Zealand Pharma A/S

OTC:ZLDPF

Earnings Call Transcript 2021-Q1

[Operator]

Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 2021 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to first speaker today, Matt Dallas. Thank you. Please go ahead.

[Matthew Donald Dallas, Senior VP & CFO]

Thank you, operator. Welcome, and thank you for joining us today to discuss Zealand's first quarter results for 2021. I'm Matt Dallas, Senior Vice President, Chief Financial Officer of Zealand. With me today are Zealand's President and Chief Executive Officer, Emmanuel Dulac; and Chief Medical Officer, Adam Steensberg. After the prepared remarks, we will open the call to take your questions. You can find the related company announcement and additional supporting information on our website at www.zealandpharma.com. I would like to point out that we will be making forward-looking statements that are subject to risks and uncertainties. These statements are valid only as of today, and the company assumes no obligation to update them, except as required by law. Please refer to recent filings for a more complete picture of risks and other factors. With that, I will turn the call over to President and CEO, Emmanuel Dulac.

[Emmanuel Dulac, CEO & President]

Thank you, Matt, and thanks to everyone for joining today. The first quarter brought one of the most significant milestones in Zealand Pharma's history, the U.S. FDA approval of Zegalogue, indicated for the treatment of people with diabetes who are at risk of severe hypoglycemia. Our first FDA approval as a company and our first approval in the dasiglucagon franchise. This marks a key turning point in our evolution from a research and development-focused organization to a fully integrated biopharmaceutical company with a goal of 5 commercial products by 2025. Turning to Slide 4 and 5. Under the leadership of Frank Sanders, President of Zealand Pharma U.S., we have been steadily optimizing our commercial organization over the last year in preparation for the launch of Zegalogue in late June. Through established relationships with KOLs and HCPs as well as high prescriber coverage, we are on track with our launch readiness preparation and believe this initial launch will put us in a strong position to further build out our commercial organization. To ensure a successful launch, we have 4 strategic objectives: The first is to establish a clear and distinct product position with HCPs, patients and caregivers. Second, we will focus on the back-to-school season to execute a focused launch that targets and prioritize high-volume customer segments. Third, we are working closely with top national and regional payers, pharmacy benefit managers and health systems to establish market access and make it simple for patients and providers to acquire products. And fourth, we are committed to providing a patient support program to ensure education and access for patients and caregivers. Turning to Slide 6 and 7. There is a significant unmet medical need in the treatment of severe hypoglycemia and with the arrival of newcomers, we have seen an increasing utilization of rescue therapies. For your reference, we have the indication and important safety information for Zegalogue. A copy of the full PI is available on zegalogue.com/prescribinginformation. We believe Zegalogue will be an important new option for people with diabetes to consider in the management of potential consequences of their disease. Turning to Slide 8. In parallel with Zegalogue's approval and upcoming launch, we continue to make exciting progress across our pipeline and thoughtfully build out organization. I'm excited to announce that we have strengthened our internal team with the appointment of Christina Sonnenborg Bredal to a newly created role of Head of People and Organization. The new role will bring Denmark and U.S. HR functions and internal communications together in a single elevated global function and be instrumental as we continue to attract and retain the most talented employees. I will now turn it over to our Head of Research and Development, Adam Steensberg, to discuss our pipeline in greater detail. Adam?

[Adam Sinding Steensberg]

Thank you, Emmanuel. Please turn to Slide 9. And as just mentioned by Emmanuel, our preparations for the Zegalogue late June loans are being executed while we in parallel continue to advance our pipeline programs, which range from a late-stage to preclinical candidates in a variety of metabolic and GI indications. Turning to Slide 10. We continue to pursue other indications for dasiglucagon. Among the most advanced clinical programs is the study evaluating continuous infusion of dasiglucagon in children with congenital hyperinsulinism, or CHI, which is an ultra rare disease caused by a defect in the pancreatic beta cells. And later this year, we expect the results from the second Phase III trial in CHI children age 7 days to 1 year. Please turn to Slide 11. In collaboration with Beta Bionics, we plan to initiate the pivotal Phase III trial program for the bi-hormonal iLet bionic pancreas device, which utilizes dasiglucagon in the second half of this year. We plan to enroll approximately 350 adults and 350 children with Type I diabetes and randomize them into the trial. And these trials are expected to form the basis for an NDA submission to the U.S. FDA for use of dasiglucagon and bi-hormonal artificial pancreas systems. Please turn to Slide 12. As Emmanuel mentioned earlier, we have also broadened our pipeline of metabolic therapies to target obesity and nonalcoholic steatohepatitis. Our clinical development partner, Boehringer Ingelheim recently indicated 2 additional Phase II trials for the GLP-1/Glucagon Dual Agonist BI 456906 in adults who are either overweight or obese or for adults with NASH. And we believe that our Dual Agonist tested were intended to achieve an increased weight loss via improvements to the patient's metabolism and also has the potential to alleviate NASH by reducing upstream hepatic steatosis. And we expect BI to complete the Phase II trial in people with type II diabetes and to communicate the results from the 16-week Phase Ib trial later this year. Turning to Slide 13. We also have 2 assets in preclinical development for obesity, both of which have shown additive weight loss effects when co-injected with GLP-1 analogs in preclinical models. And we anticipate starting Phase I trials with our long-acting Amylin analog ZP8396 later in the year and expect to bring our long-acting GIP analog ZP6590 into Phase 1 trials in 2022. In addition to the continued advancement of our metabolic candidates, we have also made significant progress in the clinical development of our gastrointestinal programs and recently announced new preclinical candidates in this space. Please turn to Slide 14. Glepaglutide is our long-acting GLP-2 analog with a half-life of approximately 50 hours, which is being developed in a disposable auto-injector. We are progressing with patient enrollment in the pivotal Phase III trial, which will evaluate once and twice-weekly dosing of Glepaglutide versus placebo over 26 weeks, and we expect the results from the trial in '22. Please turn to Slide 15. We are making good progress also with our long-acting GLP-1/2 dual agonist Dapiglutide, while we expect results from the Phase Ib trial later this year. While GLP-2 mainly stimulates intestinal absorption capacity, GLP-1 slows down intestinal motility thereby potentially contributing positively to enhance absorption. And I will now turn over to our CFO, Matt Dallas, to walk us through our first quarter financials. Matt?

[Matthew Donald Dallas, Senior VP & CFO]

Thanks, Adam. On Slide 16, you will see Zealand's income statement for the first quarter of 2021 and how it compares to the same period in 2020. Total revenue for the quarter was DKK 47.8 million, or USD 7.5 million. This was driven by net product revenue of the V-Go wearable insulin delivery device as well as partnership revenue from our collaboration with Alexion. The net operating result for the quarter was a loss of DKK 260.9 million or USD 41.1 million. Sales and marketing costs mainly relate to the commercial infrastructure in the U.S. to support V-Go and the upcoming Zegalogue launch, while R&D costs relate to our late-stage clinical programs. Slide 17 illustrates our strong financial position and ability to support our growing business through continued investments. Net operating expenses for the first quarter were DKK 284.8 million or USD 44.9 million. At the end of the quarter, we had a cash position of DKK 1.6 billion or USD 252.9 million, funding the company through several key upcoming milestones. And during the quarter, we also successfully completed the largest financing in company history by raising DKK 750 million. Turning to our financial guidance on Slide 18. For 2021, there are no changes to our financial guidance from what was announced in March. Net product revenue from the sales of our commercial products is expected to be DKK 220 million, plus or minus 10%. Net operating expenses in 2021 are expected to be $1.25 billion, plus or minus 10%. We expect revenue from existing license agreements; however, since such revenue is uncertain because of size and timing, we do not intend to provide guidance on such revenue. And with that, I will turn it back to Emmanuel.

[Emmanuel Dulac, CEO & President]

Thanks, Matt. Turning to Slide 19. As Matt has laid out, we are in a strong financial position to execute on the upcoming launch of Zegalogue, while continuing to advance our pipeline programs and invest in building an organization with the best and brightest talent to bring forward new peptide therapeutics aimed at meeting unmet health needs. Our continued progress would not be possible without our research and development engine. The clinical and regulatory teams who work tirelessly to advance our program and the members of our growing commercial organization who are working to bring treatment options like Zegalogue to the patients who need it most. I am grateful and proud of all the hard work the Zealand team has done to get us to this point and look forward to continuing to work together to deliver on our vision of offering 5 commercialized products by 2025. Thank you all. I will now turn it over to the operator for questions. Operator?

[Operator]

[Operator Instructions] And your first question comes from the line of David Lebowitz from Morgan Stanley.

[David Neil Lebowitz, Vice President]

Could you just, I guess, speak to the Glepaglutide trial? And how, I guess, enrollment has continued in that study? Have things stabilized in recent months after, I guess, certainly, the pandemic has had increased challenges over the last year or so?

[Matthew Donald Dallas, Senior VP & CFO]

Adam, will you take this question?

[Adam Sinding Steensberg]

Yes. And thanks for the question. Yes, they have, and we are continuing to see good progress as we also communicated at our full year. So we are, you can say, positive with regards to how we see recruitment right now. And so, so far, it is coming out as we are hopeful here with vaccinations being rolled out across the U.S. and Europe.

[David Neil Lebowitz, Vice President]

That's good to hear. And with respect to the upcoming launch, how have market dynamics been changing? And I guess, how is your launch been evolving as you prep for June?

[Emmanuel Dulac, CEO & President]

Yes, I'll take this one. The market has clearly signaled shift away from the legacy products to innovative new products for the patients and the caregivers. And the shift is still underway. So I think based on current trends, there is plenty of room to convert legacy shares of the innovative products. That's actually one side of the story. The other side of the story is that we have seen with the launch of the recently approved products, an expansion of the market by 6% in 2019 and 10% in 2020, even though it was heavily market impacted by COVID and by no return back-to-school, which again accounts for around 60% of the total year. So we believe that Zegalogue will be attractive -- very attractive new option with HCPs and patients alike. And the launch sequence right now is ongoing. so that we are confident that we will be actually ready to launch our product mid to late June, ready on time for the back-to-school season.

[Operator]

And your next question comes from the line of Graig Suvannavejh from Goldman Sachs.

[Nicholas Hallatt, Research Analyst]

It's Nick on for Greg here. First question, if I may, on -- regarding Zegalogue. Given that the launch has been timed for the back-to-school season, how should we be thinking about the progression of quarterly sales, i.e., are they going to be a high watermark in 2Q, 3Q when we consider the first several quarters of sales? Or are we more likely to see a more steady rise on a quarter-on-quarter basis? And then a follow-up on 906 with the expected Phase II completion in type 2 diabetes in the third quarter this year. Is it reasonable to expect that we might see some data from BI? Or should we -- it'll be more safe to assume in 2022?

[Emmanuel Dulac, CEO & President]

I'll take the first part on Zegalogue and Adam will talk to you about the BI collaboration and product. So our 2021 guidance is on a total combined revenue. So we are not providing individual guidance on the product level and definitely not phasing it by quarter. That said, our field operating model is really well-positioned to continue support both the V-Go and the Zegalogue. And regarding the, I would say, the launch and the plan for the launch. Our plans are anchored around ensuring that we can execute the full product launch in late June consigning with the annual market opportunity on the back-to-school season. And so we are on track to achieving this objective. In fact, our market access teams have already -- are active, engaging with national and regional payers and PBMs around the clinical value of Zegalogue. Discussions with formularies and drug formulary decisions makers has been favorable, and we expect broad market access. Actually, we haven't seen any management or any barriers for these products by payers put in place until now. So to build over the first -- so we'll continue to build this momentum over the next 2 quarters and the 2 quarters of launch. And our sales team is in place and present with customers today. So we'll pivot in late June to begin to execute the launch ahead of the back-to-school season market lift. Adam, do you want to talk about BI?

[Adam Sinding Steensberg]

Yes. Thanks for that question as well. So we are, as you know, truly excited about this collaboration that we had with BI and the progress that they are making, also starting 2 new studies. What we do expect is, as I mentioned, to see that they report the Phase Ib 16-week data, which was conducted in overweight patients data this year. We're also hopeful that they will share the data in type 2 diabetes that is expected to read out later this year that they'll do that this year, but we cannot comment on it, if they will release these data this year or only next year. This is really up to BI and we don't have a firm commitment and communication from them on this part. So I cannot be more precise here on the type 1 -- sorry, on the study in type 2 diabetes.

[Operator]

Next question comes from the line of Lucy Codrington from Jefferies.

[Lucy-Emma Mary Sarah Codrington-Bartlett]

Just a couple. Just on the V-Go performance this quarter, should we view that as a sensible run rate for the rest of the year? Or were there any kind of one-offs within the quarter that we should be factoring in? Secondly, on the artificial pancreas Phase III and this might be misguided question. But given the plan is that hopefully, the majority of the patients in the insulin-only trial will roll over into the -- to a hormone trial, will those patients then be stratified given that it's likely that those patients have already been on an insulin-only pump, will have better control. And therefore, will that be reflected then in your dual hormone trial?

[Emmanuel Dulac, CEO & President]

So I guess the first question on the financial quarter will go to our CFO, Matt Dallas. And then Adam will take the next one on the dual-hormone pump, the bi-hormonal pump.

[Matthew Donald Dallas, Senior VP & CFO]

Yes, so for the run rate, I mean, right now, what we do have is we have a large amount of launch costs and activities ahead of Zegalogue as we prepare for that late June launch. Those costs will normalize as we head into -- as the drug is being sold, but it will be offset with additional clinical spending we'll have as we approach the BHAP and, obviously, the Glepa studies are ongoing as well with CHI. So I think our run rate should be relatively consistent within the year. With that, I'll turn it over to Adam.

[Adam Sinding Steensberg]

Yes. So you are correct that the insulin-only -- the patients who participate in the insulin-only trial can be offered to also enroll into the bi-hormonal study that we initiate -- that we plan to start. There will not be a direct rollover. So -- but -- and you asked about the stratification. And I think that's a very reasonable thought that you want to make sure that there is an equal number of patients who comes from the insulin-only studies in each of the 3 groups that we are going to have in the bi-hormonal study as well. But it's not a direct rollover. There will be a little bit of time between they exit that study and then they enter the bi-hormonal study.

[Lucy-Emma Mary Sarah Codrington-Bartlett]

Okay. And then just back on the first one. Just in terms of the V-Go sales though, is that a good run rate for the rest of the year rather than the run rate of OpEx?

[Matthew Donald Dallas, Senior VP & CFO]

I would rather -- I mean for both revenue and OpEx, we don't provide guidance on a quarterly basis. It's more within the annual number. I'd kind of refer to you to those targets versus providing quarterly.

[Operator]

Our next question comes from the line of Etzer Darout from Guggenheim Securities.

[Etzer Darout, Senior Analyst]

Just a couple here. So I guess maybe first, wondering what you're learning from the pivotal trial of -- for the insulin-only bionic pancreas, particularly anything you could kind of provide in terms of performance of the pump, as you prepare for the bi-hormonal Phase III launch later this year? That's the first question.

[Emmanuel Dulac, CEO & President]

Adam, do you want to take?

[Adam Sinding Steensberg]

Yes, I can take that. Thanks for the question. I think it's a very important thing you raised here. We have to remember that for Beta Bionics and the islet in particular, it's the first time that the commercial islet is actually being tested in a large clinical setting here in the insulin-only study. So of course, there are issues that are being solved, especially in the start of that study. So -- and this is something that we consider is a significant upside for when we are to do the bi-hormonal study because it's really being, you can say, the technical risks are being reduced significantly. So what I -- you can say, so in our mind, it's really helpful that we can then enter the large bi-hormonal study, which includes both adults and children and around 700 patients with a device that has already been tested for 6 months across 440 patients with the only difference being that the glucagon, you can say, [ chamber ] has been activated. So that, of course, you can say, risk, reduce our study significantly from a device perspective. So we are extremely happy with the progress that beta bionics are making in insulin-only. We look very much forward to have them complete the insulin-only study and then see the results of that study. That should hopefully provide some guidance also for what we can expect for the bi-hormonal study when we then correlate back to what has been seen in Phase II trials and so on. So it's for us, also a very important milestone to have Beta Bionics to complete the insulin-only studies.

[Etzer Darout, Senior Analyst]

And maybe, Adam, just on sort of the Phase II trials for the dasiglugacon mini dose, if you could just maybe provide a little bit more color on sort of the trials that are planning, I guess, from the press release from this quarter, any further details you could provide would be great.

[Adam Sinding Steensberg]

Yes. I mean we have actually, you can say both in type 1 diabetes, the mini-dose [indiscernible] for exercise-induced hypoglycemia but really giving smaller doses than what we use for rescue therapy. That concept we have tested. We know that smaller doses of dasiglucagon works for correcting mild-to-moderate hypoglycemia. Similarly in patients with post-biotic hypoglycemia who can, I mean, not tolerate eating without getting hypoglycemia that we've also done an in-clinic study to show that dasiglucagon can actually correct the situation. So they don't get as hypoglycemic as -- when they just take placebo. So -- but these are studies conducted in the clinics and the studies that we plan to are starting this quarter. They are actually outpatient studies. So -- and we have the actual pen that can be the ultimate device in the hands of patients to see how they will utilize this in this type 1 setting to correct mild and moderate hypoglycemia and exercise settings in type 1 diabetes and then for patients with post-biotic hypoglycemia. How they will utilize such a pen in real life. So it's really going from in-clinic studies into the real-life setting and thereby also, you can say, with positive results setting the scene for moving into Phase III. So we are extremely happy to see the progress that we are making here. We look forward to seeing the results in both these -- for both these opportunities once they are finalized.

[Operator]

[Operator Instructions] And your next question comes from the line of Joseph Stringer from Needham & Company.

[Joseph Robert Stringer, Associate]

Just a general question on the 5x25 strategy here. I know you recently announced that you could potentially have these 5 products coming online. But just curious if there was a goal of sort of a first year of profitability or at least maybe an idea of perhaps a peak operating loss year. And what are the levers in terms of not only R&D, but just OpEx in general that need to be pulled over the next several years to get there.

[Emmanuel Dulac, CEO & President]

Matt, will you take this one?

[Matthew Donald Dallas, Senior VP & CFO]

Yes. So Joe, great question. One area that we focus on -- we've got the 5x25 strategy. But behind that, that's not kind of in that 5 grouping. It's all of the research and the early-stage candidates that we have behind those kind of 5 late-stage or commercial candidates we have now. Our goal is to continue to fund those programs so that beyond 25, there's a lot more than that 5 that are coming to market. And so with that, we don't provide any guidance on profitability because it's all going to be determined based on the success of the early-stage pipeline.

[Operator]

There are no further questions at this time.

[Emmanuel Dulac, CEO & President]

Okay, great. Well, I guess if there's no more question, then we will actually complete this call. And Operator, I think you can potentially close the line now. Thank you, everyone, for joining this call, and thank you for actually participating and listening to us. We remain available for any additional questions if you have. But thank you, again. Talk to you soon.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.