The following is excerpted from the question-and-answer section of the transcript.
(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)
Question: Lucy Codrington - Jefferies - Analyst
: Hi there. Thanks for taking my questions. A couple for me. Just firstly on the, say, 2b design. The five dose arms, can I just confirm -- sorry if this has
already been said. But is that five different doses or a fewer, fewer doses but with different [titration] regimes being evaluated across the different
cohorts? And I know you said doses, plural, for the Phase 3. So is the intention to take more than one dose through to a Phase 3 trial?
Secondly, one of the competitors was showcasing initial data for their amylin asset at ObesityWeek as well and talked about the calcitonin activity
having potential taste of the (technical difficulty) but is taste aversion something that is you are -- something you are hearing about from patients
taking petrelintide.
And then finally, just on the -- to clarify on the dasiglucagon filing, is the part two data set already complete and it's just a case of waiting for part
one to be derisked or is there still additional work ongoing? I'm just trying to work out the timing of why -- what's holding up filing that part two.
And any read across at what point do we start worrying about the glepaglutide approval when this classification hasn't been granted? Thank you.
Question: Charlie Haywood - Bank of America - Analyst
: Yeah, thank you, Charlie here with Bank of America. I've got two questions, please. So first is you've obviously stepped up your partner conversations
a few months ago. So I wondered if you could share any color on how the early discussions are going. What, if any, of the key debates you're having?
And on that, I guess you've previously talked about targeting having a seat at the table with a co-commercialization, co-development agreement.
I don't believe you stated that today. So can you confirm that's still your ambition? And do you remain confident in achieving that post initial
conversations?
And then the second question is we've got fairly imminent data for CagriSema coming. So obviously, we've seen in the early data you showed
superior weight loss to cagri. I'm interested in how you think the petri molecule compares to cagri and what differences you'd call out there and
whether you think you've been able to dose effectively higher than cagri has in its Phase 3. Thank you.
Question: Rajan Sharma - Goldman Sachs & Co. - Analyst
: Hi, thanks for taking my question. I just got a couple. Firstly, on glepaglutide, just could you maybe just help us understand what this potential
early launch could look like from a Zealand perspective. It sounds like there's not going to be a partnership on that one before a potential approval.
So just in terms of what a go-to-market strategy could look like, potential investment there and whether you'd require kind of incremental SG&A
costs and personnel costs from here.
And then secondly, Eric, you talked about potential for developing petrelintide as a foundational first-line therapy in obesity. In order to do that,
ultimately, do you think you need a head-to-head trial against current GLP-1 agonists? Even if you didn't, do you think that could be a logical trial
to run just to cement the differentiation that you talk to?
And then finally, just one on petrelintide, a follow-up from the ObesityWeek presentation. We didn't see a split of kind of weight loss in males versus
females in the presentation. So could you just confirm on the trial, was there higher weight loss in female participants? I'm conscious there are only
a few of them, but it would be helpful to get some color on that. Thank you.
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NOVEMBER 07, 2024 / 1:00PM, ZELA.CO - Q3 2024 Zealand Pharma A/S Earnings Call
Question: Suzanne van Voorthuizen - Van Lanschot Kempen - Analyst
: Hi, team. Thanks for taking my questions. My question relates to Obesity Week amylin data. First, on petrelintide, we noted that there was also a
reduction in the heart rate. Curious if you have some thoughts what could explain this mechanistically and how you look at this additional interesting
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finding in the overall picture for the asset. And secondly, on the AstraZeneca amylin data that was also shown this week, clearly not as good weight
loss and more adverse events as you compare it to petrelintide.
But could you frame what you think is behind the differences with petrelintide, assuming here different receptor potency? But are there other
elements such as the shorter half-life that can be factors driving the difference in the risk benefit? Thank you.
Question: Prakhar Agrawal - Cantor Fitzgerald - Analyst
: Hi. Thank you for taking my questions and a great presentation at ObesityWeek. One thing that maybe we are still hoping to get more clarity on
is on the dose response. The weight loss trajectory looks fairly similar for the 4.8 and 9-milligram dose even in the [nation] titration period. But you
clearly believe that based on individual patient data, there should be dose response and longer duration. So anything that you would note based
on the data that drives this conviction?
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And a couple more, if I may. On partnership discussions for petrelintide, what would be some of the important factors for you in the deal structure?
Is having a co-commercial structure in the US important?
And then lastly, just quickly on -- you talk about the CagriSema data coming in 4Q. Maybe just talk about the implications for petrelintide from the
cagrilintide monotherapy arm in the trial. Just wanted to understand what you're hoping to see on that from an efficacy and safety standpoint.
And thank you so much.
Question: Thomas Bowers - Danske Bank - Analyst
: Yes, thank you very much. So just a couple of questions remaining here from my side. So just on petrelintide, do you actually have any CRP reduction
data from that Phase 1? I'm not sure whether you actually tested for that. And also dapiglutide, is that something that we could expect from the
Phase 1 as well?
And then just on the GLP-1 combination with petrelintide, is this going to be a combination with what you can say commercially available once-weekly
approved GLP-1 in obesity or is it something that you also have internally in the pipeline?
And then my last question. So looking at the slides from ObesityWeek, so when I zoom in on the efficacy curves, wouldn't it be fair to sort of make
a conclusion that we at least see an indication of the weight loss effect tailing off a bit after 12, 13 weeks for actually both of the high dose cohort?
So I know, of course, it's a very small sample size and I'm playing the devil's advocate. But is there anything that we should be a little bit concerned
about at least arguing for the 20% weight reduction that you are targeting or could this maybe be also an effect of a low baseline BMI for these
patients in the study? Thank you.
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