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: Joey Stringer - Needham & Company - Analyst
: Great. Well, thank you, Adam, for that. I guess with your new position here, can you just talk about -- you touched on it earlier in your opening
remarks about the recent corporate strategy change? And sort of outline your vision for Zeeland going forward.
Question: Joey Stringer - Needham & Company - Analyst
: Great. And so, let's start off with your marketed products and we'll work our way through the rest of the pipeline. But you have two marketed
products here. Can you give us a reminder of what the updated sales guidance is for 2022? And what are the assumptions that are built into that?
Question: Joey Stringer - Needham & Company - Analyst
: Got it. And focusing more on Zegalogue, there are multiple players in that rescue glucagon market. What's the current market size of that and how
do you see this evolving and changing over time and Zegalogue fitting into -- step in to fit the unmet need there?
Question: Joey Stringer - Needham & Company - Analyst
: And how should we think about the Zegalogue launch over time? Is there a good comp for this?
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APRIL 11, 2022 / 1:30PM, ZELA.CO - Zealand Pharma A/S at Needham Healthcare Conference (Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: Now you're also leveraging dasiglucagon into other indications. I want to touch on your Phase 3 program here in CHI. Can you outline the -- for
those who are not as familiar with that particular indication, can you outline the standard of care and the potential market opportunity in this
indication?
Question: Joey Stringer - Needham & Company - Analyst
: Got it. Now you have a Phase 3 program in CHI that's ongoing. Can you outline that program? There are two Phase 3 trials, and just specifically
what does a potential registrational path forward look like given the results of one Phase 3 trial that you've already announced, one is upcoming
and how would a potential NDA submission look like?
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APRIL 11, 2022 / 1:30PM, ZELA.CO - Zealand Pharma A/S at Needham Healthcare Conference (Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: And, Adam, is that -- the second Phase 3 readout you said, is that -- what's the timeline for that in terms of the anticipated readout?
Question: Joey Stringer - Needham & Company - Analyst
: So, shifting to your short bowel syndrome program, another Phase 3 program that's ongoing. Here just curious if you could provide us with an
overview of this program. You have a couple of different Phase 3 trials ongoing. Can you describe each of those and explain the purpose of each
one of those? And when we can expect to see data from the EASE-SBS 1 trial?
Question: Joey Stringer - Needham & Company - Analyst
: Now on the EASE-SBS 1 trial, Adam, can you remind us on the primary endpoint here, what would you consider a clinically meaningful change on
the primary endpoint?
Question: Joey Stringer - Needham & Company - Analyst
: Yes, and to that point on sort of a semi-apples to apples comparison to the marketed drug Gattex, do you think that that greater than 20% parenteral
support reduction is something that we could look at in terms of whenever this -- your SBS trial reads out to sort of compare -- somewhat compared
to Gattex?
Question: Joey Stringer - Needham & Company - Analyst
: Got it. Fair enough. Now another question on sort of what regulatory and clinical success here. But in terms of what glepaglutide needs to show,
do you think, to be successful commercially, what is -- would a scenario in which you have equivalent efficacy but yet the more convenient dosing
of glepa, do you think that would translate into commercial success? Or do you think you need -- what type of profile do you think you need for
glepa to be successful in the market?
Question: Joey Stringer - Needham & Company - Analyst
: Yes, yes, understandable. Now in terms of the SBS market, when can we expect a generic version of Gattex to come online. And how do you think
this will affect the overall market just in terms of pricing and access and things like that for a potential glepa entry?
Question: Joey Stringer - Needham & Company - Analyst
: Now, for EASE-SBS 1, you have two treatment arms. You have a once-weekly and a twice-weekly. Can you talk about the importance of each of
those in terms of dosing frequency? Is that a huge advantage if you can get to once weekly? Or can you just talk about each of those and how you
think -- how important each of those are in terms of hitting the primary endpoint?
Question: Joey Stringer - Needham & Company - Analyst
: Yes, last question on SBS, because I want to touch on some of the other programs. But there are two notable competitor SBS programs out there.
What are the differentiating features of the glepa program versus some of those other programs? What are the advantages you guys have?
Question: Joey Stringer - Needham & Company - Analyst
: Okay, now a couple questions on the bi-hormonal pump for a type I diabetes cure. You have a collaboration with Beta Bionics on this program.
Can you describe that collaboration? What does the Phase 3 program look like and when can we see initial results from that trial?
Question: Joey Stringer - Needham & Company - Analyst
: And what do you think the market opportunity is in this indication, Adam, this bi-hormonal pump?
Question: Joey Stringer - Needham & Company - Analyst
: Okay, you have obesity programs and I want to touch on those. So, you have this dual GLP-1 glucagon program partnership with Behringer. You
have a couple of Phase 2 trials that are ongoing. Can you describe which indications you're running those Phase 2 trials? And what's -- when can
we expect readouts from those programs?
Question: Joey Stringer - Needham & Company - Analyst
: Adam, have you thought about an indication for the amylin analog 8369? Or is it just working through some early stage (multiple speakers)?
Question: Joey Stringer - Needham & Company - Analyst
: Okay, got it. Now you have another dual agonist here, dapiglutide. Can you describe the advantages of that dual agonist approach? And how do
you plan to position the dapiglutide program? What indications are a priority here moving forward?
Question: Joey Stringer - Needham & Company - Analyst
: Okay, fair enough. Well, we'll just wait for the next steps for that one. One question that we get is on these triple agonists that are out there, GLP-1,
GIP, glucagon. How do these compare to the mono and the dual agonists? And do you see the field shifting through this triple agonist only or --
what are your thoughts on that?
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APRIL 11, 2022 / 1:30PM, ZELA.CO - Zealand Pharma A/S at Needham Healthcare Conference (Virtual)
Question: Joey Stringer - Needham & Company - Analyst
: Okay.
Question: Joey Stringer - Needham & Company - Analyst
: Now you touched on the Boehringer collaboration a bit earlier, but are there any near-term milestone payments or anything associated with that
partnership expected either this year or next year (multiple speakers)?
Question: Joey Stringer - Needham & Company - Analyst
: Okay, and last question here. You have several preclinical programs ongoing, have a partnership with Alexion on some complement programs.
Which one of these preclinical programs are you most excited about? And can we expect a preclinical program to move into the clinic over the
next year?
Question: Joey Stringer - Needham & Company - Analyst
: Okay. Well, we're coming up on time and I want to thank everyone for joining us on the webcast. And thanks to Adam and Matt, to you and the
rest of the Zealand team for participating. I hope everyone has a good day.
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