Zealand Pharma A/S

Welcome and thank you for joining us today to discuss Zeeland's first quarter results for 2022. I'm Matt Dallas, Senior Vice President and Chief Financial Officer at Zeeland. With me today is Zeeland's President and Chief Executive Officer, Adam Sainsberg. You can find the related company announcement and additional supporting information on our website at zeelandpharma.com. I'd like to point out that we'll be making forward-looking statements that are subject to risk 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 findings for a more complete picture of risk and other factors. With that, I'll turn the call over to President and CEO, Adam Stainsberg.

Thank you, Matt, and thanks to everyone for joining today. Please turn to slide three. As you all know, at the end of the first quarter, following a thorough review of our business operations, we announced an organizational restructuring and a strategic refocusing to transition CELA into a more cost-effective company focused on our core competencies, the research and development of innovative peptide therapeutics, addressing areas of high unmet medical need. We believe this decision better supports our mission to change the lives of patients with next-generation peptide therapeutics. With a new commercial partnership strategy and a more streamlined organization, we are financially well-positioned to achieve our goals in the next few years, which includes the potential for three more commercialized products and a highly valued product pipeline, including programs targeting diabetes, obesity, chronic inflammation, leveraging our strong and innovative peptide platform. Please turn to slide four. One of my top priorities since taking over as the CEO has been to execute on the announced restructuring, including securing a strong financial runway that will take us beyond near-term clinical milestones. The cost savings associated with the restructuring and the amendment to our finance agreement with Oberland Capital have delivered financial stability, which enable us to deliver on our R&D focus, as Matt will discuss later in greater details. We expect to have completed the announced downscaling in the US by the end of the third quarter. As announced today, Matt will be leading Sealand to pursue new opportunities by the end of August and we have initiated the search for a new CFO for the company. Matt joined Sealand in 2019 and played an important part in building Sealand's commercial operations in the US and has created a very strong finance organization for the company. Personally, I've really enjoyed working with Matt and I look forward to work with him until the end of his tenure here at Sealand. Securing strong commercial partnerships is a fundamental element to our new strategy. Our business development team has been very busy engaging potential partners for VEGO and Seagalock, and I look forward to delivering on these negotiations in the coming months. Lastly, we look forward to top-line results for two of our phase three programs, which of course, depending on the data, could lead to NDA filings. Please turn to slide five. We continue to make progress on our clinical pipeline. All programs are based on innovation coming from our peptide platform, which is the foundation of our refocus strategy. Our excellence in understanding peptides and our broad know-how in how to create innovative peptide therapeutics will be at the center when considering future strategic partnerships. Our clinical programs, they target type 1 diabetes, rare diseases, obesity, and we have a late preclinical assets targeting chronic inflammation. We have strong momentum across the pipeline and a number of upcoming significant milestones this year. Importantly, we have three major clinical data readouts approaching with people to phase III results both for glipaglutide in SVS and basic lorgon in CHI, both of which I will expand upon in a moment, and phase II data for BI456906 in type II diabetes. This candidate is partnered with Berger Ingelheim and is the lead program in our obesity portfolio, which also includes an amylin analog in phase I development and GIB analog in late preclinical development. Applying our peptide know-how and cutting-edge platform to create therapeutics to tackle obesity is an important part of our refocus strategy, and I look forward to sharing updates from these programs with you later in the year. Turning to slide six. As I mentioned earlier, in the coming weeks, we expect top-line results from our Phase III study evaluating Dacid Glucon for the treatment of congenital hyperinsulinism, or CHI, in neonates and infants. CHI is an ultra-rare pediatric disease characterized by recurrent and persistent hyperglycemia. Our randomized placebo-controlled study of 12 children with CHI, ranging in age from seven days to 12 months, will measure a primary endpoint of reduced need for intravenous glucose. We believe basigluoban has the potential to be an important new treatment option for children with CHI, where there is a significant unmet medical need, and we look forward to sharing the results from this phase three study soon. With positive data, we plan to pursue an NDA submission, which will also include data from the phase three trial in older children with CHI with the FDA. Please turn to slide seven. Let me now turn to another product in our pipeline, where we look forward to share phase three data later this year. Glipaglutide, our long-acting GLP-2 analog, being investigated for the potential treatment of short-viral syndrome or SPS. We believe there's significant opportunity to improve the care for these patients and also believe that glipaglutide holds significant potential as a next-generation long-acting GLP-2 analog. The once- or twice-weekly profile delivered via an auto-injector provides a clear differentiation and the upcoming phase three data will provide more insight into the clinical profile of the drug, and the positive data will pursue an NDA finding with the FDA. Please turn to slide eight. Our data readout for EaseSDS-1 Our clopaclotype remains on track for data in the third quarter. Also, later this year, we expect to see the data from each SDS two and three, as you can see on this picture. And we look very much forward to sharing the data with you later in the year. Please turn to slide nine. For our additional late-stage DASIC-Logon programs, our partner BetaBionics initiated the Phase III program for DASIC-Logon in the bi-hormonal artificial pancreas pump for the management of type 1 diabetes in late 2021, and we expect that the first patients will be dosed later in this year. Beta Bionics recently presented results from their insulin-only bionic pancreas pivotal study at the International Conference of Advanced Technologies and Treatments for Diabetes, achieving key primary and secondary endpoints and demonstrating improved outcomes over standard of care in people living with type 1 diabetes While this trial did not involve deadly lubricants, it demonstrated the encouraging potential of the bionic pancreas pump for the management of type 1 diabetes, and we look forward to advancing our phase 3 program. In summary, we have a strong momentum across our robust preclinical pipeline and clinical pipeline, and with the refocused strategy prioritizing R&D announced at the end of the first quarter, we feel well-positioned to continue this progress. I will now turn over to our CFO, Matt Dallas, to walk us through our quarterly financials and the ways in which our organizational restructuring have improved our operational efficiency.

Thanks, Adam. This last quarter, we not only outlined our refocus strategy, but initiated our organizational restructuring and took steps to strengthen our financial future, ensuring that we can continue to discover and develop innovative new peptide therapeutics in 2022 and beyond. Slide 10 illustrates the immediate and long-term impact of the organizational restructuring. We are estimating an operating expense reduction from our 2021 level of 1.25 billion Danish kroner of 200 million in 2022. This is primarily related to a 90% reduction in the workforce of our U.S. subsidiary, and we anticipate that the long-term impact of the restructuring will result in a 400 million Danish kroner annual reduction in operating expenses beginning in 2023. In addition, on May 10th, we completed an amendment to our no-purchase agreement with Oberlin Capital. This amendment was completed as a result of our change in strategy and helps position the company financially to execute on this strategy. With the amendment, Zealand has paid down 50 million USD of the original 100 million principal balance, and there are up to 75 million in additional capital available to Zealand following the completion of specific events. The amendment removes any restrictions on use of cash and extends the company's cash runway into 2023. On slide 11, you will see Zealand's income statement for the first quarter of 2022 and how it compares to 2021. The total revenues for the first quarter was 15.1 million Danish kroner, or 2.3 million U.S. dollars. This was driven by net ZigaLog product revenue and partnership revenue from our collection with Alexion, collaboration with Alexion. The net operating result for the quarter was a loss of 302.1, 302 million Danish kroner, or 45.1 million USD. Sales and marketing costs mainly relate to the commercial infrastructure in the U.S. for ZigaLog, while R&D costs mainly relate to our late stage clinical programs. And as a result of our announced restructuring, all gross margin and operating expenses related to the Vigo wearable insulin delivery device are accounted for as discontinued operations. Total discontinued operations for the first quarter of 2022 were a loss of 41.8 million Danish kroner, or 6.2 million USD. Slide 12 illustrates our financial position and ability to support our growing business through continued investment. Net operating expenses for the quarter were 314.2 million Danish kroner, or 46.9 million USD. Included in net operating expenses for the first quarter of 2022 are 75.8 million Danish kroner related to our announced restructuring. Cash on hand at the end of Q1 2022 was 1.1 billion Danish kroner, or 167.6 million USD. Turning to our financial guidance on slide 13. On March 30th, Zeeland updated the guidance for net product revenue from the sales of commercial products to be 115 million Danish Kroner plus or minus 10%. This was a decrease of 120 million Danish Kroner from the guidance issued on March 10th. Combined sales of Vigo and Zegalog in Q1 were 39.2 million Danish Kroner and were in line with the updated guidance. Following the company's announced intent to sell Vigo, net product for the device is to be accounted for as discontinued operations. As such, Net product revenue reported in the Q1 earnings release only reflects sales of Zegalog, which were 4.1 million Danish kroner, with full-year net product revenue projected to be 19 million Danish kroner, excluding any potential partnerships or license agreements. In 2022, Xenopharm expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Xenopharm does not intend to provide guidance on such revenue. Net operating expenses for 2022 are expected to be 1 billion Danish kroner plus or minus 10%. This is unchanged from our guidance issued on March 30th and is a decrease of 200 million Danish kroner from the guidance issued on March 10th. With that, I will now turn it back to Adam.

Thanks, Matt. Please join me on slide 14. We expect 2022 to be a catalyst-rich year. and we look forward to sharing data from our Phase III studies evaluating dasyclogon in CHI and glipacretide in SPS, along with updates from our ongoing Phase III study of the dasyclogon bi-hormonal pancreas pump, and progress on our obesity portfolio. Partnering our commercial and late-stage assets will provide us with the financial strength to focus on the continuous advancement of our early-stage pipeline while leveraging our preparatory platform for the discovery and development of innovative new peptides in 2022 and beyond. This will allow us to take full advantage of our well-documented strength in research and development and enable us to deliver on our mission to ensure our medicines reach the people who need them the most. Thank you all. I will now turn it over to the operator for questions.

Operator? Ladies and gentlemen, we now begin the question and answer session. To ask a question, you will need to press 3 and 1 on your telephone and wait for your name to be announced. The first question from Thomas Bose from Danske Bank. Please go ahead.

Yes, thank you very much, Thomas Bose from Danske. So, three questions here from my side. So, just kicking off with the with this financing agreement with Oberland. So you're paying a premium of 10 million US to remove the liquidity covenant. So can you maybe just help me understand why you had this construct in the first place? So is there anything that has changed in regards to your original expectations of when you were supposed to breach this level. Would that be at a much later stage originally? Because it seems a little bit strange when you know that the data would come out in Q3. And then just to understand with the updated agreement here, so the cash run rate into 2023, I'm just wondering, is that including the 75 million that you have additionally from Oberland And also in that 75, you have 50 million as a sort of dependency on M&A, or how will you actually be able to get access to those additional 50 million without any M&A? So just help me understand this item here. And then second question, just on your pipeline and new strategy. So assuming that you have positive readout here very near term on CHI, So firstly, will you still advance and submit and do all the regulatory stuff and then aim to out-license afterwards? And how should we think about timing in regards to, of course, the other trials that you're doing with the ACQ going to a mini-dose and also the hormone pump? So anything here that you want to wait, any catalyst that you want to wait, aside, of course, from the very upcoming near-term here on the CHI, And then lastly, just on your dual listing, I guess you spent some money here, maybe 5, 10 million U.S. on an annual basis on the U.S. listing, and basically that's zero volume. So why haven't you also considered to delist in the U.S. in connection with the whole restructuring to save money? Thank you.

Thanks, Thomas. Maybe I just start by addressing the pipeline question, and then Matt, he will address the Oberland question and also the dual listing. You're correct that we expect to see the Phase III readout from the CHI Phase III study within the coming weeks, and I can also confirm that if it's positive, then we expect to submit an NDA late in the year. including the data from the first phase three study. That also means, of course, that you can say our teams here at Sealand are completely engaged in writing that NDA already now in the anticipation of and hope, with the hope that we will see positive data. So we, with the new strategy, we would still anticipate to submit the NDA and then in parallel seek a commercial partner for the program.

Matt? Yeah, Thomas, let's get to some of your financial questions. Let's start with the cash runway. The cash runway Into 2023, that's just what we have in the bank based on our current operating plan. It does not account for any additional cash coming into this company. So it doesn't factor in any new business development or any additional funding from Oberlin. And that Oberlin additional funding, that's $75 million. It's $50 million tied to business development, $12.5 million tied to glupaglutide positive data, and $12.5 million at a mutual option. All right? And then the amendment on the O'Brien agreement, that was driven by the fact that when we entered this deal, we were a commercially focused company. And as such, that deal had components in it that were tied to net sales targets by the company that would release a liquidity covenant. Once we made the change and announced our restructuring, it would have been impossible for us to achieve those targets because we were no longer going to be the commercial entity for our programs. So with that, we did the reason why of this amendment. And it removed that liquidity covenant. We prepaid a portion of it down, but it frees up the remaining balance without any commercial ties. On the dual listing, you know, what I'd say there is you're absolutely right in the cost behind it. With the restructuring and also kind of as our normal course of doing business, we're always evaluating the cost drivers in this company. And you know, with that, you know, the dual listing is always something that is under our approach and we'll look at as we move forward as to not only that, but what everything else and how we operate, what's the best and most logical way for us to be spending our proceeds.

All right. Great. Thank you very much for the call.

Thank you for your question. We have the next question from Joffe Stringer from Needham. Please go ahead.

Hi. Thanks for taking our question. Ours is on the Phase III SBS readout for cleptoglutide. Can you comment on potential impact of mist injections due to COVID? And do you have a stats plan or sort of pre-specified rules for handling mist injections? And have you... or has this been discussed and reviewed by regulators? And thanks for taking our question.

Thanks. And if I understood the question correct, then it was relating to the risk of misinjections of hepatotide in the study, so compliance to taking the drug, and if we have statistics to account for that. it's not something we have observed, and to be honest, it's not something you can say we would expect would increase with the COVID situation. We have had a key focus here throughout COVID to secure drug supply for the patients, and there's not been situations where we have not been able to supply that product to the patients. So we do not see any issues here. So if that was correctly understood, your question... I don't think we have a specific issue here.

Okay, great. Thank you for taking our question.

Thank you for your question. The next question from Lucy Coddington from Jefferies. Please go ahead.

Hi there. Thanks for taking my questions, just a few. Starting with the artificial pancreas, just wanted to get more on your thoughts about how the insulin-only data stacked up versus your expectations and whether you see any implications from those for your planned dual trial. And then related to that, just what seems to be the delay in starting the dosing of that trial, particularly given we are expecting a significant proportion of the patients from the insulin only to roll over into the dual trial. And then just to double check, on the revised Oberland Agreement, are there any changes to the royalty obligations with that? Thank you.

Thank you, Lucia. I'll take the first question and then Matt will address the Oberland. As many of you probably saw, and as we also shared here on the call, then Beta-Bionics, they, a few weeks ago, shared the phase three data for the Pivotal study and the insulin-only at ATTB. And the way we see these data is that they're very confirming, they're confirming our ambition for this product in the sense that they are very much in line with what we could have expected based on the phase two data of the insulin-only system. So of course, in our minds, it also speaks well for what we can expect for the bi-hormonal data. As you may remember, we did a head-to-head study, a small phase two study a few years ago. So it really, for us, it's extremely encouraging data when you think about what the dual hormone islet, how that could perform compared to existing systems. So we have really been reassured about the potential, I would say, seeing these data, and perhaps even more importantly, Also, the fact that the device is now being submitted for a regulatory approval with the FDA, so that also confirms, you can say, the technical progress that data bionics are making with the device. We would have liked to see the first station being dosed yet. There has been slight delays in that, as you alluded to. We are happy with what we see right now. Data bionics wanted to make sure that the device that we apply in the Phase III bi-hormonal study is completely similar to the commercial device that has been submitted to the FDA. And we agree to that strategy and accept that that introduced a little bit of a delay with regard to dosing the first patients. Patients who participated in the insulin-only study could, of course, still be eligible to enroll into the bi-hormonal study. So we are comfortable, but, of course, would have liked to see it happening a little bit before.

And Lucy, on the royalty obligation, because we reduced the principal down from $100 million to $50 million with that prepayment, the royalty obligation was subsequently reduced by half.

Great. Thanks very much.

Thank you for your question. I will now hand back the conference over to Mr. Adam Sinsberg. Please go ahead.

Thank you. So with that, we would like to thank you all for attending and for your questions. We look forward to connecting with you at future announcements and updates. Have a great day.