Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Zealand Pharma AS (ZLDPF, Financial) reported positive data from the Phase 1 trial of petrelintide, showing it is well-tolerated and could offer a better patient experience compared to GLP-1-based therapies.
- The company is exploring collaboration opportunities with large pharma companies to further develop petrelintide as a potential first-line therapy for weight management.
- Positive top-line data from the Phase 1b trial of dapiglutide, a GLP-1, GLP-2 dual agonist, supports its potential as a first-in-class therapy for obesity and inflammation-related comorbidities.
- Boehringer Ingelheim, a partner of Zealand Pharma AS (ZLDPF), has initiated a large global Phase 3 program for survodutide in MASH, which has received FDA breakthrough therapy designation.
- Zealand Pharma AS (ZLDPF) has a strong cash position of DKK9.2 billion, enabling significant investments into their obesity programs.
Negative Points
- Operating expenses for the first nine months of 2024 were high at DKK919 million, primarily driven by research and development costs.
- The company received a complete response letter from the FDA for dasiglucagon due to issues with a third-party manufacturing facility, delaying its approval.
- There is a significant overlap between obesity and MASH, which could complicate the development and positioning of survodutide.
- Real-world data suggests that up to 30% of patients on GLP-1 treatments stop within a month, indicating potential challenges in patient adherence.
- The company faces competition from other amylin analogs and incretin-based therapies, which could impact the market potential of petrelintide.
Q & A Highlights
Q: Can you confirm if the Phase 2b trial will evaluate five different doses or fewer doses with different titration regimes? Also, is the intention to take more than one dose through to a Phase 3 trial?
A: The Phase 2b trial will evaluate different top or maximal exposure doses with a similar dose escalation scheme across each. For Phase 3, it is not certain yet if a single or multiple doses will be necessary; this will be determined after reviewing the data from the Phase 2b trial.
Q: Are you hearing about taste aversion from patients taking petrelintide, similar to what was reported by a competitor?
A: We have not observed reports of taste aversion with petrelintide. The potential for taste aversion is not mediated through the calcitonin receptors but rather the CGRP receptor component, which petrelintide does not significantly activate.
Q: How are the early partnership discussions for petrelintide progressing, and do you still aim for a co-commercialization agreement?
A: We are very pleased with the progress of our partnership discussions. We aim for a co-development and co-commercialization opportunity, focusing on the US and potentially other major markets. So far, we have not faced significant pushback on this ambition.
Q: What are the implications of the upcoming CagriSema data for petrelintide, particularly regarding the cagrilintide monotherapy arm?
A: We are interested in seeing the data, especially the cagrilintide monotherapy arm. While it can provide some guidance, we recognize that petrelintide has a higher bioavailability and will be dosed higher in our studies, so we need to conduct our own Phase 2b to fully understand its potential.
Q: Could you explain the potential early launch strategy for glepaglutide and whether it would require additional SG&A costs?
A: The launch of glepaglutide would involve a limited footprint similar to rare diseases, with some increase in SG&A costs. We are looking for a commercial partner to expand reach and maximize commercial potential.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
