA
1,000
100
9
9
*Hansa Biopharma
Australia
Pty Ltd
1
100
0
0
Closing balance December 31,
—
—
5,095
5,
095
*Dormant
C
ompany
Note
6
Intercompany balances
Receivables, group companies
N
on
-
current assets
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance January 1,
1,
972
2,244
Change in receivables, net
231
(272)
Closing balance December 31
,
2,
203
1,
972
C
urrent assets
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance January 1,
—
1,061
Change in
receivables, net
—
(1,061)
Closing balance December 31,
—
—
Liabilities
, group companies
C
urrent
liabilities
As of December 31,
(in thousands of SEK)
2021
2020
Opening balance January 1,
1,613
2,
793
Change in
liabilities
, net
2,28
8
(1,
180
)
Closing balance December 31,
3,901
1,613
Note
7
Inventories
The Inventories held by the Parent
Company
is the same as for the Group, see note 7 for the
Group.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
No
te 2
I
nt
ang
ib
le As
set
s
contin
ued
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Hansa Biopharma Annual Report 2021
Note
8
Trade Receivables
The Trade receivables held by the Parent
Company
is the same as for the Group, see note
8
for the
Group
.
Note
9
Prepaid expenses and accrued income
As of December 31,
(in thousands of SEK)
2021
2020
I
nsurance
s
829
494
Healthcare conferences
124
1,664
Software
1,177
1,378
Pension
1,644
—
Rent
2,512
1,161
Legal expenses
8,325
—
Lice
nce fee
s
3,999
262
Other
2,21
1
4
35
Total
20
,8
20
5,394
Note
10
Other receivables
As of December 31,
(in thousands of SEK)
2021
2020
VAT receivables
9,670
3,786
Advance payments to suppliers
11,292
3,124
Other receivables
1,419
2,853
Total
22
,
381
9,763
Other receivables are mainly comprised of
VAT
receivables, advance payments to suppliers
and other receivables.
Note
11
Accrued Expenses
As of December 31,
(in thousands of SEK)
2021
2020
Annual leave accrual
1
5,376
10,49
5
Accrued social security contribution on salaries
4,395
2,964
Accrued
short term incentives
,
incl. related social security contributions
21,713
13,127
R&D project costs
7,791
13,223
Consulting fees
17,
600
11,269
Other
2,509
4,311
Closing balance December 31
69,38
4
55,387
Other receivables are mainly comprised of
VAT receivables, advance payments to suppliers
and other receivables.
Note
12
Oth
er liabilities
/
Current
As of December 31,
(in thousands of SEK)
2021
2020
Personnel related liabilities
13
,
35
8
8,325
Closing balance December 31
13
,
358
8,325
Note
13
Revenue
The Revenue generated by the Parent Company
is the same as for the Group, see not
e 13 for
the Group.
Note 1
4
Employees and
accrued
person
nel cost
–
Group and Parent
Company
2021 Guidelines for remuneration to seni
or executives
The
2021
guideli
nes
proposed
by
the
Board
of
Directors
entail
that
executive
management
is
offered
a
remuneration
which
is
competitive
and
on
m
arket
terms.
The
level
of
the
remuneration
fo
r
the
individual
manager
shall
be
based
on
factors
such
as
position,
expertise,
experience,
and
performance.
The
remuneration
consists
of
a
fixed
salary
and
pension
benefits
and,
in
addition,
may
consist
of
variable
salary,
share
based
long
-
term
incentive
programs,
severance
remuneration
and
non
-
monetary
benefits.
The
variable
salary
is
based
on
th
e
achievement
of
quantitative
and
qualitative
targets
and
should
not
exceed
75
percent
of
the
annual
fixed
salary.
Salary
during
the
notice
of
termination
period
and severance remuneration
can be a maximum
amount of 18 months salaries.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
Hansa Biopharma
Annual Report 202
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Hansa Biopharma Annual Report 2021
Please also visit the
Company’s website
at www.
hansabi
opharma.com for information on the
2021 guidelines for remuneration to seni
or executives.
Total compensation
-
related
expenses recorded in the
Group,
or
the Parent Company
are
presented below
in different break
-
downs.
Group
2021
Total
compensation
-
related
expenses in the Group broken down to geographical areas
(in thousands of SEK)
Parent
Company
Subsidiaries
Total
Group
Salaries,
bonuses
and
other
benefits
135
,
656
18,
930
154
,
586
Social
security
contribution
29
,
342
1 216
30
,
558
Pension cost,
contribution
plan
17,557
547
18,104
Share
-
based
compensation
56
,
624
–
56,624
Total
compensation
-
related
expenses
239,179
20
,
693
259,872
Total
compensation
-
related
expenses in
the
Parent
C
ompany
broken down to senior
management and other employees
(in thousands of SEK)
Senior
management
Other
employees
Total
Parent
Company
Salaries,
bonuses
and
other
benefits
32
,
282
103
,
374
135
,
656
Social
security
contribution
10
,
04
0
19,
302
29
,
342
Pension cost,
contribution
plan
2 723
14,835
17,55
7
Share
-
based
compensation
33,860
22,764
56,624
Total
compensation
-
related
expenses
78,905
160,274
239,180
Parent Company 2021
C
ompensation
-
related
expenses related to Senior management
(in thousands of
SEK)
Base
salary
Directors’
fees
Variable
compen-
sation
Other
benefits
Total
Salaries,
bonuses
and other
benefits
Social
security
contri-
butions
Pension
cost
Share-
based
compen-
sation
Total
Chairman of the
Board of Directors
Ulf Wiinberg
9
46
–
–
9
46
29
7
–
–
1,24
3
Director **
Birgit Stattin
-
Norinder
134
–
–
134
14
–
–
147
Director
Anders Gersel
Pedersen
352
–
–
352
36
–
–
388
Director
Andreas Eggert
415
–
–
415
130
–
–
545
Director
Eva Nilsagård
425
–
–
425
133
–
–
558
Director ***
Hilary Malone
319
–
–
319
100
–
–
420
Director Mats
Blom
364
–
–
364
114
–
–
478
CEO Søren
Tulstrup
*7,010
3,444
128
10,582
3,325
–
12,049
25,955
Other senior
executives
(5 persons)
12,877
5,579
291
18,746
5,890
2,723
21,811
49,171
Total
22
,
840
9
,0
23
419
32
,
282
10
,
040
2,
723
33
,
860
78
,
905
*
Includes
1,
619
KSEK, representing 30% of base salary, intended for own pension contribution
**
Board member until AGM 2021.
***
Board
member from AGM 20
21
.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
No
te 1
4 Em
pl
oyee
s and a
cc
rue
d pe
rs
onn
el co
st – G
rou
p an
d Par
ent C
omp
any
continued
Hansa Biopharma
Annual Report 202
1
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Hansa Biopharma Annual Report 2021
Group
2020
Total compensation
-
related
expenses in the Group broken down to geographical areas
(in thousands of SEK)
Parent
Company
Subsidiaries
Total
Group
Salaries,
bonuses
and
other
benefits
85,179
11,506
96,685
Social
security
contribution
18,243
836
19,079
Pension cost,
contribution
plan
10,074
613
10,688
Share
-
based
compensation
43,348
–
43,348
Total
compensation
-
related
expenses
156,844
12,956
169,800
Total compensation
-
related
expenses in Parent
C
ompany broken down to senior
management and other employees
(in thousands of SEK)
Senior
management
Other
employees
Total
Parent
Company
Salaries,
bonuses,
and
other
benefits
28,896
56,283
85,179
Social
security
contribution
8,894
9,349
18,243
Pension cost,
contribution
plan
1,357
8,717
10,074
Share
-
based
compensation
23,882
19,466
43,348
Total
compensation
-
related
expenses
63,029
93,815
156,844
Parent Company 2020
C
ompensation
-
related
expenses
related to Senior management
(in thousands of
SEK)
Base
salary
Directors’
fees
Variable
compen-
sation
Other
benefits
Total
Salaries,
bonuses
and other
benefits
Social
security
contri-
butions
Pension
cost
Share-
based
compen-
sation
Total
Chairman of the
Board of Directors
Ulf Wiinberg
925
–
–
925
291
–
–
1,216
Director
Birgit
Stattin
-
Norinder
365
–
–
365
37
–
–
402
Director
Anders
Gersel
-
Pedersen
350
–
–
350
36
–
–
386
Director Andreas
Eggert
365
–
–
365
115
–
–
480
Director
Eva
Nilsagård
375
–
–
375
118
–
–
493
Director
Mats Blom
340
–
–
340
107
–
–
447
CEO
Søren
Tulstrup
*6,341
2,406
107
8,854
2,748
–
9,493
21,095
Other
senior
executives
(5
persons)**
13,054
4,230
38
17,322
5,443
1,357
14,389
38,510
Total
22,115
6,636
145
28,896
8,894
1,357
23,882
63,029
*
Includes 1 506 KSEK, representing 30% of base salary, intended for own pension contribution.
**
Includes remuneration for one new member of the Executive committee (CMO) appointed 1 June 2020
and one former member of the Executive committee who served through 30 September 2020.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
No
te 1
4 Em
pl
oyee
s and a
cc
rue
d pe
rs
onn
el co
st – G
rou
p an
d Par
ent C
omp
any
continued
Hansa Biopharma
Annual Report 202
1
117
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
10
Hansa Biopharma Annual Report 2021
Average number of employees
2021
2020
Number
Of which
are men
Number
Of which
are men
Total Group
116
40%
63
43%
Parent
Company
Sweden
109
40%
58
42%
Subsidiaries
UK
4
75
%
1
100%
US
3
25%
4
25%
Total subsidiaries
7
–
5
–
Breakdown of senior management according to gender
Share of women
2021
2020
Total Group
Board of Directors
33%
33%
Other senior management
17%
17%
Parent Company
Board
of
Directors
33%
33%
Other
senior
management
17%
17%
Benefits to senior executives
Senior
management
of
the
Company
includes
the
Board
of
Directors,
th
e
CEO
and
the
other
members
of
th
e
executive
management.
Remuneration to Board of Directors
Fees are payable to the chairman of the Board of
Directors and other directors pursuant to a
resolution adopted by the annual general meeting (“AGM”). The 2021 AGM resolved that
fees
paid to directors for work duri
ng 2021 will be SEK 900,000 to the chair of t
he Board of Directors
and SEK 300,000 to each of the other directors,
SEK
150
,000 to the chair and SEK
75,000
each to the other directors who are members of the Audi
t Committee, SEK 40,000 to the chair
and SEK 25,000 each to other directors who are member
s of the Remuneration Committee
,
USD 20,000 to the cha
ir
of the U.S. co
mmittee
and SEK 25,000 each to directors
who are
members of the Scientific Committee. There are no contracts regardi
ng severance
compensation or other benefits for
the chair of the Board of Directors or ot
her directors.
Salaries and other remuneration to t
he CEO
Salaries, bonuses,
and other benefits
In 2021, the CEO received a total of
SEK 10,582k
in salaries, bonuses and other benefits.
Notice of termination periods and severance comp
ensation
If notice of terminati
on of employment is made by the Company, the notice period may not
exceed six months. Fixed cash salary duri
ng the period of notice and any severance pay may
together not exceed an amount equivalent to t
he fixed cash salary for 18 months for t
he CEO,
i.e.,
6 plus 12 months.
Pension contributions
The CEO is responsible for his pension pr
ovision, thus the Company has no direct pension cost
for the CEO.
Salaries and other remuneration to ot
her mem
bers of executive management
Sala
ries and other remuneration to the other members of the executive management is
determined by the CEO and approved by the chair of the Board of Di
rectors. In 2021, executive
management comprised of six people including the CEO.
Salaries,
bonuses,
and other
benefits to the other members of the executive management
amounted
to SEK 18,746k in
2021.
Notice period of terminat
ion and severance payments
Fixed cash salary during the peri
od of notice and any severance pay may together not exceed
an amount equivalent
to the fixed cash s
alary for 6 months, and in exceptional cases, 12
months for the other members of the executive management. When termination is made by the
executive officer the peri
od of notice may not exceed six months.
During their notice period, oth
er members of executive management are enti
tled to full salary
and other employment benefits.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
No
te 1
4 Em
pl
oyee
s and a
cc
rue
d pe
rs
onn
el co
st – G
rou
p an
d Par
ent C
omp
any
continued
Hansa Biopharma
Annual Report 202
1
11
8
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
11
Hansa Biopharma Annual Report 2021
Pension contributions
Other members of executive management, Donato Spota, Christ
ian Kjellman and Anne
Säfstöm Lanner, are entitled to ret
ire at the age of 65
without any requirement of not
ice.
However, they are entitled to continue working until
68 years of age. Henk Doude van
Troostwijk’s employment terminat
es without any requirement of notice at the age with r
ight to
retirement age according to Dutch Old Age
Pension Act (AOW). Other members of executive
management are entitled to pension benefits in accordance wit
h the Company’s insurance and
pension policy.
Share
-
based compensation
The share
-
based
compensation
recorded and presented by the Parent Company is t
he same
as for the Group, see note 14 for the Group.
Note 1
5
Provisions
The
provisions
recorded
by the Parent Company
is the same as for the Group, see
note
15
for
the Group.
Note 1
6
Incom
e
Taxes
Unrecognized deferred tax assets
Deferred tax
assets have not been recognized regarding t
emporary differences and losses
carried forward since it i
s not probable that such can be set off against taxabl
e profits in the
foreseeable future.
The
Parent Company
’s
losses carried forward in 202
1
amounted to
SEK
1,855
,
284,
000 (20
20
:
SEK
1,
3
69
,
772,000
). The losses carried forward is, in all
material respects, attributable
to
Swedish companies and therefore has no due date.
A reconciliation of Hansa’s effective t
ax
rate relative to the Swedish statutory t
ax rate is as follows:
2021
2020
%
(in thousands
of SEK)
%
(in thousands
of SEK)
Result before tax
—
(549,098)
—
(42
1,
644
)
Tax according to current tax rate
20.6
113,114
2
1.4
90,232
Non
-
deductible expenses
(2.
4)
(
13
,
099
)
(2.2)
(9,119)
Increase in loss carry forwards without
corresponding capitalization of deferred
tax
(1
8.2)
(100,015
)
(19.2)
(8
1,
113
)
Reported effective tax
—
—
—
—
The corporate tax rate in Sweden
is
20.6%
,
from January 1, 2021.
Note 1
7
Contingent Consideration
The Contingent consideration recorded by
the Parent Company
is the same as for the Group,
see note 1
8
for the Group.
Note 1
8
Capital Management
The
Capital
management of the
P
arent
Company
and the Group is the same
as for the Group,
see n
ote 19
for the Group.
Note
19
Financial Risk and Financial Instr
uments
The Parent
C
ompany
has exposure to the
same financial
risks
arising f
rom financial
instruments as the Group
, see note 20 for the Group.
Carrying amounts of financial
assets and
financial liabilities
The table below shows the carrying amounts for
financial assets and financial li
abilities broken
down by measurement categories under IFRS 9
in the Parent Company.
Financial assets valued at
amortized cost
Financial assets
valued at fair value
through the income statement
(in thousands of SEK)
2021
2020
2021
2020
Financial assets:
Short term investments
—
—
23
7,
619
238,144
Receivables, group companies
2,203
1,972
—
—
Trade
receivable
s
9,
7
12
110
—
—
Other receivables
1,419
2,853
—
—
Cash and cash equivalents
644
,
975
1,13
3,
647
—
—
Total financial assets
65
8,3
09
1,1
38,
582
23
7,
619
238,144
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
No
te 1
4 Em
pl
oyee
s and a
cc
rue
d pe
rs
onn
el co
st – G
rou
p an
d Par
ent C
omp
any
continued
Hansa Biopharma
Annual Report 202
1
11
9
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
12
Hansa Biopharma Annual Report 2021
Financial liabilities valued
at amortized cost
Financial liabilities valued
at fair value through the
consolidated statement of profit or
loss and other comprehensive
income
(in thousands of SEK)
2021
2020
2021
2020
Financial liabilities
:
Contingent consideration
—
—
722
663
Liabilities, group companies
3,901
1,613
Trade
payable
s
53,240
26,623
—
—
Accrued expenses (see note 11)
27,
900
28,802
—
—
Total financial liabilities
85,0
41
5
7,039
722
663
Note
20
Finance Income and Expenses
Years Ended December 31,
(in thousands of SEK)
2021
2020
Interest income
67
388
Changes in the fair value of interest funds during the year
—
1,782
Finance income
67
2,170
Interest expense
s
(693)
(
307
)
Changes in the air value of interest funds during the year
(
525
)
—
Finance costs
(1,218)
(307)
Net finance
costs
/income
(1,151)
1,863
Note 2
1
Share capital and number of shares
The Share Capital stated
and number of shares
for
the
Parent Company
is the same as for
the
Group, see note
2
3 for the Group.
Note
22
Share Premium
The Share Premium stated by the Parent Company is the same as for t
he Group, see note 22
for the Group above.
Note 2
3
Treasury shares included in equity
The
Treasury sha
res
included in equity stated
by the Parent Company
is the same as for t
he
Group, see note
24
for the Group.
Note 2
4
Reserves
Treasury share reserve
The treasury share reserve comprise own shar
es repurchased by the Group.
Fair value reserves
Fair
value fund includes the accumulat
ed change in fair value after tax on the holding of
shares
and shares that the Group has chosen to report at
fair value through other comprehensive
income according to IFRS 9.
Please refer to Note 14 related to t
he Group’s LTIP programs and respective vesting dates
.
Note 2
5
Royalty Agreements
The
Parent Company is party to the same
royalty agreements as the Group,
see note 26
for
the
Group
.
Note 2
6
Other operating income and expenses
Years Ended December 31,
(in thousands of SEK)
2021
2020
Other operating income
Foreign currency gains on receivables/liabilities fr
om operating activities
—
2,270
Total other operating income
—
2,270
Other operating expenses
Foreign currency losses on
receivables/liabilities from o
perating activities
(7,395)
—
Total other operating expenses
(7,395)
—
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
Note
1
9
Financial Risk
and Finan
cial Instruments
con
tinued
Hansa Biopharma
Annual Report 202
1
12
0
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
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Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
13
Hansa Biopharma Annual Report 2021
Note 2
7
Operating expenses by nature
The table below presents an analysis of oper
ating expenses presented in profit or loss
in
classification based on the nat
ure of the expenses:
Years Ended December 31,
(in thousands of SEK)
2021
2020
Personnel expenses
(245,189)
(
165,173
)
Third party expenses
(
305,969
)
(
259,354
)
Depreciation
and
amortization
expenses
(
8,418
)
(
6,350
)
Other
operating
expenses
(6,824)
—
Total operating expenses
(
566,400
)
(4
30
,
877)
Following table summarizes amortiz
ation and depreciation expenses from note
2
,
3
and
4
above presented by function in profi
t or loss and other comprehensive income (loss).
Years Ended December 31,
(in thousands of SEK)
2021
2020
Research and development expenses
5,516
1,894
Sales, general and administrative expenses
2,902
4,456
Total
8,418
6,
350
Note 28
Supporting information to the c
ash flows
As of December 31,
(in thousands of SEK)
2021
2020
Cash and cash equivalent
s
consist of:
Cash and bank
deposits
644,975
1,133,647
Total according to
the
statement of financial positio
n
644,975
1,133,647
Total according to
the cash flow
644,975
1,133,647
Reconciliation of liabiliti
es
arising from financin
g activities
:
(in thousands of SEK)
2021
2020
Opening balance
January 1,
5,04
5
9,458
Termination of lease agreement
(
308
)
(
280
)
New lease agreements
35,
499
540
Payment of lease liabilities
(4
,
857
)
(4,674)
Closing balance December 31,
35
,
379
5,
04
5
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
Hansa Biopharma
Annual Report 202
1
12
1
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
14
Hansa Biopharma Annual Report 2021
Note 29
Audit fees
–
Group and
Parent
Company
Years Ended December 31,
(in thousands of SEK)
2021
2020
Group
KPMG AB
:
*
Auditing services
9,892
695
Other services closely related to audit services
30
0
160
Tax services
—
—
Azets
Audit Services
Auditing services
68
64
Parent Company
KPMG AB
:
*
Auditing services
9
,842
545
Other services closely related to audit services
300
160
Tax services
—
—
*
Thereof
PCAOB Audit services related to the preparation for
d
ual listing on NASDAQ, USA, amounts
to 8
,832
.
Note
30
Collateral provi
ded, contingent liabiliti
es and contingent assets
Nothing to report related to the financi
al
year
202
1
and 20
20
.
Note
31
Related party
transactions
Subsidiaries
Interest in subsidiari
es
and
intercompany
receivables
and
liabilities
are set out i
n Note
6
.
Transactions with key persons in a senior management position
Transactions with key persons in a seni
or management posit
ion are set forth in Note
14.
Note
32
Information
regarding the Par
ent Company
Hansa Biopharma AB (publ) is a Swedish registered public company (Company reg. no.
556734
-
5359).
The registered office is l
ocated in Lund. The Parent Company’s shares are reg
ist
ered on
NASDAQ Stockholm. The address of the headquarters is Scheelevägen 22, 223 63 Lund.
The consolidated
accounts for 2021 and 2020 cover
the Parent Company and its subsidiaries,
jointly referred to as the Group.
Note
33
Appropriation
of loss carried forward
Unrestricted shareholders’ equity in the Parent
Company:
As of December 31,
(in SEK)
2021
2020
Share premium reserve
2,572,925,209
2,509,457,908
Treasury shares
(
1,86
1,
909
)
(1,421,457)
Loss carried forward
(
1,312,35
2,9
87
)
(890,710,
056)
Loss for the year
(549,
09
7,9
16
)
(421,642,931)
Total
709,612,3
97
1,195,683,464
The Board of Directors proposes that t
he loss carried forward and unrestricted res
erves to be
allocated as follows:
As of December 31,
(in SEK)
2021
2020
Share premium reserve
2,572,925,209
2,509,457,908
Treasury shares
(
1,86
1,
909)
(1,421,457)
Loss carried forward
(1,
861
,
450
,
903
)
(1,312,352,987)
Total
7
09,612
,
397
1,195,683,464
Note
34
Subsequent events
The
subsequent events
for
the Parent Company
are
the same as for the Group, see note
30
for
the Group.
Notes to the Par
ent Company Fina
ncial S
tateme
nts
cont
inued
Hansa Biopharma
Annual Report 202
1
12
2
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Sig
natures
Th
e Board of D
irec
tors an
d the CEO a
rm that th
e con
soli
dated n
anci
al sta
temen
ts have be
en
prepared in
accordance with In
ternational Financial
Repor
ting
Standards (IFRS
) as adop
ted b
y
the EU a
nd give a f
air vi
ew of the Gro
up’
s 
nanc
ial p
ositi
on an
d resul
ts. Th
e annu
al rep
or
t has
be
en pre
pare
d in acc
orda
nce w
ith ge
nera
lly ac
cepte
d acco
unti
ng pri
ncip
les fo
r the Gro
up an
d
the Pa
rent C
ompa
ny and gi
ves a fa
ir over
vi
ew of the d
evelo
pme
nt of the Gr
oup’
s and th
e Paren
t
Co
mpany’s ope
ratio
ns, na
ncia
l posi
tion
s and re
sult
s, and de
scr
ibes m
ateri
al ris
ks and
uncer
taint
ies facing the
Parent
Company and the
companies included in the
Group
.
Lun
d 6 Apr
il 2022
Ulf Wii
nberg
Chairman o
f the B
oard
Hilar
y
Malone
Di
re
ctor
Mats Blom
Di
re
ctor
Andrea
s
Eggert
Di
re
ctor
Eva
Nilsagård
Di
re
ctor
Anders Gersel P
edersen
Di
re
ctor
Søren T
uls
trup
CEO an
d Exe
cuti
ve Pres
ide
nt
Th
e Boar
d of Dire
ctors a
nd CEO a
pprove
d the an
nual re
por
t for p
ubli
cati
on on 6 A
pril 20
22
.
Th
e cons
olid
ated in
come s
tateme
nt, repo
rt o
n comp
rehe
nsi
ve inco
me an
d statem
ent of na
nci
al
pos
itio
n as wel
l as the Pa
rent C
ompa
ny’
s inc
ome st
ateme
nt, repo
rt o
n comp
rehe
nsi
ve inco
me
an
d statem
ent of na
nci
al pos
itio
n will b
e subj
ect to ado
ption at th
e annu
al ge
nera
l mee
ting to be
he
ld on 1
6 Ju
ne 2022.
Ou
r audi
tors’ repo
r
t was sub
mit
ted on 7 A
pril 20
22
.
KPM
G AB
Jonas
Nihlberg
Aut
horize
d Publ
ic Acco
untant
Hansa Biopharma
Annual Report 202
1
12
3
Strateg
y
T
echnology
Grow
th
The share
Directors
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repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Au
di
tor
’
s
Rep
or
t
T
o th
e gen
era
l meeti
ng of the s
hare
hold
ers of H
ans
a Biop
har
ma AB, c
orp. id 556734-5
359
Re
por
t on t
he a
nnu
al ac
cou
nts a
nd co
nso
lid
ate
d acc
oun
ts
Opinions
We have au
dited th
e ann
ual ac
coun
ts and c
onso
lidate
d acc
ounts of H
ansa B
iop
har
ma AB for t
he
yea
r 202
1
. The a
nnu
al acc
ounts a
nd co
nsol
idated a
cco
unts of th
e comp
any are i
nclu
ded o
n
pag
es 58-
66 a
nd 7
6
-
1
22 in th
is do
cume
nt.
In ou
r opin
ion, th
e annu
al ac
coun
ts have be
en pre
pare
d in acc
orda
nce wi
th the A
nnua
l Acco
unts
Act, an
d pres
ent fa
irly,
in a
ll mater
ial re
spe
cts, the 
nan
cial p
osit
ion of the p
aren
t comp
any as of
31
D
ece
mber 20
2
1 and i
ts nan
cia
l per
for
man
ce and c
ash ow fo
r the yea
r then e
nde
d in
acc
orda
nce w
ith the A
nnu
al Acc
ounts Ac
t. The c
onso
lidate
d acc
ounts h
ave bee
n prep
ared i
n
acc
orda
nce w
ith the A
nnua
l Acco
unts Act a
nd pre
sent fa
irl
y
, i
n all mate
rial r
espe
cts, th
e nan
cial
pos
itio
n of the gro
up as of 31 Dece
mbe
r 202
1 an
d thei
r nan
cial p
er
for
manc
e and ca
sh ow fo
r
the y
ear then ended in a
ccordance with Int
ernational Financial Reporting Standards
(IFRS)
, as
ado
pted by the EU, an
d the An
nual A
ccou
nts Act. T
he stat
utor
y admi
nistr
ation r
epor
t i
s
co
nsis
t
e
nt with th
e othe
r par
ts of the a
nnua
l acc
ounts a
nd co
nsol
idated a
ccou
nts.
We ther
efore re
comm
end th
at the g
ene
ral me
eting of s
hare
hol
der
s adopts th
e inc
ome st
ateme
nt
an
d bala
nce s
heet fo
r the pa
rent co
mpa
ny and th
e group.
Ou
r opin
ions i
n this re
por
t on th
e the an
nua
l acco
unts an
d con
soli
dated ac
cou
nts are co
nsi
stent
wi
th the co
ntent of th
e addi
tiona
l repo
r
t that ha
s bee
n subm
itte
d to the par
ent co
mpany’s aud
it
co
mmit
tee in a
ccor
danc
e with t
he Audi
t Reg
ulati
on (537
/201
4) Ar
ti
cle 1
1
.
Basis for
Opinions
We
conducted our
audit in accor
dance with Int
ernational Standards
on Auditing
(ISA) and
generally accepted
auditing standards
in Sweden.
Our responsibilities under t
hose standards
are
further described in t
he Audit
or’
s Responsibilities
section.
W
e are
independent of
the par
ent
co
mpany a
nd the g
roup in a
cco
rdanc
e with p
rofes
sion
al eth
ics for a
cco
unta
nts in Swe
den a
nd
have oth
er
wis
e ful
lled o
ur ethi
cal re
spo
nsib
iliti
es in ac
cord
anc
e with th
ese re
quire
men
ts.
T
his
inc
lud
es that, ba
sed o
n the be
st of our k
nowl
edg
e and b
elie
f
, no pro
hib
ited se
rv
ice
s refer
red to in
the Au
dit R
egul
ation (5
3
7
/201
4) Ar
tic
le 5.
1 hav
e bee
n provid
ed to the a
udite
d comp
any or
, wh
ere
ap
plic
abl
e, its pare
nt co
mpany o
r its co
ntroll
ed co
mpa
nies w
ithi
n the EU.
We bel
ieve that th
e audi
t evid
enc
e we have obta
ined i
s suc
ien
t and ap
propr
iate to prov
ide a
basis for
our opinions.
Key Audit M
atter
s
Key aud
it mat
ters of t
he aud
it are th
ose ma
tter
s that, in ou
r profe
ssio
nal j
udgm
ent, were of m
ost
si
gni
can
ce in ou
r audi
t of
th
e annu
al acc
ounts a
nd co
nsol
idated a
ccou
nts of the cu
rre
nt per
iod.
Th
ese ma
tter
s were add
res
sed in th
e contex
t of our au
dit of, and i
n formi
ng our o
pini
on the
reon,
the a
nnua
l acc
ounts a
nd co
nsol
idated a
ccou
nts as a w
hole, b
ut we do not p
rovid
e a sepa
rate
opinion on t
hese matters.
Reve
nu
e
Se
e disc
losu
re in note 1
3 an
d acco
untin
g pri
ncip
les o
n page
s 82
-8
3 in the a
nnua
l acco
unt an
d
consolidat
ed accoun
ts for
detailed
informat
ion and descrip
tion o
f the
matter
.
De
scr
ip
tio
n of key a
udi
t mat
t
er
Response
in the
audit
Du
ring 20
2
1
, th
e Com
pany re
cogn
ize
co
ntract r
evenu
e in the a
mount of
SEK 1
5.
7 mi
llio
n relate
d to its agre
eme
nt wi
th
Sa
repta T
hera
peu
tics Ltd. T
his re
lates to an
upf
ront pay
ment of U
SD 1
0 mil
lion re
ce
ived in
Jul
y 2020. The r
evenu
e from th
e upfro
nt
pay
ment i
s reco
gnize
d over the p
eri
od wh
en
the
Company
fulls its
performance obliga
tion
under
the a
greement
.
The assessment o
f performance obligat
ions
and allocat
ion of
the up
front
payment
req
uire
s sign
ic
ant kn
owle
dge an
d deta
iled
revi
ew of the c
ontra
ct term
s and
accounting s
tandards.
Th
e Comp
any ha
s prep
ared a b
udge
t of t
ota
l
es
timated h
our
s expec
ted to be use
d for the
fu
lll
ment of th
e obli
gatio
n. The h
ours s
pent
up to ea
ch rep
or
ting d
ate is the
n used to
measure pr
ogress.
The estima
tion of
the
hou
rs ne
ede
d to
f
ull th
e obli
gatio
n requ
ires
management’
s judgment
.
We have rev
iewed th
e agre
eme
nt as to the
ter
ms and th
e per
for
man
ce obl
igati
on ide
nti
ed
by management
.
Th
e revenu
es fr
om Sar
epta Th
era
peu
tics Ltd.
have a
lso be
en ver
ie
d agai
nst upf
ront pay
ment.
We have pe
rf
orme
d a retros
pec
tive rev
iew an
d
compared management’
s estimated
hours, with
the a
ctua
l hour
s spe
nt up unti
l repo
rt
ing date.
Fur
the
remo
re we have by sa
mpl
e trace
d such
hours t
o underlying records.
We
have
also assessed accounting principles
an
d the dis
clo
sures r
elate
d t
o reve
nue
included in the
annual accounts
and
consolidated accounts
.
Other Information than t
he annual accounts and consolidated accounts
Th
is doc
ume
nt als
o conta
ins oth
er info
rmat
ion tha
n the a
nnua
l acco
unts a
nd con
soli
dated
acc
ount
s and is fo
und o
n page
s 2
-57
, 67
-
7
5 an
d 1
27
-
1
55. T
he othe
r infor
matio
n com
pris
es al
so
of the re
mun
erati
on rep
or
t on pag
es 1
4
7
-
1
52
. T
he Boa
rd of Dire
ctor
s and th
e Mana
ging D
irec
tor
are r
esponsible for
this
other i
nformat
ion.
Ou
r opin
ion on t
he ann
ual ac
cou
nts and c
onso
lid
ated acc
ounts d
oes n
ot cover t
his othe
r
info
rmat
ion an
d we do not exp
ress a
ny form of a
ssur
ance c
onc
lusi
on reg
ardin
g this
other
informa
tion.
In connect
ion with
our audit
of t
he annual accou
nts and
consolidat
ed account
s, our
responsibility
is to rea
d the info
rmati
on id
enti
ed ab
ove and co
nsid
er wh
ethe
r the info
rmati
on is mate
ria
lly
inc
ons
istent w
ith th
e annu
al acc
ounts a
nd co
nsol
idate
d acco
unts.
T
ranslation from the
Swedish o
riginal
Hansa Biopharma
Annual Report 202
1
12
4
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
In th
is proc
edu
re we als
o take into ac
cou
nt our k
nowle
dge ot
her
wis
e obta
ined i
n the au
dit an
d
assess whether
the in
formation
otherwise appears t
o be
mat
erially misstat
ed.
If we, ba
sed on t
he wor
k per
for
med c
once
rni
ng thi
s infor
matio
n, conc
lud
e that the
re is a mate
ria
l
mis
state
ment of th
is othe
r infor
mati
on, we are re
quir
ed to repo
rt t
hat fac
t. W
e have n
othing to
rep
or
t in thi
s rega
rd.
Res
pons
ibilit
ies of the B
oard of D
irec
tors a
nd the Ma
nagin
g Dire
ctor
Th
e Boar
d of Dire
ctors a
nd the M
anag
ing Di
recto
r are res
pon
sibl
e for the p
repa
ratio
n of the
an
nual a
ccou
nts an
d cons
olid
ated acc
ount
s and th
at they gi
ve a fair p
rese
ntati
on in ac
cord
anc
e
wi
th the An
nua
l Accou
nts Act a
nd, con
cer
ning t
he con
soli
dated a
ccou
nts, in ac
cord
anc
e with
IFR
S as ado
pted by the EU. Th
e Board o
f Dire
ctors a
nd the M
anag
ing Di
recto
r are als
o
responsible
for such
internal
control
as the
y det
ermine is
necessar
y t
o enable
the prepar
ation o
f
an
nual a
ccou
nts an
d cons
olid
ated acc
ount
s that are f
ree f
rom mate
rial m
iss
tateme
nt, whet
her
du
e t
o fr
aud or e
rror
.
In pr
epar
ing th
e ann
ual ac
coun
ts and c
onso
lidate
d acc
ounts T
he Boa
rd of Dir
ector
s and th
e
Ma
nagi
ng Dire
ctor a
re resp
onsi
ble fo
r the as
ses
smen
t of the co
mpany
’
s a
nd the g
roup’
s abi
lit
y to
co
ntinu
e as a goi
ng co
ncer
n. The
y disc
lose, a
s appl
ica
ble, mat
ters r
elate
d t
o go
ing c
once
rn an
d
using the
going concern basis of
accounting.
The going concern basis o
f accounting
is how
ever
not a
ppli
ed if th
e Boar
d of Dire
ctors a
nd the M
anag
ing Di
recto
r intend to l
iqui
date the c
ompa
ny
,
to cea
se op
erati
ons, or h
as no re
alis
tic al
tern
ative bu
t to do so.
The Audit
Committee shall
, wit
hout prejudice
to
the Boar
d of
Direct
or’
s r
esponsibilities
and tasks
in ge
ner
al, amo
ng othe
r thing
s overs
ee the c
ompa
ny’
s na
ncia
l repo
r
ting pro
ces
s.
Audit
or’
s responsibility
Ou
r obje
ctive
s are to obt
ain re
ason
abl
e assu
ranc
e abo
ut whe
ther th
e ann
ual ac
coun
ts and
co
nsol
idated a
cco
unts as a w
hole a
re fre
e from m
ateri
al mis
state
ment, wh
ethe
r due to fr
aud or
er
ror
, a
nd to is
sue an a
udito
r’
s r
epor
t th
at incl
ude
s our op
ini
ons. Re
aso
nabl
e ass
uran
ce is a hi
gh
leve
l of ass
uran
ce, but i
s not a gua
rante
e that an a
udi
t cond
ucted i
n acco
rdan
ce wi
th ISAs a
nd
ge
nera
lly a
ccepte
d audi
ting s
tand
ards i
n Swede
n wil
l always d
etect a m
ateri
al mis
statem
ent
wh
en it exi
sts. Mi
sstate
ments c
an ar
ise f
rom fra
ud or er
ror an
d are co
nsid
ered m
ateri
al if,
ind
ivi
dual
ly or in t
he agg
regate, th
ey coul
d reas
onab
ly be exp
ecte
d t
o in
uen
ce the e
con
omic
de
cisi
ons of u
sers t
aken o
n the bas
is of the
se an
nual a
cco
unts an
d cons
olid
ated ac
coun
ts.
As pa
r
t of an audi
t in acc
orda
nce wi
th ISAs, we exe
rcise p
rofes
sion
al jud
gme
nt and ma
inta
in
profe
ssi
ona
l scepti
cis
m throu
ghou
t the aud
it. We also:
>
Ide
ntif
y an
d ass
ess th
e ris
ks of mater
ial m
isst
ateme
nt of the an
nua
l acco
unts an
d
co
nsol
idated a
cco
unts, wh
ether d
ue to fra
ud or e
rror
, de
sign a
nd pe
rfo
rm au
dit pro
ced
ures
res
pon
sive to tho
se ris
ks, an
d obtai
n audi
t evid
enc
e that is s
uf
fic
ient a
nd ap
propr
iate to
prov
ide a ba
sis fo
r our op
inio
ns. Th
e ris
k of not dete
cting a m
ateri
al mi
sstate
ment re
sul
ting
fro
m frau
d is hig
her t
han for o
ne res
ulti
ng fro
m erro
r
, as f
raud m
ay invol
ve coll
usi
on, forge
r
y
,
int
entional omi
ssions, misr
epresentat
ions, or
the o
verride o
f int
ernal contr
ol.
>
Obt
ain an u
nde
rsta
ndin
g of the co
mpa
ny’
s i
ntern
al co
ntrol re
levan
t t
o ou
r audi
t in ord
er to
de
sign a
udit p
roce
dure
s that a
re appr
opri
ate in the c
ircum
stan
ces, b
ut not fo
r the pur
pos
e of
exp
ress
ing an o
pin
ion on th
e ef
fecti
vene
ss of th
e comp
any’
s in
t
e
rnal c
ontro
l.
>
Evalu
ate
the appr
opriateness o
f accoun
ting policies
used and t
he reasonableness
of
acc
ount
ing es
timate
s and re
lated di
scl
osure
s made by t
he Boa
rd of Dire
ctor
s and the
Managing Direct
or
.
>
Co
nclu
de on th
e appr
opri
atene
ss of the B
oard of D
irec
tors’ and t
he Man
agin
g Dire
ctor’s, use
of the g
oing c
onc
ern b
asis of a
cco
untin
g in prep
ari
ng the a
nnua
l acco
unts a
nd con
soli
dated
acc
ount
s. W
e al
so draw a c
onc
lusi
on, bas
ed on th
e audi
t evid
enc
e obtai
ned, a
s t
o wh
ethe
r
any m
ateri
al unc
er
tai
nty ex
ists re
lated to eve
nts or co
ndit
ions t
hat may ca
st si
gnif
ica
nt dou
bt
on th
e comp
any’
s a
nd the gro
up’
s a
bil
ity to c
ontin
ue as a go
ing c
once
rn. If we c
oncl
ude th
at a
mate
rial u
nce
rt
aint
y exi
sts, we are re
quir
ed to draw at
tenti
on in ou
r audi
tor’
s rep
or
t to the
rel
ated di
sclo
sure
s in the a
nnua
l acco
unts a
nd con
soli
dated ac
cou
nts or
, if su
ch dis
clos
ures
are i
nade
quate, to mo
dif
y our o
pini
on ab
out th
e annu
al acc
ount
s and co
nsol
idate
d acco
unts.
Ou
r conc
lusi
ons a
re base
d on the a
udi
t evid
ence o
btai
ned up to th
e date of our a
udito
r’
s
rep
or
t. However
, fu
ture eve
nts or c
ondi
tion
s may cau
se a com
pany a
nd a grou
p to ceas
e to
continue
as a goi
ng concern.
>
Eval
uate the ove
rall p
rese
ntati
on, stru
ctur
e and co
ntent of th
e annu
al acc
ount
s and
consolidated
accounts,
including the disclosur
es, and whet
her the annual a
ccounts and
co
nsol
idated a
cco
unts rep
rese
nt the u
nder
lyi
ng tra
nsac
tion
s and eve
nts in a ma
nne
r that
achiev
es fair pr
esentation
.
>
Obt
ain su
ff
ici
ent a
nd app
ropr
iate aud
it evi
den
ce reg
ardin
g the f
inan
cia
l infor
matio
n of the
ent
itie
s or bus
ine
ss acti
viti
es wi
thin th
e grou
p t
o exp
res
s an opi
nio
n on the co
nso
lidate
d
acc
ount
s. W
e ar
e resp
onsi
ble fo
r the dir
ecti
on, sup
er
vis
ion an
d per
for
man
ce of the g
roup
audit
. W
e remain
solely responsible
for our
opinions.
We must i
nfor
m the Boa
rd of Dir
ector
s of
, am
ong othe
r mat
ters, th
e pla
nned s
cop
e and tim
ing of
the a
udit. We mus
t also i
nform of s
igni
ca
nt audi
t ndi
ngs du
ring o
ur aud
it, inc
ludi
ng any
si
gni
cant d
eci
enc
ies in i
ntern
al con
trol that we i
dent
ied.
We must a
lso p
rovide t
he Boa
rd of Dire
ctor
s with a st
ateme
nt that we h
ave comp
lie
d with
rel
evant et
hica
l requ
irem
ents re
gard
ing in
dep
ende
nce, a
nd to com
muni
cate wit
h them a
ll
rel
ation
shi
ps and oth
er mat
ters t
hat may re
ason
abl
y be tho
ught to be
ar on o
ur ind
epe
nde
nce,
an
d wher
e appl
ica
ble, me
asur
es that h
ave bee
n take
n t
o el
imin
ate the thr
eats or r
elate
d
safeguards.
From th
e mat
t
e
rs com
muni
cated w
ith the B
oard of D
irec
tors, we d
etermi
ne tho
se mat
ters th
at
were of m
ost si
gni
can
ce in the a
udit of th
e annu
al ac
count
s and co
nsol
idate
d acco
unts,
inc
lud
ing the m
ost im
por
ta
nt ass
esse
d ris
ks for ma
teria
l mis
statem
ent, an
d are the
refore th
e key
aud
it mat
ters. We d
escr
ibe th
ese m
atter
s in the a
udito
r’
s repo
r
t unle
ss law o
r regu
latio
n
precludes disclosur
e about the
matter
.
Aud
itor
’
s Rep
or
t
cont
inued
T
ranslation from the
Swedish o
riginal
Hansa Biopharma
Annual Report 202
1
12
5
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Report on
other legal
and regulato
r
y
requirements
Auditor’
s audit
of
the administration and
the proposed
appropriations of
pr
ot o
r loss
Opinions
In ad
diti
on to our au
dit of th
e annu
al ac
count
s and co
nso
lidate
d acco
unts, we h
ave also a
udite
d
the a
dmin
istrati
on of the B
oard of D
irec
tors an
d the Ma
nagi
ng Di
rector of H
ans
a Biop
har
ma AB
for th
e year 2021 and t
he prop
osed a
ppro
pri
ation
s of the com
pany’s prot or l
oss.
We reco
mme
nd to the ge
nera
l meet
ing of sh
areh
olde
rs tha
t the pro
t be app
ropr
iated in
acc
orda
nce w
ith the p
ropo
sal in t
he statu
tor
y admi
nistr
ation r
epor
t a
nd that th
e mem
bers of t
he
Boa
rd of Dire
ctor
s and the M
anag
ing Di
recto
r be disc
harg
ed fro
m lia
bili
ty for th
e na
ncia
l year
.
Basis for
Opinions
We con
ducte
d the au
dit in ac
cord
anc
e with g
ene
rall
y acce
pted au
ditin
g stan
dard
s in Swe
den.
Our responsi
bilities under
those s
tandards ar
e further described in
the Audit
or’
s Responsibilit
ies
se
ctio
n. W
e are i
nde
pend
ent of th
e pare
nt com
pany a
nd the gr
oup in a
ccord
anc
e with
profe
ssi
ona
l ethic
s for acc
ount
ants in S
wede
n and have oth
er
wis
e ful
lle
d our ethi
cal
responsibilit
ies in accor
dance with
these r
equirements.
We bel
ieve that th
e audi
t evid
enc
e we have obta
ined i
s suc
ien
t and ap
propr
iate to prov
ide a
basis for
our opinions.
Res
pons
ibilit
ies of the B
oard of D
irec
tors a
nd the Ma
nagin
g Dire
ctor
Th
e Board of D
irec
tors is re
spo
nsib
le for th
e propo
sal fo
r appro
pri
ation
s of the co
mpany’s prot
or l
oss. At th
e propo
sal of a d
ivid
end, th
is inc
lud
es an a
sse
ssme
nt of wh
ether th
e div
ide
nd is
jus
tia
ble co
nsi
deri
ng the re
quir
eme
nts whi
ch the co
mpa
ny’
s and th
e group’
s t
ype of op
erati
ons,
size a
nd ri
sks pl
ace on t
he size of th
e pare
nt com
pany’s and th
e group’
s eq
uit
y
, c
ons
olid
ation
requirements,
liquidit
y
and position in general.
Th
e Boar
d of Dire
ctors i
s resp
onsi
ble fo
r the co
mpany’s orga
niz
ation a
nd the ad
mini
strati
on of
the c
ompa
ny’
s aai
rs. Th
is inc
lude
s amo
ng othe
r thing
s conti
nuou
s ass
ess
ment of th
e
co
mpany’s and th
e group’
s n
anci
al sit
uatio
n and en
sur
ing tha
t the com
pany’s orga
nizat
ion is
de
sign
ed so th
at the ac
count
ing, ma
nage
ment of a
ssets a
nd the c
ompa
ny’
s na
ncia
l aai
rs
othe
rw
ise a
re cont
rolle
d in a rea
ssu
ring m
ann
er
.
The Managing Direct
or shall manage
the ongoing administ
ration accor
ding to
the Board
of
Directors
’ guidelines and in
structions and among
other matt
ers take measur
es that ar
e
ne
ces
sar
y to ful
ll th
e comp
any’
s ac
count
ing in ac
cord
anc
e with law a
nd ha
ndle th
e
management of
assets in a
reassuring manner
.
Audit
or’
s responsibility
Our objective
concerning the audit o
f the a
dministration
, and ther
eby our opinion
about discharge
fro
m liab
ili
ty
, is to obt
ain au
dit ev
iden
ce to as
sess w
ith a re
ason
abl
e degr
ee of as
sura
nce wh
ethe
r
any me
mbe
r of
the B
oard of Dir
ector
s or the Man
agin
g Dire
ctor in any mate
ria
l
re
spe
ct:
>
ha
s unde
rt
aken a
ny actio
n or be
en gu
ilt
y of any om
issi
on wh
ich ca
n give r
ise to li
abil
it
y t
o th
e
company
, or
>
in a
ny other way h
as acte
d in con
traventi
on of the C
omp
anie
s Act, the A
nnu
al Acc
ounts Ac
t or
the Articles o
f Associat
ion.
Ou
r obje
ctive c
onc
erni
ng the au
dit of th
e propo
sed a
pprop
riat
ions of th
e comp
any’
s pro
t or
lo
ss, and t
here
by our op
inio
n abo
ut thi
s, is to ass
ess w
ith rea
sona
ble d
egre
e of ass
uran
ce
wh
ether t
he prop
osa
l is in ac
cord
ance w
ith th
e Comp
anie
s Act.
Re
ason
able a
ssu
ranc
e is a hi
gh leve
l of assu
ranc
e, but is n
ot a gua
rante
e that an a
udit
co
nduc
ted in ac
cord
ance w
ith ge
ner
ally a
cce
pted aud
iting s
tan
dards i
n Swed
en wil
l alway
s
dete
ct acti
ons o
r omis
sio
ns that c
an giv
e rise to li
abi
lit
y to the com
pany
, or t
hat the p
ropos
ed
ap
propr
iati
ons of the c
ompa
ny’
s pro
t or los
s are not in a
ccord
anc
e with th
e Comp
ani
es Act.
As pa
r
t of an aud
it in ac
cord
anc
e with g
ene
rall
y acce
pted aud
itin
g stan
dard
s in Swed
en, we
exerc
ise profe
ssi
ona
l judg
ment a
nd mai
ntai
n profes
sion
al sc
eptic
ism thro
ugh
out the a
udit. T
he
exam
inati
on of the ad
mini
strati
on an
d the prop
ose
d appro
pri
ation
s of the com
pany’s prot o
r
lo
ss is ba
sed pr
ima
ril
y on the au
dit of th
e acc
ounts. Ad
diti
onal a
udi
t proce
dure
s per
for
med a
re
bas
ed on o
ur profe
ssi
onal j
udgm
ent w
ith sta
rt
ing po
int in r
isk a
nd mater
ial
ity. This m
ean
s that
we foc
us the exa
minat
ion on s
uch ac
tions, a
reas a
nd rel
ation
ship
s that are m
ateri
al for th
e
operations
and where
deviation
s and viola
tions w
ould hav
e particular importance f
or the
co
mpany’s situ
ation. We exa
mine a
nd test d
ecis
ion
s unde
rt
aken, su
ppor
t fo
r deci
sio
ns, acti
ons
ta
k
e
n and oth
er circ
umst
anc
es that a
re rele
vant to our o
pin
ion co
nce
rnin
g disc
harg
e from
lia
bil
ity. As a bas
is for ou
r opi
nion o
n the Bo
ard of Di
rector
s’ propo
sed ap
prop
riati
ons of th
e
co
mpany’s prot o
r loss we ex
amin
ed wh
ether th
e prop
osal i
s in acc
orda
nce wi
th the
Companies Act
.
The auditor’s
examination o
f the Esef report
Opinion
In ad
diti
on to our au
dit of th
e annu
al ac
count
s and co
nso
lidate
d acco
unts, we h
ave also
exam
ine
d that the B
oard of Di
recto
rs and th
e Man
agin
g Dire
ctor have pre
pare
d the an
nual
acc
ount
s and co
nsol
idate
d acco
unts in a fo
rmat t
hat en
able
s uni
form e
lec
troni
c repo
rti
ng (the
Ese
f repor
t) pu
rsua
nt to Chapte
r 1
6, S
ecti
on 4(a) of the Swe
dis
h Secu
riti
es Ma
rket Act (20
0
7
:528)
for H
ansa B
iop
har
ma AB for ye
ar 2021
.
Ou
r exami
natio
n and ou
r opin
ion re
late onl
y t
o th
e statuto
ry re
quir
eme
nts.
In ou
r opin
ion, th
e Esef re
por
t #
[checksu
m]
has be
en pre
pare
d in a for
mat that, i
n all mate
ria
l
respects
, enables unif
orm electronic
reporting.
Aud
itor
’
s Rep
or
t
cont
inued
T
ranslation from the
Swedish o
riginal
Hansa Biopharma
Annual Report 202
1
12
6
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
Basis for opin
ion
We have pe
rfo
rme
d the exam
inati
on in ac
cord
ance w
ith FAR’
s rec
omme
ndati
on Rev
R 1
8
E
xami
natio
n of the Esef r
epor
t. Ou
r resp
onsi
bili
ty un
der th
is rec
omme
ndat
ion is d
escr
ibe
d in
mo
re deta
il in the A
uditor
s’ resp
onsi
bili
ty se
ctio
n. We are ind
epe
nde
nt of Han
sa Bio
pha
rma A
B in
acc
orda
nce w
ith profe
ssi
onal et
hic
s for acc
ounta
nts in Swe
den a
nd have oth
er
wise f
ul
lled o
ur
ethical
responsibilities
in accor
dance with
these requir
ements.
We bel
ieve that th
e evid
enc
e we have obta
ine
d is su
cien
t and ap
prop
riate to prov
ide a ba
sis for
our opinion.
Res
pons
ibilit
ies of the B
oard of D
irec
tors a
nd the Ma
nagin
g Dire
ctor
Th
e Boar
d of Dire
ctors a
nd the M
anag
ing Di
recto
r are res
pon
sibl
e for the p
repa
ratio
n of the Ese
f
rep
or
t in ac
corda
nce w
ith the C
hapter 16, Sec
tion 4(a) of th
e Swed
ish Se
cur
itie
s Mar
ket Act
(2007
:528)
, and fo
r suc
h intern
al co
ntrol tha
t the Boa
rd of Dire
ctors a
nd the M
anag
ing Di
rector
dete
rmin
e is ne
ces
sar
y to pre
pare th
e Esef re
por
t wi
thou
t mater
ial mi
ssta
t
e
ments, w
heth
er due
to fra
ud or er
ror
.
Audit
or’
s responsibility
Our responsi
bility is t
o obt
ain reasonable
assurance whet
her the
Esef r
epor
t
is in al
l mat
erial
res
pec
ts prep
ared i
n a form
at that me
ets the r
equi
reme
nts of Cha
pter 1
6, Se
ctio
n 4(a) of the
Swe
dish S
ecur
iti
es Mar
ket Act (2007
:528)
, ba
sed on th
e proc
edur
es per
fo
rme
d.
Rev
R 1
8 re
quire
s us to pla
n and exec
ute proc
edur
es to achi
eve reas
ona
ble as
sura
nce th
at the
Ese
f repo
rt i
s prep
ared i
n a forma
t that me
ets the
se req
uire
ments.
Re
ason
able a
ssu
ranc
e is a hi
gh leve
l of assu
ranc
e, but i
t is not a gu
aran
tee that a
n enga
gem
ent
ca
rri
ed ou
t acco
rding to R
evR 1
8 and g
ene
rall
y acc
epted au
ditin
g stan
dard
s in Swe
den wi
ll
al
ways detec
t a materi
al mi
sstate
ment w
hen i
t exists. M
isst
ateme
nts ca
n aris
e from f
raud or e
rror
an
d are con
sid
ered ma
teria
l if, indi
vidu
all
y or in agg
reg
ate
, th
ey coul
d reas
onab
ly be ex
pecte
d to
in
uen
ce the e
cono
mic de
cis
ions of u
ser
s taken o
n the bas
is of the Es
ef repo
rt.
Th
e audi
t rm ap
pli
es ISQC 1 Q
ual
ity C
ontro
l for Fir
ms that Pe
rfo
rm Aud
its an
d Revie
ws of
Financial Stat
ements, and
other Assurance and
Related Services Engagements and accor
dingly
maintains
a comprehensiv
e sys
tem o
f quality cont
rol,
including
documented
policies and
procedures
regarding
compliance with
prof
essional eth
ical requiremen
ts,
professional
standards
an
d lega
l and re
gul
ator
y requ
irem
ents.
Th
e exami
natio
n invol
ves obta
inin
g evid
enc
e,
th
rough va
rio
us proc
edu
res, tha
t the Esef re
por
t
ha
s bee
n prepa
red in a f
orma
t that en
able
s uni
form e
lec
troni
c repo
rti
ng of the a
nnua
l acc
ounts
an
d cons
olid
ated ac
count
s. The p
roce
dure
s sele
cted d
epe
nd on th
e audi
t
or
’
s j
udgm
ent,
inc
lud
ing the a
sse
ssm
ent of the r
isk
s of materi
al mi
sstate
ment i
n the re
por
t, whet
her du
e to frau
d
or e
rror
. In ca
rr
yi
ng out th
is ri
sk as
sess
men
t
, an
d in ord
er to des
ign p
roce
dure
s that are
ap
propr
iate in th
e circ
umsta
nce
s, the au
ditor c
onsi
der
s those e
lem
ents of i
ntern
al co
ntrol tha
t
are re
leva
nt to the pre
para
tion of th
e Esef re
por
t by the B
oard of D
irec
t
or
s and th
e Man
agin
g
Di
rector
, bu
t not for the p
urpo
se of exp
ress
ing an o
pini
on on th
e eecti
vene
ss of tho
se inter
nal
contr
ols. The
examina
tion also
includes an
evalua
tion o
f t
he appropria
teness and
reasonableness
of the a
ssu
mption
s made by t
he Boa
rd of Dire
ctors a
nd the M
ana
ging D
irec
tor
.
Th
e proc
edure
s mai
nly in
clud
e a techn
ica
l valid
ation of t
he Esef re
por
t, i.e. if the l
e cont
aini
ng
the Es
ef rep
or
t meets th
e tech
nica
l spe
cic
atio
n set out i
n the Co
mmis
sion’
s De
leg
ated
Re
gulat
ion (EU
) 20
1
9/81
5 an
d a reco
nci
liati
on of the Es
ef rep
or
t with th
e audi
ted an
nual a
ccou
nts
and consolidated
accounts.
Fur
the
rmo
re, the pro
cedu
res al
so in
clud
e an as
ses
smen
t of wheth
er the E
sef rep
or
t has b
een
marked
with iXBRL which
enables a
fair and
complete
machine-readable
version o
f the
co
nsol
idated s
tateme
nt of na
ncia
l per
for
man
ce, na
ncia
l pos
itio
n,
ch
ang
es in eq
uit
y and
ca
sh ow
.
KPM
G AB, Box 227
, 20
1 22 , Ma
lmö, was ap
poin
ted aud
itor of Han
sa Bi
opha
rma A
B by
th
e
ge
nera
l mee
ting of th
e shar
ehol
der
s on the 1
2 May 20
2
1
. K
PMG AB o
r audi
tors op
erati
ng at
KPM
G AB have b
een th
e comp
any’
s au
ditor s
ince 201
4.
Ma
lmö Ap
ril 7
, 20
22
KPM
G AB
Jonas
Nihlberg
Aut
horize
d Publ
ic Acco
untant
Aud
itor
’
s Rep
or
t
cont
inued
T
ranslation from the
Swedish o
riginal
Hansa Biopharma
Annual Report 202
1
12
7
10
Go
v
ernan
ce
Genera
l
principles
1
29
The B
oar
d
1
3
3
Executive management
1
38
Inte
rna
l cont
rols a
nd ri
sk ma
nage
ment
in r
espe
ct of th
e nan
cial r
epo
rt
ing
1
4
1
Compliance 1
4
3
Aud
itor st
ateme
nt on th
e cor
por
ate
gov
ernance repor
t
1
44
Hansa Biopharma
Annual Report 202
1
12
7
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Introduct
ion
Th
e Boa
rd of D
ire
cto
rs of H
an
sa Bi
oph
arm
a AB (
pub
l) (t
he “
Boar
d”
),
Com
pa
ny reg
. no. 5
567
34
-5
3
59 (“
Han
sa” o
r th
e “Com
pany
”) h
er
eby
su
bmi
ts t
he 2
021 Co
rpo
ra
te Gove
rna
nce R
epo
rt i
n acc
ord
an
ce wi
th
th
e re
qui
rem
ent
s of t
he S
wedi
sh A
nnu
al Acc
oun
ts Ac
t (1
9
95:155
4)
(Sw
. årsredo
visningslagen)
and the
Swedish Co
de of
Corporate Go
vernance
(t
he “C
ode”; se
e th
e Swe
dis
h Cor
por
ate G
over
nan
ce Bo
ard we
bs
ite at
htt
ps:/
/w
ww.bolagsst
yrning.s
e
/
).
Th
e Comp
any’
s sh
are
s were adm
itte
d for trad
ing o
n Nasd
aq Stock
hol
m in Nove
mber 201
5. Th
e
Co
mpany’s sha
res wer
e previ
ousl
y
, s
ince 20
07
, l
isted o
n Nasd
aq Fir
st Nor
th. T
he Co
mpany’s
co
rpor
ate gover
nan
ce is ma
inly r
egul
ated by the p
rovis
ion
s of the Co
mpany’s ar
ticl
es of
as
soci
ation, th
e Swedi
sh Com
pani
es Act (200
5
:55
1
) (Sw.
ak
ti
ebol
agsl
age
n)
an
d other Swe
dish
legislation
, the
Nordic
Main Marke
t Rulebook f
or Issuers
of Shar
es and the
Code.
Th
e Cor
porate G
overn
anc
e Repo
rt h
as be
en rev
iewed by th
e Com
pany’s audi
t
or
s in acc
orda
nce
wi
th the Swe
dish A
nnu
al Acc
ounts A
ct. It doe
s not co
nstit
ute a par
t of the f
orma
l ann
ual
report documents.
Th
e Grou
p comp
ris
es the Pa
rent C
ompa
ny
, Ha
nsa B
iop
harm
a AB, an
d its wh
olly ow
ned
sub
sidi
ari
es Car
tel
a R
& D AB, Han
sa Bio
pha
rma Ltd, Hans
a Bio
phar
ma Inc, an
d
Ha
nsa
Bi
opha
rma Au
stral
ia P
ty Ltd.
Th
ere are n
o devi
ation
s from th
e Code to re
por
t for th
e nan
cia
l year 2021
. N
o infr
inge
ment
s of
Na
sdaq’
s ru
les a
nd no br
each of g
ood p
racti
ce on th
e secu
riti
es ma
rket were r
epor
te
d by the
stoc
k ex
ch
ang
e
’
s di
scip
lina
ry c
omm
itte
e or the Swe
dis
h Secu
riti
es Co
unci
l duri
ng the n
anc
ial
yea
r 202
1
.
Shareholders
Th
ere ar
e no limi
tati
ons on th
e tran
sfera
bili
ty of H
ansa B
iop
har
ma’
s s
hare
s due to le
gal
restrict
ions or pr
ovisions
of t
he articles of
association
. T
o Hansa
Biopharma’
s knowledge
, no
agreement
has been ent
ered in
to
between any
shareholders which
might
lim
it the tr
ansf
erab
ilit
y of the s
hare
s. As of De
cem
ber 31
, 2021
, R
edmi
le
Gro
up LLC is th
e only s
hare
hold
er own
ing mo
re tha
n 1
0 p
erce
nt of the
Company’
s shares, b
y its
shareholdings of 1
3 percent.
Si
gni
c
ant ex
ter
na
l and in
ter
na
l reg
ula
tio
ns an
d poli
cie
s
wh
ich a
ec
t cor
por
ate g
overn
anc
e:
Signicant int
ernal regulations
and po
licies:
>
Ar
t
icles of
association
>
Instruction f
or the
CEO
, including t
he financial reporting instruction
>
Work
procedures f
or the
Board
>
Disclosure policy
>
Insider polic
y
>
Proc
urem
ent an
d expe
ndit
ure po
licy
>
T
reasury policy
>
Finance policy
>
Risk management
policy
>
Financial handbook
>
Staff handbook
>
Executive
remunerat
ion policy
>
Co
de of Con
duc
t
>
Supplier Code
>
Global Da
ta Priva
cy policy
>
Informa
tion polic
y
Signicant e
xternal regulations
>
Market
Abuse Regula
tion
>
Swedish Companies
Act
>
Swedish Accoun
ting Act
>
Swedish Annual
Accounts
Act
>
Int
ernational standards f
or audits and
financial repor
ting
(IFRS
)
>
No
rdic Ma
in Ma
rket Rul
ebo
ok for Is
sue
rs of Sh
ares
>
Swe
dish C
ode of C
orp
orate Gove
rna
nce
Gener
al principles
Hansa Biopharma
Annual Report 202
1
12
8
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Informatio
n regarding
Hansa Bio
pharma AB
shares
Th
e sha
res in th
e Comp
any are d
ivi
ded i
nto ordin
ar
y sha
res an
d C-sh
ares. O
n Dec
emb
er 31
, 2021
,
the tota
l numb
er of sh
ares i
ssu
ed was 46,3
35,361 with 4
4
,4
73,
452 ord
inar
y s
hare
s outst
and
ing an
d
1
,8
6
1
,909 C
-sha
res, wi
th a quot
ient va
lue of SE
K 1
. Eac
h ordi
nar
y sh
are ca
rri
es on
e vote and ea
ch
C-s
hare c
arr
ies o
ne tenth. A
ll C-s
hare
s are own
ed by the C
omp
any
. Eac
h per
son en
title
d to vot
e
may vote for h
is or h
er ful
l numb
er of sh
ares
.
Eac
h ordi
nar
y sh
are co
nfers t
he rig
ht to an eq
uall
y larg
e perc
ent
age of the C
omp
any’
s
dis
trib
utab
le pro
ts. The C
-sha
res do n
ot entitl
e to divi
den
ds and a
re subj
ect to a red
empti
on
and r
eclassication claus
e.
General meeting
The Company
’
s h
ighest decision-making
body is t
he general meet
ing,
where the
shareholders
’
in
uen
ce over th
e Comp
any is exerc
ised. I
n addi
tion to wha
t follow
s from ap
pli
cabl
e law
regarding shareholders
’ right t
o participate
at general meet
ings, shareholders who wish
to par
tic
ipate at a ge
ner
al me
eting, pe
rso
nall
y or thro
ugh a prox
y mus
t give not
ice of
their attendance
.
Noti
ces to at
tend g
ene
ral me
eting
s are gi
ven thr
ough a
dver
tis
eme
nt as wel
l as on th
e Comp
any’
s
website
(ww
w
.hansabiopharma.com
).
The annual general meeting
(“
AGM”) must
be held within
si
x month
s from th
e clos
e of the na
ncia
l year
. At the AGM, th
e sha
reho
lder
s adopt r
esol
utio
ns
reg
ardi
ng, amo
ng othe
r thing
s:
th
e Board a
nd aud
itors; th
e proce
dure fo
r appo
intin
g the
no
minati
on co
mmit
tee; an
d disc
harg
e from l
iabi
lit
y for the B
oard a
nd the C
EO in res
pec
t of the
preceding y
ear
. Resolutions
are also
adopt
ed regar
ding adop
tion o
f the
annual report;
disposition
of pro
ts or trea
tment of l
osse
s; fees fo
r the dir
ector
s and au
ditor
s
; an
d, if app
lic
able, gu
ide
line
s
for re
mune
rati
on to seni
or execu
tive
s.
2
021 A
nnu
al Ge
ne
ral M
eet
ing
Th
e 202
1 AGM wa
s held o
n May 1
2
, wi
th par
ti
cipati
on thr
ough ad
vanc
e voting a
cco
rding to
se
ctio
ns 20 and 22 in t
he Act on te
mpor
ar
y exemptio
ns in or
der to fac
ilit
ate the con
duct
ion of
ge
nera
l meeti
ngs (Sw
. lag (2020:
1
98) om till
fäl
liga un
dant
ag för att und
erl
ätt
a
ge
nomf
öran
det av
bo
lags- o
ch före
nin
gsst
ämmo
r)
. In tota
l, 20 439 93
0 of the sh
ares i
n the Co
mpany we
re
rep
rese
nted, me
anin
g that 45.81 per
cent of th
e total nu
mbe
r of votes and 4
4
.54 p
erce
nt of the
total n
umbe
r of sha
res in th
e Com
pany wer
e repre
sente
d.
Hansa
’
s corp
orate
gov
ernance
structure
Over
vi
ew of Hans
a
’
s co
rpo
rate govern
ance s
truc
ture dur
ing 2021
Board of D
irec
tors
E
xec
uti
ve
Co
mmi
tte
e
E
xte
rn
al
auditors
Nomi
nation
Co
mmi
tte
e
Ris
k
Management
Compliance
General
Meeting
Electing /
Appointing
Reporting / Informing
General principles
cont
inued
Audi
t
Co
mmi
tte
e
Remuneration
Co
mmi
tte
e
Scientic
Co
mmi
tte
e
U.S
.
Co
mmi
tte
e
Hansa Biopharma
Annual Report 202
1
12
9
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Th
e AGM adopte
d the 2020 a
nnua
l acco
unts, ad
opted a re
solu
tion r
egar
ding th
at the me
mbe
rs
of the B
oard sh
all be s
ix wi
th no dep
ut
y memb
ers, a
nd gra
nted the di
recto
rs and C
EO a
dis
cha
rge fro
m lia
bili
ty
. Th
e gen
era
l meeti
ng res
olve
d that no d
ivid
end wo
uld be p
aid. T
he AGM
res
olve
d that Ul
f Wiin
berg, A
nde
rs Ge
rse
l Pede
rse
n, Andr
eas Eg
ger
t, Eva Nil
sagå
rd and M
ats
Blom are
re-elected
as members o
f the
Board,
and resolv
ed election
of Hilary Malone
as new
me
mber of t
he Boa
rd, all for th
e per
iod un
til the e
nd of the nex
t AGM. Bi
rgit St
atti
n Nori
nde
r
,
prev
iou
s memb
er of th
e Board u
ntil th
e end of th
e A
GM 20
2
1
, wa
s not sta
ndin
g for re-
ele
ctio
n.
Th
e AGM fur
th
er res
olve
d t
o re
-el
ect Ul
f Wii
nber
g as cha
irm
an of the B
oard fo
r the pe
riod u
ntil
the e
nd of the nex
t AGM. T
he AGM reso
lved to re
-el
ect K
PMG AB as a
uditor
, wi
th Jona
s Nihl
berg
as th
e audi
t
or i
n char
ge, for the p
eri
od unti
l the en
d of the nex
t AGM.
Th
e A
GM r
esol
ved tha
t the fee
s for the Bo
ard, for th
e per
iod un
til the e
nd of the nex
t AGM,
sh
ould re
mai
n unch
ang
ed fro
m the prev
iou
s year a
nd sha
ll be SE
K 900,00
0 to the ch
air
man of
Th
e Boar
d and SEK 3
00,00
0 eac
h t
o th
e other B
oard m
embe
rs. It wa
s fur
the
r reso
lved t
hat the
rem
une
ratio
n t
o th
e chai
r of the Aud
it Co
mmit
tee sh
ould b
e SEK 1
50,00
0 and SEK 75,00
0 to
ea
ch othe
r memb
er in th
e Audi
t Comm
it
tee, SEK 40,00
0 to the ch
air of th
e Remu
nera
tion
Co
mmit
tee an
d SEK 25,
0
00 to eac
h othe
r memb
er in th
e Rem
uner
ation C
ommi
tte
e, and SEK
25,
0
00 to eac
h board m
emb
er in th
e Scie
ntic C
ommi
tte
e. For the ch
air of th
e new U.S.
Co
mmit
tee th
e remun
erati
on sh
ould b
e USD 20,00
0. It was fu
rt
her re
solv
ed that th
e
rem
une
ratio
n t
o th
e audi
t
or s
hal
l be pai
d as pe
r approve
d cur
rent ac
cou
nt.
Th
e AGM fur
th
er res
olve
d, in acc
orda
nce wi
th the Bo
ard’
s pro
pos
al, to adopt n
ew gui
deli
nes fo
r
execu
tive re
mune
ratio
n, to
am
end th
e ar
ticl
es of as
soci
ation, a
dopt a lo
ng-term i
nce
ntive
pro
gram b
ased o
n per
for
man
ce-
base
d shar
e righ
ts for em
ploye
es at Ha
nsa B
ioph
arm
a, adopt a
lo
ng-term i
nce
ntive pr
ogra
m base
d on em
ploye
e stock opt
ions fo
r emp
loyee
s in Han
sa
Bi
opha
rma a
nd to ame
nd the te
rms of th
e long
-t
er
m inc
enti
ve progr
ams ba
sed o
n empl
oyee
stoc
k optio
ns adopte
d in 201
9 a
nd 2020.
It was f
ur
the
r reso
lved, in a
cco
rdanc
e with t
he Boa
rd’
s prop
osa
l, t
o au
thor
ize the B
oard, for t
he
pe
rio
d up to the nex
t AGM, to adopt d
ecis
ion
s, wheth
er on on
e or seve
ral oc
cas
ions a
nd
wh
ether w
ith or w
itho
ut pre
-em
ptive ri
ghts for t
he sha
reho
lde
rs, to iss
ue new o
rdina
r
y shar
es,
an
d warra
nts an
d/or conve
r
tible
s; provid
ed howe
ver that s
uch i
ssue
s, or nu
mber of s
hare
s
cre
ated in c
onne
ctio
n with c
onver
sio
n of warr
ants an
d/or conve
r
tible
s, in ag
greg
ate, may not
co
rres
pond to a d
iluti
on of mo
re than 20 p
er ce
nt of the tota
l numb
er of sh
ares o
utsta
ndin
g af
ter
fu
ll exerci
se of the au
thor
izati
on. It sh
ould a
lso be p
ossi
ble to make s
uch an i
ssu
e resol
utio
n
sti
pulati
ng pay
ment in c
ash, in k
ind p
ayme
nt, the rig
ht to oset d
ebt or othe
r con
diti
ons. Th
e
pur
pos
e of the auth
ori
zatio
n is to incr
ease t
he na
ncia
l exi
bili
ty of the C
ompa
ny and th
e actin
g
sc
ope of the B
oard a
s well a
s t
o pote
ntia
lly bro
ade
n the sha
reho
lde
r base.
Min
utes f
rom the AGM 20
2
1 are ava
ila
ble at Ha
nsa B
ioph
arm
a
’
s web
site
(w
ww.hans
abi
opha
rma
.
co
m)
. Th
e 2022 AGM wil
l take pl
ace on 16 June 20
22
.
Remuneration
to senior
ex
ecutives
Th
e remu
nerat
ion gu
ide
line
s for sen
ior exe
cutiv
es ado
pted by the 2021 AGM, ame
ndin
g the 2020
gui
del
ine
s, enta
il thos
e seni
or execu
tives a
re oere
d remu
nera
tion wh
ich i
s comp
etiti
ve and on
ma
rket term
s. The l
evel of the re
mun
erati
on for th
e indi
vidu
al se
nior exe
cuti
ve shal
l be bas
ed on
fac
tors su
ch as po
sitio
n, expe
rti
se, expe
rie
nce a
nd per
fo
rma
nce. Th
e remu
nera
tion co
nsi
sts of a
xe
d base s
alar
y a
nd pen
sion b
ene
ts and, i
n addit
ion, may c
onsi
st of a vari
abl
e cash
remuneration
(including STI)
, shar
e-based long-t
erm incentive
programs (L
TIP) as resolved
by t
he
AGM, seve
ran
ce remu
ner
ation, a
nd othe
r bene
ts. Th
e vari
able s
ala
ry s
hall b
e on mar
ket term
s
an
d be base
d on the a
chie
veme
nt of quan
titati
ve and qu
ali
tative t
arget
s and sh
ould n
ot ex
ce
ed
75
pe
rce
nt of the an
nual 
xed bas
e sala
r
y
.
The variable
cash remunera
tion is
intended
to
support recruitment or
ret
ention
of k
ey personnel
or to rewa
rd extr
aordi
nar
y pe
rfo
rma
nce beyo
nd the i
ndiv
idu
al’
s ordi
nar
y res
pon
sibi
litie
s and s
hall
not exce
ed 30 p
erce
nt of the an
nual 
xed bas
e sala
r
y
. C
ontri
buti
ons to pen
sio
n plan
s shal
l not
exce
ed 30 pe
rcent of t
he ann
ual xe
d base s
ala
ry. Sala
ry d
uri
ng the noti
ce of ter
minat
ion pe
rio
d
an
d severa
nce re
mune
rati
on sha
ll be po
ssib
le in a total m
ax
imum a
mou
nt of 1
8 mo
nthl
y
base salaries.
If noti
ce of ter
minat
ion is m
ade by the C
ompa
ny
, th
e notic
e peri
od may not exc
eed si
x mont
hs
an
d the xed c
ash s
alar
y du
rin
g the pe
riod of n
otice a
nd seve
ranc
e pay may toge
ther not exc
eed
an a
mount e
qui
vale
nt to the xed c
ash s
alar
y fo
r 1
8 mo
nths for th
e CEO, and, for oth
er se
nior
execu
tive
s, may not exce
ed an am
ount e
quiva
len
t t
o the 
xed ca
sh sal
ar
y for 6 mo
nths, an
d in
exce
ptiona
l cas
es, 1
2 m
onths. W
hen te
rmin
ation i
s made by th
e seni
or execu
tive, the p
eri
od of
noti
ce may not exce
ed si
x month
s and no s
evera
nce pay w
ill be p
aid.
General principles
cont
inued
Hansa Biopharma
Annual Report 202
1
13
0
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Sha
re and s
hare b
ase
d long
-
ter
m inc
enti
ve progr
ams sh
all b
e deci
ded by th
e Ann
ual G
ene
ral
Meeting.
For inf
ormation regarding
the adop
ted ongoing long
-t
erm incentive pr
ograms, please
refe
r to the Dir
ector
s Repo
r
t and Note 2 a
nd Note 1
4 to th
e Con
soli
dated Fi
nan
cial S
tatem
ents
el
sewh
ere in th
is An
nual R
epor
t 2021
.
Th
e Board of D
irec
tors may te
mpor
aril
y reso
lve to der
ogate fro
m the exec
utive re
mune
ratio
n
gui
del
ine
s, in who
le or in pa
r
t
, if i
n a spec
ic c
ase the
re is sp
eci
al cau
se for th
e derog
atio
n and a
derogation is
necessar
y t
o ser
v
e the Compan
y’
s long-term
interests
, including it
s sustainability
,
or to en
sure th
e Comp
any’
s na
nci
al via
bil
ity.
Ple
ase ref
er to Note 1
4 to th
e Fina
nci
al State
ment
s of the Pare
nt Com
pany a
nd the Re
mun
erati
on
rep
or
t in thi
s Ann
ual Re
por
t 2021 for fu
rt
her in
form
ation o
n the 2021 guid
eli
nes.
Th
e Boar
d of Dire
ctors w
ill pro
pose a
n ame
ndm
ent to the c
urre
nt guid
eli
nes at th
e 2022 AGM by
which a
tailored emplo
yee incen
tive p
rogram t
hat balances
individual achie
vement and
organisat
ional contrib
ution is
to
be implement
ed in which
it is
proposed t
hat t
he performance
cr
iteri
a for the “Annu
al Sho
r
t
-
T
er
m Ince
ntive (“
STI”) s
hall i
nclu
de both c
orp
orate an
d indi
vid
ual
obj
ecti
ves. Fur
th
erm
ore, it is p
ropo
sed th
at the pe
rfo
rma
nce c
riter
ia, we
ighti
ng and t
arge
ts for
the i
ndiv
idu
al obj
ecti
ves un
der th
e STI are to be p
ropo
sed, eva
luated a
nd ap
proved a
nnua
lly C
EO
as ma
nag
er for me
mbe
rs of the exec
utive c
ommi
tte
e or
, i
f it is not th
e CEO
, the
n the re
spe
ctive
ma
nage
r for suc
h mem
bers of t
he execu
tive co
mmit
tee, an
d for the CEO th
e Rem
uner
ation
Co
mmit
tee. Th
e prop
osed a
djust
ments h
ave bee
n ree
cted in th
ese gu
ide
line
s whic
h will b
e
sub
jec
t to the sha
reho
lde
rs’ app
roval at the a
nnu
al ge
nera
l meet
ing 2022 a
nd are a
ppen
ded to
thi
s docu
ment a
s an app
end
ix to this Co
rpo
rate Gove
rnan
ce Se
ctio
n.
Du
ring 20
2
1
, n
eith
er the R
emun
erati
on Co
mmit
tee n
or the Bo
ard of Di
recto
rs rec
eive
d any
comments
or questions
from t
he shareholders
on the
remuneration
guidelines adop
ted
at the
2021 AGM.
Nominatio
n
Commit
tee
Pri
or to the 2022 AG
M, Hans
a
’
s No
mina
tion C
ommi
ttee c
omp
rise
s of Lau
ra Fei
nlei
b (temp
orar
y
replacement for
Natalie Berner and repr
esenting Redmile Group
)
, L
otta Sjöberg (
representing
Handelsbanken Fonder)
, and Jannis Kitsakis (
chair of t
he Nomination Committee
and
rep
rese
nting A
P
4)
. Ulf W
iin
berg (ch
air
man of th
e Board
) is the c
onven
or of the
Nomination Committee
.
Acc
ordi
ng to the Co
de, Han
sa is re
quire
d to have a No
minati
on Co
mmit
tee, wh
ich i
s not a
sta
ndin
g com
mit
tee of the B
oard. T
he AGM sha
ll ap
poin
t the me
mber
s of the No
min
ation
Co
mmit
tee or r
esol
ve on pro
ced
ures fo
r appo
inti
ng the me
mbe
rs. Su
ch proc
edu
res wer
e
ado
pted by the 2021 AGM. T
he Nom
inati
on Com
mit
tee sh
all, pu
rsua
nt to the Co
de, con
sist of a
t
least th
ree members o
f which a
majority shall be
independent in
relation
to
Hansa Biopharma
and its
management
. In a
ddition,
at least
one member
of the
Nominat
ion Committee
shall be
ind
epe
nde
nt in rel
atio
n t
o th
e larg
est sh
areh
old
er in ter
ms of votin
g rig
hts or gro
up of
shareholders who cooperat
es in t
erms of Hansa
’
s management.
The Nominat
ion Committee
’
s responsibilit
ies include pr
eparing a pr
oposal for
the n
umber of
dir
ector
s and pe
rso
ns to be el
ecte
d as dire
ctors, i
ncl
udin
g the cha
irm
an of the B
oard, a
nd a
pro
posa
l for re
mune
ratio
n to the cha
irm
an and t
he othe
r Boar
d memb
ers, a
s well a
s a propo
sal
for
remuneration
for t
he Board
members’
committee w
ork. The
Nomination
Committee also
proposes
election of
a chairman
of t
he annual general
meeting
, and elect
ion of
auditors
including
remunerat
ion t
o the
auditor
. Finally
, the
Nomination
Committee pr
oposes principles f
or the
Nominat
ion Committee p
rior to
the A
GM 2
023
. The p
roposals will
be published
in connection
wi
th the noti
ce to the 2022 AG
M.
Ex
ternal
auditors
Th
e exter
nal a
udit of th
e acco
unts of th
e Parent C
ompa
ny and th
e Group, as we
ll as of the
ma
nage
ment by t
he Boa
rd and th
e CEO, was ca
rrie
d out i
n acco
rdan
ce wi
th gen
eral
ly ac
cepted
acc
ount
ing sta
nda
rds in Sw
ede
n. The au
ditor p
ar
tici
pates in at l
eas
t one Bo
ard me
eting p
er yea
r
,
go
ing thro
ugh th
e acc
ounts fo
r the yea
r and l
eadi
ng a dis
cuss
ion w
ith the d
irec
tors wi
thou
t the
CEO o
r any other s
eni
or execu
tive pre
sent.
Pur
sua
nt to
th
e ar
ticl
es of ass
oci
ation, Ha
nsa m
ust have a re
giste
red acc
ounti
ng r
m as its
ex
terna
l audi
tor
. T
he acc
ounti
ng r
m KPMG AB h
as bee
n the au
ditor of th
e Comp
any sin
ce the
201
4 AGM. As f
rom the 201
8 AGM cer
ti
ed pu
bli
c acco
unta
nt Jona
s Nihl
berg i
s audito
r in
ch
arge. From th
e 20
1
4 AGM up to and i
nclu
ding th
e 20
1
8 AGM, ce
rt
ied p
ubli
c acco
unta
nt
Da
n Kje
llqv
ist wa
s audi
tor in ch
arge. D
an Kj
ellq
vis
t per
sona
lly wa
s the Co
mpany’s audi
tor
co
mmen
cing a
t the tim
e of the 201
4 AGM u
p t
o an
d incl
udi
ng the 201
5 AG
M. Jona
s Nihl
berg
an
d Dan K
jell
qvi
st are m
embe
rs of th
e Swedi
sh Ins
titute of Au
thor
ized Pu
blic A
ccou
ntan
ts.
For i
nform
ation r
egar
ding fe
es pa
id to the au
ditor
s, ple
ase refe
r to Note 29 to the Fi
nanc
ial
Sta
temen
ts of the Par
ent Co
mpany e
lsew
here i
n this 2021 an
nual re
por
t.
Hansa Biopharma
Annual Report 202
1
13
1
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
General principles
cont
inued
The o
verall task of the
Boar
d
is to
manage the aairs of
the Company in the best possible manner on beha
lf o
f
the shareholde
rs.
Th
e Board m
ust co
ntinu
ousl
y evalu
ate the Gro
up’
s o
pera
tions, d
evel
opme
nt and 
nanc
ial
situation
, as w
ell as the
operative management
including identifying how sustainability issues
imp
act ri
sks to an
d busi
nes
s oppo
r
tunit
ies fo
r the Gro
up. The B
oard de
cid
es up
on, amo
ng othe
r
thi
ngs: iss
ues c
once
rni
ng the G
roup’
s strate
gic foc
us and o
rgan
izati
on; busi
nes
s pla
ns; nan
cial
pl
ans an
d budg
et; sign
ic
ant agre
eme
nts; maj
or inve
stmen
ts and co
mmi
tment
s
; an
d nan
ce,
dis
clo
sure, an
d ris
k mana
geme
nt po
lici
es. Th
e Boa
rd must a
lso en
sure th
at the Co
mpa
ny
pre
pare
s insi
der i
nstru
ctio
ns. Th
e Boa
rd works a
ccor
ding to r
ules of p
roce
dure w
hich a
re
ado
pted an
nual
ly
, a
nd wh
ich go
vern th
e freq
uen
cy and a
gend
a of Boa
rd meet
ings, d
istri
buti
on of
mate
rial
s for me
eting
s, and m
atter
s to be pre
sente
d to the Boa
rd for inf
orma
tion or f
or a dec
isi
on.
Th
e rul
es of pro
cedu
re als
o gover
n how the B
oard wo
rk is al
loc
ated am
ong th
e Board a
nd its
committees.
The Board
has also
adopt
ed CEO
instructions
which go
vern the
allocation
of w
ork
am
ong the B
oard, th
e chai
rma
n, and the C
EO
, and w
hic
h dene
s the CEO’s autho
rit
y
.
Th
e Boar
d, incl
udin
g the ch
airm
an, is e
lecte
d by the sh
areh
old
ers at th
e AGM up unt
il the e
nd of
the n
ext AGM, w
ith the p
ossi
bili
ty of re
-el
ecti
on. In add
itio
n, the Com
pany’s empl
oyees m
ay
,
pur
sua
nt to statu
t
or
y r
ule
s rega
rding t
he rep
rese
ntatio
n of emp
loyee
s on the B
oard, e
lect
em
ploye
e repre
sent
ative
s t
o th
e Board. C
urre
ntly
, the B
oard h
as no e
mploye
e repr
esen
tative
s.
Al
l curr
ent Bo
ard me
mber
s are co
nsi
dere
d to be ind
epe
nden
t unde
r the co
rpo
rate gove
rnan
ce
sta
nda
rds of the C
ode a
nd Nas
daq Stoc
kho
lm. Th
e chai
rma
n must ke
ep him
self w
ell in
forme
d
about,
and monit
or
, the
Company’
s business.
The chairman is
responsible
for ensuring
that
the
Boa
rd’
s work i
s car
rie
d out e
cien
tly an
d that the B
oard fu
ll
s its obl
igati
ons in a
ccord
anc
e with
applicable la
ws and
regulations
, the
Code,
the articles of
association
, resolut
ions o
f the
general
me
eting, a
nd the B
oard’s own rul
es of pro
ced
ure. Th
e chai
rma
n is als
o resp
ons
ible fo
r ensu
rin
g
that t
he Boa
rd car
rie
s out th
e dec
isio
ns that a
re mad
e and th
at thei
r work i
s evalu
ated. Fur
the
r
on, th
e chai
rma
n is als
o resp
ons
ible fo
r ensu
rin
g that the d
irec
tors re
gula
rly u
pdate th
eir
kn
owle
dge a
bout th
e Com
pany an
d that n
ew dire
ctors re
cei
ve nec
ess
ar
y intro
duc
t
or
y tr
aini
ng.
The chairman r
epresents
the Compan
y in o
wnership quest
ions and is
responsible
for the
day-to-d
ay cont
act wi
th the CEO a
nd sen
ior exec
utive
s. The c
hair
man m
ust al
so app
rove
rem
une
ratio
n and othe
r emp
loyme
nt term
s and co
ndi
tions fo
r sen
ior exec
utive
s. The c
hair
man
is a
lso res
pon
sibl
e for the C
ompa
ny’
s arc
hive
s, in whi
ch min
utes f
rom all D
ire
ctors’ me
eting
s and
ge
nera
l mee
tings m
ust be s
aved.
Th
e chai
rma
n prep
ares B
oard m
eetin
gs toget
her w
ith the C
EO
. Th
e notic
e of the me
eting a
nd
the a
gend
a are se
nt to the di
rector
s onl
y af
t
e
r they have b
een a
pprove
d by the ch
airm
an.
Af
ter thi
s, the noti
ce is se
nt togeth
er wi
th su
cien
t deci
sio
n-mak
ing d
ocum
enta
tion to the
dir
ector
s. As the c
ase may b
e, a Boar
d meeti
ng inc
lud
es a revi
ew of the b
usin
ess, i
nclu
ding
development
and adv
ances within
research and
development
, b
usiness developmen
t,
co
nsol
idated e
arn
ings a
nd na
nci
al pos
itio
n, nan
cial re
por
ts, a
nd fore
cast
s.
Pur
sua
nt to the ar
tic
les of a
ssoc
iati
on, the Bo
ard mu
st com
pris
e not le
ss tha
n three a
nd not
mo
re than te
n direc
tors e
lecte
d by the ge
ner
al me
eting. T
he Boa
rd is qu
orate wh
en mo
re than
ha
lf of the di
recto
rs are p
rese
nt. The a
rti
cle
s of ass
ocia
tion d
o not cont
ain a
ny provi
sion
s
reg
ardi
ng app
oint
ment o
r dism
iss
al of dire
ctors o
r reg
ardin
g ame
ndme
nt of the a
rt
icle
s
of
association
.
Di
rector
s’
fe
es were s
et at the 2021 AGM for a pe
rio
d up to and in
clud
ing the n
ext AGM. T
he fee
s
for the Boa
rd’
s work in 202
1 were set as follow
s:
Th
e
cha
irm
an is
pa
id SEK 900,00
0,
an
d
ea
ch
othe
r dire
ctor is p
aid SEK 3
00,00
0. Furt
her
, SEK 1
50,00
0 is pa
id to the ch
air
man an
d SEK
75
,00
0 is pa
id to eac
h other b
oard m
embe
r in the A
udit C
ommi
ttee, S
EK 40,000 i
s paid to th
e
ch
airm
an an
d SEK 25
,00
0 is pa
id to eac
h other b
oard m
emb
er in th
e Remu
nera
tion Co
mmi
ttee
an
d SEK 25
,00
0 is pa
id to each b
oard me
mbe
r in the Sc
ient
ic Co
mmit
tee. Fo
r the U.S.
Co
mmit
tee, wh
ich was a
dopted i
n 202
1
, USD 20,00
0 is pa
id to the ch
air
man. No re
mun
erati
on
othe
r than th
e above
ment
ione
d fees h
ave bee
n paid to th
e Board exc
ept for trave
l cos
t
rei
mbur
sem
ents. T
he Boa
rd mem
ber
s are not e
ntitl
ed to any sh
are-
base
d com
pens
atio
n.
No pe
nsi
on pre
mium
s or simi
lar b
ene
ts were pa
id to dire
ctors. N
one of the d
irec
tors are
ent
itle
d t
o be
net
s afte
r comp
letio
n of thei
r duti
es. Ple
ase se
e the Re
mune
ratio
n Rep
or
t and
Note 1
4 to the Fi
nanc
ial S
tateme
nts of the Pa
rent c
ompa
ny els
ewhe
re in thi
s 202
1 an
nual
report for a
dditional in
formation
regarding
employment
terms and
conditions
for t
he Board
and
se
nior exe
cuti
ves.
Dir
ectors
Th
e Board c
urre
ntly c
ompr
ise
s six in
divi
dua
ls, inc
ludi
ng the ch
air
man.
Th
e 202
1 AGM re
-el
ected U
lf Wi
inbe
rg, And
ers G
ers
el Ped
ers
en, An
drea
s Egge
rt, Eva Ni
lsa
gård,
and Mat
s Blom as
members of
the Bo
ard.
Further
, Hilary Malone was
elected as
new member
of
the B
oard. B
irgit S
tat
tin Nor
ind
er
, p
revi
ous me
mbe
r of the Boa
rd, was not s
tand
ing fo
r re-
election.
The A
GM further resolved
to
re-elect Ulf
Wiinberg as
chairman of
the Boar
d.
Each
dir
ector’s term co
ntinu
es unt
il the en
d of the nex
t AGM.
Pri
or to the 2021 AGM, the N
omin
atio
n Comm
itte
e ann
ounc
ed that i
t had ap
pli
ed the p
rovis
ions
of ru
le 4.
1 of th
e Code a
s Boa
rd dive
rsit
y po
licy
. T
he aim i
s that th
e Board a
s a col
lect
ive sho
uld
pos
ses
s the re
quire
d mix in te
rms of ba
ckgrou
nd and k
nowl
edge, w
here
by an even g
end
er
dis
trib
utio
n is take
n into acc
ount. T
he res
ult of th
e Nomi
natio
n Comm
it
tee’
s a
ppli
cati
on of the
di
vers
ity p
olic
y is a Boa
rd that rep
rese
nts a mix of b
oth profe
ssio
nal ex
per
ienc
e and k
nowl
edge
as we
ll as ge
ogr
aphi
cal a
nd cul
tura
l backgro
und
s. One th
ird (
1
/3) of the b
oard m
emb
ers e
lecte
d
by the AGM a
re wome
n.
Th
e Boa
rd
Hansa Biopharma
Annual Report 202
1
13
2
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
The Boar
d
con
tin
ued
Ulf Wii
nberg
Me
mbe
r and C
ha
irm
an of t
he Bo
ard s
inc
e 2016.
Me
mbe
r of th
e Boa
rd an
d ac
ting C
EO fr
om
Nove
mb
er 9, 20
1
7 u
nti
l Mar
ch 2
0, 2018.
Shareholding:
1
24,350 shares
Ulf Wiinberg has
served as the chairman
of the
Bo
ard si
nce M
ay 201
6. Ul
f also s
er
ved a
s the ac
tin
g
Ch
ief Exe
cut
ive O
cer f
rom Nove
mbe
r 20
1
7 unt
il
Ma
rch 201
8. Ul
f
is a
n
ex
per
ien
ced he
alt
hca
re
in
dust
ry p
rofes
sio
nal w
ith ove
r 40 ye
ars of
exp
eri
enc
e, and ha
s ser
ved on th
e boa
rds of seve
ral
healthcare ind
ustry associations.
He serves as
the
Ch
ief Exe
cut
ive O
cer of X-V
a
x T
e
chno
log
y
, Inc., a
co
mpa
ny see
kin
g to deve
lop a v
acci
ne ag
ain
st
he
rpe
s, sin
ce A
pril 2
0
1
7
. Ul
f als
o ser
ve
d as Chi
ef
E
xecu
tive O
cer of H. Lu
ndb
eck A
/S (CSE: LUN
),
a
pharmaceutical
company speciali
zed in
psychia
tric
an
d neu
rolo
gic
al di
sord
ers
, from J
une 20
08 to
De
cem
ber 2014
. Pr
ior to t
hat, he h
eld m
ulti
ple
exec
uti
ve role
s at Wyeth, LLC (ac
qui
red by P
zer Inc.
(N
YSE: PFE
))
, ser
v
ing as wo
rld
wide Pr
esi
den
t
fr
om
20
02 to 200
5 and Pr
esi
dent o
f the Eu
rope
an, Mi
ddl
e
Ea
ster
n and Af
ri
can re
gio
n fro
m Febr
uar
y 20
02 to
Ju
ne 200
8, an
d has al
so be
en Pr
esi
dent o
f the
Gl
oba
l con
sume
r he
alth c
are b
usin
ess
. Ulf a
lso
se
rve
s as a non-
exec
utiv
e
me
mbe
r of the boa
rd of
Al
fa Lava
l AB (STO: ALFA), Agen
us Inc. (N
ASDAQ:
AGEN
)
, Mi
NK The
rap
euti
cs, In
c. (NAS
DAQ:
IN
KT
), a
clinical-stage
precision oncology company
dev
elo
pin
g cel
l ther
api
es for c
anc
er a
nd othe
r
immune-mediated diseases (
subsidiary of Agenus
In
c.
), and a
t the Be
lgi
an ph
arm
ace
uti
cal C
ompa
ny
Un
ion Ch
imiq
ue Be
lge (U
CB) (Eur
onex
t: UCB). He is
al
so ch
air
man of th
e boa
rd of Si
gri
d The
rap
euti
cs
AB. H
e was b
orn i
n 1
958.
Ul
f is me
mbe
r of Han
sa’
s Re
mun
erat
ion C
ommi
tte
e,
Sc
ient
ic Co
mmi
tte
e
an
d U
.S. C
ommi
tte
e.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Eva
Nilsagård
Me
mbe
r of th
e Boa
rd si
nce 2
019.
Shareholding:
3,000 shares
Eva N
ilsa
går
d has se
r
ved as a m
emb
er of th
e Boa
rd
an
d cha
ir of the A
udi
t Com
mit
tee si
nce M
ay 201
9.
Si
nce Ju
ly 201
5, Eva h
as se
rv
ed as th
e fou
nde
r and
Ch
ief Exe
cut
ive O
cer of Ni
lsa
gård C
onsu
lti
ng AB.
She previously
ser
ved
as interim
Chief Financial
O
cer of va
rio
us com
pan
ies, in
clu
din
g
O
ptiG
roup
AB f
rom Ja
nua
ry 2
0
19 to Octob
er 2019 and A
pri
l
2020 to D
ece
mbe
r 2020, Pl
asta
l fro
m Septe
mbe
r
201
6 to Septe
mbe
r 201
7
, an
d
V
itro
life AB (STO: VI
TR)
fro
m Mar
ch 200
9 to Aug
ust 2010. She a
lso se
r
ved in
var
iou
s sen
ior p
osi
tion
s at the Vol
vo Gro
up, or Vol
vo
(STO: VOL
V
), incl
udi
ng Sen
ior Vi
ce Pre
sid
ent
Str
ateg
y &
Bu
sin
ess De
velo
pme
nt fro
m
Se
ptem
ber
201
0 to Ju
ne 201
4. Ear
lie
r in he
r ca
reer, Eva al
so
he
ld sen
ior po
sit
ion
s
in n
anc
e and bu
sin
ess
dev
elo
pme
nt at Astr
aZe
nec
a plc (L
SE: AZ
N) and AB
SK
F
(STO: SK
F). She i
s
a bo
ard me
mbe
r
an
d chai
r of
the a
udit c
ommi
tte
e of SEK (Swed
ish E
xp
or
t
Cr
edi
t
Co
mpa
ny),
Ad
dLi
fe (STO:
A
LIF
)
, Bu
fab Gr
oup (STO:
BU
F
AB), Irr
as AB (STO: IRR
AS), Nim
bus Gro
up AB
(STO: BOA
T
),
Na
nexa (STO: NA
NE
XA
) and Xb
ran
e
Bi
oph
arm
a
(STO: XB
RA
NE), the c
hair of Sp
erm
ose
ns
AB (Sp
otli
ght: SPER
M) and D
iag
ona
l
Bi
o AB (STO:
DI
ABIO), a
nd a boa
rd me
mbe
r of eEd
ucat
ion A
lbe
rt
AB (STO: AL
BERT
). Eva has mo
re than te
n
ye
ars of
exp
eri
enc
e as a mento
r for youn
g fema
le ma
nage
rs
wi
th hig
h
pot
enti
al. She ho
lds a
n
E
xecu
tive M.B
.A. in
Eco
nom
ics a
nd a
B.S
c. in acc
ount
ing an
d
n
anc
e
fro
m Sch
ool of B
usi
nes
s, Eco
nom
ics a
nd La
w in
Gothenburg
. She
was born
in 1
9
64
.
Eva
is Chair of
Hansa’
s Audit Committee.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Mats Blom
Me
mbe
r of th
e Boa
rd si
nce 2
019.
Shareholdi
ng: 1
,000 shares
Mat
s Blo
m has s
er
ved as a m
emb
er of th
e Boa
rd
si
nce M
ay 201
9. Mats h
as se
rv
ed as th
e Chi
ef
Fi
nan
cial O
ce
r of Nor
thS
ea The
rap
eut
ics B.
V
. sin
ce
Se
ptemb
er 2019
. Pr
ior to t
hat, he s
er
ved as C
hie
f
Fi
nan
cial O
ce
r of Modu
s The
rape
uti
cs AB (STO:
MO
DTX
) fro
m Ap
ril 2019 to July 2
0
19, Zeal
and
Pha
rma A
/S (CS
E:
ZE
LA
)
f
rom Mar
ch 201
0 to Marc
h
201
9, an
d Swed
ish O
rph
an In
tern
atio
nal A
B
(acq
uir
ed by Bi
o
V
itru
m, now S
wedi
sh Or
pha
n
Bi
ovit
rum AB (
publ
) (STO:SOBI)) f
rom Octo
ber 20
07
to Ma
rch 2010. Mats al
so se
rv
ed as C
hief F
ina
nci
al
O
cer at Ac
tive Bi
otec
h
AB (
pub
l) (STO:ACTI) a
nd
An
oto Grou
p AB (STO:
AN
OT). Ea
rli
er in hi
s
ca
ree
r
,
he a
lso s
er
ved as a m
ana
gem
ent c
onsu
lta
nt at
Ge
min
i
Co
nsu
ltin
g and Er
nst & Y
o
ung. M
ats is a
bo
ard me
mbe
r
of Eg
etis Th
era
peu
tic
s
AB (STO:
EGT
X), Al
tam
ira Th
era
peu
tic
s
Ltd. (N
ASDAQ: CY
TO)
an
d
Pe
phex
ia Th
era
peu
tics A
pS. He ho
lds a B.A
.
in Business Administ
ration and
Economics from
the U
niv
ers
ity o
f Lund a
nd an M
.B.A
. from t
he IES
E
Un
iver
sit
y of Nav
arr
a, Bar
cel
ona. H
e was b
orn
i
n 19
6
5
.
Mats
is member o
f Hansa
’
s Audit
Committee.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Th
e foll
owing i
s a list of th
e dire
ctors,
containing inf
ormation regarding
their years
of bir
th a
nd el
ecti
on to the Bo
ard,
educat
ion,
work
experien
ce,
engagemen
t
in th
e Comp
any and oth
er si
gni
cant
engagements and holdings
in the Compan
y
as of 31 Dec
emb
er 2021
. Ho
ldin
gs in th
e
Company includes one
’
s own holdings
as
wel
l as thos
e of clo
sel
y relate
d per
sons.
T
enure (years)
5
LONGE
ST
1
SHORTEST
Gender div
ersit
y
33
%
FEMAL
E
67
%
MALE
Meeting
s
11
BOARD
MEETINGS
98
%
AT
T
E
N
D
A
N
C
E
Hansa Biopharma
Annual Report 202
1
13
3
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
The Boar
d
con
tin
ued
Andrea
s
Eggert
Me
mbe
r of th
e Boa
rd si
nce 2
018.
Shareholding: 5,500 shares
An
dre
as Egg
er
t has s
er
ved a
s a mem
ber of t
he
Bo
ard si
nce M
ay 201
8. An
dre
as has o
ver 25 yea
rs of
cross-functional
leadership experience
including
commercial opera
tions,
launch and portfolio
management
, brand
stra
tegy
, market
access,
and
strat
egic consulting. He
has served as the
Chief
Op
erat
ing O
cer at X-V
a
x T
e
chn
olo
gy Inc. in th
e U
.S.
si
nce O
ctobe
r 201
8. Pre
vio
usl
y
, h
e ser
ve
d as Se
nio
r
Gro
up Vi
ce Pres
ide
nt, Glo
bal Pr
oduc
t Strate
gy &
Portfolio Development
, and
Member of
the
Corporate
Management Committee
at H
. Lundbeck
A
/S (CSE: LUN
)
in D
enm
ark fr
om Nove
mbe
r 20
10
to
June 2
01
5, where
he w
as responsible
for mult
iple
new pr
oduct launches
and the
commercial
leadership for shaping
the product
por
tfolio and
development pipeline.
Previously
, Andreas ser
v
ed in
var
iou
s sen
ior c
omm
erci
al ro
les at W
yeth, L
LC
(acq
uir
ed by Pze
r Inc. (N
YSE: PFE
))
in th
e U
.S.,
Ja
pan a
nd in G
erm
any fr
om 1
99
9 to 201
0, inc
lud
ing
as V
ice Pre
sid
ent & Gl
obal B
usin
es
s
Ma
nag
er fro
m
Se
ptemb
er 20
05 to Ap
ril 2010. Ear
lie
r in hi
s car
eer,
An
dre
as als
o was a M
anag
em
ent Co
nsu
lta
nt at A.
T
.
Kea
rne
y
. He hol
ds an M.B.
A. fro
m Azu
sa Paci
c
Un
iver
sit
y
. He w
as bo
rn in 1967
.
Andreas is Chair
of Hansa
’
s Remuneration
Committee,
and member o
f the
Audit Committ
ee
an
d
Sc
ien
ti
c
Co
mmi
tte
e.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Anders Gersel P
edersen
Me
mbe
r of th
e Boa
rd si
nce 2
018.
Shareholding:
2,500 shares
An
der
s Ger
sel P
ede
rse
n, M.D.
, Ph.
D
., has s
er
ved a
s
a me
mbe
r of the B
oard s
inc
e May 201
8. A
nde
rs ha
s
ove
r
32 ye
ars of exp
eri
enc
e in the inte
rn
atio
nal
ph
arm
ace
utic
al in
dus
try. From J
anu
ar
y 200
0 to
De
cem
ber 2018, he se
r
ved in va
ri
ous ro
les at H
.
Lu
ndbe
ck A
/S in Den
mar
k (CSE: LUN
)
, inc
lud
ing
mo
st rece
ntl
y
as E
xec
utiv
e
V
ice Pre
sid
ent of
Re
sea
rch & Deve
lop
men
t,
wh
ere he wa
s resp
ons
ibl
e
for t
he di
scove
ry a
nd de
velo
pme
nt of th
e prod
uct
pipeline from pr
eclinical activities to
post
-launch
ma
rketi
ng stu
die
s. Pri
or to th
at, he se
rv
ed in va
rio
us
rol
es at Eli L
ill
y
an
d Comp
any (N
YSE: LL
Y
)
f
rom
August 1
988 to
Decembe
r
1
999,
including most
recently as
a director
overseeing worldwide
clinical
re
sea
rch in o
nco
log
y
. He is a m
emb
er of th
e
European
Society of
Medical Oncology
, t
he
Interna
tional Associat
ion for
the Study
of Lung
Ca
nce
r and th
e Ame
ri
can S
oci
ety of C
lin
ica
l
Oncology
. Anders serves on
the s
uper
visory boards
of Avil
lio
n LLP
, Bava
ri
an Nord
ic A
/S (CSE: BAV
A),
an
d
G
enm
ab A/
S
(CS
E: GMA
B).
He re
cei
ved hi
s
me
dic
al de
gre
e and a d
octor
al de
gre
e in
neuro-oncology from
the Un
iversity of Copenha
gen
and a B
.Sc.
in Business Administr
ation from
Copenhagen Business
School. He
was born
in 1
95
1
.
An
der
s is Cha
ir of Hans
a’
s Sci
enti
c Co
mmit
tee, an
d
member of
the Remuner
ation Committee
.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Hilar
y
Malone
Me
mbe
r of th
e Boa
rd si
nce 2
021.
Sh
ar
eho
ldin
g: –
Hi
lar
y M. Ma
lon
e, Ph.D., has se
r
ved as a m
emb
er of
the B
oar
d sinc
e May 20
2
1
. Hi
lar
y ha
s over 25 ye
ars
of exp
eri
enc
e in glo
bal dr
ug deve
lop
men
t,
re
gul
ator
y
an
d
g
overn
men
t aai
rs, man
ufa
ctur
ing an
d
commercialization
within t
he pharmaceutical
in
dust
ry. She ha
s
se
r
ved as Ch
ief Exe
cut
ive O
cer
of a pr
ivate l
ife s
cie
nce
s com
pany i
n star
t-up p
has
e
since Nov
ember 202
1
. She pre
viously served as
Ch
ief Op
erat
ing O
cer a
nd Exe
cuti
ve Vic
e Pres
ide
nt
at Val
o Hea
lth In
c. fro
m Janu
ar
y 2020 to Se
ptem
ber
2021
. Pr
ior to th
at, Hil
ar
y ser
ve
d as the C
hie
f
Re
gul
ator
y Oc
er and S
eni
or Vic
e Pres
ide
nt &
He
ad
of Gl
obal R
egu
lator
y Aa
irs at Sa
no Inc. (su
bsi
dia
ry
of Sa
no SA (Eur
onex
t: SAN
))
. He
r
pr
evio
us
exp
eri
enc
e als
o
in
clu
des se
nio
r regu
lator
y an
d drug
development
roles a
t Reata
Pharmaceuticals
, Inc
.
(N
ASDAQ: RE
T
A
),
P
zer In
c. (NYSE:PF
E), Wyet
h,
LLC (acq
uire
d by Pze
r Inc.),
As
tra
Zen
eca pl
c (LSE:
A
ZN) an
d Gla
xoSm
ith
Kli
ne plc (L
SE: GSK
). Hila
ry
se
rve
d on th
e boa
rd of Inh
ibi
kas
e The
rap
euti
cs
(N
ASDAQ: IK
T
) fro
m 201
6 to 2019
. S
he ho
lds a P
h.D.
in Molecular
Neuropharmacology and
a B.
Sc. in
Phy
siol
ogy f
rom t
he Uni
ver
sit
y of Du
nde
e, Scot
land
.
Sh
e was bo
rn in 196
5 and is a U.S
.
, U.K., an
d Iri
sh
cit
izen.
Hilary is Chair of
Hansa’
s U.
S. Committee and
me
mbe
r of
th
e
Sc
ie
nti
c
Co
mmi
tte
e.
In
dep
end
ent of Han
sa an
d
it
s
exe
cuti
ve
management.
In
dep
end
ent of m
ajor s
har
eho
lde
rs of Ha
nsa
.
Hansa Biopharma
Annual Report 202
1
13
4
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
The Boar
d
con
tin
ued
The Board of Dir
ectors’ w
ork in 2021
Du
ring 20
2
1
, th
e Boa
rd has he
ld 1
1 me
eting
s, all of w
hich we
re hel
d via T
ea
ms, of whi
ch on
e was
the in
auguration
meeting
and one w
as a combi
ned board
meeting and
remunerat
ion committee
meeting
. The Boar
d has al
so made
resolutions
per capsulam a
t four
occasions.
At the Bo
ard me
eting
s hel
d duri
ng the 2021 na
ncia
l year
, the d
irec
tors were p
rese
nt as set fo
r
th
be
low
. Th
e numb
er of me
eting
s and the m
ax
imum n
umbe
r of meet
ings e
ach di
rector c
ould h
ave
be
en pre
sent at d
urin
g the n
anci
al yea
r are state
d in par
enthe
ses.”
Eval
uat
ion o
f th
e Boar
d of D
ire
cto
rs’ wo
rk
Pur
sua
nt to the Cod
e, the Bo
ard is to eva
luate its wo
rk an
nua
lly
, usi
ng a syste
matic a
nd
str
uctu
red pro
ces
s, with th
e aim of deve
lop
ing the B
oard’s work
ing met
hods a
nd ec
ienc
y
.
The ev
aluation
has been carried out
by t
he chairman o
f the
Board
by an
independent ev
aluation
co
mpany
, in t
he end of 20
2
1
, i
nter
vie
wing th
e dire
ctors w
ith qu
esti
ons ab
out th
e work of th
e
Boa
rd. The r
esul
t of the re
spon
ses h
as be
en ver
ball
y dec
lare
d to the dire
ctor
s and th
e memb
ers
of t
he nomination
commit
t
ee.
Bo
ard m
em
ber
s an
d me
eti
ng pr
es
enc
e for t
he r
ep
or
ti
ng pe
ri
od,
1 Ja
nua
r
y – 31 Dec
em
ber 2
0
21
1
Board member
Elected
Present
at
meetings of
the
Board
Present
at
meetings of
the Remu-
neration
Committee
Present
at
meetings of
the Audit
Committee
Present
at
meetings of
the Scientic
Committee
Independent
in relation
to t
he Co
m-
pany
and
Executive
management
Independent
in r
el
at
ion t
o
the Compa-
ny’s
largest
share-
holders
Ulf Wiinberg
1
2
016
11
(
11
)
4
(4)
–
2(2)
Ye
s
Ye
s
Hilary Malone
1,
2
20
21
6
(6)
–
–
2(2)
Ye
s
Ye
s
Anders Gersel
Pedersen
2
018
1
0
(
11
)
4
(4)
–
2(2)
Ye
s
Ye
s
Birgit Stattin
Norinder
3
2
012
5(5)
2(2)
–
–
Ye
s
Ye
s
And
reas
Egge
rt
4
2
018
11(
11
)
2(2)
7(
7
)
2(2)
Ye
s
Ye
s
Eva Nils
agård
2
019
11
(
11
)
–
7(
7
)
–
Ye
s
Ye
s
Mats Blom
2
019
11
(
11
)
–
7(
7
)
–
Ye
s
Ye
s
1
Th
e U.S. Com
mit
tee d
id not h
ave any s
epa
rate me
etin
gs, as U.S. to
pic
s were d
isc
uss
ed dur
ing r
egu
lar B
oard m
eeti
ngs.
2
Bo
ard me
mbe
r sin
ce AGM 20
2
1
.
3
Bo
ard me
mbe
r unti
l AGM 2021
.
4
Me
mbe
r of Rem
une
rati
on Co
mmi
ttee s
inc
e AGM 2021
.
Hansa Biopharma
Annual Report 202
1
13
5
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
The Boar
d
con
tin
ued
Board commit
tees
Audit Commit
tee
Af
ter th
e 202
1 AGM, the A
udit C
ommi
tte
e cons
isted of Eva N
ils
agård, c
hair
, Ma
ts Blo
m and
An
drea
s Egge
rt. T
he Aud
it Com
mit
tee is o
blig
ated to keep m
inu
t
e
s of its me
eting
s and ma
ke the
minut
es avai
lable t
o the
Board.
The Audit
Committee shall
per
f
orm the
duties incumben
t upon
aud
it co
mmit
tee
s as requ
ired by l
aw and th
e Cod
e.
Th
e Audi
t Comm
itte
e assi
sts the B
oard in ove
rse
ein
g the Com
pany’s acco
untin
g and n
anc
ial
rep
or
ting p
roce
sse
s. The Au
dit Co
mmit
tee co
nsi
sts exclus
ivel
y of mem
ber
s of the Boa
rd who ar
e
na
nci
ally l
itera
t
e an
d are ea
ch con
side
red a
n “
au
dit co
mmit
tee n
anc
ial exp
er
t” a
s dene
d by
ap
plic
abl
e SEC rul
es an
d has the re
qui
site na
nci
al sop
histi
cati
on as de
ned u
nde
r the
ap
plic
abl
e Nasd
aq rul
es an
d regu
latio
ns. Th
e Boar
d has dete
rmi
ned th
at all of th
e mem
bers of
the Au
dit C
ommi
ttee s
atisf
y th
e “ind
epe
nde
nce” req
uire
ment
s set for
th in R
ule 1
0A-3 u
nder t
he
E
xchan
ge Act. Th
e Audi
t Comm
itte
e is gove
rne
d by a
ch
ar
ter that c
omp
lies w
ith Na
sdaq r
ules.
Th
e prim
ar
y duti
es of th
e Audit C
ommi
tte
e are to:
>
Assist the
Board in o
verseeing the Compan
y’
s financial position
, performance, and reporting;
>
Wi
th resp
ect to th
e fin
anci
al rep
or
ting, m
onito
r the ef
fec
tiven
ess of th
e Com
pany’s inter
nal
co
ntrol sys
tem, inter
nal a
udit a
nd ri
sk man
age
ment;
>
Kee
p itse
lf info
rme
d of the au
dit of the a
nnu
al acc
ounts a
nd co
nsol
idate
d acco
unts;
>
Rev
iew an
d moni
tor the au
ditor’s impa
r
tiali
ty a
nd ind
epe
nde
nce, an
d, in this c
ontex
t,
pa
rti
cula
rly m
oni
t
or w
heth
er the au
ditor i
s provi
ding t
he Com
pany wi
th ser
v
ice
s other th
an
auditing services; and
>
T
a
ke dec
isio
ns reg
ardi
ng gui
deli
nes fo
r ser
vi
ces oth
er tha
n the au
diti
ng ser
v
ice
s whic
h the
ex
terna
l audi
tor ca
n provid
e.
Remuneration Committe
e
Af
ter th
e 202
1 AGM, the R
emu
nerat
ion Co
mmi
ttee h
as con
siste
d of And
reas Eg
ger
t, ch
air
, Ulf
Wi
inbe
rg and A
nde
rs Ge
rse
l Pede
rsen. T
he Re
mune
rati
on Com
mit
tee is c
harg
ed wit
h per
for
ming
the d
utie
s set for
th i
n the Swe
dish C
orp
orate Gove
rna
nce C
ode. T
he Rem
une
ratio
n Comm
itte
e
is o
blig
ated to keep m
inute
s of its me
eting
s and m
ake the mi
nutes av
aila
ble to the B
oard.
Th
e prim
ar
y duti
es of th
e Remu
ner
ation C
ommi
tte
e are to:
>
Prop
ose gu
ide
line
s and p
rinc
ipl
es for re
mune
rati
on and oth
er ter
ms of em
ploym
ent of th
e
Chi
ef E
x
e
cuti
ve Of
fi
cer an
d sen
ior exec
utive
s;
>
Mo
nitor a
nd evalu
ate any pro
gram
s pen
ding o
r adopte
d duri
ng the ye
ar for va
ria
ble
rem
une
ratio
n for sen
ior exe
cutiv
es;
>
Monitor
and ev
aluat
e the
implementation
of t
he guidelines
for r
emuneration o
f senior
execu
tive
s adopte
d by the AGM, as we
ll as a
ppli
cab
le remu
ner
ation s
truc
tures a
nd leve
ls for
the C
ompa
ny;
>
Ove
rse
e and ad
mini
ster th
e Comp
any’
s em
ploye
e shar
e optio
n sche
me or e
quit
y inc
enti
ve
pl
ans in o
pera
tion f
rom tim
e t
o tim
e.
Scient
ic
Commit
tee
Af
ter the 20
2
1 AGM, the Sc
ien
tic Co
mmi
ttee c
onsi
sts of An
ders G
ers
el Ped
ers
en, cha
ir
,
An
drea
s Egge
rt, U
lf Wii
nbe
rg and Hi
lar
y Ma
lon
e. The co
mmi
ttee i
s obli
gated to kee
p minu
tes of
its m
eetin
gs an
d make the m
inu
t
e
s availa
ble th
e Boa
rd.
Th
e prim
ar
y duti
es of the Sc
ient
ic Co
mmit
tee a
re to
:
>
As
sist th
e Boa
rd with re
com
mend
atio
ns reg
ardin
g the Co
mpany
’
s re
sea
rch an
d devel
opm
ent
strat
egies and possibilities;
>
Per
for
m suc
h other d
utie
s as are c
onsi
dere
d nec
ess
ar
y and a
ppro
pri
ate in con
junc
tion w
ith
the wo
rk set fo
r
th above a
nd per
fo
rm suc
h othe
r dutie
s as in
stru
cted by the B
oard f
rom tim
e
to ti
me.
U.S. Committee
Th
e rul
es of pro
cedu
re for th
e U
.S. Co
mmit
tee wa
s adopte
d by the Boa
rd at a me
eting h
eld on
Jul
y 1
4, 2021
. Af
ter th
e 202
1 AGM, th
e U
.S. Co
mmit
tee c
onsi
sts of Hil
ar
y Mal
one, ch
air
, an
d Ulf
Wi
inbe
rg. The U.S. Co
mmi
ttee i
s obli
gated to kee
p minu
tes of its m
eeti
ngs an
d make th
e minu
tes
avai
lable t
o the
Board.
Th
e prim
ar
y duti
es of th
e U.S. Com
mit
tee ar
e to
:
>
Di
scus
s and p
rovide i
npu
t t
o si
gni
fic
ant is
sue
s and as
pec
ts rela
ted to the Co
mpany
’
s U. S.
op
erati
ons an
d envi
ronm
ent, inc
ludi
ng R&D, reg
ulator
y an
d com
merc
ial as
pec
ts; and
>
Provi
de ad
vic
e and pro
pos
als for r
esol
utio
ns, sub
jec
t t
o f
inal a
pprova
l by the Bo
ard or th
e
CEO, as the c
ase m
ay be, reg
ardin
g mat
ters re
lated to the C
omp
any’
s an
d the gro
up’
s U.S.
operations
and dev
elopment.
Hansa Biopharma
Annual Report 202
1
13
6
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Th
e Board a
ppo
ints a CEO to ma
nage th
e Com
pany
. In ad
ditio
n to the CEO, there a
re ve
ind
ivi
dual
s who tog
ether m
ake up Co
mpany exe
cuti
ve mana
gem
ent:
>
Pre
side
nt and C
hief E
xec
utive O
ff
ic
er
>
Senior Vice President
, Chief
Financial Of
ficer
>
Senior Vice P
resident
, Chief
Commercial Officer
>
Senior Vice P
resident
, Chief
Scientific Officer and Chief
Operating
Of
ficer
>
Senior Vice President
, Chief
Human Resources Off
icer
>
Senior Vice P
resident
, Chief
Medical Off
icer
Th
e executi
ve man
agem
ent ho
lds m
eetin
gs ever
y mo
nth to disc
uss th
e Group’
s ea
rni
ngs an
d
na
nci
al pos
itio
n, the stat
us of rese
arch a
nd deve
lop
ment p
rojec
ts, ope
ratio
nal a
nd strate
gic
is
sues
, and fol
low-up o
n budg
ets an
d forec
asts.
The CE
O’
s responsibilit
y
Th
e CEO is re
spo
nsib
le for ma
nagi
ng the C
ompa
ny’
s day-to-d
ay ope
ratio
ns pur
suan
t t
o th
e
Boa
rd’
s gui
del
ines a
nd in
struc
tion
s. The C
EO is al
so res
pons
ible, i
n acco
rdan
ce wit
h the Boa
rd’
s
wr
itte
n instr
ucti
ons, fo
r prep
arin
g and p
rese
nting to th
e Boar
d issu
es wh
ich fa
ll beyo
nd the sc
ope
of day-to-d
ay man
agem
ent, an
d he mus
t act in ac
cord
anc
e with th
e instr
ucti
ons to th
e CEO
ado
pted by the B
oard, th
e deci
sio
ns of the B
oard an
d the ge
ner
al me
eting, a
nd in th
e best
inter
ests of
all shareholders.
He mu
st als
o resp
ect th
e duc
iar
y du
ty an
d dut
y of con
denti
ali
ty wh
ich a
pply to aa
irs a
nd
cir
cumst
anc
es wh
ich mi
ght ca
use da
mage to th
e Com
pany if d
iscl
ose
d, as well a
s the du
ty to
rep
or
t mat
ters a
nd circ
umst
ance
s whi
ch are m
ateri
al to the Co
mpany.
In ac
cord
anc
e with th
e Board’s inst
ruct
ions, th
e CEO mu
st take a
ny and al
l mea
sure
s whic
h are
ne
ces
sar
y to en
sure tha
t the Co
mpany’s boo
kkee
ping i
s leg
all
y comp
lian
t and to en
sure th
at
fu
nds ar
e mana
ged in a s
atisf
actor
y ma
nner
. Ac
cordi
ngl
y
, it i
s the CEO’s resp
onsi
bili
ty to en
sure
that t
he Com
pany h
as goo
d inter
nal ma
nag
eme
nt and ro
utine
s to ens
ure app
lic
ation of t
he
ado
pted pri
nci
ples fo
r na
ncia
l repo
rti
ng an
d intern
al co
ntrol.
Fur
the
r
, the C
EO sha
ll eac
h month (w
ith the exc
eptio
n of Janua
r
y and Ju
ly) co
mpil
e a repor
t
reg
ardi
ng the Co
mpa
ny’
s 
nan
cial s
ituati
on. He is r
espo
nsib
le for e
nsur
ing th
at the Co
mpany
complies with applicable la
ws and guidelines,
including Swedish la
w
, the
Nordic Main Mark
et
Rul
ebo
ok for Is
sue
rs of Sh
ares a
nd the C
ode. T
he CEO mu
st ens
ure, at a mi
nimu
m, that the
si
x
-mo
nth repo
r
t or the ni
ne-m
onth re
por
t is rev
iewed by a
n audi
t
or
. Th
e CEO al
so has sp
eci
c
res
pon
sibi
lit
y t
o en
sure th
e comp
etiti
ve supp
ly of all p
urch
ases of g
oods o
r ser
vi
ces exce
edi
ng
SEK 1 m. T
he CEO mu
st prov
ide th
e Board w
ith al
l nec
ess
ar
y bac
k
gro
und i
nform
ation a
nd
do
cume
ntati
on, both be
fore an
d bet
ween B
oard me
etin
gs. Th
e CEO mus
t atten
d Boar
d
me
eting
s unle
ss th
e chai
rma
n infor
ms him th
at he ne
ed not to at
tend.
Th
e CEO mus
t also a
tten
d all ge
ner
al me
eting
s of the Co
mpany, inclu
din
g both AGM’
s an
d
ex
traord
ina
ry g
ene
ral me
eting
s. The CE
O may not have a
ny enga
gem
ents ou
tsid
e of the
Company wit
hout the
Board’
s approv
al.
Th
e CEO is a
lso re
spon
sibl
e for im
plem
enti
ng the str
ategy a
pprove
d by the Bo
ard an
d t
o
propose
such ot
her str
ategies
and operation
al measures t
o t
he Board
which he
deems
ap
propr
iate. Th
e CEO is re
spo
nsib
le for th
e Comp
any’
s in
terna
l orga
niz
ation, bu
t must o
btai
n the
Board’
s appro
val prior t
o major
organizational
changes. The CE
O is r
esponsible for
issuing and
ma
intai
ning i
nstr
uctio
ns for d
ele
gatio
n t
o se
nio
r ex
e
cutiv
es of the Co
mpa
ny
. He i
s also
res
pon
sibl
e for ente
rin
g into or ter
minat
ing em
ploy
ment a
gree
ments a
nd for ot
her em
ploy
ment
ter
ms and c
ondi
tion
s; however th
e cha
irma
n of the Bo
ard’
s ap
proval i
s nec
ess
ar
y for su
ch is
sues
in re
spe
ct of sen
ior exec
utive
s.
In a cr
isi
s situ
ation, i
t is the CE
O
’s respo
nsi
bili
ty to info
rm the B
oard i
mmed
iatel
y and, if
ne
ces
sar
y
, to form a
nd in
struc
t a cri
sis co
mmi
ttee a
nd to prep
are a co
nting
enc
y plan fo
r the
bus
ine
ss. Th
e CEO mu
st imme
diate
ly rep
or
t any eve
nt or pro
ced
ure whi
ch he s
uspe
cts may b
e
si
gni
cant
ly adve
rse to the b
usin
ess o
r the Com
pany’s nan
cia
l posi
tion, e.g. a liqu
idit
y cr
isis, to
the c
hair
man of t
he Boa
rd.
Info
rmati
on reg
ardi
ng the CEO’s age, pri
mar
y ed
ucati
on, wor
k expe
rie
nce, si
gni
cant
engagements outside o
f Hansa Biopharma, and
his holdings o
f shares in
the Company
and
tho
se of clo
sel
y relate
d per
sons a
re set for
th b
elow.
Senior ex
ecutives
Ha
nsa Bi
opha
rma’
s se
nior exe
cuti
ves cur
rentl
y com
pris
e six in
div
idua
ls: Pres
iden
t and CEO
Sø
ren T
u
lstru
p
; Se
nio
r Vice P
resi
dent, Ch
ief Sc
ienti
c O
cer a
nd Chi
ef Ope
ratin
g Oce
r
E
x
ecut
iv
e management
Hansa Biopharma
Annual Report 202
1
13
7
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Christian Kjellman;
Senior Vice President
,
Chi
ef Fin
anci
al O
cer D
onato Sp
ota; Sen
ior
Vi
ce Pre
side
nt, Chie
f Comm
erci
al O
cer
He
nk Dou
de van T
roo
stw
ijk; Se
nio
r Vic
e
Pre
side
nt, Chie
f Medi
cal O
ce
r Achim
Kaufhold and Senior Vice Pr
esident, Chief
Hum
an Re
sourc
es O
cer A
nne S
äfströ
m
L
a
n
n
e
r.
Hansa Biopharma’
s current
senior
execu
tive
s, the yea
rs whe
n they as
sum
ed
their posit
ions,
their years
of bi
r
th
, educat
ion,
work
experien
ce,
signicant
engagemen
ts
outside the
Company and holdings
in Hansa
Bi
opha
rma a
s of 3
1 De
cemb
er 2021 are
lis
ted fu
rth
er be
low in th
is Cor
por
ate
Governance report.
Holdings in t
he Company includes
both
one’
s own
holdings and/
or those
of closely
relat
ed persons.
Th
e numb
er of sh
are ri
ghts refe
rs to the
ma
xi
mum num
ber of o
rdina
r
y share
s whi
ch
the exe
cuti
ve may obta
in as a res
ult of the
implementation o
f the incent
ive programs
L
T
IP201
8, L
TIP
20
1
9, L
TI
P2020, and
L
T
IP2021
. Fo
llowi
ng the m
aturi
ty of th
e
incentive
programs and pr
ovided that
cer
tain
pe
rfo
rma
nce co
ndi
tions h
ave bee
n ful
lle
d,
the s
hare r
ights w
ill e
ntitle t
he hol
der to
rec
eive a c
er
tai
n numb
er of ord
inar
y s
hare
s
fre
e of cha
rge. Al
loc
ation of s
hare
s cou
ld be
lowe
r or zero d
epe
ndin
g on the s
hare p
ric
e
deve
lop
ment a
nd wh
ether o
r not
per
f
ormance conditions
are me
t.
Executive management
cont
inued
Søren T
uls
trup
CEO
Shareholding: 1
5,000
Sh
ar
e rig
hts
: 1
72
,42
9
ESO
Ps: 31
5,
107
Sø
ren T
ul
stru
p has s
er
ved a
s Pres
ide
nt an
d Chie
f
E
xecu
tive O
cer s
inc
e
Ma
rch 201
8. He ha
s
ex
tens
ive exp
eri
enc
e as a seni
or exec
utiv
e
in th
e
global biopharma industry
. Prior
to joining
Hansa, he
se
rve
d as Chi
ef Exe
cuti
ve Oc
er of Vi
for Pha
rma AG
(SI
X: VIFN
)
, (now pa
r
t
of CS
L
Be
hr
ing), a Glat
tbr
ugg,
Switzerland-based g
lobal pharmaceutical comp
any
.
Sø
ren al
so prev
iou
sly se
r
ved as Chi
ef Exe
cut
ive
O
cer of Sa
nta
ris Ph
arm
a
A
/S (now pa
rt of F
.
Ho
man
n-L
a Roch
e AG, or Roch
e (SIX: RO
G)),
a
leading clinical stage
biopharmaceutical Company
developing RNA
-target
ed drugs f
or various
therapeutic areas including
rare genetic
diseases.
Fur
th
erm
ore, Sø
ren h
as se
rve
d in se
vera
l sen
ior
general management
and commercial
roles within
Sh
ire Ph
arm
aceu
tic
als (n
ow The Taked
a
Pha
rma
ceu
tic
al Com
pany L
imi
ted (T
SE: 4502)),
Me
rck & Co., Inc. (NYS
E: MRK
) and Sa
ndoz Ph
arm
a
AG (now Nova
r
tis AG, or Nova
rt
is (NYS
E:
N
VS)) in
bot
h Europ
e and t
he Un
ited S
tates
. He hol
ds a
Master
of Science,
Economics and
Business
Administra
tion from
Copenhagen Business School.
He wa
s bor
n in 1965.
Christian Kjellman
Se
nio
r Vic
e
Pr
esi
den
t, Ch
ief Sc
ien
ti
c Oc
er
an
d Chie
f Ope
rat
ing O
ce
r
Sh
ar
eho
ldin
g: –
Sh
ar
e rig
hts
: 94,
356
ESOPs:
1
34,38
0
Ch
rist
ian K
jel
lma
n
ha
s ser
ved a
s
Ch
ief Sc
ient
ic
O
cer s
ince J
anua
r
y
20
08 and C
hief O
pera
ting
O
cer s
ince J
anua
r
y
202
0.
Pr
ior to joi
nin
g Hans
a, he
se
rve
d as Pri
nci
pal Sc
ient
ist at Bi
oInve
nt AB (STO:
BIN
V
) from 20
07 to 200
8, whe
re he fo
cus
ed on n
ovel
target
evaluation
and anti
body technology
. Prior t
o
tha
t, Chr
isti
an se
rve
d as He
ad of Re
se
arch a
t the
biopharmaceutical
development
company C
artela
AB f
rom 20
04 to 20
0
7
, ma
inl
y focu
sin
g on nov
el dr
ug
ta
rget eva
lua
tion. H
e
ha
s exte
nsi
ve rese
arc
h
exp
eri
enc
e in cel
l and mo
lec
ula
r
bi
olo
gy an
d
as a
n
As
sis
tant P
rofes
sor i
n Mol
ecu
lar G
enet
ics a
t Lund
University
. Christian holds
a M.Sc
. in
Chemical
Bi
olo
gy an
d a Ph.D. in T
um
our Im
mun
olo
gy fro
m
Lu
nd Uni
ver
sit
y
. He wa
s bor
n in 1967
.
Donato Spot
a
Se
nio
r Vic
e
Pr
esi
den
t, Ch
ief Fi
nan
cia
l
O
ce
r
Sh
ar
eho
ldin
g: –
Sh
ar
e rig
hts
: 1
02
,073
ESOP’
s: 1
76,842
Do
nato Spo
ta has se
rv
ed as Chi
ef Fin
anc
ial O
ce
r
si
nce M
ay 201
9. Don
ato bri
ngs m
ore th
an 20 ye
ars
of pha
rma
ceu
tic
al ind
ustr
y exp
eri
enc
e in
international
environments,
including strat
egic
n
anc
e,
bu
sin
ess d
evel
opme
nt, inve
stor re
lati
ons
and int
ernational capital market
s transactions t
o the
Co
mpa
ny
. Pri
or to jo
ini
ng Ha
nsa, h
e ser
ve
d in
var
iou
s rol
es at Ba
sil
ea Ph
arm
ace
utic
a AG, or
Ba
sil
ea (SIX
:
BS
LN), inc
lud
ing as Ch
ief Fi
nan
cia
l
O
cer
from N
ovem
ber 2
0
13 to Apr
il 2019
. H
e hol
ds
a B.A
. in In
for
matio
n T
ech
nol
ogy f
rom th
e Swi
ss BB
T
(Bundesamt für Berufsbildung
und T
echnologie) and
an M.
B.A
. from t
he Hoc
hsc
hul
e für W
ir
tsch
af
t und
Umw
elt Nü
r
ting
en-
Gei
sli
nge
n. He was b
orn i
n 1
97
1
.
Hansa Biopharma
Annual Report 202
1
13
8
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Executive management
cont
inued
Henk Doude van T
roost
wijk
Se
nio
r Vic
e
Pr
esi
den
t, Ch
ief Co
mme
rci
al O
cer
Sh
ar
eho
ldin
g: –
Sh
ar
e rig
hts
: 71
,71
7
ESOPs: 91
,
231
Henk Doude
van T
roostwijk has
served as Senior
Vi
ce Pre
sid
ent an
d
Ch
ief Co
mme
rcia
l Oc
er sin
ce
Ju
ne 201
9. In ad
diti
on, H
enk se
r
ved as H
ans
a’
s Vi
ce
President
Global Commercial
Operations fr
om March
201
6 to Ju
ne 201
9. Pr
ior to jo
ini
ng Ha
nsa
, he ser
ve
d
as General
Manager of
European Commer
cial
Op
erat
ion
s and Em
erg
ing M
arket
s at Rap
tor
Pharmaceutical Corp.
(acquired
by Horizon
Pharma
pl
c
(N
ASDAQ: HZN
P)),
an o
rph
an dis
eas
e
fo
cus
ed
gl
oba
l biop
har
ma co
mpa
ny bas
ed in t
he U.S., from
Ap
ril 2012 to Marc
h 201
6. Pri
or to th
at, he se
rv
ed as
Business Unit
Director
Oncology and T
ransplantation
at Ge
nz
yme Eur
ope B.
V
. (acq
uire
d
by Sa
no S.
A.
(Eu
rone
xt: SAN
)) from Ja
nua
ry 20
08 to Apr
il 201
2.
He
nk ho
lds a
n M.B.A
. fro
m Hen
ley Ma
nag
eme
nt
Co
lle
ge at th
e Uni
vers
it
y of Rea
din
g, UK. He w
as
bo
rn in 1965.
Anne Säfström
Lanner
Senior
Vice Presiden
t,
Ch
ief Hu
man R
eso
urc
es O
cer
Shareholding: 61
0
Sh
ar
e rig
hts
: 89,618
ESOPs: 70,00
0
An
ne Säf
strö
m
L
ann
er has se
r
ved as Ch
ief Hum
an
Re
sou
rces O
ce
r sinc
e June 202
0.
In ad
diti
on,
An
ne se
rv
ed as H
ans
a
’s Vic
e Pres
ide
nt Gl
oba
l
Hu
man Re
sou
rce
s from J
anu
ar
y 201
9 to Jun
e 2020.
Sh
e
br
ing
s 1
8 year
s of
hu
man re
sou
rce
s
ex
per
ien
ce
in int
ernational environments.
Prior t
o joining Hansa,
sh
e ser
ve
d in var
iou
s sen
ior ro
les a
t the Eur
ope
an
Spallation Source
, a
European multi-disciplinary
re
sea
rch fa
cili
ty, from A
ugu
st 201
1 to Ja
nua
ry 2019,
in
clud
ing H
ead of R
eso
urci
ng fr
om Jan
uar
y 201
7 to
Ja
nua
ry 2019. Prio
r to that, A
nne s
er
ved a
s Hea
d of
Hu
man Re
sou
rces at C
ella
vis
ion AB (STO:CE
VI), a
provider
of d
igital solution
s for
medical micro
scopy
wi
thin h
ema
tolog
y
, fro
m Ap
ril 2010 to Augu
st 201
1
.
She has
held positions
both
as Head o
f HR,
Head
of Re
sour
cing
,
HR Ma
nag
er & Dep
ut
y
He
ad of HR
an
d
ha
s exte
nsi
ve expe
rie
nce f
rom fas
t
gr
owin
g
start-up in
ternational companies.
Anne holds a
Bachelor of
Social Science in
Human Resource
Management,
focusing
on stra
tegic organiza
tional
dev
elo
pme
nt &
l
eade
rs
hip, fro
m
Lu
nd Uni
ver
sit
y
.
She was
born in
1
969.
Achim Kaufhold
Se
nio
r Vic
e
Pr
esi
den
t, Ch
ief Me
dic
al O
cer
Sh
ar
eho
ldin
g: –
Sh
ar
e rig
hts
: 60,0
00
ESOP’s: 70,000
Ach
im Kau
fh
old ha
s
se
r
ved as Ch
ief Me
dic
al Oc
er
si
nce Ju
ne 2020. He is a hig
hly ex
per
ien
ced s
eni
or
leader in immunology
, infectious diseases and
on
col
ogy. Achi
m has ov
er 25 yea
rs of in
tern
atio
nal
exp
eri
enc
e with
in the bi
otec
hno
log
y
an
d
pharmaceutical industry and has a
successful track
re
cord i
n tak
ing p
rodu
cts f
rom ea
rly d
isc
over
y
thr
oug
h deve
lop
ment a
nd to th
e mar
ket. Pri
or to
joining Hansa, A
chim served in various senior
exec
uti
ve posi
tio
ns in gen
era
l mana
gem
ent, pr
oduc
t
an
d bus
ine
ss dev
elo
pme
nt. He se
rv
ed as C
hief
E
xecu
tive O
ce
r of Ate
ch AS i
n 200
9 and
Pha
rme
xa A/
S
in 20
08 (wh
ich co
mpa
nie
s merg
ed),
Ch
ief Me
dic
al Oc
er of Bas
ile
a Phar
mac
eut
ica AG,
or Ba
sil
ea (SIX
:
BS
LN) f
rom Feb
rua
ry 2010
to
De
cem
ber 201
7
, Pha
rmex
a A/S f
rom 2007 to 200
8,
Ch
iron (ac
quir
ed by Nova
rti
s (NYSE: N
VS)) from 20
05
to 200
6 and Be
rna Bi
otec
h
AG (now Jo
hns
on &
Jo
hnso
n (LSE: JN
J)) from 20
01
to 200
5. Prio
r to
th
at,
he headed
the worldwide
clinical dev
elopment of
the
pe
diat
ric va
ccin
e por
tf
oli
o
of Gl
axo
Smi
thK
line p
lc
(LS
E: GSK
).
He c
urre
ntly a
lso se
rve
s on the bo
ard of
di
recto
rs of Bio
ser
gen AB (STO: BIO
SGN). Ac
him
graduat
ed as a
Doctor
of Medicine
from t
he
University of Cologne
and holds a
professorship in
Medical Microbiology and Inf
ectious Diseases at
the
Un
iver
sit
y of Aa
che
n, Ge
rma
ny
. He wa
s bor
n in 1
957
.
Th
e numb
er of ESOP
’
s r
efers to th
e numb
er
of
employee
stock
options
which the
ex
ecutive
holds f
ollowing t
he implementa
tion
of the i
nce
ntive pro
gra
ms L
TI
P201
9,
L
T
IP2020 an
d L
TI
P2021
. In L
TIP201
9, eac
h
employ
ee st
ock opt
ion entit
les the h
older to
sub
scr
ibe for o
ne new o
rdin
ar
y shar
e at a
subscript
ion price corr
esponding t
o 1
1
0 p
er
ce
nt of the vol
ume we
ighte
d averag
e sha
re
pr
ice du
rin
g the ten (1
0
) tradin
g days
imm
edi
ately p
rior to th
e oer to subs
cri
be for
the e
mpl
oyee stoc
k option
s. In L
T
IP2020 an
d
L
T
IP2021
, e
ach em
ploye
e stock opt
ion
entitles
the holder
to
subscribe f
or one ne
w
ord
inar
y sh
are at an exe
rcise p
ric
e
co
rres
pond
ing to the h
igh
er of (i
) 1
25 per
ce
nt of the vol
ume we
ighte
d averag
e sha
re
pr
ice du
rin
g the 1
0 an
d 30 trad
ing days,
respectively
, immediately
preceding t
he
respective
allot
ment of
the emplo
yee s
tock
option
s. The emplo
yee s
tock
options
were
al
lotte
d free of c
harg
e and h
ave a vestin
g
pe
rio
d of three ye
ars.
Hansa Biopharma
Annual Report 202
1
13
9
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Int
ernal controls
and risk
management in r
espec
t
of the nancial r
epor
t
ing
Introduc
tion
Th
e foll
owing d
esc
ripti
on is ba
sed on g
uid
elin
es is
sue
d in 200
8
by the C
onfe
derat
ion of Swe
dis
h Enter
pris
e and FAR.
Th
e Comp
any’
s in
terna
l cont
rol pro
cedu
res in re
spe
ct of the
na
nci
al rep
or
ting hav
e been fo
rmu
lated to en
sure, wi
th
reasonable certaint
y
, quality
, and accuracy in
the reporting.
Th
e proc
edur
es are d
esi
gned to e
nsure t
hat the re
por
tin
g is
pre
pare
d in acc
orda
nce w
ith ap
plic
abl
e laws an
d regu
latio
ns
as w
ell as the
requiremen
ts which
are imposed
on companies
wi
th sha
res adm
itte
d for trad
ing o
n a regu
lated ma
rket in
Swe
den. T
he imp
or
tant p
rereq
uisi
tes for ac
hiev
ing th
is are: (i)
the ex
isten
ce of a sati
sfacto
ry c
ontrol e
nviro
nme
nt; (ii) th
e
execu
tion of re
lia
ble ri
sk as
ses
smen
ts; (iii
) the exis
tence of
established con
trol s
tructures
and contr
ol act
ivities;
and (iv)
satisf
actory inf
ormation,
communicat
ions, and
follow
-up
.
Internal a
udit
Th
e Boar
d has eva
luated t
he nee
d for an i
ntern
al aud
it fu
ncti
on
an
d has co
nclu
ded th
at it is n
ot warr
anted fo
r Hans
a due to th
e
sc
ope an
d size of th
e oper
ation
s and b
ecau
se the B
oard’s
fol
low-up of th
e inter
nal co
ntrol is d
eem
ed su
cie
nt to ensu
re
that th
e inter
nal c
ontrol i
s eect
ive. The B
oard w
ill rev
iew the
ne
ed in th
e event of c
hang
es wh
ich may g
ive ri
se to re-
evalua
tion and
at least
once annually
.
Control environment
Int
ernal contr
ol is b
ased on Hansa
’s
contr
ol envir
onment,
which comprises
the v
alues and et
hics from
which the
Board
,
the Au
dit Co
mmi
ttee, th
e CEO
, the E
xec
utive C
ommi
ttee, a
nd
othe
r emp
loyee
s comm
unic
ate and o
per
ate. The co
ntrol
environmen
t also inc
ludes the Com
pany’
s organizat
ional
structur
e,
leadership
, decisional st
ructure
, decision-making
aut
hori
ty
, re
spon
sibi
lit
y
, a
nd emp
loyee p
roci
ency.
Risk
assessment
Ris
k ide
ntic
atio
n and eva
luati
on are ca
rri
ed ou
t in a man
ner to
al
so inc
lude r
isks re
gard
ing n
anci
al rep
or
ting. A
s par
t of this
pro
cedu
re, items i
n the in
com
e statem
ent an
d statem
ent of
na
nci
al pos
itio
n enta
ilin
g a great r
isk of si
gni
can
t erro
r are
id
enti
ed. For Ha
nsa
, accr
ued pr
ojec
t costs i
n the Co
mpany’s
cli
nic
al proj
ects h
ave, at vari
ous tim
es, invo
lved s
igni
ca
nt
am
ounts. T
he size of th
ese i
s base
d, t
o gre
at exte
nt, on
management’
s assessment o
f the
degree of
completion
. More
rec
entl
y
, p
roduc
t sal
es, co
ntract r
evenu
e and inve
ntor
y
valuat
ion became it
ems which
could include
an eleva
ted
risk of
si
gni
cant e
rror a
s they may in
volve si
gni
can
t amou
nt of
jud
gem
ent a
nd esti
mates. Fu
rth
er
, cas
h and e
quiva
len
ts, as
wel
l as cur
rent inve
stme
nts, co
mpri
se a sig
ni
cant p
erce
ntage
of the C
ompa
ny’
s total a
ssets a
nd are t
herefo
re dee
med to
gi
ve rise to a ri
sk in th
e nan
cial re
por
ti
ng. More
over
, the fa
ct
that H
ans
a
’
s adm
inis
tratio
n is ha
ndle
d by a rela
tivel
y sma
ll
num
ber of i
ndiv
idu
als is l
isted a
s a ris
k sinc
e the de
pen
denc
y
on a s
mall n
umbe
r of key indi
vid
uals b
eco
mes g
reat a
nd the
possibilit
y
to
allocate tasks and
responsibilit
y
become
s
limited.
Th
e Comp
any’
s ri
sk ma
nage
ment p
olic
y
, n
anc
ial ha
ndbo
ok
an
d fur
the
r poli
cie
s inc
lude c
ontro
ls to preven
t and de
tect
shor
t
comings in t
hese and ot
her areas.
Con
trol s
tructure
and c
ontrol
activ
ities
Th
e Boar
d’
s r
ule
s of proc
edur
e and the i
nstr
ucti
ons for t
he
CEO a
nd Boa
rd com
mit
tees e
nsure a c
lea
r all
ocati
on of rol
es
and responsi
bility
. The Bo
ard has
overall
responsibility f
or
int
ernal contr
ols. The
CEO is
responsible f
or the
development
of the sy
stem of rou
tine
s, proc
edu
res, an
d contro
ls for t
he
day
-t
o-day operations
. This includes,
among other
things,
guidelines,
and role
descriptions
for t
he various
decision-
ma
kers as we
ll as re
gul
ar rep
or
ting to th
e Board b
ase
d on
established r
outines.
Policies,
procedures
, rout
ines,
ins
truc
tion
s and tem
plates fo
r the n
anci
al rep
or
ting a
nd the
day-to-d
ay admi
nistr
ative n
anci
al op
erati
ons an
d nan
cia
l
is
sues a
re doc
ume
nted in Ha
nsa’
s po
lici
es. Ro
utin
es and
act
ivit
ies have b
een d
esi
gned to ma
nag
e and re
ctif
y sig
ni
cant
ri
sks whi
ch are re
lated to th
e nan
cia
l repor
ti
ng, and w
hich a
re
id
enti
ed in th
e risk a
nal
ysis. T
he mos
t sign
ic
ant, overa
ll,
group-wide
corporate go
vernance documents ar
e the w
ork
pro
cedu
res for t
he Boa
rd, instr
ucti
ons for t
he CEO, nan
cial
handbook,
disclosure
policy
, insider policy
, risk management
policy
, and Code
of Con
duct.
Th
e pri
mar
y pur
pos
e of contro
l acti
viti
es is th
e preve
ntion a
nd
ea
rly-s
tage d
etecti
on of err
ors in th
e nan
cia
l repo
rti
ng so tha
t
they c
an be a
ddre
ssed a
nd co
rrec
ted. Th
e Group h
as
implement
ed entity le
vel cont
rols as
well as
process cont
rols.
Acc
ess to IT s
ystems i
s limi
ted an
d contro
lle
d in acc
orda
nce
with po
wers and
authorizat
ion. Manu
al and aut
omat
ed cont
rol
step
s are inc
orp
orated t
hroug
hout t
he acc
ounti
ng, na
ncia
l
cl
osin
g and n
anci
al rep
or
ting p
roce
ss. Th
e CFO com
pile
s
mo
nthly 
nanc
ial re
por
ts wh
ich, am
ong oth
er thin
gs, are to
rep
or
t ear
ning
s and c
ash ow fo
r the pre
ced
ing pe
rio
d and
state b
udge
t devi
ation
s. The
se rep
or
ts, an
d above al
l the
bud
get de
viati
ons, a
re ana
lyse
d and c
omme
nted up
on by
Company management
. Follow
-up tak
es place thr
ough regular
me
eting
s for revi
ew of the
se rep
or
ts and a
nal
yses w
ith the
various managers and pr
oject managers. The w
ork involv
ed
wi
th annu
al ac
coun
ts and a
nnua
l repo
rts a
re pro
ces
ses wh
ich
pos
e addi
tion
al ris
ks for er
rors i
n the n
anci
al rep
or
ts. Thi
s
wor
k is of a le
ss rep
etiti
ve nature a
nd co
ntai
ns more e
valuat
ive
elements.
Important contr
ol activit
ies include
, among o
ther
thi
ngs, ex
tern
al con
rmat
ions (e.g. ban
k statem
ents or 3
rd
pa
rt
y vend
or co
nrm
ation
s
) as we
ll as en
sur
ing tha
t there i
s a
properly functioning r
epor
ting
structure in
which the v
arious
managers and project
managers repor
t
pursuant t
o
standardized
templat
es, and t
hat important income stat
ement
an
d statem
ent of na
nci
al pos
itio
n items a
re ana
lyze
d and
comment
ed upon.
Hansa Biopharma
Annual Report 202
1
14
0
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Information and communication
The inf
ormational
activities ar
e gov
erned by
an info
rmation
po
licy
. T
here a
re guid
elin
es for ex
ter
nal co
mmun
icati
ons w
hich
en
sure th
at the Co
mpany m
eets h
igh st
anda
rds for p
rovid
ing
co
rrec
t infor
matio
n to
th
e shar
ehol
der
s and th
e nan
cial
ma
rket. Han
sa’
s c
ommu
nic
ation
s must b
e char
acter
ized by
tra
nspa
renc
y and mu
st be co
rrec
t, releva
nt, reli
abl
e and cl
ear;
they m
ay not be mi
slea
ding. A u
nifor
m strate
gy for ex
tern
al
communication
s reduces t
he risk o
f erroneous
informat
ion,
rumours, and misunderstandings
. All communications
must
ta
k
e pl
ace i
n acco
rdan
ce wit
h Nasd
aq Stock
hol
m
’
s Is
sue
r
Rul
es, th
e Swedi
sh Co
de of Cor
por
ate Gover
nanc
e, and th
e
laws and
requirements imposed on
Swedish companies whose
sh
ares a
re admi
tted fo
r tradi
ng on a re
gul
ated mar
ket. The
po
licy a
ppli
es to all e
mpl
oyees a
nd dire
ctors o
f Hans
a
Bi
opha
rma a
nd app
lie
s to both ora
l and wr
it
ten info
rmati
on.
Th
e Board r
ele
ases a
nnua
l repo
r
ts, nan
cia
l statem
ents an
d
inte
rim re
por
ts. Al
l nan
cia
l repo
rts a
re publ
ish
ed on the
web
site (w
ww.hans
abi
opha
rma
.
co
m) afte
r havin
g rst b
een
pub
lis
hed pu
rsua
nt to Nas
daq Stoc
kho
lm’
s r
ule
s and
regulat
ions. The
annual report is ma
de av
ailable on t
he websit
e
an
d is provi
ded a
s a hard c
opy to thos
e shar
ehol
der
s who
so wish
.
Fol
low-u
p
The Board
’
s f
ollow
-up on
internal
controls
in respect
of t
he
na
nci
al rep
or
ting ta
kes pl
ace, amo
ng othe
r thin
gs, throu
gh
fol
low-up by a
nd thro
ugh the A
udit C
ommi
tte
e, on the wor
k
an
d repor
ts of th
e CFO and t
he exte
rna
l audi
t
or
s. The wo
rk
includes ensuring that
measures are t
aken in r
espect of the
shor
t
comings and pr
oposed measures generated
in
co
njun
ction w
ith the ex
ter
nal au
dit. Th
e focus of th
e foll
ow-up
is Hansa compliance with
policies, rules and guidelines
; and
the ex
isten
ce of ec
ient a
nd sui
tabl
e proc
esse
s for ri
sk
management
, operat
ional management
, and
internal
control
.
Eac
h year
, the ex
ter
nal au
ditor fo
llows u
p on the se
lec
ted
elements o
f the
int
ernal contr
ol within
the scope
of t
he
statut
or
y audit
.
Th
e audi
tor repo
rt
s the res
ults of th
e exami
natio
n t
o the
Aud
it Com
mit
tee an
d Comp
any man
age
ment. Si
gni
can
t
obse
rvatio
ns are repor
ted, where a
pplica
ble, directl
y t
o
the
Boar
d.
Th
e CEO is re
spon
sibl
e for co
mpil
ing al
l exper
ien
ce fro
m the
Company’
s risk management work
and, f
ollowing discussions
with Company
management, pr
oposing any changes which
the C
EO dee
ms ne
ces
sar
y or a
ppli
cab
le. Th
e Board w
ill
de
cide o
n any ch
ang
es.
Internal co
ntrols and risk
management
in res
pect of th
e
n
ancial re
por
ting
conti
nued
Hansa Biopharma
Annual Report 202
1
141
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Co
mpliance
Ha
nsa ha
s adopte
d a Code o
f Cond
uct for a
ll of its d
irec
tors,
oc
ers, a
nd ass
ocia
tes whi
ch sets fo
rt
h the sta
ndard
s for
business behaviours tha
t apply throughout
the Company
and
de
scri
bes th
e expe
ctati
ons Ha
nsa ha
s for its b
usin
ess
pa
rtn
ers, a
nd tho
se acti
ng on be
hal
f of the Co
mpany.
Th
e Cod
e cont
ains g
uida
nce in t
he are
as of pe
rson
al an
d
corporat
e int
egrity
, r
esponsibility to
ward
the Compan
y
, its
associat
es and t
he community as
well as
responsible and
comprehensive compliance management
.
Aligned with
the Code
of Cond
uct,
Hansa has estab
lished a
global compliance framework.
This compliance framework
inc
lud
es, but i
s not li
mited to, com
plia
nce a
nd bus
ine
ss uni
t
policies and
procedure
documents,
compliance risk
mitigation
and violat
ion reporting pr
ocesses, dat
a privacy
precautions
as
well as
internal audit
ing and monit
oring activities.
Hansa Biopharma
Annual Report 202
1
14
2
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
E
x
ecut
iv
e Remuner
ation –
to be appr
o
v
ed by A
GM’22
Th
e seni
or execu
tive
s, the CEO an
d mem
ber
s of the execu
tive co
mmit
tee, fal
l with
in the
prov
isio
ns of thi
s poli
cy
. T
o the ex
tent a bo
ard me
mbe
r cond
ucts wo
rk for th
e Comp
any
, i
n
add
itio
n to the boa
rd work
, cons
ulti
ng fee
s and oth
er co
mpen
satio
n for su
ch wor
k may be pa
id.
Th
e poli
cy is fo
rwa
rd loo
kin
g, i.
e. ap
plic
abl
e t
o re
mune
ratio
n agre
ed, and a
men
dme
nts to
rem
une
ratio
n alre
ady agr
eed, af
ter a
doptio
n of the po
licy by t
he ann
ual g
ene
ral me
eting i
n 2022.
A pre
requ
isite fo
r the su
cce
ssfu
l impl
eme
ntati
on of the c
ompa
ny’
s bus
ine
ss strate
gy an
d
safe
gua
rdin
g of its
long-
term
int
erests,
including its sustainability
, is tha
t the company
is able t
o
rec
rui
t and ret
ain qu
ali
ed pe
rson
nel, c
onse
que
ntly
, it is n
ece
ssa
ry t
hat the c
ompa
ny oers
mar
k
et com
petitive remu
neration.
For i
nform
ation re
gard
ing Ha
nsa B
ioph
arm
a
’
s stra
tegic p
rio
riti
es, ple
ase v
isit h
ttps:/
/
hansabiopharma.com/this-is-hansa/
our
-commitment/
For i
nform
ation re
gard
ing Ha
nsa B
ioph
arm
a
’
s eq
uit
y stor
y
, p
lea
se vis
it htt
ps:/
/
inves
tors.
hansabiopharma.com/English/
our
-equity-st
or
y
/
default
.aspx
Long-
term (
share-based) incentive
programs ha
ve been implement
ed in the
company
. Such
pro
gram
s have bee
n reso
lved by th
e gen
eral m
eeti
ng and a
re there
fore exclu
ded f
rom the
se
gui
del
ine
s. The pr
ogra
m incl
ude, am
ong othe
rs, the C
EO and oth
er se
nior exe
cutiv
es in the
co
mpany. The pe
r
form
ance c
rite
ria u
sed to as
ses
s the outc
ome of th
e plan
s are di
stinc
tly li
nked
to the bu
sin
ess st
rategy a
nd the
reby to the c
ompa
ny’
s lo
ng-term va
lue c
reati
on, inc
ludi
ng its
sustainability
.
For mor
e informat
ion regarding t
hese incentive pr
ograms, including
the criteria which
the
outcome
depends on, please
see https
:/
/
hansabiopharma.
com/this-is-hansa/corporat
e-
governance/
.
Th
is pol
icy en
abl
es the co
mpa
ny t
o oe
r seni
or execu
tive
s a comp
etitiv
e remun
erati
on. Th
e
rem
une
ratio
n shal
l be on ma
rket term
s and may c
onsi
st of the fo
llowi
ng com
pon
ents: xed b
ase
sa
lar
y
, vari
abl
e cas
h remun
erati
on (i
nclu
ding ST
I)
, pe
nsio
n ben
ets an
d other b
ene
ts. Th
e
co
mpon
ents, th
eir p
urpo
se and l
ink to the c
omp
any’
s bus
ine
ss str
ategy a
re des
crib
ed be
low
.
The decisio
n-making process
to
determine,
review
and implemen
t the po
licy
Th
e Boar
d of Dire
ctors h
as est
abli
she
d a Comm
it
tee wit
hin the B
oard (th
e Rem
uner
ation
Co
mmit
tee), with th
e task
s of prep
arin
g, with
in the B
oard of D
irec
t
or
s, the po
licy fo
r remu
ner
ation
for se
nio
r executi
ves. T
he Boa
rd of Dire
ctors s
hall p
ropo
se a revi
sed po
licy at l
east e
ver
y four
th
yea
r and su
bmi
t it to the ge
ner
al me
eting. T
he gui
del
ines s
hal
l be in forc
e unti
l new gui
del
ine
s are
adopt
ed b
y the
general meeting
. The R
emuneration
Committee shall
also monit
or and
evaluat
e
pro
gram
s for var
iabl
e remu
nera
tion for s
eni
or execu
tives, th
e app
lica
tion of th
e guid
elin
es for
execu
tive re
mune
ratio
n as wel
l as the cu
rrent r
emun
erati
on str
uctur
es and c
omp
ensa
tion le
vels
in th
e comp
any
. Th
e mem
bers of t
he Rem
une
ratio
n Comm
itte
e are in
dep
end
ent of the c
ompa
ny
an
d its execu
tive ma
nage
ment.
Unl
ess ot
her
wi
se state
d here
in, the Bo
ard of Di
recto
rs sha
ll res
olve o
n matte
rs reg
ardi
ng
rem
une
ratio
n
an
d empl
oyme
nt provi
sion
s for all othe
r seni
or execu
tives. T
he CEO may
de
cide u
pon Varia
ble Ca
sh Rem
uner
ation, in
clu
ding STI, for th
e other se
nio
r
exec
utive
s. The
Remuneration
Committee and
the C
EO
, as
applicable,
shall conti
nuously report t
o the
Board o
f
Di
rector
s. The CEO a
nd the othe
r seni
or execut
ives sh
all not be p
rese
nt when th
eir re
spe
ctive
remun
eration ter
ms are decid
ed.
Additionally
, the general
meeting m
ay –
irrespective
of t
his policy
– resolv
e on,
among o
ther
thing
s,
sh
are-related o
r share pri
ce-relate
d
rem
uneratio
n.
Purpose and
li
nk to stra
tegy
Su
ppor
ts t
he at
tract
ion a
nd rete
ntio
n of the be
st ta
len
t. Ensu
res co
mpet
itiv
ene
ss wh
ile
co
ntrol
lin
g
xed cos
ts to
ma
xi
mis
e eci
enc
y
.
Ope
rational
Details
>
No
rma
lly rev
iewe
d annu
all
y and in
crea
ses w
ill us
uall
y be ee
ctive f
rom 1 Ap
ril or fo
llow
ing
a change
in responsibilit
ies.
>
The Remunerat
ion Committee
will consider
, among o
ther thi
ngs, the
followin
g paramet
ers
wh
en revi
ewi
ng xed b
ase sa
lar
y:
–
Economic and
salar
y conditions
and trends
–
The individual
’
s performance and r
esponsibilities
–
Ba
se sal
ari
es a
nd total r
emu
nera
tion a
t other c
omp
ani
es tha
t ope
rate in th
e sam
e
ma
rkets, t
yp
ica
lly b
enc
hmar
ked ag
ain
st sim
ila
r role
s.
V
ariable Cash
Remuneration
A por
ti
on of the tota
l remun
erati
on for th
e seni
or exec
utive
s are lin
ked to busi
nes
s per
for
man
ce
so th
at total rem
une
ratio
n will i
ncre
ase or d
ecre
ase i
n line w
ith pe
r
forma
nce, th
us prom
oting
the c
ompa
ny’
s bus
ine
ss stra
t
e
gy and l
ong-te
rm inte
rests (se
e “
A
nnua
l Sho
rt-
T
er
m Ince
ntive
(STI)” bel
ow)
.
For rete
ntio
n or recr
uitm
ent pu
rpo
ses or ex
trao
rdin
ar
y per
for
man
ce beyo
nd the in
div
idua
l’
s
ord
inar
y ta
sks th
e Remu
nera
tion C
ommi
ttee, b
ased o
n prop
osal of C
EO
, may
, on a
n ind
ivid
ual
Hansa Biopharma
Annual Report 202
1
14
3
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
bas
is, de
cid
e on an add
itio
nal var
iab
le ca
sh remu
ner
ation. Su
ch rem
une
ratio
n may not excee
d
an a
nnua
l amou
nt cor
resp
ond
ing to 30 pe
rcent of th
e total xe
d annu
al ca
sh sal
ar
y and m
ay not
be pa
id mo
re than o
nce e
ach yea
r per i
ndiv
idu
al.
Annual Shor
t
-
T
erm Incentive (STI)
Purpose and
li
nk to stra
tegy
Su
ppor
ts t
he at
tract
ion a
nd rete
ntio
n of the be
st ta
len
t. Ensu
res co
mpet
itiv
ene
ss wh
ile
co
ntrol
lin
g
xed cos
ts to
ma
xi
mis
e eci
enc
y
.
Ope
rational
Details
>
The performance criteria,
weightin
g and tar
gets f
or the
corporate
objectives ar
e to
be
pro
pos
ed by the R
emu
ner
atio
n Comm
it
tee an
nua
lly
, eva
lua
ted an
d appr
oved by th
e Boa
rd
of Di
rec
tors. S
tretch
ed ta
rgets s
hal
l be set by r
efere
nce to t
he co
mpan
y’
s op
erati
ng pl
an
and hist
orical and projected
per
formance.
>
Th
e per
fo
rma
nce c
rite
ria, w
eig
hting a
nd ta
rget
s for the i
ndi
vid
ual o
bje
ctive
s are to b
e
pro
pos
ed, eva
luate
d and a
pprov
ed an
nual
ly by th
e CEO as m
ana
ger fo
r mem
ber
s of the
exec
utiv
e comm
itte
e or
, if it is n
ot the CEO, the
n the res
pec
tive ma
nag
er for su
ch
me
mbe
rs of the exe
cuti
ve comm
it
tee, and fo
r the CEO th
e Remu
ner
atio
n
C
ommi
tte
e.
>
Th
e outc
ome of c
rite
ria fo
r award
ing ST
I is to be m
eas
ured ov
er a pe
rio
d of one ye
ar an
d
de
pen
d on the de
gre
e
of fu
ll
men
t
of pr
edete
rmi
ned ta
rget
s.
>
Th
e Boa
rd of Dir
ecto
rs sh
all hav
e the po
ssi
bili
ty, unde
r ap
plic
abl
e law or c
ontr
actu
al
prov
isi
ons, s
ubj
ect to th
e rest
ric
tion
s that m
ay app
ly un
der l
aw or co
ntrac
t, to recl
aim i
n
wh
ole o
r in par
t ST
I paid o
n inc
orr
ect gr
ound
s (claw-
back
).
Opportunity
Level
s
Th
e ma
ximu
m opp
or
tuni
ty for ST
I can am
oun
t
up to ma
x 75
p
erce
nt of xed ba
se sa
lar
y
.
The Remunerat
ion Committee
shall hav
e the
possibility to
review
the opportunity lev
els in
ord
er to en
sure m
arke
t com
petit
iven
es
s.
Performance
criteria
Th
e STI pl
an awa
rds sh
all b
e base
d on co
rpo
rate ob
jec
tive
s and i
ndi
vidu
al ob
jec
tive
s and b
e
link
ed t
o prede
termined
and m
easurable
criteria.
Th
e cri
teri
a sha
ll be d
esi
gne
d so as to co
ntri
bute to th
e com
pany
’
s bus
ine
ss str
ategy a
nd
lo
ng-te
rm inte
res
ts.
For 
nanc
ial o
bje
ctive
s, the eva
luat
ion sh
all be b
ase
d
o
n
th
e lates
t
n
anc
ial in
form
atio
n made
pu
blic by t
he co
mpa
ny
.
Pension
Benets
Purpose and
li
nk to stra
tegy
Prov
ide c
ompe
titi
ve and co
st-ee
ctiv
e
be
ne
ts.
Ope
rational
Details
>
Ot
her be
ne
ts may inc
lud
e but is not l
imite
d to life in
sura
nce, s
ur
vivo
r ben
et, acc
ide
nta
l
de
ath and d
isa
bili
ty in
sur
anc
e,
me
dic
al in
sura
nce
/
cove
r (Sw
.: sjuk
vå
rdsfö
rsä
kr
ing), and a
company
car or
car allo
wance.
>
For exe
cuti
ve oc
ers gov
ern
ed by rul
es oth
er tha
n
Sw
edis
h, ben
ets m
ay be dul
y
ad
juste
d
for c
omp
lia
nce w
ith ma
ndato
ry r
ule
s or es
tab
lish
ed lo
cal p
rac
tice, t
aki
ng into a
cco
unt, to
the ex
ten
t
po
ssi
ble, th
e overa
ll pur
pos
e
of th
is pol
icy.
>
E
xecu
tive oc
ers w
ho are in
tern
atio
nal as
sig
nee
s (for exa
mpl
e
ex
patr
iates) to or fr
om
Swe
den m
ay rece
ive ad
diti
ona
l
re
mun
erat
ion an
d other b
ene
ts to the ex
tent re
ason
abl
e
in light
of
the special
circumstances associa
ted wit
h the
internat
ional assignment
ar
ran
gem
ent, ta
kin
g
in
to
ac
cou
nt, to the exte
nt pos
sib
le, the ove
ral
l
pu
rpo
se of thi
s
po
lic
y
.
Opportunity
Level
s
Ot
her be
ne
ts may am
ount to not mo
re tha
n
10
p
erce
nt of the xe
d annu
al ca
sh sal
ar
y and
sh
all be se
t at a
le
vel wh
ich th
e
Re
mun
erat
ion Co
mmi
ttee c
ons
ide
rs to
:
>
prov
ide th
e rele
vant le
vel of be
net d
epe
ndin
g on rol
e and the i
ndiv
idu
al cir
cums
tan
ces,
>
be in l
ine wi
th com
para
ble ro
les i
n
co
mpa
nie
s with si
mil
ar size a
nd com
plex
it
y in the
rel
evan
t mar
ket, and
>
be ap
pro
pri
ate comp
are
d
to the b
ene
ts oer
ed to the wi
der wo
rk
force i
n the rel
evant
ma
rket.
Other Benets
Purpose and
li
nk to stra
tegy
Prov
ide c
ompe
titi
ve and co
st-ee
ctiv
e
be
ne
ts.
Ope
rational
Details
>
Ot
her be
ne
ts may inc
lud
e but is not l
imite
d to life in
sura
nce, s
ur
vivo
r ben
et, acc
ide
nta
l
de
ath and d
isa
bili
ty in
sur
anc
e,
me
dic
al in
sura
nce
/
cove
r (Sw
.: sjuk
vå
rdsfö
rsä
kr
ing), and a
company
car or
car allo
wance.
>
For exe
cuti
ve oc
ers gov
ern
ed by rul
es oth
er tha
n
Sw
edis
h, ben
ets m
ay be dul
y
ad
juste
d
for c
omp
lia
nce w
ith ma
ndato
ry r
ule
s or es
tab
lish
ed lo
cal p
rac
tice, t
aki
ng into a
cco
unt, to
the ex
ten
t
po
ssi
ble, th
e overa
ll pur
pos
e
of th
is pol
icy.
>
E
xecu
tive oc
ers w
ho are in
tern
atio
nal as
sig
nee
s (for exa
mpl
e
ex
patr
iates) to or fr
om
Swe
den m
ay rece
ive ad
diti
ona
l
re
mun
erat
ion an
d other b
ene
ts to the ex
tent re
ason
abl
e
in light
of
the special
circumstances associa
ted wit
h the
internat
ional assignment
ar
ran
gem
ent, ta
kin
g
in
to
ac
cou
nt, to the exte
nt pos
sib
le, the ove
ral
l
pu
rpo
se of thi
s
po
lic
y
.
Executiv
e R
emuneration –
to be app
rov
ed by A
GM’22
cont
inued
Hansa Biopharma
Annual Report 202
1
14
4
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Opportunity
Level
s
Ot
her be
ne
ts may am
ount to not mo
re tha
n
10
p
erce
nt of the xe
d annu
al ca
sh sal
ar
y and
sh
all be se
t at a
le
vel wh
ich th
e
Re
mun
erat
ion Co
mmi
ttee c
ons
ide
rs to
:
>
prov
ide th
e rele
vant le
vel of be
net d
epe
ndin
g on rol
e and the i
ndiv
idu
al cir
cums
tan
ces,
>
be in l
ine wi
th com
para
ble ro
les i
n
co
mpa
nie
s with si
mil
ar size a
nd com
plex
it
y in the
rel
evan
t mar
ket, and
>
be ap
pro
pri
ate comp
are
d
to the b
ene
ts oer
ed to the wi
der wo
rk
force i
n the rel
evant
ma
rket.
T
ermination o
f emplo
yment
Details
>
If n
otic
e
of ter
min
atio
n of
e
mplo
yme
nt is mad
e by
th
e comp
any:
–
Th
e notic
e per
iod may n
ot excee
d six mo
nths.
–
Fi
xed cas
h sal
ar
y duri
ng the p
eri
od of noti
ce and s
evera
nce p
ay may toget
her not
exce
ed an am
oun
t
e
quiv
ale
nt to
th
e xed ca
sh sa
lar
y for 18
mo
nths fo
r the CEO,
i.e. 6 + 1
2 mo
nths.
–
Fi
xed cas
h sal
ar
y duri
ng the p
eri
od of noti
ce and s
evera
nce p
ay may toget
her not
exce
ed an am
oun
t
e
quiv
ale
nt to
th
e xed ca
sh sa
lar
y for 6 mo
nths, a
nd in exce
ption
al
ca
ses, 12
mo
nths fo
r the othe
r seni
or exec
uti
ves.
>
Wh
en ter
mina
tion i
s
ma
de by the se
nio
r execu
tive the p
eri
od of noti
ce may not exc
eed s
ix
mo
nths. N
o seve
ranc
e pay wi
ll be p
aid.
>
Re
patr
iati
on – If the se
nior exe
cut
ive is an in
tern
atio
nal as
sig
nee th
e com
pany may
rei
mbu
rse re
aso
nab
le co
st for th
e repa
tria
tion o
f good l
eave
rs, ta
kin
g into ac
cou
nt, to the
ex
tent po
ssi
ble, the ov
eral
l pur
pose of th
is pol
icy.
For s
eni
or execu
tive
s gover
ned by r
ule
s other th
an Swe
dis
h,
pay
me
nts in co
nne
ctio
n with
termination
may be
duly adjusted
for compliance with
mandatory rules or established local
pr
acti
ce, tak
ing in
to
ac
cou
nt, to the exte
nt pos
sib
le, the ove
ral
l
pu
rpo
se of this p
oli
cy
.
Salar
y
and emplo
yment conditions
for
employ
ees
In th
e prep
arati
on of the Bo
ard of Di
recto
rs’ prop
osal fo
r this re
mun
erati
on pol
icy
, sa
lar
y an
d
em
ploym
ent c
ondi
tion
s for emp
loyee
s of the co
mpa
ny have be
en take
n into acc
ount by i
nclu
ding
informa
tion on
the emplo
yees
’ to
tal income
, t
he components
of t
he remunera
tion and
increase
an
d grow
th rate over ti
me.
Derogation from the policy
Th
e Boar
d of Dire
ctors m
ay tempo
rari
ly re
solve to d
erog
ate from th
e poli
cy
, i
n who
le or in p
ar
t, if
in a sp
eci
c cas
e ther
e is spe
cial c
ause f
or the de
rogat
ion an
d a dero
gatio
n is nec
ess
ar
y to ser
ve
the company
’
s long-
term in
terests
, including its
sustainability
, or
to ensur
e the compan
y’
s
na
nci
al via
bil
ity. As set ou
t above, the R
emun
erati
on Co
mmit
tee’
s tas
ks inc
lude p
repa
ring t
he
Board
of Dir
ectors
’ resolut
ions in
remuneration
-relat
ed matt
ers. This inc
ludes any
resolutions
to
derogat
e from
the polic
y
.
Add
itio
nal inf
orma
tion re
gard
ing execu
tive re
mune
ratio
n is avail
abl
e in the Ha
nsa B
ioph
arm
a
Annual Repor
t.
De
scr
ipt
ion o
f mat
eri
al ch
an
ges to t
he gu
id
eli
nes a
nd how t
he v
iews of
shareholders’ ha
ve
been tak
en into
consideration (
this informativ
e element
to
be r
emove
d onc
e ap
prove
d by AGM’2
2)
In or
der to dr
ive the b
usin
ess o
utcom
es thro
ugh a ta
ilo
red em
ploye
e ince
ntive p
rogra
m that
balances individual
achievemen
t and or
ganisational con
tribution
it is pr
oposed tha
t the
pe
rfo
rma
nce c
riter
ia for th
e “
A
nnua
l Sho
rt-
T
er
m Ince
ntive (“
STI”) s
hall i
nclu
de both c
orp
orate an
d
individual objectives.
Furthermore, it
is proposed tha
t the performance criteria, w
eighting and
ta
rgets fo
r the ind
ivi
dual o
bje
ctive
s unde
r the STI a
re to be pro
pose
d, evalu
ated an
d appr
oved
an
nual
ly CEO as m
anag
er for m
embe
rs of the exe
cuti
ve comm
itte
e or
, i
f it is not th
e CEO, then
the re
spe
ctive m
anag
er for s
uch me
mbe
rs of the exec
utive c
ommi
tte
e
, an
d for the CE
O the
Re
mune
ratio
n Comm
itte
e. The p
ropos
ed adj
ustme
nts have b
een re
ecte
d in the
se gui
deli
nes
wh
ich wi
ll be su
bje
ct to the sh
areh
olde
rs’ app
roval at th
e annu
al ge
ner
al mee
ting 2022.
Du
ring 20
2
1
, n
eith
er the R
emun
erati
on Co
mmit
tee n
or the Bo
ard of Di
recto
rs rec
eive
d any
comments
or questions
from t
he shareholders
on the
remuneration
guidelines adop
ted
at the
an
nual g
ene
ral me
etin
g 202
1
.
Executiv
e R
emuneration –
to be app
rov
ed by A
GM’22
cont
inued
Hansa Biopharma
Annual Report 202
1
14
5
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y
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echnology
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th
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Directors
’
repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
Auditor st
ateme
nt on th
e
corpor
ate go
v
er
nance re
por
t
Hansa Biopharma
Annual Report 202
1
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6
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y
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echnology
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th
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Directors
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repo
rt
ESG
Financials
Remuneration
Ma
rket
Ove
rv
iew
Gov
ernance
T
o th
e gen
era
l meeti
ng of the s
hare
hold
ers i
n Hans
a Bio
pha
rma AB, c
orp
orate id
enti
ty nu
mbe
r
5567
3
4
-5359
Engagement and responsibilit
y
It is t
he boa
rd of dire
ctors w
ho is re
spo
nsib
le for th
e corp
orate g
overn
ance s
tatem
ent for th
e
yea
r 202
1 on p
age
s 1
27
-
1
45 an
d that it h
as be
en pre
pare
d in acc
orda
nce wi
th the A
nnua
l
Acco
unts Act.
Th
e sco
pe of t
he au
dit
Ou
r exami
natio
n has be
en co
nduc
ted in acc
orda
nce w
ith F
AR’s audi
ting st
anda
rd RevU 16 The
aud
itor’s
exa
mina
tion of th
e corp
orate gove
rna
nce st
ateme
nt. Thi
s mean
s that ou
r exami
natio
n of
the c
orp
orate gove
rna
nce st
ateme
nt is die
rent a
nd sub
stant
iall
y les
s in sco
pe tha
n an audi
t
conducted in
accordance with I
nternational
Standards on Audit
ing and generally accept
ed
aud
itin
g stan
dards i
n Swed
en. We beli
eve that th
e exami
natio
n has prov
ide
d us with s
uc
ient
basis for
our opinions.
Opinions
A co
rpor
ate gover
nan
ce state
ment h
as be
en pre
pare
d. Disc
losu
res in a
cco
rdanc
e with c
hapte
r 6
se
ctio
n 6 the se
cond p
arag
raph p
oints 2-6 t
he Ann
ual Ac
cou
nts Act an
d cha
pter 7 sec
tion 31
the s
eco
nd par
agra
ph the s
ame law a
re con
siste
nt wit
h the an
nual a
ccou
nts and t
he
co
nsol
idated a
cco
unts an
d are in ac
cord
anc
e with th
e Ann
ual Ac
coun
ts Act.
Ma
lmö 7 Ap
ril 202
2
KPM
G AB
Jonas
Nihlberg
Authorized
public accountant
11
R
emuner
atio
n
Remuneration Report
1
4
8
Hansa Biopharma
Annual Report 202
1
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y
T
echnology
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th
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Directors
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repo
rt
ESG
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Governance
Ma
rket
Ove
rv
iew
Remuneration
1
Hansa Biopharma Annual Report 2021
Introduction
This remuneration report provi
des an outline of how Hansa’s guidelines for remunerati
on (the
“Remuneration guidelines”), adopted
by Hansa’s Annual General Meeting 2021, were
implemented in 2021. The report also provides information on r
emuneration to the C
EO and a
summary of Hansa’s outstanding share
-
based long
-
ter
m incentive programs. The report has
been prepared in accordance with the Swedish Companies Act and the Remunerati
on Rules
issued by the Swedish Corporate Governance Board.
Further information on senior
executive remuneration is available in Note 14 t
o the Financial
Statements of the Parent Company elsewhere in this
annual report 202
1
. Information on the
work of the remuneration committee in 2021 is set out in the cor
porate governance report
availa
ble
on pages
128
– 1
43
in the
annual report 2021.
Remuneration of the Board of Directors is not covered by this r
eport. Such remuneration is
resolved annually by the annual general meeting and disclosed i
n
Note 14 to the Financial
Statements of the Parent
Company elsewhere in this
annual report 2021
.
Key Developments 2021
Overall
Company performance in 2021
The CEO summarizes the Company’s overall performance in hi
s statement on
pages
7 – 9
in
the annual report 2021. In additi
on, the directors report on pages
58
–
66
of the annual report
2021 summarizes the Company’s 2021 business and operations.
The
Company’s remuneration guidelines: scope,
purpose
,
and deviations
A prerequisite for the successf
ul implementation of the Company’s business strategy and
safeguarding of its long
-
term in
terests, incl
uding its sustainability, is
that the Company is able to
recruit and retain highly qualifi
ed personnel, consequently, it is necessary that the Company
offers market competitive remunerati
on. This has been becoming of paramount importance as
th
e Company is required to attract talent
from and in Sweden, other European countries
,
and
the US. Under Hansa’s remuneration guidelines,
remuneration of senior executives shall be on
market terms and may consist of the following components: fixed base sal
a
ry, variable cash
remuneration (including STI), pension benefits
and other benefits.
The Remuneration guidelines, adopted by the annual
general meeting 2021, can be found on
pages 86
–
93
in the annual report 2021. During 2021, the Company has
complied with the
applicable Remuneration guidelines adopted by t
he general meeting. No deviations from the
guidelines have been decided and no derogations from t
he procedure for implementation of the
guidelines have been made. The auditor’s report
regarding the Company’s compliance with the
guidelines is available on the Company’s websi
te, www.hansabiopharma.com. No remuneration
has been reclaimed.
In addition to remuneration covered by
the Remuneration guidelines, the annual general
meetings of Hansa have
resolved to implement long
-
term share
-
based incentive plans for
certain groups of Hansa employees and. on remunerati
on guidelines for the Board of Directors.
Table 1
–
Total
remuneration of the CEO (kSEK)
1
Table 1 below sets out the total
remuneration related to Hansa’s CEO for 2021.
1
Fixed remuneration
2
Variable remuneration
Name of Director, position
Financial year
Base salary
Other benefits
One-year
variable
Multi-year
variable
3
Extraordinary
items
4
Pension
expense
5
Total
remuneration
6
Proportion of fixed
and variable
remuneration in %
Søren Tulstrup (CEO)
2021
7,010
2
128
3
3,444
0
0
0
10,582
67
/
33
1
Except
for Multi
-
year variable remuneration, the table reports remuneration earned in 2021. Multi
-
year
variable remuneration is reported if vested in 2021, as set out in [column 8 of Table 2 and column 10 of Table 3] below (as applicable). Disbursement of any payments may or may
not have been made the same year
2
Includes KSEK 1,
619
, representing 30% of base salary, intended for own pension contribution
3
Company car
Remuneration report 2021
Remuner
at
ion R
epor
t
Hansa Biopharma
Annual Report 202
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Ove
rv
iew
Remuneration
2
Hansa Biopharma Annual Report 2021
Share based remuneration
Outstanding share
-
based long
-
term incent
ive programs
The Company has three long
-
term incentive programs out
standing in which amongst others
also the CEO participates; long
-
term incentive program (“LTIP”) 2019, 2020 and 2021. The
Company has LTIP 2018 partly outstanding and partly lapsed during 2021. The CEO did
participate in the porti
on of the program which lapsed during 2021.
As a general condition to all progr
ams, any rights may only vest provided that the parti
cipant,
with certain exceptions, from the start of
the incentive program and during the three (3) years
vesting period thereafter maint
ains his or her employment within the Group.
Long
-
term incentive program 2019
On May 22, 2019, the annual general meeting in Hansa Biopharma resolv
ed to adopt a long
-
term incentive program for certai
n employees of the Group. The long
-
term incentive pr
ogram
2019 includes two elements; one performance
-
based share rights program, and one option
program comprising two series, a warrant
,
and a
n
employee stock option series. The CEO was
granted 35,151 share rights and 66,347 employee stoc
k options but chose not to acquire any
warrants under incentive program 2019.
Under the performance
-
based share rights program, each share right enti
tles the holder to
receive one ordinary share in Hansa Biopharma AB free
-
of
-
charge provided that the below
performance conditions are met during the vest
ing period. In addition to the requirement for
the
participant’s continued employment,
the final number of ordinary
shares t
hat each participant is
entitled to receive is condi
tional upon the following performance conditions bei
ng met during the
vesting period: (a) 22 percent of
the shares in the event that market approval is obt
ained by
EMEA within the EU, (b) 22 percent of the s
hares in the event that at least 10 patients enr
olled
in US RCT (ConfIdes), and (c) up to 56 percent of the shares relat
ed to the total shareholder
return on the Company’s ordinary shares (if the tot
al shareholder return for the Company’s
ordin
ary share during the vesting per
iod reaches or exceeds 75 percent, the participant wi
ll be
awarded 56 percent of the performance shares and if t
he total shareholder return for the
Company’s ordinary share falls below 25 percent, no allotment of
performance
shares will be
made under this performance condition. In between the percentages,
allotment will be made
linearly).
The option program comprises two series
:
Series 1
–
Warrants, and Series 2
–
Em
ployee s
tock
options. Series 1 consists of warr
ants which can be exercised for subscripti
on of ordinary
shares during the period from 15 June 2022 up to and i
ncluding 15 July 2022. The transfer of
the warrants to participant
s was made at a price corresponding to the market value of the
warrants at the time of trans
fer.
The Company subsidized up to 100 percent of the pric
e for the transfer of the warrants. Series
2 consists of employee stock options al
lotted free
-
of
-
charge. The employee stock options
have
a vesting period of three years and an exerc
ise period of th
ree years. Each warrant or
employee stock option entitles t
he holder to receive one new ordinary share in Hansa
Biopharma AB at a strike price of SEK 196.20, whi
ch corresponds to 110 percent of the volume
weighted average share price during the ten (10) tr
ading days immediately prior
to the offer to
subscribe for the options and/or
warrants.
In total, 278,181 share right
s, 149,148 employee stock options and 11,000 warrants were
outstanding under the long
-
term incent
ive program 2019 as of 31 December 2021, w
hich
corresponds to a maximum dilution of appr
oximately 0.9% on a fully diluted basis.
Long
-
term incentive program 2020
On June 23, 2020, the annual general meeting in Hansa Biopharma resol
ved to adopt a long
-
term incentive program for cert
ain employees of
the Group. The long
-
term incentive progr
am
2020 includes two elements
:
one performance
-
based share ri
ghts program, and one employee
stock option program. The CEO has been granted 57,278 share r
ights and 128,760 employee
stock options under the long
-
term i
ncentive program 2020.
Under the performance
-
based share rights program, each share right enti
tles the holder to
receive one ordinary share in Hansa Biopharma AB free
-
of
-
charge provided that the below
performance conditions are met during the vest
ing period. In addition to t
he requirement for the
participant’s continued employment,
the final number of shares that each participant i
s entitled
to receive is also conditi
onal upon the following performance conditions being met dur
ing the
vesting period: (a) 22 percent
of the shares in the event the US RCT study (ConfIde
S
) is fully
enrolled, (b) 11 percent of the shar
es in the event that top line data read out of the ongoi
ng
phase 2 study in either AMR or GBS is completed with data prov
iding a solid scientific ra
tional
to continue either of the two pr
ograms, (c) 11 percent of the shares in the event t
hat at least 70
percent of the targeted transplant
ation centres in Europe have been initiated, and (d)
up to 56
percent of the shares related to t
he total shareholder
return on the Company’s ordinary shares
(if the total shareholder return
for the Company’s ordinary share during the vesting period
reaches or exceeds 75 percent, the participant wil
l be awarded 56 percent of the performance
shares and if the total shareh
older return for the Company’s ordinary share fall
s below 25
percent, no allotment of performance shar
es will be made under this performance condition. In
between the percentages, allotment will
be made linearly).
Remuneration
Repor
t
cont
inued
Hansa Biopharma
Annual Report 202
1
14
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y
T
echnology
Grow
th
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repo
rt
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rket
Ove
rv
iew
Remuneration
3
Hansa Biopharma Annual Report 2021
The option program 2020 consists of emp
loyee st
ock options allotted free
-
of
-
charge. Each
employee stock option entitles t
he holder to subscribe for one new ordinary share in Hansa
Biopharma AB. The employee stock options have a vesting per
iod of three years, and an
exercise period of three year
s. Each employee stock option entitles the holder t
o acquire one
share in the Company, provided that the part
icipant, with certain exceptions, r
emains employed
within the Group, at an exercise price of SEK 315.75 which corresponds t
o 125 percent of the
vol
ume weighted average share price during the 10 tradi
ng days immediately preceding the
respective allotment of the employee stock options.
In total, 400,556 share right
s and 497,520 employee stock options were outstanding under the
long
-
term incentive program 2020 as of 31 December 2021, which corr
esponds to a maximum
dilution of approximately 1.9% on a ful
ly diluted basis.
Long
-
term incentive program 2021
On May 12, 2021, the annual general meeting in Hansa Biopharma resolv
ed to adopt a long
-
term incentive program for certai
n employees of the Group. The long
-
term incentive pr
ogram
2021 includes two elements; one performance
-
based share rights program, and one employee
stock option program. The CEO has been granted 80,000 share ri
ghts and 120,000 employee
sto
ck options under the long
-
term incenti
ve program 2021.
Under the performance
-
based share rights program, each share right enti
tles the holder to
receive one ordinary share in Hansa Biopharma AB free
-
of
-
charge provided that the below
performance conditions are met during t
he vesting period. In addition to the requir
ement for the
participant’s continued employment,
the final number of shares that each participant i
s entitled
to receive is also conditi
onal upon the following performance conditions being met du
ring the
vesting period: (a) 22 percent of
the shares in the event the U.S. FDA has accepted a BLA filing
for approval of imlifidas
e in the U.S., (b) 11 percent of the shares in t
he event that a phase 3
study in either AMR or GBS is initi
ated or a filing for regulatory appr
oval is accepted by either
the FDA or EMA for one of these indications or
anti
-
GBM, (c) 11 percent of the shares in the
event that at least 80% of the target
ed transplantation centers in Europe have been initi
ated,
and (d) up to 56 percent of the share
s related to the total shareholder retur
n on the Company’s
ordinary shares (if the tot
al shareholder return for the Company’s ordinary share duri
ng the
vesting period reaches or exceeds 75 percent
, the participant will be awarded 56 percent o
f the
performance shares and if the total shar
eholder return for the Company’s ordinary share fall
s
below 25 percent, no allotment of perfor
mance shares will be made under this performance
condition. In between the percentages,
allotment will be made linea
rly).
The option program 2021 consists of employee st
ock options allotted free
-
of
-
charge. Each
employee stock option entitles t
he holder to subscribe for one new ordinary share in Hansa
Biopharma AB. The employee stock options have a vesting per
iod of th
ree years, and an
exercise period of three years. Each employ
ee stock option entitles the holder to acquir
e one
share in the Company, provided that the part
icipant, with certain exceptions,
remains employed
within the Group, at an exercise price of SEK 192
.20 which corresponds to 125 percent of
the
volume weighted average share price during t
he 30 trading days immediately preceding the
respective allotment of the employee stock options.
In total, 557,000 share right
s and 430,000 employee stock options were outstandi
ng under the
long
-
term incentive program 2021 as of 31 December 2021, which corr
esponds to a maximum
dilution of approximately 2.1% on a ful
ly diluted basis.
Remuneration
Repor
t
cont
inued
Hansa Biopharma
Annual Report 202
1
15
0
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y
T
echnology
Grow
th
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Directors
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repo
rt
ESG
Financials
Governance
Ma
rket
Ove
rv
iew
Remuneration
4
Hansa Biopharma Annual Report 2021
Remuneration of the CEO in share ri
ghts and employee stock options
Table 2
–
Remuneration of the CEO in share rights
Name, position
The main conditions of share rights
Information regarding the reported financial year
Opening balance
During the year 2021
Closing balance 31 Dec 2021
1
Name of plan
2
Performance
period
3
Award date
4
Vesting date
5
End of retention
period
6
Share rights held
at the beginning
of the year
7
Awarded
8
Vested
9
Expired
10
Subject to a
perfomance
condition(s)
11
Awarded
and
unvested
12
Shares
subject to a
retention
period
Søren Tulstrup
(CEO)
LTIP2018
2018
-
2021
2018
-
06
-
15
2021
-
06
-
15
2021
-
06
-
15
51,389
0
0
51,389
0
0
0
LTIP2019
2019
-
2022
2019
-
06
-
17
2022
-
06
-
17
2022
-
06
-
17
35,151
0
0
0
35,151
35,151
35,151
LTIP2020
2020
-
2023
2020
-
07
-
23
2023
-
07
-
23
2023
-
07
-
23
57,278
0
0
0
57,278
57,278
57,278
LTIP2021
2021
-
2024
2021
-
05
-
12
2024
-
05
-
12
2024
-
05
-
12
0
80,000
1
0
0
80,000
80,000
80,000
143,818
80,000
0
51,389
172,429
172,429
172,429
1
Each of the 80,000 Share rights represents a computed fair val
ue of SEK 98.94 per
share right calculated based on a Monte Carlo simulation. For further information please refer
to Note 14 to the Consolidated
Financial Statements elsewhere in this annual
report 2021
Table 3
–
Remuneration of the CEO in stock options
Name, position
The main conditions of share rights
Information regarding the reported financial year
Opening balance
During the year 2021
Closing balance 31 Dec 2021
1
Name of plan
2
Performance
period
3
Award date
4
Vesting date
5
End of
retention
period
6
Exercise
period
7
Exercise
Price (SEK)
6
Stock options
held at the
beginning of
the year
7
Awarded
8
Vested
9
Expired
10
Stock options
subject to a
performance
condition
11
Stock
Options
Awarded
and
unvested
12
Stock
options
subject to a
retention
period
Søren Tulstrup
(CEO)
LTIP2019
2019
-
2022
2019
-
06
-
17
2022
-
06
-
17
2022
-
06
-
17
2022
-
06
-
17
2025
-
06
-
17
196.20
66,347
0
0
66,347
66,347
66,347
LTIP2020
2020
-
2023
2020
-
07
-
23
2023
-
07
-
23
2023
-
07
-
23
2023
-
07
-
23
2026
-
07
-
23
315.75
128,760
0
0
128,760
128,760
128,760
LTIP2021
2021
-
2024
2021
-
05
-
12
2024
-
05
-
12
2024
-
05
-
12
2024
-
05
-
12
2027
-
05
-
12
192.20
0
120,000
1
0
0
120,000
120,00
0
120,000
195,107
120,000
0
0
315,107
315,107
315,107
1
Each of the 128,760 Stock options represents a computed fair v
alue of SEK 42.98 per stock option calculated based on a Black
-
Scholes valuation. For further information please refer to Note 14 to the C
onsolidated Financial Statements
elsewhere in Hansa Biopharma’s annual report 2021
Remuneration
Repor
t
cont
inued
Hansa Biopharma
Annual Report 202
1
151
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y
T
echnology
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th
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rt
ESG
Financials
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rket
Ove
rv
iew
Remuneration
5
Hansa Biopharma Annual Report 2021
Comparative information on r
emuneration and Company
performance
2021
2020
CEO remuneration
Søren
Tulstrup, CEO
kSEK 10,582
kSEK 8,854
Company’s performance
Achievement of the annual corporate objectives
85%
100%
Operating profit / loss
kSEK
(
548,282
)
kSEK
(
422,807
)
Average remuneration (base salary) on a full
-
time
equivalent basis of
employees
Non
-
executive employees of the Company
kSEK
827
kSEK 822
Application of performance criteria related t
o the 2021 CEO
compensation
Both, long
-
term and short
-
term performance measures hav
e been selected to reflect key milestones in del
ivering the Company’s strategy and to
encourage behaviour which is in the long
-
term int
erest
of the Company. This is reflected in t
he performance criteria related to the Company’s long
-
term incentive programs as well as t
he corporate objectives applied to performance measurement r
elated to
the
short
-
term incentive program of Hansa. In select
ing performance measures, the strategic object
ives as well as short
-
term and long
-
term busines
s priorities have been taken into account.
In 2021, a portion of the share ri
ghts program under the LTIP 2018 vested, in which t
he CEO held 51,389 performance share rights. The single pre
-
defined performance condition related to the port
ion
which vested was
Total shareholder return of at
least 125% of the base value of SEK 221.10
. Since the perf
ormance criteria was not met upon vesting on June 15, 2021, t
he share rights expired
without value and no shares were granted. No other share
-
based long
-
term compensation vested during 2021.
Set out in Table 4 below is a descripti
on of how the criteria for payment of variable s
hort
-
term compensation have been applied for t
he financial year 2021. Such criteria are based on t
he annual
corporate objectives and form the basi
s for the short
-
term performance measurement of the CEO and all
other members of the executive management.
Tab
le 4
–
Criteria for payment of variable short
-
term compensation
Name, Position
Description of the criteria related to the corporate goals
2021
corporate goals
Overall
weight
a)
Measured goal achievement and
b)
Actual weighted outcome
Søren Tulstrup,
(
CEO
)
Imlifidase commercial launch and launch readiness in key EU countries
4 sub
-
goals
20%
a)
84%
b)
17%
Progressing pipeline activities in transplantation, autoimmune indications and NiceR
5 sub
-
goals
50%
a)
75%
b)
37%
Business development and financial
strength
2 sub
-
goals
25%
a)
104%
b)
26%
Corporate Social Responsibility
1 sub
-
goal
5%
a)
100%
b)
5%
Total: 85%
Remuneration
Repor
t
cont
inued
Hansa Biopharma
Annual Report 202
1
15
2
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y
T
echnology
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th
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rt
ESG
Financials
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rket
Ove
rv
iew
Remuneration
12
Glo
ssar
y
Glossary
1
54
Hansa Biopharma
Annual Report 202
1
15
3
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
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Governance
Remuneration
Ma
rket
Ove
rv
iew
Financials
15
3
Hansa Biopharma
Annual Report 202
1
Glo
ssar
y
Adeno-associated
virus (AAV)
A
A
V is a ve
rsat
ile vi
ral ve
ctor tech
nol
ogy th
at can b
e
en
gine
ere
d for ver
y spe
ci
c fun
ction
ali
ty in g
ene
therapy
applications
.
Allogeneic
hematopoietic
stem cell
transplantation
(HSCT
)
Allogeneic HSC
T
, also known
as “bonemarro
w”
transplant
ation,
inv
olves tr
ansferring st
em cells fr
om a healt
hy
person (t
he donor)
to
the pa
tient’
s body after
high-int
ensity
ch
emoth
erapy o
r radi
ation. T
he do
nated ste
m cell
s can c
ome
fro
m eith
er a rel
ated or a
n unre
lated d
onor
.
AMR
Antibody
mediated
transplant
rejection.
Antibody
On
e ty
pe of protei
n prod
uced by t
he bod
y’
s imm
une sys
tem
wi
th the ab
ilit
y to rec
ogni
ze forei
gn sub
stan
ces, b
acter
ia or
viruses. Antibodies are also
called immunoglobulins. The
hum
an imm
une sys
tem use
s die
rent cl
ass
es of anti
bod
ies, so
ca
lled “
isot
ype
s,
” k
nown a
s IgA
, IgD, IgE, Ig
G, and I
gM. Th
e
di
eren
t isot
ype
s have sli
ghtly d
iere
nt stru
cture
s and th
ey play
di
eren
t roles i
n the imm
une sys
tem. Immu
nog
lobu
lin G, Ig
G, is
the m
ost co
mmon t
yp
e in the b
lood a
nd tis
sue a
nd prov
ides
the majority of
antibody-based
immunity against inv
ading
path
oge
ns. Ig
A is mai
nly fo
und in m
ucos
al are
as an
d preven
ts
colonization
by
pathogens.
IgD mainly
functions
as recept
or on
B-
cell
s that have n
ot yet be
en acti
vated. Ig
E bind
s to alle
rgen
s
an
d is invol
ved in a
lle
rgy
. IgM i
s main
ly fou
nd in th
e bloo
d and
is pa
r
t of
th
e rst re
spo
nse aga
inst a
n infe
ction.
Anti-GBM disease (Goodpasture
syndrome)
An
ti-GB
M antib
ody d
isea
se is a d
isord
er in w
hich c
ircu
latin
g
ant
ibod
ies a
re dire
cted ag
ains
t an anti
gen i
ntrin
sic to the
glomerular basement
membrane (
GBM) in
the kidney
, thereby
resulting
in acut
e or
rapidly pr
ogressive g
lomerulonephritis.
Autoimmune
disease
Di
seas
es tha
t occu
r whe
n the bo
dy’
s im
mune sy
stem rea
cts
against
the body’
s own
structur
es.
B-cells
B-
cell
s, als
o know
n as B-l
ymph
ocy
tes, a
re a ty
pe of whi
te
bl
ood ce
ll of the l
ymp
hocy
te subt
yp
e. They a
re an im
por
ta
nt
pa
rt of th
e adapt
ive imm
une sys
tem an
d secr
ete antib
odie
s.
Biologics License Application (BL
A)
A Biologics
License Application
(BL
A)
is submitt
ed t
o the
Food
an
d Dru
g Admin
istra
tion (F
D
A) to o
btain p
erm
issi
on for
distribut
ion of
a biologic
product a
cross the
U
.S.
Biopharmace
utical
A pharmaceutical drug tha
t is manufact
ured using
biot
echnology
.
Biotechnology
Th
e use of li
ve cel
ls or c
ompo
nent
s of cell
s, to produ
ce or
modify products
used in
health care
, food
and agricult
ure.
CD20
B-l
ymp
hocy
te anti
gen, C
D20
, is a p
rotein exp
ress
ed on th
e
sur
fa
ce of B-
cell
s. Its fu
ncti
on is to en
able o
ptima
l B-c
ell
immune r
esponse.
Clinical
studies
Inve
stiga
tion of a n
ew dru
g or trea
tment u
sing h
eal
thy sub
ject
s
or pa
tient
s with the i
ntenti
on to stud
y the ec
acy an
d safet
y of
a not-yet
-a
pprove
d treatm
ent ap
proac
h.
Clinical
Phase 1
Th
e rst ti
me a dru
g und
er deve
lopm
ent is a
dmin
istere
d to
hum
ans. Ph
ase I st
udie
s are of
ten co
ndu
cted wi
th a sma
ll
num
ber of h
eal
thy volu
nteer
s to asse
ss the s
afet
y and d
osin
g
of a not yet a
pprove
d form of t
reatme
nt.
Clinical
Phase 2
Refe
rs to the r
st tim
e a
dr
ug un
der de
velo
pmen
t is
adm
inis
tered to pat
ients fo
r the stu
dy of sa
fety
, do
sage a
nd
ec
acy of a not yet a
pprove
d treatm
ent reg
ime
n.
Clinical
Phase 3
T
r
ial
s that invo
lve ma
ny patie
nts an
d ofte
n conti
nue for a l
ong
er
tim
e
; the
y are inten
ded to id
enti
fy th
e dru
g
’s
ee
cts an
d side
ee
cts dur
ing or
dina
ry, but stil
l care
full
y contr
olle
d, cond
itio
ns.
DSA
Donor specic
antibodies.
Donor specic
antibodies
are
ant
ibod
ies in a t
rans
plan
t patie
nt whi
ch bin
d to HL
A and
/
or
non-HLA molecules on
the endo
thelium o
f a t
ransplanted
org
an, or a pote
ntia
l dono
r orga
n. The p
rese
nce of
pre
-form
ed and d
e novo (newl
y form
ed) DS
A, sp
eci
c to
donor
/
recipient mismat
ches,
are major risk
factors
for
antibody
-mediat
ed rejection
.
EMA
Th
e Europ
ean M
edic
ine
s Agen
cy (EMA
) is a Euro
pean U
nio
n
agency f
or the
evalua
tion o
f medicinal pr
oducts.
Enzy
me
A prote
in that ac
cel
erate
s or sta
rt
s a chem
ica
l reac
tion w
ithou
t
itself being
consumed.
ESOT
Th
e Europ
ean So
ciet
y for O
rgan T
ra
nspl
antat
ion (ESOT
) is a
n
umbrella
organization
which o
versees how
transplanta
tions ar
e
struc
tured and stre
amline
d.
Hansa Biopharma
Annual Report 202
1
15
4
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y
T
echnology
Grow
th
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Directors
’
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rt
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Financials
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rket
Ove
rv
iew
Remuneration
FDA
Th
e U
.S. Foo
d and D
rug Ad
mini
strati
on is th
e age
ncy
responsible for
, among other
things, pr
otecting
the public
he
alth by as
sur
ing th
e safet
y
, e
ecti
vene
ss, qua
lit
y
, a
nd
security of human and
vet
erinar
y drugs,
vaccines and o
ther
biological pr
oducts,
and medical de
vices.
Guillian-Barré syndrome
GBS,
Guillian-Barré
syndrome
, is
an acut
e aut
oimmune
disease in
which the
peripheral nervous sy
stem
is attack
ed by
the i
mmun
e system a
nd Ig
G antib
odie
s.
HBP
Heparin Binding Pr
otein
is a nat
urally occurring pro
tein tha
t is
produced by
cer
tain immune cells,
i.
e. neutr
ophilic
gra
nul
ocy
tes, to dire
ct im
mune c
ell
s from th
e bloo
dstre
am into
the ti
ssu
es.
HLA
Hum
an Leu
kocy
te Anti
gen is a p
rotein co
mpl
ex found o
n the
sur
fa
ce of al
l huma
n cell
s. The i
mmun
e system u
ses H
LA to
distinguish be
tween endogenous and foreign.
IgG
Ig
G, Immu
nogl
obul
in G, is th
e pred
omin
ant t
ype of a
ntibo
dy
in serum.
Imlidase
Iml
ida
se, is the i
mmun
ogl
obul
in G-d
egra
ding e
nzy
me of
Str
ept
ococcus
pyo
genes, a
bact
erial
enzyme with
strict
sp
eci
cit
y for Ig
G antib
odi
es. Th
e enz
yme h
as a uniq
ue ab
ilit
y
to cle
ave and th
ere
by inact
ivate hum
an Ig
G antib
odi
es, whi
le
le
aving ot
her Ig
-isot
yp
es inta
ct.
IND
An I
nvesti
gatio
nal Ne
w Dru
g (IND) ap
pli
catio
n is req
uire
d t
o ge
t
ap
proval f
rom the F
D
A to adm
inis
ter an inve
stig
ation
al dr
ug or
biological pr
oduct t
o humans
.
INN
Int
ernational Non
proprietary Name (IN
N) is a
generic and
no
n-prop
riet
ar
y nam
e to
fa
cili
tate the id
enti
cati
on of a
pharmaceutical substance or a
ctive pharmaceutical ingredient
.
Eac
h INN is a u
niqu
e nam
e that is g
loba
lly re
cog
nized a
nd is
pub
lic p
roper
t
y
. The I
NN syste
m has be
en co
ordi
nated by th
e
Worl
d Hea
lth Org
ani
zatio
n (W
HO) sin
ce 1
953.
In vi
tro
T
e
rm wi
thin bi
ome
dica
l scie
nce to in
dic
ate that exp
erim
ents o
r
obs
er
vatio
ns are m
ade, for exa
mple, i
n t
es
t tube
s, i.
e. in a
n
ar
ti
cia
l envir
onme
nt and n
ot in a liv
ing org
ani
sm.
In viv
o
T
e
rm wi
thin bi
ome
dica
l scie
nce to in
dic
ate that exp
erim
ents o
r
obs
er
vatio
ns are m
ade in l
ivin
g orga
nis
ms.
IVD
IV
D
, In vi
tro dia
gnos
tics, a
re tests th
at can d
etect d
ise
ases,
conditions
, or in
fections,
usually fr
om blood or
urine samples.
So
me tests a
re use
d in lab
orator
y o
r other h
eal
th profes
sio
nal
set
ting
s and oth
er tes
ts are for c
onsu
mer
s to use at ho
me.
Marketing Authorization Application (MA
A)
A Mark
eting
Authorization
Application
(MA
A)
is an appl
ication
sub
mit
ted to the Eu
rope
an Me
dici
nes Ag
ency (
EMA) to ma
rket
a medicinal
product
in the
EU member
states
.
Neutralizing Antibodi
es
(NAbs)
NA
b is an a
ntibo
dy that d
efen
ds a cel
l from a p
athog
en or
infe
ctio
us par
ti
cle by ne
utra
lizi
ng any ee
ct it ha
s biol
ogi
call
y
.
Pivo
tal trial
A cli
nic
al tri
al inten
ded to prov
ide e
cacy a
nd safe
ty dat
a for
NDA ap
proval at e.g. FDA or EM
A. In s
ome c
ases, p
has
e 2
stu
dies c
an be u
sed a
s pivota
l studi
es if t
he dru
g is inte
nde
d t
o
treat life
-threatening or seve
rely deb
ilitating c
onditio
ns.
PRA
Panel R
eactive
Antibody (P
RA) is an
immunological labora
tory
test
routinely
per
f
ormed on the
blood o
f people a
waiting
organ
tra
nspl
antat
ion. Th
e PRA sc
ore is ex
pres
sed a
s a perce
ntag
e
bet
wee
n 0% and 99%. It r
epre
sents t
he prop
or
tion of t
he
population
to
which the
person being
test
ed will
react via
pre-
existing anti
bodies.
Preclinical dev
elopment
T
esting and documenta
tion of
a pharmaceutical candidate
’s
properties (
e.
g.
safety and
feasibility) be
fore
initiation
of
clinical t
rials.
RCT
Ra
ndom
ized Co
ntrol
led T
ria
l (RCT
) is a st
udy de
sig
n whe
re the
tri
al su
bjec
t is ran
doml
y all
ocate
d to one of t
wo or mor
e study
co
hor
ts to test a sp
eci
c inter
ve
ntion a
gain
st othe
r alter
nativ
es,
suc
h as pl
aceb
o or sta
nda
rd of care. T
he stu
dy pa
rti
cipa
nts
are fo
llowe
d up to comp
are ou
t
co
mes of d
iere
nt coh
or
ts.
Streptococcus
pyogen
es
A Gra
m-po
siti
ve bacte
rium t
hat pr
imar
ily c
an be fo
und in th
e
human upper respira
tory tract
. Some str
ains can cause thr
oat
or s
kin.
Hansa Biopharma
Annual Report 202
1
15
5
Strateg
y
T
echnology
Grow
th
The share
Directors
’
repo
rt
ESG
Financials
Governance
Ma
rket
Ove
rv
iew
Glos
sar
y
cont
inued
Remuneration
Hansa Bi
opharma AB
P
.O
. Box 785
SE-220 0
7 Lu
nd, Swed
en
Pho
ne: +46 46 1
6 56 70
E-mail
: in
[email protected]
ww
w
.hansabiophar
ma.
com
®