Zealand Pharma A/S (ZEAL) Earnings Call Transcript & Summary

On behalf of the Board of Directors and Executive Board, I am pleased to welcome you to the Annual General Meeting 2023 of Zealand Pharma A/S. Today, the Board of Directors is represented by myself as Chairman and the Executive Board is represented by CEO, Adam Steensberg; and CFO, Henriette Wennicke. I would like to thank our shareholders for your attendance and continued support of the company. A year ago, we announced a change in strategy. We choose to prioritize investments in research and development. Zealand's core strength, as many of you already know, is the design and development of therapeutic peptides, and this has led to a rich pipeline of promising candidates targeting rare diseases, obesity and inflammation. The company has demonstrated its ability to independently bring a product from discovery to market through the launch of Zegalogue in the U.S. However, Zealand also knows that to reach more patients in more regions around the world, the company should partner with global and regional leaders. Therefore, we scaled back Zealand's commercial operations and are emphasizing strategic partnerships to ensure the company's treatments reach patients. With the change in strategy, we appointed Adam Steensberg to the role of Chief Executive Officer. And during 2022, Adam built a strong management team to lead Zealand's transformation. The refreshed management adapted to the changing environment and to the shift in strategy, Together with the other members of the Board, I've had close supervision and oversight of the management team and the execution of the new strategy. Over the last 12 months, we believe that shareholders have been -- have seen a more focused organization and has -- that has delivered its promises. And we have seen this reflected in the growth of the company's share price during some of the most challenging conditions that the market has seen. So looking ahead, the Board and I are focused on ensuring that Zealand continues to play strength -- on its strength on its strength to maximize the value of our pipeline and assets and deliver new peptide-based therapies to patients. Attorney at Law, Thomas Holst Laursen has been appointed Chairman of this general meeting by the Board of Directors in accordance with Section 914 of the company's Articles of Association. And I will now, with pleasure, pass the word to Thomas to ensure that all applicable rules, regulations are complied with in connection with the holding of this meeting.

Thank you very much. So starting with a customary cautionary statement about forward-looking statements to be made at this meeting, and swiftly moving on to present the agenda, which I will come back to. Thank you very much for the appointment. This general meeting will be held in English. We will not have any simultaneous interpretation. If anybody needs help with questions or comments, I will assist them. This general meeting is held partly electronic and partly with presence here in the room. As the Chairman of the meeting, I have established that the notice to convene the general meeting and the publication of the notice on the 2nd of March comply with the articles and the Danish statutory provisions, and therefore, that the meeting has been duly convened in accordance with applicable rules. 56% of the voting share capital is represented at the general meeting today, including proxies, et cetera. If no one objects, I will conclude that the meeting is legally convened. I'm following above you here in the room, and then I'm following my screen. I'm happy to confirm that, that is not the case. You should know that this general meeting is audio and visually recorded, and the webcast will be made available on the company's website after the general meeting. If you wish to raise any questions or comments at the general meeting, you are welcome to either type that in writing by using the chat box function, which is shown on the screen, if you're attending electronically. If you are here in person, we will make sure to pass your microphone if you raise your hand when I ask for questions and comments, and then you will be able to provide it. You will state your name before you question and/or comment for the minutes of the meeting. We will try to keep it rather informal. As I said, I will be happy to help if anybody needs translation from a question and to the transmission. And we are in the fortunate situation that the agenda and the proposals from the Board has received a wide approval from shareholders in advance on proxy voting. Of course, I will be asking every time if there are any shareholders who wishes to have a vote, in which case that will be held, but we would deal with that as we go along through the agenda. Shareholders who are here in person today, if you vote, then what you do is you scan the QR code that you have received together with your access to the general meeting, and you use your camera to do that. If you need any help, Computershare is here to help you. Please note that if you have submitted a postal vote or proxy prior to the meeting, then you cannot vote today at the meeting. Minor delays in the transmission may occur. So therefore, there can be small breaks, but we'll try and make it as fluent as possible. When you look there at the screen, you will see today's overall general meeting agenda. I will not read out loud the various proposals, but we will deal with them as we go along. What we will do is, and this is the proposal, we will this year process the general meeting such that items 1, 2 and 3 are taken together. Then once gone through, the shareholders will get the opportunity to submit questions or comments as introduced before. With that, and here on the -- with Martin, Adam and Henriette, taking the word, I will pass the word to Adam Steensberg first to give the management report on the company's activities in 2022, and a presentation of the company's financial highlights will be supplemented by Henriette.

Thank you, Thomas. So I would also like to extend a warm welcome to all our shareholders. Every day, we work diligently to leverage our peptide platform to deliver new medicines to patients with unmet medical needs at a range of different diseases. And we can do this because of your continued support. So let's move to Slide 7. 2022 was a transformational year for Zealand, and I'm proud of the progress our team has made since announcing the strategy shift to prioritize investments in peptide R&D. We achieved key milestones across our clinical pipeline. We reported positive Phase III results, both for our assets in rare diseases, dasiglucagon in newborns and children with a congenital hyperinsulinism and for glepaglutide in short bowel syndrome. We also advanced our portfolio of peptides targeting obesity. Following our decision to scale back on commercial operations, we executed 2 partnerships for our marketed products. We sold the V-Go insulin delivery device to MannKind, and we entered into a partnership agreement with Novo Nordisk to commercialize Zegalogue. Finally, and despite the financial markets, we were able to strengthen our balance sheet through equity raises that extend our cash runway into mid-'24. So let's move to Slide 8. As our Chairman, Martin, mentioned, we have built a very strong management team to lead Zealand, and we added 3 new members during 2022. David Kendall was appointed Zealand's Chief Medical Officer in June. David has a broad and deep expertise in diabetes and metabolism, and he has held senior leadership positions in clinical and academic medicine as well as in the biopharmaceutical industry, including Eli Lilly. Ravinder Chahil. He was promoted to join the corporate management team as our General Counsel and Head of Legal and IR. Ravinder has international experience in intellectual property law in the life science sector, with expertise in litigation, licensing and mergers and acquisitions. Finally, in November, Henriette Wennicke joined Zealand as our Chief Financial Officer, and Henriette has a broad finance and business experience from companies like GN Store Nord and Novo Nordisk. Together with Christina Bredal, our Global Head of People and Organization; and Ivan Møller, our Chief Operating Officer, I believe we have the right team in place today to lead Zealand. We have a shared ambition for Zealand to be the leading peptide drug discovery and development company. Please move to Slide 9. Today, we have a rich R&D pipeline of promising candidates targeting unmet medical needs across several disease areas. In rare diseases, we have 2 -- we have the potential to address 2 devastating diseases for patients, which we reported positive Phase III results from last year. In congenital hyperinsulinism, we have shown that dasiglucagon has the potential to manage blood glucose in both babies and children. And we believe that there are up to 800 children living with diffuse congenital hyperinsulinism in the U.S. alone that we may be able to treat with dasiglucagon, if approved. In short bowl syndrome, we are developing glepaglutide as a next-generation GLP-2 therapy delivered by an auto-injector, which we believe has the potential to substantially reduce the burden of parental support in patients with intestinal failure as well as the burden of daily injections with currently approved GLP-2 therapies. Turning to obesity. There's little doubt that this represents one of the most significant health care challenges of our time, and we believe that we have a rich and differentiated pipeline of novel assets to address this challenge. Obesity is a complex disease that can be managed pharmacologically by targeting a number of unique biological pathways. We are using 2 specific approaches at Zealand Pharma, either dual pharmacology built into a single patient -- peptide or potent and differentiated single receptor agonists that can be used alone or in combination with other peptides, either loosely combined or as co-formulations. I would like to briefly highlight the new data that we reported yesterday from CP-8396, our amylin analog. In a Phase Ia study in healthy volunteers, we observed dose-dependent body weight reductions of up to a mean of 4.2%, or 4.8% when correcting for placebo, following a single dose of this molecule. Although these data are very early and in a small number of patients, we believe the data continue to support the potential for our amylin analog to be best-in-class. So let's turn to the next slide. 2023 looks to be a very exciting year for Zealand, and we have 3 key strategic objectives aiming at maximizing the value potential of our pipeline. Our first objective is to progress our rare disease assets, dasiglucagon and glepaglutide, towards the regulatory submissions. Our second objective is to advance our obesity portfolio. We expect to initiate new clinical studies with our 3 wholly owned assets. This includes dapiglutide, our first-in-class GLP-1, GLP-2 receptor dual agonist, and our long-acting analogs of amylin and GIP. We also anticipate key Phase II data from our partner, Boehringer Ingelheim, for the glucagon GLP-1 receptor dual agonist, BI 456906, in obesity, and this molecule has the potential to move into Phase III this year. Finally, our third key objective is to engage in strategic partnership discussions aligned with the change in strategy. As we evaluate these partnerships, we seek to continue to participate in the programs across the value chain, leveraging our strengths and capabilities to maximize the value of the assets. And in addition to the 3 key objectives I just described here, we are also focused on activities that support our programs in type 1 diabetes management. This includes submitting a marketing authorization application with the European Medicines Agency for Zegalogue, which we are responsible for under the global agreement with Novo Nordisk. And with that, I would now pass over the word to Henriette.

Thanks, Adam, and hello, everyone, from me as well. Let's move on to Slide 12 and the income statement. Revenue for 2022 was DKK 104 million driven by a development agreement with elections and the partnership agreement we did in Q2 2022 with Novo Nordisk. The operating expenses for the period were DKK 941 million. This is slightly above last year when comparing the continued operations. The increase is driven by the progression of our research and development activities, as Adam just described, especially our late-stage development programs. The sales and marketing expenses decreased compared to last year following the announced restructuring in March 2022. Net financial items for the period resulted in a loss of DKK 135 million. These costs are primarily related to the loan agreement we have with Oberland. As a result of the announced restructuring, all income and expenses related to commercial efforts latest to V-Go and Zegalogue are accounted for as discontinued operations in the numbers. Let's move on to Slide 13 and the cash position. In 2022, we were able to strengthen our balance sheet with gross proceeds worth more than DKK 1 billion, despite the very challenging market conditions we all experienced. We also paid down half of the facility with Oberland and made significant investment in progressing our pipeline. At year-end 2022, cash, cash equivalent and marketable securities were approximately DKK 1.2 billion. With this, we have a cash run rate to mid-'24, as Adam mentioned, and this allow us to continue to invest in progressing our R&D pipeline. As communicated on March 12, Zealand had DKK 163 million in cash deposits at SVB Bank, as the bank was closed for operations by the California Department of Financial Protection. This represented at the time approximately 15% of the total cash, cash equivalent and marketable securities on that date. Fortunately, with the support from the U.S. government, the Zealand cash was recovered the day after, and we have full access to the cash today and can access it. And let's move to Slide 14 and the financial guidance. As Adam said, 2023 looks to be a very exciting year for Zealand. We will invest in progressing our rare disease assets towards regulatory submissions while, at the same time, investing in our key obesity assets. In 2023, we guide for net operating expenses of between DKK 800 million to DKK 900 million. This is somewhat lower than recent years' expense levels and reflect the restructuring implementation we did last year. In 2023, we will also engage in partnership discussion, in line with our change in strategy. However, we will not provide guidance on revenue anticipated from existing and new license and partnership agreements due to the uncertainty related to the timing at the size of this revenue. And with these brief remarks, I will pass the word back to Thomas.

We're now at the point in time where shareholders are welcome to come with any comments or questions to these first 3 agenda items. Looking in the group here available, no, I'm not having anything on my screen. So while we look at that, what the next phase is to resolve on items 1, 2 and 3 on the agenda. So that means taking into account the report by the management, approve the audited annual report for 2022 and approve of the Board of Directors that the annual result at a loss of DKK 1.2 billion is carried forward to the following year. These 3 proposals set out in the agenda item 1 to 3 are therefore proposed to be resolved and approved. There are no objections. With that, I consequently consider them to be adopted. And with that, I will pass the word to Martin to present the Board of Directors' proposal under Item #4 in relation to the election of the Board of Directors.

Thank you, Thomas. The Board members are elected by the general meeting on an annual basis. As recommendation -- recommended by the Nomination Committee, the Board of Directors proposes reelection of all incumbent Board members. In accordance with the Danish recommendations on corporate governance, the Board of Directors has undertaken a self-evaluation of its performance for 2022, engaging external assistance from relevant advisers. The evaluation was based on a questionnaire comprising 35 questions covering different areas such as Board composition, qualifications, management and handling of strategy, policies, controls, the quality of interaction with management and the leadership of me as the Chairman of the Board. Further, I have, as a Chairman, conducted one-on-one conversations with each Board member. The rating and feedback of the various questions or issues within each evaluation area showed, in general, high scores with low variability, which indicates and supports the fact that the Board of Directors of Zealand Pharma are working efficiently with passion, with professionalism, and has an integrated -- and is an integrated team. Further, the evaluation also reflected that the Board is well composed regarding skills, diversity and size. Areas to focus on, however, as action items, are to have more strategic items on a regular basis on the agenda, allowing for more discussions and to even further improve communication with the management in between meetings. I'll now hand back the word to you, Thomas.

Thank you very much. And the relevant agenda item is according to the company's Article of Association, the Board of Directors elected for 1 year at a time. All incumbent members stand for reelection, and the Board was presented there on your screen, as you saw, with the full proposal. And I will not read out therefore the names of each of the proposed members going forward, but rather encourage for any questions or comments from shareholders in the room or outside. Looking around the room, we don't have any questions either on the screen. With that, I will proceed to resolving on the agenda item, and I will consider the Board to be reelected as proposed, in accordance with the proposal, unless there are anyone who wishes otherwise. That is not the case. So with that, we will move on to the agenda Item #5, which is the election of the Auditor. The Board of Directors proposes the reelection of EY Godkendt Revisionspartnerselskab in accordance with the Audit Committee's recommendation. And I'll let that be there for a second, allowing people to raise any questions or comments, in which case, the proposal has been finally resolved by the general meeting. And we will proceed to agenda Item #6, authorization for the company to acquire treasury shares directly. The -- well, let's just see there. I lost that one. I will leave that. The Board of Directors request that the general meeting authorizes the company to acquire treasury shares directly, provided that the acquisition is in accordance with the Danish Companies Act. It will be funded by free reserves. Otherwise, that -- by means of funds that can be otherwise distributed as ordinary dividends. It will not exceed 10%, and it will occur at market price, meaning it will not deviate by more than 10% from the quoted price of the company's shares at the Nasdaq Copenhagen. Moving on to any questions or comments in respect of agenda Item #6. With the General Meeting's permission, I'll therefore consider that as resolved in accordance with the proposal set out in the notice. Moving on to agenda item #7, which is the proposal from the Board of Directors to amend the company's remuneration policy. I'll pass the word to Martin.

Thank you. The Board of Directors proposes that the General Meeting approves a revised remuneration policy of the company. The company's existing remuneration policy was adopted at the company's Annual Meeting in 2022 in accordance with Section 139 of the Danish Companies Act. The reason for the proposed amendments of the remuneration policy was, among others, to ensure that the company's remuneration structure enables the company to attract and retain talented members of the executive management and the Board of Directors. Compared to the existing remuneration policy, the revised policy involves the following material amendments. Firstly, for the Board of Directors, it was proposed to retain the reduced cash element of the last -- of last year and to use of RSU at the same level for us -- for the last year. However, the award is now awarded in 1/3 increments over a 3-year period, provided the Board member stays as a member of the Board. Second, to cap the total value of the RSUs that can be granted to any member of the Board to prevent any unintended levels of return. For the executive management, the terms of the long-term incentives for members of the executive management are proposed to be amended, so that, firstly, it consists of a combination of 50% so-called PSUs, performance share units, and 50% warrants. The terms of the PSUs are unchanged. The proposed terms of warrant involves a 3-year vesting period, with 1/3 vesting each year followed by an exercise period of 5 years. Secondly, reduced the cap on share-based remuneration, so that the award for executive management at the date of grant cannot exceed 250%, which is down from the previous 400% of their fixed annual salary to ensure that share-based compensation is not excessive. A draft version of the revised remuneration policy has been available for the shareholders on the company's website since the date of the notice convening the General Meeting. And I'll pass again over to you, Thomas.

Thank you very much. And again, we would welcome comments or questions from shareholders. None at this stage, and none from our participants outside the room. With that, I will allow the proposal to be considered as approved by the General Meeting, unless anybody wishes to vote, which is not the case. And with that, we will proceed to agenda Item #8, which is proposal from the Board of Directors to approve the company's remuneration report, with -- as presented by Martin.

Thank you. The Board of Directors proposes that the general meeting approves the company's remuneration report for the fiscal year 2022. The remuneration report has been prepared in accordance with the requirements prescribed by Section 139b of the Danish Companies Act and contains, inter alia, an overall view of the total remuneration for 2022 of each member of the Board of Directors and the executive management of the company. The remuneration report also contains additional descriptions in accordance with Section 139b of the Danish Companies Act, including, inter alia, explanation on how the remuneration for 2022 complies with the company's remuneration policy, how it contributes to the company's long-term results and how the performance criteria has been applied. Further, information and details can be found in the remuneration report, which has been available on the company's website since the date of notice convening the General Meeting. Over to you again, Thomas.

Thank you so much. Allowing shareholders for any questions or comments in respect of agenda Item #8 on the remuneration report. No. With that, we would proceed to resolving on the proposal from the Board, and I will consider that as approved by the General Meeting unless anybody objects, which is not the case. So agenda Item #8 approved. And moving to agenda Item #9, the proposal from the Board of Directors to approve the fees for the Board of Directors for the financial year 2023. Martin?

Thank you. The Board of Directors proposes that the General Meeting approves the fees for the Board of Directors for the financial year 2023 as presented on this slide. The proposed fees for the Board of Directors for the financial year 2023 remain unchanged compared to 2022. The value of each restricted share unit, RSU, is determined by multiplying the simple average of the closing price of the company's share on Nasdaq Copenhagen for the period of 5 trading days following the Annual General Meeting of the company. Additional information on the share-based components can be found in the company's remuneration policy adopted under agenda Item 7, which has been available in draft version on the company's website since the date of notice convening the General Meeting. Over to you, Thomas.

Thank you so much. And first of all, encouraging any questions or comments. Then before we go to resolution, a formal just notice to the meeting here. There was a typo in the report made available at the website with a minus in front of the annual change in company performance remuneration on Page 21. That has been corrected and stands corrected in what is available at the website. It does not change in any substantive way the proposal and/or the presented information to the general meeting. So with that, and seeing if there are any questions or comments, I will move on to resolution and consider the proposal as approved by the general meeting. With that, we move to Item #10. This is a proposal from the Board of Directors to approve a new authorization to increase the share capital of the company by way of a cash contribution without redemption rights for the company's existing shareholders at market price. The company, in its late stage of delivering on clinical and preclinical pipelines and prior to significant revenue generation, Zealand will, as in all biotechs at the same stage of development, require access to capital, which is the background for the proposal. Technically, the proposal will authorize the Board of Directors to increase the share capital by way of cash contributions, corresponding to a maximum of 20% of the company's existing share capital. It is a market standard market price authorization and will support the company's strategy and plans as presented by management in the report earlier today. A draft version of the revised Articles of Association was made available to shareholders since the date of the notice, and you can see technically the proposal shown on screen. And with that, I will proceed to inquire whether there are any questions or comments in respect of Item #10, which is not the case. And therefore, I will proceed to resolution, and I will consider the agenda Item #10 proposal as adopted by the General Meeting. With that, we move swiftly on to agenda Item #11. This is the proposal from the Board of Directors to approve a renewal of the authorization to issue warrants as presented in the notice and shown on the screen here in the back of you. It is inserted in the Articles of Association that has been made available to shareholders since the date of the notice convening the general meeting. It is, as set out, a standard authorization with, if you like, normal contents of such an authorization to the Board. Happy to take any questions or comments in respect of item #11. It's not the case. And with that, after having observed that, we move to resolution of Item #11 and consider that to be approved by the shareholders' meeting, unless anyone objects. That's not the case. So the proposal #11 is approved by the general meeting. That means that we have emptied the agenda moving into Item 12, allowing any shareholders to make any final comments or questions. That is not the case. And with that, the agenda has been fully gone through and approved by the General Meeting in accordance with the formal requirements, and I will, on that basis, pass the word back to Martin.

Thank you. On behalf of the Board of Directors, I thank sincerely our shareholders for joining us today and for your valuable support of our business endeavors. I also thank the management and the rest of the Zealand organization for their great contributions and execution of our new strategy. I and the Board are looking forward to our continued engagement and governance of Zealand and to success -- to our successful outcome of our new way of operating under the leadership of Adam Steensberg. Finally, I want to thank Thomas Holst Laursen for sharing this AGM, as always, in an excellent manner. And I hereby close the meeting, and thank you for your attention. Thank you.