Half Year 2024 Zealand Pharma A/S Earnings Call Transcript

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

Question: Rajan Sharma - The Goldman Sachs Group Inc - Analyst : Hi. And thanks for taking my question. I've got a couple. Firstly, on dapiglutide. I just wanted to understand what drove the decision include the higher dose cohort in the Phase 1 rather than just kind of including that in the Phase 2. And then given that you should expect the same timelines for the initiation of the Phase 2, do you expect to use those higher doses in the Phase 2, even if the data from the part 2 of the Phase 1 are not available? And then just longer term, how high do you think you could actually go on dosing there? And then maybe just staying on dapi, what do you think would constitute a good outcome from the initial Phase 1 data that we're expecting in the second half of the year? You kind of -- we're quite clear on how you were thinking about the petrelintide readout. So if you could just provide some color around that? And then should we expect any data on inflammation markers in the initial data set? And then maybe if I could just follow up with one on petrelintide. So I think you said that you'll be using MRI to assess body composition in the Phase 2. Just wanted to understand your rationale for that relative to using other measures. Do you think MRI will likely be the standard measurement across the space? And will you also be able to assess bone density in that trial? Thank you.

Question: Rajan Sharma - The Goldman Sachs Group Inc - Analyst : Yeah. Thank you very much.

Question: Thomas Bowers - Danske Bank A/S - Analyst : Yes. Thank you very much for taking the question. So first of all, on -- in the slide presentation, you highlight that 30% discontinued obesity treatment after one month. But how many do you believe actually discontinue due to tolerability issues and maybe testing my luck. But how many of these patients would you think could have the needed tolerability improvement on amylin to successfully stay on therapy, actually, I guess that's main goal, of course. And then also a second question on petrelintide. So I remember in connection with the top line results that you argued for the expected 1-plus year rate reduction of 15% to 20%. So what data do you have to support the tail here? Because I -- to my understanding and also reading through some research material, one of the concerns with amylin as a stand-alone is that you will hit the ceiling quite early on. So is there anything I have missed here that actually proves the opposite that you will see a GLP-1 like curve going towards those 60 and 70 weeks. And then just lastly, just on the ion channel blocker that you're now moving into Phase 1. I'm just wondering whether you're talking specific autoimmune diseases? Or is this something that you actually could see more could complement the obesity pipeline, so of course, improving potentially comorbilities given the link between the [naive T cells] and the adipose tissue. So just a bit curious there. Thank you.

Question: Thomas Bowers - Danske Bank A/S - Analyst : Great. Thank you very much for the additional color.

Question: Suzanne van Voorthuizen - Van Lanschot Kempen NV - Analyst : Hi, team. This is Susan. Thanks for taking my questions. Allow me to start off with -- on the exploratory partnering discussions that you are initiating on petrelintide. Can you elaborate what you wish to get out of these conversations and give some context on those features you look for in finding, let's say, the right partner? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 15, 2024 / 12:00PM, ZELA.CO - Half Year 2024 Zealand Pharma A/S Earnings Call And then my second question is on the full data for petrelintide that's coming in the coming months. Can you elaborate to what extent we can expect information on comorbidity biomarkers and the quality of weight loss, like which metrics will be reported on and which elements in there

Question: Lucy Codrington - Jefferies Group LLC - Analyst : Hi there. Thanks for taking my questions. I have a few, if I may. Just to jump on that. recent comment about the aspiration for co-development and co-commercialization rights. Are they -- is that an absolutely must have for you? And if that is not on the table, would -- that prevent any future discussions with the possible partners? I'm just wondering, yes, the investment required on your behalf to commercialize in such key geographies and also the willingness of a potential partner to give up those rights just wanted to as a kind of hard and fast ambition of yours. And then just on some of the other kind of follow-ups. You mentioned about the dapiglutide part 2 being based on the tolerability observed to date. Is that based primarily on the DREAM profile? Or also does that include blinded data from the part 1 ongoing data set? And just related to that, I guess, is there anything to explain why the 6-milligram dose had the same degree of weight loss at 4 weeks as it did at 12 weeks in the DREAM study. Secondly, obviously, lots of quite rightly investment in expanding your -- the studies around your obesity program. I guess on that, it seems to me like the weight loss with amylin does seem to be largely assured now. I mean I know we need additional studies, but will that weight loss be relevant if you don't have the CV benefit along with it? And therefore, is that something you could consider to start evaluating sooner rather than later? Or is that only something that will be done once you start a Phase 3 trial? And second, also in terms of other -- your other obesity pipeline, I wonder when we might get some visibility on any non-clinical obesity assets that you may have in development and what your priorities are there? And then a final one, if I may, I appreciate it. You mentioned about the high percentage of male participants in the amylin data set you have. I just want to I guess, understand your confidence that with a more balanced or potentially even a female-dominant group, you might not risk a deterioration in the tolerability profile given there are some data to suggest that tolerability does tend to be worse in females than men at least for GLP-1s. Thank you.

Question: Lucy Codrington - Jefferies Group LLC - Analyst : You did. Thank you so much. Sorry about that. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. AUGUST 15, 2024 / 12:00PM, ZELA.CO - Half Year 2024 Zealand Pharma A/S Earnings Call

Question: Julian Harrison - BTIG - Analyst : Hi. Thank you for taking my questions and congrats on all the recent progress. First, I'm wondering if you can maybe remind us of glepaglutide's market opportunity in short bowel syndrome and how you're thinking about developments in competitive positioning from earlier this year.

Question: Julian Harrison - BTIG - Analyst : Okay. Excellent. And then I guess, both for SBS and CHI, are these launches you're preparing for and can initiate internally if you need to? Or are you expecting partners to step in sooner than later?

Question: Julian Harrison - BTIG - Analyst : Okay. Excellent. And then finally, I just have a quick housekeeping question. Sorry if I missed it, but wondering if you have any updated cash runway guidance in light of the equity raise in June. Henriette Wennicke - Zealand Pharma A/S - Executive Vice President, Chief Financial Officer, Member of the Executive Management Thank you for that question, Julian. So let me cover that. You can say before the capital raise, we guided for a run rate into '27 and clearly, with the cash position we now have that has been extended. You can say when we also guided for the cost run rate, we did not include any potential milestones of runs from newer existing partnerships, which, of course, would add. So for the time being, we are not guiding. There is so many swing factors that can impact our cash run rate. But I think it's fair to say we are really been funded to progress the assets we have in the pipeline.

Question: Kerry Holford - Joh. Berenberg Gossler & Co KG - Analyst : Thank you very much. Kerry Holford, Berenberg. Two points of clarification for me, please, on petrelintide. So in the context of your move to Phase 2, did you mention earlier on the call that you plan to run a study looking at petrelintide in combo with the GLP-1 or did I mishear that? Is it just more the concept of potentially being used in that way ultimately? And then secondly, on partnerships. I wonder if you can just clarify. Do you have ongoing live discussions on this here today? And indeed, whether you would clarify whether you would be happy to consider a partnership ahead of the Phase 2b data readout? Thank you.

Question: Prakhar Agrawal - Cantor Fitzgerald LP - Analyst : Hi. Thank you for taking my questions. Firstly, on petrelintide Phase 2b plants. You mentioned five doses in Phase 2b. Just wanted to confirm with the highest dose in Phase 1 is the highest you will go in Phase 2 or the protocol will have flexibility to go higher in dose and dosing like you did with dapiglutide. And if you're not going higher on dosing for petrelintide and Phase 2b what's the reason? Second question, just following up on combination strategy. Obviously, monotherapy is a focus right now. But from your perspective, which combination mechanism might be most attractive for an amylin drug from an efficacy and safety perspective. Obviously, some of the competitors are -- have a different strategy with Novo going after GLP-1, but there seems to be some additive effects of GI rates that for an amylin while [Libia] is using [glepaglutide] for their amylin. So I wanted to get your perspective on combination mechanism for Amylin. Thank you.

Question: Michael Novod - Nordea Bank Abp - Analyst : Thank you very much. Just two short questions. With funding in place -- significant funding in place, what are your considerations around oral development, oral technologies? How can it be applied to existing assets? What are you thinking around that? And when could we potentially hear something around that? And then secondly, can you talk to whether you've sensed that you have the right balance between calcitonin and amylin receptor agonism with petrelintide, also compared to competition and sort of the bang for the buck on the weight loss without causing too many side effects.

Question: Michael Novod - Nordea Bank Abp - Analyst : Great. Thanks a lot.

Question: Jesper Ils°e - Carnegie Investment Bank - Analyst : Thank you so much. A few questions from my side on petrelintide as well. Firstly, thanks for the comments on new studies in both in [combo] and Type 1. Perhaps since you've now announced this, what is your current thoughts on also making head-to-head studies versus GLP-1 to really prove differentiation and beta tolerability versus GLP-1. That's my first question. Second question, just a follow-up on your comments about keeping 50% rights to US. So I understand that you want to stay involved in development. But can you please explain why it's good for a big pharma partner to have new onboard on commercialization as well because I guess they can already that quite good given the current sales force and focus. And also on that note, have you had any initial feedback from partners on those demands for 50% US rights. So I just wonder if it could mean that a partner potentially will avoid a partnership as, I guess, a long-term value creation for a partner would be lower if they give away, if you can say that 50% US rights. And just last question. Will that also be the demands for our partnership programs such as the people type? Thank you so much.

Question: Jesper Ils°e - Carnegie Investment Bank - Analyst : Thanks so much.