Cosmo Reports Double-Digit Recurring Revenue Growth in H1 2026, Advances Clascoterone 5% Topical Solution Toward Regulatory Submission, and Confirms Full-Year Guidance
Rhea-AI Summary
Cosmo (OTC: CMOPF) reported H1 2026 results showing recurring revenues of €49.6 million, up 18% year-over-year, driven by Winlevi (+38%), Lialda (+35%) and CDMO (+14%). Total revenue was €50.2 million, slightly below H1 2025 due to lower project-based revenues.
The company completed Phase III for Clascoterone 5% topical solution in androgenetic alopecia with positive 12‑month data supporting chronic use and is preparing regulatory submissions in the US (Q1 2027) and Europe (Q2 2027). Cosmo also completed enrolment and dosing in its Phase II rifamycin SV enema trial for distal ulcerative colitis, with topline data expected Q4 2026, and continued the Phase II colesevelam MMX study.
Cosmo ended the period debt-free, with €205.1 million in cash, equivalents and investments, an equity ratio of 81.5%, and reaffirmed its 2026 guidance for total revenues of €105–110 million and EBITDA of €10.5–13.5 million.
Positive
- Recurring revenues +18% YoY to €49.6 million in H1 2026
- Winlevi net revenue +38% YoY, Lialda +35%, CDMO +14% in H1 2026
- Phase III completed for Clascoterone 5% solution with positive 12‑month data; filings planned 2027
- Strong balance sheet with €205.1 million cash, equivalents and investments and no financial debt
- High equity ratio of 81.5% as of June 30, 2026
- 2026 guidance reaffirmed: €105–110 million revenue, €10.5–13.5 million EBITDA, ~€200 million cash/investments
Negative
- Total revenue down to €50.2 million from €51.7 million in H1 2025
- Project-based revenues fell sharply to €0.7 million from €9.8 million YoY
- EBITDA weakened to approximately €0 million from €4.9 million in H1 2025
- Net loss widened to €4.7 million from €2.0 million in H1 2025
- Operating loss increased to €6.6 million versus €1.4 million a year earlier
- SG&A costs +22% YoY to €16.6 million, driven partly by Winlevi amortization and prior investments
AI-generated analysis. How Rhea-AI works. Not financial advice.
Ad hoc announcement pursuant to Art. 53 LR
- Recurring revenues from Winlevi® up
38% , Lialda® up35% , and CDMO up14% year-over-year - Clascoterone Phase III 12-month data support chronic use, with regulatory submissions underway in the US and in Europe
- Debt-free with more than €205 million in cash, cash equivalents and investments
- Investor call today at 3 pm CET
Dublin, Ireland--(Newsfile Corp. - July 23, 2026) - Cosmo N.V. (SIX: COPN) (FSE: C43) (“Cosmo”), a global leader in AI-driven healthcare and specialty pharmaceuticals, today reported financial results for the first half of 2026. During the period, the Company delivered double-digit growth in recurring revenues, advanced its dermatology pipeline toward regulatory submission, further strengthened the GI Genius™ platform with next-generation commercial and technological capabilities, and maintained a strong financial position. Cosmo ended the reporting period debt-free, with more than €205 million in cash, cash equivalents and investments, and reaffirms its full-year 2026 financial guidance.
The Company's recurring base continued to grow, with Winlevi® net revenue up
Cosmo ended the first half of 2026 with €205.1 million in cash and no financial debt, providing the flexibility to invest in its pipeline, scale its platforms and pursue value-creating business development from a position of financial strength.
Reiterated Full-Year 2026 Guidance
Based on this performance, Cosmo reaffirms its full year 2026 guidance:
- Total Revenues: €105 – 110 million, with €98 – 102 million in recurring revenues and €7 – 8 million in project-based revenues
- EBITDA: €10.5 – 13.5 million
- Cash, Equivalents & Investments: approximately €200 million
H1 2026 Highlights
Cosmo delivered strong financial and operational performance in the first half of 2026, with strong momentum in Winlevi®, Lialda® and CDMO, continued cost discipline, and a strong balance sheet.
- Total Revenues: €50.2 million, comprising €49.6 million of recurring revenues and €0.7 million of project-based revenues
- Recurring revenues grew
18% year-over-year, reflecting continued strength across the Company's diversified recurring revenue base. Growth was driven by:
-
- Winlevi® (+
38% ), reflecting increased manufacturing and supply activities supporting the ongoing European commercial launches by Cosmo's partners. - Lialda® (+
35% ), demonstrating the continued strength of the Company's legacy gastrointestinal franchise. - CDMO (+
14% ), supported by new customer wins and continued expansion of manufacturing activities.
- Winlevi® (+
- Operating Expenses: €56.8 million, of which:
- Cost of Sales: €27.9 million (+
9% YoY) primarily reflecting the higher level of recurring revenues during the period. - R&D: €15.1 million (–
16% YoY) primarily reflecting the completion of the Phase III clinical development program for Clascoterone5% topical solution, partially offset by continued investment in the gastrointestinal pipeline and MedTech AI development. - SG&A: €16.6 million (+
22% YoY) primarily reflecting non-cash amortization associated with the European commercialization of Winlevi® and the annualized impact of investments made during the second half of 2025 to strengthen the Company's corporate capabilities and support its next phase of growth. The Company expects operating expenses to remain well controlled during the second half of 2026, with a modest reduction compared with the first half.
- Cost of Sales: €27.9 million (+
- Cash, Equivalents, and Investments: €205.1 million as of June 30, 2026
- Treasury Shares: 0.4 million shares held as of June 30, 2026 (approximately €25.5 million), a decrease of 1.0 million shares vs. December 31, 2025
H2 2026 Value Drivers
Cosmo expects continued momentum in the second half of 2026, with:
- Recurring revenues in the range of €48 – 52 million and project-based revenues of approximately €7 million
- Double-digit growth from GI Genius® as well as from Winlevi® and steady growth from Gastro and CDMO business
Continued investment in the Company's Phase II programs for Bile Acid Diarrhoea and Distal Ulcerative Colitis. Operating expenses expected to decline modestly in the second half of the year as prior investments normalize.
Business Highlights
Dermatology. Cosmo completed the Phase III clinical program for Clascoterone 5 % topical solution in androgenetic alopecia, with positive 12-month efficacy and safety results supporting chronic use. Preparations for regulatory submissions in the United States and in Europe are underway, and scientific publications from the program are expected to follow. Winlevi® expanded into 14 additional markets during the reporting period, bringing its total to 23 commercial markets. In the United States, cumulative prescriptions surpassed 1.8 million since launch in November 2021, and net revenue grew
Gastrointestinal Pipeline. Enrolment and dosing were completed in the Phase II study of rifamycin SV enema for Distal Ulcerative Colitis, with topline data expected in the fourth quarter of 2026. The Phase II study of colesevelam MMX® for Bile Acid Diarrhoea continued to enroll, with completion expected by the end of 2026.
MedTech AI. Cosmo continued to extend its GI Genius™ platform. The rollout of GI Genius™ Module 300 on NVIDIA IGX hardware advanced across the United States and Europe. The deployment of electronic medical record integration and automated reporting began in the US, and a new research collaboration was launched to extend the platform into Barrett's Esophagus and upper gastrointestinal disease. The installed base expanded, supported by real world evidence from more than 334,000 colonoscopies across US Veterans Affairs facilities, further validating the platform's clinical performance at scale.
Manufacturing. CDMO recurring revenue grew
Management Commentary
Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented: “The first half of 2026 was about delivery. We completed the Phase III program in Clascoterone and moved it toward regulatory submission in the United States and Europe. We completed dosing in our Phase II study in ulcerative colitis, with data due before the end of this year. And we kept extending GI Genius™ as the standard in AI driven endoscopy. Each of these moves the same plan forward, to build a company that leads in dermatology, in gastroenterology, and in medical AI. We said what we would do, and we are doing it. The second half of 2026 will show even more.”
Svetlana Sigalova, Chief Financial Officer, added: “Our results for the first half of 2026 reflect disciplined execution and the increasing strength of Cosmo's financial profile. With a growing base of recurring revenues, more than €200 million in cash, cash equivalents and investments, and no financial debt, we have the flexibility to invest in our pipeline, expand our commercial platforms, pursue value creating business development opportunities, and continue delivering attractive returns to shareholders through our sustainable dividend policy.”
Analyst, media and investors call today at 3 pm CET
Cosmo invites investors, financial analysts and business/life sciences journalists to a live webcast presentation which will follow today at 3:00 pm CET.
To join via Web browser, click here
To join via phone, please use one of the following dial-in numbers:
| Switzerland / Europe: | +41 (0) 58 310 50 00 |
| United Kingdom: | +44 (0) 203 059 58 63 |
| United States: | +1 (1) 631 570 56 13 |
The webcast, along with the presentation, will be available online shortly after the event and accessible for three months.
Key figures
| EUR 1,000 | H1 2026 | H1 2025 |
| Income statement | ||
| Revenue | 50,235 | 51,720 |
| Recurring Revenues | 49,582 | 41,925 |
| Project Based Revenues | 653 | 9,795 |
| Cost of sales | (27,904) | (25,571) |
| Gross profit | 22,331 | 26,149 |
| Other income | 2,830 | 4,123 |
| R&D costs | (15,136) | (17,997) |
| SG&A costs | (16,632) | (13,686) |
| Net operating expenses | (28,938) | (27,560) |
| Operating profit/(loss) | (6,607) | (1,411) |
| Net financial income | 2,819 | 741 |
| Profit/(loss) before taxes | (3,788) | (670) |
| Profit/(loss) after taxes for the period | (4,731) | (2,030) |
| EBITDA | (5) | 4,852 |
| Statement of financial position | As of 30 | As of 31 December 2025 |
| Non-current assets | 430,982 | 429,358 |
| Cash and cash equivalents | 30,775 | 55,865 |
| Other current assets | 231,725 | 127,414 |
| Liabilities | 121,530 | 123,458 |
| Equity attributable to owners of the Company | 565,262 | 482,300 |
| Non-controlling interests | 6,690 | 6,879 |
| Equity ratio (in %) | | |
| Shares | H1 2026 | H1 2025 |
| Weighted average number of shares | 17,042,708 | 15,970,541 |
| Earnings/(loss) per share (in EUR) | (0.279) | (0.126) |
The full Half-Year 2026 Report of Cosmo can be found for download as pdf-document on the Company’s website via https://www.cosmohealthconfidence.com/key-financial-reports.
About Cosmo
Cosmo is a life sciences company focused on MedTech AI, dermatology, gastrointestinal diseases, and contract development and manufacturing (CDMO). We design, develop, and manufacture advanced solutions that address critical medical needs and raise the standard of care. Our technologies are trusted by leading global pharmaceutical and MedTech companies and reach patients and healthcare providers around the world. Guided by our purpose - Building Health Confidence - our mission is to empower patients, healthcare professionals, and partners by innovating at the intersection of science and technology. Founded in 1997, Cosmo is headquartered in Dublin, Ireland, with offices in San Diego (USA), and in Lainate, Rome, and Catania (Italy).
For more information, visit www.cosmohealthconfidence.com.
Financial calendar
| H.C. Wainright 28. Annual Global Investment Conference, NYC Morgan Stanley 24. Annual Global Healthcare Conference, NYC UBS Best of Switzerland Conference, Virtual Berenberg Swiss Stockpicker Day, Geneva Jefferies Global Healthcare Conference, London Berenberg European Conference, Windsor | September 14-16, 2026 September 14-16, 2026 September 22, 2026 September 30, 2026 November 16-19, 2026 November 30-December 3, 2026 |
For further information, please contact:
investor.relations@cosmohc.com
This press release contains forward-looking statements that reflect Cosmo’s current expectations regarding the clinical development, regulatory assessment, and potential future availability of the investigational product. Such statements are subject to significant known and unknown risks and uncertainties, which may cause actual results, performance or achievements to differ materially from those expressed or implied herein. These risks and uncertainties include, without limitation, the completion and outcomes of additional clinical analyses, interactions with and determinations by regulatory authorities, reliance on third-party partners, the potential impact of external scientific or medical developments, and other factors described in the Cosmo’s publicly available filings and reports. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Cosmo, and Cosmo assumes no obligation and disclaims any intent to update any such forward-looking statements, except as required by applicable la
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