XCSE:ZEAL ESEF Annual Report
ZEALAND PHARMA A/S (XCSE:ZEAL)
ESEF Annual Report
2025-08-21
For: 2025-03-31
View Original
Added on
September 22, 2026
Company announcement
No. 11 / 2025
1
Zealand Pharma Announces Financial
Results for the First Three Months of 2025.
Significant progress in the clinical pipeline, strengthening of organizational capabilities, and
strategic partnership for petrelintide create strong foundation for accelerated growth.
• Entered historic and transformative partnership with
Roche to co-develop and co-commercialize petrelintide
as a future foundational therapy for weight
management and rapidly expand into related
indications, aiming to establish the leading amylin-based
franchise.
• Enrolled the last participant in the large, global Phase 2
ZUPREME-1 trial with petrelintide in people with
overweight or obesity, three months after trial initiation.
• Appointed Utpal Singh as Chief Scientific Officer in April
2025 to lead the next wave of differentiated and
innovative medicines, building on Zealand Pharma’s
strong peptide heritage and its ambition to become a
generational biotech company.
Copenhagen, Denmark, May 8, 2025 – 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 three months ended March 31, 2025,
and provided a corporate update.
Embarking on a new chapter with
transformative partnership for petrelintide
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“Zealand Pharma has never been in a stronger position than
we are today - financially, organizationally and in terms of
our clinical development pipeline. The strong foundation
enables us to unlock the full value potential of petrelintide
in partnership with Roche and significantly accelerate
investments in our early-stage research pipeline of next-
generation peptide therapeutics targeting obesity and
inflammation.”
Key financial results for Q1 2025
DKK million
Q1-25
Q1-24
Revenue
8
15
Operating expenses
1
-393
2
-266
Operating result
-385
2
-256
Net financial items
70
26
DKK million
Mar-31,
2025
Dec-31,
2024
Cash position
3
8,544
4
9,022
Notes:
1. Operating expenses consist of R&D, S&M, and G&A.
2. Excluding transaction costs of DKK 21.6 million related to the Roche
partnership agreement. Operating expenses including transaction fees
in Q1 2025 amount to DKK 415 million.
3. Cash position includes cash, cash equivalents and marketable
securities.
4. Upfront payment of USD 1.4 billion from Roche is expected in the
second quarter of 2025.
Highlights in the first quarter of 2025
Obesity
• Petrelintide, amylin analog. Entered a collaboration and
license agreement with Roche. The two companies will
co-develop and co-commercialize petrelintide and
potential combination products, including
petrelintide/CT-388, aiming to establish the leading
amylin-based franchise for weight management and
related indications. The companies will share profits and
losses on a 50/50 basis for petrelintide and
petrelintide/CT-388 in the U.S. and Europe, and Zealand
Pharma is eligible to receive royalties on net sales in the
rest of the world. Total deal consideration amounts to
USD 5.3 billion, including upfront cash payments of USD
1.65 billion and potential development milestone
payments of USD 1.2 billion, primarily linked to initiation
of Phase 3 trials with petrelintide monotherapy.
Company announcement
No. 11 / 2025
2
• Petrelintide, amylin analog. Completed enrollment in the
large, global Phase 2 ZUPREME-1 trial with petrelintide in
people with overweight or obesity, three months after
trial initiation.
• Survodutide, glucagon/GLP-1 receptor dual agonist.
Boehringer Ingelheim completed participant enrollment
in the Phase 3 SYNCHRONIZE
TM
-CVOT trial, marking full
enrollment of all trials in the Phase 3 obesity program.
Corporate
• Appointed Steven R. Smith, MD, as Senior Global
Medical Advisor in Obesity. Steven will support Zealand
Pharma’s obesity research and clinical development
programs.
Events after the reporting date
Obesity
• Petrelintide, amylin analog. In April 2025, Zealand
Pharma initiated the Phase 2 ZUPREME-2 trial with
petrelintide in people with overweight or obesity and
type 2 diabetes, investigating the efficacy and safety of
petrelintide over a treatment duration of 28 weeks.
Corporate
• Appointed Utpal Singh as Chief Scientific Officer. Utpal
joins the executive team to lead discovery research and
translational sciences at Zealand Pharma. Utpal brings
nearly 25 years of pharmaceutical industry experience
spanning the full drug discovery and development
lifecycle.
Upcoming events next 12 months
Obesity
• Petrelintide, amylin analog. In the first half of 2026,
Zealand Pharma expects to report topline results from
the Phase 2 ZUPREME-1 trial and complete the Phase 2
ZUPREME-2 trial with petrelintide.
• Petrelintide/CT-388, amylin+GLP-1/GIP fixed-dose
combination. Zealand Pharma and Roche expect to
initiate Phase 2 trials with petrelintide/CT-388 in the first
half of 2026.
• Dapiglutide, GLP-1/GLP-2 receptor dual agonist. In the
second quarter of 2025, Zealand Pharma expects to
announce topline results from Part 2 of the Phase 1b trial
evaluating higher doses of dapiglutide over 28 weeks of
treatment, with subsequent initiation of a Phase 2 trial
expected in the second half of 2025. Zealand Pharma will
present the results from Part 1 of the Phase 1b trial at
the American Diabetes Association’s 85
th
Scientific
Sessions in Chicago, Illinois in June 2025.
• Survodutide, glucagon/GLP-1 receptor dual agonist.
Topline data from SYNCHRONIZE
TM
-1 and
SYNCHRONIZE
TM
-2, the Phase 3 trials with survodutide in
participants with overweight or obesity without and with
type 2 diabetes, respectively, are expected in the first
half of 2026.
Rare diseases
• Glepaglutide in SBS. In the second half of 2025, Zealand
Pharma expects to submit a Marketing Authorization
Application (MAA) to the European Medicines Agency
(EMA) and initiate a Phase 3 clinical trial of glepaglutide
(EASE-5) that is anticipated to provide further
confirmatory evidence for a regulatory submission in the
U.S. and to support regulatory submissions outside the
U.S. and the EU. In parallel, the company is engaging in
partnership discussions for future commercialization.
• Dasiglucagon in CHI. Zealand Pharma is ready to
resubmit the New Drug Application for dasiglucagon for
up to three weeks of dosing and to submit the requested
analyses from existing continuous glucose monitoring
datasets to support use beyond three weeks. The
regulatory submissions are, however, contingent on an
inspection classification upgrade of a third-party
manufacturing facility. In parallel, the company is
engaging in partnership discussions for future
commercialization.
Chronic inflammation
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma
expects to complete the first-in-human clinical trial with
ZP9830 in the fourth quarter of 2025 and report topline
data in the first half of 2026.
Corporate
• Zealand Pharma Capital Markets Day. Zealand Pharma
will host a Capital Markets Day in London on December
11, 2025. Speakers will include Management as well as
external experts and thought leaders in obesity.
Company announcement
No. 11 / 2025
3
Financial guidance for 2025
• Guidance unchanged from February 20, 2025, excluding
transaction-related costs associated with the Roche
collaboration, which are expected to be approximately
DKK 200 million in 2025.
DKK million
2025
Guidance
5,6
2024
Actuals
Revenue anticipated
from existing and new
license and partnership
agreements
No guidance
63
Net operating expenses
2,000-2,500
1,327
Notes:
5. Excluding transaction-related costs related to the Roche collaboration.
6. Financial guidance based on foreign exchange rates as of May 7, 2025.
Conference call today at 2 PM CET / 8 AM ET
Zealand Pharma’s management will host a conference call
today at 2:00 PM CET / 8:00 AM ET to present results
through the first three months of 2025 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-
conf.media-
server.com/register/BI52c8f77e4cea4195bc9f471f636e1b
ba. The live listen-only audio webcast of the call and
accompanying slides presentation will be accessible at
https://edge.media-server.com/mmc/p/tcdv3c9d/.
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 Pharma’s website at
https://www.zealandpharma.com/events/.
Financial Calendar for 2025
Q2 2025
August 14, 2025
Q3 2025
November 13, 2025
Q4/FY 2025
February 19, 2026
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology
company focused on the discovery and development of
peptide-based medicines. More than 10 drug candidates
invented by Zealand Pharma 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 Pharma was founded in 1998 and is headquartered
in Copenhagen, Denmark, with a presence in the U.S. For
more information about Zealand Pharma’s business and
activities, please visit www.zealandpharma.com.
Forward-looking Statements
This company announcement 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
clinical trials and the reporting of data therefrom and the
company’s significant events and potential catalysts in 2025
and Financial Guidance for 2025. 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 labelling; 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
Company announcement
No. 11 / 2025
4
global economy; and political uncertainty. 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.
Contacts
Adam Lange
Vice President, Investor Relations
Zealand Pharma
Email: [email protected]
Neshat Ahmadi
Investor Relations Manager
Zealand Pharma
Email: [email protected]
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate
Communications
Zealand Pharma
Email: [email protected]
Company announcement
No. 11 / 2025
5
R&D Pipeline
Company announcement
No. 11 / 2025
6
Obesity
Petrelintide (amylin analog)
First quarter 2025 update:
• Entered a collaboration and license agreement with
Roche to co-develop and co-commercialize petrelintide.
• Completed enrollment in the large, global Phase 2
ZUPREME-1 trial, three months after initiation.
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 and a
future foundational therapy for the treatment of overweight
and obesity, targeting weight loss comparable with GLP-
1RA-based therapies but with significantly improved
gastrointestinal tolerability.
In March 2025, Zealand Pharma announced a collaboration
and license agreement with Roche to co-develop and co-
commercialize petrelintide as a future foundational therapy
for weight management and rapidly expand into related
indications.
Zealand Pharma 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 Pharma 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 at baseline 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 by 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)
Background:
Dapiglutide is a long-acting, dual GLP-1R/GLP-2R agonist for
the potential treatment of obesity. This is a potential first-in-
class peptide designed to leverage the weight loss effects of
Company announcement
No. 11 / 2025
7
a potent GLP-1 agonist and address co-morbidities
associated with low-grade inflammation through improved
intestinal barrier function by GLP-2.
In the second quarter of 2025, Zealand Pharma expects to
report topline results from Part 2 of the Phase 1b trial
(ClinicalTrials.gov ID: NCT06000891) investigating high
doses of dapiglutide over a treatment period of 28 weeks,
with subsequent initiation of a Phase 2 trial expected in the
second half of 2025. In June 2025, Zealand Pharma will
present the results from Part 1 of the Phase 1b trial at the
American Diabetes Association’s 85
th
Scientific Sessions.
Zealand Pharma 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
(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).
Zealand Pharma 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)
licensed to Boehringer Ingelheim
First quarter 2025 update:
• Boehringer Ingelheim completed participant enrollment
in the Phase 3 SYNCHRONIZE
TM
-CVOT trial, marking full
enrollment of all trials in the Phase 3 obesity program.
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™). Participant enrollment in all
clinical trials in this program has been completed.
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 has enrolled
people without type 2 diabetes (eligible HbA1c <6.5%) and
SYNCHRONIZE-2 has enrolled 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
Company announcement
No. 11 / 2025
8
of 5% or more at week 76. Over 700 participants have been
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 has enrolled 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), are also ongoing. 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
and is fully enrolled.
In October 2024, Boehringer Ingelheim announced U.S. 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
U.S. 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 U.S. 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).
Company announcement
No. 11 / 2025
9
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
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 Ingelheim solely
responsible for development and commercialization
globally. Zealand Pharma 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)
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 U.S. FDA
and the European Commission have both granted orphan
drug designation to dasiglucagon for the treatment of CHI.
Zealand Pharma is ready to resubmit the New Drug
Application (NDA) for dasiglucagon for up to three weeks of
dosing and to submit the requested detailed analyses from
existing continuous glucose monitoring (CGM) datasets to
support use beyond three weeks. CGM was included as a
secondary outcome measure in the Phase 3 program. The
regulatory submissions are, however, contingent on an
inspection classification upgrade of a third-party
manufacturing facility.
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
Company announcement
No. 11 / 2025
10
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)
Background:
Glepaglutide is a long-acting GLP-2 analog that is stable in
aqueous solution. Zealand Pharma 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 (EASE-1-4) evaluating the
potential for glepaglutide to reduce or eliminate the need for
parenteral support in SBS patients with intestinal failure. The
U.S. FDA has granted orphan drug designation to
glepaglutide for the treatment of SBS.
In December 2024, Zealand Pharma received a Complete
Response Letter (CRL) from the FDA for the glepaglutide NDA
for the treatment of adult patients with SBS with intestinal
failure (IF). The submitted NDA included a single randomized,
placebo-controlled Phase 3 trial (EASE-1). In the CRL, the
FDA recommended an additional placebo-controlled clinical
trial to provide further evidence confirming the efficacy and
safety of the to-be-marketed dose of twice-weekly
glepaglutide. In the second half of 2025, Zealand Pharma
expects to initiate a single Phase 3 clinical trial (EASE-5) that
is anticipated to provide further confirmatory evidence for a
regulatory submission in the U.S. and to support regulatory
submissions outside the U.S. and EU. In the second half of
2025, Zealand Pharma also expects to submit a Marketing
Authorization Application (MAA) to the European Medicines
Agency (EMA).
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
Company announcement
No. 11 / 2025
11
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, in EASE-4 (ClinicalTrials.gov ID: NCT04991311),
a Phase 3b trial to assess long-term effects of glepaglutide
on intestinal fluid and energy uptake, glepaglutide 10 mg
once-weekly increased intestinal absorption and reduced
the need for parenteral support in people with SBS. In
March 2025, the results were presented at the American
Society for Parenteral and Enteral Nutrition (ASPEN) 2025
Nutrition Science & Practice Conference.
Inflammation
Zealand Pharma is pursuing multiple programs in
inflammatory diseases which will be detailed more as they
progress through development.
ZP9830 (Kv1.3 Ion Channel Blocker)
ZP9830 is a potent and selective Kv1.3 blocker with
potential to treat a broad range of T-cell-mediated
autoimmune diseases.
Kv1.3 is a potassium conducting ion channel, which is
selectively upregulated on T effector memory cells. T
effector memory cells are dependent on Kv1.3 to function
and play a key role in autoimmunity and chronic
inflammation by releasing pro-inflammatory cytokines,
which drive tissue damage. The specific and selective
location of the Kv1.3 on the effector memory T cells makes
it an attractive pharmaceutical target, as blocking Kv1.3 is
believed to preserve the protective effects of the rest of the
immune system.
The anti-inflammatory effects of blocking the Kv1.3 ion
channel have been demonstrated in pre-clinical models of
autoimmune diseases, demonstrating concentration-
dependent inhibition of pro-inflammatory cytokine release
from stimulated human whole blood.
In December 2024, Zealand Pharma initiated the first-in-
human clinical trial of ZP9830. This Phase 1 single ascending
dose (SAD) trial will investigate the safety and tolerability of
ZP9830, its pharmacokinetic profile to determine the
appropriate dose levels for potential future clinical trials,
and the pharmacodynamics to evaluate its effect on the
body’s immune system.
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.
The complement system is a part of the innate immune
system, and a central component of the complement
cascade is the C3 protein. Since C3 is at the core of the
complement system, its inhibition is believed to block all
downstream effects of the complement cascade.
In 2024, Alexion Pharmaceuticals discontinued development
of ZP10068 citing business reasons and transferred the
asset back to Zealand Pharma. Zealand Pharma will evaluate
the potential for advancing ZP10068 into the first-in-human
clinical trials in 2025.
1 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Financial highlights and key figures.
Financial highlights (DKK thousand) Note
Q1-25 YTD Q1-24 YTD
Revenue 2 8,092 15,089
Cost of goods sold -405 -4,597
Gross profit 7,687 10,492
Research and development expenses -290,321 -190,936
Sales and marketing expenses -37,361 -9,243
General and administrative expenses -65,467 -66,153
Net operating expenses *** -393,149 -266,332
Operating result *** -385,462 -255,840
Net financial items 4 70,319 25,841
Result before tax *** -315,143 -229,999
Corporate tax 1,376 1,352
Net result for the period *** -313,767 -228,647
Loss per share, basic/diluted (DKK) -4.75 -3.71
Statement of financial position (DKK thousand) Note
Mar-31, 2025 Dec-31, 2024
Cash and cash equivalents 8 776,151 726,033
Marketable securities 6 7,768,317 8,295,983
Cash, cash equivalents and marketable securities 8,544,468 9,022,016
Total assets 9,122,227 9,505,600
Total shareholders' equity 8,308,484 8,616,742
Cash flow (DKK thousand) Note
Q1-25 YTD Q1-24 YTD
Undrawn borrowing facilities * - 350,000
Cash used in operating activities -500,791 -223,676
Cash (used in)/provided by investing activities 554,618 -1,378,470
Cash (used in)/provided by financing activities -791 1,821,607
Purchase of intangible assets -2,304 -
Purchase of property, plant and equipment -6,454 -3,531
Free cash flow ** -507,245 -227,207
Other Note
Mar-31, 2025 Dec-31, 2024
Share price (DKK) 517.0 715.5
Number of shares ('000 shares) 71,051 71,024
Market capitalization (mDKK) ** 36,548 50,550
Equity ratio (%) ** 91% 91%
Equity per share (DKK) ** 117.53 121.96
Average number of full time employees 371 289
Number of full-time employees at the end of the period 385 335
* The revolving credit facility provided by Danske Bank (RCF) was terminated in Q3, 2024. EIB loan Tranches B and C are excluded as they are
dependent on predefined milestones being met.
** For basis of calculation refer to 2024 Annual Report p. 187.
*** Excluding transaction-related costs of DKK 22 million associated with the Roche partnership agreement. Net operating expenses including
transaction-related costs amount to DKK 414.7 million.
2 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Financial Review.
• Operating expenses in the first three months of 2025 of
DKK 393 million, excluding DKK 22 million in transaction
costs related to the Roche partnership agreement, are
mainly driven by clinical advancement of the obesity
pipeline.
• Solid cash position of DKK 8.5 billion as of March 31,
2025, to be strengthened even further by USD 1.65 billion
in upfront payments from Roche, allowing Zealand
Pharma to honor all cost obligations related to the
collaboration and accelerate investments in the early-
stage research pipeline of next-generation peptide
therapeutics.
Revenue
Revenue in the first three months of 2025 of DKK 8 million is
mainly driven by the license and development agreement for
Zegalogue® with Novo Nordisk. Revenue from the initial
upfront payment related to the collaboration and license
agreement with Roche, announced on March 12, 2025, will
be accounted for upon closing of the agreement, which is
expected in Q2 2025.
Net operating expenses
Research and development expenses in the first three
months of 2025 of DKK 290 million are mainly driven by
development of the company’s wholly owned obesity assets,
including the large Phase 2 ZUPREME-1 trial with and
preparations for the Phase 2 ZUPREME-2 trial with
petrelintide, which was initiated in April 2025.
Selling and marketing expenses of DKK 37 million in the first
three months of 2025 are mainly driven by pre-commercial
activities associated with dasiglucagon for congenital
hyperinsulinism (CHI) and glepaglutide for short bowel
syndrome (SBS).
General and administrative expenses of DKK 65 million
reflect strengthening of organizational capabilities in select
corporate functions, investments in IT infrastructure, and
legal expenses related to our patent portfolio.
Financial items
Financial items in the first three months of 2025 of DKK 70
million are mainly driven by interest income of DKK 42 million
from the excess liquidity invested in marketable securities
and fair value adjustment of DKK 31 million of warrants
granted to the European Investment Bank (EIB) following the
disbursement of Tranche A of the EIB loan facility in March
2024. This is partly offset by exchange rate adjustments of
DKK -12 million, which primarily relate to USD deposits and
interest expenses related to the EIB loan.
Equity
On March 31, 2025, equity was DKK 8,308 million, reflecting
a slight decrease compared to December 31, 2024 (DKK
8,617 million) driven by the loss for the period.
Cash position
Cash, cash equivalents and marketable securities as of
March 31, 2025 was DKK 8.5 billion, reflecting a decrease
compared to the DKK 9.0 billion in cash, cash equivalents and
marketable securities as of December 31, 2024. Cash used
in operating activities during the period was DKK 0.5 billion.
The closing of the Roche collaboration and license
agreement, expected in the second quarter of 2025, triggers
a USD 1.4 billion upfront payment to Zealand Pharma, and an
-38
-37
-68
-65
-66
-9
-191
Q1 2024
-12
-212
Q2 2024
-3
-65
-29
-263
Q3 2024
-117
-254
Q4 2024
-291
Q1 2025
-266
-292
-360
-409
-393
R&D S&M G&A Other operating items
OPEX by quarter excl. transaction fees
1
DKK million
3 Zealand Pharma A/S | Interim Financial Statements Q1 2025
additional USD 250 million over the first two anniversaries of
the collaboration.
As of March 31, 2025, Zealand Pharma has placed DKK 7.8
billion in low-risk marketable securities in line with the
company’s treasury policy. Cash and cash equivalents
amount to DKK 0.8 billion.
For further information on the marketable securities, please
refer to note 6.
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 March 31, 2025.
Outlook for the year
Revenue from the initial upfront payment related to the
collaboration and license agreement with Roche, announced
on March 12, 2025, will be accounted for upon closing of the
agreement, which is expected in Q2 2025.
There are no changes to the outlook for the year compared
to the FY 2024 Company announcement on February 20,
2025. Financial guidance is confirmed with net operating
expenses for 2025 still expected to be between DKK 2.0-2.5
billion, excluding transaction-related costs associated with
the Roche collaboration. Total transaction costs related to
the Roche partnership agreement are expected to be
approximately DKK 200 million in 2025.
Cash position compared to FY24
DKK million
8,542
7,768
480
Cash position
Dec-2024
1,2
-501
Cash flow
from operating
activities
23
Other cash
adjustments
776
Cash position
Mar-2025
9,022
8,544
Cash and cash equivalents
Marketable securities
4 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim financial statements.
Unaudited interim condensed consolidated financial statements for Q1 2025:
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. Other operating items ........................................................................................................................................................................................ 11
4. Financial items ..................................................................................................................................................................................................... 12
5. Trade receivables ............................................................................................................................................................................................... 12
6. Marketable securities ......................................................................................................................................................................................... 13
7. Financial instruments.......................................................................................................................................................................................... 13
8. Cash and cash equivalents ............................................................................................................................................................................... 15
9. Share capital ........................................................................................................................................................................................................ 15
10. Cash flow adjustments .................................................................................................................................................................................... 16
11. Capital Management ........................................................................................................................................................................................ 16
12. Contingent assets and liabilities .................................................................................................................................................................... 17
13. Significant events after the reporting period .............................................................................................................................................. 17
Statement by the Executive Management and the Board of Directors. .......................................................................................................... 18
5 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim statement of loss.
DKK thousand Note
Q1-25 YTD Q1-24 YTD
Revenue 2 8,092 15,089
Cost of goods sold -405 -4,597
Gross profit 7,687 10,492
Research and development expenses -290,321 -190,936
Sales and marketing expenses -37,361 -9,243
General and administrative expenses -65,467 -66,153
Other operating expenses 3 -21,576 -
Net operating expenses -414,725 -266,332
Operating result -407,038 -255,840
Financial income 4 90,336 32,296
Financial expenses 4 -20,017 -6,455
Result before tax -336,719 -229,999
Corporate tax 1,376 1,352
Net result for the period -335,343 -228,647
Loss per share, basic/diluted (DKK) -4.75 3.71
6 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim statement of comprehensive loss.
DKK thousand Note
Q1-25 YTD Q1-24 YTD
Net result for the period -335,343 -228,647
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 674 16
Total comprehensive result for the period -334,669 -228,631
7 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim statement of financial position.
DKK thousand Note
Mar-31, 2025 Dec-31, 2024
Intangible assets 14,140 12,620
Property, plant and equipment 50,536 46,479
Right-of-use assets 79,083 78,768
Corporate tax receivable 1,375 -
Deferred tax assets 947 985
Other receivables 18,062 19,412
Marketable securities 6 - 819,632
Total non-current assets 164,143 977,896
Inventory 10,698 10,698
Trade receivables 5 314,526 193,559
Other receivables 78,344 87,205
Corporate tax receivable 10,048 10,232
Other investments 7 - 23,626
Marketable securities 6 7,768,317 7,476,351
Cash and cash equivalents 8 776,151 726,033
Total current assets 8,958,084 8,527,704
Total assets 9,122,227 9,505,600
Share capital 9 71,051 71,024
Share premium 14,684,289 14,680,771
Currency translation reserve 23,062 22,388
Accumulated losses -6,469,918 -6,157,441
Total shareholders' equity 8,308,484 8,616,742
Borrowings 7 289,780 285,332
Derivative financial liabilities 7 78,696 109,665
Lease liabilities 88,416 90,388
Total non-current liabilities 456,892 485,385
Lease liabilities 16,444 16,036
Trade payables 244,339 254,843
Other payables 96,068 132,594
Total current liabilities 356,851 403,473
Total liabilities 813,743 888,858
Total shareholders' equity and liabilities 9,122,227 9,505,600
8 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim statement of cash flow.
DKK thousand
Note
Q1-25 YTD Q1-24 YTD
Net result for the period -335,343 -228,647
Adjustment for other non-cash items 10 -43,042 -2,415
Changes in working capital 10 -179,298 -4,562
Financial income received 60,057 10,426
Financial expenses paid -3,165 -3,978
Corporate taxes received - 5,500
Cash flow used in operating activities -500,791 -223,676
Proceeds from sale of marketable securites 6 3,102,882 409,822
Purchase of marketable securities 6 -2,563,132 -1,784,761
Purchase of intangible assets -2,304 -
Purchase of property, plant and equipment -6,454 -3,531
Proceeds from sale of equity investment in Beta Bionics Inc. 7 23,626 -
Cash flow from/(used in) investing activities 554,618 -1,378,470
Proceeds from borrowings - 369,867
Lease installments -4,336 -3,856
Proceeds from issuance of shares - 1,453,620
Proceeds from issuance of shares related to exercise of share-based
compensation
9 3,545 24,924
Costs related to issuance of shares - -22,948
Cash flow from/(used in) financing activities -791 1,821,607
Increase in cash and cash equivalents 53,036 219,461
Cash and cash equivalents at beginning of period 726,033 449,311
Exchange rate adjustments -2,918 3,622
Cash and cash equivalents at end of period 776,151 672,394
9 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Interim statement of changes in equity.
DKK thousand
Share
capital
Share
premium
Currency
translation
reserve
Accumu-
lated losses
Total
Equity at January 1, 2025 71,024 14,680,771 22,388 -6,157,441 8,616,742
Net result for the period - - - -335,343 -335,343
Other comprehensive income for the period - - 674 - 674
Total comprehensive income - - 674 -335,343 -334,669
Transactions with owners:
Exercise of warrants 27 3,518 - - 3,545
Share-based compensation expenses - - - 22,866 22,866
Equity at March 31, 2025 71,051 14,684,289 23,062 -6,469,918 8,308,484
Equity at January 1, 2024 58,751 6,406,225 22,704 -4,894,841 1,592,839
Net result for the period - - - -228,648 -228,648
Other comprehensive income for the period - - 16 - 16
Total comprehensive income - - 16 -228,648 -228,632
Transactions with owners:
Exercise of warrants 135 24,789 - - 24,924
Share-based compensation expenses - - - 18,160 18,160
Capital increases 3,761 1,449,859 - - 1,453,620
Costs related to capital increases - -22,948 - - -22,948
Equity at March 31, 2024 62,647 7,857,925 22,720 -5,105,329 2,837,963
10 Zealand Pharma A/S | Interim Financial Statements Q1 2025
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, 2024.
New standards, interpretations and amendments adopted by the Group
Several amendments apply for the first time in 2025, 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 judgements 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 2024. Please refer to note 1.3 in the 2024 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 classification of marketable securities acquired in Q1, 2025 year-to-date. Refer to note 6. Marketable
securities.
▪ Judgement on classification of investment in money market fund managed by J.P. Morgan. Refer to note 8. Cash and cash
equivalents.
11 Zealand Pharma A/S | Interim Financial Statements Q1 2025
2. Revenue
Revenue can be specified as follows:
DKK thousand
Q1-25 YTD Q1-24 YTD
Alexion Pharmaceuticals Inc. - 86
Novo Nordisk A/S 7,687 10,406
Total revenue from license and collaboration agreements 7,687 10,492
Product sales 405 4,597
Sale of goods revenue 405 4,597
Total revenue 8,092 15,089
Total revenue recognized over time 7,687 10,492
Total revenue recognized at a point in time 405 4,597
DKK thousand
Q1-25 YTD Q1-24 YTD
Royalty revenue 324 261
Reimbursement revenue for R&D services 7,363 10,231
Product sales 405 4,597
Total revenue by revenue stream 8,092 15,089
Total revenue in Q1, 2025 year-to-date of DKK 7.7 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 2024 Annual Report.
On March 12, 2025, Zealand Pharma and Roche entered into a collaboration and license agreement to co-develop and co-
commercialize petrelintide. Revenue from the initial upfront payment will be accounted for upon closing of the agreement, which
is expected in Q2 2025.
3. Other operating items
DKK thousand
Q1-25 YTD Q1-24 YTD
Transaction fees related to Roche partnership agreement -21,576 -
Total other operating items -21,576 -
Presentation in income statement:
Other operating expenses -21,576 -
Other operating expenses of DKK 21.6 million comprise legal and consulting fees related to the collaboration and license
agreement between Zealand Pharma and Roche. Additional fees will be booked in Q2, 2025 upon closing of the transaction.
12 Zealand Pharma A/S | Interim Financial Statements Q1 2025
4. Financial items
Financial items include interests and banking fees from managing financial transactions, as well as foreign exchange rate
adjustments, fair value adjustments of other investments, derivative financial liabilities and marketable securities.
DKK thousand
Q1-25 YTD Q1-24 YTD
Interest income 41,622 19,774
Interest expenses from financial liabilities measured at amortized cost -7,204 -5,519
Interest expenses from lease liabilities -447 -686
Fair value adjustment of marketable securities 17,745 4,132
Fair value adjustment of other investments - 359
Fair value adjustments warrants, EIB (Tranche A) 30,969 -
Exchange rate adjustments -11,960 8,031
Other financial expenses -406 -250
Financial items in total 70,319 25,841
Presentation in income statement:
Financial income 90,336 32,296
Financial expenses -20,017 -6,455
Interest income in Q1, 2025 year-to-date of DKK 41.6 has increased due to excess liquidity from recent capital increases
invested into marketable securities in line with the Group’s treasury policy. Refer to note 6. Marketable securities.
Interest expenses from financial liabilities measured at amortized cost in Q1, 2025 year-to-date of DKK 7.2 million relate to the
EIB loan (Tranche A) disbursed on March 11, 2024.
Fair value adjustment of warrants, EIB (Tranche A) of DKK 31.0 million in Q1, 2025 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.
5. Trade receivables
Trade and other receivables can be specified as follows:
DKK thousand
Mar-31, 2025 Dec-31, 2024
Trade receivables 8,078 499
Receivables related to license and collaboration agreements 63,458 86,670
Prepaid expenses 242,990 106,390
Total trade receivables 314,526 193,559
Non-current - -
Current 314,526 193,559
As of March 31, 2025, receivables related to license and collaboration agreements amount to DKK 63.5 million (2024: DKK 86.7
million) and include withholding tax receivable from the Boehringer Ingelheim (BI) milestone payment of DKK 35.5 million as well
as receivables from the license and development agreement with Novo Nordisk A/S.
13 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Prepaid expenses of DKK 243.0 million (2024: 106.4 million) comprise large prepayments for drug substance related to
petrelintide.
6. Marketable securities
As of March 31, 2025, Zealand has placed DKK 7,768 million into low-risk marketable securities in line with the Group’s treasury
policy. The investments can be specified as follows:
DKK thousand
Mar-31, 2025 Dec-31, 2024
DKK portfolio:
DK bonds 6,919,345 7,341,039
Total DKK portfolio
6,919,345 7,341,039
EUR portfolio:
IG Corporate bonds (investment grade) 848,972 954,944
Total EUR portfolio
848,972 954,944
Total portfolio
7,768,317 8,295,983
Non-current -
819,632
Current 7,768,317
7,476,351
All marketable securities have a fixed interest rate but different maturities. As of March 31, 2025, all outstanding securities
mature within 16 months (2024: 19 months). All securities in the portfolio have an investment graded rating of AAA to BBB-.
Zealand Pharma recognizes marketable securities at settlement date.
Marketable securities acquired in 2025 are managed and evaluated on a fair value basis in accordance with its stated investment
guidelines and the information provided internally to Management. This classification is consistent with prior year's classification.
Refer to note 7. Financial instruments for information on fair value measurement and the fair value hierarchy.
In Q1 2025, Management exercised judgement regarding the presentation of marketable securities in the money market fund
managed by J.P. Morgan. These investments will now be classified as cash equivalents due to their high liquidity and short-term
maturity profile. Consequently, comparative figures have been adjusted, resulting in the reclassification of DKK 245.7 million from
marketable securities to cash equivalents as of December 31, 2024. As of March 31, 2025, these investments amount to DKK
204.2 million, refer to note 8. Cash and cash equivalents.
7. Financial instruments
As of March 31, 2025, and December 31, 2024, 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 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 three months period ending March 31, 2025.
14 Zealand Pharma A/S | Interim Financial Statements Q1 2025
DKK thousand
Mar-31, 2025 Dec-31, 2024
Categories of financial instruments:
Trade receivables excluding prepaid expenses 71,536 87,169
Other receivables 96,408 106,617
Financial assets measured at amortized cost 167,944 193,786
Marketable securities (Level 1) 7,768,317 8,295,983
Other investments (Level 3) - 23,626
Financial assets measured at fair value through profit and loss 7,768,317 8,319,609
Borrowings 289,780 285,332
Lease liabilities 104,860 106,424
Trade payables 244,339 254,843
Other payables 96,068 132,594
Financial liabilities measured at amortized cost 735,047 779,193
Cash-settled warrant liability from EIB loan, Tranche A (Level 3) 78,696 109,665
Financial liabilities measured at fair value through profit and loss 78,696 109,665
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at January 1, 2025 23,626 109,665
Derecognition from sale of equity investment in Beta Bionics Inc. -23,626 -
Fair value adjustment of warrant liability from EIB loan, Tranche A - -30,969
Carrying amount at March 31, 2025 - 78,696
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 October 2024 a termination agreement was signed and the partnership with Beta Bionics was concluded. Fair value of DKK
23.6 million as of December 31, 2024 reflected the agreed selling price. In January 2025 the sale of all shares in Beta Bionics was
completed.
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
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 78.7 million as of March 31, 2025. On initial recognition in March 2024, Management
has determined that the transaction price is equal to fair value and that consequently, there is no day 1 gain/loss to account for
15 Zealand Pharma A/S | Interim Financial Statements Q1 2025
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 March 31, 2025, the applied volatility is 56% 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 March 31, 2025, 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 -20%, decrease in fair value of DKK -14.1 million
▪ Expected volatility +20%, increase in fair value of DKK 8.6 million
▪ Expected dividend +1%, decrease in fair value of DKK -14.9 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 March 31, 2025, the prepayment option does not have any significant fair value.
Other fair value measurements
For information about fair value measurements of marketable securities, please refer to note 6. Marketable securities.
8. Cash and cash equivalents
Cash and cash equivalents can be specified as follows:
DKK thousand
Mar-31, 2025 Dec-31, 2024
Cash 571,966 480,303
Cash equivalents 204,185 245,730
Total cash and cash equivalents 776,151 726,033
Investment in Money Market Fund
As part of Zealand Pharma’s treasury policy, Zealand Pharma has invested in a money market fund managed by J.P. Morgan.
These investments are classified as cash equivalents due to their high liquidity and short-term maturity profile.
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.
9. Share capital
16 Zealand Pharma A/S | Interim Financial Statements Q1 2025
DKK thousand
Mar-31, 2025 Dec-31, 2024
Share capital at start of period 71,024 58,751
Shares issued for cash - 12,112
Exercise of warrants 27 161
Share capital at end of period 71,051 71,024
New shares from exercise of warrants in Q1, 2025 year-to-date were issued at a weighted average subscription price of DKK
129.3. Total proceeds from exercise of share-based compensation amount to DKK 3.5 million.
Treasury shares
As of March 31, 2025, there were 357,888 treasury shares, equivalent to 0.5% of the share capital (2024: 376,933, 0.5%). The
treasury shares are allocated to performance share units (PSUs) and restricted share units (RSUs).
Potential dilutive effects
In the calculation of the diluted loss per share for Q1 2025 year-to-date, 1,706,953 potential ordinary shares related to share-
based payment instruments have been excluded as they are anti-dilutive (2024: 1,755,202).
10. Cash flow adjustments
DKK thousand
Q1-25 YTD Q1-24 YTD
Depreciation, amortization and impairment losses 5,959 6,618
Share-based compensation expenses 22,866 18,160
Financial income -90,336 -32,296
Financial expenses 19,845 6,455
Corporate tax -1,376 -1,352
Adjustments for non-cash items in total -43,042 -2,415
In Q1, 2025 year-to-date adjustments for financial income of DKK 90.3 million relate mainly to accrued interest on marketable
securities, fair value adjustments on marketable securities and derivative financial liabilities.
Adjustments for financial expenses in Q1, 2025 year-to-date of DKK 19.8 million include amortization of loan costs related to the
EIB loan (Tranche A) and exchange rate adjustments, mainly on USD deposits.
DKK thousand
Q1-25 YTD Q1-24 YTD
Changes in accounts receivable -4,402 12,669
Changes in prepaid expenses -137,215 -11,339
Changes in other receivables 8,707 -3,303
Changes in inventory - 5,018
Changes in accounts payable -10,474 3,346
Changes in other liabilities -35,914 -10,953
Changes in working capital in total -179,298 -4,562
11. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2024 Annual Report.
17 Zealand Pharma A/S | Interim Financial Statements Q1 2025
In Q1 2025, Management exercised judgement regarding the presentation of marketable securities in the money market fund
managed by J.P. Morgan. These investments will now be classified as cash equivalents due to their high liquidity and short-term
maturity profile. Refer to notes 6. Marketable securities and 8. Cash and cash equivalents.
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, future payments under these agreements qualify as contingent assets. However, it is
impossible to estimate the amount of variable consideration for these contingent assets, and as such, no assets have been
recognized.
As part of the license and collaboration agreements that Zealand has entered, 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 notes 6.3 and 6.7 in the Annual Report 2024.
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 March 31, 2025.
18 Zealand Pharma A/S | Interim Financial Statements Q1 2025
Statement by the Executive Management
and the Board of Directors.
Management
Board of Directors