• Revenue: DKK63 million for the full year 2024, primarily from the license and development agreement with Novo Nordisk for Zegalogue.
• Net Operating Expenses: DKK1.33 billion, within the guidance range of DKK1.25 billion to DKK1.35 billion.
• R&D Expenses: DKK920 million, representing 69% of operating expenses, driven by clinical advancement of obesity assets.
• Selling and Marketing Expenses: DKK88 million, mainly for pre-commercial activities for rare disease assets.
• Net Financial Items: Net gain of DKK189 million, compared to a net loss of DKK137 million in 2023, due to interest income from marketable securities.
• Cash Position: DKK9 billion as of December 31, 2024, an increase of DKK7.4 billion from the start of the year.
• 2025 Operating Expenses Guidance: Expected to be between DKK2.0 billion and DKK2.5 billion, to support mid-stage obesity pipeline and early-stage research efforts.

• Warning! GuruFocus has detected 6 Warning Signs with ZLDPF.

Release Date: February 20, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Zealand Pharma AS (ZLDPF) reported significant clinical advancements in their obesity pipeline, particularly with petrelintide and survodutide.
• The company has a strong cash position of DKK9 billion, which is DKK7.4 billion higher than the previous year, enabling further investment in R&D.
• Enrollment for the ZUPREME-1 Phase 2b trial with petrelintide has been faster than anticipated, indicating strong interest and progress.
• Zealand Pharma AS (ZLDPF) is committed to advancing its rare disease programs, including congenital hyperinsulinism and short bowel syndrome.
• The company has launched a dedicated sustainability strategy, focusing on responsible operations and reducing greenhouse gas emissions.

Negative Points

• GLP-1-based therapies, a focus area for Zealand Pharma AS (ZLDPF), are associated with gastrointestinal adverse events, leading to high discontinuation rates.
• The company received a complete response letter from the US FDA for glepaglutide, requiring an additional Phase 3 trial for approval.
• Operating expenses are expected to significantly increase in 2025, ranging from DKK2.0 billion to DKK2.5 billion, due to expanded R&D efforts.
• There is uncertainty regarding the timing of partnerships for petrelintide, with no specific guidance provided.
• The company faces challenges in the competitive obesity market, with the need for differentiation in their treatment options.

Q & A Highlights

Q: Can you confirm if more data is needed for petrelintide partnerships, and how important is it to retain co-promotion rights in the US and/or Europe? A: Adam Steensberg, CEO, stated that they are not waiting for additional data for petrelintide partnerships. The focus is on finding a large pharma partner with a shared vision for petrelintide as a foundational therapy. Co-development and co-commercialization with profit share are important, rather than just a licensing agreement.

Q: What is your confidence in achieving 15% to 20% weight loss with petrelintide, and what are the plans for Phase 3 trials? A: David Kendall, Chief Medical Officer, expressed confidence in petrelintide's potential for 15% to 20% weight loss due to its balanced receptor agonism and higher dosing potential compared to competitors. Phase 3 planning is underway, and they aim to start as soon as possible, with partner involvement being beneficial.

Q: What are the expectations for dapiglutide's 28-week data, and how does it compare to glepaglutide's EMA approval prospects? A: Adam Steensberg, CEO, mentioned that dapiglutide aims for weight loss similar to current therapies, with a focus on inflammation reduction. For glepaglutide, they believe the EMA will review the existing data package favorably, despite the FDA's request for additional evidence.

Q: Can you provide updates on the petrelintide Phase 2b study and Novo's Phase 3 study with cagrilintide monotherapy? A: Adam Steensberg, CEO, stated that they will not share interim data from the petrelintide Phase 2b study. Novo's Phase 3 study with cagrilintide monotherapy supports the potential of amylin monotherapies, validating Zealand's approach with petrelintide.

Q: What is the optimal timing for a petrelintide partnership, and how do monotherapy and combination therapy discussions resonate with potential partners? A: Adam Steensberg, CEO, emphasized that they do not guide on partnership timing but noted that partners would likely want to be involved in Phase 3 planning. There is significant interest in monotherapy potential, with combination therapies also recognized for higher weight loss needs.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.