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

Good afternoon, everyone, and thank you for joining us today. I'm Gio Di Napoli, Chief Executive Officer of Cosmo, joined by our Chief Financial Officer, Svetlana Sigalova. This year, Cosmo marks 30 years anniversary. As the theme reflected, those 3 decades have been spent on a single discipline, translating rigorous science into medicines and technologies that improve patients' lives. Proprietary drug delivery platforms, approved therapies used by patients around the world, state-of-the-art manufacturing at our own production site, giving us end-to-end control from molecule to finished product and now artificial intelligence in the hands of physicians during real-time procedures. None of this happened by accident. It comes from a culture built to innovate and the people who have carried that culture for 30 years. This is what has taught us to advance on evidence and let the data lead, and it is exactly the foundation of confidence we carry into today. Let me walk you through it. Before we begin, the usual but important note on forward-looking statements. Everything we share today reflects our current beliefs and the information available to us now, and actual results may differ. I'd encourage you to review the disclaimer at your leisure. With that behind us, let's talk about the business now. Here is how we spend our time together. I'll start with our business and strategic execution in the first half. And I think that's where the real story is. Then Svetlana will take you through the H1 financials in detail. I'll come back for closing remarks, and then we'll open up for questions. So let's begin with the business. If you take one thing away from today, please take this. H1 2026 is the half in which Cosmo became a multi-engine compounder. For many years, we were a company largely defined by a single question. Today, we have 3 engines. All of them are now firing at once. In dermatology, our acne franchise is scaling, and we have a first in 30 years hair loss breakthrough moving to regulatory filing. In MedTech AI, GI Genius is evolving from polyp detection into a full GI platform. And in pharma CDMO, new customer wins are driving recurring revenue growth. 3 engines advancing together on a fortress balance sheet, and let me show you now the detail. This is the scorecard, and I want to be precise about it. We did not just stay on track this half. We actually accelerated. We led net revenue grew 38% year-over-year, and we added 14, 1-4, new markets. We are now in 23 countries. Recurring revenue was up 18%, and it was broad-based. Every franchise contributed. We closed the half with over EUR 200 million in cash and investments and 0 debt. And critically, every strategic pillar advanced on or ahead of plan. The hair-loss package is complete. Our GI readouts are approaching. The AI platform is expanding and guidance is reaffirmed. Let me take each engine in turn now. This slide is the entire first half on a single page, and the headline is that we made progress on every engine, not just one. In dermatology, Clascoterone 5% topical solution Phase III is now complete, and Winlevi European launch is underway. In our GI pipeline, Distal Ulcerative Colitis and Bile Acid Diarrhea are both moving towards near-term readouts. In MedTech AI, we rolled out the next generation of GI Genius platform and expanded both our installed base and our clinical evidence. And underpinning all of it, recurring revenue is up 18% over EUR 200 million in cash, debt-free, guidance reaffirmed and Capital Group joining our shareholder base. Let me now go deeper on the pieces that matter the most. Let's start with what could be the single biggest opportunity in our portfolio. For roughly 30 years, there has been no genuinely new mechanism in male hair loss. Clascoterone 5% topical solution is that breakthrough, a first-in-class topical anti-androgen. Our pivotal Phase III is now complete with a fivefold improvement in Target-Area Hair Count versus vehicle and 12 months of durability confirmed, which support chronic use. The next milestone is regulatory filing in both the U.S. and in Europe. As we announced this morning in the press release, we aim to file the NDA Q1 FY '27 and then a quarter after the European submission. And the price is a market north of EUR 28 billion, where -- and I want to be clear about this, we would enter with no mechanistic-level competitor. This is a potential blockbuster, and it is moving to filing. Now to our GI pipeline and the next value inflection. Distal Ulcerative Colitis is a large market with no dedicated therapy, more than 3.5 million patients worldwide and an addressable market around EUR 1.1 billion. Our candidate, Rifamycin SV enema, it is a local targeted therapy that treats the root cause, inflammation and microbiome dysbiosis. Phase II enrollment and dosing are now complete, and we expect top line data in the fourth quarter of this fiscal year. That's a near-term derisking catalyst with first-mover potential in a badly underserved population. Now let's talk about the second one which is Bile Acid Diarrhea. And the number here is striking, roughly 95 million patients worldwide, an addressable market around EUR 21 billion. And again, no dedicated therapy. Our candidate, Colesevelam MMX could be the first colon targeted therapy purpose-built for this large underdiagnosed population. Phase II enrollment is completing toward the year-end. So hold these 2 GI programs together in your mind, 2 large markets, not dedicated therapy, both derisking in the near term and both capital efficient. This is exactly the kind of asymmetric opportunity Cosmo is built to pursue. Turning to MedTech AI. GI Genius began as a polyp detection. It is becoming a multi-application AI platform and is compounding across 4 dimensions at once. Commercially, our next-generation GGM300 hardware continues rolling out across the U.S. and also Europe with high customer retention. And I want to highlight the high customer retention. On the platform, we have begun deploying EMR functionality, extending to our procedural support. In the pipeline, an R&D collaboration is extending our AI into Barrett's oesophagus, a precancerous lesion and the upper GI tract. And on evidence, we added fresh clinical validation this half that reinforce physicians adoption. Let me be direct. The platform thesis is just getting started with more capabilities advancing through this second half and also in 2027. Let me make the platform concrete with one capability I'm especially excited about. Today, writing the procedure report is manual, time-consuming, work for physicians and nurses. With GI Genius automated reporting, the report during a colonoscopy writes itself. The system captures every finding through AI as a structured data during the procedures, annotates, generates the finished report and go straight to the EMR system. That's real measurable time handed back to the physicians and to the nurse. And it's exactly how a detection tool become indispensable workflow infrastructure. This is the kind of capabilities that deepens our moat with every single procedure. Before I hand to Svetlana, let me frame the road ahead because the second half is a catalyst dense. In dermatology, expect AGA publications about our topical solution, Clascoterone 5%. And the European Winlevi continues to expand in Europe. In MedTech AI, the automated reporting launch embeds progress in development. In our GI pipeline, Distal UC Phase II top line readout in Q4 and also Solid Tumors Phase I readout. And new skin and gut candidates are progressing also into clinical from preclinical. Multiple value-driving milestones across every engine before the year-end. And there is more in motion on the platform and the manufacturing side that we look forward to unveiling as it matures. With that, let me hand over to Svetlana for the financials.

Thank you, Gio. I'll now take you through our financial results for the first half of 2026. As you'll see over the next few slides, our business continues to execute well against our plan. We remain on track to deliver our full year guidance with continued growth in recurring revenues and expected acceleration of revenues in the second half, disciplined cost management and a balance sheet that continues to provide significant financial flexibility. Let's start with our outlook for the full year. We are reaffirming our 2026 financial guidance across all key metrics and remain on track to deliver another year of strong operational execution. We continue to expect total revenues of EUR 105 million to EUR 110 million, including EUR 98 million to EUR 102 million of recurring revenues and EUR 7 million to EUR 8 million of project-based. As planned, we expect revenues to accelerate in the second half of this year, driven by continued growth across our recurring revenue base as well as the timing of project-based revenues. We also continue to expect EBITDA of EUR 10.5 million to EUR 13.5 million, representing double-digit year-over-year growth. This is an important milestone for Cosmo as we continue our transition to a business where more than 90% of revenues are recurring, providing greater visibility, predictability and operating leverage while maintaining disciplined cost management. Finally, we expect to end the year with approximately EUR 200 million in cash, equivalents and short-term investments, while remaining debt-free. This exceptionally strong balance sheet provides us with the flexibility to continue investing in our pipeline and commercial opportunities, pursue value-enhancing business development where appropriate and execute our long-term growth strategy without compromising financial discipline. With that framework in mind, let's now turn to our first half financial performance. Turning now to our first half results. We delivered EUR 50.2 million in total revenues, of which EUR 49.6 million or almost 99% were recurring. Recurring revenues grew 18% year-over-year, demonstrating the continued strength of our core business and the ongoing transition towards a more predictable, higher-quality revenue base. Growth was broad-based across our recurring revenue streams. Winlevi revenues increased 38%, driven by product supply for our partners' European launches. Lialda grew 35%, reflecting the continued strong performance of our legacy mesalamine business following the amended agreement with Takeda, while our CDMO business delivered 14% growth, supported by new customer contracts and manufacturing programs. GI Genius revenue was lower in the first half, reflecting the planned timing of Module 300 production scale-up and customer shipments. As these activities progress, we continue to expect revenues to be weighted towards the second half of the year and reaffirm our expectation of double-digit growth for GI Genius for both the second half and full year 2026. As anticipated, project-based revenues were limited in the first half and are expected to increase in the second half alongside continued growth in our recurring revenue base. This gives us confidence in reaffirming our full year guidance. Our financial position remains a key strategic strength. We closed the first half with over EUR 205 million in cash, equivalents and investments after returning approximately EUR 36 million to shareholders through our annual dividend payment during the period. Combined with 0 financial debt, this gives us flexibility to continue investing in our pipeline, support commercial expansion, pursue attractive business development opportunities where appropriate and execute our long-term growth strategy while maintaining disciplined capital allocation. Turning to the income statement. Total revenues for the first half of EUR 50.2 million. While this was modestly below the prior year, the quality of our revenue base continued to improve with recurring revenues increasing 18% year-over-year to EUR 49.6 million, while project-based revenues reflected the expected timing of milestone recognition and are anticipated to increase in the second half. Looking below the revenue line, other income was lower than the prior year, primarily reflecting lower dividend income received from our investment in RSLs, together with lower R&D tax credits following the completion of the Phase III Clascoterone program. Cost of sales increased 9%, broadly in line with the growth of our commercial product sales and CDMO activities. Research and development expenses declined 16%, reflecting the completion of the Phase III Clascoterone studies, while we continue to invest in advancing our gastrointestinal pipeline, including our Phase II programs in Bile Acid Diarrhea and Distal Ulcerative Colitis. Selling, general and administrative expenses increased year-over-year, reflecting noncash amortization associated with the European launch of Winlevi and the investments we made during the second half of 2025 to strengthen the corporate capabilities and support the company's next phase of growth. As we move through the second half, we expect operating expenses to remain well controlled with a modest reduction compared to the first half while continuing to support our strategic priorities. Overall, the first half results demonstrate the continued strength of our underlying business. Despite lower project-based revenues and lower other income compared with prior year, we delivered approximately breakeven EBITDA, reflecting the growing contribution of our recurring revenue base. Looking ahead, we expect revenues to accelerate in the second half, supported by both continued growth in recurring revenues and the timing of project-based revenues, while operating expenses are expected to moderate. This underpins our confidence in reaffirming our full year guidance. Finally, we closed the first half with over EUR 205 million of cash equivalents and investments, while remaining debt-free. This exceptionally strong balance sheet gives us flexibility to continue investing in our pipeline and commercial opportunities, evaluate value-enhancing business development and execute our long-term strategy while maintaining the disciplined capital allocation. To conclude the financial section, I would like to reiterate that we are reaffirming our full year 2026 guidance across all key financial metrics. We continue to expect total revenues of EUR 105 million to EUR 110 million, driven by continued double-digit growth in our recurring revenue base, together with the expected contribution from project-based revenues in the second half of the year. We also continue to expect EBITDA of EUR 10.5 million to EUR 13.5 million, supported by the anticipated revenue acceleration and continued operating discipline. Finally, we expect to end the year with approximately EUR 200 million in cash, equivalents and investments while remaining debt-free. This strong financial position provides us with significant strategic flexibility to continue investing in our business while maintaining the disciplined capital allocation. Overall, our first half year results reinforce our confidence in the outlook for the remainder of the year, and we remain well positioned to deliver on our financial commitments. Before I hand the call back to Gio, I'd like to conclude with our approach to capital allocation. Our balance sheet is a strategic asset and our philosophy is simple. Every year we deploy must create long-term shareholder value. With a debt-free balance sheet and more than EUR 200 million in cash equivalents and investments, we have the financial flexibility to invest from a position of strength while maintaining disciplined capital allocation. We allocate capital across 3 clear priorities. First, we invest in differentiated innovation where we believe we can generate attractive long-term returns. We maintain a minimum targeted return of more than 4x our R&D investment, ensuring that capital is directed toward programs addressing significant unmet medical needs with compelling commercial potential. Second, we pursue disciplined business development, whether expanding our AI and MedTech ecosystem or strengthening our pharmaceutical portfolio through licensing and strategic partnerships. We remain selective and focused on opportunities that enhance our platform and create sustainable value. Third, we remain committed to returning capital to shareholders through a sustainable dividend as demonstrated by the 2025 dividend paid during the first half of this year. In summary, our capital allocation framework is straightforward: invest where returns justify the risk, partner where we can accelerate value creation and consistently return capital to shareholders. Combined with our strong balance sheet, we believe this disciplined approach positions Cosmo well to deliver sustainable long-term growth and shareholder value. I will now pass it back to Gio for the concluding remarks.

Thank you, Svetlana. A strong first half financially and a balance sheet built to invest. Let me close by pulling it all together. So let me be clear about what 2026 means for Cosmo. This is not a year of reinventing the strategy. It's a year of execution. The first half demonstrated exactly that. Commercial momentum, recurring revenue growth, pipeline advancement and regulatory execution and operating leverage from a position of financial strength and with more than EUR 200 million in cash and investments without any debt. We have a real strategic flexibility. The ability to invest behind our best opportunities and create value on our own terms and our own time line, execute, scale and create value. That's the plan, and we are delivering on it. I'll leave you with this. Cosmo enters the second half of 2026 stronger than it has ever been. We have the firepower. We have cash. We have no debt. We can invest and reward shareholders. We have a platform in GI Genius that's compounding into multi-application AI franchise. We have a pipeline with a potential hair loss blockbuster moving into regulatory filing. And we have momentum, recurring revenue up 18% on our commercial franchise in scaling, 3 engines all firing on a fortress balance sheet. We will execute the strategy, scale the business and create value. With that said, thank you so much, and we'll open up for Q&A.

The first question comes from the line of Ben Jackson from Jefferies.

I've got 3, and I'm happy to come back to them as a reminder, if that's easy to separate them out. The first, we've obviously seen results for the extended-release oral minoxidil for the hair loss section over the last half. So I was wondering if you at all have changed your view on how potentially Clascoterone as a topical solution could be positioned? And any thoughts you have on -- in and around combination approaches between orals and topicals. So that's my first. If I could do the second as well, perhaps if you have any updated thoughts on what you're looking for in a commercial partner for Clascoterone as well. Are you looking more for one global partner? Or are you looking taking the regional approach that you also went with Winlevi? And then finally, I just want to check really briefly, the IP dynamics for the asset as well, your current working expectations and assumptions. Is there any chance of any extensions could be granted from there? And perhaps what strategies or studies could be conducted by either yourselves or a partner that could extend out that IP? So 3 questions for you. If you want me to repeat any, I'm more than happy to.

No, I'm good. Ben, thank you so much for the questions. Nice to hear your voice, Gio here. Let me start with your first question. I think you're referring to the oral minoxidil phase II/III results that were published a few weeks after our 12-month data. I mean I'm sure you know very well that those are 2 very different mechanism of actions. Ours attack the root cause of a loss, the DHT. Another point of view is that minoxidil is a well-known and very old generic molecule with well-known also side effect. I think if you focus on our safety profile on the 12-month data, you really appreciate the fact that this is ready for chronic use. I think for that reason, we stay bullish about our results, both on the efficacy, but also on the safety profile. Regarding your question on the combo use, talking to dermatologists, especially in the U.S., they keep telling us that those 2 products are complementary and not in competition against each other. As a matter of fact, minoxidil in pills is already sold in the U.S. It's a generic sold via pharmacy or telehealth with a degradation time of 2 hours instead of a longer degradation time that the other company is claiming. And they believe that could be also an opportunity for patients to use both. Ours is going to be the first topical approved with a unique mechanism of action that can be used in combination with other molecule. In this case, generic minoxidil. Now with that said, this needs to be proved also through clinical evidence prescribed by dermatologists, but we know that this is the feeling, especially from the doc side in the U.S. Licensing, great question. We have been very busy. We still are very busy. And the good news, like Svetlana said, we have a fortress balance sheet. I think we want to create and maximize value for Cosmo and Cosmo shareholders. We are assessing and evaluating different optionalities, both global versus regional. I think we are going to decide based on what brings the most value out of those conversations, which are happening as we speak. On the IP, I think you know very well that our IP is very strong, which is also make very unique our product versus other potential competitors you just mentioned earlier. Our IP expired 2037. And yes, we really are looking into extension, but it's too early to speculate around this, but that's an optionality also we have.

The next question comes from the line of Ram Selvaraju from H.C. Wainwright.

Congratulations on all of the recent progress. Also 3 very quick ones from me. I was wondering if you could elaborate a little bit on the publication strategy with respect to the clascoterone pivotal results. In particular, if you can give us a flavor of what kind of fora or journals, the level of impact factor you are anticipating? And if there's any additional granularity on timing as well as whether in that context, do you anticipate providing additional analyses of the efficacy data beyond those that were previously disclosed in the top line press release? So that's one. Number two, I was wondering if you could comment on capital allocation initiatives and in particular, how potential stock repurchases might fit into how you see the optimal way to deploy your capital going forward? And then lastly, with respect to the pipeline, Gio, you mentioned in your prepared remarks, extensive commentary on the GI-focused development stage pipeline at Cosmo. Maybe just give us your updated thoughts on how you anticipate potentially unlocking value from those pipeline assets and within what time frame this might occur?

Yes. Okay. So let me take the first question, Ram. Nice to hear your voice as well, and thanks for the question. Publications. So we are extremely busy with all the data we were able to collect. And I can tell you that there will be tons of publication coming out moving forward, especially in the fall. We are targeting high-impact journal, and that's where we want to have the Phase III results published 6 and 12 months with all the information that we will share, including also TAHC and subgroups, you will have a full set of information. That's the goal, and that's the reason why we're moving into that direction. But also, there will be additional publication, especially on the mechanism of actions that is a very unique differentiator of our molecule. What does the mechanism of action means in androgenetic alopecia, why inflammation is also important to be treated and why clascoterone does treat that inflammation as well. So expect to see over the next 3 to 4 months, those publications coming out. The submission of the paper expected to be at the end of the fall. So I'm expecting this by the end of October. Then based on publication acceptance, this could be as early as 2027. So that's the time line. Now let me take the GI pipeline, and then I'll let Svetlana reply to you on the capital allocation. We are super excited about how we are moving forward on the GI pipeline. At Distal UC, we really accelerated enrollment, completed the study. We have perceived from those centers in the study trial excitement from the doctors about the opportunity. So that's why you saw an acceleration versus last year. And this is happening also for bile acid diarrhea as we speak. So we reaffirm our forecast of closing the enrollment for bile acid diarrhea by year-end. So then by the end of the year, you will have a publication on Phase II, and you will have also a finished enrollment on every Phase II. Yes, with that in mind, I think you have 2 assets in 2 large markets. And I think we're going to also there take decisions whether we want to find a partner, license it or drive like we have done in the past to Phase III to maximize additional value. It's great to have optionality, I'm telling you, and it's great to have also our balance sheet managed very well by the leadership team in terms of cost, in terms of opportunities. So we're going to reassess this as we go through the next few milestones. Svetlana?

Thank you. Ram, thank you for the question. We understand why investors on the street are asking us about the share buybacks, particularly given our strong balance sheet. As we've said previously, the Board and the management regularly reviews all capital allocation alternatives, including investments in the business, strategic opportunities, returning capital to shareholders and share repurchases. At this stage, we have no announcement to make regarding the particular share repurchase program. Our priority remains on allocating capital where we believe it can create the greatest long-term shareholder value, and we'll continue to evaluate all available options as the market conditions evolve. Thank you so much for the question.

The next question comes from the line of Martial Descoutures from ODDO BHF.

Martial Descoutures, ODDO BHF. Two quick questions, if I may. On Winlevi, the sales continue to grow strongly. So what are your expectations for the pace of the European launch over the next years? And my second question is regarding GI Genius. The growth is expected to accelerate in the second half. So could you help us to modelize the short-term dynamics of GI Genius for the next quarters or maybe the years?