Company announcement - No. 11 / 2025
Zealand Pharma Announces Financial Results for the First Three Months of 2025
Significant progress in the clinical pipeline, strengthening of organizational capabilities, and strategic partnership for petrelintide create strong foundation for accelerated growth.
- Entered historic and transformative partnership with Roche to co-develop and co-commercialize petrelintide as a future foundational therapy for weight management and rapidly expand into related indications, aiming to establish the leading amylin-based franchise.
- Enrolled the last participant in the large, global Phase 2 ZUPREME-1 trial with petrelintide in people with overweight or obesity, three months after trial initiation.
- Appointed Utpal Singh as Chief Scientific Officer in April 2025 to lead the next wave of differentiated and innovative medicines, building on Zealand Pharma's strong peptide heritage and its ambition to become a generational biotech company.
Copenhagen, Denmark, May 8, 2025 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the interim report for the three months ended March 31, 2025, and provided a corporate update.
Embarking on a new chapter with transformative partnership for petrelintide
Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said:
"Zealand Pharma has never been in a stronger position than we are today - financially, organizationally and in terms of our clinical development pipeline. The strong foundation enables us to unlock the full value potential of petrelintide in partnership with Roche and significantly accelerate investments in our early-stage research pipeline of next-generation peptide therapeutics targeting obesity and inflammation."
Key financial results for Q1 2025
| DKK million | Q1-25 | Q1-24 |
| Revenue | 8.1 | 15.1 |
| Operating expenses1 | -393.12 | -266.3 |
| Operating result | -385.52 | -255.8 |
| Net financial items | 70.3 | 25.8 |
| DKK million | Mar-31, 2025 | Dec-31, 2024 |
| Cash position3 | 8,544.54 | 9,022.0 |
Notes:
1. Operating expenses consist of R&D, S&M, and G&A.
2. Excluding transaction costs of DKK 21.6 million related to the Roche partnership agreement. Operating expenses including transaction fees in Q1 2025 amount to DKK 415 million.
3. Cash position includes cash, cash equivalents and marketable securities.
4. Upfront payment of USD 1.4 billion from Roche is expected in the second quarter of 2025.
Highlights in the first quarter of 2025
Obesity
- Petrelintide, amylin analog. Entered a collaboration and license agreement with Roche. The two companies will co-develop and co-commercialize petrelintide and potential combination products, including petrelintide/CT-388, aiming to establish the leading amylin-based franchise for weight management and related indications. The companies will share profits and losses on a 50/50 basis for petrelintide and petrelintide/CT-388 in the U.S. and Europe, and Zealand Pharma is eligible to receive royalties on net sales in the rest of the world. Total deal consideration amounts to USD 5.3 billion, including upfront cash payments of USD 1.65 billion and potential development milestone payments of USD 1.2 billion, primarily linked to initiation of Phase 3 trials with petrelintide monotherapy.
- Petrelintide, amylin analog. Completed enrollment in the large, global Phase 2 ZUPREME-1 trial with petrelintide in people with overweight or obesity, three months after trial initiation.
- Survodutide, glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim completed participant enrollment in the Phase 3 SYNCHRONIZETM-CVOT trial, marking full enrollment of all trials in the Phase 3 obesity program.
Corporate
- Appointed Steven R. Smith, MD, as Senior Global Medical Advisor in Obesity. Steven will support Zealand Pharma's obesity research and clinical development programs.
Events after the reporting date
Obesity
- Petrelintide, amylin analog. In April 2025, Zealand Pharma initiated the Phase 2 ZUPREME-2 trial with petrelintide in people with overweight or obesity and type 2 diabetes, investigating the efficacy and safety of petrelintide over a treatment duration of 28 weeks.
Corporate
- Appointed Utpal Singh as Chief Scientific Officer. Utpal joins the executive team to lead discovery research and translational sciences at Zealand Pharma. Utpal brings nearly 25 years of pharmaceutical industry experience spanning the full drug discovery and development lifecycle.
Upcoming events next 12 months
Obesity
- Petrelintide, amylin analog. In the first half of 2026, Zealand Pharma expects to report topline results from the Phase 2 ZUPREME-1 trial and complete the Phase 2 ZUPREME-2 trial with petrelintide.
- Petrelintide/CT-388, amylin+GLP-1/GIP fixed-dose combination. Zealand Pharma and Roche expect to initiate Phase 2 trials with petrelintide/CT-388 in the first half of 2026.
- Dapiglutide, GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2025, Zealand Pharma expects to announce topline results from Part 2 of the Phase 1b trial evaluating higher doses of dapiglutide over 28 weeks of treatment, with subsequent initiation of a Phase 2 trial expected in the second half of 2025. Zealand Pharma will present the results from Part 1 of the Phase 1b trial at the American Diabetes Association's 85th Scientific Sessions in Chicago, Illinois in June 2025.
- Survodutide, glucagon/GLP-1 receptor dual agonist. Topline data from SYNCHRONIZETM-1 and SYNCHRONIZETM-2, the Phase 3 trials with survodutide in participants with overweight or obesity without and with type 2 diabetes, respectively, are expected in the first half of 2026.
Rare diseases
- Glepaglutide in SBS. In the second half of 2025, Zealand Pharma expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and initiate a Phase 3 clinical trial of glepaglutide (EASE-5) that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. and to support regulatory submissions outside the U.S. and the EU. In parallel, the company is engaging in partnership discussions for future commercialization.
- Dasiglucagon in CHI. Zealand Pharma is ready to resubmit the New Drug Application for dasiglucagon for up to three weeks of dosing and to submit the requested analyses from existing continuous glucose monitoring datasets to support use beyond three weeks. The regulatory submissions are, however, contingent on an inspection classification upgrade of a third-party manufacturing facility. In parallel, the company is engaging in partnership discussions for future commercialization.
Chronic inflammation
- ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma expects to complete the first-in-human clinical trial with ZP9830 in the fourth quarter of 2025 and report topline data in the first half of 2026.
Corporate
- Zealand Pharma Capital Markets Day. Zealand Pharma will host a Capital Markets Day in London on December 11, 2025. Speakers will include Management as well as external experts and thought leaders in obesity.
Financial guidance for 2025
- Guidance unchanged from February 20, 2025, excluding transaction-related costs associated with the Roche collaboration, which are expected to be approximately DKK 200 million in 2025.
| DKK million | 2025 Guidance5,6 | 2024 Actuals |
| Revenue anticipated from existing and new license and partnership agreements | No guidance | 63 |
| Net operating expenses | 2,000-2,500 | 1,327 |
Notes:
5. Excluding transaction-related costs related to the Roche collaboration.
6. Financial guidance based on foreign exchange rates as of May 7, 2025.
Conference call today at 2 PM CET / 8 AM ET
Zealand's management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results for the first three months of 2025 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; Chief Medical Officer, David Kendall; and Chief Commercial Officer, Eric Cox. The conference call will be conducted in English.
The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/tcdv3c9d/. To receive telephone dial-in information and a unique personal access PIN, please register at https://register-conf.media-server.com/register/BI52c8f77e4cea4195bc9f471f636e1bba. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand Pharma's website at https://www.zealandpharma.com/investors/events-presentations/.
Financial Calendar for 2025
| Q2 2025 | August 14, 2025 |
| Q3 2025 | November 13, 2025 |
| Q4/FY 2025 | February 19, 2026 |
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products.
Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. For more information about Zealand Pharma's business and activities, please visit www.zealandpharma.com.
Forward-looking Statements
This company announcement contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development, and commercialization of pharmaceutical products, the timing of the company's clinical trials and the reporting of data therefrom and the company's significant events and potential catalysts in 2025 and Financial Guidance for 2025. These forward-looking statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would", and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labelling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Zealand Pharma® is a registered trademark of Zealand Pharma A/S.
Contacts
Adam Lange
Vice President, Investor Relations
Zealand Pharma
Email: ALange@zealandpharma.com
Neshat Ahmadi
Investor Relations Manager
Zealand Pharma
Email: NeAhmadi@zealandpharma.com
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: AKrassowska@zealandpharma.com
