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Zealand Pharma

Interim / Quarterly Report Aug 15, 2024

3391_ir_2024-08-15_278e4da6-cb12-4f8c-9b78-df851ab5ebe4.pdf

Interim / Quarterly Report

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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 expenses1 -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 position2 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/m2 . 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 investigatorled trial DREAM with low doses of dapiglutide. Topline results showed mean weight loss of up to 4.3% after 12

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 dysfunctionassociated 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, SYNCHRONIZETM, 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

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
expenses3
1,250-1,350 1,100-1,200

Notes:

  1. 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

Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.

Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand's business and activities, please visit www.zealandpharma.com.

Forward-looking Statements

This company announcement and interim report contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom and the company's Upcoming Events and Financial Guidance for 2023. These forwardlooking 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 forwardlooking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Zealand Pharma® is a registered trademark of Zealand Pharma A/S.

Contacts:

Adam Lange Investor Relations Officer Zealand Pharma Email: [email protected]

Anna Krassowska, PhD Vice President, Investor Relations & Corporate Communications Zealand Pharma Email: [email protected]

No. 39 / 2024

R&D Pipeline

Therapeutic area Product candidatea Partnered Pre-clinical Phase 1 Phase 2 Phase 3 Registration
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. bSurvodutide 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.

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 coformulation 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 83rd 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 companysponsored 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

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, placebocontrolled 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 82nd 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 singlehormone 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 (SYNCHRONIZETM).

SYNCHRONIZETM-1 (ClinicalTrials.gov ID: NCT06066515) and SYNCHRONIZETM-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. SYNCHRONIZETM-1 will enroll people without type 2 diabetes (eligible HbA1c <6.5%) and SYNCHRONIZETM-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.

SYNCHRONIZETM-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 SYNCHRONIZETM-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, SYNCHRONIZETM-CN (ClinicalTrials.gov ID: NCT06214741), and in Japanese people living with overweight or obesity, SYNCHRONIZETM-JP (ClinicalTrials.gov ID: NCT06176365), have also been initiated. A Phase 3 trial in people with overweight or obesity and confirmed or presumed metabolic dysfunctionassociated 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

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 83rd Scientific Sessions in June 2023. Additional data, presented at the 59th 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, doubleblind 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 dosedependent 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 (SYNCHRONIZETM). 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 lowdouble 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.

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 thirdparty 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 selfmeasured plasma glucose. However, dasiglucagon treatment resulted in a 40–50% reduction in hypoglycemia compared to SOC alone, when assessed by blinded continuous glucose monitoring.

The Phase 3 trial 17106 (ClinicalTrials.gov ID: NCT03941236) is evaluating the long-term safety of dasiglucagon in 42 of the 44 children older than 1 month with CHI who completed either of the Phase 3 trials 17103 or 17109.

Glepaglutide (long-acting GLP-2 analog) for short bowel syndrome (SBS)

Background:

Glepaglutide is a long-acting GLP-2 analog that is stable in aqueous solution. Zealand is developing glepaglutide as a ready-to-use, fixed dose product designed for subcutaneous delivery via auto-injector for the potential treatment of SBS. The Phase 3 program, named EASE, includes four clinical trials evaluating the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. Efficacy and safety data from these trials formed the basis of an NDA submission to the US FDA in December 2023. The FDA has granted a PDUFA date on December 22, 2024 for glepaglutide in SBS with intestinal failure. The FDA has also granted orphan drug designation to glepaglutide for the treatment of SBS.

EASE-1 (ClinicalTrials.gov ID: NCT03690206) is a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks.

In EASE-1, glepaglutide given twice weekly significantly reduced the total weekly volume of parenteral support at 24 weeks as compared to placebo (p=0.0039). When

administered once weekly, glepaglutide treatment also resulted in a numeric reduction in weekly parenteral support, however this did not achieve statistical significance. At 24 weeks, the average reduction in parenteral support from baseline was 5.13 Liters/week for patients treated with glepaglutide twice weekly and was 3.13 Liters/week for patients treated with glepaglutide once weekly. Placebo treatment resulted in a reduction in parenteral support of 2.85 Liters/week. Clinical response, defined as a patient achieving at least 20% reduction in weekly parenteral support volume from baseline at both 20 and 24 weeks, was significantly higher with twice weekly glepaglutide compared to placebo (p=0.0243). Among patients receiving glepaglutide twice weekly, 65.7% achieved a clinical response, whereas 45.7% and 38.9% of patients achieved a clinical response in the once weekly and placebo treatment groups, respectively.

In the twice weekly dosing group, 14% of patients (n=5) were completely weaned off parenteral support (enteral autonomy). In total, 9 patients treated with glepaglutide achieved enteral autonomy, while no placebo-treated patients were able to discontinue parenteral support. Glepaglutide appeared to be safe and was well-tolerated in the trial. The most frequently reported adverse events were injection site reactions and gastrointestinal events. These results were presented at the ASPEN 2023 Nutrition Science & Practice Conference in April 2023 and Digestive Diseases Week in May 2023.

In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, longterm 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 autoinjector. 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 antiinflammatory 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,

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, selflearning, 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 mealinduced hypoglycemia following gastric bypass surgery (post bariatric hypoglycemia, or PBH). Four investigatorinitiated 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.

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
Jun-30, Dec-31,
Statement of financial position (DKK thousand) Note 2024 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
Purchase of property, plant and equipment
-990 -
Free cash flow 2) -8,625
-463,630
-3,686
-376,166
Other Note Jun-30, Dec-31,
2024 2023
Share price (DKK)
Number of shares ('000 shares)
892.5
71,001
373.2
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.

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 writedown associated with Zegalogue®.

Financial items

OPEX by quarter

DKK million

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.

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.

Cash position compared to FY23

    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.
    1. 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.

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.

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 equity20
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 items23
4. Trade and other receivables 24
5. Marketable securities 25
6. Financial instruments26
7. Cash and cash equivalents 28
8. Share capital28
9. Cash flow adjustments29
10. Capital Management 29
11. Contingent assets and liabilities30
12. Significant events after the reporting period30
Statement by the Executive Management and the Board of Directors 31

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

Interim statement of comprehensive loss.

Note Q2-24 Q2-23 Q2-24 YTD Q2-23 YTD
-292,752 -319,502 -521,398 -513,133
-60 -26 -44 3,759
-509,374
-292,812
-319,528
-521,442

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 5 814,936 -
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 4 203,085 122,359
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

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

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

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.

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
Q2-24 YTD Q2-23 YTD
15,000 -
477 444
19,658 22,866
14,085 726
49,220 24,036
Q2-24
Q2-23
15,000
-
216
9,426
9,489
34,131
210
9,471
726
10,407

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.

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.

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.

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.

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

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.

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.

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 sharebased 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.

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.

Statement by the Executive Management and the Board of Directors

The Board of Directors and the Executive Management have today discussed and approved the interim report of Zealand Pharma A/S for the period January 1, 2024 to June 30, 2024.

The interim report has not been audited or reviewed by the company's independent auditors.

The interim report has been prepared in accordance with IAS 34 Interim Financial Reporting as adopted by the EU and additional Danish disclosure requirements for interim financial reporting of listed companies.

In our opinion, the interim consolidated financial statements give a true and fair view of the Group's consolidated assets, liabilities and financial position as of June 30, 2024 and of the results of the Group's consolidated operations and cash flows for the period January 1, 2024 to June 30, 2024.

Furthermore, in our opinion, the Management review includes a fair review of the development in the Group's operations and financial conditions, the results for the period, cash flows and financial position while also describing the most significant risks and uncertainty factors that may affect the Group.

Copenhagen, August 15, 2024

Management

Adam Sinding Steensberg Henriette Wennicke 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 Elaine Sullivan Board member Board member Board member

Enrique Alfredo Conterno Martinelli Anneline Nansen Frederik Barfoed Beck Board member Board member Board member

Ludovic Tranholm Otterbein Adam Krisko Nygaard Board member Board member Employee elected Employee elected

President and Executive Vice President and

Employee elected Employee elected

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