Company announcement
No. 28 / 2023
1
Results for the First Half of 2023.
Strong progress across R&D pipeline and significant strengthening of the balance sheet
• Boehringer Ingelheim to move into Phase 3 trials with
GCGR/GLP-1R dual agonist survodutide (BI456906) in
obesity following positive Phase 2 data
• Encouraging weight loss and tolerability data from long-
acting amylin analog ZP8396
• Regulatory submission of NDA to the US FDA for
dasiglucagon in congenital hyperinsulinism and
submission of MAA to EMA for dasiglucagon for the
treatment of severe hypoglycemia
• Strengthened balance sheet with DKK 1.5 billion,
resulting in a runway to mid-2026
Copenhagen, Denmark, August 17, 2023 – Zealand Pharma
A/S (Nasdaq: ZEAL) (CVR-no. 20045078 ), a biotechnology
company focused on the discovery and development of
innovative peptide-based medicines, today announced the
interim report for the six months ended June 30, 2023 and
provided a corporate update.
Strong progress in obesity portfolio and
execution of regulatory submissions for
dasiglucagon
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said: "The first six months of 2023 have
been phenomenal for Zealand Pharma, with impressive
clinical data readouts from our obesity portfolio, including
presentations at ADA for survodutide and our amylin analog
ZP8396, regulatory submissions for dasiglucagon, and a
strengthened balance sheet.
“We look forward to an eventful second half of the year as
well, which we expect among other events will include the
regulatory submission to the FDA for glepaglutide in SBS, a
potential partnership agreement for dasiglucagon in CHI,
and initiation by Boehringer Ingelheim of the Phase 3
program with survodutide in obesity.”
Key financial results for H1 2023
DKK million
H1 2023
H1 2022
*
Revenue
24.0
36.3
Net operating expenses
1
-388.1
-470.5
Net operating result
-364.0
-434.1
Net financial items
-152.0
-61.8
Cash position
2
1,692
1,178
Funding available incl.
undrawn committed
RCF
3
2,042
1,178
*Comparative numbers are adjusted for discontinued operations.
Notes:
1. Net operating expenses consist of R&D, S&M, G&A and other
operating items.
2. Cash position includes cash, cash equivalents and marketable
securities.
3. RCF = Revolving Credit Facility provided by Danske Bank.
Highlights in the second quarter 2023
Obesity
• Survodutide: Presented results from Phase 2 dose-
finding clinical trial with survodutide (formerly BI
456906), a glucagon/glucagon-like peptide-1 receptor
(GCGR/GLP-1R) dual agonist, in people living with
overweight or obesity. Survodutide achieved up to 18.7%
mean weight loss from baseline after 46 weeks based on
the actual maintenance dose. Up to 40% of people who
reached the highest two doses of survodutide in the trial
achieved a weight loss of at least 20%. The safety and
tolerability profile of survodutide was in line with other
incretin-based pharmacotherapies. The data were
presented at the 2023 American Diabetes Association’s
(ADA) 83
rd
Scientific Sessions.
• ZP8396: Presented results from Phase 1a single
ascending dose (SAD) trial of long-acting amylin analog
ZP8396. Healthy participants with a mean BMI of 25.8
treated with ZP8396 had dose-dependent and sustained
reductions in mean body weight of up to 4.2% from
baseline. Placebo-treated participants had a mean body
weight increase of 0.6%. The plasma half-life of ZP8396
was approximately 10 days, which supports once-weekly
Company announcement
No. 28 / 2023
2
dose administration. ZP8396 was well tolerated in this
study, with no serious or severe adverse events (AEs) and
no withdrawals. The data were presented at the ADA 83
rd
Scientific Sessions.
• ZP8396: Initiated 16-week multiple ascending dose
(MAD) trial with long-acting amylin analog ZP8396, Part
2 of the Phase 1b trial. Based on the mild adverse event
profile observed in the 6-week Part 1 of the MAD trial,
Zealand has progressed ZP8396 into 16 weeks of dosing
to explore significantly higher exposure levels of ZP8396
using a dose up-titration scheme.
• Dapiglutide: Initiated DREAM, a Phase 2 investigator-led
clinical trial of dapiglutide, a first-in-class GLP-1/GLP-2
receptor dual agonist in people with obesity. The
DREAM trial aims to evaluate the potential for weight loss
following 12 weeks and gain key mechanistic insights
into the effects of dapiglutide on inflammatory markers.
Zealand expects the trial to complete in the first half of
2024.
Rare diseases
• Dasiglucagon (CHI): Submitted new drug application
(NDA) to the US Food and Drug Administration (FDA) for
dasiglucagon for the treatment of congenital
hyperinsulinism. The submission is based on the results
from two pivotal Phase 3 trials and interim results from
an ongoing long-term extension trial.
• Glepaglutide (SBS): Completed the interim analyses of
EASE-2, EASE-3, and EASE-4 clinical trials of glepaglutide
in patients with short bowel syndrome (SBS). Zealand
Pharma is on track to submit the NDA to the US FDA in
the second half of 2023. The submission will be based
on EASE-1 and interim results from EASE-2, EASE-3 and
EASE-4.
Type 1 diabetes
• Dasiglucagon (severe hypoglycemia): Submitted
marketing authorization application (MAA) to the
European Medicines Agency (EMA) for dasiglucagon for
the treatment of severe hypoglycemia in adults,
adolescents and children aged six years or older with
diabetes. Dasiglucagon injection was approved under
the brand name Zegalogue® by the US FDA on March
22, 2021, for the treatment of severe hypoglycemia in
pediatric and adult people with diabetes aged six years
and above. In September 2022, Zealand entered into a
global license and development agreement with Novo
Nordisk to commercialize Zegalogue®. The MAA
submission triggered a milestone payment to Zealand of
DKK 15 million.
Financing
• Strengthened balance sheet and extended runway to
mid-2026. In April, Zealand received gross proceeds of
DKK 1.5 billion from a directed issue and private
placement of 6,578,948 new shares. In May 2023,
Zealand repaid the Oberland Capital loan in full and the
loan agreement is now terminated. The repayment is
refinanced through a new undrawn Credit Facility
provided by Danske Bank and expected near-term
upcoming milestones from existing partners.
Events after the reporting date
• ZP8396: Announced topline results in July 2023 from 6-
week MAD trial with long-acting amylin analog ZP8396,
Part 1 of the Phase 1b trial. Low doses of 0.6 and 1.2 mg
ZP8396 administered once-weekly for six weeks led to
5.3% and 5.1% mean weight loss compared to 2.6%, 3.6%
and 4.2% mean weight loss following single doses of 0.7,
1.4 and 2.4 mg ZP8396, reported from the SAD trial.
Based on the mild AE profile observed in the 6-week
MAD trial, Zealand has initiated Part 2 of the MAD trial, a
16-week study exploring significantly higher doses of
ZP8396 using a dose up-titration scheme.
• Survodutide: Announced advancement into three global
Phase 3 trials in obesity. On August 17, Boehringer
Ingelheim announced their decision to advance to
Phase 3 in people living with overweight or obesity with
initiation expected in the second half of 2023.
Upcoming events next 12 months
• Glepaglutide in SBS. In the second half of 2023, Zealand
anticipates submitting an NDA to the FDA for
glepaglutide administered via autoinjector for the
treatment of SBS with intestinal failure and engage in
more detailed partnership discussions.
• Dasiglucagon in CHI. In the second half of 2023, Zealand
aims to enter into a partnership agreement for the
commercialization of dasiglucagon in CHI.
• Survodutide in obesity. Boehringer Ingelheim expects to
start enrolment of patients in the Phase 3 clinical
program with survodutide in people living with
overweight or obesity in the second half of 2023, with
details on the trials to be disclosed prior to their initiation.
• Survodutide in NASH. Boehringer Ingelheim and Zealand
Pharma expect to report topline results from the Phase
2 trial with survodutide in NASH in the first half of 2024.
Company announcement
No. 28 / 2023
3
• Dapiglutide, GLP-1/GLP-2 receptor dual agonist. Zealand
expects to initiate a 13-week dose titration trial in people
with obesity in the second half of 2023. Topline results
from the ongoing investigator-initiated Phase 2 trial
DREAM are expected in the first half of 2024.
• ZP8396, long-acting amylin analog. In the first half of
2024, Zealand expects to report topline results from the
16-week MAD trial.
• ZP6590, GIP analog. Zealand expects to complete pre-
clinical activities in 2023 and advance this program into
first-in-human clinical trials in the first half of 2024.
• ZP10068, Complement Inhibitor. Zealand expects to
complete pre-clinical activities in the second half of
2023 for the investigational long-acting complement
inhibitor. Subsequent regulatory, clinical and
development efforts will be led and conducted by
Alexion.
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects the
Kv1.3 ion channel blocker to be Phase 1-ready in the first
half of 2024 and to initiate first-in-human clinical trials in
2024.
Financial guidance for 2023
• Guidance unchanged from March 2, 2023
DKK million
2023
Guidance
2022
Actual
Revenue anticipated
from existing and new
license and partnership
agreements
No guidance due
to uncertain size
and timing
104
Net operating
expenses
4
800-900
941
Notes:
4. Financial guidance based on foreign exchange rates as of August 17,
2023.
Conference call today at 2 PM CET / 8 AM ET
Zealand’s management will host a conference call today at
2:00 PM CET / 8:00 AM ET to present results through the
first six months of 2023 followed by a Q&A session.
Participating in the call will be Chief Executive Officer, Adam
Steensberg; Chief Financial Officer, Henriette Wennicke;
and Chief Medical Officer, David Kendall. The conference
call will be conducted in English.
Telephone dial-in information and a unique personal access
PIN will be provided upon registration at
https://register.vevent.com/register/BI08d950a0d12f438da
57a04a02449f692. A live listen-only audio webcast of the
call, including an accompanying slide presentation, will be
accessible at https://edge.media-
server.com/mmc/p/5hqhqe4i. 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/.
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. that
includes Boston. 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
Company announcement
No. 28 / 2023
4
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.
Zegalogue® is a registered trademark of Novo Nordisk A/S.
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. 28 / 2023
5
R&D Pipeline
Rare diseases
Dasiglucagon for congenital hyperinsulinism (CHI)
Second quarter 2023 update:
• Submission of the NDA to the US FDA on June 30, 2023.
Background:
Dasiglucagon is a glucagon analog that is stable in aqueous
solution and is thus suitable for chronic pump use. The
Phase 3 program comprises three clinical trials evaluating
the potential for chronic dasiglucagon infusion delivered
subcutaneously via a pump to prevent hypoglycemia in
children with CHI. The FDA and the European Commission
have both granted orphan drug designation to dasiglucagon
for the treatment of CHI.
The 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,
continuous glucose monitoring (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
Therapeutic area
Product candidate
*
Rare diseases Dasiglucagon: S.C. Continuous Infusion
Congenital Hyperinsulinism
Glepaglutide (GLP-2 Analog) Short Bowel Syndrome
Obesity
Survodutide (GCGR/GLP-1R Dual Agonist)
1
Obesity, NASH and T2D
Dapiglutide (GLP-1/GLP-2 Dual Agonist) Obesity
ZP 8396 (Amylin Analog) Obesity
ZP 6590 (GIP Receptor Agonist) Obesity
Type 1 diabetes Dasiglucagon: Bi-Hormonal Artificial Pancreas Systems Type 1 Diabetes management
Dasiglucagon: Mini-Dose Pen T1D exercise-induced hypoglycemia
Inflammation
ZP 10068 (Complement C3 Inhibitor)
2
Undiscl.
ZP 9830 (Kv1.3 Ion Channel Blocker) Undiscl.
ZP 10000 (ɑ4β7 Integrin Inhibitor) IBD
2) Licensed to Alexion: USD $610 million potential development, regulatory and commercial milestones + high single to low double digits % royalties on net sales
Pre-clinical
Phase 1
Phase 2
Phase 3
Registration
*) Investigational compounds whose safety and efficacy have not been evaluated or approved by the FDA or any other regulatory authority
1) Co-invented by Boehringer Ingelheim and Zealand: EUR 345 million outstanding potential development, regulatory and commercial milestones + high single to low double
digit % royalties on global sales to Zealand
Company announcement
No. 28 / 2023
6
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)
Second quarter 2023 update:
• Presentation of EASE-1 results at the ASPEN 2023
Nutrition Science & Practice Conference in April 2023
and Digestive Diseases Week in May 2023.
• Completion of interim analyses for the EASE-2, EASE-3
and EASE-4 clinical trials of glepaglutide in patients with
short bowel syndrome and intestinal failure to support
regulatory submission expected in the second half of
2023.
Background:
Glepaglutide is a long-acting GLP-2 analog that is stable in
aqueous solution and can be administered as a ready-to-use
liquid formulation. 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 includes four clinical
trials evaluating the potential for glepaglutide to reduce or
eliminate the need for parenteral support in patients with
SBS.
EASE-1 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 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, 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 is a Phase 3b trial to assess long-term
effects of glepaglutide on intestinal fluid and energy uptake.
Zealand has completed the interim analysis of the trial and
expects to present results from this study at a future
scientific conference.
For more information on the EASE trials, please visit
ClinicalTrials.gov (IDs: NCT03690206, NCT03905707,
NCT04881825, NCT04991311).
The company expects efficacy and safety data from the full
EASE Phase 3 program to form the basis of an NDA
Company announcement
No. 28 / 2023
7
submission with the FDA in the second half of 2023. FDA
has granted orphan drug designation to glepaglutide for the
treatment of SBS.
Phase 2 data have shown the potential of glepaglutide to
increase intestinal absorption in people with SBS and were
published in the journal The Lancet Gastroenterology &
Hepatology in 2019.
Obesity
ZP8396 (long-acting amylin analog)
Second quarter 2023 update:
• Presentation of detailed results from Phase 1a SAD trial
in healthy participants at ADA 83
rd
Scientific Sessions in
June 2023, showing mean weight loss of 4.2% from
baseline (4.8% placebo adjusted) with ZP8396 2.4 mg
treatment.
• Announcement of topline results in July 2023 of the
Phase 1b MAD trial Part 1, showing mean weight loss of
5.3% and 5.1% after administration once-weekly for six
weeks of relatively low doses of 0.6 and 1.2 mg ZP8396
(placebo: 0.4% mean weight loss).
• Initiation of the 16-week Phase 1b MAD trial Part 2,
exploring significantly higher doses of ZP8396 using a
dose up-titration scheme.
Background:
ZP8396 is a long-acting amylin analog designed to improve
solubility and allow for co-formulation with other peptides,
including GLP-1 analogs. Amylin analogs hold potential as
both mono and combination therapies for obesity and type
2 diabetes.
Zealand has completed a Phase 1a, first-in-human,
randomized, single ascending dose (SAD) trial to assess the
safety, tolerability, pharmacokinetics, and
pharmacodynamics of ZP8396 in healthy volunteers
(ClinicalTrials.gov ID: NCT05096598). Healthy participants
with a mean BMI of 25.8 were randomized (6:2) within seven
dose cohorts and treated with either subcutaneous ZP8396
or placebo. After one week, participants treated with
ZP8396 had reductions in mean body weight of 2.6%, 3.6%
and 4.2% from baseline following single doses of 0.7, 1.4 and
2.4 mg ZP8396. Body weight reductions were well-
sustained during the additional five weeks of observation
without further doses of ZP8396. Placebo-treated
participants had a mean body weight increase of 0.6% after
one week that continued to increase in most participants
during the follow-up period. The plasma half-life of ZP8396
was 230 hours, or approximately 10 days, which supports
once-weekly dose administration. ZP8396 was well
tolerated in this study, with no serious or severe adverse
events (AEs) and no withdrawals. The detailed results were
presented at the ADA 83rd Scientific Sessions in June 2023.
Zealand is conducting a Phase 1b, randomized, multiple
ascending dose (MAD) clinical trial of ZP8396 in normal
weight and overweight healthy participants
(ClinicalTrials.gov ID: NCT05613387). The MAD trial consists
of Part 1 and Part 2. Part 1 includes 20 participants receiving
six once-weekly subcutaneous doses of ZP8396 or placebo.
Part 2 includes 48 participants receiving 16 once-weekly
doses of ZP8396 or placebo using a dose up-titration
scheme. In July 2023, Zealand reported topline results from
the 6-week MAD trial Part 1. Low doses of 0.6 mg and 1.2
mg ZP8396 administered once-weekly for six weeks led to
5.3% and 5.1% mean weight loss from baseline. In the 6-
week trial, ZP8396 was judged to be well tolerated, with no
serious or severe AEs and no withdrawals. The most
common AEs were related to the gastrointestinal system,
were all mild and most occurred within two days of the first
dose. Based on the mild adverse event profile, Zealand has
initiated Part 2 of the MAD trial, exploring significantly higher
doses of ZP8396 using a dose up-titration scheme, and
expects results from the 16-week study in the first half of
2024.
Dapiglutide (long-acting GLP-1R/GLP-2R dual agonist)
Second quarter 2023 update:
• Initiation of a Phase 2 investigator-led clinical trial in
collaboration with Zealand in people with obesity
(DREAM).
Background:
Dapiglutide is a long-acting dual GLP-1R/GLP-2R agonist for
the potential treatment of obesity. 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. The
pharmacokinetics (PK) showed dose proportionality with a
low inter-subject variability and a mean half-life of 123-129
hours across the four dose cohorts and supported that
dapiglutide is suitable for once-weekly dosing. 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.
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
Company announcement
No. 28 / 2023
8
expects topline results from the trial in the first half of 2024.
Please visit ClinicalTrials.gov for further information (ID:
NCT05788601).
Separately, Zealand expects to initiate a 13-week dose
titration trial in people with obesity in the second half of
2023.
Survodutide (long-acting dual GCGR/GLP-1R agonist) in
collaboration with Boehringer Ingelheim
Second quarter 2023 update:
• Presentation of detailed results from the Boehringer
Ingelheim-sponsored Phase 2 clinical trial in people
living with overweight or obesity at the ADA 83
rd
Scientific Sessions in June 2023, showing dose-
dependent reductions in body weight of up to 18.7% at
Week 46.
• Announcement by Boehringer Ingelheim in August 2023
of decision to advance survodutide to Phase 3
development in people living with overweight or obesity,
expected to be initiated in the second half of 2023.
Background:
Survodutide (formerly BI 456906) is a long-acting dual
GCGR/GLP-1R agonist for once-weekly subcutaneous
administration that activates two key gut hormone receptors
simultaneously and may offer better efficacy than current
single-hormone receptor agonist treatments. Survodutide is
targeting the treatment of obesity and associated metabolic
diseases.
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
studies in type 2 diabetes (T2D) 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.
Boehringer Ingelheim announced on August 17, 2023 plans
to advance survodutide to Phase 3 in people living with
overweight or obesity, with further details on the trials to be
disclosed prior to their initiation.
A Phase 2 randomized, placebo-controlled, double-blind
trial evaluated survodutide in people with T2D 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. Different
doses of survodutide were escalated every 1–2 weeks to
ensure that 10 weeks were spent on a maintenance dose.
At the 58th EASD annual meeting in September 2022,
Boehringer Ingelheim presented results for the primary
endpoint of change from baseline in HbA1c after 16 weeks
of treatment. 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%.
A third Phase 2 trial is assessing survodutide in non-alcoholic
steatohepatitis, or NASH (ClinicalTrials.gov ID:
NCT04771273). The NASH program has received Fast Track
Designation from the US FDA. In people living with
overweight and obesity, it is estimated that 75% have
nonalcoholic fatty liver disease (NAFLD) and 34% have
NASH. Boehringer Ingelheim and Zealand Pharma expect to
report topline results from the Phase 2 trial with survodutide
in NASH in the first half of 2024.
Survodutide was co-invented by Boehringer Ingelheim and
Zealand. Boehringer Ingelheim is funding all research,
development and commercialization activities related to
survodutide. Zealand is eligible to receive up to EUR 345
million in outstanding milestone payments and high-single
to low-double digit royalties on global sales.
Company announcement
No. 28 / 2023
9
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.
Zealand anticipates that Beta Bionics will begin the Phase 3
Bihormonal iLet® Bionic Pancreas Pivotal Program in the
second half of 2023. The Phase 3 program consists of three
planned studies designed to support the marketing
applications for the iLet Duo and an NDA for the use of
dasiglucagon in Bihormonal Artificial Pancreas systems for
the treatment of T1D. The pivotal study plan includes an
initial crossover trial of approximately 60 participants to
assess safety and efficacy of the bihormonal and insulin-only
configurations of the iLet® Bionic Pancreas. Subsequently,
the companies plan to initiate full-scale, randomized,
controlled pivotal trials in 350 adult and 350 pediatric
participants with T1D to assess the efficacy of the iLet Duo™
as compared to the insulin-only system.
Dasiglucagon mini-dose pen
Background:
Zealand is developing a dasiglucagon mini-dose pen for the
potential treatment of exercise-induced hypoglycemia in
people living with T1D and for people who suffer from meal-
induced hypoglycemia following gastric bypass surgery
(post bariatric hypoglycemia, or PBH). Four investigator-
initiated trials conducted in collaboration with Zealand
evaluated mini-dose dasiglucagon to support this
development program.
Investigators from the Steno Diabetes Center Copenhagen
conducted a Phase 2 trial using the dasiglucagon mini-dose
pen in people with T1D in free-living conditions
(ClinicalTrials.gov ID: NCT04764968). The trial results were
published online in April 2023 in the journal Diabetologia
and showed that dasiglucagon administered by pen
improved glycemic control and reduced carbohydrate
intake among the study participants. These data build on
two prior clinical studies conducted in hospital settings with
results that show the potential for using low doses of
dasiglucagon to correct moderate hypoglycemia: a Phase
2a dose-finding trial in people with T1D (ClinicalTrials.gov ID:
NCT04449692) presented at the ADA Scientific Sessions in
2021, and a Phase 2a trial in PBH (ClinicalTrials.gov ID:
NCT03984370) published in the journal Diabetes Care in
2022.
A Phase 2 trial in PBH conducted in an out-patient setting
(ClinicalTrials.gov ID: NCT04836273) has been completed
and met the primary endpoint.
Inflammation
Zealand is pursuing multiple pre-clinical programs in
inflammatory diseases which will be detailed more as they
progress through development.
Complement inhibitors (collaboration with Alexion,
AstraZeneca Rare Disease)
Zealand and Alexion are collaborating on the discovery and
development of novel peptide therapies for complement-
mediated diseases. Under the terms of the agreement,
Alexion and Zealand entered into an exclusive collaboration
for the discovery and development of subcutaneously
delivered peptide therapies directed to up to four
complement pathway targets. The lead program, ZP10068,
is an investigational long-acting inhibitor of Complement C3
which has the potential to treat a broad range of
complement mediated diseases. Zealand will lead the joint
discovery and research efforts through the pre-clinical
stage, and Alexion will lead development efforts beginning
with Investigational New Drug (IND) filing and Phase 1 trials.
In 2023, Zealand expects to complete activities to support
advancing ZP10068 into clinical studies. Subsequent
regulatory, clinical, and development efforts will be led and
conducted by Alexion.
For the lead target, Zealand is eligible to receive up to USD
610 million in development and sales milestone payments,
plus royalties on global sales in the high single to low double
digits. In addition, Alexion has the option to select up to
three additional targets with Zealand eligible for USD 15
million upfront per target plus potential
development/regulatory milestones for each target selected
similar to the lead target with slightly reduced commercial
milestones and royalties.
1 Zealand Pharma A/S | Interim Financial Statements H1 2023
Financial highlights and key
figures.
Financial highlights (DKK thousand)
Note Q2-23
Q2-22*
H1-23
H1-22*
Revenue 2 10,407 25,390 24,036 36,347
Research and development expenses -155,564 -151,359 -297,827 -306,912
Sales and marketing expenses -7,135 -10,470 -11,751 -22,478
Administrative expenses -48,275 -70,337 -90,759 -123,052
Net other operating items 3 5,202 1,715 12,263 -18,013
Net operating expenses -205,773 -230,451 -388,074 -470,455
Net financial items 4 -125,684 -194,873 - 152,334 -61,839
Result before tax -321,050 -399,934 -516,373 -495,947
Corporate tax 1,548 2,306 3,239 3,280
Net result for the period from continuing operations -319,502 -397,628 -513,134 -492,667
Net result for the period from discontinued operations -
-90,872
-
-218,678
Net result for the period -319,502 -488,500 -513,134 -711,345
Earnings/loss per share from continuing operations -
basic/diluted (DKK)
-5.50 -9.77 -9.36 -14.03
Statement of financial position (DKK thousand) Note
Jun-30,
2023
Dec-31,
2022
Cash, cash equivalents and marketable securities 1,692,374 1,177,845
Total assets 2,049,678 1,539,806
Total shareholders' equity 1,727,435 815,911
Cash flow (DKK thousand) Note
H1-23 H1-22
Undrawn borrowing facilities (1) 350,000 -
Cash (used in)/provided by operating activities -372,480 -543,920
Cash (used in)/provided by investing activities -1,260,893 101,399
Cash (used in)/provided by financing activities 897,384 -154,942
Purchase of property, plant and equipment -3,686 -4,759
Free cash flow (2) -376,166 -548,679
Other Note
Jun-30,
2023
Dec-31,
2022
Share price (DKK) 244.6 201.4
Number of shares ('000 shares) 58,642 51,702
Market capitalization (MDKK) (2) 14,251 9,305
Equity ratio (%) (2) 84% 53%
Equity per share (DKK) (2) 29.65 17.66
Average number of full time employees 221 247
Number of full-time employees at the end of period 236 196
* Comparatives numbers for Q2 and H1 2022 are adjusted to reflect the effect of discontinued operations. For further details refer to note 2.8
in the 2022 Annual Report.
1) In May 2023, Zealand entered a new DKK 350 million revolving credit facility provided by Danske Bank as refinancing following the
repayment of the Oberland loan, refer to note 6.
2) For basis of calculation refer to 2022 Annual Report p. 110.
2 Zealand Pharma A/S | Interim Financial Statements H1 2023
Financial Review.
• Net operating expenses in H1 of DKK -388 million are
mainly driven by the progression of the late-stage rare
disease assets and the obesity pipeline.
• Financial items in H1 2023 of DKK -152 million mainly
represent costs associated with the final repayment and
termination of the loan with Oberland Capital.
• Runway to mid-2026 following the directed issue and
private placement in April 2023 bringing in gross
proceeds of DKK 1.5 billion.
Revenue
Revenue in H1 2023 of DKK 24 million is mainly driven by
the license and development agreement for Zegalogue
®
with Novo Nordisk A/S, signed in September 2022.
Net operating expenses
Research and development expenses in H1 2023 of DKK
-298 million are mainly driven by the progression of the
late-stage rare disease assets and the obesity pipeline. The
spend is slightly below H1 2022 due to timing of clinical
activities.
Selling and marketing expenses of DKK -12 million and
administrative expenses of DKK -91 million in H1 2023 are
significantly below H1 2022 due to cost reduction efforts
following the announced restructuring on March 30, 2022.
Net other operating items of DKK 12 million in H1 2023 are
related to a reversal of inventory write-down associated
with Zegalogue
®
.
Financial items
Financial items in H1 2023 of DKK -152 million are mainly
driven by the final repayment and termination of the loan
with Oberland Capital in May 2023. Interest expenses and
banking fees in H1 2023 of DKK -20 million, mainly related
to interest payments on the now terminated Oberland loan
agreement, are partly offset by interest income of DKK 18
million related to the funds from the Oberland loan, which
were placed on an investment account and interest on
marketable securities.
In H1 2023, the investment in Beta Bionics was subject to a
fair value adjustment of DKK -15 million.
Equity
On June 30, 2023, equity was DKK 1,724 million, reflecting
a significant increase compared to June 30, 2022, mainly
driven by the proceeds from the directed issue and private
placement of new shares in April 2023 and partly offset by
the loss for the period.
Cash position
Cash, cash equivalents and marketable securities as of
June 30, 2023 was DKK 1.7 billion and DKK 2.0 billion
including a DKK 350 million new Revolving Credit Facility
provided by Danske Bank, reflecting a significant increase
compared to the DKK 1.2 billion in cash position as of
December 31, 2022. This development in the first half of
2023 is mainly driven by the DKK 1.5 billion in gross
proceeds from the directed issue and private placement of
new shares in April 2023 and partly offset by cash used in
operating activities during the period (DKK -372 million) and
repayment of the Oberland loan (DKK -526 million).
The final repayment and termination of the loan
agreement with Oberland Capital in May 2023 was
refinanced through a new Revolving Credit Facility
provided by Danske Bank and expected near-term
upcoming milestones from existing partners. For further
information on the capital increase in April, repayment of
the Oberland loan in May, and the new Revolving Credit
Facility, please refer to note 6.
Zealand expects the new funds to provide cash runway to
mid-2026 and expects to advance the clinical pipeline and
as such reach several potential key milestones within this
timeframe.
Zealand’s cash is intended to:
• Support the remaining late-stage rare disease assets,
and pursue a strong strategic partner for future
commercialization
-151
-70
-54
-60
-48
-40
2
-10
Q2 2022
-6
-145
Q3 2022
-4
-162
Q4 2022
7
-42
-5
-142
Q1 2023
5
-7
-156
Q2 2023
-230
-205
-265
-182
-206
R&D S&M G&A Net other operating items
OPEX by quarter
DKK million
3 Zealand Pharma A/S | Interim Financial Statements H1 2023
• Advance the clinical-stage candidates, including the
obesity/metabolic disease portfolio that includes the
clinical-stage GLP-1/GLP-2 dual agonist dapiglutide,
the amylin analog ZP8396, and the non-clinical stage
GIP analog ZP6590
• Progress additional peptide candidates from non-
clinical development into early clinical development
• Continue the early discovery and research to develop
additional peptide candidates
• Strengthen the Zealand’s capital base and cash
preparedness (general corporate purposes)
On March 12, 2023, Zealand provided a statement on the
closure of Silicon Valley Bank (SVB). On closure, Zealand’s
cash deposits in SVB were DKK 162.6 million, however the
closure eventually had no impact as all depositors were
granted access to their money from March 13. In the light
of this event, Zealand has implemented an even higher
diversification in its management of funds.
Events after the reporting date
On August 17, 2023 Boehringer Ingelheim announced their
decision to advance to Phase 3 in people living with
overweight or obesity with initiation expected in the
second half of 2023. Zealand is eligible to receive a one-
time milestone payment upon Phase 3 initiation.
Outlook for the year
There are no changes to the outlook for the year and
guidance is confirmed. Net operating expenses for the year
are still expected between DKK 800-900 million. For
further information refer to p. 10 in the 2022 Annual
Report.
Cash position compared to FY22
DKK million
1,365
1,069
1,500
328
109
Cash
position
Dec-2022
-372
Cash flow
from
operating
activities
-88
Other cash
adjustments
Gross
proceeds
from capital
increase
April 2023
-526
Repayment
Oberland
Capital loan
May 2023
350
Cash
position
Jun-2023
1,178
2,042
Undrawn borrowing facilities
Cash and cash equivalents
Marketable securities
4 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim financial statements.
Unaudited interim condensed consolidated financial statements H1 2023:
Interim income statement for H1, 2023 .............................................................................................................................................................. 5
Interim statement of comprehensive loss for H1, 2023 .................................................................................................................................. 6
Interim statements of financial position as of H1, 2023 .................................................................................................................................. 7
Interim statements of cash flow for H1, 2023 .................................................................................................................................................... 8
Interim statements of changes in equity as of H1, 2023 ................................................................................................................................. 9
Notes to the interim condensed consolidated financial statements .............................................................................................................. 10
1. Basis of preparation and changes to the Group’s accounting policies ................................................................................................. 10
2. Revenue ................................................................................................................................................................................................................. 11
3. Net other operating items ................................................................................................................................................................................. 11
4. Net financial items .............................................................................................................................................................................................. 12
5. Inventory ............................................................................................................................................................................................................... 12
6. Financial instruments ......................................................................................................................................................................................... 13
7. Cash and cash equivalents ............................................................................................................................................................................... 14
8. Share capital......................................................................................................................................................................................................... 14
9. Capital Management ......................................................................................................................................................................................... 15
10. Contingent assets and liabilities .................................................................................................................................................................... 15
11. Significant events after the reporting period .............................................................................................................................................. 15
Statement by the Executive Management and the Board of Directors ......................................................................................................... 16
Independent auditor's report ..................................................................................................................................................................................... 17
5 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim income statement for H1, 2023.
DKK thousand Note
Q2-23 Q2-22* H1-23 H1-22*
(reviewed) (reviewed) (reviewed) (reviewed)
Revenue 2 10,407 25,390 24,036 36,347
Research and development expenses -155,564 -151,359 -297,827 -306,912
Sales and marketing expenses -7,135 -10,470 -11,751 -22,478
Administrative expenses -48,275 -70,337 -90,759 -123,052
Net other operating items 3 5,202 1,715 12,263 -18,013
Net operating expenses -205,773 -230,451 -388,074 -470,455
Operating result (EBIT) -195,365 -205,061 -364,039 -434,108
Financial income 4 11,760 -41,614 19,197 111,891
Financial expenses 4 -137,445 -153,259 -171,531 -173,730
Result before tax -321,050 -399,934 -516,373 -495,947
Corporate tax 1,548 2,306 3,239 3,280
Net result for the period from continuing operations -319,502 -397,628 -513,134 -492,667
Net result for the period from discontinued operations* - -90,872 - -218,678
Net result for the period -319,502 -488,500 -513,134 -711,345
Earnings/loss per share from continuing operations -
-5.50 9.77 9.36 14.03
Earnings/loss per share from discontinued operations -
Earnings/loss per share - basic/diluted (DKK) -5.50 -11.04 -9.36 -16.27
* Comparatives numbers for Q2 and H1 2022 are adjusted to reflect the effect of discontinued operations. For further details
refer to note 2.8 in the 2022 Annual Report.
6 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim statement of comprehensive loss
for H1, 2023.
DKK thousand Note Q2-23 Q2-22 H1-23 H1-22
(reviewed) (reviewed) (reviewed) (reviewed)
Net result for the period -319,502 -488,500 -513,134 -711,345
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 -26 2,861 3,759 4,887
Total comprehensive result for the period -319,528 -485,639 -509,374 -706,458
7 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim statements of financial position
as of H1, 2023.
DKK thousand Note
Jun-30, 2023 Dec-31, 2022
Assets (reviewed) (audited)
Property, plant and equipment 48,819 50,528
Right-of-use assets 108,432 114,960
Other investments 6 16,194 30,943
Corporate tax receivable 2,750 -
Deferred tax assets 1,983 2,017
Other receivables 20,499 18,105
Other financial assets 6 7,131 6,901
Total non-current assets 205,808 223,454
Inventory 5 12,823 1,286
Trade and other receivables 117,077 115,622
Corporate tax receivable 21,596 21,599
Marketable securities 6,7 1,364,688 108,611
Cash and cash equivalents 7 327,686 1,069,234
Total current assets 1,843,870 1,316,352
Total assets 2,049,678 1,539,806
Shareholders equity and liabilities
Share capital 8 58,642 51,702
Currency translation reserve 18,376 14,617
Retained earnings 1,650,417 749,592
Total shareholders' equity 1,727,435 815,911
Other payables 19,058 19,058
Borrowings including embedded derivatives 6 - 401,346
Lease liabilities 102,074 108,000
Total non-current liabilities 121,132 528,404
Lease liabilities 14,787 14,729
Trade and other payables 186,324 180,762
Total current liabilities 201,111 195,491
Total liabilities 322,243 723,895
Total shareholders' equity and liabilities 2,049,678 1,539,806
8 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim statements of cash flow for H1,
2023.
DKK thousand Note H1-23 H1-22
(reviewed) (reviewed)
Net result for the period -513,134 -711,345
Adjustment for other non-cash items 180,147 106,683
Changes in working capital -35,053 77,929
Financial income received 15,665 1,226
Financial expenses paid -20,341 -17,713
Corporate taxes paid/received 236 -700
Cash flow from/(used in) operating activities -372,480 -543,920
Proceeds from sale of marketable securites 204,744 673,995
Purchase of marketable securities 6 -1,461,951 -672,449
Purchase of property, plant and equipment -3,686 -4,759
Divestment of activities - 104,852
Change in deposits - -240
Cash flow from/(used in) investing activities -1,260,893 101,399
Repayment of borrowings 6 -525,764 -417,340
Lease installments -6,351 -4,225
Proceeds from issuance of shares 8 1,500,000 274,776
Purchase of treasury shares 8 -41,600 -
Proceeds from issuance of shares related to exercise of share-based
compensation
8 42,422 -
Costs related to issuance of shares -71,323 -8,153
Cash flow from/(used in) financing activities 897,384 -154,942
(Decrease)/increase in cash and cash equivalents -735,989 -597,463
Cash and cash equivalents at beginning of period 1,069,234 1,129,103
Exchange rate adjustments -5,559 21,602
Cash and cash equivalents at end of period 7 327,686 553,242
9 Zealand Pharma A/S | Interim Financial Statements H1 2023
Interim statements of changes in equity
as of H1, 2023.
DKK thousand
Share
capital
Translation
reserve
Retained
earnings*
Total
Shareholder's equity at Jan-1, 2023 51,702 14,617 749,592 815,911
Other comprehensive income for the period
Net result for the period - - -513,134 -513,134
Acquisition of treasury shares - - -81,045 -81,045
Share-based compensation - - 30,935 30,935
Capital increase 6,940 - 1,535,392 1,542,332
Costs related to capital increase - - -71,323 -71,323
Shareholder's equity at Jun-30, 2023 (reviewed) 58,642 18,376 1,650,417 1,727,435
Shareholder's equity at Jan-1, 2022 43,634 14,155 870,014 927,803
Other comprehensive income for the period
Net result for the period - - -711,345 -711,345
Share-based compensation - - 16,979 16,979
Capital increase 2,893 - 271,883 274,776
Costs related to capital increase - - -8,153 -8,153
Shareholder's equity at Jun-30, 2022 (reviewed) 46,527 19,042 439,378 504,947
*Treasury shares, Share premium, Warrant compensation expenses and Retained losses have been merged into the column
Retained earnings to ease accessibility of information.
10 Zealand Pharma A/S | Interim Financial Statements H1 2023
Notes to the interim condensed
consolidated financial statements.
1. Basis of preparation and changes to the Group’s accounting policies
Basis of preparation
The interim condensed consolidated financial statements of Zealand Pharma A/S (The Group) have been prepared in
accordance with IAS 34, Interim Financial Reporting, as adopted by EU and additional requirements of the Danish Financial
Statements Act. The interim condensed consolidated financial statements are presented in Danish kroner (DKK) which is also
the functional currency of the parent company.
The accounting policies used in the interim condensed consolidated financial statements are consistent with those used in the
Group’s annual financial statement for the year ended December 31, 2022.
Going concern assessment
Management’s judgement and assessment of the Group’s ability to continue as a going concern includes evaluation of the
Group's operational cash flow requirements for the forthcoming 12 months from the balance sheet date and future sources
and uses of cash. Following the capital increase completed in April 2023 the Group received gross proceeds of DKK 1.5 billion.
On this basis the interim condensed consolidated financial statements are prepared using the going concern assumption.
New standards, interpretations and amendments adopted by the Group
Several amendments apply for the first time in 2023, but do not have an impact on the interim condensed consolidated
financial statements of the Group. The Group has not early adopted any standard, interpretation or amendment that has been
issued but is not yet effective.
Significant accounting estimates and judgements
The preparation of the interim condensed consolidated financial statements requires Management to make judgments and
estimates that affect the reported amounts of revenues, expenses, assets and liabilities, and the accompanying disclosures. In
applying our accounting policies, Management is required to make judgements and estimates about the carrying amounts of
assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on
historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The
estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in
the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future
periods if the revision affects both current and future periods.
The estimates used are based on assumptions assessed to be reasonable by Management. However, estimates are inherently
uncertain and unpredictable. The assumptions may be incomplete or inaccurate, and unexpected events or circumstances may
occur. Furthermore, we are subject to risks and uncertainties that may result in deviations in actual results compared with
estimates.
Except for the items listed below, no material changes in significant accounting estimates and judgements have occurred since
the Annual Report 2022. Please refer to note 1.4 in the 2022 Annual Report for further information:
• Estimate of net realizable value of Zegalogue
®
raw materials (Inventory). Refer to note 5.
• Estimate of fair value on investment in Beta Bionics (Other investments). Refer to note 6.
• Estimate of fair value of Oberland’s call option for repayment of loan (Borrowings including embedded derivatives).
Refer to note 6.
• Judgement in assessing operational cash-flow and capital requirements for the forthcoming 12 months from the
balance sheet date. Refer to the going concern assessment above.
11 Zealand Pharma A/S | Interim Financial Statements H1 2023
2. Revenue
Revenue can be specified as follows:
DKK thousand Q2-23 Q2-22* H1-23 H1-22*
(reviewed) (reviewed) (reviewed) (reviewed)
Alexion Pharmaceuticals Inc. 914 25,390 2,704 36,346
Novo Nordisk A/S 9,493 - 21,332 -
Total revenue from license and collaboration agreements 1 0,407 25,390 24,036 36,346
Total sale of goods revenue net - 24,816 - 64,647
- Hereof related to discontinued operations - -24,816 - -64,647
Sale of goods revenue from continuing operations - - - -
Total revenue from continuing operations 10,407 25,390 24,036 36,346
Total revenue recognized over time 10,407 25,390 24,036 36,3 46
Total revenue recognized at a point in time from
discontinued operations
- 24,816 - 64,647
* Comparatives numbers for Q2 and H1 2022 are adjusted to reflect the effect of discontinued operations. For further details
refer to note 2.8 in the 2022 Annual Report.
3. Net other operating items
Net other operating items can be specified as follows:
DKK thousand Q2-23 Q2-22 H1-23 H1-22
(reviewed) (reviewed) (reviewed) (reviewed)
Proceeds from insurance claims - 1,849 - 1,849
Restructuring costs - -134 - -19,120
Loss on sale of fixed assets - - - -742
Reversal of inventory write-down 5,202 - 12,263 -
Net other operating items in total 5,202 1,715 12,263 -18,013
All restructuring costs in Q2 and H1 2022 were incurred as a result of the March 30, 2022, company announcement on
refocused strategy.
As of June 30, 2023 management has estimated the net realizable value of raw materials to be DKK 12.8 million as all materials
are expected to be utilized in the production under the supply agreement with Novo Nordisk, and therefore a reversal of
inventory write-down of DKK 12.3 million has been made in H1, 2023 of which DKK 5.2 million relates to Q2, 2023. Reference is
made to note 5.
12 Zealand Pharma A/S | Interim Financial Statements H1 2023
4. Net financial items
Financial items include interests, as well as foreign exchange rate adjustments, fair value adjustments of other investments,
embedded derivatives and marketable securities and dividends from marketable securities.
DKK thousand Q2-23 Q2-22 H1-23 H1-22
(reviewed) (reviewed) ( reviewed) (reviewed)
Interest income 13,038 1,684 17,747 1,684
Interest expenses and banking fees -8,653 -7,518 -20,446 -26,355
Loss on settlement of borrowings, including embedded
derivatives under Oberland loan
-135,588 -144,729 -135,5 88 -144,729
Fair value adjustment of lender's call option -1,128 - 1,16 1 -
Fair value adjustment of prepayment option - -71,0 50 - 71,050
Fair value adjustment of marketable securities -100 -1,013 289 -2,646
Fair value adjustment of other investments 229 - -14,519 2,259
Fair value adjustment of other financial assets -50 - - -
Amortization of loan costs -287 - -9 43 -
Exchange rate adjustments 6,85 4 27,753 -35 36,898
Financial items in total -125,685 -194,873 -152,334 -61,839
Presentation in income statement:
Financial income 11,760 -41,614 19,197 111,891
Financial expenses -137,445 -153,259 -171,531 -173,730
Interest income mainly comprise interest related to the USD 50 million from the Oberland loan which was placed on an
investment account and interest on marketable securities.
Interest expenses and banking fees mainly consists of interest payments due to the loan agreement with Oberland.
Loss on settlement of borrowings relates to the settlement of the Oberland loan on May 10, 2023. Fair value adjustment of
lender call option (embedded derivative) relates to the value adjustments of Oberland's option to call for repayment of the loan
under certain conditions. Please refer to note 6 for further information.
Fair value adjustment on other investments comprises the accounting impact of the investment in Beta Bionics as described in
note 6.
Exchange rate adjustments primarily relates to USD deposits.
5. Inventory
In Q1 and Q2, 2023 a reversal of Zegalogue
®
inventory write-down has been made as the raw materials are expected to be
utilized under the license and development agreement with Novo Nordisk. The adjustments affect net other operating items in
H1, 2023 by DKK 12.3 million of which DKK 5.2 million relates to Q2, 2023, see note 3.
For further information regarding significant accounting estimates and judgements, refer to note 1.4 in the 2022 Annual Report.
13 Zealand Pharma A/S | Interim Financial Statements H1 2023
6. Financial instruments
As of June 30, 2023, and December 31, 2022, the following financial instruments are measured at fair value through profit or
loss. The fair value of marketable securities is measured using inputs categorized as Level 1 and 2 in the fair value hierarchy,
whereas the other investments and other financial assets is based on inputs categorized as Level 3 in the fair value hierarchy.
Embedded derivatives is measured using inputs categorized as Level 3 in the fair value hierarchy.
No transfers occurred between the levels of the fair value hierarchy in the six months ending 30 June 2023.
DKK thousand
Jun-30,
2023
Dec-31,
2022
(reviewed) (audited)
Assets measured at fair value:
Marketable securities (Level 1) 1,146,383 -
Marketable securities (Level 2) 218,305 108,611
Other investments (Level 3) 16,194 30,943
Other financial assets (Level 3) 7,131 6,901
Financial assets measured at fair value through profit and loss 1,388,013 146,455
Liabilities measured at fair value:
Embedded derivatives, lender's call option (Level 3) - 80,603
Financial liabilities measured at fair value through profit and loss - 80,603
Financial
assets
(Level 3)
Financial
liabilities
(Level 3)
Carrying amount at start of period 37,844 80,603
Fair value adjustments through profit and loss -14,519 -1,16 1
Exchange rate effect through other comprehensive income - -1 ,916
Derecognition of call option on settlement of Oberland Capital loan - -77 ,526
Carrying amount at end of period 23,325 -
Investment in marketable securities
As of June 30, 2023 Zealand has placed DKK 1,365 million into low risk marketable securities in line with the Group’s treasury
policy.
Fair value measurement of other investments
Other investments consist of an investment in Beta Bionics, Inc., the developer of iLet™, a fully integrated dual-hormone pump
(bionic pancreas) for autonomous diabetes care.
In determining fair value, Zealand considers the value per share from the most recent closed financing round, adjusted for
valuation infliction points through the balance sheet date, including (i) discount for lack of marketability, (ii) information
obtained from third party valuation reports, and (iii) company announcements.
Fair value of the investment amounted to DKK 16.2 million as of 30 June, 2023 (DKK 30.9 million as of December 31, 2022).
The fair value adjustment of DKK -14.5 million in H1, 2023 is included in financial items off which DKK 0.2 million relates to Q2,
2023, see note 4.
Fair value measurement of lender's call option (Oberland Capital loan)
Fair value of the lender call option is determined as the difference between the present value of the probability weighted
contractual cash flow upon the occurrence of a call option trigger event and the present value of the contractual cash flows
without a call option trigger event occurring, discounted at the expected internal rate of return of 14.3%. It is assumed that any
14 Zealand Pharma A/S | Interim Financial Statements H1 2023
call option trigger event will result in full repayment of the loan. As of December 31, 2022, the likelihood of a lender call option
trigger event within the next two years was assessed as realistic and fair value of the option was assessed to DKK 80.6 million.
At the time of settlement on May 10, 2023, the fair value of the option amounted to DKK 77.5 million and is included in financial
items under ‘Loss on settlement of borrowings, including embedded derivatives under Oberland loan’ in note 4. The fair value
change, DKK 1.2 million, is included in financial items, while the effect of changes to the exchange rate, DKK 1.9 million, is
included in other comprehensive income. Valuation is based on unobservable data (level 3).
Settlement of Oberland Capital loan
On April 20, 2023, Oberland Capital exercised an option in the loan agreement to provide an additional loan of USD 12.5 million
on similar terms as the existing loan, bringing the total principal amount to USD 62.5 million. The additional loan of USD 12.5
million was not provided in cash.
On May 10, 2023, Zealand settled the Oberland Capital loans in a one-time payment of USD 77.3 million (DKK 525.7 million).
With this final repayment, the Group’s loan agreement with Oberland Capital is now fully terminated. As a result of the
settlement Zealand in 2023 recognized a net loss of USD 19.9 million (DKK 135.6 million) under financial items, including
derecognition of Oberland Capital’s call option with a carrying value as of May 10, 2023, of USD 11.4 million (DKK 77.5 million).
With the final repayment, Oberland has released all rights to collateral provided for under the loan agreement.
Refinancing with new credit facility
The repayment of the Oberland Capital loan has been refinanced through a new DKK 350 million Revolving Credit Facility
provided by Danske Bank. The facility matures in 2 years from June, 2023 where any outstanding amount must be repaid in full,
and carries an interest of CIBOR + fixed margin.
Other fair value measurements
For information about fair value measurements of other financial assets and marketable securities, please refer to note 3.7 and
4.3 of the 2022 Annual Report.
7. Cash and cash equivalents
Restricted cash and cash equivalents
As of December 31, 2022, DKK 348.6 million was held as restricted cash subject to certain conditions following the second
amendment to the Oberland loan agreement. With the final repayment of the Oberland loan agreement on May 10, 2023 all
previous restrictions have been released. For further information, please refer to note 4.4 of the 2022 Annual Report.
Pledges provided in relation to revolving credit facility in Danske Bank
As security for the undrawn revolving credit facility of DKK 350 million, as disclosed in note 6, the Group has provided pledge
over Zealand’s designated custody accounts under management by Danske Asset Management and pledge over Zealand’s
designated cash accounts attached to the custody accounts. As of June 30, 2023 marketable securities and cash and cash
equivalents held in these pledged accounts amount to DKK 446.0 million and DKK 3.8 million, respectively.
8. Share capital
Jun-30,
2023
Dec-31,
2022
DKK thousand (reviewed) (audited)
Share capital at January 1, 2023 51,702 43,634
Shares issued for cash 6,579 7,867
Exercise of warrants 361 201
Share capital at June 30, 2023 58,642 51,702
15 Zealand Pharma A/S | Interim Financial Statements H1 2023
Total new shares in H1, 2023 were issued at a weighed average subscription price of DKK 222.3.
New shares from exercise of warrants in H1, 2023 were issued at a weighed average subscription price of DKK 117.7. Total
proceeds from exercise of share-based compensation amounts to DKK 42.4 million.
On March 30, 2023 Zealand announced an issue of 6,578,948 new ordinary shares at a subscription price of DKK 228 per new
share resulting in gross proceeds of DKK 1.5 billion. The capital increase was completed in April 2023.
Treasury shares
In Q2, 2023 the number of treasury shares has increased by 300,000 to a total of 378,633 treasury shares, equivalent to 0.6% of
the share capital. The treasury shares are allocated to performance share units (PSUs) and restricted stock units (RSUs).
As of June 30, 2023 payable treasury shares amount to DKK 81.0 million included in trade and other payables. The payable
amount as of December 31, 2022 of DKK 41.6 million has been settled and paid in full during H1, 2023.
Potential dilutive effects
In the calculation of the diluted loss per share for H1, 2023 2,110,903 potential ordinary shares related to share-based payment
instruments have been excluded as they are anti-dilutive (2,190,503 for 2022).
9. Capital Management
The Group’s capital management objectives and policies are unchanged from the ones described in the 2022 Annual Report.
On March 12 and 13, 2023 the company provided statements on the closure of Silicon Valley Bank (SVB), and in the light of that
line of events Zealand is seeking to achieve an even higher diversification in its management of funds. For further information
refer to note 4.1 in the 2022 Annual Report.
On March 30, 2023 Zealand announced an issue of 6,578,948 new ordinary shares at a subscription price of DKK 228 per new
share resulting in gross proceeds of DKK 1.5 billion. The capital increase was completed in April 2023.
On June 30, 2023 Zealand entered a new DKK 350 million Revolving Credit Facility provided by Danske Bank. The facility
matures in 2 years from June, 2023 where any outstanding amount must be repaid in full, and carries an interest of CIBOR +
fixed margin.
10. Contingent assets and liabilities
Zealand is entitled to potential milestone payments and royalties on successful commercialization of products developed under
license and collaboration agreements with partners. Since the size and timing of such payments are uncertain until the
milestones are reached or sales are generated, the agreements may qualify as contingent assets. However, it is impossible to
measure the value of contingent assets, and as such, no assets have been recognized.
As part of the license and collaboration agreements that Zealand has entered into, once a product is developed and
commercialized, Zealand may be required to make milestone and royalty payments. It is not possible to measure the value of
such future payments, but Zealand expects to generate future income from such products which will exceed any milestone
and royalty payments due, and as such, no liabilities have been recognized. Refer to note 6.4 and 6.8 in the Annual Report
2022.
11. Significant events after the reporting period
On August 17, 2023 Boehringer Ingelheim announced their decision to advance to Phase 3 in people living with overweight or
obesity with initiation expected in the second half of 2023. Zealand is eligible to receive a one-time milestone payment upon
Phase 3 initiation.
16 Zealand Pharma A/S | Interim Financial Statements H1 2023
Statement by the Executive
Management and the Board of
Directors
The Board of Directors and the Management have
considered and adopted the interim report of Zealand
Pharma A/S for the three- and six-month periods ended
June 30, 2023.
The interim condensed consolidated financial statements
are prepared in accordance with IAS 34
Interim Financial
Reporting
as adopted by the EU, and additional
requirements of the Danish Financial Statements Act. In our
opinion, the interim condensed consolidated financial
statements give a true and fair view of the Group’s assets,
equity and liabilities and financial position as of June 30,
2023 as well as of the results of the Group’s operations and
cash flow for the three- and six-month periods ended June
30, 2023.
Moreover, in our opinion, the Management’s Review gives
a fair view of the development in the Group’s operations
and financial conditions, of the net result for the periods
and the financial position while also describing the most
significant risks and uncertainty factors that may affect the
Group.
Copenhagen, August 17, 2023
Management
Adam Sinding Steensberg Henriette Wennicke
President and Executive Vice President and
Chief Executive Officer Chief Financial Officer
Board of Directors
Alf Gunnar Martin Nicklasson Kirsten Aarup Drejer Jeffrey Berkowitz
Chairman Vice Chairman Board member
Bernadette Mary Connaughton Leonard Kruimer Alain Munoz
Board member Board member Board member
Michael John Owen Anneline Nansen Iben Louise Gjelstrup
Board member Board member Board member
Employee elected Employee elected
Jens Peter Stenvang Frederik Barfoed Beck
Board member Board member
Employee elected Employee elected
17 Zealand Pharma A/S | Interim Financial Statements H1 2023
Independent auditor's report
To the shareholders of Zealand Pharma A/S
We have reviewed the interim condensed consolidated
financial statements of Zealand Pharma A/S for the three-
and six-month periods ended June 30, 2023, which
comprise income statement and statement of
comprehensive loss for the three- and six-month periods
ended June 30, 2023, statement of financial position as of
June 30, 2023, statement of cash flow and statement of
changes in equity for the six-month period ended June 30,
2023, and notes, including accounting policies. The interim
condensed consolidated financial statements are prepared
in accordance with IAS 34 Interim Financial Reporting, as
adopted by the EU, and additional requirements of the
Danish Financial Statements Act.
Management's responsibilities for the interim condensed
consolidated financial statements
Management is responsible for the preparation of interim
condensed consolidated financial statements in
accordance with IAS 34 Interim Financial Reporting, as
adopted by the EU, and additional requirements of the
Danish Financial Statements Act and for such internal
control as Management determines is necessary to enable
the preparation of interim condensed consolidated
financial statements that are free from material
misstatement, whether due to fraud or error.
Auditor's responsibilities
Our responsibility is to express a conclusion on the interim
condensed consolidated financial statements. We
conducted our review in accordance with the International
Standard on Review of Interim Financial Information
Performed by the Independent Auditor of the Entity and
additional requirements applicable in Denmark.
This requires us to conclude whether anything has come
to our attention that causes us to believe that the interim
condensed consolidated financial statements, taken as a
whole, are not prepared, in all material respects, in
accordance with IAS 34 Interim Financial Reporting, as
adopted by the EU, and additional requirements of the
Danish Financial Statements Act. This standard also
requires us to comply with relevant ethical requirements.
A review of the interim condensed consolidated financial
statements in accordance with the International Standard
on Review of Interim Financial Information Performed by
the Independent Auditor of the Entity is a limited assurance
engagement. The auditor performs procedures primarily
consisting of making enquiries of Management and others
within the company, as appropriate, applying analytical
procedures and evaluate the evidence obtained.
The procedures performed in a review are substantially less
that those performed in an audit conducted in accordance
with the International Standards on Auditing. Accordingly,
we do not express an audit opinion on the interim
condensed consolidated financial statements.
Conclusion
Copenhagen, August 17, 2023
EY Godkendt Revisionspartnerselskab
Christian Schwenn Johansen Rasmus Bloch Jespersen
State Authorized Public Accountant State Authorized Public Accountant
mne33234 mne35503