Release Date: August 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Zealand Pharma A/S (ZLDPF, Financial) reported positive top-line data from the Phase 1b trial of petrelintide, showing significant weight loss and a favorable tolerability profile.
- The company successfully raised DKK7 billion in an oversubscribed equity offering, strengthening its financial position.
- Partnership discussions for Dasiglucagon in congenital hyperinsulinism and Glepaglutide in short bowel syndrome are progressing well.
- Zealand Pharma A/S (ZLDPF) has initiated dialogues with potential partners for petrelintide, aiming to find a committed partner for its development.
- The company has a strong pipeline with multiple promising assets, including survodutide and dapiglutide, showing positive results in clinical trials.
Negative Points
- Operating expenses for the first six months of 2024 were high at DKK559 million, driven primarily by research and development costs.
- The company faces significant competition in the obesity treatment market, particularly from GLP-1-based therapies.
- There is a high dropout rate for obesity treatments, with up to 30% of patients discontinuing within the first month due to tolerability issues.
- Zealand Pharma A/S (ZLDPF) needs to secure a commercial partnership to maximize the long-term value of its assets, which may pose a challenge.
- The company is heavily reliant on the success of its obesity programs, which are still in the early stages of clinical development.
Q & A Highlights
Q: What drove the decision to include the higher dose cohort in the Phase 1 trial for dapiglutide rather than waiting for Phase 2?
A: The decision was driven by the need to understand safety and tolerability at higher doses. The higher dose cohort will not impact the initiation of the Phase 2b trial but could potentially be included if well tolerated. The goal is to achieve weight loss comparable to petrelintide, aiming for at least 20% weight loss in longer-term studies.
Q: Can you elaborate on the rationale for using MRI to assess body composition in the Phase 2 trial for petrelintide?
A: MRI is considered the most predictive and reproducible measure for body composition. It will be used to assess the quality of weight loss, including lean body mass preservation. Bone density will also be observed.
Q: How many patients discontinue obesity treatment due to tolerability issues, and how does amylin compare?
A: Recent publications suggest that 30% of patients discontinue GLP-1 treatments within a month due to tolerability issues. We believe amylin, with its differentiated mechanism, offers a better tolerability profile, potentially reducing dropout rates.
Q: What data supports the long-term weight reduction potential of petrelintide?
A: Data from studies up to 32 weeks show continuous weight loss with petrelintide. The highest dose in the recent trial showed signs of continued weight loss, suggesting potential for long-term efficacy.
Q: What are the key features you look for in a partner for petrelintide?
A: We seek a large pharma partner committed to developing petrelintide as a backbone therapy for weight management. The partner should be willing to invest in clinical development, manufacturing, and global commercialization. We aim for co-development and co-commercialization rights, especially in major markets.
Q: What can we expect from the full data set for petrelintide?
A: The full data set will include safety markers, effects on blood pressure, heart rate, and some biomarkers. The Phase 2b study will have a more comprehensive biomarker assessment and MRI for body composition.
Q: Is co-development and co-commercialization a must-have for Zealand Pharma in partnership discussions?
A: Yes, it is crucial for us to stay involved in both development and commercialization to maximize long-term value creation. We believe we have a unique opportunity with petrelintide and aim to negotiate a deal that includes these rights.
Q: What is the market opportunity for glepaglutide in short bowel syndrome (SBS)?
A: Glepaglutide has a strong competitive profile with significant reductions in the need for parenteral support. The SBS market is growing, currently around USD 800-900 million, and we see significant opportunities to expand it with second-generation molecules.
Q: Are you preparing for internal launches for SBS and CHI, or do you expect partners to step in?
A: We are prepared to make these products available to patients if needed, but our focus remains on securing partnerships to drive commercial rollout. We are ready for CHI, given its ultra-rare nature, and are making prelaunch preparations for SBS.
Q: What are your thoughts on oral development technologies for existing assets?
A: We are exploring oral delivery technologies as part of our life cycle management strategy. While injectables will remain the primary administration method, we are making preparatory steps for oral delivery, especially within a partnership framework.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
