Zealand Pharma A/S at Goldman Sachs Global Healthcare Conference Transcript

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

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : So, Adam, lots to talk about. So maybe we'll jump straight into it, kind of big upcoming task list for you. You have the long-acting amylin petrelintide coming up. Could you maybe just frame expectations?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. There's obviously a lot of focus on the 7% to 9% that you've kind of put out there as a target. So can we just think about either side of the range there. So if the data come in slightly below that 7%, what does that tell you? Is there a reason that you may still continue to a Phase 2 trial? And then at the other side of things, if it came in higher than that expectation, does that change anything in terms of the company's planning?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then you mentioned the point on tolerability. So again, conscious that this is a Phase 1b trial, 16 weeks, what is a good tolerability outcome in that data set?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. You mentioned the titration. How does the titration schedule for a long-acting amylin compared to the GLP-1 products that we know exist right now?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Just you mentioned kind of six weeks data where you saw the 5% body weight reduction, just kind of again thinking about the range that's out there and where people are kind of anchored to. Why is it not the right thing to do to kind of just extrapolate? So if you're at 5% at 6 weeks, then at 16 weeks, why would that not mean that kind of 7% is not easily achievable?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And I realize you went kind of straight into the data and the readout there, but maybe just take a step back and looking at the bigger picture, how do you -- that profile that you're looking for, why you're looking for that, how do you think amylin fits into the treatment algorithm? What are the differentiations?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then the other piece of the amylin story, and it's something that people are increasingly focused on is kind of potential for muscle sparing and a better kind of quality of weight loss and it's something that's in being investigated in certain ways. So first question on that, to what extent do you think that is a real issue? And then secondly, do you think there's an opportunity here to differentiate and why?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then just kind of thinking about amylin, there's obviously a few other programs in development. I think kind of for obvious reasons people are focused on Eli Lilly's developments there. Novo obviously kind of have an amylin, slightly different strategy. AstraZeneca talked about taking one to Phase 2. How do you think petrelintide fits within that? What gives you confidence that this is a best-in-class asset?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay, okay. And then thinking ahead to the Phase 2 trial that we may potentially have for petrelintide, obviously, you've got to get through the initial data readout and make sure that kind of the profile fits. But to what extent is that already in planning and what are the considerations?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then just thinking about the muscle preservation endpoints, how do you think about incorporating that into a clinical trial? Of course, we're not going to get it in the Phase 1b that's imminent, but in Phase 2 and beyond, how are those implemented?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then in terms of other endpoints and you talked to kind of comorbidities related to obesity, are you confident that amylin should have benefits on kind of external effects? So kind of cardiovascular, renal, as we've seen with the GLP-1s, what gives you that confidence?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then just in terms of partnering and commercialization and kind of longer term on amylin, obviously, as we talked about, Novo, Lilly, AstraZeneca kind of within this market, at what point do you kind of seriously consider a partnership for petrolintide, and considering that these companies were kind of a billion dollars of R&D spend that you're competing with?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Perfect. And just a few kind of housekeeping bits on petrelintide to kind of tie up. So timing, obviously, this quarter is what you've communicated. So are data in-house? Where are you in terms of the process?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And just on that release to the market, what should we expect the top-line release to look like? Will it be kind of date by dose? Will it be [any] data in there as well?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then just thinking about kind of the broader pipeline that you have, both internally and kind of the competitive landscape. Amylin, kind of how focused are you on monotherapy? Is there a point in time when it might make sense to start to do kind of combination trials with other

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Okay. That's clear. As I said, kind of there are a few other assets in the pipeline. Before we go to survodutide, I just wanted to kind of touch on dapiglutide the GLP-1, GLP-2. We saw some data from an investigator-led trial last month. Could you just put that into context for us?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then I guess, timelines on dapiglutide, say, your own company-sponsored Phase 1 data is expected to the second half of the year? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 8:00PM, ZELA.CO - Zealand Pharma A/S at Goldman Sachs Global Healthcare Conference

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then, of course, you talked about kind of the inflammation benefits that come with the GLP-2 component. A similar question, how do you demonstrate that in a clinical trial? Is that in an obesity trial or do you run a separate trial to do that?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then similarly, on partnering on that side, is that a focus for dapiglutide, and is it kind of reasonable to expect that it might make more sense to partner that earlier than relative to petrelintide given there's probably more work to do to validate it?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Moving to survodutide, we're just coming out of EASL, where we had full Phase 2 data for that asset. Could you just characterize the data that were presented at EASL and kind of your confidence in the sense that we got coming out of the conference is there's a huge amount of interest in particularly from a physician perspective. But could you put it into context, especially related to competitor data?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And within MASH, we obviously have an approval there with Rezdiffra. How do you think about survodutide positioning in MASH relative to Rezdiffra and other kind of liver-directed therapies?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And in terms of kind of the flip side, we've talked about the positive data, there are obviously a few that people have kind of picked holes in the data set. One was the lack of the dose response between the mid-dose and the higher dose on the fibrosis side. We also saw that with tirzepatide synergy MASH trial. What do you think is the underlying reason for that? Is there something in the baseline characteristics of patients who are more amenable to those higher doses?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. The other thing is discontinuations that some investors have been kind of a little bit concerned on with survodutide, both with the obesity data. And then in the MASH -- or the MASH trial -- where we saw kind of 20%-ish. Could you kind of put into context why people shouldn't be concerned?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then now that you have Phase 2 data in hand in both MASH and obesity, as you think about servodutide, which is the bigger opportunity?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Maybe we should talk about the rare disease pipeline as well. I think it's kind of something that's overlooked, and we spent 25 minutes on obesity. What are the latest developments on glepaglutide in terms of your interactions with the agency ahead of the PDUFA at the end of this year? without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies. JUNE 12, 2024 / 8:00PM, ZELA.CO - Zealand Pharma A/S at Goldman Sachs Global Healthcare Conference

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And on glepaglutide, you've kind of been clear publicly, and you discussed it multiple times that the strategy there is a partnership for a licensing deal. What -- firstly, timing, how do you think about that? Is it likely to be pre- or post-potential approval?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then maybe just to kind of push a little bit more on that point. So I'd say in a scenario, you get an approval at the end of this year. So you have kind of a commercial-ready product. What are the options there? Could you start to think about an initial launch yourself without a partner?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : And then you talked about dasiglucagon as well. Similar question there. Your strategy has been to partner it. If not, would you kind of consider the initial commercial launch and what could that look like in terms of energy OpEx that you may need?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. And then just one thing on the PDUFA for glepaglutide. So well, for dasiglucagon, you got a CRL previously on the manufacturing. And our understanding is contract manufacturer, they're using for both products. Are you confident that that's resolved, and it wouldn't be an impediment to approval?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay, okay. And so in the last minute on financials, so you said cash runway guidance is to 2027, and that's ex any potential milestones or partnerships. Where does that take you operationally?

Question: Rajan Sharma - Goldman Sachs Group Inc - Analyst : Okay. Perfect. Well, we are right on time. So thank you very much, Adam, and thank you, everyone, for your attention on the last session and with some storms in the background. Thank you.