Zealand Pharma A/S Q4 2024 Earnings Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: James Gordon - JPMorgan - Analyst : Firstly, petre partnership and the rate limiting factors for getting that done. So can you just confirm, do you think any more data might be needed either for your products or for competitor amylin molecules? Might a potential partner want to see CagriSema data presented, or if you think all the necessary data is now available, why wouldn't a partnership, say, potentially happen in the coming months versus later in the year or even into 2026? Second question on partnership. Just how important is it that you retain co-promotion rights in the US and/or Europe versus who the partner is and what they can do for the product? And a final question just on glepa, you mentioned the EASE-5 study, which you need probably to get to the US, when do you think that will be done? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 20, 2025 / 1:00PM, ZELA.CO - Q4 2024 Zealand Pharma A/S Earnings Call

Question: Charlie Haywood - Bank of America - Analyst : I have two, please. So the first is on your target petre 15% to 20% weight loss given cagri saw 12% weight loss. What's your confidence in still being able to achieve the top end of that range, so the 20% weight loss and what drives that confidence? And secondly, can you remind us of your plan and timelines for your petre Phase 3 trial discussion with regulators or the FDA? How do you expect to start those? And I think as you're likely to be discussing fairly broad Phase 3 plans, including a CV trial with them. From partner discussions you've had to date, do you think that's a conversation that a potential partner is likely to want to be involved in?

Question: Michael Novod - Nordea - Analyst : A couple of questions. So starting with dapiglutide. Can you sort of try to detail what you're sort of hoping to see in terms of the 28-week data of 26 milligrams in order to say that this is a qualifying candidate to move further with and where they could also potentially be partnering interest for this asset in terms of weight loss or other biomarkers? And then secondly on glepaglutide. Is there any reason to believe that EMA would not take the same stance as the FDA because the CRL was clearly surprising? So maybe you can go into a bit of more details on why we should not expect the same risk on an EMA approval or non-approval?

Question: Suzanne van Voorthuizen - Van Lanschot Kempen - Analyst : First, on the petrelintide Phase 2b study that's ongoing. Fully understood that it remains blinded until 42 weeks, but I'm just wondering if we could expect some sort of communication from the company around the 20-week time point, not data, but, for example, having reached this point or updates on the regulatory interactions. And secondly, I was wondering if you can share your views with regards to Novo also starting a Phase 3 study with cagrilintide monotherapy. Obviously petrelintide seems like a better molecule, but since there's a change in Novo's side to also develop as monotherapy, just wondering how you look at this.

Question: Prakhar Agrawal - Cantor Fitzgerald - Analyst : So maybe firstly a clarification, Adam. The press articles today morning are saying that you're guiding partnerships by end of 2025, early 2026 versus you're not commenting on timing here. So if you can clarify this, please, on the potential timing of partnership discussions? And as a follow up, discussion around amylin monotherapy versus combinations, how is that resonating with potential partners? And is there interest from companies that are not involved in the obesity space as you are working through the partnerships?

Question: Rajan Sharma - Goldman Sachs & Co - Analyst : Just on the partnering point, sorry to ask another one on this. But could you just kind of remind us how you think about the optimal timing for this partnership? I guess the question that I'm trying to ask is beyond the additional capital that a larger partner may bring. At what point do they add value to petrelintide's development process beyond what Zealand can do alone given that you probably have as much experience as any company with the mechanism itself? And then secondly, sort of related to that, just on that combination trial with the GLP-1. Is that likely to come after a partnership has been announced? Just trying to think about what the identity of that GLP-1 partner could be or is there potential to initiate a combination with dapi?

Question: Rajan Sharma - Goldman Sachs & Co - Analyst : Maybe just on -- maybe less sneaky then the bit that I also asked on the dapi combination, could that be a potential combination partner with petrelintide?

Question: Benjamin Jackson - Jefferies - Analyst : So firstly, just a very short one on the dapi part to data. Is the hope here to present it alongside the 13-week data at the Medical Conference that is referenced this year? Is that the hope or is it too early to think about because we haven't had the readout yet? And then the second question is more about the rationale of ZUPREME-2 and the obese diabetics here. Is the end goal to try and find a label for obese diabetics with this molecule, obviously noting the different impact on HbA1c that it has or is it more of an exploratory study? And alongside that, what is building confidence of the potential difference of amylin when you look at the weight loss in obese individuals versus obese diabetic individuals? I think some data has pointed to that potentially there's a little bit more weight loss, relative to GLP-1s in diabetic individuals. What builds confidence around that? And is there anything you can point to for us for this trial?

Question: Thomas Franken - KBC Securities - Analyst : I want to ask one question. Given that you view amylin as a potential backbone therapy and obesity, what is your strategy for this target beyond petre? Do you plan to explore alternative or less frequent dosing regimens, for example, or monthly versus weekly dosing?

Question: Kerry Holford - Berenberg - Analyst : Couple of questions left to me, please. With regard to the Phase 3 preparation investment that you have, does that relate to both petrelintide and dapiglutide? And I wonder if you can just talk about exactly what you are looking to entail here? And in the context of thinking about Phase 3, is there any scenario under which you would consider pursuing that next stage of development on your own for both or one of those two products? Then, with regard to the Phase 2b program for petrelintide, I wanted to check, are you measuring body composition, quality of weight loss in both ZUPREME-1 and 2? I can see on your slides that ZUPREME-1, but also second study. And then essentially you talked at great length about the differentiation potential perpetual inside tolerability, but I'd just love to hear your expectations of whether the body composition angle could be a key point of differentiation for this drug also.

Question: Laura Hindley - Morgan Stanley - Analyst : So yes, following on the theme of Phase 3 planning, can you remind us what your current cash position would support in terms of development progress for your wholly-owned obesity pipeline assets? And then back on the theme of quality of weight loss, on your slide for dapiglutide Phase 2B design, you have a body composition endpoint. Is there any evidence that you would flag to suggest that GLP-2 would have a differentiated effect on quality of weight loss? And then finally, when you're having your negotiations for partnership around petrelintide, is there also any discussion around dapiglutide or is it entirely focused on amylin for now?

Question: Jesper Ilsoe - Carnegie - Analyst : A question for Eric Cox. It's a bit more broader question, but you previously worked in Carmot, which were acquired by Roche. So perhaps you can share your, sort of, view on the general deals space in the obesity market today versus back when you worked in Carmot? Because I think the typical question we also get is, yes, we have very good -- obesity has it's more and more innovation, but we haven't yet seen the bigger deals and we're starting to see some deals happening from China for smaller early-stage assets. So just interested in your view and sort of what is the barriers to this these bigger deals happening or holding it back? Thank you.

Question: Rei Tan - Zealand Pharma A/S - Analyst : This is Rei on for Julian. Congrats on all the progress. Just a couple from us on glepaglutide. First, is it abundantly clear that an additional study is necessary in the US or is there an opportunity to potentially refile based on the existing data? And then as a follow up to that, what could the approximate timeline to refiling the NDA for glepaglutide in the US look like? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. FEBRUARY 20, 2025 / 1:00PM, ZELA.CO - Q4 2024 Zealand Pharma A/S Earnings Call