Company announcement
No. 39 / 2024
1
Zealand Pharma Announces Financial
Results for the First Half of 2024.
Very strong progress across R&D pipeline followed by substantial capital raise enabling further
investments to accelerate the development programs for wholly owned obesity assets.
• Extremely encouraging weight loss and tolerability data
announced with long-acting amylin analog petrelintide
from MAD Part 2 (16-week trial)
• Impressive data from Boehringer Ingelheim’s Phase 2
clinical trial with survodutide in MASH presented at the
EASL congress in Milan, Italy
• Significant strengthening of the balance sheet with
completion of upsized equity offering raising gross
proceeds of DKK 7 billion / USD 1 billion, which enables
further investments to accelerate the development of
our differentiated obesity assets resulting in a guidance
update of net operating expenses to DKK 1.25 – 1.35
billion for 2024
Copenhagen, Denmark, August 15, 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 six months ended June 30, 2024, and
provided a corporate update.
Phenomenal first half of 2024 with impressive
data in obesity followed by one of the
strongest ever capital raises in Europe
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“I am very pleased with our progress in the first six months
of 2024 that included impressive data across the obesity
portfolio. In particular, the 16-week data with petrelintide
reaffirmed our conviction in our amylin analog as an
alternative to GLP-1RA-based therapies with potential to
become the future backbone therapy for weight
management. Looking into the second half of the year, we
have an important data read-out for dapiglutide and
potential approvals in the US for both our rare disease
programs. Backed by a very solid financial position following
the extraordinary capital raise in June, we are investing
significantly in our differentiated obesity candidates to
accelerate the development programs as we explore
partnership opportunities.”
Key financial results for H1 2024
DKK million
H1 2024
H1 2023
Revenue
49.2
24.0
Net operating expenses
1
-558.7
-388.1
Net operating result
-523.5
-364.0
Net financial items
-0.5
-152.3
DKK million
Jun-30,
2024
Dec-31,
2023
Cash position
2
9,747.7
1,633.1
Notes:
1. Net operating expenses consist of R&D, S&M, G&A and other
operating items.
2. Cash position includes cash, cash equivalents and marketable
securities. Revolving Credit Facility is not included.
Highlights in the second quarter 2024
Obesity
• Petrelintide, amylin analog: Reported positive topline
data from the 16-week multiple ascending dose (MAD)
trial, Part 2 of the Phase 1b trial. Topline results showed
mean body weight reductions of up to 8.6% after 16
weeks with once-weekly dosing of petrelintide using a
dose escalation scheme, versus 1.7% mean body weight
reduction for the pooled placebo group. 79% of the 48
trial participants were male and median BMI was 29
kg/m
2
. Petrelintide was very well tolerated, with no
serious or severe adverse events (AEs). All gastrointestinal
(GI) AEs were mild, except for two moderate events
(nausea and vomiting) reported in one participant who
discontinued treatment. No other trial participants
discontinued treatment due to AEs. No other events of
vomiting occurred, and two events of diarrhea were
reported, both of which were mild.
• Dapiglutide, GLP-1/GLP-2 receptor dual agonist:
Reported topline data from the mechanistic investigator-
led trial DREAM with low doses of dapiglutide. Topline
results showed mean weight loss of up to 4.3% after 12
Company announcement
No. 39 / 2024
2
weeks with low doses of dapiglutide treatment.
Dapiglutide was assessed to be well tolerated, with no
treatment emergent adverse events (TEAEs) leading to
treatment discontinuation and fewer GI 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. Higher doses of
dapiglutide are being investigated in the ongoing Phase
1b trial, with topline results from Part 1 of the trial
exploring doses of dapiglutide up to 13 mg over 13
weeks of treatment expected in the second half of 2024.
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.
MASH
• Survodutide, glucagon/GLP-1 receptor dual agonist:
Boehringer Ingelheim presented breakthrough results at
the EASL congress from Phase 2 trial in MASH. The
detailed results showed that 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 metabolic dysfunction-
associated steatohepatitis (MASH) after 48 weeks of
survodutide treatment, versus 25.8% with placebo.
Survodutide demonstrated safety data consistent with
GLP-1RA-based molecules, with no new safety data
concerns. Boehringer Ingelheim confirmed that
survodutide will advance into Phase 3 for the potential
treatment of MASH.
Financial
• Solid financial position. Completed an upsized equity
offering of 8.35 million new ordinary shares raising gross
proceeds of USD 1 billion / DKK 7 billion representing
one of the strongest ever capital raises in Europe. The
net proceeds will support the advancement of Zealand’s
proprietary obesity programs in Phase 2b clinical trials
and beyond, including investments in associated CMC
activities and additional clinical development activities in
related indications. The net proceeds will also support
continued early-stage research and fund general
corporate purposes.
Events after the reporting date
Type 1 diabetes
• Zegalogue® (dasiglucagon injection for severe
hypoglycemia) approval in the EU. The European
Commission granted marketing authorization for
dasiglucagon injection for the treatment of severe
hypoglycemia in adults, adolescents and children aged
six years or older with diabetes in Europe under the
brand name Zegalogue®. Zegalogue® is licensed to
Novo Nordisk who is responsible for commercialization
worldwide.
Corporate
• Appointed Eric Cox as Chief Commercial Officer. Eric
will lead Zealand’s commercial strategy and assume
responsibility for business development.
Financial
• Terminated the Revolving Credit Facility provided by
Danske Bank. The Revolving Credit Facility of DKK 350
million provided by Danske Bank was terminated in July
2024 following the equity offering in June 2024 that
resulted in a cash position of DKK 9.7 billion as of June
30, 2024.
Upcoming events in 2024
Obesity
• Petrelintide, amylin analog. Detailed results from Part 2
of the MAD trial to be presented at a scientific congress
in the coming months. In the second half of 2024,
Zealand expects to initiate the Phase 2b program with
petrelintide in people with overweight or obesity.
• Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In
the second half of 2024, Zealand expects to report
topline results from Part 1 of the Phase 1b dose titration
trial, evaluating doses of dapiglutide treatment up to 13
mg and thus significantly higher doses compared to the
prior 4-week MAD trial and the investigator-led trial
DREAM. Based on the tolerability profile observed to
date, a cohort (Part 2 of the Phase 1b trial) evaluating
even higher doses up to 26 mg and with 28 weeks of
treatment has been added, with topline results
expected in the first half of 2025. The added cohort will
have no impact on the expected timing for initiation of
a Phase 2b trial in the first half of 2025.
• Survodutide in MASH. In the second half of 2024,
Boehringer Ingelheim is expected to initiate the Phase 3
program with survodutide in MASH. The Phase 3
program with survodutide in obesity, SYNCHRONIZE
TM
,
was initiated in 2023.
Rare diseases
• Glepaglutide in SBS. US FDA has set a Prescription Drug
User Fee Act (PDUFA) date on December 22, 2024. In
parallel with the regulatory review process, Zealand is
Company announcement
No. 39 / 2024
3
engaging in partnership discussions for future
commercialization.
• Dasiglucagon in CHI. US FDA has set a PDUFA date on
October 8, 2024 for Part 1 of the NDA review related to
dosing of up to three weeks. For Part 2 of the NDA
review, which relates to use beyond three weeks, the US
FDA requested additional analyses from existing
continuous glucose monitoring (CGM) datasets, which
Zealand expects to submit in the second half of 2024.
CGM was included as a secondary outcome measure in
the Phase 3 program. 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.
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
• Following the capital raise in June 2024, our significantly
strengthened cash position provides a unique
opportunity to accelerate the development programs of
our differentiated obesity assets.
• Guidance updated compared to February 27, 2024
DKK million
2024
Guidance
(15 August)
2024
Guidance
(27 February)
Revenue anticipated
from existing and
new license and
partnership
agreements
No guidance due
to uncertain size
and timing
No guidance due
to uncertain size
and timing
Net operating
expenses
3
1,250-1,350
1,100-1,200
Notes:
3. Financial guidance based on foreign exchange rates as of August 15,
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 six 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.
To receive telephone dial-in information and a unique
personal access PIN, please register at
https://register.vevent.com/register/BI317d27d63df44f09b
ded2febfbe6b52a. The live listen-only audio webcast of the
call and accompanying slide presentation will be accessible
at https://edge.media-server.com/mmc/p/ya97oe47.
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
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
Company announcement
No. 39 / 2024
4
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. 39 / 2024
5
R&D Pipeline
Therapeutic area
Product candidate
a
Obesity Dapiglutide (GLP-1R/GLP-2R dual agonist) Obesity
Petrelintide (amylin analog) Obesity
ZP6590 (GIP receptor agonist) Obesity
Survodutide (GCGR/GLP-1R dual agonist)
b
Obesity and MASH
Rare diseases Dasiglucagon: S.C. continuous infusion Congenital hyperinsulinism
Glepaglutide (GLP-2 analog) Short bowel syndrome
Inflammation ZP9830 (Kv1.3 ion channel blocker)
Undisclosed
ZP10068 (complement C3 inhibitor)
Undisclosed
Type 1 diabetes Dasiglucagon: bi-hormonal artificial pancreas systems T1DM management
Dasiglucagon: mini-dose pen T1DM exercise-induced hypoglycemia
a
Investigational compounds whose safety and efficacy have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
Partnered
b
Survodutide is licensed to Boehringer Ingelheim from Zealand Pharma, w ith Boehringer solely responsible for development and commercialization globally (subject to Zealand's co-promotion rights
in the Nordic countries): EUR 315 million outstanding potential development, regulatory and commercial milestones + high single to low double digit % royalties on global sales.
GCGR=glucagon receptor; GIP=gastric inhibitory polypeptide; GLP-1R=glucagon-like peptide-1 receptor; GLP-2=glucagon-like peptide-2; GLP-2R=glucagon-like peptide-2 receptor; MASH=metabolic
dysfunction-associated steatohepatitis (formerly NASH, or nonalcoholic steatohepatitis); SC=subcutaneous; T1DM=type 1 diabetes mellitus.
Pre-clinical
Phase 1
Phase 2
Phase 3
Registration
Company announcement
No. 39 / 2024
6
Obesity
Petrelintide (long-acting amylin analog)
Second quarter 2024 update:
• Announced positive topline results from MAD Part 2
(16-week trial).
Background:
Petrelintide (formerly ZP8396) is a long-acting amylin analog
that reduces food intake by restoring leptin sensitivity and
increasing satiety, in contrast to GLP-1RAs that reduce food
intake by suppressing appetite. The molecule is designed to
improve solubility, minimize fibrillation, and allow for co-
formulation with other peptides, including GLP-1RA-based
molecules. Petrelintide holds potential as a next-generation,
best-in-class alternative to GLP-1RA-based therapies for the
treatment of overweight and obesity, targeting weight loss
comparable with GLP-1RA-based therapies but with
significantly improved tolerability.
In the second half of 2024, Zealand expects to initiate a
large, comprehensive Phase 2b trial with petrelintide in
people with overweight or obesity.
Zealand conducted a Phase 1b, randomized, multiple
ascending dose (MAD) clinical trial of petrelintide in normal
weight and overweight healthy participants
(ClinicalTrials.gov ID: NCT05613387). The MAD trial
consisted of Part 1 and Part 2. Part 1 included 20 participants
(eligible BMI 21.0–29.9) receiving six once-weekly
subcutaneous doses of petrelintide or placebo. Part 2
included 48 participants (eligible BMI 27.0–39.9) receiving 16
once-weekly doses of petrelintide or placebo using a dose
up-titration scheme. Part 1 results were presented at the
Obesity Society Annual Meeting (ObesityWeek) in October
2023. Low doses of 0.6 mg and 1.2 mg petrelintide
administered once weekly for six weeks led to 5.3% and 5.1%
mean weight loss from baseline in enrolled participants
(mean body weight of 82 kg and BMI of 25.4). In the 6-week
trial, petrelintide was judged to be well tolerated, with no
serious or severe adverse events and no withdrawals. The
most common adverse events were related to the
gastrointestinal system, such as nausea. All gastrointestinal
side effects were mild, and most occurred within two days
of the first dose. Based on the mild adverse event profile,
Zealand initiated Part 2 of the MAD trial, exploring higher
doses of petrelintide over 16 weeks using a dose up-titration
scheme, with topline results reported in June 2024.
In Part 2 of the MAD trial, 48 participants were randomized
(3:1) within three dose cohorts using dose escalation to
reach different maintenance doses, administered 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. Petrelintide was well tolerated, with
no serious or severe adverse events. All gastrointestinal
adverse events were mild, except for two moderate events
(nausea and vomiting) reported in one participant who
discontinued treatment. No other participants discontinued
treatment due to AEs. No other events of vomiting occurred,
and two events of diarrhea were reported, both of which
were mild. Detailed results from Part 2 of the MAD trial will
be presented at a scientific congress in the coming months.
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)
Second quarter 2024 update:
• Announced topline results from investigator-led trial
DREAM.
Background:
Dapiglutide is a long-acting, dual GLP-1R/GLP-2R agonist for
the potential treatment of obesity. This is a first-in-class
peptide designed to leverage the weight loss effects of a
potent GLP-1 agonist and address co-morbidities associated
with low-grade inflammation through improved intestinal
barrier function by GLP-2.
Zealand has to date reported results 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. In the second half of
2024, Zealand expects to report topline data from a
company-sponsored 13-week Phase 1b dose titration trial,
evaluating significantly higher doses of dapiglutide
compared to the prior 4-week Phase 1 trial and the
investigator-led trial DREAM.
Zealand initiated the 13-week randomized, double-blind,
placebo-controlled, dose titration trial (ClinicalTrials.gov ID:
NCT06000891) to evaluate higher doses of dapiglutide in
Company announcement
No. 39 / 2024
7
overweight or obese but otherwise healthy people (eligible
BMI 27.0–39.9). The trial is currently evaluating doses of
dapiglutide up to 13 mg, which is 2 to 3 times higher than
the doses investigated in the prior 4-week Phase 1 trial and
the investigator-led trial DREAM. However, based on the
mild tolerability profile observed to date, Zealand has
amended the trial to include an additional cohort to
investigate even higher doses up to 26 mg over a treatment
duration of 28 weeks. Results from this added cohort will be
reported in the first half of 2025 but with no impact on the
expected timing for initiation of a Phase 2b trial in the first
half of 2025 as well.
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. 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
Second quarter 2024 update:
• Boehringer Ingelheim presented detailed results from
Phase 2 trial in MASH at the EASL congress.
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).
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.
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
Company announcement
No. 39 / 2024
8
of survodutide in one of four dose groups or placebo and
included 20 weeks of dose escalation and 26 weeks of
maintenance. Based on the planned maintenance dose
assigned at randomization regardless of whether the
planned dose was reached during the dose escalation
phase, survodutide achieved up to 14.9% mean weight loss
from baseline after 46 weeks. An analysis based on the
actual maintenance dose regardless of assignment at
randomization, showed up to 18.7% mean weight loss after
46 weeks. Bodyweight reductions with survodutide had not
reached a plateau at week 46, suggesting additional weight
loss could be achieved with longer treatment duration. Up
to 40% of people who reached the highest two doses of
survodutide, 3.6 mg and 4.8 mg, achieved a weight loss of
at least 20%.
Serious adverse events were reported by 4.2% of participants
on survodutide versus 6.5% of those on placebo. Treatment
discontinuation due to adverse events occurred in 24.6%
and 3.9% of participants on survodutide and placebo,
respectively, mainly due to gastrointestinal adverse events.
Most treatment discontinuations due to adverse events
occurred during the rapid 20-week dose-escalation phase
with up-titration every second week. Thus, the safety and
tolerability profile of survodutide was in line with other
incretin-based pharmacotherapies. The treatment
discontinuation rate of survodutide was also roughly similar
to the treatment discontinuation rates seen with other
incretin-based pharmacotherapies in previous Phase 2 trials
in type 2 diabetes and obesity. Boehringer Ingelheim and
Zealand Pharma expect that treatment discontinuations due
to adverse events can be mitigated with more gradual dose
escalation over a longer duration in Phase 3. The detailed
results from the Phase 2 trial were presented at the ADA 83
rd
Scientific Sessions in June 2023. Additional data, presented
at the 59
th
Annual Meeting of the European Association for
the Study of Diabetes (EASD) in October 2023,
demonstrated reductions in absolute waist circumference
(up to 16.0 cm), absolute body weight (up to 19.5 kg) and
absolute systolic and diastolic blood pressure (up to 8.6
mmHg and 4.8 mmHg, respectively).
A second Phase 2 randomized, placebo-controlled, double-
blind trial evaluated survodutide in people with type 2
diabetes on stable metformin background therapy
(ClinicalTrials.gov ID: NCT04153929). Participants received
multiple rising doses of survodutide in one of six dose
groups, placebo or open-label weekly semaglutide 1.0 mg
for 16 weeks. Treatment with survodutide led to dose-
dependent decreases in HbA1c, with mean reductions of -
0.93% to -1.88% at 16 weeks across the six dose groups,
compared with -0.25% seen with placebo. Treatment with
open-label weekly semaglutide at 1.0 mg led to a decrease
in HbA1c of -1.47%. Boehringer Ingelheim presented these
results at the 58th Annual Meeting of the European
Association for the Study of Diabetes (EASD) in September
2022.
A third Phase 2 trial assessed survodutide in metabolic
dysfunction-associated steatohepatitis (MASH), formerly
known as non-alcoholic steatohepatitis (NASH), and liver
fibrosis stages F1/F2/F3 (ClinicalTrials.gov ID:
NCT04771273). The double-blind, placebo-controlled trial
studied three doses of survodutide at 2.4 mg, 4.8mg and 6.0
mg. At the highest dose, 83.0% of adults treated with
survodutide achieved a biopsy-proven improvement in
MASH after 48 weeks without worsening of fibrosis stages
F1, F2 and F3 (mild to moderate or advanced scarring),
versus 18.2% with placebo [response difference: 64.8% (CI
51.1% - 78.6%), p<0.0001]. Survodutide also met all
secondary endpoints, including a statistically significant
improvement in liver fibrosis. The detailed results were
presented at the European Association for the Study of the
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 the Phase
3 program in people with overweight or obesity
(SYNCHRONIZE
TM
). Boehringer Ingelheim have confirmed
that they expect to initiate a Phase 3 program with
survodutide in MASH.
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)
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.
Company announcement
No. 39 / 2024
9
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
reported in December 2020 showed that dasiglucagon on
top of standard of care (SOC) did not significantly reduce
the rate of hypoglycemia compared to SOC alone when
assessed by the primary endpoint, intermittent self-
measured plasma glucose. However, dasiglucagon
treatment resulted in a 40–50% reduction in hypoglycemia
compared to SOC alone, when assessed by blinded
continuous glucose monitoring.
The Phase 3 trial 17106 (ClinicalTrials.gov ID: NCT03941236)
is evaluating the long-term safety of dasiglucagon in 42 of
the 44 children older than 1 month with CHI who completed
either of the Phase 3 trials 17103 or 17109.
Glepaglutide (long-acting GLP-2 analog) for short bowel
syndrome (SBS)
Background:
Glepaglutide is a long-acting GLP-2 analog that is stable in
aqueous solution. Zealand is developing glepaglutide as a
ready-to-use, fixed dose product designed for
subcutaneous delivery via auto-injector for the potential
treatment of SBS. The Phase 3 program, named EASE,
includes four clinical trials evaluating the potential for
glepaglutide to reduce or eliminate the need for parenteral
support in SBS patients with intestinal failure. Efficacy and
safety data from these trials formed the basis of an NDA
submission to the US FDA in December 2023. The FDA has
granted a PDUFA date on December 22, 2024 for
glepaglutide in SBS with intestinal failure. The FDA has also
granted orphan drug designation to glepaglutide for the
treatment of SBS.
EASE-1 (ClinicalTrials.gov ID: NCT03690206) is a
randomized, double-blind Phase 3 trial that enrolled a total
of 106 SBS patients with intestinal failure who were
dependent on parenteral support for at least three days per
week. Patients were evenly randomized to receive
treatment with 10 mg glepaglutide administered either once
or twice weekly, or placebo. The primary endpoint in the trial
was the absolute change in weekly parenteral support
volume from baseline at 24 weeks.
In EASE-1, glepaglutide given twice weekly significantly
reduced the total weekly volume of parenteral support at 24
weeks as compared to placebo (p=0.0039). When
Company announcement
No. 39 / 2024
10
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.
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
discontinued development of ZP10068 citing business
reasons and is currently in the process of transferring the
asset to Zealand. Zealand will subsequently evaluate the
potential next steps for ZP10068.
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,
Company announcement
No. 39 / 2024
11
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.
12 Zealand Pharma A/S | Interim Financial Statements H1 2024
Financial highlights and key
figures.
Financial highlights (DKK thousand) Note
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Revenue 2 34,131 10,407 49,220 24,036
Cost of goods sold -9,489 - -14,085 -
Gross profit 24,642 10,407 35,135 24,036
Research and development expenses -211,516 -155,564 -402,451 -297,827
Sales and marketing expenses -12,435 -7,135 -21,678 -11,751
General and administrative expenses -68,369 -48,275 -134,523 -90,759
Other operating items - 5,202 - 12,263
Net operating expenses -292,320 -205,772 -558,652 -388,074
Operating result -267,678 -195,365 -523,517 -364,038
Net financial items 3 -26,390 -125,685 -548 -152,334
Result before tax -294,068 -321,050 -524,065 -516,372
Corporate tax 1,316 1,548 2,667 3,239
Net result for the period -292,752 -319,502 -521,398 -513,133
Loss per share, basic/diluted (DKK) -4.67 -5.50 -8.39 -9.36
Statement of financial position (DKK thousand) Note
Jun-30,
2024
Dec-31,
2023
Cash and cash equivalents 7 7,155,313 449,311
Marketable securities 5 2,592,371 1,183,746
Cash, cash equivalents and marketable securities 9,747,684 1,633,057
Total assets 10,155,609 1,979,993
Total shareholders' equity 9,396,102 1,592,839
Cash flow (DKK thousand) Note
Q2-24 YTD Q2-23 YTD
Undrawn borrowing facilities 1) 350,000 350,000
Cash used in operating activities -455,005 -372,480
Cash used in investing activities -1,408,895 -1,260,893
Cash provided by financing activities 8,565,334 897,384
Purchase of intangible assets -990 -
Purchase of property, plant and equipment -8,625 -3,686
Free cash flow 2) -463,630 -376,166
Other Note
Jun-30,
2024
Dec-31,
2023
Share price (DKK) 892.5 373.2
Number of shares ('000 shares) 71,001 58,751
Market capitalization (mDKK) 2) 63,298 21,787
Equity ratio (%) 2) 93% 80%
Equity per share (DKK) 2) 132.48 27.28
Average number of full time employees 272 235
Number of full-time employees at the end of the period 288 253
1) In May 2023, Zealand entered a new DKK 350 million revolving credit facility provided by Danske Bank. The RCF has been terminated in Q3,
2024, refer to note 12 Subsequent events. 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.
13 Zealand Pharma A/S | Interim Financial Statements H1 2024
Financial Review.
• Net operating expenses in the first six months of 2024 of
DKK -559 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.
• Significant strengthening of balance sheet with
completion of upsized equity offering raising gross
proceeds of USD 1 billion / DKK 7 billion.
• Strengthened cash position enables further investments
in differentiated obesity assets resulting in a guidance
update of net operating expenses to DKK 1.25 – 1.35
billion for 2024.
Revenue
Revenue in the first six months of 2024 of DKK 49 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 six months
of 2024 of DKK -402 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), both
approaching Prescription Drug User Fee Act (PDUFA) dates
in the fourth quarter of 2024. The increase in research and
development expenses in the first six months of 2024
compared to the first six months of 2023 is mainly driven by
the significant clinical advancement of the obesity pipeline,
including preparations for large, comprehensive Phase 2b
trials for the wholly owned obesity assets. The Phase 2b trial
for petrelintide is expected to be initiated in the second half
of 2024.
Selling and marketing expenses of DKK -22 million in the first
six months of 2024 are mainly driven by pre-commercial
activities associated with dasiglucagon in CHI and
glepaglutide in SBS. Administrative expenses of DKK -135
million reflect additional legal expenses related to our patent
portfolio and strengthening of organizational capabilities,
also in selected corporate functions, as the company
prepares for large, comprehensive Phase 2b trials with the
wholly owned obesity assets.
Net other operating items of DKK 12 million in the first six
months of 2023 were related to a reversal of inventory write-
down associated with Zegalogue®.
Financial items
Financial items in the first six months of 2024 of DKK 0.5
million are mainly driven by interest income of DKK 39
million from the excess liquidity invested in marketable
securities and favorable exchange rate adjustments of DKK
11 million, primarily related to USD deposits. This is offset by
DKK -43 million in fair value adjustment of warrants granted
to the European Investment Bank (EIB) following
disbursement of the EUR 50 million Tranche A of the EIB
loan facility in March 2024 as well as financial expenses of
DKK -10 million related to interest expenses on the Tranche
A of the EIB loan and commitment fee relating to the
Revolving Credit Facility (RCF) of DKK 350 million provided
by Danske Bank. The significant improvement in financial
items in the first six months of 2024 compared to the first
six months of 2023 is mainly driven by the final repayment
and termination of the loan with Oberland Capital in May
2023, representing DKK -136 million in financial expenses.
Equity
On June 30, 2024, equity was DKK 9,396 million, reflecting
a significant increase compared to December 31, 2023,
mainly driven by the proceeds from the equity offering and
issuance of new shares in June 2024 and the directed issue
and private placement of new shares in January 2024. This
was partly offset by the loss for the period.
-191
-51
-66
-68
5
-48
-7
-156
Q2 2023
2
-44
-6
-197
Q3 2023
-9
-13
-190
Q4 2023
-9
Q1 2024
-12
-212
Q2 2024
-206
-245
-263 -266
-292
R&D S&M G&A Other operating items
OPEX by quarter
DKK million
14 Zealand Pharma A/S | Interim Financial Statements H1 2024
Cash position
Cash, cash equivalents and marketable securities as of June
30, 2024 was DKK 9.7 billion, reflecting a significant increase
compared to the DKK 1.6 billion in cash, cash equivalents
and marketable securities as of December 31, 2023. This
development in the first six months of 2024 is mainly driven
by the DKK 7 billion in gross proceeds from the equity
offering and issuance of new shares in June 2024 and the
DKK 1.45 billion in gross proceeds from the directed issue
and private placement of new shares in January 2024, as
well as disbursement of the EUR 50 million Tranche A of the
EIB loan facility. This was partly offset by cash used in
operating activities during the period (DKK -455 million).
As of June 30, 2024, Zealand has placed DKK 2.6 billion in
low-risk marketable securities, whereas cash and cash
equivalents amount to DKK 7.2 billion (of which DKK 6.8
billion is placed in a short-term deposit in Danske Bank with
a fixed low single digit interest). In Q3 2024, the excess
liquidity will be placed in securities in line with the
company’s treasury policy.
For further information on the capital increases in January
2024 and June 2024, the EIB loan, and the RCF, please refer
to notes 7 and 8.
Zealand’s cash is intended to:
• Advance the proprietary obesity programs in Phase 2b
clinical trials and beyond, including investment in CMC
activities, and pursue clinical development in related
indications with the potential to provide additional
therapeutic benefit to patients.
• Support the regulatory review process of the late-stage
rare disease assets and pursue strong strategic partners
for future commercialization.
• Progress additional peptide candidates from non-clinical
development into early clinical development.
• Continue the early discovery and research to develop
additional peptide candidates.
• Strengthen corporate functions and IT infrastructure.
Events after the reporting date
The Revolving Credit Facility of DKK 350 million provided by
Danske Bank was terminated in July 2024 following the
equity offering in June 2024 resulting in a cash position of
DKK 9.7 billion.
Outlook for the year
Following the capital raise in June 2024, the company’s
significantly strengthened cash position provides a unique
opportunity to expand the depth and breadth of the
development programs for the wholly owned obesity assets.
This results in a guidance update on net operating expenses
for the year 2024 from previously DKK 1.1 – 1.2 billion to now
DKK 1.25 – 1.35 billion.
1. Cash position includes cash, cash equivalents and marketable securities.
Revolving Credit Facility of DKK 350 million provided by Danske Bank was
terminated in July 2024 and not included in this chart, refer to note 12 on
Subsequent events.
2. EIB loan Tranches B and C (EUR 20 million each) are excluded from this
chart. The two tranches are subject to pre-specified milestones being met.
Cash position compared to FY23
DKK million
1,184
2,593
1,427
7,155
449
Cash
position
Dec-
2023
1,2
-455
Cash flow
from
operating
activities
-19
Other cash
adjustments
Net
proceeds
from capital
increase
January
2024
373
Proceeds
from EIB
loan
(Tranche A)
in March,
2024
6,789
Net
proceeds
from capital
increase
June 2024
Cash
position
Jun-2024
1,2
1,633
9,748
Cash and cash equivalents
Marketable securities
15 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim financial statements.
Unaudited interim condensed consolidated financial statements for H1 2024:
Interim statement of loss ...................................................................................................................................................................................... 16
Interim statement of comprehensive loss ......................................................................................................................................................... 17
Interim statement of financial position .............................................................................................................................................................. 18
Interim statement of cash flow ............................................................................................................................................................................ 19
Interim statement of changes in equity ............................................................................................................................................................. 20
Notes to the interim condensed consolidated financial statements. ............................................................................................................ 21
1. Basis of preparation and changes to the Group’s accounting policies ................................................................................................. 21
2. Revenue ................................................................................................................................................................................................................ 22
3. Financial items ..................................................................................................................................................................................................... 23
4. Trade and other receivables ............................................................................................................................................................................ 24
5. Marketable securities ......................................................................................................................................................................................... 25
6. Financial instruments ......................................................................................................................................................................................... 26
7. Cash and cash equivalents ............................................................................................................................................................................... 28
8. Share capital......................................................................................................................................................................................................... 28
9. Cash flow adjustments ...................................................................................................................................................................................... 29
10. Capital Management ....................................................................................................................................................................................... 29
11. Contingent assets and liabilities ..................................................................................................................................................................... 30
12. Significant events after the reporting period .............................................................................................................................................. 30
Statement by the Executive Management and the Board of Directors ......................................................................................................... 31
16 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim statement of loss.
DKK thousand Note
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Revenue 2 34,131 10,407 49,220 24,036
Cost of goods sold -9,489 - -14,085 -
Gross profit 24,642 10,407 35,135 24,036
Research and development expenses -211,516 -155,564 -402,451 -297,827
Sales and marketing expenses -12,435 -7,135 -21,678 -11,751
General and administrative expenses -68,369 -48,275 -134,523 -90,759
Other operating income - 5,202 - 12,263
Net operating expenses -292,320 -205,772 -558,652 -388,074
Operating result -267,678 -195,365 -523,517 -364,038
Financial income 3 31,152 11,760 63,448 19,197
Financial expenses 3 -57,542 -137,445 -63,996 -171,531
Result before tax -294,068 -321,050 -524,065 -516,372
Corporate tax 1,316 1,548 2,667 3,239
Net result for the period -292,752 -319,502 -521,398 -513,133
Loss per share, basic/diluted (DKK) -4.67 -5.50 -8.39 -9.36
17 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim statement of comprehensive
loss.
DKK thousand Note
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Net result for the period -292,752 -319,502 -521,398 -513,133
Other comprehensive income/loss
Items that will be reclassified to income statement when
certain conditions are met (net of tax):
Exchange differences on translation of foreign operations -60 -26 -44 3,759
Total comprehensive result for the period -292,812 -319,528 -521,442 -509,374
18 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim statement of financial position.
DKK thousand Note
Jun-30, 2024 Dec-31, 2023
Assets
Intangible assets 11,976 12,255
Property, plant and equipment 50,362 47,047
Right-of-use assets 95,974 102,805
Other investments 6 14,058 14,004
Corporate tax receivable 2,750 -
Deferred tax assets 955 925
Other receivables 4 8,900 15,794
Marketable securities 5
Other financial assets 6 8,007 7,375
Total non-current assets 1,007,918 200,205
Inventory 803 7,935
Trade and other receivables
4
Corporate tax receivable 11,055 16,437
Marketable securities 5 1,777,435 1,183,746
Cash and cash equivalents 7 7,155,313 449,311
Total current assets 9,147,691 1,779,788
Total assets 10,155,609 1,979,993
Shareholders' equity and liabilities
Share capital 8 71,001 58,751
Share premium 14,678,067 6,406,225
Currency translation reserve 22,660 22,704
Accumulated losses -5,375,626 -4,894,841
Total shareholders' equity 9,396,102 1,592,839
Borrowings 6 276,790 -
Derivative financial liabilities 6 142,215 -
Lease liabilities 83,350 102,575
Total non-current liabilities 502,355 102,575
Lease liabilities 29,854 16,655
Trade and other payables 227,298 267,924
Total current liabilities 257,152 284,579
Total liabilities 759,507 387,154
Total shareholders' equity and liabilities 10,155,609 1,979,993
19 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim statement of cash flow.
DKK thousand Note
Q2-24 YTD Q2-23 YTD
Net result for the period -521,398 -513,134
Adjustment for other non-cash items 9 51,875 180,147
Changes in working capital 9 4,464 -35,053
Financial income received 18,132 15,665
Financial expenses paid -13,556 -20,341
Corporate taxes received 5,478 236
Cash flow used in operating activities -455,005 -372,480
Proceeds from sale of marketable securites 5 920,784 204,744
Purchase of marketable securities 5 -2,320,064 -1,461,951
Purchase of intangible assets -990 -
Purchase of property, plant and equipment -8,625 -3,686
Cash flow used in investing activities -1,408,895 -1,260,893
Proceeds from borrowings 7 369,867 -
Repayment of borrowings - -525,764
Lease installments -7,676 -6,351
Proceeds from issuance of shares 7 8,492,752 1,500,000
Purchase of treasury shares 8 -81,030 -41,600
Proceeds from issuance of shares related to exercise of share-based
compensation
8 25,541 42,422
Costs related to issuance of shares -234,120 -71,323
Cash flow from financing activities 8,565,334 897,384
Increase/decrease in cash and cash equivalents 6,701,435 -735,989
Cash and cash equivalents at beginning of period 449,311 1,069,234
Exchange rate adjustments 4,567 -5,559
Cash and cash equivalents at end of period 7,155,313 327,686
20 Zealand Pharma A/S | Interim Financial Statements H1 2024
Interim statement of changes in equity.
DKK thousand
Share
capital
Share
premium
Currency
translation
reserve
Accumu-
lated losses
Total
Equity at January 1, 2024 58,751 6,406,225 22,704 -4,894,841 1,592,839
Net result for the period - - - -521,398 -521,398
Other comprehensive loss for the period - - -44 - -44
Total comprehensive income - - -44 - 521,398 -521,442
Transactions with owners:
Exercise of warrants 138 25,403 - - 25,541
Share-based compensation expenses - - - 40,613 40,613
Capital increases 12,112 8,480,559 - - 8,492,671
Costs related to capital increases - -234,120 - - -234,120
Equity at June 30, 2024 71,001 14,678,067 22,660 -5,375,626 9,396,102
Equity at January 1, 2023 51,702 4,921,232 14,617 -4,171,640 815,911
Net result for the period - - - -513,134 -513,134
Other comprehensive income for the period - - 3,759 - 3,759
Total comprehensive income - - 3,759 -513,134 -509,375
Transactions with owners:
Purchase of treasury shares - - - -81,045 -81,045
Exercise of warrants 301 32,865 - - 33,166
Share-based compensation expenses - - - 30,935 30,935
Capital increases 6,638 1,502,528 - - 1,509,166
Costs related to capital increases - -71,323 - - -71,323
Equity at June 30, 2023 58,641 6,385,302 18,376 -4,734,884 1,727,435
21 Zealand Pharma A/S | Interim Financial Statements H1 2024
Notes to the interim condensed
consolidated financial statements.
1. Basis of preparation and changes to the Group’s accounting policies
Basis of preparation
The interim condensed consolidated financial statements of Zealand Pharma A/S (The Group) have been prepared in
accordance with IAS 34, Interim Financial Reporting, as adopted by EU and additional requirements of the Danish Financial
Statements Act. The interim condensed consolidated financial statements are presented in Danish kroner (DKK) which is also
the functional currency of the parent company.
The accounting policies used in the interim condensed consolidated financial statements are consistent with those used in the
Group’s annual financial statement for the year ended December 31, 2023.
Going concern assessment
Management’s judgement and assessment of the Group’s ability to continue as a going concern includes evaluation of the
Group's operational cash flow requirements for the forthcoming 12 months from the balance sheet date and future sources
and uses of cash. Following the capital increases completed in January 2024 and June 2024 the Group received gross
proceeds of DKK 1.45 billion and DKK 7.0 billion, respectively. On this basis the interim condensed consolidated financial
statements are prepared using the going concern assumption.
New standards, interpretations and amendments adopted by the Group
Several amendments apply for the first time in 2024, but do not have an impact on the interim condensed consolidated
financial statements of the Group. The Group has not early adopted any standard, interpretation or amendment that has been
issued but is not yet effective.
Significant accounting estimates and judgements
The preparation of the interim condensed consolidated financial statements requires Management to make judgments and
estimates that affect the reported amounts of revenues, expenses, assets and liabilities, and the accompanying disclosures. In
applying our accounting policies, Management is required to make judgements and estimates about the carrying amounts of
assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on
historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The
estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in
the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future
periods if the revision affects both current and future periods.
The estimates used are based on assumptions assessed to be reasonable by Management. However, estimates are inherently
uncertain and unpredictable. The assumptions may be incomplete or inaccurate, and unexpected events or circumstances may
occur. Furthermore, we are subject to risks and uncertainties that may result in deviations in actual results compared with
estimates.
Except for the items listed below, no material changes in significant accounting estimates and judgements have occurred since
the Annual Report 2023. Please refer to note 1.3 in the 2023 Annual Report for further information:
• Estimate of fair value of cash-settled warrant liability from disbursement of EIB loan, Tranche A (Borrowings including
derivative financial liabilities). Refer to note 6. Financial instruments.
• Judgement on milestone payment from Novo Nordisk (Revenue). Refer to note 2. Revenue.
22 Zealand Pharma A/S | Interim Financial Statements H1 2024
2. Revenue
Revenue can be specified as follows:
DKK thousand
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Alexion Pharmaceuticals Inc. 163 914 249 2,704
Novo Nordisk A/S 24,479 9,493 34,886 21,332
Total revenue from license and collaboration agreements
24,642 10,407 35,135 24,036
Product sales 9,489 - 14,085 -
Sale of goods revenue
9,489 - 14,085 -
Total revenue 34,131 10,407 49,220 24,036
Total revenue recognized over time 9,643 10,408 20,135 23,310
Total revenue recognized at a point in time 24,489 - 29,086 726
DKK thousand
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Milestone revenue 15,000 - 15,000 -
Royalty revenue 216 210 477 444
Reimbursement revenue for R&D services 9,426 9,471 19,658 22,866
Product sales 9,489 726 14,085 726
Total revenue by revenue stream
34,131 10,407 49,220 24,036
Total revenue in Q2, 2024 year-to-date of DKK 49.2 million is driven by the license and development agreement with Novo
Nordisk A/S signed in September 2022. For further information on the above agreements refer to note 2.1 in the 2023 Annual
Report.
On May 31, 2024, the Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing
authorization for Zegalogue
©
triggering DKK 15 million in milestone payments from Novo Nordisk A/S. Based on this it is
Management’s judgement that the two milestone payments (each of DKK 7.5 million) are no longer constrained and that it is
highly probable that a significant revenue reversal will not occur.
23 Zealand Pharma A/S | Interim Financial Statements H1 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
Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
Interest income 18,764 13,038 38, 538 17,747
Interest expenses from financial liabilities measured at
amortized cost
-10,131 -8,940 -15,651 -21,388
Interest expenses from lease liabilities -658 - -1,342 -
Loss on settlement of borrowings, including embedded
derivatives under Oberland loan
- -135,588 - -135,588
Fair value adjustment of lender's call option - -1,128 - 1,161
Gain from sale of marketable securities 3,556 - 3,981 -
Fair value adjustment of marketable securities 5,638 -100 9,345 289
Fair value adjustment of other investments 329 229 686 -14,519
Fair value adjustment of other financial assets - -50 - -
Fair value adjustments warrants, EIB (Tranche A) -43,153 - -43,153 -
Exchange rate adjustments 2,865 6,854 10,898 -36
Other financial expenses -3,600 - -3,850 -
Financial items in total -26,390 -125,685 -548 -152,334
Presentation in income statement:
Financial income 31,152 11,760 63,448 19,197
Financial expenses -57,542 -137,445 -63,996 -171,531
Interest income in Q2, 2024 year-to-date of DKK 38.5 million is significantly higher compared to Q2, 2023 year-to-date (DKK
17.7 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 Q2, 2024 year-to-date of DKK 10.0 million relates to
the EIB loan (Tranche A) disbursed on March 11, 2024 and commitment fee from the DKK 350 million credit facility in Danske
Bank, with the latter terminated in Q3, 2024 as described in note 12. Significant events after the reporting period. The decrease
in interest expenses compared to Q2, 2023 year-to-date (DKK 20.4 million) is a result of the settlement of the Oberland Capital
loan in May, 2023.
Fair value adjustment on other investments of DKK -14.5 million in Q2, 2023 year-to-date comprises the accounting impact of
the investment in Beta Bionics, refer to note 6. Financial instruments for further information on the investment.
Fair value adjustment of warrants, EIB (Tranche A) of DKK -43.2 million in Q2, 2024 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 6. Financial
instruments for further information.
Exchange rate adjustments primarily relate to USD deposits.
24 Zealand Pharma A/S | Interim Financial Statements H1 2024
4. Trade and other receivables
Trade and other receivables can be specified as follows:
DKK thousand
Jun-30, 2024 Dec-31, 2023
Deposits 8,900 8,908
Trade receivables 11,615 1,004
Receivables related to license and collaboration agreements 91,852 68,793
Other receivables 39,277 24,556
Prepaid expenses 60,341 34,892
Total trade and other receivables
211,985 138,153
Non-current 8,900 15,794
Current 203,085 122,359
Receivables related to license and collaboration agreements include withholding tax receivable from the Boehringer Ingelheim
(BI) milestone payment of DKK 35.6 million. Other receivables of DKK 39.3 million include accrued interest on marketable
securities and VAT receivables.
25 Zealand Pharma A/S | Interim Financial Statements H1 2024
5. Marketable securities
As of June 30, 2024, Zealand has placed DKK 2,592 million into low-risk marketable securities in line with the Group’s treasury
policy. The investments can be specified as follows:
DKK thousand
Jun-30, 2024 Dec-31, 2023
Securities/bonds in DKK portfolio
1,123,184 509,948
Securities/bonds in EUR portfolio
1,236,611
454,467
Securities/bonds in USD portfolio
232,576
219,331
Total portfolios
2,592,371 1,183,746
DKK thousand
Jun-30, 2024 Dec-31, 2023
DKK portfolio:
DK bonds
1,123, 184
509,948
Total DKK portfolio
1,123,184 509,948
EUR portfolio:
IG Corporate bonds (investment grade)
1,236, 611
454,467
Total EUR portfolio
1,236,611 454,467
USD portfolio:
Asset-backed securities
1,786 2,738
Certificates of deposit
127,684
125,178
Commercial paper
97,674
69,823
U.S. Treasury Debt
3,993
2,664
U.S. Treasury Repurchase Agreement
1,439
18,928
Total USD portfolio
232,576 219,331
Total portfolio
2,592,371 1,183,746
Non-current 814,936
-
Current 1,777, 435
1,183, 746
All marketable securities have a fixed interest rate but different maturities. As of June 30, 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. Management is still assessing how to invest the excess liquidity from the capital increase
completed in June 2024 bringing in gross proceeds of DKK 7.0 billion. Until then, the excess liquidity from the capital increase
has been placed in a locked short-term deposit in Danske Bank with a fixed low single digit interest.
26 Zealand Pharma A/S | Interim Financial Statements H1 2024
6. Financial instruments
As of June 30, 2024, and December 31, 2023, the following financial instruments are measured at fair value through profit or
loss. The fair value of marketable securities is measured using inputs categorized as Level 1, whereas fair value of other
investments and other financial assets is based on inputs categorized as Level 3 in the fair value hierarchy. Cash-settled warrant
liability is measured using significant unobservable inputs categorized as Level 3 in the fair value hierarchy.
No transfers occurred between the levels of the fair value hierarchy in the three months ending June 30, 2024.
DKK thousand
Jun-30, 2024 Dec-31, 2023
Categories of financial instruments
Trade and other receivables excluding prepaid expenses
151,644
103,261
Financial assets measured at amortized cost 151,644 103,261
Marketable securities (Level 1)
2,592, 371
1,183, 746
Other investments (Level 3)
14,058
14,004
Other financial assets (Level 3)
8,007
7,375
Financial assets measured at fair value through profit and loss 2,614,436 1,205,125
Borrowings
-276,789
-
Lease liabilities
-168,381
-167,986
Trade and other payables
-226,496
-267,923
Financial liabilities measured at amortized cost -671,666 -435,909
Cash-settled warrant liability from EIB loan, Tranche A (Level 3)
-142,215
-
Financial liabilities measured at fair value through profit and loss -142,215 -
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at January 1, 2024 21,379 -
Fair value adjustments through profit and loss 686 -
Cash-settled warrant liability from EIB loan, Tranche A - -142,215
Carrying amount at June 30, 2024 22,065 -142,215
Fair value measurement of other investments
Other investments consist of an investment in Beta Bionics, Inc., the developer of iLet™, a fully integrated dual-hormone pump
(bionic pancreas) for autonomous diabetes care.
In determining fair value, Zealand considers the value per share from the most recent closed financing round, adjusted for
valuation infliction points through the balance sheet date, including (i) discount for lack of marketability, (ii) information
obtained from third party valuation reports, and (iii) company announcements.
Fair value of the investment amounted to DKK 14.1 million as of June 30, 2024 (2023: DKK 14.0 million). The fair value
adjustment of DKK 0.1 million in Q2, 2024 year-to-date is included in financial items, 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
events as delisting, default e.g. which could also lead to exercisability). Each Tranche has a maturity date of 6 years from
27 Zealand Pharma A/S | Interim Financial Statements H1 2024
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 142.2 million as of June 30, 2024. On initial recognition in March 2024, we have
determined that the transaction price is equal to fair value and that consequently, there is no day 1 gain/loss to account for in
financial items. The warrants are subsequently measured at fair value through profit and loss (FVTPL) and adjustments are
included under financial items, refer to note 3.
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 June 30, 2024, the applied volatility is 53% 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 June 30, 2024, the applied
expected dividend yield is 0%.
An increase in volatility will increase the fair value of the warrants. Further, an increase in expected dividend will decrease the
fair value and vice versa. The below summarizes the effect of altering the unobservable inputs that would change the fair value
significantly.
▪ Expected volatility -10%, decrease in fair value of DKK -7.9 million
▪ Expected volatility +10%, increase in fair value of DKK 6.4 million
▪ Expected dividend +0.5%, decrease in fair value of DKK -14.4 million
▪ Expected dividend +1%, decrease in fair value of DKK -27.4 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 June 30, 2024, the prepayment option does not have any significant fair value.
Other fair value measurements
For information about fair value measurements of other financial assets and marketable securities, please refer to note 3.7 and
4.5 of the 2023 Annual Report.
28 Zealand Pharma A/S | Interim Financial Statements H1 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.
On April 25, 2024, Zealand received confirmation from Danske Asset Management that all registrations of pledges over the
Cash Accounts and the Custody Accounts have been removed.
Pledges provided in relation to the EIB loan
The EIB loan contains a negative pledge clause preventing Zealand Pharma A/S or any of its subsidiaries from creating or
permitting to subsist any new security over any of its assets.
Capital increase
On January 8, 2024, Zealand announced an issue of 3,761,470 new ordinary shares, which represented the remaining
authorization, at a subscription price of DKK 386.45 per new share resulting in gross proceeds of DKK 1.45 billion. The capital
increase was completed in January 2024.
As announced on June 25, 2024, the Board of Directors exercised the authorization granted by Zealand's annual general
meeting held on March 20, 2024, to increase the Group's share capital by issue of 8,350,000 new ordinary shares at a
subscription price of DKK 843 per new share bringing in gross proceeds of DKK 7 billion. The excess liquidity from the capital
increase has been placed in a locked short-term deposit in Danske Bank with a fixed low single digit interest. Management is
currently assessing how to invest the excess liquidity. The capital increase was completed in June 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
Jun-30, 2024 Dec-31, 2023
Share capital at start of period 58,751 51,702
Shares issued for cash 12,115 6,579
Exercise of warrants 135 470
Share capital at end of period 71,001 58,751
Total new shares in Q2, 2024 year-to-date were issued at a weighted average subscription price of DKK 695.4.
New shares from exercise of warrants in Q2, 2024 year-to-date were issued at a weighted average subscription price of DKK
184.9. Total proceeds from exercise of share-based compensation amount to DKK 25.5 million.
29 Zealand Pharma A/S | Interim Financial Statements H1 2024
Treasury shares
As of June 30, 2024, there were 78,349 treasury shares, equivalent to 0.1% of the share capital (2023: 373,134, 0.6%). The
treasury shares are allocated to performance share units (PSUs) and restricted share units (RSUs).
In June 2023 Zealand acquired 300,000 new treasury shares by entering a bank credit with Danske Bank. The payable amount
for treasury shares of DKK 81.0 million was recognized under equity in 2023 when Zealand acquired the 300,000 new treasury
shares. The agreement relating to the bank credit contains both a net settlement alternative and a gross settlement alternative.
Management has chosen to account for the treasury shares gross and the chosen accounting policy reflects Management’s
intention with the acquisition of the new treasury shares.
In April 2024 Zealand gross settled the payable amount of DKK 81.0 million previously included as a liability in trade and other
payables.
Potential dilutive effects
In the calculation of the diluted loss per share for Q2 2024 year-to-date, 1,816,880 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
Q2-24 YTD Q2-23 YTD
Depreciation, amortization and impairment losses 13,381 12,383
Reversal of inventory write-down - -12,263
Share-based compensation expenses 40,613 30,935
Financial income -63,448 -24,170
Financial expenses 63,997 176,502
Corporate tax -2,668 -3,239
Adjustments for non-cash items in total 51,875 180,147
DKK thousand
Q2-24 YTD Q2-23 YTD
Changes in accounts receivable -16,399 18,586
Changes in prepaid expenses -25,402 -12,465
Changes in other receivables -723 -10,134
Changes in inventory 7,132 735
Changes in accounts payable 37,305 -13,115
Changes in other liabilities 2,551 -17,324
Changes in rebate and discount liabilities - -1,336
Changes in working capital in total 4,464 -35,053
In Q2, 2024 year-to-date adjustments for financial income of DKK 63.4 million include DKK 23.7 million from accrued interest
on marketable securities, DKK 9.3 million from fair value adjustments on marketable securities and DKK 10.9 million from
exchange rate adjustments.
Adjustments for financial expenses in Q2, 2023 year-to-date of DKK 176.5 million included the loss from settlement of the
Oberland Capital loan of DKK 135.6 million as well as DKK 14.7 million fair value adjustment on the investment in Beta Bionics
Inc.
10. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2023 Annual Report.
30 Zealand Pharma A/S | Interim Financial Statements H1 2024
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
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
The Revolving Credit Facility of DKK 350 million provided by Danske Bank was terminated in July 2024 following the equity
offering in June 2024 resulting in a cash position of DKK 9.7 billion. Apart from that, no events have occurred subsequent to the
balance sheet date that could significantly affect the interim financial statements as of June 30, 2024.
31 Zealand Pharma A/S | Interim Financial Statements H1 2024
Statement by the Executive
Management and the Board of
Directors
Management
Board of Directors