Survodutide

Investors who were eager for news of a partnering deal for the Zealand Pharma’s mid-stage asset petrelintide had a disappointing Thursday morning: The company reported 2024 results without a big pharma signing up. “We are exactly where we want to be,” Zealand CEO Adam Steensberg told Endpoints News in an interview, dismissing the notion that potential partners are waiting for data from the ongoing Phase 2b trial of petrelintide, due in the first half of this year. The group’s 2024 revenues were 62.7 million Danish kroner ($8.8 million), down 82% from 2023. This is because 2023’s figure was buoyed by milestone payments, most notably $30 million from Boehringer Ingelheim. Still, the biotech is well-capitalized, having raised $1 billion last year. Steensberg declined to say whether any milestones might come in 2025, though he did say that if a petrelintide partnership were to happen, it would “provide a pretty significant upfront.” But a deal has been slow — the group has been seeking a partner for the amylin analog for around a year. Steensberg said this is not so much because of big companies’ reluctance, but because of its own determination to sign up the right collaborator. The ideal partner would be one of the 10 biggest pharma companies, with “a vision of winning in this space in the future, and not just playing.” This is a big ask now that Novo Nordisk and Eli Lilly are already way ahead of any competition. In fact, these two companies are the only ones that Zealand believes would not be interested in a deal for petrelintide. More remarkably, Steensberg said a partner would have to share Zealand’s belief that amylin analogs will become “foundational” obesity therapies, meaning that they could eventually become the largest category within weight management, outpacing GLP-1s. This is despite the late-stage disappointment with Novo’s amylin/GLP-1 combo CagriSema. Steensberg said this had no effect on Zealand’s partnering discussions. “If anything, it just underscored what we have been saying for a long time,” he said. “If you ask patients, most are not looking for 25 to 30% weight loss. Most are looking for 15 to 20% weight loss.” Instead, it is petrelintide’s expected better tolerability that could lure patients away from the current GLP-1s, Novo’s Wegovy and Lilly’s Zepbound. “That’s hugely important when you think not just about weight loss, but also weight maintenance,” Steensberg said. Once patients are in the maintenance stage, they will not put up with unpleasant side effects, he added. “I actually, personally think there will be more obese individuals who have tried a GLP-1 and said, ‘never again.’” Steensberg does not believe that an oral therapy will be necessary to do well in the maintenance setting. All of Zealand’s obesity therapies — it has two clinical-stage assets aside from petrelintide — are injected. “If it’s an oral small molecule GLP-1, I actually think the patient experience is going to be significantly worse than on an injectable because of the tolerability issues,” he said, pointing out that GLP-1 pills must be dosed at much higher levels than shots because of the molecules’ low oral bioavailability. But the company has not one but two GLP-1-based drugs in the clinic. The most advanced is survodutide, a GLP-1/glucagon agonist partnered with Boehringer, which is in late-stage trials in both obesity and the fatty liver disease called MASH. Zealand is hoping for around 20% weight loss in the SYNCHRONIZE-1 obesity study, but Steensberg says the key differentiator for survodutide will be its effects in MASH. Boehringer has started two massive trials here, in a total of nearly 3,400 patients. It has not been said when these will report, but Steensberg said that Boehringer expects the product to be on the market in 2027 or 2028 “in either obesity or MASH.” This, at least, will trigger a milestone. Editor’s note: This article was updated to correct the expected date of the petrelintide Phase 2b readout.

Company announcement – No. 2 / 2025 Zealand Pharma Announces Financial Results for the Full Year 2024 A transformational year with significant clinical advancement across differentiated obesity pipeline, while building the foundation for accelerated growth in the years to come Positive results with long-acting amylin analog petrelintide in 16-week Phase 1b trial and advancement into large, comprehensive Phase 2b trial in people with overweight or obesity Positive topline results with GLP-1/GLP-2 receptor dual agonist dapiglutide in 13-week Phase 1b trial and expansion of trial to investigate higher doses over a longer treatment period Positive results with glucagon/GLP-1 receptor dual agonist survodutide in Boehringer Ingelheim Phase 2 trial in MASH and advancement into largest Phase 3 MASH program with an incretin-based therapy DKK 8.5 billion (USD 1.2 billion) secured through two equity raises enabling significant investments in R&D pipeline and organizational capabilities Copenhagen, Denmark, February 20, 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 financial results for the year ended December 31, 2024 and provided a corporate update. Driving innovation in obesity with differentiated mid- to late-stage pipeline “2024 was a transformational year for Zealand Pharma with positive data across our mid- to late-stage obesity pipeline and significant capital raised to further invest in our pipeline and the organization, preparing the company for the next phase of growth,” said Adam Steensberg, President and Chief Executive Officer at Zealand Pharma. “From this very solid foundation, both financially and organizationally, we expect accelerated momentum in 2025 with important clinical advancement of our obesity programs.” Key financial results for FY 2024 DKK millionFY 2024FY 2023Revenue62.7342.8Net operating expenses1-1,327.0-895.9Net operating result-1,272.2-572.2Net financial items188.8-136.6Cash position29,022.01,633.1 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. Financial guidance for 2025 The strong cash position enables Zealand Pharma to significantly accelerate its investments in the company’s wholly-owned obesity programs, which in 2025 will include three large Phase 2b trials. Net operating expenses expected in 2025 are mostly driven by research and development. Development costs primarily relate to the clinical advancement of the wholly-owned obesity programs, including Phase 2b trials, CMC activities related to API and Drug Product, as well as Phase 3 preparations. Research costs are mainly driven by enhanced investments in next-generation peptide therapeutics focused on obesity and inflammation. DKK million 2025 Guidance2024 ActualRevenue anticipated from existing and new license and partnership agreementsNo guidance62.7Net operating expenses32,000 – 2,5001,327.0 Notes:3. Financial guidance based on foreign exchange rates as of February 19, 2025. Highlights of the year and key events anticipated in 2025 Obesity – advancing the differentiated pipeline Petrelintide, a long-acting amylin analog. Zealand Pharma reported positive results from the 16-week Phase 1b trial with petrelintide and presented the data at the Obesity Society Annual Meeting (ObesityWeek). In December 2024, the company subsequently initiated ZUPREME-1, a large, comprehensive Phase 2b trial in people with overweight or obesity and anticipates completion of participant enrolment in the first half of 2025. The company also expects to expand the development program of petrelintide by initiating ZUPREME-2, a Phase 2b trial in people with overweight or obesity and type 2 diabetes in the first half of 2025. Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist. Zealand Pharma reported positive topline results from the 13-week Phase 1b trial with dapiglutide, providing support for advancing this candidate into a large Phase 2b trial in people with overweight or obesity, which is planned for initiation in the first half of 2025. The company also expanded the Phase 1b trial to evaluate higher doses of dapiglutide over a longer treatment period, with topline results from this part of the trial expected in the first half of 2025. Survodutide, a glucagon/GLP-1 receptor dual agonist. Boehringer Ingelheim reported positive results from the Phase 2 trial with survodutide in MASH, presented the data at the European Association for the Study of the Liver (EASL), and received a Breakthrough Therapy Designation from the U.S. FDA. Boehringer Ingelheim subsequently initiated two large registrational Phase 3 trials with survodutide in people with MASH; LIVERAGE™ in people with moderate or advanced liver fibrosis (stages 2 or 3) and LIVERAGE™-Cirrhosis in people with compensated cirrhosis (fibrosis stage 4). In 2024, Boehringer Ingelheim also completed participant enrolment for SYNCHRONIZE™-1 and SYNCHRONIZE™-2, the Phase 3 clinical trials of survodutide in people with overweight or obesity without and with type 2 diabetes, respectively. Rare diseases – long-term commitment to patients with CHI and SBS Dasiglucagon in congenital hyperinsulinism (CHI). Zealand Pharma is prepared to resubmit the New Drug Application (NDA) for three weeks of dosing to the U.S. FDA contingent on the third-party manufacturing facility receiving an inspection classification upgrade. Subsequently, Zealand Pharma also expects to submit the required and detailed analyses from existing continuous glucose monitoring datasets to support the use of dasiglucagon beyond three weeks. Glepaglutide in short bowel syndrome (SBS). In December 2024, Zealand Pharma received a Complete Response Letter (CRL) for the NDA for glepaglutide, a long-acting GLP-2 analog under development for the treatment of adults with SBS with intestinal failure. In 2025, the company expects to initiate a single placebo-controlled Phase 3 trial (EASE-5) to provide further confirmatory evidence for a regulatory submission in the U.S. and to support regulatory submissions for glepaglutide in geographies outside the U.S. and the EU. In parallel, Zealand Pharma anticipates proceeding with current plans to submit a Marketing Authorization Application to support EU approval. Chronic inflammation – progressing the pipeline ZP9830, Kv1.3 ion channel blocker. Zealand Pharma initiated the first-in-human clinical trial with ZP9830, a Kv.1.3 ion channel blocker in late 2024 and anticipates completing this trial in 2025. The company believes this candidate holds potential to treat a broad range of cell-mediated autoimmune diseases. Sustainability – building a sustainable organization In 2024, Zealand Pharma launched a refined sustainability strategy and developed a Climate Change Transition Plan, outlining activities and targets for climate change mitigation. The company will further accelerate its sustainability efforts in 2025, with key focus areas including the expected submission of the Climate Change Transition Plan to the Science Based Targets Initiative and continued preparations for the EU’s Corporate Sustainability Reporting Directive. Zealand Pharma achieved notable organizational growth in 2024 with a 30% increase in the number of employees compared to 2023. Yet, the company maintained its high employee engagement score of 8.8/10 and decreased the employee turnover rate from 10.3% in 2023 to 7.3% in 2024. Conference call today at 2 PM CET / 8 AM ET Zealand Pharma’s management will host a conference call today February 20 at 2:00 PM CET / 8:00 AM ET to present results for the full year 2024 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/96nk8pep. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI735075144114493ead489441f1d0740f. 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/. About Zealand Pharma 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. 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, 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. Contacts Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: akrassowska@zealandpharma.com Adam Lange (Investors)Investor Relations OfficerZealand PharmaEmail: alange@zealandpharma.com Neshat Anis Ahmadi (Investors)Investor Relations ManagerZealand PharmaEmail: neahmadi@zealandpharma.com Attachment Zealand Pharma 2024 Annual Report