Zealand Pharma A/S

OTC:ZLDPF

Earnings Call Transcript 2019-Q1

[Operator]

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to today's Zealand Pharma Results for the First Quarter of 2019 Conference Call. [Operator Instructions] I must advise you that this conference is being recorded today, Thursday, the 16th of May 2019. And I would now like to hand the conference over to your speaker today, Lani Morvan. Please go ahead.

[Lani Pollworth Morvan, Investor Relations & Communications Officer]

Thank you, Serena, and welcome to Zealand Pharma's First Quarter Conference Call for Fiscal Year 2019. On today's call, I'm very pleased to welcome Emmanuel Dulac, Zealand's new President and CEO; as well as Adam Steensberg, Zealand's Chief Medical & Development Officer. Emmanuel will provide business and financial highlights for the first quarter and the period thereafter. Adam will follow with highlights from our research and development programs. After the prepared remarks, we will open the call to take your questions. Joining for the Q&A will be Ivan Møller, Senior Vice President of Technical Development & Operations, who is further responsible for duties as interim Chief Financial Officer; and Marino Garcia, Senior Vice President of Corporate & Business Development. You can find the company announcement containing the Q1 interim report, corporate presentation and additional supporting information in the Investors section of our website at zealandpharma.com. As a company headquartered in Denmark, our financials are reported in Danish crowns, also referred to as kroner. Key figures may have been converted to U.S. dollars for convenience. On Page 1, I will 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 the company's recent filings for a more complete picture of risks and other factors.Advancing to Page 2, I will now turn the call over to Emmanuel. Welcome, Emmanuel.

[Emmanuel Dulac, CEO & President]

Thank you, Lani, and thanks to everyone for joining the call today. It's a real pleasure. It's been several exciting weeks [indiscernible] starting at Zealand. I am honored actually by the opportunity to lead this impressive team with a strong track record. And I look forward to building upon these relationships with all the key stakeholders and investors, so I hopefully look forward to meeting all of you soon.Moving ahead to Page 3. You will see highlights from Zealand's [indiscernible] in 2019. In the first quarter, Zealand had net operating expenses and equivalent operating loss of DKK 135.8 million. We have strong financial condition at the end of 2018. And this first quarter increase led to almost DKK 1.3 billion in cash and securities. The upfront payment and share subscription proceeds from Alexion contributed to this increase.I'd like to add as well that progress continues across our early and late-stage portfolios of next-generation peptide therapeutics. We achieved a number of milestones during the quarter, including initiating the pivotal Phase III trial of dasiglucagon to treat congenital hyperinsulinism, known as CHI, and the Phase III expansion studies for both glepaglutide and dasiglucagon in CHI.At the start of the quarter, we finalized the equity investment to strengthen our partnership with Beta Bionics. This project investment and the use of Zealand's dasiglucagon will help Beta Bionics maintain its leadership position in the clinical development of their dual-hormone artificial pancreas. Finally, 2 days ago, we received results from the complementary Phase III trial of dasiglucagon to treat severe hypoglycemia administered in the HypoPal rescue pen [indiscernible]. Adam Steensberg, our Chief Medical & Development Officer, will describe the top line results with you in a few minutes. Based on these results, we are even more confident that the HypoPal rescue pen can become the official choice of patients and families having to deal with severe hypoglycemic events. And HypoPal rescue pen proved to be both fast and easy-to-use system for one of the most [ severe aspects ] of living with type 1 diabetes.On Page 4, we see the details of our collaboration with Alexion. It is a good example of how we can engineer superior peptide therapeutics [indiscernible] platform, be recognized by market leaders such as Alexion and establish into a beneficial collaboration. Leveraging Alexion's leadership in treating complement-mediated disease is an outstanding opportunity to reach to more patients and help improve more lives affected by a broad area of disease. On Page 5, we can see a summary of our financial results for the first quarter ended March 31, 2018. I point your attention to [ the absence ] of revenue and the related expenses attributed actually to having sold the royalty stream related to Soliqua and Lyxumia. The net results for the quarter was a loss of DKK 128 million compared to the loss of DKK 97 million for the same period of 2018.Move to Page 6, which illustrates Zealand's sustained, strong financial position. The year-over-year increase in the net operating expenses is in line with our guidance. And it reflects the clinical activity of running 5 clinical programs, which includes 3 Phase III programs and continue to support our preclinical research activities, so a lot of activities. Turning to the balance sheet. We note a very healthy increase, which paralleled the growth in operating expansion. For the first quarter, we recorded securities, cash and cash equivalents of close to DKK 1.3 billion or USD 190 million. We believe our current fiscal results put us in a strong position to fund our programs and operations. Our 2019 financial guidance on Page 7 is unchanged. We estimate that total net operating expenses in 2019 are expected to be within the range of DKK 550 million, DKK 570 million or $85 million to $88 million. Moving to Page 8. I ask that if you could withhold any questions until later during the call. And I will now actually hand the meeting to Adam to discuss our pipeline in greater detail. Adam?

[Adam Steensberg]

Thank you, Emmanuel. So on Page 9, we have an overview of Zealand's extremely robust pipeline. I will cover each [indiscernible] late-stage programs in the next slides. But I would like to turn your attention to the early clinical and partner programs here. Two of the earlier programs are being developed in partnership with Ingelheim. The first one is a once-weekly GLP-1 glucagon agonist for treatment of obesity and/or diabetes. We expect BI to conclude the Phase I studies this year. And this one is a novel once-weekly amylin analog also for the treatment of obesity and/or diabetes, which we expect BI to take into Phase I trials this year. From our early types we are also looking very much forward to advance 7570 into Phase I studies this year as a potential next-generation therapy for short bowel syndrome. For our complement C3 inhibitor program, we are in discussions with Alexion about the progress towards Phase I initiation in 2020.Please turn to Page 10. The glepaglutide is our long-acting GLP-2 analog in development in an auto-injector with potential for convenient weekly administration. In 2018, we initiated a pivotal Phase III trial. This trial remains on track to announce results in 2020 with 16 patients randomized as of the beginning of May and a significant number of new potential patients in the screening phase. Earlier this month, we initiated the Phase III extension study to evaluate the long-term safety and efficacy of glepaglutide. We see the transfer in our SBS patients from the earlier clinical trials into this extension study as a very positive sign of good tolerability of the drug and good study conduct. With an expected half-life of approximately 50 hours, glepaglutide has the potential to become the best-in-class GLP-2 therapy for short bowel syndrome patients, providing a fast, reliable and well-tolerated treatment option. Please move to Page 11. Dasiglucagon is a potential first-in-class stable glucagon analog invented and developed by Zealand in their ready-to-use HypoPal rescue pen for easy, fast and effective treatment of severe hypoglycemia. Earlier this week, we announced the key results from our confirmatory Phase III trial, which reiterated dasiglucagon's fast onset of action and efficacy in treating hypoglycemia. Both the pivotal and this confirmatory study report a median time to plasma glucose recovery of 10 minutes from time of injection. The confirmatory trial also and importantly demonstrated that [indiscernible] as needed for accuracy and easy administration. The ongoing Phase III pediatric trial using the same dose as administered to the adults is expected to report results in September this year. This is slightly later than originally anticipated. And as this study is a critical path for the planned NDA submission with the USFDA, that has been adjusted to early 2020. Page 12. Here, we highlight the upcoming Phase II trials with Beta Bionics [indiscernible] bionic pancreas system. This Phase II study will compare the performance of the dual-hormone versus the insulin-only artificial pancreas pump in people with type 1 diabetes. Our development of dasiglucagon in a 1-milliliter cartridge for use in dual-hormone artificial pancreas pumps continues to make firm progress. And we look forward to the imminent start of the Phase II home use study and should report the results from this study later this year.I'm going to Page 13. Earlier in the first quarter, we began dosing CHI children with dasiglucagon in the first of 2 Phase III trials with this indication. The first trial will evaluate potential for dasiglucagon as a new treatment for CHI children in the -- to prevent persistent episodes of hypoglycemia. Continuous low doses of dasiglucagon will be infused via subcutaneous pump in the trial. I'm really happy to announce that the first trial has successfully completed dosing in this pivotal Phase III trial together with the investigator. And the investigator has now decided to enroll these patients into the long-term safety and efficacy trial.The second Phase III trial for dasiglucagon in CHI is expected to start in [ September '19 ] and will enroll up to 12 children with CHI from newborns up to the age of 1 year. And this study will evaluate the ability to reduce the dependency on intravenous glucose.Now on Page 14, I would like to return the call to Emmanuel for his concluding remarks.

[Emmanuel Dulac, CEO & President]

Well, thanks, Adam. And again, good progress for the quarter. There are 2 more slides to show. On Page 18, it shows the objective for 2019. These focal points I have provided here [ to our internal team ] and they will remain set for the rest of the year.So we continue [ threading ] our clinical pipeline with several Phase II and III studies ongoing and look forward to announcing results to some of these studies [ later this year ]. In our early pipeline, we look forward to ZP7570 entering Phase I while continuing productive partnership with Boehringer Ingelheim and Alexion on early and preclinical targets. And finally, progress continues on creating and operationalizing our U.S. commercial footprint. We look forward to providing more specifics around our intentions throughout the rest of the year.Next page, Page 16, provides an overview of activities for 2019 [indiscernible] and supporting activities. We have already achieved progress in our development activities. And we believe we have significant opportunities on the horizon to create further value for our shareholders. Zealand continues on a clear path towards achievements for 2019, and we are very enthusiastic about the progress we made.This concludes our prepared remarks. Thank you for your attention thus far. And now I would like to ask the operator to open the lines for questions.

[Operator]

[Operator Instructions] Your first question comes from the line of David Lebowitz.

[David Neil Lebowitz, Vice President]

I guess, first, on the pediatric trial, what's the reason for the short delay?

[Emmanuel Dulac, CEO & President]

David, thanks for your question. So the question is actually for the pediatric study. And I will pass this question to Adam Steensberg.

[Adam Steensberg]

Yes. So the simple reason is that the last child there was actually screened and ready to be randomized before the study decided not to participate after the parents decided to recall that child. So that means that we had to open up the screen again and then [ find ] new patients. So there was a slight delay.

[David Neil Lebowitz, Vice President]

Okay, makes sense. And then looking to, I guess, some of your candidates, you have data coming from the long-acting GLP-1 dual agonist. And I guess what should we expect to see from that data being presented midyear?

[Emmanuel Dulac, CEO & President]

Yes. So this is, of course, our partner, Boehringer Ingelheim, who is responsible for this study. And we, of course, expect them to, once they have concluded the study, to make a decision to -- and we hope that they will make a decision to move into Phase II. But this is again where they are in control. And I think the dialogue we have expect them to conclude the Phase I studies and then make these decisions on the next steps later this year. And we will inform the market. As you know, Boehringer is not a public company, so they don't have any disclosure obligation, but we have. So when we have -- when we know about their decision, we will disclose it.

[David Neil Lebowitz, Vice President]

And then I guess as far as your short bowel dual-agonist follow-on, what advantages could a dual agonist have on the long-acting GLP-2 analog?

[Adam Steensberg]

Okay. So I think that actually potentially has many advantages. And I think the very interesting thing is that there's already, to some degree, clinical proof-of-concept in that investigator [indiscernible] infusion of, the injection of GLP-1 with a GLP-2 strain [ in a synergistic effect ]. But basically, what we believe and expect that [indiscernible] GLP-2 component, that is very strong in increasing [indiscernible] across the intestinal barrier and also increases intestinal blood flow, which has been deficient in these patients. The GLP-1 component slows down gastric motility, allowing the food and [indiscernible] to spend more time in the intestines and then more time for absorption. But that is a key parameter. The other thing the GLP-1 is doing is that it causes the pancreas to release more insulin and thereby making the liver more effective in handling the nutritions. So you can see that we have probably 4 key mechanisms with the 2 receptors that would be responsible for 2 weeks. And that is why we see it's much more effective. So you could expect more ability to reduce [indiscernible] but also and importantly much less [ diarrhea ] for the patients.

[Operator]

Your next question comes from the line of Graig Suvannavejh.

[Graig Suvannavejh]

I have several questions. My first has to do with dasiglucagon. The CHI indication is very interesting. And I know you're just starting out basically. But when do you think we will see first data from that program?

[Emmanuel Dulac, CEO & President]

So your question -- thanks for asking. So your question is related to the time of the result really of the communication. So again, I will pass it to Adam.

[Adam Steensberg]

We have provided a guidance on this now because we know it is difficult to [indiscernible] studies [indiscernible] with children. We actually see a lot of interest and a strong commitment from investigators. And as we said we have the first and several more now on screening phase. It's the third [indiscernible] study, but we have an interim readout planned after 16 weeks. It could allow an early [indiscernible] for efficacy. Yes, so it is, I would say, the result for the [indiscernible] outside with [indiscernible] recruitment.

[Graig Suvannavejh]

Okay. My next question, and maybe, Emmanuel, you can answer this question, given your background. But as you got dasiglucagon being developed across the 3 indications, how should we be thinking about pricing across the 3 different indications or product presentations? And assuming success on all 3, how are you thinking about that pricing dynamic as each of those products come to market?

[Emmanuel Dulac, CEO & President]

Yes. So again, I think, Graig, I mean, the first indication usually is the one that defines the price for the drug. And you have to look at the value of the drug you bring as well as the existing approved products. So that answers kind of your [ your ] question. How do we price smaller indication [indiscernible]? I mean in between the rescue pen and the vial that would go, for example, in the pumping [indiscernible], these are 2 different products for 2 different use and with different dosing. And so this would actually probably combine different prices -- command different prices. In some key markets, in Europe, for example, sometimes they go by milligram price. But I don't think this will be the case here, even in this market just because the use and the dosing will be -- and the packaging will be very different and indication will be different. So we haven't answered yet this pricing question. And we are not there yet. It will be going, I would say, a few months to launch based on the market dynamics based on the methodology that we have ingrained. And right now, we're just using some sort of guidance price for [ indiscernible ] forecasting matter. But we are nowhere near the final pricing strategy that we are going to take to market. It's an ever-evolving environment, the access [indiscernible] so we will adapt. And the plan is to be really innovative as well in this year as innovative as we have been in the [ research ] side. More to come.

[Graig Suvannavejh]

Okay. And then maybe my last question before I jump back into the queue and again this is for Emmanuel, as the new incoming CEO -- and I realize that you've only been at the company for a relatively short time. But do you already have in your mind what you would like Zealand Pharma to look like in the next 2, 3, 5 years? And if that's premature to ask, then is it fair to assume that you're doing some sort of initial top-to-bottom strategic review of the company? And if so, when might we hear something about the outcome of such a review if it is happening?

[Emmanuel Dulac, CEO & President]

Yes, Graig, thanks again for your question. Yes, you're right. I don't [indiscernible] because I'm still [indiscernible] for a period of time, 5 weeks now in the job. But what I saw from outside is pretty much what I saw as well. Zealand is a company which is -- has an amazing pipeline, great know-how in terms of developing peptide therapeutics, which are superior to the existing solutions. And so as a result, I think the valuation of the company's [indiscernible] doesn't reflect the value of its assets and of its potential. So there's no secret that I think this company should be far better valued. And I think that we need to actually get more visibility, more awareness to the market for our story, our pipeline. But at the same time, our intention -- and you're right that I think maybe we haven't been clear yet in exactly what is our ambition. My secret ambition and what I hope to share is that I think Zealand, by becoming commercial -- so right now, we are a very small R&D company. I think we have to become a very strong RD&T company. And by becoming a fully integrated biotech company with global presence, I think we will be serving the patients and the market better. We have developed amazing drugs. Now it's our ambition and our mission as well to bring that -- I think we are best equipped to do it ourselves. But we will actually continue to pursue partnerships where it makes sense and where the value is actually for us, either on the finance side of things, helping us to pursue other projects in the R&D side or the [indiscernible] that would help us to reach more patients faster. And again, that's, I think, something we have to keep in mind is that ultimately our goal is to make sure that all the patients that deserve our drugs are getting our drugs. And we will at least find innovative ways on the [indiscernible] side as well as on the commercialization side to make that happen.

[Graig Suvannavejh]

Okay. Congrats on the progress in the quarter. And Emmanuel, congrats on the new position.

[Emmanuel Dulac, CEO & President]

Thank you.

[Operator]

[Operator Instructions] Your next question comes from the line of Eric Le Berrigaud.

[Eric Le Berrigaud, Managing Partner Equity & Research]

Thanks for the transition since the two questions are commercialization-related. The first one, we're clearly moving now towards the commercialization phase of dasiglucagon, HypoPal. How would you advise us in our modeling for this? And first of all, should we still expect the partner to do this on your behalf? Or are you -- and maybe are you ready to say a word about how ongoing discussions on where you are here? And maybe any sensitivity to Lilly's and Xeris' drug approvals coming towards June, July? And the second question, if we move to CHI, how do you see this opportunity also from a commercial perspective? And is the preferred route to do it yourself?

[Emmanuel Dulac, CEO & President]

Thank you, Eric. So your first question about -- there is no strategy -- no change in the strategy, as I said before. So we are going to pursue exactly what we announced before, so looking for a partnership where it makes sense. To the specific to the market of the HypoPal rescue pen, I just wanted to point out that if you look at the market today, which is about $300 million, $400 million in the U.S., I mean it's a vastly undeveloped market, about very low numbers of [ indiscernible ] in this case they are actually not working, and they are not necessarily meeting their needs. And as a result, they are sometimes not used. But even when they are used, they are rarely used. I think only 15% of the patients who are using the kits are using them properly, 15%, 1-5, so very low. Our intention is to look at the HypoPal rescue pen, which is fast, easy to use, very safe and I think meets the acute requirements of responding to a serious hypoglycemic event in a patient. So we are actually looking at the market. And if you actually project the fact that if we were doing a good job at commercializing these drugs, making sure that every patient is equipped not only with one pen but has the possibility to potentially store a pen for pediatric patients, a pen at home, a pen at school and a pen at their sports club, for example, which should be the case because that's where [ all these ]. And if we make it innovative enough on the access side so that we can actually achieve that storing and storage, and I think the market will look very different from today. And I don't have numbers for you, but I think we can make this assumption that our intention is to make sure as many patients as possible will be equipped. And they will be equipped with pens where they need to be to have these pens stored. So that's our goal. On the CHI, a question maybe again I will pass to Adam for your CHI question.

[Adam Steensberg]

Yes. And maybe that's -- because I heard you also ask about the Xeris and Lilly products for severe hypoglycemic events. I think we don't have any other insights in the market of these products. And of course, we look forward to see -- it's public knowledge that Xeris has a PDUFA date in June 10. So it's going to be exciting to see what they present there. And Lilly's product was just announced a few months delayed. So it's going to be interesting to see how they come out. On the CHI, on the commercial case, I think Emmanuel talked a little bit about it before. On the pricing side, we still need to do work on the pricing side. There's no doubt that what we are doing here for these children is basically -- if we succeed with what we have set out to achieve, it will change the lives of these patients and their families. So of course, it's a product that will be, you can say, highly appreciated in the market and make a significant difference to these patients. And we see it as, from a commercial point of view, there is, of course, a good opportunity here. It's also an opportunity to launch the chronic use of dasiglucagon at an earlier stage than for the dual-hormone activities. So I think we should all see it in the light of the combined activities we have with dasiglucagon.

[Operator]

Your next question comes from the line of Alan Carr.

[Alan Carr, Senior Analyst]

A couple of follow-ups to previous questions and then another one. So coming back to you, Emmanuel, in terms of strategy, did you -- coming onboard, did you have any sense of what sort of things might need to change? And then also around the pen, you all have been putting partnership as the, I think, the primary goal at this point. It seems like that's fair to say. But if you don't identify a partner, can you all describe or review for us what the process would be in terms of getting ready to commercialize that on your own? When do you have to start that process? And then Adam, around the interim analysis for your CHI program, can you tell us more about what the endpoint there is and thresholds and that sort of thing?

[Emmanuel Dulac, CEO & President]

Thank you. Thank you, Alan, for your questions. So the first question was related to my observations, I believe. I must say that I've been again probably still in the honeymoon period, but I'm very positively surprised with the talents of the teams. I mean the team has proven itself over the last 20 years by developing these drugs but as well as remarkably growth in our in-house, external talents so that they have had great insights into what it takes to get to the next step. So that's actually an amazing situation to step in. And again, kudos to the previous leadership team and previous CEO for doing that early. We still have to actually bring a lot more talents to especially penetrate the U.S. market. And with the expertise of the team and being on the ground in the U.S. because you can't really do that remotely. So that's an obvious one. But again, the collaborative nature of the teams, the, I would say, ability to engage each other and challenge each other is present, which is a remarkable culture. And I will work and use my time and my efforts to maintain that and transfer these traits to the U.S. entity that we are going to build. Related to the partner, we are pursuing partnerships and discussions are ongoing. If we have enough cash to carry [ through fighting ], as we say, so this is our plan. We haven't -- I cannot speculate whether or not we will and we will not and if we don't, what will happen. We are actually working on every opportunities and cases. I see everything as an opportunity. So again, this is a fantastic product. We released amazing results 2 days ago. And it's actually continuing to grow and strengthen. Related to CHI, I will pass this one to Adam.

[Adam Steensberg]

Yes. So on the planned interim readout [indiscernible] patients, it's based on efficacy. And it's something that the FDA asked us to do. As you know, it's the first time we are actually testing dasiglucagon in CHI patients. It's an open-label study. And you can say -- so the [indiscernible] study if we see the effect carry a very, very high typical [indiscernible]. So I would put it this way that, I mean, if we missed [indiscernible] readout from efficacy, it's not something that we expect to see [indiscernible] right now because the p-value would have to be enormously high for such few patients. But I think it boosts the confidence in the approach. I will say that they have this readout and...

[Alan Carr, Senior Analyst]

Right. Emmanuel, coming back to you, you said something about having enough cash. Did you say you have enough cash to bring the pen program forward on your own to commercialize on your own? Or I misunderstand you?

[Emmanuel Dulac, CEO & President]

No. To the market, registration into the market.

[Operator]

[Operator Instructions] Your next question comes from the line of Lucy Codrington.

[Lucy-Emma Mary Sarah Codrington-Bartlett]

Just a quick one. Given that the HypoPal pediatric study has now been delayed, whether you're still considering potentially delaying that filing until you have the CHI data in order to file in that indication first and therefore potentially get a priority review that shows the results. And then just secondly, the line unfortunately cut out, when -- roughly when did you say you might potentially expect to get the data, the first CHI data?

[Emmanuel Dulac, CEO & President]

Thank you, Lucy. So again, I will pass it to Adam. I wanted to clarify your questions. So you asked several. You asked if about the CHI again, the timing between CHI and the pen. You asked about what the -- what would be the first approval, if I correctly understand. From dasiglucagon, what would be the first indication?

[Lucy-Emma Mary Sarah Codrington-Bartlett]

Yes. Whether you would hold off until you'd get -- as I understand it in order to get the voucher, the first approval has to be in the -- it has to be the first approval for that drug.

[Adam Steensberg]

Yes. As we also said for the HypoPal rescue pen, it is a few months delayed that we are facing, so we anticipate to be able to submit the NDA early 2020. For the CHI program, we do not, as it stands right now, expect Phase III data before 2020. So I will say to kind of change the sequence of submitting these NDAs, that would probably introduce a quite significant delay. So you can say it's not the most likely scenario that we will do that. As it stands right now, then we would have probably had to have extraordinary fast improvement in the CHI study. We are, of course, entirely aware about the opportunity with the voucher. And we will continue to monitor that opportunity is probably what we can say here.

[Emmanuel Dulac, CEO & President]

But again, these products are different in nature. So I think in terms of entry market and end pricing, they won't impact each other. In terms of pediatric voucher, you're right that the pediatric voucher would be a nice one to have. But as Adam said, I don't think we should delay further the pen just to get behind the CHI indication.

[Operator]

There are no further questions at the moment. Please continue.

[Emmanuel Dulac, CEO & President]

Okay. So should we then...

[Lani Pollworth Morvan, Investor Relations & Communications Officer]

Yes. If there are no further questions, we would like to thank everybody for participating today.

[Emmanuel Dulac, CEO & President]

Yes, thank you very much everyone. And again, we look forward to potentially having following calls with you. But thanks again for joining and listening to us. We'll meet you soon. Thanks to the team as well. Bye now. This call is obviously closed now.

[Operator]

This does conclude our conference for today. Thank you for participating. You may all disconnect. Speakers, please standby.