Company announcement
No. 38 / 2023
1
Zealand Pharma Announces Financial
Results for the First Nine Months of
2023.
Strong progress across obesity pipeline, first PDUFA date for dasiglucagon in CHI in 2023 and
solid financial position
• Boehringer Ingelheim advances GCGR/GLP-1R dual
agonist survodutide (BI456906) into Phase 3 trials in
obesity
• Zealand presents amylin analog ZP8396 6-week trial
results at ObesityWeek and initiates GLP-1R/GLP-2R dual
agonist dapiglutide 13-week dose titration trial
• Zealand to host Obesity R&D Event in London on
December 5th
• Dasiglucagon for congenital hyperinsulinism granted
Priority Review with December 30, 2023 PDUFA date for
up to three weeks of dosing; plans to make product
available in the US as soon as possible following
potential approval
• Revenue recognized for expected milestone payments
from existing partnerships of EUR 30 million and USD 10
million respectively, contributing to the solid financial
position
Copenhagen, Denmark, November 9, 2023 – Zealand
Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a
biotechnology company focused on the discovery and
development of innovative peptide-based medicines, today
announced the interim report for the nine months ended
September 30, 2023, and provided a corporate update.
Building momentum into 2024
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“Survodutide advancing into global Phase 3 trials in obesity
by Boehringer Ingelheim is a significant step for Zealand. At
the same time, I am truly excited about the acceleration we
are seeing with our pipeline of wholly owned and
differentiated obesity candidates. We look forward to
sharing more of the scientific and clinical rationale behind
these assets at our Obesity R&D Event on December 5.
Finally, we will end this transformative year with a planned
NDA submission for glepaglutide in short bowel syndrome
and the first PDUFA date for dasiglucagon in congenital
hyperinsulinism.”
Key financial results for Q3 2023 year-to-date
DKK million
Q3-23
YTD
Q3-22
YTD
*
Revenue
319,553
80,061
Net operating expenses
1
-633,150
-676,245
Net operating result
-313,597
-596,184
Net financial items
-124,785
-53,421
Cash position
2
1,582,189
729,886
Funding available incl.
undrawn committed
RCF
3
1,932,189
729,886
*Comparative numbers are adjusted for discontinued operations.
Notes:
1. Net operating expenses consist of R&D, S&M, G&A and other
operating items.
2. Cash position includes cash, cash equivalents and marketable
securities.
3. RCF = Revolving Credit Facility provided by Danske Bank.
Recent highlights
Rare diseases
• Dasiglucagon (CHI): FDA granted a priority review for the
prevention and treatment of hypoglycemia in pediatric
patients 7 days of age and older with congenital
hyperinsulinism (CHI) for up to three weeks of dosing
with a Prescription Drug User Fee Act (PDUFA) date on
December 30, 2023. The regulatory review will be
conducted in two parts under the same NDA. Part 1
relates to dosing of up to three weeks. Part 2 relates to
use beyond three weeks, in support of which the FDA
has requested additional analyses from existing
continuous glucose monitoring (CGM) datasets,
included as a secondary outcome measure in the Phase
3 program.
Company announcement
No. 38 / 2023
2
Obesity
• Survodutide (BI 456906), a glucagon/GLP-1 receptor
dual agonist: Boehringer Ingelheim announced Phase 3
program in people living with overweight or obesity.
SYNCHRONIZE
TM
-1 and SYNCHRONIZE
TM
-2 are
designed to evaluate survodutide in people living with
overweight or obesity without and with type 2 diabetes,
respectively. SYNCHRONIZE
TM
-CVOT is a long-term
cardiovascular safety trial of survodutide in people living
with overweight or obesity with cardiovascular disease,
chronic kidney disease or with risk factors for
cardiovascular disease. The Phase 3 trials include a
longer treatment period (76 weeks) and a higher
maximum maintenance dose (6.0 mg) compared with
Phase 2.
• ZP8396, a long-acting amylin analog: Presented results
at Obesity Week from 6-week MAD trial. In Part 1 of the
Phase 1b trial, low doses of up to 1.2 mg ZP8396
administered once weekly for only six weeks led to
reductions in body weight of up to 5.3% in healthy lean
and overweight participants (mean body weight of 82 kg
and BMI of 25.4) and were well tolerated with a mostly
mild adverse event profile.
• Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual
agonist: Initiated 13-week dose titration trial. The trial is
evaluating dapiglutide in healthy overweight or obese
participants (eligible BMI 27.0–39.9) and aims to include
higher maximum maintenance doses than were used in
the prior 4-week MAD trial and the ongoing investigator-
led DREAM trial.
Financial
• Solid financial position. Milestone payments from
existing partnerships were recognized in the third
quarter of 2023, with cash inflow expected in the fourth
quarter of 2023, contributing to the company’s solid
financial position. These potential milestones include
EUR 30 million from Boehringer Ingelheim associated
with survodutide and USD 10 million from Sanofi
associated with lixisenatide.
Obesity R&D Event for investors and analysts
• Zealand management together with key external experts
in the obesity field, Professor Daniel Drucker, Professor
Louis Aronne, and Professor Carel Le Roux, will be
hosting an Obesity R&D event in London on December
5
th
to discuss the scientific rationale and clinical potential
of the company’s differentiated product candidates.
Please visit
https://www.zealandpharma.com/event/zealand-
pharmas-obesity-rd-event/ to register for this event.
Upcoming events next 12 months
Rare diseases
• Dasiglucagon in CHI. The FDA has granted a December
30, 2023 PDUFA date for dasiglucagon for the
prevention and treatment of hypoglycemia in pediatric
patients 7 days of age and older with congenital
hyperinsulinism (CHI) for up to three weeks of dosing. If
approved, Zealand plans to make dasiglucagon available
to healthcare professionals and patients in the US as
soon as possible. In addition, the company expects to
submit Part 2 of the NDA that includes analyses of CGM
data to support the use of dasiglucagon in CHI beyond
three weeks in the first half of 2024. Zealand continues
to engage in partnership discussions for
commercialization of the product.
• Glepaglutide in SBS. In the fourth quarter of 2023,
Zealand expects to submit an NDA to the FDA for
glepaglutide administered via autoinjector for the
treatment of short bowel syndrome with intestinal failure
and subsequently engage in more detailed partnership
discussions.
Obesity
• Survodutide in NASH. Boehringer Ingelheim and Zealand
Pharma expect to report topline results from the Phase
2 trial with survodutide in NASH in the first half of 2024.
• Dapiglutide. In the first half of 2024, Zealand anticipates
topline results from the ongoing investigator-led
DREAM trial that aims to evaluate the potential for
weight loss following 12 weeks of treatment and gain
key mechanistic insights into the effects of dapiglutide
on inflammatory markers. In the second half of 2024,
Zealand expects topline results from the 13-week dose
titration trial.
• ZP8396, amylin analog. In the first half of 2024, Zealand
expects to report topline results from Part 2 of the MAD
trial that is evaluating ZP8396 in participants with
overweight or obesity (eligible BMI 27.0–39.9), including
higher doses compared with Part 1 and over a longer
16-week treatment period.
• ZP6590, GIP analog. Zealand has completed pre-clinical
activities to support potential first-in-human clinical trials
in 2024.
Chronic Inflammation
• ZP10068, Complement Inhibitor. Zealand has
completed pre-clinical and CMC activities for the
investigational long-acting complement inhibitor.
Company announcement
No. 38 / 2023
3
Subsequent regulatory, clinical and development efforts
will be led and conducted by Alexion.
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand has
completed pre-clinical activities for the Kv1.3 ion
channel blocker to support potential first-in-human
clinical trials in 2024.
Financial guidance for 2023
• Guidance unchanged from March 2, 2023
DKK million
2023
Guidance
2022
Actual
Revenue anticipated
from existing and new
license and partnership
agreements
No guidance due
to uncertain size
and timing
104
Net operating
expenses
4
800-900
941
Notes:
4. Financial guidance based on foreign exchange rates as of November
9, 2023.
Conference call today at 2 PM CET / 8 AM ET
Zealand’s management will host a conference call today at
2:00 PM CET / 8:00 AM ET to present results through the
first nine months of 2023 followed by a Q&A session.
Participating in the call will be Chief Executive Officer, Adam
Steensberg; Chief Financial Officer, Henriette Wennicke;
and Chief Medical Officer, David Kendall. The conference
call will be conducted in English.
To receive telephone dial-in information and a unique
personal access PIN, please register at
https://register.vevent.com/register/BId73e050fc44d47be8
1015697a873e070. The live listen-only audio webcast of the
call and accompanying slide presentation will be accessible
at https://edge.media-server.com/mmc/p/b9gpnynv.
Participants are advised to register for the call or webcast
approximately 10 minutes before the start. A recording of
the event will be available following the call on the Investor
section of Zealand’s website at
https://www.zealandpharma.com/events/.
Financial Calendar for 2024
FY/Q4 2023
February 27, 2024
Q1 2024
May 16, 2024
Q2 2024
August 15, 2024
Q3 2024
November 7, 2024
About Zealand Pharma A/S
biotechnology company focused on the discovery and
development of peptide-based medicines. More than 10
drug candidates invented by Zealand have advanced into
clinical development, of which two have reached the
market and three candidates are in late-stage development.
The company has development partnerships with a number
of pharma companies as well as commercial partnerships
for its marketed products.
Zealand was founded in 1998 and is headquartered in
Copenhagen, Denmark, with a presence in the U.S. For
more information about Zealand’s business and activities,
please visit www.zealandpharma.com.
Forward-looking Statements
This company announcement and interim report contains
“forward-looking statements”, as that term is defined in the
Private Securities Litigation Reform Act of 1995 in the United
States, as amended, even though no longer listed in the
United States this is used as a definition to provide Zealand
Pharma’s expectations or forecasts of future events
regarding the research, development and
commercialization of pharmaceutical products, the timing
of the company’s pre-clinical and clinical trials and the
reporting of data therefrom and the company’s Upcoming
Events and Financial Guidance for 2023. These forward-
looking statements may be identified by words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” “would” and other words and terms of
similar meaning. You should not place undue reliance on
these statements, or the scientific data presented. The
reader is cautioned not to rely on these forward-looking
statements. Such forward-looking statements are subject to
risks, uncertainties and inaccurate assumptions, which may
cause actual results to differ materially from expectations set
forth herein and may cause any or all of such forward-
looking statements to be incorrect, and which include, but
are not limited to, unexpected costs or delays in clinical trials
and other development activities due to adverse safety
events or otherwise; unexpected concerns that may arise
from additional data, analysis or results obtained during
clinical trials; our ability to successfully market both new and
existing products; changes in reimbursement rules and
governmental laws and related interpretation thereof;
government-mandated or market-driven price decreases for
our products; introduction of competing products;
production problems; unexpected growth in costs and
expenses; our ability to effect the strategic reorganization of
our businesses in the manner planned; failure to protect and
enforce our data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property
claims and challenges; regulatory authorities may require
Company announcement
No. 38 / 2023
4
additional information or further studies, or may reject, fail
to approve or may delay approval of our drug candidates or
expansion of product labeling; failure to obtain regulatory
approvals in other jurisdictions; exposure to product liability
and other claims; interest rate and currency exchange rate
fluctuations; unexpected contract breaches or terminations;
inflationary pressures on the global economy; and political
uncertainty, including due to the ongoing military conflict in
Ukraine. If any or all of such forward-looking statements
prove to be incorrect, our actual results could differ
materially and adversely from those anticipated or implied
by such statements. The foregoing sets forth many, but not
all, of the factors that could cause actual results to differ
from our expectations in any forward-looking statement. All
such forward-looking statements speak only as of the date
of this press release/company announcement and are
based on information available to Zealand Pharma as of the
date of this release/announcement. We do not undertake to
update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof.
Information concerning pharmaceuticals (including
compounds under development) contained within this
material is not intended as advertising or medical advice.
Zealand Pharma® is a registered trademark of Zealand
Pharma A/S.
Contacts:
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: [email protected]
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate
Communications
Zealand Pharma
Email: [email protected]
Company announcement
No. 38 / 2023
5
R&D Pipeline
Therapeutic area
Product candidate
*
Rare diseases Dasiglucagon: S.C. Continuous Infusion
Congenital Hyperinsulinism
Glepaglutide (GLP-2 Analog) Short Bowel Syndrome
Obesity
Survodutide (GCGR/GLP-1R Dual Agonist)
1
Obesity and NASH
Dapiglutide (GLP-1/GLP-2 Dual Agonist) Obesity
ZP 8396 (Amylin Analog) Obesity
ZP 6590 (GIP Receptor Agonist) Obesity
Type 1 diabetes Dasiglucagon: Bi-Hormonal Artificial Pancreas Systems Type 1 Diabetes management
Dasiglucagon: Mini-Dose Pen T1D exercise-induced hypoglycemia
Inflammation
ZP 10068 (Complement C3 Inhibitor)
2
Undiscl.
ZP 9830 (Kv1.3 Ion Channel Blocker) Undiscl.
ZP 10000 (ɑ4β7 Integrin Inhibitor) IBD
2) Licensed to Alexion: USD 610 million potential development, regulatory and commercial milestones + high single to low double digits % royalties on net sales.
Pre-clinical
Phase 1
Phase 2
Phase 3
Registration
*) Investigational compounds whose safety and efficacy have not been evaluated or approved by the FDA or any other regulatory authority
1) Co-invented by Boehringer Ingelheim and Zealand: EUR 345 million outstanding potential development, regulatory and commercial milestones, plus high single to low
double digit % royalties on global sales to Zealand.
Company announcement
No. 38 / 2023
6
Rare diseases
Dasiglucagon for congenital hyperinsulinism (CHI)
Third quarter 2023 update:
• US FDA granted Priority Review and December 30, 2023,
PDUFA date for dasiglucagon for the prevention and
treatment of hypoglycemia in pediatric patients with CHI
7 days of age and older for up to 3 weeks of dosing.
Background:
Dasiglucagon is a glucagon analog that is stable in aqueous
solution and is thus suitable for chronic pump use. Three
clinical trials, including two pivotal studies and an ongoing
long-term extension trial, evaluate the potential for chronic
dasiglucagon infusion delivered subcutaneously via a pump
to prevent hypoglycemia in children with CHI. The FDA and
the European Commission have both granted orphan drug
designation to dasiglucagon for the treatment of CHI.
The FDA has granted priority review designation to
dasiglucagon for the prevention and treatment of
hypoglycemia in pediatric patients 7 days of age and older
with CHI for up to three weeks of dosing with a PDUFA date
on December 30, 2023. The regulatory review will be
conducted in two parts under the same NDA. Part 1 relates
to dosing of up to three weeks, whereas Part 2 relates to the
use beyond three weeks. Supporting the use of
dasiglucagon in CHI beyond three weeks, the FDA has
requested additional analyses from existing continuous
glucose monitoring (CGM) datasets, which the company
expects to submit in the first half of 2024. CGM was included
as a secondary outcome measure in one of the two pivotal
Phase 3 clinical trials.
The global, 2-part, Phase 3 trial 17103 (ClinicalTrials.gov ID:
NCT04172441) evaluated the efficacy of dasiglucagon in
reducing glucose requirements in 12 children (ranging in
age from 7 days to 12 months) with persistent CHI requiring
continuous intravenous glucose administration to prevent
or manage hypoglycemia.
In Part 1 of the Phase 3 trial, dasiglucagon significantly
reduced the requirement for intravenous (IV) glucose to
maintain glycemia in newborns and infants with CHI.
Dasiglucagon significantly reduced the mean IV glucose
infusion rate (GIR) in the last 12 hours of the 48 hour
treatment period by 55% as compared to placebo (4.3
mg/kg/min for dasiglucagon and 9.4 mg/kg/min for
placebo with a treatment difference of 5.2 mg/kg/min;
p=0.0037). Dasiglucagon also reduced GIR over the entire
48-hour treatment period by 3.5 mg/kg/min compared to
placebo (p=0.0107). Dasiglucagon treatment resulted in a
reduction of 31 g/day in total carbohydrate intake (IV and
gastric) compared to placebo (107 g/day for dasiglucagon
vs. 138 g/day for placebo; p = 0.024), a 22% reduction in
carbohydrate calories. Dasiglucagon was observed to be
well tolerated in Part 1 of the trial, with skin reactions and
gastrointestinal disturbances as the most frequently
reported adverse events (no serious adverse events
reported).
In the 21-day open-label Part 2 of the Phase 3 trial,
dasiglucagon reduced time in hypoglycemia and enabled
discontinuation of intravenous glucose in most infants and
limited the need for pancreatectomy. Continuous
subcutaneous infusion of dasiglucagon enabled reduction
and either periodic or permanent discontinuation of IV
glucose infusion in 10 out of 12 infants during the study
period. Seven infants, who did not require pancreatectomy,
were completely weaned off IV glucose at the completion
of the trial. During the 21-day treatment with dasiglucagon,
CGM measures of hypoglycemia trended lower with median
time <70 mg/dL reduced from 7.0% to 5.2% and <54 mg/dL
reduced from 1.9% to 0.88%. There was no increase in
hyperglycemia. The safety profile of dasiglucagon in Part 2
was consistent with Part 1, with no adverse event requiring
discontinuation of treatment and no serious adverse events
reported.
The open-label Phase 3 trial 17109 (ClinicalTrials.gov ID:
NCT03777176) evaluated the efficacy of dasiglucagon in
reducing hypoglycemia in 32 children (ranging in age from
3 months to 12 years) with CHI with more than three
hypoglycemic events per week despite previous near-total
pancreatectomy and/or maximum medical therapy. Data
reported in December 2020 showed that dasiglucagon on
top of standard of care (SOC) did not significantly reduce
the rate of hypoglycemia compared to SOC alone when
assessed by the primary endpoint, intermittent self-
measured plasma glucose. However, dasiglucagon
treatment resulted in a 40–50% reduction in hypoglycemia
compared to SOC alone, when assessed by blinded
continuous glucose monitoring.
The Phase 3 trial 17106 (ClinicalTrials.gov ID: NCT03941236)
is evaluating the long-term safety of dasiglucagon in 42 of
the 44 children older than 1 month with CHI who completed
either of the Phase 3 trials 17103 or 17109.
Glepaglutide (long-acting GLP-2 analog) for short bowel
syndrome (SBS)
Third quarter 2023 update:
• Regulatory submission for glepaglutide in short bowel
syndrome with intestinal failure expected in the fourth
quarter of 2023.
Background:
Glepaglutide is a long-acting GLP-2 analog that is stable in
aqueous solution. Zealand is developing glepaglutide as a
ready-to-use, fixed dose product designed for
subcutaneous delivery via auto-injector for the potential
treatment of SBS. The Phase 3 program, named EASE,
includes four clinical trials evaluating the potential for
Company announcement
No. 38 / 2023
7
glepaglutide to reduce or eliminate the need for parenteral
support in SBS patients with intestinal failure. Efficacy and
safety data from these trials will form the basis of an NDA
submission with the FDA expected in 2023. FDA has granted
orphan drug designation to glepaglutide for the treatment
of SBS.
EASE-1 (ClinicalTrials.gov ID: NCT03690206) is a
randomized, double-blind Phase 3 trial that enrolled a total
of 106 SBS patients with intestinal failure who were
dependent on parenteral support for at least three days per
week. Patients were evenly randomized to receive
treatment with 10 mg glepaglutide administered either once
or twice weekly, or placebo. The primary endpoint in the trial
was the absolute change in weekly parenteral support
volume from baseline at 24 weeks.
In EASE-1, glepaglutide given twice weekly significantly
reduced the total weekly volume of parenteral support at 24
weeks as compared to placebo (p=0.0039). When
administered once weekly, glepaglutide treatment also
resulted in a numeric reduction in weekly parenteral
support, however this did not achieve statistical significance.
At 24 weeks, the average reduction in parenteral support
from baseline was 5.13 Liters/week for patients treated with
glepaglutide twice weekly and was 3.13 Liters/week for
patients treated with glepaglutide once weekly. Placebo
treatment resulted in a reduction in parenteral support of
2.85 Liters/week. Clinical response, defined as a patient
achieving at least 20% reduction in weekly parenteral
support volume from baseline at both 20 and 24 weeks, was
significantly higher with twice weekly glepaglutide
compared to placebo (p=0.0243). Among patients receiving
glepaglutide twice weekly, 65.7% achieved a clinical
response, whereas 45.7% and 38.9% of patients achieved a
clinical response in the once weekly and placebo treatment
groups, respectively.
In the twice weekly dosing group, 14% of patients (n=5) were
completely weaned off parenteral support (enteral
autonomy). In total, 9 patients treated with glepaglutide
achieved enteral autonomy, while no placebo-treated
patients were able to discontinue parenteral support.
Glepaglutide appeared to be safe and was well-tolerated in
the trial. The most frequently reported adverse events were
injection site reactions and gastrointestinal events. These
results were presented at the ASPEN 2023 Nutrition Science
& Practice Conference in April 2023 and Digestive Diseases
Week in May 2023.
In total, 102 of 106 participating patients completed EASE-1,
of which 96 continued into the ongoing two-year, long-
term safety and efficacy extension trial, EASE-2. EASE-2
(ClinicalTrials.gov ID: NCT03905707) is a randomized,
double-blind trial in which SBS patients continued their
assigned treatment from EASE-1 with glepaglutide 10 mg
once or twice weekly. Patients who received placebo in
EASE-1 were re-randomized to treatment with either
glepaglutide 10 mg once or twice weekly. In an interim
analysis conducted at six months, clinical response to
glepaglutide across the key efficacy endpoints was generally
maintained or showed continued improvement. Data also
demonstrated that additional patients on both doses
weaned off parenteral support successfully.
Patients who complete EASE-2 are eligible to participate in
EASE-3 (ClinicalTrials.gov ID: NCT04881825), evaluating
glepaglutide administered once weekly using an auto-
injector. An interim analysis of EASE-3, conducted with the
first 43 patients rolled over from EASE 2, showed that the
reduction in prescribed PS was generally maintained.
Glepaglutide appeared to be safe and well-tolerated in
EASE-2 and EASE-3, with a profile consistent with that
observed in EASE-1. Both EASE-2 and EASE-3 long-term
extension trials are ongoing.
In addition, EASE-4 (ClinicalTrials.gov ID: NCT04991311) is a
Phase 3b trial to assess long-term effects of glepaglutide on
intestinal fluid and energy uptake. Zealand has completed
the interim analysis of the trial and expects to present results
from this trial at a future scientific conference.
Phase 2 data have shown the potential of glepaglutide to
increase intestinal absorption in people with SBS and were
published in the journal The Lancet Gastroenterology &
Hepatology in 2019.
Obesity
ZP8396 (long-acting amylin analog)
Third quarter 2023 update:
• Presentation of detailed results from Phase 1b MAD trial
Part 1 at ObesityWeek, showing mean weight loss of up
to 5.3% and mostly mild adverse event profile after
administration once weekly for six weeks of relatively
low doses of up to 1.2 mg ZP8396.
Background:
ZP8396 is a long-acting amylin analog designed to improve
solubility, minimize fibrillation, and allow for co-formulation
with other peptides, including GLP-1-based molecules.
ZP8396 holds potential as a next-generation treatment for
overweight and obesity that could provide weight loss
comparable with GLP-1-based therapies with improved
tolerability.
Zealand is conducting a Phase 1b, randomized, multiple
ascending dose (MAD) clinical trial of ZP8396 in normal
weight and overweight healthy participants
(ClinicalTrials.gov ID: NCT05613387). The MAD trial consists
of Part 1 and Part 2. Part 1 includes 20 participants (eligible
BMI 21.0–29.9) receiving six once-weekly subcutaneous
doses of ZP8396 or placebo. Part 2 includes 48 participants
(eligible BMI 27.0–39.9) receiving 16 once-weekly doses of
Company announcement
No. 38 / 2023
8
ZP8396 or placebo using a dose up-titration scheme. Part 1
has been completed and the results were presented at the
Obesity Society Annual Meeting (ObesityWeek) in October
2023. Low doses of 0.6 mg and 1.2 mg ZP8396
administered once weekly for six weeks led to 5.3% and 5.1%
mean weight loss from baseline in enrolled participants
(mean body weight of 82 kg and BMI of 25.4). In the 6-week
trial, ZP8396 was judged to be well tolerated, with no
serious or severe adverse events and no withdrawals. The
most common adverse events were related to the
gastrointestinal system, such as nausea. All gastrointestinal
side effects were mild, and most occurred within two days
of the first dose. Based on the mild adverse event profile,
Zealand initiated Part 2 of the MAD trial, exploring higher
doses of ZP8396 over 16 weeks using a dose up-titration
scheme, with topline results expected in the first half of
2024.
The Phase 1a, first-in-human, randomized, single ascending
dose (SAD) trial to assess the safety, tolerability,
pharmacokinetics, and pharmacodynamics of ZP8396 in
healthy volunteers (ClinicalTrials.gov ID: NCT05096598).
Healthy participants with a mean BMI of 25.8 were
randomized (6:2) within seven dose cohorts and treated
with either subcutaneous ZP8396 or placebo. After one
week, participants treated with ZP8396 had reductions in
mean body weight of 2.6%, 3.6% and 4.2% from baseline
following single doses of 0.7, 1.4 and 2.4 mg ZP8396. Body
weight reductions were well-sustained during the additional
five weeks of observation without further doses of ZP8396.
Placebo-treated participants had a mean body weight
increase of 0.6% after one week that continued to increase
in most participants during the follow-up period. The plasma
half-life of ZP8396 was 230 hours, or approximately 10 days,
which supports once-weekly dose administration. ZP8396
was well tolerated in this trial, with no serious or severe
adverse events and no withdrawals. The detailed results
were presented at the ADA 83
rd
Scientific Sessions in June
2023.
Dapiglutide (long-acting GLP-1R/GLP-2R dual agonist)
Third quarter 2023 update:
• Initiation of a 13-week dose titration trial in people with
overweight or obesity.
Background:
Dapiglutide is a long-acting, dual GLP-1R/GLP-2R agonist for
the potential treatment of obesity. This is a first-in-class
peptide designed to leverage the weight loss effects of a
potent GLP-1 agonist and address co-morbidities associated
with low-grade inflammation through improved intestinal
barrier function by GLP-2.
A Phase 2 investigator-led randomized, double-blind,
placebo-controlled clinical trial in up to 54 people living with
overweight and obesity, named DREAM, aims to evaluate
the potential for weight loss and gain key mechanistic
insights into the effects of dapiglutide on inflammatory
markers following a 12-week treatment period. Zealand
expects topline results from the trial in the first half of 2024.
Please visit ClinicalTrials.gov for further information (ID:
NCT05788601).
Separately, Zealand has initiated a 13-week randomized,
double-blind, placebo-controlled, dose titration trial
(ClinicalTrials.gov ID: NCT06000891) to evaluate higher
doses of dapiglutide in overweight or obese but otherwise
healthy people (eligible BMI 27.0–39.9). The company
expects topline results in the second half of 2024.
Phase 1 results of dapiglutide in healthy volunteers
demonstrated dose-dependent weight loss of up to 4.3%
from baseline body weight after only four weeks of
treatment. Dapiglutide also delayed gastric emptying and
reduced plasma glucose and insulin concentrations in a
dose-dependent manner. Pharmacokinetics showed a
mean half-life of 123-129 hours across the four dose
cohorts, which supports once-weekly dose administration.
No trial participants developed anti-drug antibodies. Multiple
weekly doses of dapiglutide were well-tolerated and the
safety profile was as expected for GLP-1 and GLP-2 receptor
agonists. These results were presented at the ADA 82
nd
Scientific Sessions in June 2022.
Survodutide (long-acting dual GCGR/GLP-1R agonist) in
collaboration with Boehringer Ingelheim
Third quarter 2023 update:
• Announcement by Boehringer Ingelheim of global
Phase 3 program (SYNCHRONIZE
TM
) in people living
with overweight or obesity, with and without diabetes,
cardiovascular disease and chronic kidney disease,
including a longer overall treatment period and a higher
maximum maintenance dose compared with Phase 2.
Background:
Survodutide (BI 456906) is a long-acting glucagon/GLP-1
receptor dual agonist for once-weekly subcutaneous
administration that activates two key gut hormone receptors
simultaneously and may offer better efficacy than current
single-hormone receptor agonist treatments. Survodutide is
targeting the treatment of obesity and NASH.
Boehringer Ingelheim is advancing survodutide into three
global Phase 3 trials in people living with overweight or
obesity.
SYNCHRONIZE
TM
-1 (ClinicalTrials.gov ID: NCT06066515)
and SYNCHRONIZE
TM
-2 (ClinicalTrials.gov ID:
NCT06066528) are Phase 3 trials investigating survodutide
in people with obesity (eligible BMI ≥30) or overweight
(eligible BMI ≥27) with comorbidities, including dyslipidemia,
hypertension and obstructive sleep apnea.
SYNCHRONIZE
TM
-1 will enroll people without type 2
Company announcement
No. 38 / 2023
9
diabetes (eligible HbA1c <6.5%) and SYNCHRONIZE
TM
-2 will
enroll people with type 2 diabetes (eligible HbA1c ≥6.5%
<10%).
For both trials, the primary endpoints are percentage
change in body weight at week 76 and the proportion of
people who achieve body weight loss of 5% or more at week
76. A total of 600 participants will be enrolled in each of the
two trials, randomized to receive weekly subcutaneous
injections of either survodutide, reaching a maximum dose
of 3.6 mg or 6.0 mg for maintenance treatment, or placebo.
SYNCHRONIZE
TM
-CVOT (ClinicalTrials.gov ID:
NCT06077864) is a Phase 3 trial that will enroll people with
overweight or obesity with cardiovascular disease, chronic
kidney disease, or risk factors for cardiovascular disease. In
SYNCHRONIZE
TM
-CVOT, the primary endpoint is the time to
first occurrence of any one of five major adverse cardiac
events (5P-MACE): cardiovascular death, non-fatal stroke,
non-fatal myocardial infarction, ischemia-related coronary
revascularization and heart failure events.
A Phase 2 randomized, placebo-controlled, double-blind,
trial evaluated survodutide compared to placebo in people
with overweight or obesity (ClinicalTrials.gov ID:
NCT04667377). Participants received multiple rising doses
of survodutide in one of four dose groups or placebo and
included 20 weeks of dose escalation and 26 weeks of
maintenance. Based on the planned maintenance dose
assigned at randomization regardless of whether the
planned dose was reached during the dose escalation
phase, survodutide achieved up to 14.9% mean weight loss
from baseline after 46 weeks. An analysis based on the
actual maintenance dose regardless of assignment at
randomization, showed up to 18.7% mean weight loss after
46 weeks. Bodyweight reductions with survodutide had not
reached a plateau at week 46, suggesting additional weight
loss could be achieved with longer treatment duration. Up
to 40% of people who reached the highest two doses of
survodutide, 3.6 mg and 4.8 mg, achieved a weight loss of
at least 20%.
Serious adverse events were reported by 4.2% of participants
on survodutide versus 6.5% of those on placebo. Treatment
discontinuation due to adverse events occurred in 24.6%
and 3.9% of participants on survodutide and placebo,
respectively, mainly due to gastrointestinal adverse events.
Most treatment discontinuations due to adverse events
occurred during the rapid 20-week dose-escalation phase
with up-titration every second week. Thus, the safety and
tolerability profile of survodutide was in line with other
incretin-based pharmacotherapies. The treatment
discontinuation rate of survodutide was also roughly similar
to the treatment discontinuation rates seen with other
incretin-based pharmacotherapies in previous Phase 2 trials
in type 2 diabetes and obesity. Boehringer Ingelheim and
Zealand Pharma expect that treatment discontinuations due
to adverse events can be mitigated with more gradual dose
escalation over a longer duration in Phase 3. The detailed
results from the Phase 2 trial were presented at the ADA 83
rd
Scientific Sessions in June 2023.
A Phase 2 randomized, placebo-controlled, double-blind
trial evaluated survodutide in people with type 2 diabetes on
stable metformin background therapy (ClinicalTrials.gov ID:
NCT04153929). Participants received multiple rising doses
of survodutide in one of six dose groups, placebo or open-
label weekly semaglutide 1.0 mg for 16 weeks. Treatment
with survodutide led to dose-dependent decreases in
HbA1c, with mean reductions of -0.93% to -1.88% at 16
weeks across the six dose groups, compared with -0.25%
seen with placebo. Treatment with open-label weekly
semaglutide at 1.0 mg led to a decrease in HbA1c of -1.47%.
Boehringer Ingelheim presented these results at the 58th
Annual Meeting of the European Association for the Study
of Diabetes (EASD) in September 2022.
A third Phase 2 trial is assessing survodutide in non-alcoholic
steatohepatitis (NASH) and liver fibrosis stages F1/F2/F3
(ClinicalTrials.gov ID: NCT04771273). The NASH program
has received Fast Track Designation from the US FDA. In
people living with overweight and obesity, it is estimated that
75% have nonalcoholic fatty liver disease (NAFLD) and 34%
have NASH. Boehringer Ingelheim and Zealand expect to
report topline results from the Phase 2 trial with survodutide
in NASH in the first half of 2024.
Survodutide was co-invented by Boehringer Ingelheim and
Zealand. Boehringer Ingelheim is funding all research,
development and commercialization activities related to
survodutide. Zealand is eligible to receive up to EUR 345
million in outstanding milestone payments, including the
EUR 30 million recognized in the third quarter of 2023, and
high-single to low-double digit royalties on global sales.
Type 1 Diabetes Management
Dasiglucagon for Bihormonal Artificial Pancreas systems
Background:
Zealand is developing a pre-filled dasiglucagon cartridge
intended for use in Bihormonal Artificial Pancreas systems,
which hold potential to improve the management of type 1
diabetes (T1D). Zealand is collaborating with Beta Bionics,
developer of the Bihormonal iLet® Bionic Pancreas (iLet
Duo™), a pocket-sized, dual chamber (insulin and
glucagon), autonomous, glycemic control system. The iLet
Duo™ is an investigational device, limited by federal (or
United States) law to investigational use only. The iLet®
Bionic Pancreas platform is designed to use adaptive, self-
learning, control algorithms, together with continuous
glucose monitoring and pump technology, to
autonomously compute and administer doses of insulin
and/or glucagon and mimic the body’s natural ability to
maintain tight glycemic control.
Company announcement
No. 38 / 2023
10
Zealand anticipates that Beta Bionics will begin the Phase 3
Bihormonal iLet® Bionic Pancreas Pivotal Program in the
second half of 2023. The Phase 3 program consists of three
planned studies designed to support the marketing
applications for the iLet Duo and an NDA for the use of
dasiglucagon in Bihormonal Artificial Pancreas systems for
the treatment of T1D. The pivotal study plan includes an
initial crossover trial of approximately 60 participants to
assess safety and efficacy of the bihormonal and insulin-only
configurations of the iLet® Bionic Pancreas. Subsequently,
the companies plan to initiate full-scale, randomized,
controlled pivotal trials in 350 adult and 350 pediatric
participants with T1D to assess the efficacy of the iLet Duo™
as compared to the insulin-only system.
Dasiglucagon mini-dose pen
Background:
Zealand is developing a dasiglucagon mini-dose pen for the
potential treatment of exercise-induced hypoglycemia in
people living with T1D and for people who suffer from meal-
induced hypoglycemia following gastric bypass surgery
(post bariatric hypoglycemia, or PBH). Four investigator-
initiated trials conducted in collaboration with Zealand
evaluated mini-dose dasiglucagon to support this
development program.
Investigators from the Steno Diabetes Center Copenhagen
conducted a Phase 2 trial using the dasiglucagon mini-dose
pen in people with T1D in free-living conditions
(ClinicalTrials.gov ID: NCT04764968). The trial results were
published online in April 2023 in the journal Diabetologia
and showed that dasiglucagon administered by pen
improved glycemic control and reduced carbohydrate
intake among the study participants. These data build on
two prior clinical studies conducted in hospital settings with
results that show the potential for using low doses of
dasiglucagon to correct moderate hypoglycemia: a Phase
2a dose-finding trial in people with T1D (ClinicalTrials.gov ID:
NCT04449692) presented at the ADA Scientific Sessions in
2021, and a Phase 2a trial in PBH (ClinicalTrials.gov ID:
NCT03984370) published in the journal Diabetes Care in
2022.
A Phase 2 trial in PBH conducted in an out-patient setting
(ClinicalTrials.gov ID: NCT04836273) has been completed
and met the primary endpoint.
Inflammation
Zealand is pursuing multiple pre-clinical programs in
inflammatory diseases which will be detailed more as they
progress through development.
Complement inhibitors (collaboration with Alexion,
AstraZeneca Rare Disease)
Zealand and Alexion are collaborating on the discovery and
development of novel peptide therapies for complement-
mediated diseases. Under the terms of the agreement,
Alexion and Zealand entered into an exclusive collaboration
for the discovery and development of subcutaneously
delivered peptide therapies directed to up to four
complement pathway targets. The lead program, ZP10068,
is an investigational long-acting inhibitor of Complement
C3, which has the potential to treat a broad range of
complement mediated diseases. Zealand will lead the joint
discovery and research efforts through the pre-clinical
stage, and Alexion will lead development efforts beginning
with Investigational New Drug (IND) filing and Phase 1 trials.
Zealand has completed activities to support advancing
ZP10068 into clinical trials. Subsequent regulatory, clinical,
and development efforts will be led and conducted by
Alexion.
For the lead target, Zealand is eligible to receive up to USD
610 million in development and sales milestone payments,
plus royalties on global sales in the high single to low double
digits. In addition, Alexion has the option to select up to
three additional targets with Zealand eligible for USD 15
million upfront per target plus potential development and
regulatory milestones for each target selected, similar to the
lead target with slightly reduced commercial milestones and
royalties.
1 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Financial highlights and key
figures.
Financial highlights (DKK thousand) Note Q3-23 Q3-22*
Q3-23
YTD
Q3-22
YTD*
Revenue 2 295,517 43,714 319,553 80,061
Research and development expenses -196,893 -145,653 -494,720 -452,565
Sales and marketing expenses -6,061 -6,166 -17,812 -28,644
Administrative expenses -43,641 -53,998 -134,400 -177,050
Net other operating items 4 1,519 27 13,782 -17,986
Net operating expenses -245,076 - 205,790 -633,150 - 676,245
Net financial items 5 27,549 8,418 - 124,785 -53,421
Result before tax 72,828 -153,658 -443,545 -649,605
Corporate tax 1,317 1,776 4,556 5,056
Net result for the period from continuing operations 74,145 -151,882 -438,989 -644,549
Net result for the period from discontinued operations -
3,540
-
-215,138
Net result for the period 74,145 -148,342 -438,989 -859,687
Earnings/loss per share from continuing operations, basic (DKK) 1.27 -3.29 -7.84 -14.46
Earnings/loss per share from continuing operations, diluted (DKK) 1.23 -3.29 -7.84 -14.46
Statement of financial position (DKK thousand) Note
Sep-30,
2023
Dec-31,
2022
Cash, cash equivalents and marketable securities 1,582,189 1,177,845
Total assets 2,175,505 1,539,806
Total shareholders' equity 1,816,796 815,911
Cash flow (DKK thousand) Note
Q3-23
YTD
Q3-22
YTD
Undrawn borrowing facilities 1) 350,000 -
Cash (used in)/provided by operating activities -485,183 -669,927
Cash (used in)/provided by investing activities -1,100,730 178,566
Cash (used in)/provided by financing activities 901,416 -178,535
Purchase of intangible assets -8,840 -
Purchase of property, plant and equipment -4,522 -5,083
Free cash flow 2) -489,705 -675,010
Other Note
Sep-30,
2023
Dec-31,
2022
Share price (DKK) 305.8 201.4
Number of shares ('000 shares) 58,677 51,702
Market capitalization (MDKK) 2) 17,828 9,305
Equity ratio (%) 2) 84% 53%
Equity per share (DKK) 2) 31.16 17.66
Average number of full time employees 228 247
Number of full-time employees at the end of period 249 196
* Comparatives numbers for Q3 and Q3, 2022 year-to-date are adjusted to reflect the effect of discontinued operations. For further details refer
to note 2.8 in the 2022 Annual Report.
1) In May 2023, Zealand entered a new DKK 350 million revolving credit facility provided by Danske Bank as refinancing following the
repayment of the Oberland loan, refer to note 10.
2) For basis of calculation refer to 2022 Annual Report p. 110.
2 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Financial Review.
• Revenue in the first nine months of 2023 of DKK 320
million is mainly driven by recognition of EUR 30
million from an upcoming expected milestone
payment from Boehringer Ingelheim associated with
survodutide and USD 10 million from a milestone
payment from Sanofi associated with lixisenatide.
Revenue from these milestones have been recognized
in Q3 2023 and cash inflow is expected in Q4 2023.
• Net operating expenses in the first nine months of 2023
of DKK -633 million are mainly driven by the
progression of the late-stage rare disease assets
towards regulatory submission and clinical
advancement of the obesity pipeline.
• Runway to mid-2026 following the directed issue and
private placement in April 2023, bringing in gross
proceeds of DKK 1.5 billion.
Revenue
Revenue in the first nine months of 2023 of DKK 320
million is mainly driven by recognition in Q3 2023 of EUR
30 million in milestone payment from Boehringer
Ingelheim related to the expected Phase 3 initiation with
survodutide in obesity in November 2023 and USD 10
million in milestone payment from Sanofi associated with
lixisenatide. Out of the USD 10 million from Sanofi, Zealand
will pay USD 1.3 million in royalty expenses to Alkermes,
which is entitled to 13% of payments received by Zealand
in respect of lixisenatide under the Sanofi License
Agreement. As of September 30, 2023, there are no other
outstanding milestone payments associated with the
license agreement with Sanofi. All royalties related to
lixisenatide were sold to Royalty Pharma in 2018.
In Q3 2023, there is no cash effect from the two milestone
payments from Boehringer Ingelheim and Sanofi, as cash
inflow is expected in Q4 2023.
The remaining revenue in the first nine months of 2023 is
mainly related to the license and development agreement
for Zegalogue
®
with Novo Nordisk.
Net operating expenses
Research and development expenses in the first nine
months of 2023 of DKK -495 million are mainly driven by
the progression of the late-stage rare disease assets
towards regulatory submission and clinical advancement of
the obesity pipeline. The New Drug Application (NDA) for
dasiglucagon in congenital hyperinsulinism was submitted
to the US FDA in June 2023 and the NDA for glepaglutide
in short bowel syndrome is expected to be submitted to
the US FDA in Q4 2023. The spend in the first nine months
of 2023 is slightly above the first nine months of 2022 due
to progression of clinical and regulatory activities. Research
and development expenses in Q3 2023 are higher than
both Q1 2023 and Q2 2023, mainly driven by the
significant clinical advancement of the obesity pipeline.
Selling and marketing expenses of DKK -18 million and
administrative expenses of DKK -134 million in the first nine
months of 2023 are significantly below the first nine
months of 2022 due to cost reduction efforts following the
announced restructuring on March 30, 2022.
Net other operating items of DKK 14 million in the first nine
months of 2023 are related to a reversal of inventory write-
down associated with Zegalogue
®
.
Financial items
Financial items in the first nine months of 2023 of DKK -125
million are mainly driven by the final repayment and
termination of the loan with Oberland Capital in May 2023.
Interest expenses and banking fees in the first nine months
of 2023 of DKK -24 million, mainly related to interest
payments on the now terminated Oberland loan
agreement, are more than offset by interest income on
marketable securities of DKK 28 million and exchange rate
favorable adjustments of DKK 20 million, primarily related
to USD deposits.
-54
-60
-48
-40
0
-6
Q3 2022
-4
-162
Q4 2022
-5
-142
Q1 2023
5
-7
-156
Q2 2023
2
-6
-197
Q3 2023
-205
-266
-182
-206
-245
-145
7
-42
-44
R&D S&M G&A Net other operating items
OPEX by quarter
DKK million
3 Zealand Pharma A/S | Interim Financial Statements Q3 2023
In the first nine months of 2023, the investment in Beta
Bionics was subject to a fair value adjustment of DKK -17
million.
Equity
On September 30, 2023, equity was DKK 1,817 million,
reflecting a significant increase compared to December 31,
2022, mainly driven by the proceeds from the directed
issue and private placement of new shares in April 2023
and partly offset by the loss for the period.
Cash position
Cash, cash equivalents and marketable securities as of
September 30, 2023 was DKK 1.6 billion and DKK 1.9 billion
including an undrawn DKK 350 million Revolving Credit
Facility provided by Danske Bank, reflecting a significant
increase compared to the DKK 1.2 billion in cash, cash
equivalents and marketable securities as of December 31,
2022. This development in the first nine months of 2023 is
mainly driven by the DKK 1.5 billion in gross proceeds from
the directed issue and private placement of new shares in
April 2023 and partly offset by cash used in operating
activities during the period (DKK -485 million) and
settlement and repayment of the Oberland loan (DKK -526
million).
As of September 30, 2023, Zealand has placed DKK 1.2
billion in low-risk marketable securities, whereas cash and
cash equivalents amount to DKK 0.4 billion. This is in line
with the company’s treasury policy. As of December 31,
2022, the split between marketable securities and cash and
cash equivalents was largely opposite, with marketable
securities at DKK 0.1 billion and cash and cash equivalents
at DKK 1.1 billion.
The final repayment and termination of the loan
agreement with Oberland Capital in May 2023 was
refinanced through the Revolving Credit Facility provided
by Danske Bank and the milestone payments from
Boehringer Ingelheim and Sanofi associated with
survodutide and lixisenatide, respectively. In Q3 2023, there
was no cash effect from the two milestone payments from
Boehringer Ingelheim and Sanofi. Cash inflow from both
milestone payments is expected in Q4 2023. For further
information on the capital increase in April, repayment of
the Oberland loan in May, and the Revolving Credit Facility,
please refer to note 7.
Zealand’s cash is intended to:
• Support the remaining late-stage rare disease assets
and pursue strong strategic partners for future
commercialization.
• Advance the clinical-stage candidates, including the
obesity pipeline that includes the GLP-1/GLP-2 receptor
dual agonist dapiglutide and the amylin analog ZP8396.
• Progress additional peptide candidates from non-
clinical development into early clinical development.
• Continue the early discovery and research to develop
additional peptide candidates.
• Strengthen Zealand’s capital base and cash
preparedness (general corporate purposes).
Events after the reporting date
No events have occurred subsequent to the balance sheet
date that could significantly affect the interim financial
statements as of September 30, 2023.
Outlook for the year
There are no changes to the outlook for the year and
guidance is confirmed. Net operating expenses for the year
are still expected between DKK 800-900 million. For
further information, please refer to p. 10 in the 2022 Annual
Report.
Cash position compared to FY22
DKK million
1,198
1,069
1,500
384
285
109
Cash
position
Dec-2022
1
-485
Cash flow
from
operating
activities
-85
Other cash
adjustments
Gross
proceeds
from
capital
increase
April 2023
-526
Repayment
Oberland
Capital
loan May
2023
350
Cash
position
Sep-2023
1
Expected
milestone
payments
in Q4,
2023
2
1,178
1,932
Undrawn borrowing facilities
Cash and cash equivalents
Marketable securities
1. Cash position includes cash, cash equivalents and marketable securities.
2. Cash inflow from milestone payments from Boehringer Ingelheim and
Sanofi expected in Q4, 2023.
4 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim financial statements.
Unaudited interim condensed consolidated financial statements for Q3 and Q3, 2023 year-to-date:
Interim profit and loss statement .......................................................................................................................................................................... 5
Interim statement of comprehensive profit and loss ....................................................................................................................................... 6
Interim statement of financial position ................................................................................................................................................................ 7
Interim statement of cash flow .............................................................................................................................................................................. 8
Interim statement of changes in equity ............................................................................................................................................................... 9
Notes to the interim condensed consolidated financial statements. ............................................................................................................ 10
1. Basis of preparation and changes to the Group’s accounting policies ................................................................................................. 10
2. Revenue ................................................................................................................................................................................................................. 11
3. Cost of goods sold .............................................................................................................................................................................................. 11
4. Net other operating items ................................................................................................................................................................................ 12
5. Net financial items .............................................................................................................................................................................................. 13
6. Intangible assets .................................................................................................................................................................................................. 13
7. Inventory ............................................................................................................................................................................................................... 14
8. Trade and other receivables ............................................................................................................................................................................ 14
9. Other payables .................................................................................................................................................................................................... 14
10. Financial instruments ....................................................................................................................................................................................... 14
11. Cash and cash equivalents .............................................................................................................................................................................. 16
12. Share capital ....................................................................................................................................................................................................... 16
13. Capital Management ......................................................................................................................................................................................... 17
14. Contingent assets and liabilities ..................................................................................................................................................................... 17
15. Significant events after the reporting period ............................................................................................................................................... 17
Statement by the Executive Management and the Board of Directors ......................................................................................................... 18
Independent auditor's report .................................................................................................................................................................................... 19
5 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim profit and loss statement.
DKK thousand Note
Q3-23 Q3-22*
Q3-23
YTD
Q3-22
YTD*
(reviewed) (revi ewed) (reviewed) (reviewed)
Revenue 2 295,517 43,714 319,553 80,061
Cost of goods sold 3 -5,162 - -5,162 -
Gross Profit 290,355 43,714 314,391 80,061
Research and development expenses -196,893 -145,653 -494,720 -452,565
Sales and marketing expenses -6,061 -6,166 -17,812 -28,644
Administrative expenses -43,641 -53,998 -134,400 -177,050
Net other operating items 4 1,519 27 13,782 -17,986
Net operating expenses -245,076 -205,790 -633,150 -676,245
Operating result 45,279 -162,076 -318,759 -596,184
Financial income 5 33,454 18,885 52,651 130,776
Financial expenses 5 -5,905 -10,467 -177,437 -184,197
Result before tax 72,828 -153,658 -443,545 -649,605
Corporate tax 1,317 1,776 4,556 5,056
Net result for the period from continuing operations 74,145 -151,882 -438,989 -644,549
Net result for the period from discontinued operations* - 3,540 - -215,138
Net result for the period 74,145 -148,342 -438,989 -859,687
Earnings/loss per share from continuing operations, basic
(DKK)
Earnings/loss per share from continuing operations,
diluted (DKK)
Earnings/loss per share from discontinued operations,
basic (DKK)
Earnings/loss per share from discontinued operations,
diluted (DKK)
Earnings/loss per share, basic (DKK) 1.27 -3.21 -7.84 -19.28
Earnings/loss per share, diluted (DKK) 1.23 -3.21 -7.84 -19.28
* Comparatives numbers for Q3 and Q3, 2022 year-to-date are adjusted to reflect the effect of discontinued operations. For
further details refer to note 2.8 in the 2022 Annual Report.
6 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim statement of comprehensive
profit and loss.
DKK thousand Note Q3-23 Q3-22
Q3-23
YTD
Q3-22
YTD
(reviewed) (reviewed) (revi ewed) (reviewed)
Net result for the period 74,145 -148,342 -438,989 -859,687
Other comprehensive income
Items that will be reclassified to income statement when
certain conditions are met (net of tax):
Exchange differences on translation of foreign operations -7,083 -511 -3,324 4,376
Total comprehensive result for the period 67,062 -148,853 -442,313 -855,311
7 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim statement of financial position.
DKK thousand Note
Sep-30,
2023
Dec-31,
2022
Assets (reviewed) (audited)
Intangible assets 6 8,840 -
Property, plant and equipment 46,843 50,528
Right-of-use assets 107,199 114,960
Other investments 10 13,444 30,943
Corporate tax receivable 4,125 -
Deferred tax assets 2,036 2,017
Other receivables 8 19,576 18,105
Other financial assets 10 7,508 6,901
Total non-current assets 209,571 223,454
Inventory 7 10,711 1,286
Trade and other receivables 8 351,052 115,622
Corporate tax receivable 21,982 21,599
Marketable securities 10,11 1,197,748 108,611
Cash and cash equivalents 11 384,441 1,069,234
Total current assets 1,965,934 1,316,352
Total assets 2,175,505 1,539,806
Shareholders equity and liabilities
Share capital 12 58,677 51,702
Currency translation reserve 11,293 14,617
Retained earnings 1,746,826 749,592
Total shareholders' equity 1,816,796 815,911
Other payables 9 - 19,058
Borrowings including embedded derivatives 10 - 401,346
Lease liabilities 101,085 108,000
Total non-current liabilities 101,085 528,404
Lease liabilities 14,972 14,729
Trade and other payables 242,652 180,762
Total current liabilities 257,624 195,491
Total liabilities 358,709 723,895
Total shareholders' equity and liabilities 2,175,505 1,539,806
8 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim statement of cash flow.
DKK thousand Note Q3-23 YTD Q3-22 YTD
(reviewed) (reviewed)
Net result for the period -438,989 -859,687
Adjustment for other non-cash items 169,600 141,477
Changes in working capital 2,8 -211,365 63,806
Financial income received 22,217 3,045
Financial expenses paid -26,872 -20,004
Corporate taxes paid/received 226 1,436
Cash flow from/(used in) operating activities -485,183 -669,927
Proceeds from sale of marketable securites 660,511 772,405
Purchase of marketable securities 10 -1,747,880 -693,174
Purchase of intangible assets 6 -8,840 -
Purchase of property, plant and equipment -4,522 -5,083
Divestment of activities - 104,852
Change in deposits - -434
Cash flow from/(used in) investing activities -1,100,731 178,566
Repayment of borrowings 10 -525,764 -436,088
Lease installments -9,035 -10,246
Proceeds from issuance of shares 12 1,500,000 274,775
Purchase of treasury shares 12 -41,600 -
Proceeds from issuance of shares related to exercise of share-based
compensation
12 49,138 1,177
Costs related to issuance of shares -71,323 -8,153
Cash flow from/(used in) financing activities 901,416 -178,535
(Decrease)/increase in cash and cash equivalents -684,498 -669,896
Cash and cash equivalents at beginning of period 1,069,234 1,129,103
Exchange rate adjustments -295 34,548
Cash and cash equivalents at end of period 11 384,441 493,755
9 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Interim statement of changes in equity.
DKK thousand
Share
capital
Translation
reserve
Retained
earnings*
Total
Shareholder's equity at January 1, 2023 51,702 14,617 749,592 815,911
Other comprehensive income for the period - -3,324 - -3,324
Net result for the period - - -438,989 -438,989
Acquisition of treasury shares - - -81,045 -81,045
Share-based compensation - - 46,428 46,428
Capital increases 6,975 - 1,542,163 1,549,138
Costs related to capital increases - - -71,323 -71,323
Shareholder's equity at September 30, 2023 (reviewed) 58,677 11,293 1,746,826 1,816,796
Shareholder's equity at January 1, 2022 43,634 14,155 870,014 927,803
Other comprehensive income for the period - 4,376 - 4,376
Net result for the period - - -859,687 -859,687
Share-based compensation - - 26,149 26,149
Capital increases 2,904 - 273,048 275,952
Costs related to capital increases - - -8,153 -8,153
Shareholder's equity at September 30, 2022 (reviewed) 46,538 18,531 301,371 366,440
*Treasury shares, Share premium, Warrant compensation expenses and Retained losses have been merged into the column
Retained earnings to ease accessibility of information.
10 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Notes to the interim condensed
consolidated financial statements.
1. Basis of preparation and changes to the Group’s accounting policies
Basis of preparation
The interim condensed consolidated financial statements of Zealand Pharma A/S (The Group) have been prepared in
accordance with IAS 34, Interim Financial Reporting, as adopted by EU and additional requirements of the Danish Financial
Statements Act. The interim condensed consolidated financial statements are presented in Danish kroner (DKK) which is also
the functional currency of the parent company.
The accounting policies used in the interim condensed consolidated financial statements are consistent with those used in the
Group’s annual financial statement for the year ended December 31, 2022, except from Intangible assets. Intangible assets
comprise capitalized implementation costs on IT projects initially measured at cost. Costs include configuration and
customization of the underlying software, including training and testing. Capitalization ceases when the asset is in the condition
necessary for it to be capable of operating in the manner intended by management. The intangible assets are subsequently
measured at cost less accumulated depreciation and any impairment losses according to IAS 38. Depreciation is calculated on
a straight-line basis over the estimated useful life which is 3-5 years.
Going concern assessment
Management’s judgement and assessment of the Group’s ability to continue as a going concern includes evaluation of the
Group's operational cash flow requirements for the forthcoming 12 months from the balance sheet date and future sources
and uses of cash. Following the capital increase completed in April 2023 the Group received gross proceeds of DKK 1.5 billion.
On this basis the interim condensed consolidated financial statements are prepared using the going concern assumption.
New standards, interpretations and amendments adopted by the Group
Several amendments apply for the first time in 2023, but do not have an impact on the interim condensed consolidated
financial statements of the Group. The Group has not early adopted any standard, interpretation or amendment that has been
issued but is not yet effective.
Significant accounting estimates and judgements
The preparation of the interim condensed consolidated financial statements requires Management to make judgments and
estimates that affect the reported amounts of revenues, expenses, assets and liabilities, and the accompanying disclosures. In
applying our accounting policies, Management is required to make judgements and estimates about the carrying amounts of
assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on
historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The
estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in
the period in which the estimate is revised 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.
The estimates used are based on assumptions assessed to be reasonable by Management. However, estimates are inherently
uncertain and unpredictable. The assumptions may be incomplete or inaccurate, and unexpected events or circumstances may
occur. Furthermore, we are subject to risks and uncertainties that may result in deviations in actual results compared with
estimates.
Except for the items listed below, no material changes in significant accounting estimates and judgements have occurred since
the Annual Report 2022. Please refer to note 1.4 in the 2022 Annual Report for further information:
• Judgement on milestone payment from Boehringer Ingelheim (Revenue). Refer to note 2.
• Estimate of net realizable value of Zegalogue
®
raw materials (Inventory). Refer to note 7.
• Estimate of fair value on investment in Beta Bionics (Other investments). Refer to note 10.
• Estimate of fair value of Oberland’s call option for repayment of loan (Borrowings including embedded derivatives).
Refer to note 10.
• Judgement in assessing operational cash-flow and capital requirements for the forthcoming 12 months from the
balance sheet date. Refer to the going concern assessment above.
2. Revenue
Revenue can be specified as follows:
DKK thousand Q3-23 Q3-22*
Q3-23
YTD
Q3-22
YTD*
(reviewed) (reviewed) (reviewed) (reviewed)
Alexion Pharmaceuticals Inc. 554 15,136 3,258 51,483
Boehringer Ingelheim International GmbH 223,725 - 223,725 -
Novo Nordisk A/S 4,791 28,578 26,123 28,578
Sanofi-Aventis Deutschland GmbH 61,285 - 61,285 -
Total revenue from license and collaboration agreements 290,355 43,714 314,391 8 0,061
Total sale of goods revenue net 5,162 22,668 5,162 87,314
- Hereof related to discontinued operations - -22,668 - -87,314
Sale of goods revenue from continuing operations 5,16 2 - 5,162 -
Total revenue from continuing operations 295,517 4 3,714 319,553 80,061
Total revenue recognized over time 5,345 15,136 29,381 51,483
Total revenue recognized at a point in time from continuing
operations
290,172 28,5 78 290,172 28,5 78
Total revenue recognized at a point in time from
discontinued operations
- 22,668 - 87,314
* Comparatives numbers for Q3 and Q3, 2022 year-to-date are adjusted to reflect the effect of discontinued operations. For
further details refer to note 2.8 in the 2022 Annual Report.
Total revenue in Q3, 2023 of DKK 295.5 million is mainly driven by recognition of EUR 30 million in milestone payment from
Boehringer Ingelheim, and USD 8.7 million in milestone payment from Sanofi associated with lixisenatide. The revenue from
these milestones have been recognized in Q3, 2023 and cash inflow is expected in Q4, 2023.
On August 17, 2023 Boehringer Ingelheim announced their intention to advance survodutide into Phase 3, and with enrollment
of patients planned in Q4, 2023. Based on this it is Management’s judgement that the milestone payment of EUR 30 million is
no longer constrained and that it is highly probable that a significant revenue reversal will not occur.
Out of the USD 10 million from Sanofi, Zealand will pay USD 1.3 million in royalty expenses to Alkermes in line with a
termination agreement following the dissolution of a former joint venture with Elan Corporation (now Alkermes), stipulating
that Alkermes is entitled to 13% of payments received by Zealand in respect of lixisenatide under the Sanofi License Agreement.
As of September 30, 2023, there are no other outstanding milestone payments associated with the license agreement with
Sanofi. All royalties related to lixisenatide were sold to Royalty Pharma in 2018.
3. Cost of goods sold
Costs of goods sold in Q3, 2023 of DKK -5.2 million relates to inventory utilized in the production under the supply agreement
with Novo Nordisk A/S. The inventory was booked at net realizable value which equals the agreed selling price with Novo
12 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Nordisk A/S. An equivalent revenue from sale of goods of DKK 5.2 million has therefore been recognized, thus resulting in
neutral effect on gross profit.
4. Net other operating items
Net other operating items can be specified as follows:
DKK thousand Q3-23 Q3-22
Q3-23
YTD
Q3-22
YTD
(reviewed) (revi ewed) (reviewed) (reviewed)
Proceeds from insurance claims - - - 1,849
Restructuring costs - 27 - -19 ,093
Loss on sale of fixed assets 53 - 53 -742
Reversal of inventory write-down 1,466 - 13,729 -
Net other operating items in total 1,519 27 13,782 -17,986
All restructuring costs in Q3 and Q3, 2022 year-to-date were incurred as a result of the March 30, 2022, company
announcement on refocused strategy.
As of September 30, 2023 management has estimated the net realizable value of raw materials to be DKK 10.7 million as all
remaining materials are expected to be utilized in the production and sale under the supply agreement with Novo Nordisk, and
therefore a reversal of inventory write-down of DKK 13.7 million has been made in Q3, 2023 year-to-date of which DKK 1.5
million relates to Q3, 2023. Reference is made to note 7.
13 Zealand Pharma A/S | Interim Financial Statements Q3 2023
5. Net financial items
Financial items include interests, as well as foreign exchange rate adjustments, fair value adjustments of other investments,
embedded derivatives and marketable securities and dividends from marketable securities.
DKK thousand Q3-23 Q3-22
Q3-23
YTD
Q3-22
YTD
(reviewed) (reviewed) (reviewed) (reviewed)
Interest income 10,661 1,379 28,443 3,060
Interest expenses and banking fees -3,532 -10,349 -24,014 -36,705
Loss on settlement of borrowings, including embedded
derivatives under Oberland loan
- -172 -135,588 -144,901
Fair value adjustment of lender's call option - - 1,161 -
Fair value adjustment of prepayment option - - - 71,050
Fair value adjustment of marketable securities 2,842 54 3,131 -2,591
Fair value adjustment of other investments -2,373 - -16,892 2,259
Amortization of loan costs - - -943 -
Exchange rate adjustments 19,951 1 7,506 19,916 54,407
Financial items in total 27,549 8,418 -124,786 -53,421
Presentation in income statement:
Financial income 33,454 18,885 52,651 130,776
Financial expenses -5,905 -10,467 -177,437 -184,197
Interest income in Q3, 2023 year-to-date of DKK 28.4 million relates to interest on the USD 50 million from the Oberland loan
which was placed on an investment account and interest on marketable securities. Interest income in Q3, 2023 of DKK 10.7
million mainly comprise interest income on marketable securities, including interest from the new marketable securities in
Danske Bank.
Interest expenses and banking fees mainly consists of interest payments due to the loan agreement with Oberland. The
Oberland loan was settled in Q2, 2023 thus interest expenses going forward mainly comprise interest on the newly established
credit facility in Danske Bank and banking fees.
Loss on settlement of borrowings relates to the settlement of the Oberland loan on May 10, 2023. Fair value adjustment of
lender call option (embedded derivative) relates to the value adjustments of Oberland's option to call for repayment of the loan
under certain conditions. Please refer to note 10 for further information.
Fair value adjustment on other investments comprises the accounting impact of the investment in Beta Bionics as described in
note 10.
Exchange rate adjustments primarily relates to USD deposits.
6. Intangible assets
Implementation costs of DKK 8.8 million relate to two IT projects that have been capitalized as intangible assets in Q3, 2023.
14 Zealand Pharma A/S | Interim Financial Statements Q3 2023
7. Inventory
In both Q1, Q2 and Q3, 2023 a reversal of Zegalogue
®
inventory write-down has been made as the raw materials are expected
to be utilized under the license and development agreement with Novo Nordisk. The adjustments affect net other operating
items in Q3, 2023 year-to-date by DKK 13.7 million of which DKK 1.5 million relates to Q3, 2023, see note 4.
For further information regarding significant accounting estimates and judgements, refer to note 1.4 in the 2022 Annual Report.
8. Trade and other receivables
Trade and other receivables can be specified as follows:
DKK thousand Sep-30, 2023 Dec-31, 2022
(reviewed) (audited)
Deposits 8,908 9,409
Trade receivables 2,786 1,361
Receivables related to license and collaboration agreements 30 2,123 5 6,431
Other receivables 14 ,500 3 ,438
Accrued interest 8,718 -
Prepaid expenses 33 ,592 6 3,088
Total trade and other receivables
370,627 1 3 3 ,727
Non-current 19,576 18,105
Current 35 1,052 115,622
Receivables related to license and collaboration agreements of DKK 302.1 million relates to milestone payment from
Boehringer Ingelheim expected to be invoiced during Q4, 2023 when enrollment of first patient in announced Phase III study
begins and also the Sanofi milestone payment, see note 2. Receivables under the license and development agreement with
Novo Nordisk A/S amounts to DKK 18.2.
9. Other payables
Other payables (non-current) as of December 31, 2022 of DKK 19.0 million related to frozen holiday funds under the Danish
Holiday Act (Ferieloven) effective as of September 1, 2020. In Q3, 2023 the amount has been paid in full to Lønmodtagernes
Feriemidler through a voluntary payment.
10. Financial instruments
As of September 30, 2023, and December 31, 2022, the following financial instruments are measured at fair value through
profit or loss. The fair value of marketable securities is measured using inputs categorized as Level 1 and 2 in the fair value
hierarchy, whereas the other investments and other financial assets is based on inputs categorized as Level 3 in the fair value
hierarchy. Embedded derivatives is measured using inputs categorized as Level 3 in the fair value hierarchy.
No transfers occurred between the levels of the fair value hierarchy in the nine months ending September 30, 2023.
15 Zealand Pharma A/S | Interim Financial Statements Q3 2023
DKK thousand
Sep-30,
2023
Dec-31,
2022
(reviewed) (audited)
Assets measured at fair value:
Marketable securities (Level 1) 1,169,505 -
Marketable securities (Level 2) 28 ,243 108,611
Other investments (Level 3) 13,444 30,943
Other financial assets (Level 3) 7,508 6,901
Financial assets measured at fair value through profit and loss 1,218,700 146,455
Liabilities measured at fair value:
Embedded derivatives, lender's call option (Level 3) - 80,603
Financial liabilities measured at fair value through profit and loss - 80,603
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at January 1, 2023 37,844 80,603
Fair value adjustments through profit and loss -16,892 -1,161
Exchange rate effect through other comprehensive income - -1,916
Derecognition of call option on settlement of Oberland Capital loan - -77,526
Carrying amount at September 30, 2023 20,952 -
Investment in marketable securities
As of September 30, 2023 Zealand has placed DKK 1,198 million into low risk marketable securities in line with the Group’s
treasury policy.
Fair value measurement of other investments
Other investments consist of an investment in Beta Bionics, Inc., the developer of iLet™, a fully integrated dual-hormone pump
(bionic pancreas) for autonomous diabetes care.
In determining fair value, Zealand considers the value per share from the most recent closed financing round, adjusted for
valuation infliction points through the balance sheet date, including (i) discount for lack of marketability, (ii) information
obtained from third party valuation reports, and (iii) company announcements.
Fair value of the investment amounted to DKK 13.4 million as of September 30, 2023 (DKK 30.9 million as of December 31,
2022). The fair value adjustment of DKK -17.5 million in Q3, 2023 year-to-date is included in financial items of which DKK -2.7
million relates to Q3, 2023, see note 5.
Fair value measurement of lender's call option (Oberland Capital loan)
Fair value of the lender call option is determined as the difference between the present value of the probability weighted
contractual cash flow upon the occurrence of a call option trigger event and the present value of the contractual cash flows
without a call option trigger event occurring, discounted at the expected internal rate of return of 14.3%. It is assumed that any
call option trigger event will result in full repayment of the loan. As of December 31, 2022, the likelihood of a lender call option
trigger event within the next two years was assessed as realistic and fair value of the option was assessed to DKK 80.6 million.
At the time of settlement on May 10, 2023, the fair value of the option amounted to DKK 77.5 million and is included in financial
items under ‘Loss on settlement of borrowings, including embedded derivatives under Oberland loan’ in note 5. The fair value
change, DKK 1.2 million, is included in financial items, while the effect of changes to the exchange rate, DKK 1.9 million, is
included in other comprehensive income. Valuation is based on unobservable data (level 3).
Settlement of Oberland Capital loan
On April 20, 2023, Oberland Capital exercised an option in the loan agreement to provide an additional loan of USD 12.5 million
on similar terms as the existing loan, bringing the total principal amount to USD 62.5 million. The additional loan of USD 12.5
million was not provided in cash.
16 Zealand Pharma A/S | Interim Financial Statements Q3 2023
On May 10, 2023, Zealand settled the Oberland Capital loans in a one-time payment of USD 77.3 million (DKK 525.7 million).
With this final repayment, the Group’s loan agreement with Oberland Capital is now fully terminated. As a result of the
settlement Zealand in 2023 recognized a net loss of USD 19.9 million (DKK 135.6 million) under financial items, including
derecognition of Oberland Capital’s call option with a carrying value as of May 10, 2023, of USD 11.4 million (DKK 77.5 million).
With the final repayment, Oberland has released all rights to collateral provided for under the loan agreement.
Refinancing with new credit facility
The repayment of the Oberland Capital loan has been refinanced through a new DKK 350 million Revolving Credit Facility
provided by Danske Bank. The facility matures in 2 years from June, 2023 where any outstanding amount must be repaid in full,
and carries an interest of CIBOR + fixed margin.
Other fair value measurements
For information about fair value measurements of other financial assets and marketable securities, please refer to note 3.7 and
4.3 of the 2022 Annual Report.
11. Cash and cash equivalents
Restricted cash and cash equivalents
As of December 31, 2022, DKK 348.6 million was held as restricted cash subject to certain conditions following the second
amendment to the Oberland loan agreement. With the final repayment of the Oberland loan agreement on May 10, 2023 all
previous restrictions have been released. For further information, please refer to note 4.4 of the 2022 Annual Report.
Pledges provided in relation to revolving credit facility in Danske Bank
As security for the undrawn revolving credit facility of DKK 350 million, as disclosed in note 10, the Group has provided pledge
over Zealand’s designated custody accounts under management by Danske Asset Management and pledge over Zealand’s
designated cash accounts attached to the custody accounts. As of September 30, 2023 marketable securities and cash and
cash equivalents held in these pledged accounts amount to DKK 451.0 million and DKK 6.5 million, respectively.
12. Share capital
Sep-30,
2023
Dec-31,
2022
DKK thousand (reviewed) (audited)
Share capital at start of period 51,702 43,634
Shares issued for cash 6,579 7,867
Exercise of warrants 396 201
Share capital at end of perid 58,677 51,702
Total new shares in Q3, 2023 were issued at a weighed average subscription price of DKK 222.1.
New shares from exercise of warrants in Q3, 2023 were issued at a weighed average subscription price of DKK 124.0. Total
proceeds from exercise of share-based compensation amounts to DKK 49.1 million.
On March 30, 2023 Zealand announced an issue of 6,578,948 new ordinary shares at a subscription price of DKK 228 per new
share resulting in gross proceeds of DKK 1.5 billion. The capital increase was completed in April 2023.
17 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Treasury shares
As of September 30, 2023, there were 377,581 treasury shares, equivalent to 0.6% of the share capital. The treasury shares are
allocated to performance share units (PSUs) and restricted stock units (RSUs).
As of September 30, 2023 payable for treasury shares amount to DKK 81.0 million included in trade and other payables
following acquisition of 300,000 new treasury shares in Q2, 2023. The payable amount as of December 31, 2022 of DKK 41.6
million has been settled and paid in full in Q2, 2023.
Potential dilutive effects
In the calculation of the diluted earnings per share in Q3, 2023 2,048,408 potential dilutive ordinary shares are included in the
calculation due to the net profit for the period. In the Q3, 2023 year-to-date calculation of the diluted loss per share the same
2,048,408 potential ordinary shares related to share-based payment instruments have been excluded as they are anti-dilutive
(2,190,503 for 2022).
13. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2022 Annual Report.
On March 12 and 13, 2023 the company provided statements on the closure of Silicon Valley Bank (SVB), and in the light of that
line of events Zealand is seeking to achieve an even higher diversification in its management of funds. For further information
refer to note 4.1 in the 2022 Annual Report.
On March 30, 2023 Zealand announced an issue of 6,578,948 new ordinary shares at a subscription price of DKK 228 per new
share resulting in gross proceeds of DKK 1.5 billion. The capital increase was completed in April 2023.
On June 30, 2023 Zealand entered a new DKK 350 million Revolving Credit Facility provided by Danske Bank. The facility
matures in 2 years from June, 2023 where any outstanding amount must be repaid in full, and carries an interest of CIBOR +
fixed margin.
14. Contingent assets and liabilities
Zealand is entitled to potential milestone payments and royalties on successful commercialization of products developed under
license and collaboration agreements with partners. Since the size and timing of such payments are uncertain until the
milestones are reached or sales are generated, the agreements may qualify as contingent assets. However, it is impossible to
measure the value of contingent assets, and as such, no assets have been recognized.
As part of the license and collaboration agreements that Zealand has entered into, once a product is developed and
commercialized, Zealand may be required to make milestone and royalty payments. It is not possible to measure the value of
such future payments, but Zealand expects to generate future income from such products which will exceed any milestone
and royalty payments due, and as such, no liabilities have been recognized. Refer to note 6.4 and 6.8 in the Annual Report
2022.
15. Significant events after the reporting period
No events have occurred subsequent to the balance sheet date that could significantly affect the interim financial statements as
of September 30, 2023.
18 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Statement by the Executive
Management and the Board of
Directors
Management
Board of Directors
19 Zealand Pharma A/S | Interim Financial Statements Q3 2023
Independent auditor's report
Management's responsibilities for the interim condensed
consolidated financial statements
Auditor's responsibilities
Conclusion