Zealand Pharma Announces Financial Results for the First Three Months of 2025

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 expenses(1)   -393.1(2)  -266.3 
----------------------  ---------  ------ 
Operating result        -385.5(2)  -255.8 
----------------------  ---------  ------ 
Net financial items          70.3    25.8 
----------------------  ---------  ------ 
 
 
                    Mar-31,    Dec-31, 
DKK million           2025       2024 
-----------------  ----------  ------- 
Cash position(3)   8,544.5(4)  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. 
 
                               2025         2024 
DKK million                Guidance(5,6)   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$(R)$ 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

Attachment

   -- Zealand Pharma Q1 2025 Interim Report 

(END) Dow Jones Newswires

May 08, 2025 01:00 ET (05:00 GMT)