Cinclus Pharma Holding AB (publ) (CINPHA) Earnings Call Transcript & Summary

Welcome to the conference call. [Operator Instructions] Now I will hand the conference over to the speakers. Please go ahead.

Hello, everyone, and welcome to Cinclus Pharma's First Quarter 2025 Earnings Call. I'm Christer Ahlberg, CEO of Cinclus Pharma. And with me today is also our CFO, Maria Engstrom. And we will present the latest developments from the first quarter, obviously, 2025 and the upcoming news flow, after which we will be happy to answer questions you might have. Before we begin, though, I would like to share a quick reminder with our listeners that during today's call, management, we, Maria and I, we may make forward-looking statements that involve known and unknown risks, uncertainties and other important factors beyond the company's control that could cause the company's actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. So please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. So with those statements, those formalities out of the way. So let's begin with our lead asset -- discuss our lead asset, linaprazan glurate. It's actually a PCAB, as you know, potassium competitive acid blocker, which is -- I mean, we have developed it primarily for the treatment of eGERD. And linaprazan represents a new class, the PCAB, which has the potential to replace the current standard treatment, the PPIs, the protein pump inhibitors. We believe that our substance, linaprazan glurate has really the potential to become the best-in-class. And actually, it represents, I would say, the first really innovative mechanism of action in over 25 years. Our strategy is, as you know, focusing on the healing of the severe patients, and that also enable us to aim for the specialty pharma commercial focus, which is important in this case. And also, it also presents the greatest differentiation from the PPIs and also from the first generation of PCABs. And that gives us a strong competitive position in the future. And as we also have seen the positive Phase II results support that. We have already achieved significantly -- we have -- I mean, significantly result, and we have derisked the linaprazan glurate program. And we are now progressing towards the Phase III study, focusing on eGERD. As you know, since before, we are backed up by strong investors, including life science-focused institutional investors like Trill Impact Ventures, AP4, Linc and Eir Ventures. And just some business updates then. As you -- as we already discussed before, I mean, eGERD affects approximately 28 million adults in U.S. and Europe, including the 10 million with severe eGERD, which is our target population. Despite the availability of PPIs therapy, we still see that approximately 10% of the mild patients, more than 30% of the moderate and over 50% of the severe eGERD patients failing to achieve healing after 8 weeks of treatment. And in addition to that, we also can say that we see significant relapse from current treatment, including the PCABs -- first generation of PCABs. So there remains definitely a significant unmet medical need and definitely a substantial addressable market still. We are progressing linaprazan glurate now towards a Phase III study. As we have said, we have finalized successfully and completed the Phase II evaluation in Europe and also in U.S. with close to 250 patients. And the results were really, really good. We demonstrated a 93% healing rate among the most severe patients, our target population. And actually, we also saw 100% healing of the partial responders after -- who had been treated with 8 weeks PPI treatment before the study. We are preparing to initiate the Phase III study now in Europe and U.S., coming back to that, and we will have the top line during 2026. And what you could also say is that, our current financial visibility is that, we will have cash over the second 2026 over the top line results. So we will have the top line results before we are running out of any cash. And in parallel to that, we are also working quite heavily on the business development activities that has been ongoing also for the first month here. Going then to the addressable market, which we can see more details here of the market in U.S. and EU, I mean, which demonstrates how substantial the market is. The potential market for linaprazan among people suffering from the most severe forms of eGERD is estimated to 10 million in this region and 90 million globally. So we can definitely see that we have a blockbuster potential here. Just an overview of PCABs globally. What you can see is that, PCABs are taking over the market from the old PPIs and the standard treatment for gastric acid-related disease in countries where they have been launched. Takeda and the Korean, Chinese manufacturers are increasing the licensing and registering and launching their products in rest of the world market. For instance, in Mexico, PCAB has already been secured third position in the peptic ulcer market within its second year and also achieving a notable price premium over PPIs, which is very interesting to follow. We can see that association like physicians in India, they are recently issued broad consensus recommendations for the use of PCABs in managing acid peptic disorders and at least 11 brands of vonoprazan has been already launched in the country and actually more expected to come. Takeda is focusing on vonoprazan refocusing, I should say, vonoprazan in Korea and Brazil. And we see that more than 30 markets where we can see that PCABs are on sale and confirmed with the launches. So we're really seeing activity around the PCABs heating up across the world. And just the latest example is the DDW, the biggest gastric conference in the world, where we saw now the most active PCAB schedule ever in the market with more than 25 PCAB-related presentations during these days when we were there. So definitely, PCAB is on the topic now around the world. We can clearly see here how linaprazan glurate as a next-generation PCAB compares both pharmacologically and clinically to the PPIs and the first generation of PCABs, such vonoprazan. We can see that linaprazan glurate holds advantage over the other treatment options with -- I mean, thanks to the program that we have developed, we see faster symptom relief. We see the fastest healing and highest percentage over 24 hours after control, which is a must to actually to heal the patients clinically. And therefore, we also see very good healing results in half the time compared to the first -- to the PPIs and first generation of PCABs. We also have ambition in showing superiority, both in healing half the time, but also superiority in daytime and nighttime symptom relief, so we can get the best-in-class drug here. That is the ambition we have. And definitely, the substance do have that potential. Another important factor launching a product is that, specifically in eGERD market, we can see a highly dynamic with multiple drug switch possibilities. I think that is a key in a market like this. This diagram shows how eGERD patients currently experience acute healing phase followed by maintenance treatment before going back to acute healing treatment again. This means that there are substantial market potential despite us not being first to market as long as linaprazan glurate achieves best-in-class, which is definitely what we have the possibility to do. And as an example here, even though we are not first, we would like to be best. And an example of the dynamics here, you can see on vonoprazan, the first generation of PCABs, 25% of the patients relapsing within 6 months on maintenance treatment on that substance. And of course, that will be increased over the 12-month period. So definitely, there are different switch possibilities here. Going then that's the reason why I also think this slide is interesting to look at because our ambition at Cinclus is to develop a unique next-generation PCAB that meets the medical need and provide the conditions to do exactly what or less as AstraZeneca did when they launched next-generation PPI, Nexium, in fact, 12 years after the introduction of Losec or Prilosec or Omeprazole. In other words, we would like to take over the market after the first generation. And as you can see, the sales figure, what AstraZeneca managed to do, they did it in quite fast period of time. And a dynamic market in combination with the best-in-class position is the key to manage to do something like that. And that's the reason why we believe that this definitely is a possibility. Also important is the IP protection. Cinclus Pharma has a robust patent protection for linaprazan glurate. In the U.S. market, for instance, we have several patents, including a so-called polymorphic patent that protects the specific crystal structure of the drug until 2042. In addition to this, we have filed several more patent applications in the U.S., and we have similar protection in place or pending in the EU and other markets around the world. In practice, these strong patents provide protection against possible generic competition even after the data exclusivity is expected to have expired regardless how long it will last. Let's now get a quick summary of the key events from the first quarter of '25. Overall, we are continuing to strengthen our presence and visibility in academia and the medical profession by participating in a number of industry and scientific conferences. Some examples, we had during the quarter, Carnegie Healthcare Conference with Nordic Biotech and the JPMorgan Healthcare Conference. And also during this period, we have signed third-party suppliers contracts related to Phase III linaprazan glurate study. So we are good to go now for the third quarter. Post period, we published, as you have seen, an article featuring the data from the Phase II study demonstrating a high healing rate in patients with severe forms of erosive disease. We have held a scientific advisory meeting with NICE regarding the price and reimbursement for linaprazan glurate, very positive meeting. NICE is the British Institute of Health and Care Excellence. We have also participated in Digestive Disease Week in San Diego, where we -- as I mentioned, DDW, where we presented data demonstrating linaprazan glurate's strong acid effect along with the positive results from the optimized tablet formulation developed for the Phase III trials and future commercialization as you already -- we have informed about earlier. And then we also participated in the 14 expert strategies in endoscopy and gastrointestinal liver disorders in Kansas City. So all in all, we have been busy and very productive start into 2025. And if we're looking forward now and specifically looking into the Phase III trial. And here, we have some more details on our planned study starting up in third quarter with first patients recruited. This is a European, U.S. study, where we have significant number of sites, both in 7 countries in Europe and in the U.S. We intend to show that our drug candidate is more effective than PPIs according to several study measures, including superior healing and superior symptom control. A positive outcome would make linaprazan glurate unique in the market. So -- and we expect to start, as I mentioned already, patient recruitment now in third quarter for 2025, and we anticipate top line results during next year. And let's turn to the financials and to Maria. Please go ahead.

Yes. Thank you, Christer. You can go to the next slide. And I will talk about some financial highlights during the first quarter. The cash at the end of the period ended up at SEK 524 million. And the R&D expenses consisted, of course, of our Phase III preparations, including also CMC activities, along with the finalization of some preclinical studies. The R&D expenses as a percentage of OpEx was 83%, which is above the average of the last 8 quarters, which is 80%. We also saw a slight increase in the number of employees within the medical field. We can go to Slide 17. And here, we see the year-over-year financial results. And the operating expenses decreased with SEK 11.2 million, and that was -- sorry, increased with SEK 11.2 million. And that was, of course, due to the Phase III preparations. And as I said, the CMC activities and the finalization of some preclinical studies as well. The G&A expenses were slightly higher, and that is due to additional personnel compared to last year and also activities related to the company now being listed. The EBIT decreased with SEK 11.2 million, and that is, as I just mentioned, due to the high OpEx. The financial net increased with SEK 14.3 million, and that was partly due to interest from cash in bank of SEK 3.4 million. The remaining part, SEK 10.9 million was due to unrealized currency gain on group internal liabilities. We have a small tax expense, and that is due to corporate and tax from our Swiss affiliate. The net profit increased of SEK 3.2 million, and that was due to the high financial net. However, remember, part of that was the unrealized currency gain. Other current assets, if we go to the balance sheet, increased with SEK 25.9 million, and that was due to prepayments to the CRO as we are preparing for the Phase III study and all in all, in order with the contract. The cash, as I mentioned earlier, increased with SEK 471.4 million, and that was, of course, due to the new share issue back in June last year. The noncurrent liabilities decreased with SEK 6.5 million, and that was due to paying off the second tranche of the tax liability that we have had in Switzerland since the move of the IP from our Swiss affiliate. This tax liability will be paid off this year. Current liabilities decreased with SEK 123.2 million, and that is due to the offsetting of the shareholder loan in connection with the IPO back in June. And if we go to the next slide, here, we can see the shareholders at end of March, and we still have our IPO corner investors with us and our founders. So then I will turn back to you, Christer.

Okay. Thank you, Maria. That just leaves us with me to the point of you important days of the diary here, including our AGM on Thursday already this week. And with that, I will continue to the Q&A session. So please go ahead.

[Operator Instructions] The next question comes from Arvid Necander from Carnegie.

So first off, can you say anything about the reimbursement discussions you've had in Europe and whether or not they point you to any meaningful differences in price or market access compared to what you've estimated in the past? And secondly, on the reference pricing model proposed by the Trump administration. I understand that there's a lot of uncertainty here, of course. But given the high price differential for vonoprazan in the U.S. versus Japan, does this lead you to be a bit more cautious on pursuing partnerships outside the U.S. given the risk of eroding the U.S. potential? Yes, those were my questions.

Okay. Thank you, Arvid, for this question. The first question, we -- as I mentioned, we had a meeting with NICE, and it was very -- it was a very good meeting. And it's quite obvious that the European authorities are looking forward to have PCABs actually on board here in Europe as well. And in U.K., it's quite clear what threshold we need to overcome and that we're talking about cost effectiveness and cost efficiency. As long as we are cost-effective compared to standard of treatment, and we have a clear target population, definitely we can have a premium price. And the willingness to pay for that is there, definitely after -- and we are actually more confident to that after this meeting. So definitely, it's a good opportunity here to get a premium price in U.K. that we -- where we had the discussions about. And that's what I can say about. This is an advisory meeting. It's not a decision meeting or anything like that. So that -- and we definitely are confident that we can deliver a very cost-effective treatment in a specific target population. And therefore, we are having that strategy as you understand. Was that the answer on the first question?

Yes. If you're able to elaborate on the threshold for being considered cost-effective, that would, of course, be interesting if you can say anything?

Well, as you know, I mean, there are different discussions you can discuss here whether -- I mean, a PPI, definitely, even though you increase the doses, if you increase the number of doses per 24 hours, you have no possibility to increase the healing rates actually more than in average, what you can see, and that was also referred from them more than 5%. So if you look into an overall review. And that means that -- and also, we also -- that healing is definitely very important, you need to heal the patients. Otherwise, you can progress this disease into much more severe diseases and end up with cancer. So this is definitely -- you can take into account when you're calculating the cost efficiency. The other part is, of course, the symptoms, which is definitely what you can see when it comes to symptom is that, the quality of life is quite heavily impacted by these kind of symptoms and also sleep disturbance, et cetera. And that also will have a major impact on the cost efficiency for patients. And if you can -- if you have superiority in this, then it's definitely possible to measure how you can achieve cost efficiency also on that. And if you combine both healing and symptom relief, you can have a really good price on this treatment. And I will not come into any specific number, though. But what -- I mean, we have already now -- we have already earlier guided you in price levels in Europe. And if you look into the maximum outcome of that is even higher, I would say. Going into the other question you had, of course, this is very speculative. And you can always discuss whether this can have an impact or not. What we have seen in the past, though, is that, this has been on the discussion for -- I mean, during many different precedences, and we have not seen any differences yet. And so, we are not that worried about it. But, of course, we are following it very closely, I would say. And we do not expect that this will have an impact of other possibility when it comes to both U.S. partnerships or if we're going ourselves when it comes to that pricing. We are talking also about the time factor here. I mean, our launch is estimated to be in 4 to 5 years in 2029. So it's many years to go. The other part is, of course, we're still continuing our discussions overall in other parts of the world as well as partnerships. So we have not changed that strategy for this.

[Operator Instructions] There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

Well, there are some questions in the web here, and maybe I can touch on some of these. Regarding the funding, which I mentioned will be until the second part of 2026. With that said, we also will have a readout of the Phase III study also during 2026. And our plan and what -- and our forecasting looks that we will have the readout before the end of the funding. So we will have definitely time to read it out and also have raised more capital after that. I'm looking at -- if we have more questions here. What we -- also have questions about if we are going to do head-to-head studies versus the first generation of PCABs. And that is, of course -- that is a very interesting question. Of course, we are looking into these possibilities. But as a regulatory clinical study, that is not what you want to do and not neither what the regulatory authorities want us to do. We need actually to do the study compared with the current standard of care. And in Europe, for instance, we do not have any PCABs approved yet or approved. So that's impossible to do that here. And in U.S., definitely, it's very early. So definitely, it's not standard of care there today. So that will not happen. But in the future, of course, that could be of interest to look into as a Phase IV trial when we are on the market. And of course, but we think, though, it's not needed from a commercial point of view to have a head-to-head versus vonoprazan, for instance, because if you just look at it, we know that we have a significant better acid control, and that is the perfect biomarker to estimate the healing rates. And what you can also see now since we have that, we also see that we have the effect difference -- I mean, a really, really big effect difference compared to the PPIs. And we are using the same comparator as the other PCABs are, I mean, do, which means that we can have also indirectly healing rate comparison. And also what we also know is that, no one of the other PCABs has delivered a superiority when it comes to symptom relief. And thanks to our asset control, we believe definitely that will be a possibility for us. And if we can do that, we have another differentiation factor, which is definitely also important here. So we do have many different aspects that we can deliver showing that we are superior versus the first-generation PCABs, either indirectly or directly without having a head-to-head study versus vonoprazan, for instance. So we are confident that we can do that. And that is also what we have seen historically has been done when you are changing from 1 product to another, you don't need to have a head-to-head normally. Yes. And then we had some questions here regarding the IP issues with vonoprazan. And if we -- our drug is affected the same thing. Well, no, we are not. I think that's important to mention. Vonoprazan, they had -- their patent is running out 2030. And as a mitigation plan to have longer exclusivity, they actually plan to -- I mean, one of the activities they initiated was to go for H. pylori indication as a first indication to extend the data exclusivity by 5 years doing that. And that would have given them the exclusivity until 2032. But FDA has now -- they are in -- so not a citizen petition now with FDA, investigating the possibilities here that since FDA has not accepted to get the entire package, the entire substance with 5 years extension of the data exclusivity only on the H. pylori indication. And now -- so now the dispute is regarding if -- the data extension -- the data exclusivity extension should cover all indications here. And if they win, and we will know that now summertime this year, they will have an extension then to an exclusivity until '32. And that has been the problem for them. For us, on the other hand, we do not have that problem since we have a very strong patent situation valid until 2042. So an extension of our data exclusivity would only be as a bonus that we will have double control of both the data exclusivity and patents. So for us, it doesn't matter. And then, of course, an additional question to that is, whether that will have an impact on the pricing. And from our perspective, we have planned -- since we will not be first-in-class, we have planned our drug to be superior versus -- and actually to launch this as a best-in-class treatment with superior acid control, which is needed for the severe patients. And that would be the case, even though we are launching in a generic market or close to become generic. As the same situation where we saw when Nexium was launched, that was also just before the Losec went off patent. And as you see on the diagram I showed you earlier, that didn't have an impact on the Nexium launch, I would say. They had a really fast switch. And since there are many different switch opportunities in this market with this dynamic market, we see that opportunity anyhow. And that would have been the case in all cases here. And we have planned for that. And therefore, we are so much into the specialty pharma target population with superiority claims in both healing and in symptom relief. So with that said, maybe there are other questions coming up based on these questions. So I give a last chance to give us more questions. Okay. No more questions, then I stop there, and thank you for your interest and your time here, and let's stay in touch. Thank you, and have a nice day.