Company announcement
No. 49 / 2024
1
Zealand Pharma Announces Financial
Results for the First Nine Months of 2024.
Continued strong progress across obesity pipeline with proprietary assets ready for Phase 2 backed
by a solid financial position.
• Presented extremely encouraging weight loss and
tolerability data with long-acting amylin analog
petrelintide from MAD Part 2 (16-week trial) at
ObesityWeek 2024
• Announced positive topline results with GLP-1R/GLP-2R
dual agonist dapiglutide from Part 1 of Phase 1b trial (13-
week trial)
• Boehringer Ingelheim announced US FDA Breakthrough
Therapy Designation and advancement to two large
Phase 3 trials for survodutide in MASH
Copenhagen, Denmark, November 7, 2024 – 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, 2024, and provided a corporate update.
Building momentum into 2025 following
impressive data across obesity portfolio
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“I am excited about the impressive data and continued
clinical advancement across our portfolio of differentiated
obesity candidates that recently included very encouraging
topline data with dapiglutide, advancement by Boehringer
Ingelheim of survodutide into an ambitious Phase 3 program
in MASH, and of course the presentation of data with our
potentially best-in-class amylin analog petrelintide. With
petrelintide specifically, I believe we have a unique
opportunity to develop an alternative to GLP-1RA-based
therapies that could become the future foundational
therapy for weight management. We look forward to
initiating a large, comprehensive Phase 2b trial very soon
and are now exploring collaboration opportunities with
potential partners.”
Key financial results for Q3 2024 year-to-date
DKK million
Q3-24
YTD
Q3-23
YTD
Revenue
53.6
319.6
Net operating expenses
1
-919.1
-633.2
Net operating result
-872.9
-318.8
Net financial items
81.1
-124.8
DKK million
Sep-30,
2024
Dec-31,
2023
Cash position
2
9,195.3
1,633.1
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.
Highlights in the third quarter of 2024
Obesity
• Dapiglutide, GLP-1/GLP-2 receptor dual agonist:
Reported positive topline data from Part 1 of the Phase
1b dose titration trial. Topline results showed placebo-
adjusted reductions in body weight of up to a mean of
8.3% with dapiglutide after 13 weekly doses. 85% of the
54 trial participants were male and median BMI at
baseline was 30 kg/m
2
. Dapiglutide treatment with doses
up to 13 mg was assessed to be safe and well-tolerated
with gastrointestinal (GI) adverse events (AEs) consistent
with the profile reported with other incretin-based
therapies. Only two participants discontinued treatment
due to GI AEs.
Corporate
• Appointed Eric Cox as Chief Commercial Officer. Eric
will lead Zealand Pharma’s commercial strategy and
assume responsibility for business development.
Company announcement
No. 49 / 2024
2
Events after the reporting date
Obesity
• Petrelintide, long-acting amylin analog: Presented
detailed results at ObesityWeek 2024 from 16-week
multiple ascending dose (MAD) trial, Part 2 of Phase 1b
trial. Petrelintide demonstrated mean body weight
reductions of 4.8%, 8.6% and 8.3% after 16 once-weekly
doses of up to 2.4 mg, 4.8 mg and 9.0 mg, respectively,
versus 1.7% for the pooled placebo group. Dose
escalation within cohorts occurred every second week.
Participants randomized to petrelintide received the
three different maintenance doses of 2.4 mg, 4.8 mg
and 9.0 mg for twelve, eight and six weeks, respectively.
79% of the 48 trial participants were male and mean BMI
was 29.9 kg/m
2
. Petrelintide was well tolerated, with no
serious or severe adverse events. All gastrointestinal
adverse events were mild, except for two moderate
events (nausea and vomiting) reported in one participant
who discontinued treatment. No other participants
discontinued treatment due to AEs. No other events of
vomiting occurred, and two events of diarrhea were
reported, both of which were mild.
MASH
• Survodutide, glucagon/GLP-1 receptor dual agonist:
Boehringer Ingelheim announced U.S. FDA
Breakthrough Therapy Designation and initiation of two
Phase 3 trials in MASH. LIVERAGE and LIVERAGE-
Cirrhosis are global Phase 3 clinical trials investigating
the efficacy and safety of survodutide in adults with
metabolic dysfunction-associated steatohepatitis
(MASH) and fibrosis stages 2 or 3 and in those with
compensated MASH cirrhosis (stage 4), respectively.
Based on the groundbreaking results from the Phase 2
trial in MASH, survodutide has received U.S. FDA
Breakthrough Therapy Designation for the treatment of
adults with non-cirrhotic MASH and moderate or
advanced fibrosis.
Rare diseases
• Dasiglucagon in congenital hyperinsulinism (CHI): The
U.S. FDA issued a Complete Response Letter (CRL) for
dasiglucagon in CHI for up to three weeks of dosing due
to the timing of a third-party manufacturing facility
reinspection. The reinspection of the facility was
completed in August/September 2024 for which a new
inspection classification is pending. A prior inspection of
the facility had identified deficiencies that did not involve
dasiglucagon. These prior deficiencies had been
resolved as of this reinspection. The CRL did not state
any concerns about the clinical data package or safety
of dasiglucagon.
Upcoming events next 12 months
Obesity
• Petrelintide, amylin analog: advancing clinical
development. Zealand Pharma expects to initiate a
Phase 2b trial with petrelintide in people with overweight
or obesity without type 2 diabetes in the fourth quarter
of 2024, for which completion of enrollment is expected
in the first half of 2025. Zealand also expects to initiate a
Phase 2b trial in people with overweight or obesity and
type 2 diabetes in the first half of 2025.
Zealand also plans to initiate a Phase 1b combination trial
with petrelintide and a GLP-1 receptor agonist in 2025.
• Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the
first half of 2025, Zealand Pharma expects to announce
topline results from a cohort (Part 2 of the Phase 1b trial)
evaluating even higher doses up to 26 mg dapiglutide
and with 28 weeks of treatment. The cohort was added
based on dapiglutide’s tolerability profile observed to
date and will have no impact on the timing for initiation
of a Phase 2b trial in people with overweight or obesity
also expected in the first half of 2025. Zealand also plans
to present the results from the Phase 1b trial at a
scientific congress in 2025.
Rare diseases
• Glepaglutide in SBS. US FDA has set a Prescription Drug
User Fee Act (PDUFA) date on December 22, 2024. In
parallel with the regulatory review process, Zealand is
engaging in partnership discussions for future
commercialization.
• Dasiglucagon in CHI. Contingent on an inspection
classification upgrade of the third-party manufacturing
facility, Zealand expects to resubmit Part 1 of the NDA
for dasiglucagon in CHI for up to three weeks of dosing
in the fourth quarter of 2024. For Part 2 of the NDA
review, which relates to use beyond three weeks,
Zealand expects to submit the additional analyses from
existing continuous glucose monitoring (CGM) datasets
requested by the U.S. FDA in the fourth quarter of 2024
as well. Zealand is continuing pre-commercial activities
to prepare for a launch in the U.S. contingent on an
approval by the FDA. In parallel, the company is
engaging in partnership discussions for future
commercialization of the product.
Chronic inflammation
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma
expects to initiate the first-in-human clinical trial of
ZP9830 in the fourth quarter of 2024.
Company announcement
No. 49 / 2024
3
Financial guidance for 2024
• Guidance unchanged from August 15, 2024
DKK million
2024
Guidance
2023
Actuals
Revenue anticipated
from existing and
new license and
partnership
agreements
No guidance due
to uncertain size
and timing
343
Net operating
expenses
3
1,250-1,350
896
Notes:
3. Financial guidance based on foreign exchange rates as of November
7, 2024.
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 2024 followed by a Q&A session.
Participating in the call will be Chief Executive Officer, Adam
Steensberg; Chief Financial Officer, Henriette Wennicke;
Chief Medical Officer, David Kendall; and Chief Commercial
Officer, Eric Cox. 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/BI9feb9ca116c04d17ab
b506491ebf0b90. The live listen-only audio webcast of the
call and accompanying slide presentation will be accessible
at https://edge.media-server.com/mmc/p/4kd7ihsh/.
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/investors/events-
presentations/.
Financial Calendar for 2025
FY/Q4 2024
February 20, 2025
Q1 2025
May 8, 2025
Q2 2025
August 14, 2025
Q3 2025
November 6, 2025
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 2024. 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
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
Company announcement
No. 49 / 2024
4
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
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: [email protected]
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: [email protected]
Neshat Ahmadi
Investor Relations Manager
Zealand Pharma
Email: [email protected]
Company announcement
No. 49 / 2024
5
R&D Pipeline
Therapeutic area
Product candidate
a
Obesity Dapiglutide (GLP-1R/GLP-2R dual agonist) Obesity
Petrelintide (amylin analog) Obesity
ZP6590 (GIP receptor agonist) Obesity
Survodutide (GCGR/GLP-1R dual agonist)
b
Obesity and MASH
Rare diseases Dasiglucagon: S.C. continuous infusion Congenital hyperinsulinism
Glepaglutide (GLP-2 analog) Short bowel syndrome
Inflammation ZP9830 (Kv1.3 ion channel blocker)
Undisclosed
ZP10068 (complement C3 inhibitor)
Undisclosed
Type 1 diabetes Dasiglucagon: bi-hormonal artificial pancreas systems T1DM management
Dasiglucagon: mini-dose pen T1DM exercise-induced hypoglycemia
a
Investigational compounds whose safety and efficacy have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
Partnered
b
Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, w ith Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights
in the Nordic countries): EUR 315 million outstanding potential development, regulatory and commercial milestones + high single to low double digit % royalties on global sales.
GCGR=glucagon receptor; GIP=gastric inhibitory polypeptide; GLP-1R=glucagon-like peptide-1 receptor; GLP-2=glucagon-like peptide-2; GLP-2R=glucagon-like peptide-2 receptor; MASH=metabolic
dysfunction-associated steatohepatitis (formerly NASH, or nonalcoholic steatohepatitis); SC=subcutaneous; T1DM=type 1 diabetes mellitus.
Pre-clinical
Phase 1
Phase 2
Phase 3
Registration
Company announcement
No. 49 / 2024
6
Obesity
Petrelintide (long-acting amylin analog)
Third quarter 2024 update:
• Presented detailed results from MAD Part 2 (16-week
trial) at ObesityWeek 2024.
Background:
Petrelintide (formerly ZP8396) is a long-acting amylin analog
that reduces food intake by restoring leptin sensitivity and
increasing satiety, in contrast to GLP-1RAs that reduce food
intake by suppressing appetite. The molecule is designed to
improve solubility, minimize fibrillation, and allow for co-
formulation with other peptides, including GLP-1RA-based
molecules. Petrelintide holds potential as a next-generation,
best-in-class alternative to GLP-1RA-based therapies for the
treatment of overweight and obesity, targeting weight loss
comparable with GLP-1RA-based therapies but with
significantly improved tolerability.
In the fourth quarter of 2024, Zealand expects to initiate a
large, comprehensive Phase 2b trial with petrelintide in
people with overweight or obesity.
Zealand conducted a Phase 1b, randomized, multiple
ascending dose (MAD) clinical trial of petrelintide in normal
weight and overweight healthy participants
(ClinicalTrials.gov ID: NCT05613387). The MAD trial
consisted of Part 1 and Part 2. Part 1 included 20 participants
(eligible BMI 21.0–29.9) receiving six once-weekly
subcutaneous doses of petrelintide or placebo. Part 2
included 48 participants (eligible BMI 27.0–39.9) receiving 16
once-weekly doses of petrelintide or placebo using a dose
up-titration scheme.
Part 1 results were presented at the Obesity Society Annual
Meeting (ObesityWeek) in October 2023. Low doses of 0.6
mg and 1.2 mg petrelintide 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, petrelintide 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 petrelintide over 16 weeks using a
dose up-titration scheme, with topline results reported in
June 2024.
In Part 2 of the MAD trial, 48 participants were randomized
(3:1) to receive 16 once-weekly doses of petrelintide or
placebo within three dose cohorts using a dose escalation
scheme. Participants randomized to petrelintide received
the three different maintenance doses of 2.4 mg, 4.8 mg
and 9.0 mg for twelve, eight and six weeks, respectively.
After 16 weeks, mean body weight reductions were 4.8%,
8.6% and 8.3% for the three petrelintide-treated groups,
respectively, versus 1.7% for the pooled placebo group. 79%
of the 48 trial participants were male and mean BMI was
29.9 kg/m
2
. Petrelintide was well tolerated, with no serious
or severe adverse events. All gastrointestinal adverse events
were mild, except for two moderate events (nausea and
vomiting) reported in one participant who discontinued
treatment. No other participants discontinued treatment
due to AEs. No other events of vomiting occurred, and two
events of diarrhea were reported, both of which were mild.
Results from Part 2 of the MAD trial were presented at the
Obesity Society Annual Meeting (ObesityWeek) in San
Antonio, Texas on November 5, 2024.
The Phase 1a, first-in-human, randomized, single ascending
dose (SAD) trial to assess the safety, tolerability,
pharmacokinetics, and pharmacodynamics of petrelintide 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 petrelintide or placebo. After one
week, participants treated with petrelintide 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 petrelintide.
Body weight reductions were well-sustained during the
additional five weeks of observation without further doses of
petrelintide. 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 petrelintide was 230 hours, or
approximately 10 days, which supports once-weekly dose
administration. Petrelintide 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 2024 update:
• Announced positive topline results from Part 1 of Phase
1b trial (13-week trial).
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.
Zealand reported positive topline results in September 2024
from Part 1 of the Phase 1b dose titration trial
(ClinicalTrials.gov ID: NCT06000891). A total of 54
participants (~85% male) with a median age of 46 years and
a median BMI at baseline of 30 kg/m
2
.were randomized to
receive 13 weekly doses of either dapiglutide or placebo
Company announcement
No. 49 / 2024
7
(14:4) within three dose cohorts. At week 13, the estimated
mean body weight had decreased by up to 8.3% on a
placebo-corrected basis among participants on dapiglutide
treatment (up to 6.2% mean weight loss on dapiglutide; 2.1%
mean weight gain on placebo). No lifestyle medications,
such as diet or exercise, were included in the trial.
Dapiglutide treatment with doses up to 13 mg was assessed
to be safe and well-tolerated, with no severe TEAEs and one
serious AE, which was deemed not related to the drug. The
most common TEAEs were GI-related, including nausea and
vomiting. GI AEs were consistent with the profile reported
with other incretin-based therapies. Only two participants
discontinued treatment due to GI AEs (moderate vomiting).
Based on the mild tolerability profile observed with
dapiglutide to date, Zealand amended the Phase 1b trial to
include an additional cohort to investigate even higher
doses up to 26 mg over a treatment duration of 28 weeks.
Topline results from this added cohort will be reported in
the first half of 2025, with no impact on the expected timing
for initiation of a Phase 2b trial also in the first half of 2025.
Zealand had previously reported data from two clinical trials
with low doses of dapiglutide, including a company-
sponsored 4-week Phase 1 trial and a 12-week mechanistic
investigator-led trial named DREAM.
An investigator-led randomized, double-blind, placebo-
controlled clinical trial in up to 54 people living with
overweight and obesity, named DREAM (ClinicalTrials.gov
ID: NCT05788601), evaluated the potential for weight loss
and aimed to gain key mechanistic insights into the effects
of dapiglutide on inflammatory markers following a 12-week
treatment period. Topline results were reported in May
2024. Treatment with low doses of dapiglutide at 4 mg and
6 mg resulted in mean weight loss change from baseline of
2.9% and 4.3% after 12 weeks, respectively, compared to
2.2% with placebo. Dapiglutide was assessed to be well
tolerated, with no treatment emergent adverse events
(TEAEs) leading to treatment discontinuation and fewer
gastrointestinal TEAEs compared to what have been
reported from other trials with incretin-based therapies,
suggesting that doses of dapiglutide investigated were at the
lower end of the therapeutic range in an obesity setting.
Additional data from DREAM on cardiovascular risk, systemic
inflammatory markers, as well as data from gut biopsies, will
be presented at a future scientific meeting.
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 (ClinicalTrials.gov ID: NCT04612517). 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 2024 update:
• Boehringer Ingelheim announced US FDA
Breakthrough Therapy Designation and advancement
to two Phase 3 trials for survodutide in MASH.
Background:
Survodutide (formerly BI456906) 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 and a differentiated profile than current single-
hormone receptor agonist treatments. Survodutide is
targeting the treatment of obesity and metabolic
dysfunction-associated steatohepatitis (MASH) and fibrosis.
In 2023, Boehringer Ingelheim advanced survodutide into a
global Phase 3 program in people living with overweight or
obesity (SYNCHRONIZE™).
SYNCHRONIZE-1 (ClinicalTrials.gov ID: NCT06066515) and
SYNCHRONIZE-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-1 will enroll
people without type 2 diabetes (eligible HbA1c <6.5%) and
SYNCHRONIZE-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-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-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.
Phase 3 trials with survodutide in Chinese people living with
overweight or obesity, SYNCHRONIZE-CN
(ClinicalTrials.gov ID: NCT06214741), and in Japanese
people living with overweight or obesity, SYNCHRONIZE-JP
(ClinicalTrials.gov ID: NCT06176365), have also been
Company announcement
No. 49 / 2024
8
initiated. A Phase 3 trial in people with overweight or obesity
and confirmed or presumed metabolic dysfunction-
associated steatohepatitis (MASH) (ClinicalTrials.gov ID:
NCT06309992) has also been initiated.
In October 2024, Boehringer Ingelheim announced US FDA
Breakthrough Therapy Designation (BTD) and initiation of
two Phase 3 trials with survodutide in MASH, LIVERAGE and
LIVERAGE-Cirrhosis.
LIVERAGE (ClinicalTrials.gov ID: NCT06632444) will
examine whether survodutide can improve MASH and/or
fibrosis after 52 weeks of treatment and reduce the risk of
end-stage liver disease outcomes after approximately seven
years of treatment in approximately 1,800 adults living with
MASH and moderate or advanced liver fibrosis (stages 2 or
3). The US FDA has granted Breakthrough Therapy
Designation for survodutide for the treatment of adults with
non-cirrhotic MASH and moderate or advanced fibrosis.
LIVERAGE-Cirrhosis (ClinicalTrials.gov ID: NCT06632457)
will examine whether survodutide can reduce the risk of
end-stage liver disease outcomes after approximately four
and a half years of treatment in approximately 1,590 adults
living with MASH and compensated cirrhosis (fibrosis stage
4), a condition where the liver presents severe scarring.
The MASH program has also received Fast Track
Designation from the US FDA, PRIME designation (Priority
Medicines) from the European Medicines Agency (EMA) and
Breakthrough Therapy Designation from the Center for
Drug Evaluation of China’s National Medical Products
Administration (NMPA). In people living with overweight and
obesity, it is estimated that 75% have metabolic dysfunction-
associated fatty liver disease (MAFLD) and 34% have MASH.
Advancement of survodutide to Phase 3 trials in people with
overweight or obesity and in people with MASH was based
on positive results in three separate Phase 2 trials in obesity,
type 2 diabetes and MASH.
One 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. Additional data, presented
at the 59
th
Annual Meeting of the European Association for
the Study of Diabetes (EASD) in October 2023,
demonstrated reductions in absolute waist circumference
(up to 16.0 cm), absolute body weight (up to 19.5 kg) and
absolute systolic and diastolic blood pressure (up to 8.6
mmHg and 4.8 mmHg, respectively).
A second 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 assessed survodutide in metabolic
dysfunction-associated steatohepatitis (MASH), formerly
known as non-alcoholic steatohepatitis (NASH), and liver
fibrosis stages F1/F2/F3 (ClinicalTrials.gov ID:
NCT04771273). The double-blind, placebo-controlled trial
studied three doses of survodutide at 2.4 mg, 4.8mg and 6.0
mg. At the highest dose, 83.0% of adults treated with
survodutide achieved a biopsy-proven improvement in
MASH after 48 weeks without worsening of fibrosis stages
F1, F2 and F3 (mild to moderate or advanced scarring),
versus 18.2% with placebo [response difference: 64.8% (CI
51.1% - 78.6%), p<0.0001]. Survodutide also met all
secondary endpoints, including a statistically significant
improvement in liver fibrosis. The detailed results were
presented at the European Association for the Study of the
Company announcement
No. 49 / 2024
9
Liver (EASL) congress in Milan on June 7, 2024. Up to 64.5%
of adults with fibrosis stages F2 and F3 (moderate to
advanced scarring) achieved a biopsy-proven improvement
in fibrosis without worsening of MASH after 48 weeks of
survodutide treatment, versus 25.8% with placebo [response
difference: 38.6% (CI 18.1% - 59.1%), p=0005]. Treatment
with survodutide did not show unexpected safety or
tolerability issues, including at the highest dose of 6.0 mg,
which is also the maximum maintenance dose in both the
Phase 3 program in people with overweight or obesity
(SYNCHRONIZE) and in the Phase 3 trials in MASH
(LIVERAGE and LIVERAGE-Cirrhosis).
Survodutide is licensed to Boehringer Ingelheim from
Zealand Pharma, with Boehringer solely responsible for
development and commercialization globally (subject to
Zealand's co-promotion rights in the Nordic countries).
Zealand is eligible to receive up to EUR 315 million in
outstanding milestone payments and high-single to low-
double digit percentage royalties on global sales.
Rare diseases
Dasiglucagon for congenital hyperinsulinism (CHI)
Third quarter 2024 update:
• The US FDA issued a Complete Response Letter (CRL)
for dasiglucagon in CHI for up to three weeks of dosing
due to the timing of a third-party manufacturing facility
reinspection.
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.
Zealand submitted the NDA for dasiglucagon for the
prevention and treatment of hypoglycemia in pediatric
patients 7 days of age and older with CHI to the US FDA in
June 2023. The regulatory review is being 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. For Part 1 of the NDA, the US FDA issued a CRL in
December 2023 due to deficiencies identified at a third-
party manufacturing facility that were not related to
dasiglucagon. Following Zealand’s resubmission of Part 1 of
the NDA, the US FDA granted a PDUFA date of October 8,
2024. However, due to the timing of a reinspection of the
third-party manufacturing facility in August/September 2024
for which a new inspection classification is pending, the US
FDA issued another CRL in October 2024. Zealand will
resubmit Part 1 of the NDA to the US FDA contingent on an
inspection classification upgrade of the third-party
manufacturing facility, which is expected before the end of
the year 2024.
Supporting the use of dasiglucagon in CHI beyond three
weeks (Part 2 of the NDA), the FDA has requested additional
analyses from existing continuous glucose monitoring
(CGM) datasets, which the company expects to submit
before the end of the year 2024. CGM was included as a
secondary outcome measure in the Phase 3 program.
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
Company announcement
No. 49 / 2024
10
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)
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
glepaglutide to reduce or eliminate the need for parenteral
support in SBS patients with intestinal failure. Efficacy and
safety data from these trials formed the basis of an NDA
submission to the US FDA in December 2023. The FDA has
granted a PDUFA date on December 22, 2024 for
glepaglutide in SBS with intestinal failure. The FDA has also
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.
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.
Company announcement
No. 49 / 2024
11
Inflammation
Zealand is pursuing multiple pre-clinical programs in
inflammatory diseases which will be detailed more as they
progress through development.
ZP9830 (Kv1.3 Ion Channel Blocker)
Kv1.3 is a potassium conducting ion channel, which is
selectively upregulated on T effector memory cells. T
effector memory cells play a key role in autoimmunity and
chronic inflammation by releasing pro-inflammatory
cytokines, which drive tissue damage. The anti-
inflammatory effects of blocking the Kv1.3 ion channel have
been demonstrated in pre-clinical models of autoimmune
diseases. The specific and selective location of the Kv1.3 on
the effector memory T cells makes it an attractive
pharmaceutical target, as blocking preserves the protective
effects of the rest of the immune system.
ZP9830 is a potent and selective Kv1.3 blocker with potential
to treat a broad range of T-cell-driven autoimmune diseases.
Zealand has completed pre-clinical activities with ZP9830
and expects to initiate the first-in-human clinical trial in the
fourth quarter of 2024.
ZP10068 (Complement C3 inhibitor)
ZP10068 is an investigational long-acting inhibitor of
Complement C3, which has the potential to treat a broad
range of complement-mediated diseases. Zealand has
completed pre-clinical activities and will evaluate the
potential for advancing ZP10068 into the first-in-human
clinical trials.
In the first quarter of 2024, Alexion Pharmaceuticals
discontinued development of ZP10068 citing business
reasons and is currently in the process of transferring the
asset to Zealand.
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).
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.
1 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Financial highlights and key
figures.
Financial highlights (DKK thousand) Note
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Revenue 2 4,415 295,517 53,635 319,553
Cost of goods sold 3 6,620 -5,162 -7,466 -5,162
Gross profit 11,035 290,355 46,169 314,391
Research and development expenses -263,498 -196,893 -665,949 -494,720
Sales and marketing expenses -28,535 -6,061 -50,213 -17,812
General and administrative expenses -65,278 -43,641 -199,800 -134,400
Other operating items -3,137 1,519 -3,137 13,782
Net operating expenses -360,448 -245,076 -919,099 -633,150
Operating result -349,413 45,279 -872,930 -318,759
Net financial items 4 81,642 27,549 81,093 -124,786
Result before tax -267,771 72,828 -791,837 -443,545
Corporate tax 1,375 1,317 4,043 4,556
Net result for the period -266,396 74,145 -787,794 -438,989
Earnings/loss per share, basic (DKK) -3.77 1.27 -12.12 -7.84
Earnings/loss per share, diluted (DKK) -3.77 1.23 -12.12 -7.84
Statement of financial position (DKK thousand) Note
Sep-30,
2024
Dec-31,
2023
Cash and cash equivalents 8 511,018 449,311
Marketable securities 6 8,684,320 1,183,746
Cash, cash equivalents and marketable securities 9,195,338 1,633,057
Total assets 9,629,867 1,979,993
Total shareholders' equity 8,883,181 1,592,839
Cash flow (DKK thousand) Note
Q3-24 YTD Q3-23 YTD
Undrawn borrowing facilities 1) - 350,000
Cash used in operating activities -750,339 - 485,183
Cash used in investing activities -7,483,661 -1,100,731
Cash provided by financing activities 8,293,096 901,416
Purchase of intangible assets -1,278 -8,840
Purchase of property, plant and equipment -8,877 -4,522
Free cash flow 2) -759,216 - 489,705
Other Note
Sep-30,
2024
Dec-31,
2023
Share price (DKK) 813.0 373.2
Number of shares ('000 shares) 71,024 58,751
Market capitalization (mDKK) 2) 57,436 21,787
Equity ratio (%) 2) 92% 80%
Equity per share (DKK) 2) 125.74 27.28
Average number of full time employees 278 235
Number of full-time employees at the end of the period 298 253
1) In May 2023, Zealand entered a new DKK 350 million revolving credit facility provided by Danske Bank. The RCF has been terminated in Q3,
2024. EIB loan Tranches B and C are excluded as they are dependent on predefined milestones being met.
2) For basis of calculation refer to 2023 Annual Report p. 155.
2 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Financial Review.
• Net operating expenses in the first nine months of 2024
of DKK -919 million are mainly driven by clinical
advancement of the obesity pipeline and activities
supporting the regulatory review by the US FDA of the
late-stage rare disease assets.
• Driven by capital raises in January 2024 and June 2024
raising gross proceeds of approximately DKK 1.45 billion
and DKK 7 billion respectively, cash position as of
September 30, 2024 is DKK 9.2 billion, reflecting a
significant increase compared to the DKK 1.6 billion in
cash, cash equivalents and marketable securities as of
December 31, 2023.
Revenue
Revenue in the first nine months of 2024 of DKK 54 million
is mainly driven by the license and development
agreement for Zegalogue® with Novo Nordisk.
Net operating expenses
Research and development expenses in the first nine
months of 2024 of DKK -666 million are mainly driven by
clinical advancement of the company’s wholly owned
obesity assets, petrelintide and dapiglutide, and activities
supporting the regulatory review by the US FDA of the late-
stage rare disease assets, glepaglutide for short bowel
syndrome (SBS) and dasiglucagon for congenital
hyperinsulinism (CHI). The increase in research and
development expenses in the first nine months of 2024
compared to the first nine months of 2023 is mainly driven
by the significant clinical advancement of the obesity
pipeline, including preparations for large, comprehensive
Phase 2b trials for the wholly owned obesity assets. The
Phase 2b trial for petrelintide is expected to be initiated in
the fourth quarter of 2024.
Selling and marketing expenses of DKK -50 million in the
first nine months of 2024 are mainly driven by pre-
commercial activities associated with dasiglucagon in CHI
and glepaglutide in SBS. Administrative expenses of DKK -
200 million reflect additional legal expenses related to our
patent portfolio and strengthening of organizational
capabilities, also in select corporate functions, as the
company prepares for large, comprehensive Phase 2b trials
with the wholly owned obesity assets.
Other operating income of DKK 14 million in the first nine
months of 2023 were related to a reversal of inventory
write-down associated with Zegalogue®.
Financial items
Financial items in the first nine months of 2024 of DKK 81
million are mainly driven by interest income of DKK 107
million from the excess liquidity invested in marketable
securities. This is offset by DKK -28 million in fair value
adjustment of warrants granted to the European
Investment Bank (EIB) following disbursement of the EUR
50 million Tranche A of the EIB loan facility in March 2024,
as well as financial expenses of DKK -24 million related to
interest expenses on Tranche A of the EIB loan and a
commitment fee relating to the Revolving Credit Facility
(RCF). The RCF provided by Danske Bank was terminated in
July 2024. The significant improvement in financial items in
the first nine months of 2024 compared to the first nine
months of 2023 is mainly driven by the increase in interest
income and fair value adjustment of marketable securities
in 2024 as well as the final repayment and termination of
the loan with Oberland Capital in May 2023, representing
DKK -136 million in financial expenses.
Equity
On September 30, 2024, equity was DKK 8,883 million,
reflecting a significant increase compared to December 31,
2023, mainly driven by the proceeds from the equity
offering and issuance of new shares in June 2024 and the
directed issue and private placement of new shares in
January 2024. This was partly offset by the loss for the
period.
Cash position
Cash, cash equivalents and marketable securities as of
September 30, 2024 was DKK 9.2 billion, reflecting a
significant increase compared to the DKK 1.6 billion in
-191
-66
-68
2
-44
-6
-197
Q3 2023
-9
-51
-13
-190
Q4 2023
-9
Q1 2024
-12
-212
Q2 2024
-3
-65
-29
-263
Q3 2024
-245
-263 -266
-292
-360
R&D S&M G&A Other operating items
OPEX by quarter
DKK million
3 Zealand Pharma A/S | Interim Financial Statements Q3 2024
cash, cash equivalents and marketable securities as of
December 31, 2023. This development in the first nine
months of 2024 is mainly driven by the DKK 7 billion in
gross proceeds from the equity offering and issuance of
new shares in June 2024 and the DKK 1.45 billion in gross
proceeds from the directed issue and private placement of
new shares in January 2024, as well as disbursement of the
EUR 50 million Tranche A of the EIB loan facility. This was
partly offset by cash used in operating activities during the
period (DKK -750 million).
As of September 30, 2024, Zealand has placed DKK 8.7
billion in low-risk marketable securities, whereas cash and
cash equivalents amount to DKK 0.5 billion. In Q3 2024,
the excess liquidity has been placed in securities in line
with the company’s treasury policy.
For further information on the capital increases in January
2024 and June 2024, the EIB loan, and the RCF, please
refer to notes 8 and 9.
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, 2024.
Outlook for the year
There are no changes to the outlook for the year
compared to the H1 2024 Company announcement on
August 15, 2024. Guidance is confirmed with net operating
expenses for the year still expected between DKK 1.25 –
1.35 billion. For further information, please refer to
Company announcement no. 39 / 2024.
1. Cash position includes cash, cash equivalents and marketable securities.
Revolving Credit Facility of DKK 350 million provided by Danske Bank was
terminated in July 2024 and not included in this chart.
2. EIB loan Tranches B and C (EUR 20 million each) are excluded from this
chart. The two tranches are subject to pre-specified milestones being met.
Cash position compared to FY23
DKK million
1,184
1,427
449
Cash
position
Dec-
2023
1,2
-750
Cash flow
from
operating
activities
-277
Other cash
adjustments
Net
proceeds
from capital
increase
January
2024
373
Proceeds
from EIB
loan
(Tranche A)
in March,
2024
6,789
Net
proceeds
from capital
increase
June 2024
511
8,684
Cash
position
Sep-2024
1,2
1,633
9,195
Cash and cash equivalents
Marketable securities
4 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim financial statements.
Unaudited interim condensed consolidated financial statements for Q3 and Q3, 2024 year-to-date:
Interim statement of loss ........................................................................................................................................................................................ 5
Interim statement of comprehensive 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. Financial items ..................................................................................................................................................................................................... 12
5. Trade and other receivables............................................................................................................................................................................. 13
6. Marketable securities ......................................................................................................................................................................................... 14
7. Financial instruments ......................................................................................................................................................................................... 15
8. Cash and cash equivalents ................................................................................................................................................................................ 17
9. Share capital.......................................................................................................................................................................................................... 17
10. Cash flow adjustments .................................................................................................................................................................................... 18
11. Capital Management ........................................................................................................................................................................................ 19
12. Contingent assets and liabilities .................................................................................................................................................................... 19
13. Significant events after the reporting period .............................................................................................................................................. 19
Statement by the Executive Management and the Board of Directors ......................................................................................................... 20
5 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim statement of loss.
DKK thousand Note
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Revenue 2 4,415 295,517 53,635 319,553
Cost of goods sold 3 6,620 -5,162 -7,466 -5,162
Gross profit 11,035 290,355 46,169 314,391
Research and development expenses -263,498 -196,893 -665,949 -494,720
Sales and marketing expenses -28,535 - 6,061 -50,213 -17,812
General and administrative expenses -65,278 -43,641 -199,800 -134,400
Other operating income - 1,519 - 13,782
Other operating expenses -3,137 - -3,137 -
Net operating expenses -360,448 -245,076 -919,099 -633,150
Operating result -349,413 45,279 -872,930 -318,759
Financial income 4 81,051 33,454 144,499 52,651
Financial expenses 4 591 - 5,905 -63,406 -177,437
Result before tax -267,771 72,828 -791,837 -443,545
Corporate tax 1,375 1,317 4,043 4,556
Net result for the period -266,396 74,145 -787,794 -438,989
Earnings/loss per share, basic (DKK) -3.77 1.27 -12.12 -7.84
Earnings/loss per share, diluted (DKK) -3.77 1.23 -12.12 -7.84
6 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim statement of comprehensive
loss.
DKK thousand Note
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Net result for the period -266,396 74,145 -787,794 -438,989
Other comprehensive income/loss
Items that will be reclassified to income statement when
certain conditions are met (net of tax):
Exchange differences on translation of foreign operations 79 -7,083 35 -3,324
Total comprehensive result for the period -266,317 67,062 -787,759 -442,313
7 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim statement of financial position.
DKK thousand Note
Sep-30, 2024 Dec-31, 2023
Assets
Intangible assets 11,583 12,255
Property, plant and equipment 47,842 47,047
Right-of-use assets 81,078 102,805
Other investments 7 15,099 14,004
Corporate tax receivable 4,125 -
Deferred tax assets 913 925
Other receivables 5 19,753 15,794
Marketable securities 6 723,183 -
Other financial assets 7 7,847 7,375
Total non-current assets 911,423 200,205
Inventory 803 7,935
Trade and other receivables
5
Corporate tax receivable 10,743 16,437
Marketable securities 6 7,961,137 1,183,746
Cash and cash equivalents 8 511,018 449,311
Total current assets 8,718,444 1,779,788
Total assets 9,629,867 1,979,993
Shareholders' equity and liabilities
Share capital 9 71,024 58,751
Share premium 14,680,871 6,406,225
Currency translation reserve 22,739 22,704
Accumulated losses -5,891,453 -4,894,841
Total shareholders' equity 8,883,181 1,592,839
Borrowings 7 280,987 -
Derivative financial liabilities 7 127,499 -
Lease liabilities 92,568 102,575
Total non-current liabilities 501,054 102,575
Lease liabilities 15,935 16,655
Trade and other payables 229,697 267,924
Total current liabilities 245,632 284,579
Total liabilities 746,686 387,154
Total shareholders' equity and liabilities 9,629,867 1,979,993
8 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim statement of cash flow.
DKK thousand Note
Q3-24 YTD Q3-23 YTD
Net result for the period -787,794 -438,989
Adjustment for other non-cash items 10 -3,579 169,600
Changes in working capital 10 -11,755 -211,365
Financial income received 64,834 22,217
Financial expenses paid -17,591 -26,872
Corporate taxes received 5,546 226
Cash flow used in operating activities -750,339 -485,183
Proceeds from sale of marketable securites 6 2,187,719 660,511
Purchase of marketable securities 6 -9,661,225 -1,747,880
Purchase of intangible assets -1,278 -8,840
Purchase of property, plant and equipment -8,877 -4,522
Cash flow used in investing activities -7,483,661 -1,100,731
Proceeds from borrowings 8 369,867 -
Repayment of borrowings - -525,764
Lease installments -11,856 -9,035
Proceeds from issuance of shares 8 8,492,671 1,500,000
Purchase of treasury shares 9 -351,834 -41,600
Proceeds from issuance of shares related to exercise of share-based
compensation
9 30,727 49,138
Costs related to issuance of shares -236,479 -71,323
Cash flow from financing activities 8,293,096 901,416
Increase/decrease in cash and cash equivalents 59,096 -684,498
Cash and cash equivalents at beginning of period 449,311 1,069,234
Exchange rate adjustments 2,611 -295
Cash and cash equivalents at end of period 511,018 384,441
9
Zealand Pharma A/S | Interim Financial Statements Q3 2024
Interim statement of changes in equity.
DKK thousand
Share
capital
Share
premium
Currency
translation
reserve
Accumu-
lated
losses
Total
Equity at January 1, 2024
-
Net result for the period
-
-
Other comprehensive income for the period
Total comprehensive income
-
-
Transactions with owners:
Purchase of treasury shares
-
-
Exercise of warrants
Share-based compensation expenses
Capital
increases
Costs related to capital increases
-
-
Equity at September 30, 2024
-
Equity at January 1, 2023
-
Net result for the period
-
-
Other comprehensive loss for the period
-
-
Total comprehensive income
-
-
-
Transactions with owners:
Purchase of treasury shares
-
-
Exercise of warrants
Share-based compensation expenses
Capital increases
Costs related to capital increases
-
-
Equity at September 30, 2023
-
10 Zealand Pharma A/S | Interim Financial Statements Q3 2024
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, 2023.
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 increases completed in January 2024 and June 2024 the Group received gross
proceeds of DKK 1.45 billion and DKK 7.0 billion, respectively. 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 2024, 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 2023. Please refer to note 1.3 in the 2023 Annual Report for further information:
• Estimate of fair value of cash-settled warrant liability from disbursement of EIB loan, Tranche A (Borrowings including
derivative financial liabilities). Refer to note 7. Financial instruments.
• Judgement on milestone payment from Novo Nordisk (Revenue). Refer to note 2. Revenue.
• Judgement on classification of marketable securities acquired in Q3, 2024 year-to-date. Refer to note 6. Marketable
securities.
11 Zealand Pharma A/S | Interim Financial Statements Q3 2024
2. Revenue
Revenue can be specified as follows:
DKK thousand
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Alexion Pharmaceuticals Inc. 130 554 379 3,258
Boehringer Ingelheim International GmbH - 223,725 - 223,725
Novo Nordisk A/S 10,905 4,791 45,790 26,123
Sanofi-Aventis Deutschland GmbH - 61,285 - 61,285
Total revenue from license and collaboration agreements
11,035 290,355 46,169 314,391
Product sales -6,620 5,162 7,466 5,162
Sale of goods revenue
-6,620 5,162 7,466 5,162
Total revenue 4,415 295,517 53,635 319,553
Total revenue recognized over time 20,677 5,345 31,169 29,381
Total revenue recognized at a point in time 17,869 290,172 22,466 290,172
DKK thousand
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Milestone revenue - 285,010 15,000 285,010
Royalty revenue 240 190 717 634
Reimbursement revenue for R&D services 10,795 5,881 30,452 28,747
Product sales -6,620 4,436 7,466 5,162
Total revenue by revenue stream
4,415 295,517 53,635 319,553
Total revenue in Q3, 2024 year-to-date of DKK 53.6 million is driven by the license and development agreement with Novo
Nordisk A/S signed in September 2022. For further information on the above agreements refer to note 2.1 in the 2023 Annual
Report.
On May 31, 2024, the Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing
authorization for Zegalogue
©
triggering DKK 15 million in milestone payments from Novo Nordisk A/S. Based on this it is
Management’s judgement that the two milestone payments (each of DKK 7.5 million) are no longer constrained and that it is
highly probable that a significant revenue reversal will not occur. Zegalogue
©
received the marketing authorization valid
throughout the EU in July 2024.
In Q3, 2024, a reversal of product sales of DKK 6.6 million has been made, following a true-up from the agreement with Novo
Nordisk A/S on supply of goods.
3. Cost of goods sold
Cost of goods sold in Q3, 2024 year-to-date amounted to DKK -7.5 million. In Q3, 2024, a reversal of product sales of DKK 6.6
million has been made following a true-up of recognized revenue and cost of goods sold to Novo Nordisk A/S.
12 Zealand Pharma A/S | Interim Financial Statements Q3 2024
4. Financial items
Financial items include interests, foreign exchange rate adjustments, amortization of loan costs, fair value adjustments of other
investments and derivative financial liabilities, as well as dividends and interest income from investment in marketable securities.
DKK thousand
Q3-24 Q3-23 Q3-24 YTD Q3-23 YTD
Interest income 68,492 10,661 107,030 28,443
Interest expenses from financial liabilities measured at
amortized cost
-8,316 -3,191 -23,967 -22,358
Interest expenses from lease liabilities -469 -341 -1,812 -341
Loss on settlement of borrowings, including embedded
derivatives under Oberland loan
- - - -135,588
Fair value adjustment of lender's call option - - - 1,161
Fair value adjustment of marketable securities 22,575 2,842 35,902 3,131
Fair value adjustment of other investments 881 -2,373 1,567 -16,892
Fair value adjustments warrants, EIB (Tranche A) 14,717 - -28,436 -
Exchange rate adjustments -16,181 19,951 -5,283 19,916
Other financial expenses -57 - -3,908 -2,258
Financial items in total 81,642 27,549 81,093 -124,786
Presentation in income statement:
Financial income 81,051 33,454 144,499 52,651
Financial expenses 591 -5,905 -63,406 -177,437
Interest income in Q3, 2024 year-to-date of DKK 107.0, of which DKK 68.5 million relates to Q3, is significantly higher
compared to Q3, 2023 year-to-date (DKK 28.4 million), which is a result of the excess liquidity from recent capital increases
invested into marketable securities. Refer to note 6. Marketable securities.
Interest expenses from financial liabilities measured at amortized cost in Q3, 2024 year-to-date of DKK 24.0 million relates to
the EIB loan (Tranche A) disbursed on March 11, 2024, and commitment fee from the DKK 350 million credit facility in Danske
Bank, with the latter terminated in Q3, 2024.
Fair value adjustment on other investments of DKK -16.9 million in Q3, 2023 year-to-date comprises the accounting impact of
the investment in Beta Bionics, refer to note 7. Financial instruments for further information on the investment.
Fair value adjustment of warrants, EIB (Tranche A) of DKK -28.4 million in Q3, 2024 year-to-date relates to the warrants granted
to the European Investment Bank (EIB) with the disbursement of the loan’s first tranche (Tranche A), refer to note 7. Financial
instruments for further information.
Exchange rate adjustments primarily relate to USD deposits.
13 Zealand Pharma A/S | Interim Financial Statements Q3 2024
5. Trade and other receivables
Trade and other receivables can be specified as follows:
DKK thousand
Sep-30, 2024 Dec-31, 2023
Deposits 8,900 8,908
Trade receivables 207 1,004
Receivables related to license and collaboration agreements 121,920 68,793
Other receivables 88,603 24,556
Prepaid expenses 34,866 34,892
Total trade and other receivables
254,496 138,153
Non-current 19,753 15,794
Current 234,743 122,359
As of September 30, 2024, receivables related to license and collaboration agreements amounted to DKK 121.9 million (2023:
DKK 68.8 million) and include withholding tax receivable from the Boehringer Ingelheim (BI) milestone payment of DKK 35.6
million. The significant increase compared to December 2023 is primarily related to receivables from the license and
development agreement with Novo Nordisk A/S.
Other receivables of DKK 88.6 million include accrued interest on marketable securities and VAT receivables. Effective from
August 2024, the US Boston office has been subleased and is included with DKK 12.9 million as of Q3, 2024 (of which DKK 10.9
million is non-current).
14 Zealand Pharma A/S | Interim Financial Statements Q3 2024
6. Marketable securities
As of September 30, 2024, Zealand has placed DKK 8,684 million into low-risk marketable securities in line with the Group’s
treasury policy. The investments can be specified as follows:
DKK thousand
Sep-30, 2024 Dec-31, 2023
Securities/bonds in DKK portfolio
7,251,261 509,948
Securities/bonds in EUR portfolio
1,207,800
454,467
Securities/bonds in USD portfolio
225,259
219,331
Total portfolios
8,684,320 1,183,746
DKK thousand
Sep-30, 2024 Dec-31, 2023
DKK portfolio:
DK bonds
7,251,261
509,948
Total DKK portfolio
7,251,261 509,948
EUR portfolio:
IG Corporate bonds (investment grade)
1,207,800
454,467
Total EUR portfolio
1,207,800 454,467
USD portfolio:
Asset-backed securities
2,427 2,738
Certificates of deposit
136,724
125,178
Commercial paper
75,307
69,823
U.S. Treasury Debt
2,594
2,664
U.S. Treasury Repurchase Agreement
8,207
18,928
Total USD portfolio
225,259 219,331
Total portfolio
8,684,320 1,183,746
Non-current 723,183
-
Current 7,961,137
1,183,746
All marketable securities have a fixed interest rate but different maturities. As of September 30, 2024, all outstanding securities
were expected to mature within 24 months (2023: 13 months). The excess liquidity from the capital increases completed in
January 2024 and June 2024, has been placed into the DKK portfolio and EUR portfolio. At maturity funds are reinvested to
minimize lost interest income from marketable securities.
Marketable securities acquired in Q3, 2024 year-to-date are managed and evaluated on a fair value basis in accordance with its
stated investment guidelines and the information provided internally to Management. This business model does not meet the
criteria for amortized cost or FVOCI and as a result marketable securities are measured at fair value through profit and loss. This
classification is consistent with prior year's classification.
15 Zealand Pharma A/S | Interim Financial Statements Q3 2024
7. Financial instruments
As of September 30, 2024, and December 31, 2023, 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, whereas fair value of other
investments and other financial assets is based on inputs categorized as Level 3 in the fair value hierarchy. Cash-settled warrant
liability is measured using significant unobservable 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 period ending September 30, 2024.
DKK thousand
Sep-30, 2024 Dec-31, 2023
Categories of financial instruments
Trade and other receivables excluding prepaid expenses
219,629
103,261
Financial assets measured at amortized cost 219,629 103,261
Marketable securities (Level 1)
8,684,320
1,183,746
Other investments (Level 3)
15,099
14,004
Other financial assets (Level 3)
7,847
7,375
Financial assets measured at fair value through profit and loss 8,707,266 1,205,125
Borrowings
-280,987
-
Lease liabilities
-167,212
-167,986
Trade and other payables
-227,742
-267,923
Financial liabilities measured at amortized cost -675,941 -435,909
Cash-settled warrant liability from EIB loan, Tranche A (Level 3)
-127,499
-
Financial liabilities measured at fair value through profit and loss -127,499 -
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at January 1, 2024 21,379 -
Fair value adjustments through profit and loss 1,567 -
Initial fair value of cash-settled warrant liability from EIB loan, Tranche A - -99,063
Fair value adjustment of warrant liability from EIB loan, Tranche A - -28,436
Carrying amount at September 30, 2024 22,946 -127,499
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 15.1 million as of September 30, 2024 (2023: DKK 14.0 million). The fair value
adjustment of DKK 1.1 million in Q3, 2024 year-to-date is included in financial items, refer to note 4. Financial items.
Fair value measurement of warrants, derivative financial liability (EIB, Tranche A)
Fair value of the warrants granted to the European Investment Bank (EIB) with the disbursement of the loan’s first tranche
(Tranche A), classified as a derivative financial liability, is determined using Black-Scholes valuation technique in line with
16 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Zealand’s existing warrant compensation programs. The warrants will become exercisable as the loan(s) is/are repaid (ignoring
events as delisting, default e.g. which could also lead to exercisability). Each Tranche has a maturity date of 6 years from
disbursement. If not exercised, any warrant will expire 20 years from the signing date of the contract. Based on this, the
calculation of fair value assumes an expected life of 20 years for the options (contractual term).
Other inputs used are i) the current stock price of the Zealand share on the date of measurement, ii) expected volatility (see
below), iii) expected dividend (see below) and iv) the risk-free interest rate determined using a 20-year Danish government
bond.
The strike price is a 5-day volume weighted average (VWAP) calculated from the date of the disbursement offer acceptance on
February 26, 2024, from which date Zealand had an unconditional right to receive the proceeds for Tranche A.
Fair value of the warrants amounted to DKK 127.5 million as of September 30, 2024. On initial recognition in March 2024, we
have determined that the transaction price is equal to fair value and that consequently, there is no day 1 gain/loss to account
for in financial items. The warrants are subsequently measured at fair value through profit and loss (FVTPL) and adjustments are
included under financial items, refer to note 4. Financial items.
The fair value measurement of the warrants is partly determined based on unobservable input (level 3) being the expected
volatility for the Zealand share which is unobservable since there are no traded Zealand warrants. Since expected volatility has
significant impact on the valuation, especially considering the long term, i.e. 20 years, it is classified as a level 3 input in the fair
value hierarchy. As of September 30, 2024, the applied volatility is 54% based on volatility for the Zealand share in the past 5
years. Also impacting the fair value is expected dividend over the next 20 years (Level 3). As of September 30, 2024, the applied
expected dividend yield is 0%.
An increase in volatility will increase the fair value of the warrants. Further, an increase in expected dividend will decrease the
fair value and vice versa. The below summarizes the effect of altering the unobservable inputs that would change the fair value
significantly.
▪ Expected volatility -10%, decrease in fair value of DKK -8.1 million
▪ Expected volatility +10%, increase in fair value of DKK 6.5 million
▪ Expected dividend +0.5%, decrease in fair value of DKK -12.9 million
▪ Expected dividend +1%, decrease in fair value of DKK -24.5 million
Fair value measurement of prepayment option (EIB loan, Tranche A)
The loan agreement contains a prepayment option whereby Zealand may irrevocably prepay all or part of any Tranche,
together with accrued interest, prepayment fee and indemnities, if any, and any amount due in connection to such Tranche. By
prepaying any Tranche, Zealand will have to pay a low single digit prepayment fee of the prepayment amount. The fee will
decrease up until the maturity date of any Tranche, i.e. over a 6-year period.
The prepayment option will result in repayment of an amount which is not approximately equal to the loan's amortized cost at
each point of exercise, and consequently, the prepayment option shall be separated as a non-closely related embedded
derivative. As of September 30, 2024, the prepayment option does not have any significant fair value.
Other fair value measurements
For information about fair value measurements of other financial assets and marketable securities, please refer to note 3.7 and
4.5 of the 2023 Annual Report.
17 Zealand Pharma A/S | Interim Financial Statements Q3 2024
8. Cash and cash equivalents
Pledges provided in relation to the EIB loan
The EIB loan contains a negative pledge clause preventing Zealand Pharma A/S or any of its subsidiaries from creating or
permitting to subsist any new security over any of its assets.
Capital increase
On January 8, 2024, Zealand announced an issue of 3,761,470 new ordinary shares, which represented the remaining
authorization, at a subscription price of DKK 386.45 per new share resulting in gross proceeds of DKK 1.45 billion. The capital
increase was completed in January 2024.
As announced on June 25, 2024, the Board of Directors exercised the authorization granted by Zealand's annual general
meeting held on March 20, 2024, to increase the Group's share capital by issue of 8,350,000 new ordinary shares at a
subscription price of DKK 843 per new share bringing in gross proceeds of DKK 7 billion. The capital increase was completed in
June 2024. In August 2024 the excess liquidity from the capital increase has been invested in marketable securities, refer to
note 6. Marketable securities.
Proceeds EIB loan, Tranche A
On March 11, 2024, Zealand received the proceeds from the first tranche under the EIB loan agreement, Tranche A, of DKK
372.8 million (EUR 50 million).
Termination of Revolving Credit Facility in Danske Bank
The Revolving Credit Facility of DKK 350 million provided by Danske Bank was terminated in July 2024 following the equity
offering in June 2024 resulting in a cash position of DKK 9.7 billion.
9. Share capital
DKK thousand
Sep-30, 2024 Dec-31, 2023
Share capital at start of period 58,751 51,702
Shares issued for cash 12,112 6,579
Exercise of warrants 161 470
Share capital at end of period 71,024 58,751
Total new shares in Q3, 2024 year-to-date were issued at a weighted average subscription price of DKK 694.5.
New shares from exercise of warrants in Q3, 2024 year-to-date were issued at a weighted average subscription price of DKK
190.6. Total proceeds from exercise of share-based compensation amount to DKK 30.7 million.
18 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Treasury shares
As of September 30, 2024, there were 376,933 treasury shares, equivalent to 0.5% of the share capital (2023: 373,134, 0.6%).
The treasury shares are allocated to performance share units (PSUs) and restricted share units (RSUs).
In June 2023 Zealand acquired 300,000 new treasury shares by entering a bank credit with Danske Bank. The payable amount
for treasury shares of DKK 81.0 million was recognized under equity in 2023 when Zealand acquired the 300,000 new treasury
shares. The agreement relating to the bank credit contains both a net settlement alternative and a gross settlement alternative.
Management has chosen to account for the treasury shares gross and the chosen accounting policy reflects Management’s
intention with the acquisition of the new treasury shares.
In April 2024 Zealand gross settled the payable amount of DKK 81.0 million previously included as a liability in trade and other
payables.
In July 2024 Zealand acquired 300,000 treasury shares through a share buyback program with Danske Bank to support
Zealand’s Long Term Incentive programs.
Potential dilutive effects
In the calculation of the diluted loss per share for Q3 2024 year-to-date, 1,755,202 potential ordinary shares related to share-
based payment instruments have been excluded as they are anti-dilutive (2023: 1,970,432).
10. Cash flow adjustments
DKK thousand
Q3-24 YTD Q3-23 YTD
Depreciation, amortization and impairment losses 19,572 16,582
Reversal of inventory write-down - -13,729
Share-based compensation expenses 61,986 46,517
Financial income -144,499 -52,651
Financial expenses 63,405 177,437
Corporate tax -4,043 -4,556
Adjustments for non-cash items in total -3,579 169,600
DKK thousand
Q3-24 YTD Q3-23 YTD
Changes in accounts receivable -58,341 -227,974
Changes in prepaid expenses 74 29,905
Changes in other receivables -3,961 -11,094
Changes in inventory 7,132 4,313
Changes in accounts payable -6,904 2,475
Changes in other liabilities 50,245 12,230
Changes in rebate and discount liabilities - -2,162
Changes in other liabilities and provisions - -19,058
Changes in working capital in total -11,755 -211,365
In Q3, 2024 year-to-date adjustments for financial income of DKK 144.5 million relate mainly to accrued interest on marketable
securities, fair value adjustments on marketable securities and exchange rate adjustments.
Adjustments for financial expenses in Q3, 2023 year-to-date of DKK 177.4 million included the loss from settlement of the
Oberland Capital loan of DKK 135.6 million as well as DKK 17.5 million fair value adjustment on the investment in Beta Bionics
Inc.
19 Zealand Pharma A/S | Interim Financial Statements Q3 2024
11. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2023 Annual Report.
12. 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 6.3 and 6.7 in the Annual Report
2023.
13. 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, 2024.
20 Zealand Pharma A/S | Interim Financial Statements Q3 2024
Statement by the Executive
Management and the Board of
Directors
Management
Board of Directors