Company announcement
No. 26 / 2024
1
Zealand Pharma Announces Financial
Results for the First Quarter of 2024.
Strong performance in the first quarter of 2024 paving the way for important data read-outs
across differentiated obesity assets in the second quarter.
• Strong topline results announced in Boehringer
Ingelheim Phase 2 clinical trial for survodutide in MASH
• PDUFA date for glepaglutide in SBS set by US FDA for
December 22, 2024
• PDUFA date for dasiglucagon in CHI for up to three
weeks of dosing (Part 1 of NDA) set by US FDA for
October 8, 2024
• Cash runway extended into 2027 through private
placement of shares to institutional investors in January
2024 for gross proceeds of DKK 1.45 billion
Copenhagen, Denmark, May 16, 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 three months ended March 31, 2024,
and provided a corporate update.
Strong start to eventful 2024
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“I am very pleased with the continued advancement of our
business in the first months of 2024. Our partner Boehringer
Ingelheim reported impressive topline data from the Phase
2 trial with survodutide in MASH and recruitment into the
Phase 3 trials in obesity is progressing very well. With our
pipeline of wholly owned and differentiated obesity
candidates, I am truly excited about the upcoming data
read-outs for petrelintide and dapiglutide. In rare diseases,
we have potential approvals in the US later in the year for
both glepaglutide in short bowel syndrome and
dasiglucagon in congenital hyperinsulinism. Backed by a
solid financial position, we will continue to invest in our R&D
programs, including preparations for comprehensive Phase
2b trials with our differentiated obesity candidates.”
Key financial results for Q1 2024
DKK million
Q1 2024
Q1 2023
Revenue
15.1
13.6
Net operating expenses
1
-266.3
-182.3
Net operating result
-255.8
-168.7
Net financial items
25.8
-26.7
DKK million
Mar-31,
2024
Dec-31,
2023
Cash position
2
3,234.8
1,633.1
Funding available incl.
undrawn committed
RCF
3
3,584.8
1,983.1
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, as well as Tranche A of EIB loan disbursed in Q1 2024.
3. RCF = Revolving Credit Facility provided by Danske Bank.
Highlights in the first quarter 2024
Obesity and MASH
• Survodutide, a glucagon/GLP-1 receptor dual agonist:
Boehringer Ingelheim announced positive results from
Phase 2 trial in MASH. The topline results showed that up
to 83.0% of adults treated with survodutide achieved a
biopsy-proven improvement in metabolic dysfunction-
associated steatohepatitis (MASH) after 48 weeks
without worsening of fibrosis stages F1, F2 and F3 (mild
to moderate or advanced scarring), versus 18.2% with
placebo. Survodutide also met all secondary endpoints,
including a statistically significant improvement in liver
fibrosis. These results will be presented at the European
Association for the Study of the Liver (EASL) congress in
Milan, Italy on June 7, 2024.
Rare diseases
• Glepaglutide, GLP-2 analog: US FDA has granted a
Prescription Drug User Fee Act (PDUFA) date of
December 22, 2024. Zealand’s new drug application
Company announcement
No. 26 / 2024
2
(NDA) is for glepaglutide administered twice weekly for
the treatment of short bowel syndrome (SBS) with
intestinal failure.
Financial
• Solid financial position. Directed share issue of 3,761,740
new shares to two reputable institutional investors
through a private placement for gross proceeds of DKK
1.45 billion, extending the cash runway into 2027.
Tranche A of the EUR 90 million loan facility with the
European Investment Bank (EIB), representing EUR 50
million, was disbursed and made available to Zealand in
March 2024.
Events after the reporting date
Rare diseases
• Dasiglucagon (CHI): US FDA has granted a PDUFA date
of October 8, 2024 for dasiglucagon in CHI for up to
three weeks of dosing (Part 1 of NDA). 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 use beyond three weeks.
Supporting the review of Part 2, the US FDA has
requested additional analyses from existing continuous
glucose monitoring (CGM) datasets that were included
as a secondary outcome measure in the Phase 3
program. Submission of Part 2 of the NDA is moved into
the second half of 2024.
Chronic Inflammation
• ZP10068, Complement C3 Inhibitor: Alexion has
discontinued development of ZP10068 citing business
reasons and plans to return the pre-clinical asset to
Zealand.
Upcoming events in 2024
Obesity
• Petrelintide, amylin analog. In the second quarter of
2024, Zealand expects to report topline results from
Part 2 of the multiple ascending dose (MAD) trial that is
evaluating petrelintide in participants with overweight or
obesity (eligible BMI 27.0–39.9), including higher doses
compared with Part 1 and over a longer 16-week
treatment period.
• Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In
the second quarter of 2024, Zealand anticipates topline
results from the investigator-led DREAM trial that aims
to evaluate the potential for weight loss following 12
weeks of treatment and gain key mechanistic insights
into the effects of dapiglutide on inflammatory markers.
In the second half of 2024, Zealand expects topline
results from the 13-week dose titration trial, evaluating
higher doses of dapiglutide compared to the prior 4-
week MAD trial and the investigator-led DREAM trial.
• Survodutide in MASH. Boehringer Ingelheim will present
results from the Phase 2 trial with survodutide in MASH
at the EASL congress in Milan, Italy on June 7, 2024.
Rare diseases
• Glepaglutide in SBS. In parallel with the regulatory review
process, Zealand is engaging in partnership discussions
for future commercialization.
• Dasiglucagon in CHI. Zealand is engaging in partnership
discussions for future commercialization of the product.
In parallel, Zealand intends to make the product available
to patients in the US, contingent on an approval by the
FDA in October 2024 for up to three weeks of dosing
(Part 1 of NDA).
Chronic Inflammation
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to
initiate the first-in-human clinical trial of ZP9830 in the
second half of 2024.
Financial guidance for 2024
• Guidance unchanged from February 27, 2024
DKK million
2024
Guidance
2023
Actual
Revenue anticipated
from existing and new
license and partnership
agreements
No guidance due
to uncertain size
and timing
343
Net operating
expenses
4
1,100-1,200
896
Notes:
4. Financial guidance based on foreign exchange rates as of May 16,
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 three 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;
and Chief Medical Officer, David Kendall. The conference
call will be conducted in English.
Company announcement
No. 26 / 2024
3
To receive telephone dial-in information and a unique
personal access PIN, please register at
https://register.vevent.com/register/BI3bf842a335dd49a79
930cafce733506c. The live listen-only audio webcast of the
call and accompanying slide presentation will be accessible
at https://edge.media-server.com/mmc/p/ee4aippx.
Participants are advised to register for the call or webcast
approximately 10 minutes before the start. A recording of
the event will be available following the call on the Investor
section of Zealand’s website at
https://www.zealandpharma.com/events/.
Financial Calendar for 2024
Q2 2024
August 15, 2024
Q3 2024
November 7, 2024
About Zealand Pharma A/S
biotechnology company focused on the discovery and
development of peptide-based medicines. More than 10
drug candidates invented by Zealand have advanced into
clinical development, of which two have reached the
market and three candidates are in late-stage development.
The company has development partnerships with a number
of pharma companies as well as commercial partnerships
for its marketed products.
Zealand was founded in 1998 and is headquartered in
Copenhagen, Denmark, with a presence in the U.S. For
more information about Zealand’s business and activities,
please visit www.zealandpharma.com.
Forward-looking Statements
This company announcement and interim report contains
“forward-looking statements”, as that term is defined in the
Private Securities Litigation Reform Act of 1995 in the United
States, as amended, even though no longer listed in the
United States this is used as a definition to provide Zealand
Pharma’s expectations or forecasts of future events
regarding the research, development and
commercialization of pharmaceutical products, the timing
of the company’s pre-clinical and clinical trials and the
reporting of data therefrom and the company’s Upcoming
Events and Financial Guidance for 2023. These forward-
looking statements may be identified by words such as
“aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,”
“forecast,” “goal,” “intend,” “may,” “plan,” “possible,”
“potential,” “will,” “would” and other words and terms of
similar meaning. You should not place undue reliance on
these statements, or the scientific data presented. The
reader is cautioned not to rely on these forward-looking
statements. Such forward-looking statements are subject to
risks, uncertainties and inaccurate assumptions, which may
cause actual results to differ materially from expectations set
forth herein and may cause any or all of such forward-
looking statements to be incorrect, and which include, but
are not limited to, unexpected costs or delays in clinical trials
and other development activities due to adverse safety
events or otherwise; unexpected concerns that may arise
from additional data, analysis or results obtained during
clinical trials; our ability to successfully market both new and
existing products; changes in reimbursement rules and
governmental laws and related interpretation thereof;
government-mandated or market-driven price decreases for
our products; introduction of competing products;
production problems; unexpected growth in costs and
expenses; our ability to effect the strategic reorganization of
our businesses in the manner planned; failure to protect and
enforce our data, intellectual property and other proprietary
rights and uncertainties relating to intellectual property
claims and challenges; regulatory authorities may require
additional information or further studies, or may reject, fail
to approve or may delay approval of our drug candidates or
expansion of product labeling; failure to obtain regulatory
approvals in other jurisdictions; exposure to product liability
and other claims; interest rate and currency exchange rate
fluctuations; unexpected contract breaches or terminations;
inflationary pressures on the global economy; and political
uncertainty, including due to the ongoing military conflict in
Ukraine. If any or all of such forward-looking statements
prove to be incorrect, our actual results could differ
materially and adversely from those anticipated or implied
by such statements. The foregoing sets forth many, but not
all, of the factors that could cause actual results to differ
from our expectations in any forward-looking statement. All
such forward-looking statements speak only as of the date
of this press release/company announcement and are
based on information available to Zealand Pharma as of the
date of this release/announcement. We do not undertake to
update any of these forward-looking statements to reflect
events or circumstances that occur after the date hereof.
Information concerning pharmaceuticals (including
compounds under development) contained within this
material is not intended as advertising or medical advice.
Zealand Pharma® is a registered trademark of Zealand
Pharma A/S.
Contacts:
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: ALange@zealandpharma.com
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate
Communications
Zealand Pharma
Email: AKrassowska@zealandpharma.com
Company announcement
No. 26 / 2024
4
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. 26 / 2024
5
Obesity
Petrelintide (long-acting amylin analog)
Background:
Petrelintide (formerly ZP8396) is a long-acting amylin analog
designed to improve solubility, minimize fibrillation, and
allow for co-formulation with other peptides, including GLP-
1-based molecules. Petrelintide holds potential as a next-
generation treatment for overweight and obesity that could
provide weight loss comparable with GLP-1-based therapies
with improved tolerability.
Zealand is conducting a Phase 1b, randomized, multiple
ascending dose (MAD) clinical trial of petrelintide in normal
weight and overweight healthy participants
(ClinicalTrials.gov ID: NCT05613387). The MAD trial consists
of Part 1 and Part 2. Part 1 includes 20 participants (eligible
BMI 21.0–29.9) receiving six once-weekly subcutaneous
doses of petrelintide or placebo. Part 2 includes 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 has been completed and the results
were presented at the Obesity Society Annual Meeting
(ObesityWeek) in October 2023. Low doses of 0.6 mg and
1.2 mg 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 expected in
the second quarter of 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 first-in-class
peptide designed to leverage the weight loss effects of a
potent GLP-1 agonist and address co-morbidities associated
with low-grade inflammation through improved intestinal
barrier function by GLP-2.
A Phase 2 investigator-led randomized, double-blind,
placebo-controlled clinical trial in up to 54 people living with
overweight and obesity, named DREAM, aims to evaluate
the potential for weight loss and gain key mechanistic
insights into the effects of dapiglutide on inflammatory
markers following a 12-week treatment period. Zealand
expects topline results from the trial in the second quarter
of 2024. Please visit ClinicalTrials.gov for further information
(ID: NCT05788601).
Separately, Zealand initiated a 13-week randomized, double-
blind, placebo-controlled, dose titration trial
(ClinicalTrials.gov ID: NCT06000891) to evaluate higher
doses of dapiglutide in overweight or obese but otherwise
healthy people (eligible BMI 27.0–39.9). The company
expects topline results in the second half of 2024.
Phase 1 results of dapiglutide in healthy volunteers
demonstrated dose-dependent weight loss of up to 4.3%
from baseline body weight after only four weeks of
treatment. Dapiglutide also delayed gastric emptying and
reduced plasma glucose and insulin concentrations in a
dose-dependent manner. Pharmacokinetics showed a
mean half-life of 123-129 hours across the four dose
cohorts, which supports once-weekly dose administration.
No trial participants developed anti-drug antibodies. Multiple
weekly doses of dapiglutide were well-tolerated and the
safety profile was as expected for GLP-1 and GLP-2 receptor
agonists. These results were presented at the ADA 82
nd
Scientific Sessions in June 2022.
Survodutide (long-acting dual GCGR/GLP-1R agonist) in
collaboration with Boehringer Ingelheim
First quarter 2024 update:
• Boehringer Ingelheim announced positive topline
results from Phase 2 trial 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-
Company announcement
No. 26 / 2024
6
hormone receptor agonist treatments. Survodutide is
targeting the treatment of obesity and MASH.
In 2023, Boehringer Ingelheim advanced survodutide into a
global Phase 3 program in people living with overweight or
obesity (SYNCHRONIZE
TM
).
SYNCHRONIZE
TM
-1 (ClinicalTrials.gov ID: NCT06066515)
and SYNCHRONIZE
TM
-2 (ClinicalTrials.gov ID:
NCT06066528) are Phase 3 trials investigating survodutide
in people with obesity (eligible BMI ≥30) or overweight
(eligible BMI ≥27) with comorbidities, including dyslipidemia,
hypertension and obstructive sleep apnea.
SYNCHRONIZE
TM
-1 will enroll people without type 2
diabetes (eligible HbA1c <6.5%) and SYNCHRONIZE
TM
-2 will
enroll people with type 2 diabetes (eligible HbA1c ≥6.5%
<10%). For both trials, the primary endpoints are percentage
change in body weight at week 76 and the proportion of
people who achieve body weight loss of 5% or more at week
76. A total of 600 participants will be enrolled in each of the
two trials, randomized to receive weekly subcutaneous
injections of either survodutide, reaching a maximum dose
of 3.6 mg or 6.0 mg for maintenance treatment, or placebo.
SYNCHRONIZE
TM
-CVOT (ClinicalTrials.gov ID:
NCT06077864) is a Phase 3 trial that will enroll people with
overweight or obesity with cardiovascular disease, chronic
kidney disease, or risk factors for cardiovascular disease. In
SYNCHRONIZE
TM
-CVOT, the primary endpoint is the time to
first occurrence of any one of five major adverse cardiac
events (5P-MACE): cardiovascular death, non-fatal stroke,
non-fatal myocardial infarction, ischemia-related coronary
revascularization and heart failure events.
Phase 3 trials with survodutide in Chinese people living with
overweight or obesity, SYNCHRONIZE
TM
-CN
(ClinicalTrials.gov ID: NCT06214741), and in Japanese
people living with overweight or obesity, SYNCHRONIZE
TM
-
JP (ClinicalTrials.gov ID: NCT06176365), have also been
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.
Advancement of survodutide to Phase 3 trials in people with
overweight or obesity was based on positive results in
separate Phase 2 trials in obesity, type 2 diabetes and most
recently MASH. A Phase 2 randomized, placebo-controlled,
double-blind trial evaluated survodutide compared to
placebo in people with overweight or obesity
(ClinicalTrials.gov ID: NCT04667377). Participants received
multiple rising doses of survodutide in one of four dose
groups or placebo and included 20 weeks of dose
escalation and 26 weeks of maintenance. Based on the
planned maintenance dose assigned at randomization
regardless of whether the planned dose was reached during
the dose escalation phase, survodutide achieved up to 14.9%
mean weight loss from baseline after 46 weeks. An analysis
based on the actual maintenance dose regardless of
assignment at randomization, showed up to 18.7% mean
weight loss after 46 weeks. Bodyweight reductions with
survodutide had not reached a plateau at week 46,
suggesting additional weight loss could be achieved with
longer treatment duration. Up to 40% of people who
reached the highest two doses of survodutide, 3.6 mg and
4.8 mg, achieved a weight loss of at least 20%.
Serious adverse events were reported by 4.2% of participants
on survodutide versus 6.5% of those on placebo. Treatment
discontinuation due to adverse events occurred in 24.6%
and 3.9% of participants on survodutide and placebo,
respectively, mainly due to gastrointestinal adverse events.
Most treatment discontinuations due to adverse events
occurred during the rapid 20-week dose-escalation phase
with up-titration every second week. Thus, the safety and
tolerability profile of survodutide was in line with other
incretin-based pharmacotherapies. The treatment
discontinuation rate of survodutide was also roughly similar
to the treatment discontinuation rates seen with other
incretin-based pharmacotherapies in previous Phase 2 trials
in type 2 diabetes and obesity. Boehringer Ingelheim and
Zealand Pharma expect that treatment discontinuations due
to adverse events can be mitigated with more gradual dose
escalation over a longer duration in Phase 3. The detailed
results from the Phase 2 trial were presented at the ADA 83
rd
Scientific Sessions in June 2023. 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 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
Company announcement
No. 26 / 2024
7
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. 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 the Phase 3 program in
people with overweight or obesity (SYNCHRONIZE
TM
). Full
data will be presented at the European Association for the
Study of the Liver (EASL) congress in Milan on June 7, 2024.
The MASH program has received Fast Track Designation
from the US FDA and PRIME designation (Priority Medicines)
by the European Medicines Agency (EMA). In people living
with overweight and obesity, it is estimated that 75% have
metabolic dysfunction-associated fatty liver disease (MAFLD)
and 34% have MASH.
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)
First quarter 2024 update:
• US FDA has granted a PDUFA date of October 8, 2024
for dasiglucagon in CHI for up to three weeks of dosing
(Part 1 of NDA).
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 FDA has granted a PDUFA
date of October 8, 2024 after Zealand resubmitted Part 1 of
the NDA following a Complete Response Letter (CRL) issued
in December 2023 due to deficiencies identified at a third-
party manufacturing facility that were not related to
dasiglucagon. 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 in the second half of 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
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
Company announcement
No. 26 / 2024
8
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)
First quarter 2024 update:
• US FDA has granted a PDUFA date on December 22,
2024 for glepaglutide in SBS with intestinal failure.
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. FDA has
granted orphan drug designation to glepaglutide for the
treatment of SBS.
EASE-1 (ClinicalTrials.gov ID: NCT03690206) is a
randomized, double-blind Phase 3 trial that enrolled a total
of 106 SBS patients with intestinal failure who were
dependent on parenteral support for at least three days per
week. Patients were evenly randomized to receive
treatment with 10 mg glepaglutide administered either once
or twice weekly, or placebo. The primary endpoint in the trial
was the absolute change in weekly parenteral support
volume from baseline at 24 weeks.
In EASE-1, glepaglutide given twice weekly significantly
reduced the total weekly volume of parenteral support at 24
weeks as compared to placebo (p=0.0039). When
administered once weekly, glepaglutide treatment also
resulted in a numeric reduction in weekly parenteral
support, however this did not achieve statistical significance.
At 24 weeks, the average reduction in parenteral support
from baseline was 5.13 Liters/week for patients treated with
glepaglutide twice weekly and was 3.13 Liters/week for
patients treated with glepaglutide once weekly. Placebo
treatment resulted in a reduction in parenteral support of
2.85 Liters/week. Clinical response, defined as a patient
achieving at least 20% reduction in weekly parenteral
support volume from baseline at both 20 and 24 weeks, was
significantly higher with twice weekly glepaglutide
compared to placebo (p=0.0243). Among patients receiving
glepaglutide twice weekly, 65.7% achieved a clinical
response, whereas 45.7% and 38.9% of patients achieved a
clinical response in the once weekly and placebo treatment
groups, respectively.
In the twice weekly dosing group, 14% of patients (n=5) were
completely weaned off parenteral support (enteral
autonomy). In total, 9 patients treated with glepaglutide
achieved enteral autonomy, while no placebo-treated
patients were able to discontinue parenteral support.
Glepaglutide appeared to be safe and was well-tolerated in
the trial. The most frequently reported adverse events were
injection site reactions and gastrointestinal events. These
results were presented at the ASPEN 2023 Nutrition Science
& Practice Conference in April 2023 and Digestive Diseases
Week in May 2023.
In total, 102 of 106 participating patients completed EASE-1,
of which 96 continued into the ongoing two-year, long-
term safety and efficacy extension trial, EASE-2. EASE-2
(ClinicalTrials.gov ID: NCT03905707) is a randomized,
double-blind trial in which SBS patients continued their
assigned treatment from EASE-1 with glepaglutide 10 mg
once or twice weekly. Patients who received placebo in
EASE-1 were re-randomized to treatment with either
glepaglutide 10 mg once or twice weekly. In an interim
analysis conducted at six months, clinical response to
glepaglutide across the key efficacy endpoints was generally
maintained or showed continued improvement. Data also
demonstrated that additional patients on both doses
weaned off parenteral support successfully.
Patients who complete EASE-2 are eligible to participate in
EASE-3 (ClinicalTrials.gov ID: NCT04881825), evaluating
glepaglutide administered once weekly using an auto-
injector. An interim analysis of EASE-3, conducted with the
first 43 patients rolled over from EASE 2, showed that the
reduction in prescribed PS was generally maintained.
Glepaglutide appeared to be safe and well-tolerated in
EASE-2 and EASE-3, with a profile consistent with that
observed in EASE-1. Both EASE-2 and EASE-3 long-term
extension trials are ongoing.
In addition, EASE-4 (ClinicalTrials.gov ID: NCT04991311) is a
Phase 3b trial to assess long-term effects of glepaglutide on
intestinal fluid and energy uptake. Zealand expects to
present results from this trial at a future scientific
conference.
Phase 2 data have shown the potential of glepaglutide to
increase intestinal absorption in people with SBS and were
published in the journal The Lancet Gastroenterology &
Hepatology in 2019.
Company announcement
No. 26 / 2024
9
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
second half 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 has
discontinued development of ZP10068 citing business
reasons and plans to return the asset to Zealand. Zealand
expects to provide an update on the potential next steps for
ZP10068 in connection with the interim report for the 2024
second quarter/first half on August 15, 2024.
Type 1 Diabetes Management
Dasiglucagon for Bihormonal Artificial Pancreas systems
Background:
Zealand is developing a pre-filled dasiglucagon cartridge
intended for use in Bihormonal Artificial Pancreas systems,
which hold potential to improve the management of type 1
diabetes (T1D). Zealand is collaborating with Beta Bionics,
developer of the Bihormonal iLet® Bionic Pancreas (iLet
Duo™), a pocket-sized, dual chamber (insulin and
glucagon), autonomous, glycemic control system. The iLet
Duo™ is an investigational device, limited by federal (or
United States) law to investigational use only. The iLet®
Bionic Pancreas platform is designed to use adaptive, self-
learning, control algorithms, together with continuous
glucose monitoring and pump technology, to
autonomously compute and administer doses of insulin
and/or glucagon and mimic the body’s natural ability to
maintain tight glycemic control.
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.
10 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Financial highlights and key
figures.
Financial highlights (DKK thousand) Note
Q1-24 YTD Q1-23 YTD
Revenue 2 15,089 13,628
Cost of goods sold -4,597 -
Gross profit 10,492 13,628
Research and development expenses -190,936 -142,263
Sales and marketing expenses -9,243 -4,616
General and administrative expenses -66,153 -42,484
Other operating items - 7,061
Net operating expenses -266,332 -182,302
Operating result -255,840 -168,673
Net financial items 3 25,841 -26,650
Result before tax -229,999 -195,323
Corporate tax 1,352 1,691
Net result for the period -228,647 -193,632
Loss per share, basic/diluted (DKK) -3.71 -3.76
Statement of financial position (DKK thousand) Note
Mar-31, 2024 Dec-31, 2023
Cash and cash equivalents 7 672,394 449,311
Marketable securities 5 2,562,391 1,183,746
Cash, cash equivalents and marketable securities 3,234,785 1,633,057
Total assets 3,586,802 1,979,993
Total shareholders' equity 2,837,963 1,592,839
Cash flow (DKK thousand) Note
Q1-24 YTD Q1-23 YTD
Undrawn borrowing facilities 1) 350,000 -
Cash used in operating activities -223,676 -196,677
Cash used in investing activities -1,378,469 -64,846
Cash provided by financing activities 1,821,607 30,158
Purchase of property, plant and equipment -3,531 -1,117
Free cash flow 2) -227,207 -197,794
Other Note
Mar-31, 2024 Dec-31, 2023
Share price (DKK) 681.5 373.2
Number of shares ('000 shares) 62,648 58,751
Market capitalization (mDKK) 2) 42,455 21,787
Equity ratio (%) 2) 79% 80%
Equity per share (DKK) 2) 45.56 27.28
Average number of full time employees 263 235
Number of full-time employees at the end of the period 270 253
1) In May 2023, Zealand entered a new DKK 350 million revolving credit facility provided by Danske Bank. 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.
11 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Financial Review.
• Net operating expenses in the first three months of 2024
of DKK -266 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.
• Tranche A of the EUR 90 million loan facility with the
European Investment Bank (EIB), representing EUR 50
million, was disbursed to Zealand in Q1 2024.
• Runway extended into 2027 following the directed issue
and private placement of new shares in January 2024,
bringing in gross proceeds of DKK 1.45 billion.
Revenue
Revenue in the first three months of 2024 of DKK 15 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 three
months of 2024 of DKK -191 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 New Drug Application (NDA) for
glepaglutide in SBS has been accepted for review by the US
FDA with a Prescription Drug User Fee Act (PDUFA) date on
December 22, 2024, and the resubmission for dasiglucagon
in CHI for up to three weeks of dosing has been accepted
for review with a PDUFA date on October 8, 2024. The
increase in research and development expenses in the first
three months of 2024 compared to the first three months
of 2023 (DKK -142 million) is mainly driven by the significant
clinical advancement of the obesity pipeline.
Selling and marketing expenses of DKK -9 million in the first
three months of 2024 are mainly driven by pre-commercial
activities associated with dasiglucagon in CHI, which
Zealand will make available to patients in the US if approved.
Administrative expenses of DKK -66 million reflect
strengthening of the IT infrastructure and organizational
capabilities in select corporate functions as well as legal
expenses related to our patent portfolio.
Financial items
Financial items in the first three months of 2024 of DKK 26
million are mainly driven by interest income of DKK 20
million from the excess liquidity invested in marketable
securities and favorable exchange rate adjustments of DKK
8 million, primarily related to USD deposits. This is partly
offset by interest expenses and banking fees of DKK -4
million associated with Tranche A of the EIB loan as well as
the Revolving Credit Facility (RCF). Interest expenses and
banking fees are significantly lower than the DKK -11 million
in the first three months of 2023, which related to the
Oberland loan agreement that was fully repaid and
terminated in May 2023. Also in the first three months of
2023, the company’s investment in Beta Bionics was subject
to a fair value adjustment of DKK -15 million.
Equity
On March 31, 2024, equity was DKK 2,838 million, reflecting
a significant increase compared to December 31, 2023 (DKK
1,593 million), mainly driven by the proceeds from the
directed issue and private placement of new shares in
January 2024 and partly offset by the loss for the period.
Cash position
Cash, cash equivalents and marketable securities as of
March 31, 2024 was DKK 3.2 billion and DKK 3.6 billion
including the undrawn DKK 350 million RCF provided by
Danske Bank, reflecting a significant increase compared to
the DKK 1.6 billion (DKK 2.0 billion including RCF) in cash,
cash equivalents and marketable securities as of December
-191
-48
-51
-66
7
-5
-142
Q1 2023
-7
-156
Q2 2023
2
-44
-6
-197
Q3 2023
-9
-13
-190
Q4 2023
-9
Q1 2024
-182
-206
-245
-263 -266
5
-42
R&D S&M G&A Other operating items
OPEX by quarter
DKK million
12 Zealand Pharma A/S | Interim Financial Statements Q1 2024
31, 2023. This development in the first three months of 2024
is mainly driven by the DKK 1.45 billion in gross proceeds
from the directed issue and private placement of new shares
in January 2024 and disbursement of the EUR 50 million
Tranche A of the EIB loan facility, partly offset by cash used
in operating activities during the period (DKK -224 million).
As of March 31, 2024, Zealand has placed DKK 2.6 billion in
low-risk marketable securities, whereas cash and cash
equivalents amount to DKK 0.7 billion. This is in line with the
company’s treasury policy.
Refer to note 6 and 7 for further information on the EIB loan
and the capital increase in January 2024, respectively.
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, 2024.
Outlook for the year
There are no changes to the outlook for the year and
guidance is confirmed. Net operating expenses for the year
are still expected between DKK 1,100-1,200 million. For
further information, please refer to p. 11 in the 2023 Annual
Report.
Cash position compared to FY23
DKK million
449
373
672
350
1,184
Cash
position
Dec-2023
1
-224
Cash flow
from
operating
activities
-2
Other cash
adjustments
1,450
Gross
proceeds
from
capital
increase
January
2024
Proceeds
from EIB
loan
(Tranche A)
in March,
2024
350
2,562
Cash
position
Mar-2024
1
298
EIB loan
Tranche B
and C (EUR
20 million
each)
2
Cash
position
Mar-2024
including
EIB loan
1,983
3,584
3,882
Undrawn borrowing facilities
Cash and cash equivalents
Marketable securities
1. Cash position includes cash, cash equivalents and marketable securities. Undrawn
borrowing facilities comprise DKK 350 million RCF in Danske Bank.
2. The two tranches are subject to pre-specified milestones being met.
13 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim financial statements.
Unaudited interim condensed consolidated financial statements for Q1 2024:
Interim statement of loss ...................................................................................................................................................................................... 14
Interim statement of comprehensive loss ........................................................................................................................................................ 15
Interim statement of financial position .............................................................................................................................................................. 16
Interim statement of cash flow ............................................................................................................................................................................. 17
Interim statement of changes in equity ............................................................................................................................................................. 18
Notes to the interim condensed consolidated financial statements. ............................................................................................................ 19
1. Basis of preparation and changes to the Group’s accounting policies ................................................................................................. 19
2. Revenue ................................................................................................................................................................................................................ 20
3. Financial items ..................................................................................................................................................................................................... 21
4. Trade and other receivables ............................................................................................................................................................................ 22
5. Marketable securities ......................................................................................................................................................................................... 22
6. Financial instruments ......................................................................................................................................................................................... 23
7. Cash and cash equivalents ............................................................................................................................................................................... 25
8. Share capital......................................................................................................................................................................................................... 25
9. Cash flow adjustments ...................................................................................................................................................................................... 26
10. Capital Management ....................................................................................................................................................................................... 26
11. Contingent assets and liabilities ..................................................................................................................................................................... 26
12. Significant events after the reporting period .............................................................................................................................................. 27
Statement by the Executive Management and the Board of Directors ......................................................................................................... 28
14 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim statement of loss.
DKK thousand Note
Q1-24 YTD Q1-23 YTD
Revenue 2 15,089 13,628
Cost of goods sold -4,597 -
Gross profit 10,492 13,628
Research and development expenses -190,936 -142,263
Sales and marketing expenses -9,243 -4,616
General and administrative expenses -66,153 -42,484
Other operating income - 7,061
Net operating expenses -266,332 -182,302
Operating result -255,840 -168,674
Financial income 3 32,296 7,437
Financial expenses 3 -6,455 -34,086
Result before tax -229,999 -195,323
Corporate tax 1,352 1,691
Net result for the period -228,647 -193,632
Loss per share, basic/diluted (DKK) -3.71 -3.76
15 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim statement of comprehensive
loss.
DKK thousand Note
Q1-24 YTD Q1-23 YTD
Net result for the period -228,647 -193,632
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 16 3,785
Total comprehensive result for the period -228,631 -189,847
16 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim statement of financial position.
DKK thousand Note
Mar-31, 2024 Dec-31, 2023
Assets
Intangible assets 11,629 12,255
Property, plant and equipment 48,001 47,047
Right-of-use assets 99,682 102,805
Other investments 6 14,004 14,004
Corporate tax receivable 1,375 -
Deferred tax assets 946 925
Other receivables 4 15,315 15,794
Other financial assets 6 7,734 7,375
Total non-current assets 198,686 200,205
Inventory 2,917 7,935
Trade and other receivables
4
Corporate tax receivable 11,038 16,437
Marketable securities 5 2,562,391 1,183,746
Cash and cash equivalents 7 672,394 449,311
Total current assets 3,388,117 1,779,788
Total assets 3,586,803 1,979,993
Shareholders' equity and liabilities
Share capital 8 62,647 58,751
Share premium 7,857,925 6,406,225
Currency translation reserve 22,720 22,704
Retained losses -5,105,329 -4,894,841
Total shareholders' equity 2,837,963 1,592,839
Borrowings 6 272,597 -
Derivative financial liabilities 6 99,063 -
Lease liabilities 101,619 102,575
Total non-current liabilities 473,279 102,575
Lease liabilities 14,967 16,655
Trade and other payables 260,594 267,924
Total current liabilities 275,561 284,579
Total liabilities 748,840 387,154
Total shareholders' equity and liabilities 3,586,803 1,979,993
17 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim statement of cash flow.
DKK thousand Note
Q1-24 YTD Q1-23 YTD
Net result for the period -228,647 -193,632
Adjustment for other non-cash items 9 -2,415 42,677
Changes in working capital 9 -4,562 -39,881
Financial income received 10,426 3,782
Financial expenses paid -3,978 -9,680
Corporate taxes received 5,500 57
Cash flow used in operating activities -223,676 -196,677
Proceeds from sale of marketable securites 5 409,822 107,517
Purchase of marketable securities 5 -1,784,761 -171,246
Purchase of property, plant and equipment -3,531 -1,117
Cash flow used in investing activities -1,378,470 -64,846
Proceeds from borrowings 7 369,867 -
Lease installments -3,856 -3,008
Proceeds from issuance of shares 7 1,453,620 -
Proceeds from issuance of shares related to exercise of share-based
compensation
8 24,924 33,166
Costs related to issuance of shares -22,948 -
Cash flow from financing activities 1,821,607 30,158
Increase/decrease in cash and cash equivalents 219,461 -231,365
Cash and cash equivalents at beginning of period 449,311 1,069,234
Exchange rate adjustments 3,622 -6,791
Cash and cash equivalents at end of period 672,394 831,078
18 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Interim statement of changes in equity.
DKK thousand
Share
capital
Share
premium
Currency
translation
reserve
Retained
losses
Total
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
Equity at January 1, 2023 51,702 4,921,232 14,617 -4,171,640 815,911
Net result for the period - - - -193,632 -193,632
Other comprehensive income for the period - - 3,785 - 3,785
Total comprehensive income - - 3,785 -193,632 -189,847
Transactions with owners:
Exercise of warrants 301 32,865 - - 33,166
Share-based compensation expenses - - - 14,009 14,009
Equity at March 31, 2023 52,003 4,954,097 18,402 -4,351,263 673,239
19 Zealand Pharma A/S | Interim Financial Statements Q1 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 increase completed in January 2024 the Group received gross proceeds of DKK 1.45
billion. On this basis the interim condensed consolidated financial statements are prepared using the going concern
assumption.
New standards, interpretations and amendments adopted by the Group
Several amendments apply for the first time in 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 6.
20 Zealand Pharma A/S | Interim Financial Statements Q1 2024
2. Revenue
Revenue can be specified as follows:
DKK thousand
Q1-24 YTD Q1-23 YTD
Alexion Pharmaceuticals Inc. 86 1,790
Novo Nordisk A/S 10,406 11,838
Total revenue from license and collaboration agreements
10,492 13,628
Product sales 4,597 -
Sale of goods revenue
4,597 -
Total revenue 15,089 13,628
Total revenue recognized over time 10,492 13,628
Total revenue recognized at a point in time 4,597 -
DKK thousand
Q1-24 YTD Q1-23 YTD
Royalty revenue 261 234
Reimbursement revenue for R&D services 10,231 13,394
Product sales 4,597 -
Total revenue by revenue stream
15,089 13,628
Total revenue in Q1, 2024 of DKK 15.1 million is driven by the license and development agreement with Novo Nordisk A/S
signed in September 2022 as well as proceeds from the agreement with Alexion. For further information on these agreements
refer to note 2.1 in the 2023 Annual Report.
21 Zealand Pharma A/S | Interim Financial Statements Q1 2024
3. 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
Q1-24 YTD Q1-23 YTD
Interest income 19,774 4,709
Interest expenses from financial liabilities measured at amortized cost -4,113 -11,207
Interest expenses from lease liabilities -686 -
Gain from sale of marketable securities 425 -
Fair value adjustment of lender's call option - 2,289
Fair value adjustment of marketable securities 3,707 389
Fair value adjustment of other investments - -14,749
Fair value adjustment of other financial assets 359 50
Amortization of loan costs -1,406 -656
Exchange rate adjustments 8,031 -6,888
Other financial expenses -250 -586
Financial items in total 25,841 -26,649
Presentation in income statement:
Financial income 32,296 7,437
Financial expenses -6,455 -34,086
Interest income in Q1, 2024 of DKK 19.8 million is significantly higher compared to Q1, 2023 (DKK 4.7 million) as a result of the
excess liquidity invested into marketable securities both from the capital increase in April 2023 as well as from the capital
increase in January 2024. Refer to note 5. Marketable securities.
Interest expenses from financial liabilities measured at amortized cost in Q1, 2024 of DKK 4.1 million relates to the EIB loan
(Tranche A) disbursed on March 11, 2024 and interest expenses from the DKK 350 million credit facility in Danske Bank. The
decrease in interest expenses compared to Q1, 2023 (DKK 11.2 million) is a result of the settlement of the Oberland Capital loan
in May, 2023.
Fair value adjustment on other investments of DKK -14.8 million in Q1, 2023 comprises the accounting impact of the
investment in Beta Bionics as described in note 6.
Exchange rate adjustments primarily relates to USD deposits.
22 Zealand Pharma A/S | Interim Financial Statements Q1 2024
4. Trade and other receivables
Trade and other receivables can be specified as follows:
DKK thousand
Mar-31, 2024 Dec-31, 2023
Deposits 8,908 8,908
Trade receivables 8,951 1,004
Receivables related to license and collaboration agreements 55,668 68,793
Other receivables 34,903 24,555
Prepaid expenses 46,262 34,893
Total trade and other receivables
154,692 138,153
Non-current 15,315 15,794
Current 139,377 122,359
Receivables related to license and collaboration agreements include withholding tax receivable from the Boehringer Ingelheim
(BI) milestone payment of DKK 35.7 million. Other receivables of DKK 34.9 million include accrued interest on marketable
securities and VAT receivables.
5. Marketable securities
As of March 31, 2024 Zealand has placed DKK 2,562 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, 2024 Dec-31, 2023
DKK portfolio:
DK bonds
1,111, 597
509,948
Total DKK portfolio
1,111,597 509,948
EUR portfolio:
IG Corporate bonds (investment grade)
1,223, 493
454,467
Total EUR portfolio
1,223,493 454,467
USD portfolio:
Asset-backed securities
1,666 2,738
Certificates of deposit
115,796
125,178
Commercial paper
90,178
69,823
U.S. Treasury Debt
10,717
2,664
U.S. Treasury Repurchase Agreement
8,944
18,928
Total USD portfolio
227,301 219,331
Total portfolio
2,562,391 1,183,746
All marketable securities have a fixed interest rate but different maturities. As of March 31, 2024 all outstanding securities were
expected to mature within 13 months (2023: 13 months). The excess liquidity from the capital increase completed in January
2024, has been placed into the DKK portfolio and EUR portfolio. At maturity funds are reinvested to minimize lost interest
income from marketable securities.
23 Zealand Pharma A/S | Interim Financial Statements Q1 2024
6. Financial instruments
As of March 31, 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 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 ending March 31, 2024.
DKK thousand
Mar-31, 2024 Dec-31, 2023
Categories of financial instruments
Trade and other receivables excluding prepaid expenses
108,427
103,261
Financial assets measured at amortized cost 108,427 103,261
Marketable securities (Level 1)
2,562, 391
1,183, 746
Other investments (Level 3)
14,004
14,004
Other financial assets (Level 3)
7,734
7,375
Financial assets measured at fair value through profit and loss 2,584,129 1,205,125
Borrowings
-272,597
-
Lease liabilities
-168,572
-167,986
Trade and other payables
-259,673
-267,923
Financial liabilities measured at amortized cost -700,842 -435,909
Cash-settled warrant liability from EIB loan, Tranche A (Level 3)
-99,063
-
Financial liabilities measured at fair value through profit and loss -99,063 -
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at January 1, 2024 21,379 -
Fair value adjustments through profit and loss 359 -
Cash-settled warrant liability from EIB loan, Tranche A - -99,063
Carrying amount at March 31, 2024 21,738 -99,063
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.
The fair value adjustment of the investment in Q1, 2023 of DKK 14.7 million was a result of a reduction of the implied value per
share provided by a third-party valuation expert. No changes to fair value have been recognized in Q1, 2024, refer to note 3
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
Zealand’s existing warrant compensation programs. The warrants will become exercisable as the loan(s) is/are repaid (ignoring
24 Zealand Pharma A/S | Interim Financial Statements Q1 2024
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) the strike price being 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, iii) expected volatility (see below),
iv) expected dividend (see below) and v) the risk-free interest rate determined using a 20-year Danish government bond.
Fair value of the warrants amounted to DKK 99.1 million as of March 31, 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.
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. Due to the fact that 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, 2024 the applied volatility is 51% based on volatility for the Zealand share in the
past 5 years. Also impacting the fair value in expected dividend over the next 20 years (Level 3). As of March 31, 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 -7.6 million
▪ Expected volatility +10%, increase in fair value of DKK 6.1 million
▪ Expected dividend +0.5%, decrease in fair value of DKK -10.5 million
▪ Expected dividend +1%, decrease in fair value of DKK -19.9 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, 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.
25 Zealand Pharma A/S | Interim Financial Statements Q1 2024
7. Cash and cash equivalents
Pledges provided in relation to the revolving credit facility in Danske Bank
As security for the undrawn revolving credit facility of DKK 350 million, the Group has provided pledge over Zealand’s
designated custody accounts under management by Danske Asset Management and pledge over Zealand’s designated cash
accounts attached to the custody accounts. Zealand is required to have a minimum collateral value of 120% of the loan
commitment (DKK 420 million) held in these accounts. Zealand must also comply with a covenant on fulfilling certain
information requirements.
As of March 31, 2024 marketable securities and cash and cash equivalents held in these pledged accounts amount to DKK
1,223.5 million and DKK 3.9 million, respectively.
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.
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).
8. Share capital
DKK thousand
Mar-31, 2024 Dec-31, 2023
Share capital at start of period 58,751 51,702
Shares issued for cash 3,761 6,579
Exercise of warrants 135 470
Share capital at end of period 62,647 58,751
Total new shares in Q1, 2024 were issued at a weighted average subscription price of DKK 379.4.
New shares from exercise of warrants in Q1, 2024 were issued at a weighted average subscription price of DKK 184.1. Total
proceeds from exercise of share-based compensation amount to DKK 24.9 million.
26 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Treasury shares
As of March 31, 2024, there were 351,307 treasury shares, equivalent to 0.6% of the share capital (2023: 373,134, 0.6%). The
treasury shares are allocated to performance share units (PSUs) and restricted share units (RSUs).
As of March 31, 2024, a liability of DKK 81.0 million included in trade and other payables, comprise a bank credit relating to the
acquisition of 300,000 new treasury shares in 2023. 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 and will affect the cash flows once
settled. 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.
Potential dilutive effects
In the calculation of the diluted loss per share for Q1 2024, 1,803,912 potential ordinary shares related to share-based payment
instruments have been excluded as they are anti-dilutive (2023: 1,970,432).
9. Cash flow adjustments
DKK thousand
Q1-24 YTD Q1-23 YTD
Depreciation, amortization and impairment losses 6,618 -391
Share-based compensation expenses 18,160 14,009
Financial income -32,296 -7,437
Financial expenses 6,455 36,082
Corporate tax -1,352 414
Adjustments for non-cash items in total -2,415 42,677
DKK thousand
Q1-24 YTD Q1-23 YTD
Changes in accounts receivable 12,669 20,588
Changes in prepaid expenses -11,339 -2,650
Changes in other receivables -3,303 -6,530
Changes in inventory 5,018 14
Changes in accounts payable 3,346 -10,336
Changes in other liabilities -10,953 -40,967
Changes in working capital in total -4,562 -39,881
In Q1 2024 adjustments for financial income of DKK 32.3 million include DKK 9.7 million from accrued interest on marketable
securities, DKK 3.7 million from fair value adjustments on marketable securities and DKK 6.7 million from exchange rate
adjustments.
Adjustments for financial expenses in Q1 2023 of DKK 36.1 million included a DKK 14.7 million fair value adjustment on the
investment in Beta Bionics Inc. as well as DKK 6.3 million in amortization of loan costs related to the Oberland Capital loan.
10. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2023 Annual Report.
11. 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
27 Zealand Pharma A/S | Interim Financial Statements Q1 2024
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.
12. 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, 2024.
28 Zealand Pharma A/S | Interim Financial Statements Q1 2024
Statement by the Executive
Management and the Board of
Directors
Management
Board of Directors