Teresa Graham, Chief Executive Officer of Roche Pharmaceuticals, said:
“We are excited to collaborate with Zealand Pharma and develop this promising therapy, which we hope will provide people living with obesity and related comorbidities a new treatment option. We share the vision to develop petrelintide as a future foundational therapy. By adding petrelintide to our Pharmaceuticals portfolio and with our Diagnostics expertise in cardiovascular and metabolic diseases, we are aiming to transform the standard of care and positively impact patients' lives".
Terms of the agreement
Zealand Pharma and Roche will co-develop and co-commercialize petrelintide and potential combination products, including a fixed-dose combination product of petrelintide and Roche’s lead incretin asset CT-388. The two companies will co-commercialize petrelintide and other products arising from the collaboration in the U.S. and Europe, whereas Roche obtains exclusive rights to commercialization in the rest of the world. Under the terms of the agreement, Zealand Pharma can participate in up to 50% of commercialization activities in the U.S. and Europe, with opt-out and opt-in rights under certain pre-agreed conditions. Roche will be responsible for commercial manufacturing and supply.
As part of this agreement, Zealand Pharma will receive upfront cash payments of USD 1.65 billion, including USD 1.4 billion due upon closing and USD 250 million over the first two anniversaries of the collaboration. Zealand Pharma is also eligible for development milestones of USD 1.2 billion, primarily linked to initiation of Phase 3 trials with petrelintide monotherapy, and sales-based milestones of USD 2.4 billion, for a total consideration to Zealand Pharma of up to USD 5.3 billion. Profits and losses for petrelintide and petrelintide/CT-388 will be shared on a 50/50 basis in the U.S. and Europe, and Zealand Pharma is eligible to receive tiered double-digit royalties up to high teens % on net sales in the rest of the world.
Zealand Pharma will pay Roche USD 350 million, offsetable against the development milestone payments, for the petrelintide/CT-388 fixed-dose combination product or next-generation petrelintide combination products being pursued under the collaboration agreement.
The closing of the transaction is subject to regulatory approvals and other customary closing conditions. The parties expect that the agreement will close in the second quarter of 2025.
Centerview Partners UK LLP and Goldman Sachs International served as financial advisors to Zealand Pharma. Goodwin Procter LLP and Plesner Advokatpartnerselskab served as legal advisors to Zealand Pharma.
Financial guidance 2025
Zealand Pharma’s financial guidance on net operating expenses for 2025, published on February 20, 2025, is confirmed excluding transaction-related costs.
About petrelintide
Petrelintide is a long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation and co-administration with other peptides1. Amylin is produced in the pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Amylin receptor activation has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin2,3, inducing a sense of feeling full faster. Current clinical data or pre-clinical data suggest a potential of petrelintide to deliver weight loss comparable to GLP-1 receptor agonists but with improved tolerability for a better patient experience and high-quality weight loss.
In a Phase 1b multiple ascending dose trial, petrelintide demonstrated body weight reductions of up to a mean of 8.6% after 16 weeks, 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 by one participant who discontinued treatment. No other participants discontinued treatment due to adverse events. No other events of vomiting occurred, and two events of diarrhea were reported, both of which were mild4. Petrelintide is being evaluated in Phase 2b clinical trials. ZUPREME-1 is for people with obesity/overweight without type 2 diabetes (T2D) and was initiated in December 2024 (ClinicalTrials.gov ID: NCT06662539). ZUPREME-2 is for people with obesity/overweight with T2D and is expected to be initiated in the first half of 2025.
About CT-388
CT-388 is a once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity and type 2 diabetes (T2D). CT-388 was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no ß-arrestin recruitment on either receptor. This biased signaling significantly minimizes receptor internalization and consequent desensitization, which is expected to lead to prolonged pharmacological activity. CT-388 is currently being studied in Phase 2b clinical trials in people with overweight/obesity with and without type 2 diabetes.
About obesity
Obesity represents one of the greatest healthcare challenges of our time. Global prevalence of overweight and obesity is projected to reach ~50% by 20305. Obesity is a complex chronic disease associated with more than 220 complications and comorbidities, including cardiovascular disease, liver disease, type 2 diabetes, kidney disease, neuro-inflammation, and some cancers6. Today, two once-weekly GLP-1RA-based therapies have been approved for weight management. There remains a substantial unmet medical need for more and better treatment options for the very large and heterogeneous population living with overweight and obesity. Important and urgent unmet medical needs include the need for treatments with alternative mechanisms of action, more tolerable treatments associated with less frequent and less severe gastrointestinal side effects for a better patient experience, treatments offering increased preservation of lean muscle mass, treatments with even better effect on obesity-related comorbidities, and treatments with even greater weight loss efficacy for the segment of people who need the most weight loss.
Conference call and webcast information
Zealand Pharma will host a conference call today, March 12, at 1:00 PM CET / 8:00 AM ET to elaborate on the collaboration and license agreement with Roche. 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/h77iu4fr. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI1a212e1edd9d493fa03e56e48f620a75. 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/investors/events-presentations/.
About Zealand Pharma
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.
Founded in 1998 and headquartered in Copenhagen, Denmark, Zealand has a team in the U.S. For more information about Zealand Pharma’s business and activities, please visit http://www.zealandpharma.com.
Forward-looking statements and other disclaimers
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 pre-clinical and 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, patient recruitment 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 at third party manufacturers; dependency on third parties, for instance contract research or development organizations; 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 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 company announcement and are based on information available to Zealand Pharma as of the date of this company 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.
Centerview Partners UK LLP (“Centerview”), which is authorized and regulated by the Financial Conduct Authority in the United Kingdom, is acting for Zealand Pharma and no one else in connection with this transaction and will not be responsible to anyone other than Zealand Pharma for providing the protections afforded to clients of Centerview, or for giving advice in connection with this transaction or any matter referred to herein.
Goldman Sachs International, which is authorized by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and the Prudential Regulation Authority in the United Kingdom, is acting for Zealand Pharma and no one else in connection with this transaction and will not be responsible to anyone other than Zealand Pharma for providing the protections afforded to clients of Goldman Sachs International, or for giving advice in connection with this transaction or any matter referred to herein.
Contacts
Adam Lange (Investors)
Investor Relations Officer
Zealand Pharma
alange@zealandpharma.com
Neshat Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
nahmadi@zealandpharma.com
Anna Krassowska, PhD (Investors & Media)
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
akrassowska@zealandpharma.com
Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
ZealandPharma@icrhealthcare.com
+44 (0) 7739 658 783
Sources
1. Eriksson et al. Presentation at ObesityWeek, November 1–4, 2022, San Diego, CA. Link: https://www.zealandpharma.com/media/0gnfxg4b/zp8396-sema-coformulation-obesityweek-2022.pdf.
2. Mathiesen et al. Eur J Endocrinol 2022;186(6):R93–R111.
3. Roth et al. Proc Natl Acad Sci U S A 2008;105(20):7257–7262.
4. Data presented at ObesityWeek 2024 in San Antonio, Texas. Link: https://www.zealandpharma.com/media/vrypyzy1/zealand-pharma-at-obesity-week-2024.pdf.
5. World Obesity Atlas 2024 – Obesity and its consequences (March 2024 report). Link: https://www.worldobesityday.org/assets/downloads/WOF_Obesity_Atlas_2024.pdf.
6. American Medical Association 2024. Obesity. Link: https://www.ama-assn.org/topics/obesity.
