Ladies and gentlemen, welcome to the full year 2025 results conference call and live webcast. I am Ira, the conference call operator. I would like to remind you that all participants will be in listen only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can register for questions at any time by pressing star and one on your telephone. Webcast viewers may submit their questions in writing via the relative field. For operator assistance, please press star and zero. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to Giovanni Di Napoli, CEO. Please go ahead, sir.
Good morning, good afternoon, 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 2025 full year results. We walk you through our performance, our progress on strategic priorities, and the path ahead. A quick note on forward-looking statements. 2025 was not a year of noise. It was a year of execution. Today, I want to walk you through three very clear messages. First, structural transformation has been delivered. Over the past year, we fundamentally reshaped Cosmo. We simplified, we focused, we aligned the organization around scalable platforms rather than isolated assets. What you're seeing today is not incremental improvement. It is a different operating model, leaner, more disciplined, and built for leverage. Second, financial discipline and recurring revenue. We have moved from opportunistic revenue to structured, repeatable revenue streams.
Recurring components are increasing. Cost control is embedded in the culture of Cosmo. Capital allocation is deliberate. We are building predictability into the model, and predictability drives valuation. Third, 2026 catalyst and operating leverage. The work done in 2025 creates torque. The platforms we built now begin to scale. The operating structure we put in place starts to amplify growth. 2026 is not about rebuilding, it's going to be about compounding. As we go through the results today, I want you to keep one lens in mind. This is a company that has completed a decisive structural evolution. We are now entering a phase of acceleration. Let's start with structural transformation. Before we go into the numbers, let me start with something more fundamental. Cosmo's mission is simple.
We are building health confidence, health confidence for patients, for physicians, for our partners, and ultimately for our shareholders. This is not marketing language, it is how we design the company. In 2025, we translated that mission into three clear pillars. First, a recurring revenue model that brings visibility and predictability to the business. Second, an AI-enabled med tech platform that is expanding across procedures and embedding technology directly into clinical workflow. Third, a late-stage dermatology catalyst with positive phase III results in androgenetic alopecia and 12-month safety data expected this spring, 2026. Together, these elements combine durable recurring revenue, scalable technology, and pipeline value. This is how we're building health confidence. What you see here is the architecture of Cosmo. This is not a single asset company. It is a recurring growth platform with catalysts.
At the core is our recurring revenue engine, shifting the company from episodic growth to predictable growth. On top of that is AI-driven operating leverage. Our installed base continues to expand and software applications layers on top of hardware. Hardware distributes, software compounds. We add pipeline catalysts, starting with clascoterone, a late-stage dermatology asset with multiple partnering pathways. Finally, a strong balance sheet give us flexibility to invest, partner, and scale the platform. When you step back, the model here is simple. Recurring growth is the foundation. Catalysts are the multiplier. Let me now show you how that model translated into financial performance in 2025. Revenue reached EUR 104.2 million, with approximately 85% now coming from recurring revenue.
Recurring revenue grew 15% year-over-year, which was our commitment for double-digit growth, driven by strong GI Genius performance and solid contribution from Winlevi. EBITDA reached EUR 9.5 million, reflecting operating discipline while continuing to invest in growth. We closed the year with EUR 128.3 million in cash, with zero debt and the dividend maintained. The message is clear. We delivered on guidance and above guidance. We did what we said. We improved the quality and predictability of our GI programs progressing on schedule, and a capital efficient oncology strategy with clear partnering intent. This pipeline complements our recording commercial platform and adds additional value catalyst through 2026. Let me now move to MedTech AI, CDMO Gastro, and a quick update on ESG.
Starting with MedTech AI, we achieved EU MDR certification, reinforcing the durability of our platform in Europe. At the same time, we continue expanding the capabilities of the platform. colonPRO integrates real-time detection, sizing, characterization, and quality assessment. While the new application, Cerebro, brings AI guidance into upper GI procedure. We are moving from simple detection line the coast basin as in fact maps and graphs and gives.
In CDMO, we signed a multi-year manufacturing and supply agreement with Takeda, pending approvals and commercialization across region 2026, strengthening our global dermatology footprint. In CDMO, we signed a multi-year manufacturing and supply agreement with Takeda for Mesalazine, adding long-term visibility and reinforcing our recurring revenue base. Finally, on ESG, our scores improve across S&P, Morningstar, and MSCI, with MSCI upgrading us to A rating. The message here, again, is simple. We are scaling AI, we are expanding globally, and we are strengthening recurring revenues, and we continue to execute with discipline. Building long-term visibility and reinforcing our recurring revenue base. Finally, on ESG, our scores improve across S&P, Morningstar, and MSCI, with MSCI upgrading us to A rating. The message here, again, is simple.
We are scaling AI, we are expanding globally, and we are strengthening recurring revenues, and we continue to execute with discipline. Now, let me hand over to our CFO, Svetlana Sigalova, who will present our 2025 financial results.
Thank you, Gio. Good morning, everyone. I will begin with a review of our 2025 financial results and performance drivers, and then turn to our 2026 financial framework and outlook. Here, I will not repeat the full summary as Gio has already covered the key highlights, but I would like to underscore two points. First, our EBITDA performance exceeding the upper end of our guidance. That reflects operating discipline and the scalability of our recurring revenue model. Second, our balance sheet strength that preserves full strategic flexibility as we continue to invest in growth. I am particularly proud of the execution across the organization, delivering recurring growth, maintaining cost discipline, and strengthening profitability in a structurally transitioning year. With that, let me walk you through the financial details. Looking at the revenue composition.
Recurring revenues reached EUR 88.1 million, up 15% from 2024, consistent with the double-digit growth commitment we made at the start of the year. Project-based revenues were EUR 16.1 million. As a reminder, 2024 included EUR 186.3 million in Medtronic milestones. The revenue base is now significantly more predictable and commercially driven. This enhances visibility into 2026 and beyond. Let me break down the drivers of our recurring revenue growth, starting with GI Genius. Revenues reached EUR 17.9 million, representing 211% growth versus prior year. The triple-digit growth is exactly what we committed to at the beginning of 2025, and we delivered on that commitment. This reflects expanded installations, increase in adoption, and continued collaboration with our partner, Medtronic. The growth rate here demonstrate the scalability of our platform as penetration increases. Moving to Winlevi.
Revenues were EUR 17.2 million, up 27% year-over-year. The double-digit growth is what we committed to at the beginning of 2025. This reflects growing physician adoption, improved market access and geographic expansion. Winlevi continues to establish itself as a differentiated product in its category. The remainder of recurring revenues, approximately EUR 53 million, comes from our legacy gastro products and CDMO. Within that, EUR 27.9 million from mesalamine, EUR 15.6 million from CDMO, and EUR 9.7 million from all other gastroenterology products. Our diversified base provides stability while growth assets scale. Recurring revenue growth is driven by commercial assets with operating leverage, supporting continued expansion into 2026 and beyond. Let me walk you through the P&L with focus on cost discipline and profitability. As discussed, total revenues were EUR 104.2 million.
Other income was EUR 7.2 million and includes certain non-recurring items that we do not expect to repeat at the same level in 2026. On the cost side, cost of sales increased to EUR 53.6 million. The increase versus prior year primarily reflects higher commercial volumes and product mix effects as recurring revenues expanded. Turning to operating expenses. Research and development expenses were EUR 34.2 million and decreased 14% versus prior year. This reflects focused execution across the pipeline, prioritization of key programs, and disciplined external spend management while continuing to advance our strategic assets. Selling, general and administrative expenses were EUR 26.8 million and decreased 26% year-over-year. This reduction was driven by operational focus and lower personnel-related costs as we align the cost base with the current structure of the business. Overall, operating expenses decreased 6% year-over-year.
Recurring revenue growth combined with disciplined cost management delivered EUR 9.5 million in EBITDA, exceeding the upper end of our guidance. This performance reflects operational execution. We will continue to actively monitor our cost base, pursue operational efficiencies, and allocate capital to the highest return opportunities. The outcome is a more efficient operating model and improved profitability as we enter 2026. Let me now turn to 2026 guidance and the trajectory of Cosmo. On recurring revenues. For 2026, we guide to EUR 98 million-EUR 102 million, representing 11%-16% growth and a 2024-2026 CAGR of approximately 13%-15%. This reflects continued expansion of GI Genius and Winlevi, supported by the stability of our gastro and CDMO base. On profitability.
For 2026, we guide to EUR ten and a half to thirteen and a half million, representing 10%-42% growth year-over-year. As recurring revenues scale, operating leverage becomes more visible. The structural shift toward predictable commercial revenue supports our sustained EBITDA expansion. As we enter 2026, the business model is becoming increasingly recurring, scalable, and profitable. Let me summarize the 2026 financial framework. We guide to total revenues of EUR 105 million-EUR 110 million, of which EUR 98 million-EUR 102 million are recurring and project-based revenues are expected to be modest at EUR 7 million-EUR 8 million. Importantly, this guidance excludes any potential revenues from pipeline or development stage assets. Turning to R&D. For 2026, we expect research and development investments of EUR 25 million-EUR 30 million.
This represents a disciplined and focused investment level aligned with key value-driving programs, including phase III and regulatory work in androgenetic alopecia, two phase II gastro trials, and continued MedTech AI expansion. We are investing where returns are highest while maintaining overall cost discipline. On profitability. 2026 EBITDA of EUR 10.5 million-EUR 13.5 million is driven by recurring revenue growth and operating leverage combined with continued cost focus. Importantly, we expect to exit 2026 with approximately EUR 200 million in cash and investments with no debt. This strong balance sheet provides strategic flexibility to fund internal programs, evaluate partnering opportunities, and maintain resilience. The framework for 2026 is clear. Double-digit recurring revenue growth, disciplined R&D investment, expanding EBITDA, strong year-end cash position. We're scaling the business while preserving financial strength.
Cosmo today is a recurring revenue business with expanding margins and a strong balance sheet. This financial structure gives us flexibility to invest in high return opportunities, advance our late-stage pipeline, scale our AI platform, and return capital to shareholders. Against that backdrop, the board is proposing a dividend of EUR 2.10 per share. This increase reflects continued confidence in the strength of business and our disciplined capital allocation framework. We remain focused on investing in our growth opportunities while subject to AGM approval, payment is expected on May 11, 2026. Our late-stage pipeline scale our AI platform and return capital to shareholders. Against that backdrop, the board is proposing a dividend of EUR 2.10 per share. This increase reflects continued confidence in the strength of business and our disciplined capital allocation framework.
We remain focused on investing in our growth opportunities while maintaining a consistent approach to shareholder returns. Subject to AGM approval, payment is expected on May 11th, 2026. Let me close with our capital allocation framework. Our priorities remain clear and disciplined. Every year, we allocate across strategic research and development, partnership and licensing, and organic business needs is focused on expanding our recurring revenue base and driving long-term profitability. In research and development, we invest in programs with clear value creation potential. In partnerships and licensing, we pursue opportunities that accelerate growth while maintaining financial discipline. In the core business, we continue to scale our platforms efficiently. At the same time, returns to shareholders remain a priority. The proposed dividend reflects confidence in the strength and stability of our business while continuing to invest for growth.
With that, I will pass it back to Gio for closing remarks.
Thank you, Svetlana, for walking us through our 2025 financial performance. The numbers reflect discipline, focus and strong execution across the organization. That's clear. Let me now turn to 2026. We look ahead, we see a year defined by clear catalysts and increasing operating leverage. The foundation has been built, the revenue mix has improved, the balance sheet is strong. The focus shift is acceleration. In the next few slides, I will outline the key value inflection points ahead of us and how the platform we have constructed that translates into scalable growth, margin expansion and strategic optionality. 2026 is about converting structure into momentum. Let me spend a moment on clascoterone 5% topical solution. Male androgenetic alopecia is a large, medically driven and underserved market. In the U.S. alone, approximately 65 million men are impacted.
This represents a market opportunity of roughly $20 billion with premium pricing potential that we tested through a very important market research last year. Importantly, there are limited differentiated FDA-approved therapies. Patients are willing to pay. Persistence rates create recurring revenue dynamics here. Clascoterone 5% topical solution introduce a new mechanism of action in a market that has seen very little real innovation over the last 30 years. As you all know, we have already delivered positive phase III top line data. 12-month safety and tolerability data are expected in the next few months, spring 2026. Given the strength of the asset and the data set and the size of the opportunity, we are actively engaged in discussion with multiple leading global pharmaceutical companies. I will not comment on timing or structure today, but what I will say is this.
An asset of this size at this stage with this level of external interest has the potential to be value-defining for Cosmo. Our focus is simple. Maximize long-term shareholder value, structure the right partnership, execute with discipline. This is a significant opportunity for Cosmo. Let me take a moment to frame now the MedTech AI franchise and business and what does it mean for Cosmo. AI, artificial intelligence, is rapidly becoming a foundational technology also in healthcare, not only in consumer. By 2030, the addressable market for MedTech AI is expected to reach approximately EUR 162 billion, growing at close to 40% annually. For us, this is not a distant opportunity. AI is already embedded in our GI Genius platform today. What we are doing now is expanding that foundation into new clinical applications, new procedures and new software layers. Our goal is simple.
We want to build a scalable AI platform that sits directly inside the clinical workflow. What you see here is the scale of the installed base. GI Genius is already deployed across the globe. You can see here U.S. and Europe, and that installed base is the foundation of our strategy. Once the platform is in place, we can begin layering software application on top of it. colonPRO for colorectal cancer screening, EUS for pancreatic cancer detection, Barrett's esophagus detection. We just recently made an announcement with a very important partnership with Amsterdam UMC on that topic. Esophageal symptoms analysis and emerging applications such as spatial computing with the Apple Vision Pro. This is how the model works. Hardware create distributions, software creates scalability, and recurring revenue compounds over time. What makes this model powerful is that it is repeatable.
At the center is our installed base and the clinical data that it generates every day in real clinical practice. Around that foundation, we have built the infrastructure required to scale AI in medicine. We have AI engineering and in-house development capabilities, regulatory and clinical infrastructure, strategic partnership and cloud capabilities, Nvidia, Apple, and the ability to deliver end-to-end solutions directly into the clinical workflow. This combination, I promise, is very rare. Many companies develop algorithms. Very few have the platform required to deploy AI at scale inside real medical procedures. Each new application strengths the platform, expand procedural reach, and increase the value of our installed base. Importantly, the capabilities we have built in Cosmo allow us to extend this platform across additional procedures, additional specialties, and clinical workflow over time.
This is how we believe we can scale MedTech AI, that is why we believe Cosmo is uniquely positioned to lead the next phase of AI adoption in the real clinical markets. All of this leads directly into 2026. Our focus for the year is very clear. First, continue scaling recurring revenue and AI software across our installed base. Second, advance clascoterone 5% topical solution toward regulatory and partnering milestone, unlocking the value of a large stage dermatology asset. Third, expand operating leverage as revenue grows across the platform. The combination of recurring revenues, AI software expansion, and pipeline catalyst position Cosmo for meaningful value creation. This is the closing slide. Based on everything we have discussed today, the message is clear. Clascoterone with strong phase III data and active strategic discussion. An AI platform that is scaling and layering software onto hardware.
A pipeline advancing with defined milestone and partnering intent. A recurring revenue base now driving the majority of our business. Cosmo is set up for value creation. 2026 is not a planning year, it is a year of actions. It is a year of results. We have capital, we have catalysts, we have operating leverage. Execution now will drive the outcome. Thank you so much, and I'll open up now for Q&A.
On their telephone. You will hear a tone to confirm that you have entered a queue. If you wish to remove yourself from the question queue, you may press star and two. Questioners on the phone are requested to disable the loudspeaker mode and eventually turn off the volume from the webcast while asking a question. Webcast viewers may submit their questions in writing via the relative field. Anyone who has a question may press star and one at this time. First question comes from the line of Bob Pooler from valuation LAB. Please go ahead.
Good morning, Gio and Svetlana. First of all, congratulations on the strong 2025 results and also your double-digit growth outlook for this year. If I may, first a couple of questions on the products and then maybe on the operating and the financials. Just on GI Genius, we really see that the platform is now taking off. Where is this growth coming from? Is it more the US or Europe? Also you announced the collaboration last week, the R&D collaboration in the Netherlands. When do you expect also revenues coming from upper GI indications?
Bob, thank you so much for the question. Gio here. The growth we have seen for GI Genius is coming both from the U.S. and Europe as well. Clearly the U.S. market is larger by definition, so even small percentage of increase means a lot in term of volume. Both regions are demonstrating strong contribution in term of hardware adoption. In term of upper GI, so we are actively working on the software part of the upper GI with Amsterdam. We have, you know, plan to release that part of the software based also regulatory approval in the U.S. end of next year.
Just remember also we have an application in upper GI that is called Cerebro, that is going to be launched this year in June, July in Europe, as this already have received the CE marking approval late last year. And also on top of this, we are integrating GI Genius with the electronic medical record in the US, and we're gonna launch this application this year in the summer in the US, which is going to be a very important part of the growth that I was sharing during the presentation.
Okay. Just on Winlevi, when do you expect significant revenue contributions coming from Europe?
Yeah. Europe, we're going to launch. We're the first markets get to get up and running before December. We have seen a lot of pre-work done by our partners, Glenmark and InfectoPharm. We are very pleased with the success of the drug also in the U.K., which we launched last year. We expect to see, you know, strong supply requirement from Glenmark and InfectoPharm this year. It's going to be a steady growth over the next foreseeable future for that platform for us in Europe as well.
Maybe just to add, Bob, we'll see the first revenues from Winlevi Europe on the supply side when we report the first half results in July.
Okay. Okay. Clear. Just on Breezula then, just to clarify, you expect the results of the next few months, I believe. Is that what you said?
Yeah. As we announced already December and also today during the call, spring 2026. We're talking about the next 2, 3 months. We're going to release the data at 12 months, which is very important for the safety and tolerability to go together with the regulatory package for both U.S. and Europe. Also to show if the drug can be sustained over time.
Okay. Yes. On the partnering, of course, you're not going to explain who you're talking to, but could you maybe share a little bit your criteria? Because this is really a value-defining event for Cosmo.
Well, I think what I said in the presentation, it's, you know, in my opinion, clear. There is a lot of interest. We have perceived a lot of interest since December. There is active conversation with multiple partners, big partners. I think, you know, when time will come, we'll share more information. As of now, we are pleased with the interest we have perceived. The market is gigantic. I want to, you know, reiterate the fact that with the market research we conducted last year, this is a market of over $20 billion just in the U.S.
Yeah.
That's why, like I said, that this is a value-defining asset for Cosmo moving forward.
Yeah, I fully agree. Yeah, just to be on the timing of that, on the partnering announcement, of course, and the signing, of course, that could make a huge impact also maybe for this year, if you sign this year on your milestone agreements, a milestone contributions there too.
Yeah. Sure. I think you. Yeah, go ahead.
Mm-hmm. No, no. Please.
No, I was just saying that, you know, our guidance does not include any of this upside, which is a very important piece to clarify if someone did not get this. Our guidance do not guide on those opportunity, those assets that are, you know, very short-term. Yes, expect to see more in 2026 on that side.
Yeah. Just then finally on the operating expense, and your guidance there. You have really shown quite a lot of efficiency there. If you look at SG&A, quite a large drop there. How is this realized? What is your guidance going forward, both on SG&A and also then on R&D?
Thank you, Bob. I'll take this one. For R&D, we said that for 2026, we expect expenses to be EUR 25 million-30 million, which is a continuous decline. Our guidance for 2027 could remain the same or be slightly higher, depending on how the assets that are currently in phase II progress through their trials. I'm talking specifically now about bile acid diarrhea and distal ulcerative colitis. For SG&A, we believe that we now have a strong core that has been optimized. However, we continue to monitor for efficiencies, and it's possible that you will see the expenses decline slightly as we progress into 2027.
Okay. Just then, what is your estimated cash and cash equivalent? Because after the year, of course, you had the offering, in particular else with Capital Group. What is your estimated cash for as of today, more or less?
The estimated cash and equivalent ending for 2026 is expected to be approximately EUR 200 million.
Okay. Okay.
Thank you, Bob. I'd now like to open to other participants, please.
Sure.
Thank you so much for all your thoughtful questions.
Thank you.
As a reminder, if you wish to register for a question, please press star and one on your telephone. The next question comes from the line of Nicolas Pauillac from Kepler Cheuvreux. Please go ahead.
Hi. Hey, guys. Thanks for taking my question. Yeah, congrats again on the results. Maybe two for me. The first one is just on this project-based revenue guidance for next year. Could you just break it down a bit? I guess it would be like just commercial milestone that you have put into that from maybe Winlevi. A second one, just on the... If you could give us on your thoughts on the Veradermics product. There has been a lot of noise around that since the IPOs. Would be nice to have your view on that. How do you think it might or might not impact the market for Breezula?
Then maybe a third one, just, do you have any idea of, big congress or things like that you would like to present more data on the efficacy on Breezula over the next months?
Thank you, Nicolas. Let me take the first one. If I can please confirm that when you're talking about milestones, you're talking about 2026 or 2027?
26.
2026. For 2026, we expect milestones of EUR 7 million-EUR 8 million that are mainly related to legacy gastroenterology programs. The milestones for Winlevi now have been largely realized in 2025, and we do not expect any significant milestones from Winlevi until 2029 or 2030 or so.
Okay.
I will now pass it to Gio to talk about your questions regarding Veradermics.
Thanks for the question, Nicolas. We are very well aware of the Veradermics program. At, you know, at this stage, we seek more, you know, on our side the fact that we have completed a larger phase III trial with over 2,000 patients. We have, you know, in the next couple of months also ability to show data on safety and efficacy on 12 months, and I think that's gonna be a very important piece. It's a very unique mechanism of action. Ours is an androgen receptor attacking the root cause of hair loss.
you know, what I can say is that the interest about hair loss across the market is really, really high, which is good for us because, you know, we are, you know, advanced compared to any other, you know, company, and I think this is gonna bring us even more visibility than what we already have. Then, regarding your last question, yes. We are planning to be at the American Dermatology Association events. I think it's gonna be this April, May in the US. We have, you know, a few things organized, and, you know, we'll report back as soon as we have more robust information to share with you. Okay, great. Thanks for the answer.
Thank you.
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.
Maybe just one quick comment. We will respond to all the online questions via email today. Thank you.
Thank you very much. Have a nice day. Bye.
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