Cosmo N.V. (COPN) Earnings Call Transcript & Summary

Good morning, good afternoon, and welcome, everyone. I'm Giovanni Di Napoli, CEO of Cosmo, and I'm joined today by our CFO, Svetlana Sigalova. Thank you for being with us for our 2025 half year results. We'll walk you through our performance, progress on strategic priorities and the path ahead. A quick note on forward-looking statements. So let's jump into the agenda. Our agenda today will cover 2 key areas. Progress on our 2025 strategic priorities. Our financial performance for the first half of the year, closing remarks and then we'll have a Q&A session. Before we jump into the meeting, I just want to remind everyone the Cosmo mission and the Cosmo vision. We continue to drive toward our long-term goal to be the most innovative force in life sciences by delivering life-changing confidence at the intersection of science and technology. Our team is focused on execution, iteration and scale. As we look ahead to the rest of 2025, our priorities are laser focused on execution and strategic acceleration. First, we are staying disciplined on our clinical pipeline, advancing multiple programs in GI and dermatology and ensuring each study stays on track, on budget and on strategy. Second, we are building on the success of GI Genius with the launch of automated reporting and preparing to expand the platform into second AI application, reinforcing our leadership in real-time AI in MedTech. Third, we are fully committed to securing EMA approval for Winlevi, a key regulatory milestone that would unlock access across Europe for millions of patients. Fourth, we are accelerating AI and digital transformation across the company whole, not just in products but also in how we operate, we scale and we deliver value. And finally, we are pushing forward on our ESG road map after the momentum we built in H1. The recent upgrades from MSCI and LSEG have positioned us for a stronger engagement with ESG-focused investors, and we intend to build on that progress. So these priorities are aligned, are actionable and accountable and they form the foundation of our 2025 execution plan. As a part of Cosmo long-term growth engine, we have built a pipeline that's laser-focused on large underserved markets both in specialty pharma and AI-driven MedTech. Starting with our pharmaceutical programs, we are targeting 4 areas with high unmet needs and significant market potential. I'll touch base on them in the next few slides. But just as a reminder, we're talking about solid tumors, bile acid diarrhea and distal ulcerative colitis, and finally, androgenetic alopecia, a blockbuster category, which we talked about at the Investor Day on July 1, with a total addressable market of EUR 28 billion and over 1 billion affected individuals worldwide. We are proud to be advancing our asset now in Phase III and on track to become the first-in-class topical androgen receptor inhibitor in this space. Below in this slide, you'll see our MedTech AI platform pipeline, which complements perfectly our pharma pipeline. Here, the focus is on high prevalence gastrointestinal and diagnostic conditions. We are developing AI-powered application in areas like pancreatic cancer, Barrett's esophagus, esophageal symptoms and gastrointestinal metaplasia, all of which have clear diagnostic gaps to date. And our collaboration with Apple for the Apple Vision Pro is progressing rapidly. We are in late-stage development and moving toward the regulatory submission with the goal of offering the first immersive AI-guided endoscopy experience. Now with all of this combined, our pipeline addresses over EUR 60 billion in total addressable markets and position Cosmo as the intersection of science, software and scale, uniquely capable of delivering value across multiple verticals. Now let's talk about our clinical pipeline and start with solid tumor. CB-03-10 is a next-generation androgen, glucocorticoid receptor modulator being developed for solid tumors with the potential to become a first-line therapy across multiple cancer types, including prostate cancer. While it acts as a potent AR antagonist, CB-03-10 also engages additional pathways that could offer broader and more durable efficacy than existing treatments. It's currently in a Phase I dose escalation study using a standard 3+3 design to identify the maximum tolerated dose. So far, the drug has advanced through 7 dose levels, up to 1,700 milligram per day. We believe this could be a strong compelling candidate for future combination regimens, where safety and flexibility are essential. The final Phase I results are expected in H2 2025. Let's turn to bile acid diarrhea, a highly prevalent but often underdiagnosed condition that affects up to 95 million people globally and accounts for as much as 1/3 of IBS-D cases. For patients, it's more than just a GI issue. It severely disrupts daily life and confidence. We see a substantial market opportunity here. Over EUR 20 billion and with colesevelam MMX, we are aiming to address it directly in the colon using our proprietary multi-matrix technology. Our Phase II study is now fully approved across the U.K. and also EU. We have already activated the sites in the U.K., screened multiple patients, randomized the first one. Our goal is to have 26 sites fully active across Europe by end of October, supporting strong momentum in recruitment through the second half of the year. This is a clear example of how we are combining innovation, execution and focus to advance programs in areas with large clinical unmet need. Distal ulcerative colitis is a localized but highly impactful form of ulcerative colitis that affects around 3.5 million patients globally with a total addressable market of over EUR 1 billion. Symptoms like abdominal pain, bleeding and urgency severely affect quality of life and increase long-term cancer risk. Our solution is the rifamycin enema that leverages Cosmo's advanced in situ gelling technology and a custom device to ensure targeted delivery to the inflamed area, addressing both inflammation and the gut microbiota imbalance that drives the disease. Our Phase II study is active and enrolling with 16% of patients already randomized. We are on track to reach 24 active sites by Q4, and our focus is on accelerating enrollment to maintain development momentum. Now let's move into the MedTech AI. GI Genius continues to lead the industry in real-time AI for endoscopy. But what's most exciting is how this platform is evolving far beyond its initial scope, which was already a big one. Over the past few months, we have made major leaps. The new Module 300 delivers enhanced speed, precision and AI performance, and this is built for scale. The Intelligent Tablet transforms GI Genius into connected software interface that enables AI-powered workflows, structured data capture and clinical decision support. And with GI Genius XR now integrated with the Apple Vision Pro, we are pioneering the first immersive AI experience in procedural medicine, giving clinicians real-time guidance directly in their field of view. But what truly sets this platform apart is its scalability. As we shared at Investor Day, GI Genius was architected from the ground up to go beyond endoscopy and become a real-time AI platform for MedTech whole. And with Medtronic, the world's largest MedTech company as our partner, we are now actively exploring use cases across multiple franchises, anywhere real-time data, pattern recognition or procedural guidance that can improve outcomes, our platform is designed to plug in. This is more than a product. It's the foundation for an AI-operating system in MedTech. And with our technology, partner and execution, we are uniquely positioned to lead. Now let's turn into derma and talk about Winlevi. Our global expansion strategy remains firmly on track. In Southeast Asia, our partner Hyphens has initiated the commercial rollout in Singapore and Malaysia, marking another important milestone in our international growth. These are high-value dermatology markets with growing demand for innovative acne treatments, and Hyphens is well positioned to maximize reach and uptake. Now on the European front. Our EMA re-examination process is fully underway. We have worked very diligently to re-elaborate and clarify key aspects of the dossier, particularly around adolescents' use and HPA axis suppression to directly address the CHMP earlier concern. We expect an update from EMA by early fall of 2025, and we remain confident in the strength of our case and the opportunity that this represents across patients in Europe. When we set our 2034 ESG goals, we knew it will take discipline and focus to make real progress. And in just 1 year, we have moved from ambition to execution. Our MSCI rating was upgraded to A and we have entered the top 100 of the LSEG ESG peer group, now ranking 42nd. These are external validation of the work happening internally in Cosmo across governance, workforce engagement, emission and transparency. This momentum reflects our belief that ESG is not an afterthought, it is integrated into how we operate at Cosmo from energy efficiency to product design, from safety standards to long-term governance. We are still early in the journey but the direction is clear. We are building a company that's designed to perform and built to endure. So as we close the first half of 2025, what you see here in this slide is not just a checklist, it is a clear signal of momentum. So we have defined our vision 2030. We have sharpened our focus with the sale of digital trust asset and completed the evolution of our brand to reflect who we are and who we are becoming. We have announced new platforms like Cosmo Digital Health, completed Phase III enrollment for our hair loss asset and we have accelerated strategic partnership, including our collaboration with Apple and the Apple Vision Pro. We have also invested in global talent, brought new leadership into key functions and hosted an Investor Day that marked a turning point in our narrative and strategy. These milestones aren't isolated wins, they are foundational pillars that now position us to scale with discipline, unlock value across the portfolio and lead in the markets where we have chosen to play. And most importantly, we are just getting started. So let me pause here and give the stage to our Chief Financial Officer, Svetlana Sigalova, who is going to walk you through the H1 financial results. Please Svetlana, go ahead.

Good afternoon, everyone, and thank you, Gio. Today, I'll update you on our financial performance for the first half of 2025 and the progress against our established full year financial priorities. Driven by a strong year-to-date performance, we are raising our EBITDA guidance for full year 2025. Our updated financial guidance is as follows: total revenues of EUR 102 million to EUR 107 million with recurring revenues of EUR 85 million to EUR 90 million and project-based revenues of EUR 17 million. EBITDA is increased by EUR 4.5 million, now expected in the range of EUR 5.5 million to EUR 7.5 million. Cash equivalents and investments are expected to exceed EUR 110 million at year-end with no debt. We remain on track to close the year with a strong balance sheet and continued momentum across our business. Let me start with the key highlights for the first half of 2025. Revenues reached EUR 51.7 million, reflected solid performance across our core business areas. EBITDA came in at EUR 4.9 million, demonstrating operational discipline. Cash equivalents and investments totaled EUR 133.3 million, underscoring our continued financial strength and capacity to fund growth. Let's begin by taking a closer look at the revenues. As a reminder, our business is built on 2 revenue streams, recurring and project-based. Recurring revenues are generated from manufacturing activities and royalties across all of our products and franchises. This forms the foundation of our stable long-term growth. Project-based revenues include upfront and milestone payments tied to regulatory, commercial and clinical achievements. These higher margin contributions are an integral part of Cosmo business model. Our strategic focus remains on delivering double-digit growth in recurring revenues, while targeting a return of over 4x on our investments in project-based revenues. As mentioned earlier, we remain on track to deliver full year 2025 revenues of EUR 102 million to EUR 107 million. To put the year-over-year comparison into perspective, the first half of 2024 included a EUR 92.5 million project-based milestone from Medtronic, which distorts the prior year baseline. Recurring revenues for the first half of 2025 were stable at approximately EUR 42 million, reflecting sustained strength across our core business. I'll walk through the drivers of recurring revenues in more detail on the next slide. With total H1 revenues of EUR 51.7 million, we are firmly on pace to achieve our full year revenue target. For our recurring revenues, we remain on track for double-digit growth year-over-year. Recurring revenues from GI Genius grew sharply, increasing 128% year-over-year. Earlier this year, we guided to high double to low triple-digit growth, and we are now on track to deliver triple-digit growth for the full year 2025. Winlevi revenues increased 23% year-over-year, consistent with our double-digit growth expectations. We remain confident in delivering double-digit growth for the full year 2025. Gastro and CDMO was impacted by seasonality in the first half. For the full year, we continue to expect a stable and resilient performance with low single-digit growth. Our recurring revenue performance year-to-date positions us firmly on track for double-digit year-over-year growth in 2025. Let me give you some additional details on our first half 2025 financial results. As noted earlier, total revenues were EUR 51.7 million. Other income for the period was primarily driven by dividends received from our investment in [indiscernible] antibodies as well as R&D tax credits. Operating expenses totaled EUR 57.8 million. Compared to prior year, cost of goods sold increased mainly due to the changes in product mix. R&D expenses declined reflecting the planned and disciplined wind down of our Phase III hair loss trial. We expect R&D to increase in the second half as we advance our Phase II programs in bile acid diarrhea and distal ulcerative colitis. SG&A costs decreased versus prior year, driven by lower personnel costs and continued operational efficiencies. We anticipate further SG&A reductions in the second half as we maintain strict focus on business prioritization and cost discipline. EBITDA for the first half was EUR 4.9 million, and we closed the period with a strong cash position of EUR 133.3 million in cash equivalents and investments. To reiterate, our strong first half year performance and continued confidence in meeting our full year objectives have enabled us to raise our EBITDA guidance. We remain on track to deliver total revenues of EUR 102 million to EUR 107 million, with double-digit year-over-year growth in recurring revenues. EBITDA guidance has been increased by EUR 4.5 million, now expected to the range of EUR 5.5 million to EUR 7.5 million. We're also on track to exceed EUR 110 million in cash equivalents and investments by year-end with no debt. Thank you. I'll now hand it back to Gio for closing remarks.

Thank you, Svetlana. As we look ahead to the second half of the year, our focus is clear, has to be execution, has to be acceleration and we have to deliver. We're expecting double-digit growth in recurring revenues as our CFO just shared. Continued momentum on GI Genius, including the launch of automated reporting, and multiple clinical and regulatory milestones from the Phase I readout in solid tumor, to the top line results for our AGA program, to the EMA decisions on Winlevi. On the innovation front, we are pushing forward with our Apple Vision Pro partnership, completing the usability study and preparing for the FDA submission, while also advancing new dermatology and GI drug candidates into clinical development. In short, we have built a strong foundation in H1 and H2 is about scaling that impact. With that, I want to thank you all for listening, and I want to open it up for your questions.

[Operator Instructions] The first question comes from Bob Pooler from ValuationLAB.

Thank you for the excellent presentation, and in particular, congratulations on the strong first half performance, particularly on your key products, GI Genius and Winlevi, which are really shining now. To start with the questions, first off, with GI Genius. As we see, the product is now really off to a great start. Do you see any differences in the performance between the U.S. and Europe?

Bob, thank you so much for your question. Also, thank you for the compliments about [indiscernible]. Well, I guess the markets are different, but both they have momentum. So we have in both regions strong opportunities as we are working towards the release of these new upgrades, as we discussed in the call. The reporting automation is a big unmet need in both regions. So therefore, we expect to see growth almost the same but different volumes in terms of opportunities for U.S. and Europe.

Okay. And the broadening of the platform, does it also help with -- yes, increasing the placement also of the device?

Yes, correct. I think -- so there is a strong push in the field from Medtronic, both in Europe and the U.S., but also globally as GI Genius, as you know, is a global opportunity for us to expand the user base. We discussed this at the Investor Day, there are about 150, roughly 1,000 towers globally and Medtronic aspire to increase also user base as we also increase the number of applications within the platform. The activity is towards portfolio enhancement from Medtronic as there are plenty of opportunities also to leverage GI Genius for their portfolio as well. So we are at the top of their mind to expand users as well.

And just one final on the competition. It seems that they're really lagging, but really below expectations there. What is the current situation?

Yes. I think we are always watching and understanding. As of now, we believe that we are very far ahead from our competitors for not only the hardware that we have in place. Remember, the Genius 300 is in endoscopy at least the only platform using NVIDIA chip called IGX available that can run multiple AI at the same time. So there is nothing like that in the market, not only in the U.S. but also globally. And also, if you think about what we have shown at the Investor Day, it gives us more confidence and Medtronic as well to advance not only current users increase in term of application, but also like you asked the number of users using GI Genius. So yes, I think we're in a good position, but that's the moment to accelerate and that's what we are doing also in terms of R&D., as you have seen from my comments in the deck. We have a busy pipeline, and we are aiming to release those applications with the cadence of timing that is going to stay consistent and relevant to the market.

Yes. And then upper GI, so that's, of course, a huge market that will come in the next, what, 12 months or so...

Correct.

Just on Winlevi, we see a strong U.S. volume growth. Do you see lower rebates going forward? So it's a little bit -- it seems like some of the sales are being hampered a little bit by the rebates that are given. Do you see that actually now waning going forward?

Yes. So we -- as the volume stabilizes, as the number of prescription growth slows down, the gross to net is improving, and we've talked about this previously. So what we see is the growth driven primarily by the royalties on the U.S. side.

Okay. And then just finally on the gastric business, Lialda, Uceris, there you see lower volumes and pricing due to generic competition. Is this something we have to sort of factor in going forward, so like a further decrease of those products, in particular Uceris, we saw a decline there?

So this is -- as I mentioned, this is some seasonality impact from gastro and CDMO overall for full year. We expect a single low-digit growth, right? So this -- we expect a stable performance from this franchise going forward with some seasonality, obviously, as it happens.

Yes. Okay. And then just finally on CDMO. I think this is a little bit lumpy business if you look at from first half to another half like every 6 months or so. There, could we expect also a little bit of growth going forward in the second half?

Sorry, Bob, can you repeat the question, please?

Just on CDMO, this seems like a normal fluctuation because this business seems to be lumpy if you look at it every 6 months or so, just depending when you get...

Yes, Bob, if you look at this in 12 months, we still believe that we have a low single-digit growth also in CDMO. So we're not concerned about it. There are seasonality also as well there.

The next question comes from Harry Gillis from Berenberg.

Just to start, if I may. So overall, the recurring revenues were flat in H1. Could you just discuss a little bit more about what gives you confidence in the acceleration you're expecting in the second half of the year? And I know you touched on the seasonality for the CDMO and gastro business, but could you perhaps expand on that? And exactly what that means and why that should give us confidence for that second half acceleration?

Yes. So Harry, thank you for your question. I'll take that one. So we have confidence in our ability to meet the target because all of our revenues for 2025 are already contracted and committed both on our side and on the partner side. So we have very good visibility into the second half, and we feel confident that the momentum will continue and then we can deliver on those contracts.

And also Harry, if you think about the MedTech AI business, as I said also earlier to the Bob question, we are seeing a huge uptake in terms of deployment of the new Genius 300 in the U.S., and we have been waiting also for MDR approval, which should come anytime soon in Europe. So with that in mind, also expect to see upside as well in terms of opportunity for us to have Medtronic placing new system. So I think we are, like Svetlana said, very confident to achieve this. We already see demand uptaking for our CDMO business and pharma business. So we also expect there to deliver. That's why we are not changing guidance on the revenue. We are increasing guidance on the EBITDA, and we are confident to achieve what we said.

Perfect. And if I could just follow up with 2 more briefly. Just on the EBITDA guidance raise, could you like quantify how much of that maybe was because of the sort of other income and the dividend you booked there from one of your strategic investments versus like underlying performance and better cost control? And then I'll just add this on now. Just an update on -- could you just remind us with Winlevi what the possible scenarios are with the EMA decision? And then perhaps how the use at least what we've seen in the U.S. is split amongst the different age cohorts so we can think about the potential range of outcomes based on your discussions with the EMA?

Great question. Thank you, Harry. I'll take the first one. So out of the EUR 4.5 million raised on the EBITDA, approximately 2/3 are related to the events that have taken place in the first half of the year, that's the increase in dividends versus what we expected and the R&D tax credit. Approximately 1/3 of the EUR 4.5 million EBITDA raises related to operational efficiencies that are for the full year impact. Maybe I can also take the part B of the second question as well. Of the adolescent volume that we've seen in U.S. so far on Winlevi, approximately 18% of the volume is from that 12- to 18-year old. So while it's a fair portion of the market, it's not majority.

And also, let me answer to your question about the EMA. As I said during the presentation, our team at Cosmo has been working very diligently to answer and clarify further the dossier for the EMA. And I do believe that we have a strong chance to make our arguments in front of the CHMP. The process so far has been going well. We have a couple of key dates over the next 1.5 months that we are prepping for. And I just can provide you my confidence level with the data we have that sustain the indication also for this age, and we feel strong about our case as well.

The next question comes from Ben Jackson from Jefferies.

Just a couple for me. If we take them in order, I guess the first one, I just want to follow up on what Harry has just asked there about Winlevi and EMA. Are you able to just talk about your level of confidence around that compared to when we last spoke at the Investor Day, has your level of confidence changed at all around the outcome that you anticipate getting? Or has there been very few updates? Is there any further color if I push you on that, that you can provide at all?

Sure, you can push for sure. Yes, my level of confidence, it's higher than a month ago. So as we go through this, we learn, we have conversation and also internally -- now I mean, this is -- you asked me my level of confidence, that's my answer. So I think it's in a very good spot.

Yes, that's clear. And I guess, look -- if we look back to a month ago as well, you presented some interesting commercial research around Breezula. Interesting to see here that now that, that has been put out to the world, have you found that there's been any increased engagement either from potential partners or perhaps even physicians or patients that have fed back on what they've seen and heard from you there? Is there anything incremental you can provide us since you provided that update?

Yes. Thank you for the question, actually. I like it a lot because our Investor Day was very well received from not only you, analyst community investors, but also some of the potential partners watched our presentation. And yes, we have been having already some early conversation. There is a lot of interest in understanding early data from our asset. The market opportunity is clear to be big. Therefore, what we presented gave another big boost to our position in terms of opportunity once the data is going to be published and assuming the data is going to be positive.

[Operator Instructions] The next question comes from Nicolas Pauillac from Kepler Cheuvreux.

Hopefully, you can hear me. And yes, congrats on the results. Maybe 2 questions from my side, which are kind of tied, but just if you could refresh us on what's the strategy for this solid tumor asset? What's the plan assuming a successful Phase I? And is there any potential, let's say, development revenues that will be tied to the successful Phase I in your guidance?

No. We haven't guided anything about solid tumor. We're -- and I think we discussed this, Nicolas, at the Investor Day when we showed the path to leadership guidance that we have within the company and the way we're taking a look at the investment and the portfolio management. We believe solid tumor is actually an exceptional asset for someone else that has experience in that area, not a place for us to be able to win in that market. Therefore, at the moment, we have the Phase Ia results published. We're going to look for a partner and sell the asset, that's our decision. And we are already working on finishing the trial. As I said in the presentation, we expect to get the results September, early October, and then we expect to run a process with a few companies that we know that could be interested because used as a compound with other drugs and molecule, this could be a very important opportunity for some big pharma betting into prostate cancer.

Okay. Super clear. And maybe just to come back on Winlevi, and sorry to bore you with that. But when we look at the 2030 target that you gave, it looks like you have kind of, let's say, conservative assumptions. So I know it's not the [indiscernible] but would it be possible to have some breakdown on how do you get to the number that you have in the forecast?

Nicolas, thank you for the question. So maybe to comment on Winlevi. So you are correct. We have previously said that approximately 8% of the EUR 480 million, which is including the new assets in the portfolio will come from Winlevi, which is approximately EUR 40 million. We -- for 2030 outlook, we have included a degree of prudence given the ongoing EMA appeal. The European label may differ from the U.S., but if the outcome is favorable, we believe that there is a clear upside to the projections. As a reminder, for the Winlevi revenues, we received them from manufacturing, and we expect the manufacturing portion to increase as the volume increases because we are going through the global expansion, and we expect to have over 30 countries to be on board by the end of 2027. And then we also expect the growth in royalties, but the manufacturing revenue growth will outpace the royalties growth because the price of outside of U.S. is lower than the price in the U.S. Does that answer your question?

Yes, super clear. And congrats on the results again.

[Operator Instructions] We have a follow-up question from Harry Gillis from Berenberg.

Just in the same vein, when we look at your 2030 sort of ambition for GI Genius, I think based on the percentages, it implies around EUR 170 million of sales by 2030. Could you just help us understand how we sort of get to that large number? We're obviously seeing super impressive growth now, but what you need to be delivering in terms of placements per year, the split of that, that is from the manufacturing component. And then, I guess, how much comes from the apps and the different software on it just to understand how you get to that 2030 number, which is clearly ambitious.

Yes. So I think I gave some hints during the Investor Day presentation. You also were able to see some of the demos during the Investor Day presentation. Clearly, in my talk track, I have been talking about scalability of this technology. I have been talking about also adding the largest MedTech company in the world as exclusive partner for Cosmo, which is Medtronic. And as I said today, also in the presentation, we have been already in talk to Medtronic to look at opportunities to use our platform beyond endoscopy. So then think about this in the next 5 years, not only as a GI player, but think about this as a real time AI platform player. And then you can come up with a number that seems to be, oh my god, it's impossible. And that's the number that you have to account because it's not only hardware placement, which is what we also do in Cosmo, but also it's the number of applications that we are working on, not only in GI, but also beyond GI. So I mean, to be honest, it's also a conservative number, what we gave in our 2030 plan. Our ambition is to lead this space together with Medtronic, real-time procedures are everywhere. Think about surgery, think about robotics, think about cardiac, think about spine, and I can keep naming it, right? And then those are skills that we have developed in Cosmo, and those are opportunities that we can capture also across Medtronic.

Maybe one addition. Our ambition is to continue leading this space because we are currently leading this both in terms of technology and the market share when it comes to AI-driven endoscopy.

Thanks for the question. Very important to us.

Ladies and gentlemen, that was the last question. I would now like to turn the conference back over to the speakers for any closing remarks.

I want to thank you all, and we'll keep you apprised with our progress and talk to you soon. Thank you. Have a nice day.

Thank you.