Good morning, everyone, and welcome to the Zealand Pharma's corporate update conference call. Today's call is being recorded. On the call this morning, we have Martin Nicklasson, Chairman of the Board of Directors, Adam Steensberg, the Company's Chief Executive Officer, and Matt Dallas, the Company's Chief Financial Officer. Later in the call, there will be an opportunity to ask a question. Please note that the conference call may contain forward-looking statements, and that the conference will react to the forward-looking statements set out in accompanying press releases issued by Zealand earlier today. I would now like to start by turning the call over to the Chairman of the Board, Martin Nicklasson. Please go ahead.
Thank you, and thank you, everyone, for joining today. Today, we announced several updates, including our reinforced strategy to prioritize research and development and the corporate restructuring to streamline business operations. As part of this strategy and restructuring, we also have appointed Dr. Adam Steensberg, our former Executive Vice President of Research and Development and Chief Medical Officer, to the role of Chief Executive Officer. Following a review of all business operations, we have decided that this is the best path forward for the company to maximize company and shareholder value. The corporate restructuring is intended to leverage our peptide platform by prioritizing investments in our research and development pipeline programs and streamlining commercial operations. We will no longer be commercializing assets on our own. Rather, commercial operations will be restructured to pursue partnerships for Zegalogue, V-Go, and the glepaglutide and dasiglucagon late-stage clinical portfolio.
As part of this restructuring, we are reducing the U.S. workforce by 90% by the third quarter of this year, with additional cost reductions implemented in Denmark. These changes will result in an annual operating expense reduction of approximately 35% from the 2021 levels. The Board has endorsed these steps to ensure that the company continues to play to its strengths, and we believe that Adam is well qualified to take charge, having developed the company's rich and deep pipeline. Before I hand the call over to Adam to further discuss these changes and the next steps for Zealand as a refocused research and development organization, I would like to take a moment to thank Emmanuel Dulac for his stewardship of the company over the last three years.
I also would like to express my gratitude to employees affected by this restructuring, including the President of Zealand Pharma U.S., Frank Sanders. I and the Board wish Emmanuel, Frank, and everyone affected the best of luck in their future endeavors. I am excited about the future we are building at Zealand with this refocused approach, and we are confident that Adam will be a strong leader for the company. Adam has been with Zealand for several years and has served as our CMO since 2015. With his rich experience in the clinical development of our peptide platform, as well as overseeing all our early-stage programs, Adam will be an invaluable leader for our new R&D-focused company as we work to reach patients by partnering our commercial assets. With that, I will now turn the call over to hear from our new CEO, Adam Steensberg. Over to you, Adam.
Thank you, Martin. I look forward to leading the company on the next stage of our journey as we work to deliver new medicines to patients with unmet medical needs in a range of disease areas. I also want to take this opportunity to thank those employees leading the company for their hard work and dedication towards our mission. We have made the decision to refocus the company because we believe that our commercial products can generate more value for our stakeholders by entering strategic partnerships. At the same time, we will transform the company into a more focused and cost-effective organization by improving our operational efficiency and targeting business development efforts. We will be in a position to fully leverage the value of our most advanced assets and to develop new peptide-based therapies.
We have a strong R&D pipeline with two phase III readouts this year: one for dasiglucagon and congenital hyperinsulinism, or CHI, in the second quarter, and one for glepaglutide and short bowel syndrome in the third quarter. We also plan to complete our phase II trial in collaboration with Boehringer Ingelheim in obesity and to announce phase I data for our amylin analog targeting obesity later this year. In tandem, we will pursue commercial partnerships for our existing commercial assets, V-Go and Zegalogue, for the treatment of type 1 diabetes. With a strong commercial partner, we believe we will be able to better achieve our goal of reaching clinicians and ultimately patients in need for better treatments. We also will work to pursue commercial partnerships for our late-stage programs in CHI and SBS, and we look forward to providing you with updates as we make progress on this front.
With the restructuring, we are also updating our financial guidance for 2022. Net operating expenses in 2022 are now expected to be DKK 1 billion ±10%. This is a decrease of DKK 200 million from prior guidance issued March 10th this year. And due to the changes in commercial strategy, net product revenue from sales of commercial products is now expected to be DKK 150 million ±10%. This is a decrease of DKK 125 million from prior guidance and does not include revenue from existing licensing agreements or from any potential partnerships. If such partnerships occur, we will update the financial guidance accordingly. And with that, I will now open up the call for questions. Operator.
Thank you. We have the first question from Joseph Stringer. Michael Novod, your line is open. Please go ahead.
Thanks a lot. Okay. So yeah, it's Michael Novod from Nordea. First of all, congratulations, Adam, with the new position. So a few questions. First of all, when you sort of think around the licensing opportunities for glepaglutide, we saw one of your competitors, a potential competitor, do a license deal regionally for GLP-2 today. So what are your thoughts around the potential structure of a license deal should phase III data be positive? Will you pursue one big global, or is it also an opportunity to potentially carve out regions and do regional deals? And then secondly, just a clarification on the revenue guidance. What does the DKK 100 million-ish include for the revenue guidance for 2022? Just to get a feeling of what is actually included. Yeah, that's it. Thanks.
Matt, maybe I'll ask you to answer the first question. Sorry, the second question first, and then perhaps I can address the first question, David.
Sure. So the revenue guidance for 2025 represents the combined revenue that we would record for both V-Go and Zegalogue in 2022 from our sales generated from our commercial entities, right? And they've been scaled down as, with this restructuring, it changes a bit of the structure of the field force and therefore impacts the revenue accordingly. It does not represent any potential business developments or partnership or revenues or milestones, either from our existing partners or from potential future partners as part of this refocused strategy.
Okay. Thanks.
Yeah. Adam?
So it's just simply a scale down that since you don't have commercial activities, then you just don't see the same sales flow through. So that's just a small downside.
That's exactly right. It is a scale down.
Yeah. And potential partnerships on glepaglutide, I mean, I think it's a fact that glepaglutide is the most valuable asset in our pipeline right now, and we have clinical readouts coming in Q3 this year. The program has also developed with a global scope, so being discussed in both the U.S. and Europe. And key to us, when we will choose a partner, that is that we need to identify somebody we believe will be the most successful in taking the product to the market. If that's global or regional partners, that is something we will evaluate down the line, but definitely the program has a global opportunity.
Okay. And maybe on Zegalogue and V-Go, how easy do you think it is to find partners? How advanced are you sort of in potential discussions to find commercialization partners? Just so we're actually going to see that this is actually leading to partnership deals on the commercial side, so these products are still going to be sold going forward.
Yeah. Matt, do you want to comment on that?
Yeah. I mean, it's hard to, we can't comment, obviously, on stages of discussions for any business development with our programs. So we're moving forward. It's actually, obviously, with this release and change of direction, it becomes a high priority for us to partner these programs. We'll take every effort, and we will use third parties to supplement our partnering activities.
Okay. Great. Thanks a lot.
Thank you, Michael.
Thank you for your question. We have the next question from Thomas Bowers from Danske Bank. Please go ahead.
Yes. Thank you very much. A couple of questions. So I'll just kick off with—you have the liquidity covenant with Oberland that is to be breached in September without any additional milestones. So I'm just wondering, of course, this is related to a cash position, but is there any changes now that you have updated your strategy on V-Go and Zegalogue? Because there is also a low single-digit royalty of net sales attached to this loan. So any changes on the covenant and how we should see the liquidity? And then just sort of a follow-up on Zegalogue and V-Go divestment.
So I'm just wondering, are you still targeting to complete the dual hormone and CHI phase III, and then maybe also mini-dose progression before you actually make any considerations? I know that you have been, well, I think the partners you have been talking to, or potential partners you have been talking to, have been more interested in getting the whole global dasiglucagon rights. But is there any changes here that you may see an out-license of Zegalogue alone and then retain the remaining parts of dasiglucagon? Thank you.
Yeah. So, maybe I can address the last question, and then Matt can follow up on the Oberland question. So, for Zegalogue, which is a product that's on the market, we will pursue partnerships as communicated in the release as we speak now in order to make sure it gets in the hands of the best commercial entities. I think we are in a quite different situation compared to a few years ago because you can say compared with the different solutions you also described, that we have the CHI and the mini-dose. Yes, it's the same API, but today Zegalogue is a real product, so it only shares the API. The product presentation is very different from how the product will be presented in these other offerings.
I think that is a difference, you can say, a normal today compared to when we had these discussions before we had a label and a product on the market. We'll pursue a partnership for Zegalogue. Whether this will be with only Zegalogue or it will include other opportunities, that, of course, depends on further discussions. But right now, the key focus for us is to make sure that the product that's on the market gets into the hands of a committed, strong commercial entity. Matt, will you follow up on the Oberland?
Yeah. So with this, there are no changes to the terms for the liquidity covenant with Oberland Capital. It will impact our cash runway by expense reductions of this magnitude, and we'll have an earnings release coming up in May, and we'll update the impact of all of this as it pertains to cash runway with that release.
Okay. So just to completely understand, there's nothing attached on the liquidity covenant. There's nothing related to the royalties they get. That's up to you whether you will divest or will not prioritize the promotion of the product.
Right.
Okay. Perfect. Thanks.
Thank you so much.
Thank you for your question. We have the next question from Lucy Codrington from Jefferies. Please go ahead.
Hi there. Thanks for taking my questions. Just a few left. So I just want to think back to prior to Zegalogue's approval and launch, kind of how advanced you got when considering partnerships at that time and whether any of those potential partners could be reconsidered at the time. And then just with regards to glepaglutide, are we right in thinking that the partnership for this is likely to be after the phase III data rather than before? Thank you.
Yeah. We've been saying for glepaglutide, being the most valuable asset in our pipeline right now, this is a phase III asset where we will have clinical results in the third quarter. So that's, of course, a key inflection point, which in our mind will define the value of this product. So it's probably more likely to be after than before results because we see this as the key value inflection point for Zealand this year. But of course, again, I can never comment or we will not be able to comment on specific partner discussions or timing of those events. On Zegalogue, you're correct. We had some discussions before.
I think, as Matt also highlighted before, we will engage in a very structured process, engage a third party to make sure that we, you can say, identify all potentially interested parties and then look for the best potential commercial group to take this product forward. So again, I cannot be more specific on those things yet. Sorry for that.
That's okay. Thank you very much.
Thank you for your question. We have another question from the lineup. Joseph Stringer from Needham. Please go ahead.
Hi. Good morning, everyone. Thanks for taking our questions. We've got a call dropped, so apologies if this is a repeat set of questions. But just curious the timing of this announcement. Why now, sort of ahead of two phase III readouts this year? Just curious if you could add some color on what sort of drove the decision and sort of the timing of the announcement. And then secondly, to kind of ask again on SBS, you had the key readout third quarter of this year. Is that something that you would wait until the top-line data readout prior to giving an update on a decision on potential partnerships, or is it something that you would be open or willing to secure partnerships prior to data? Any additional color on that would be helpful. Thank you.
The last question on when we will do a partnership. I mean, we see, and maybe you were offline there, but we see, you can say, we know we have a major inflection point with phase III clinical data readouts expected in Q3, and for us, that is a key event, and this is where we would expect, you can say, partner discussions to kick in significantly, but having said that, we also understand that this is a very attractive asset.
So whether people will engage before or after or when we will announce something, we cannot comment on it, but we will, you can say, diligently pursue the best partner for glepaglutide, but we, of course, have high hopes for the phase III readouts that come in the third quarter, and as such, are happy to wait for those. On the first question, actually, what was that? Can you just repeat that because it's out of my timing?
Yeah. I'm just curious on the timing of today's announcement, just in terms of.
Timing of.
Yeah.
This is a dialogue that the management team have had with the board and evaluated the business operations, and we really believe it's the right time. And you can say, we think we have two attractive products on the market which have opportunities now with other commercial players. And then before we enter this extremely, you can say, data-intensive next few months, both with data coming out for CHI and for glepaglutide, we actually believe it's important to be clear on the opportunity for these assets. So that's important for the timing.
Great. Thanks for taking our questions.
Maybe our Chairman want to add something to this.
No, I think it's a very valid question, and we have done a thorough analysis that Adam refers to, and when you reach an insightful decision, you have to act, and so it's no other meaning behind this, but also the fact that we have realized how challenging it is to launch commercial brands in today's world.
It is a challenge, and we believe that if we do smart partnering with parties who already have the infrastructure in place, we hopefully in the future will enjoy revenues based on upfront milestones and royalties, which are revenues that hit the bottom line directly without any dilutive measures in between, so we hope we can have a more productive unit, company, and also a very highly profitable unit in the future with this model, so we invest where we think we get bang for the buck. Thank you. Operator ? Adam? More questions?
Thank you for your question. The other question from Jesper from Carnegie. Please go ahead.
Thank you so much. So two questions from my side. Firstly, one perhaps for Matt, so on the cost savings, so you target 35% from 2021 level. So just to do some quick math, will it be fair to assume a sort of flat DKK 800 million in OpEx from 2023 forward? So perhaps you can just give some thoughts on how this OpEx cost base will develop going forward after this announcement. Then I'll take my question afterwards.
Yeah. I mean, we're not going to obviously, it's literally to provide guidance on 2023. A lot can happen in the next year, right? But that is the trend line with the analysis following this announcement.
Okay. Thank you. Then just some questions as well on the partnership strategy. So I understand that you, of course, will refrain from commenting too much, but just to understand, can you confirm whether or not you have had and had started discussion, or will you start seeking them basically from today? And also perhaps a question for the chairman of the board. So how you as a company balance the partnership strategy on glepaglutide compared with the potential M&A potential after the phase III data here in Q3, as I would assume that partnership in some territories, potentially Japan, could be a potential poison pill to some companies. So how are you internally balancing this partnership versus M&A potential?
Yeah. So if I answer the first question, and then Martin can answer the second. But on the partnering activities, again, we cannot comment on the specific, you can say, discussions and so on. But as Matt also said, we have started a structured process. We have engaged the third party, and we are, of course, in dialogues. But we cannot be more precise on these. But it is a key priority for us in the next period to secure partnerships for the two commercialized products as we truly believe they make a huge difference for the patients. Martin, over to you.
Yes. I mean, as Adam has already said, and we, of course, agree on that from the board, glepaglutide is a true value driver, and the data and the readout in Q3 will be an inflection point for the company. However, we need to look upon this in a sober manner. I mean, we are going to pursue partnership discussions to find the best home for this brand on a global basis. And whether that will trigger some poison pill or not is something we cannot today either speculate on or take any consideration of. We really want to maximize the value of that asset. And so if there will be any kind of actions from third party, we are prepared to deal with that.
All right. Thank you so much. And congrats on this announcement.
Thank you.
Thank you for your question. The next question from Keyur Parekh from Goldman Sachs. Please go ahead, Keyur.
Hi. Thank you for taking my question. And apologies if this has been asked before I joined the call late. But a couple, please, if I may. The first one, the decision to refocus kind of from an R&D perspective, just wondering kind of how confident you guys feel about the depth of the pipeline you have today and what that might mean relative to kind of R&D spend kind of going forward. Do you need to partner the existing assets under late-stage pipeline before you can bring in new products in, or do you think those two are not kind of rate-limiting? That's kind of question number one. And then question number two, conceptually, would love to hear your thoughts. I think you mentioned how difficult commercializing products in today's market kind of is.
Would love your thoughts on kind of what was different relative to your original expectations when you decided many years back to kind of become this fully vertically integrated biopharma company? Thank you.
Yeah. So I'll address your first question first on the pipeline. When we look at this pipeline and also the discussions we have had, it has never carried more value in our eyes than it does today. We have significant late-stage assets that are reading out in the coming quarters. We have a very rich mid-stage pipeline. One of the products is partnered with Boehringer Ingelheim today, where we will present phase II data in type 2 diabetes, and we also expect to see phase II data in obesity. That could be a highly valuable asset to Zealand as well. And then we have early-stage assets in phase I and early phase II, also in the obesity space. And then the preclinical activities.
You can say, of course, the investments and how we allocate our investments will to some degree also depend on where and how we partner along the value chain because we also have an ambition of controlling our costs. But as we have put in the release, it is our ambition to find partners along the value chain with a focus right now on the two commercialized assets, then a focus on the late-stage programs as we pass our clinical milestones. And then we might engage in early-stage partnerships as well on selected assets because we truly believe we have a differentiated peptide platform that many companies could benefit from collaborating with Zealand and on. So that is what you should expect going forward. And you can say investments will depend on where we make these strategic partnerships.
I also think it's a very important question because it really addresses the core modus operandi of the company going forward. I think we should be very agnostic and open and be data-driven. The data that we are going to generate for all these products and potential brands that Adam was alluding to will be highly valuable and will be the introduction to many exciting partnership discussions, whether it's in early clinical phase or in late clinical phase. We can decide how far we want to take an asset based on how we believe the success in the future might be. So it's a matter of continuing assessment and a very nice problem to have.
Did that answer your question?
Yes, it does. Thank you.
Thank you for your question. I will now hand back the conference to Mr. Adam.
Thank you, everyone, and thank you for joining today. I'm extremely excited about this new chapter for Zealand and as we refocus our strategy towards our robust pipeline and work to streamline and strengthen operations and to partner our commercial assets, and we look very much forward to provide further updates and to interact with all of you. Thank you so much.