Cosmo Pharmaceuticals Delivers Record 2024 Results - Completes Phase III Enrollment for Androgenetic Alopecia in Males - Proposes Increased Dividend of 2.05 per share - Reinforcing Shareholder Value and Growth Momentum into 2025
Cosmo Pharmaceuticals reported record unaudited results for FY 2024, with revenue reaching €266.8 million, a 188% year-over-year increase. The company achieved an operating profit of €148.9 million and EBITDA of €161.2 million, up 1,517% from previous year.
Key highlights include:
- Cash position increased 239% to €170.4 million with zero debt
- Completed Phase III enrollment for Androgenetic Alopecia treatment in males with 1,495 patients
- GI Genius™ received FDA clearance for Module 300 hardware
- Winlevi® maintains position as #1 branded prescription topical acne treatment in U.S.
For 2025, Cosmo projects total revenues of €102-107 million, with recurring revenues of €85-90 million. The company plans to invest €40 million in R&D and proposes a dividend increase to €2.05 per share.
Cosmo Pharmaceuticals ha riportato risultati record non verificati per l'anno fiscale 2024, con un fatturato che ha raggiunto i 266,8 milioni di euro, un aumento del 188% rispetto all'anno precedente. L'azienda ha registrato un utile operativo di 148,9 milioni di euro e un EBITDA di 161,2 milioni di euro, in crescita del 1.517% rispetto all'anno precedente.
Tra i punti salienti:
- Posizione di cassa aumentata del 239% a 170,4 milioni di euro con zero debito
- Completato il reclutamento della Fase III per il trattamento dell'alopecia androgenetica negli uomini con 1.495 pazienti
- GI Genius™ ha ricevuto l'approvazione della FDA per l'hardware del Modulo 300
- Winlevi® mantiene la posizione di #1 trattamento topico per l'acne su prescrizione negli Stati Uniti.
Per il 2025, Cosmo prevede ricavi totali di 102-107 milioni di euro, con ricavi ricorrenti di 85-90 milioni di euro. L'azienda prevede di investire 40 milioni di euro in R&S e propone un aumento del dividendo a 2,05 euro per azione.
Cosmo Pharmaceuticals reportó resultados récord no auditados para el año fiscal 2024, con ingresos que alcanzaron los 266,8 millones de euros, un aumento del 188% en comparación con el año anterior. La compañía logró un beneficio operativo de 148,9 millones de euros y un EBITDA de 161,2 millones de euros, un incremento del 1.517% respecto al año anterior.
Los aspectos destacados incluyen:
- La posición de efectivo aumentó un 239% a 170,4 millones de euros, sin deudas
- Se completó la inscripción de la Fase III para el tratamiento de la alopecia androgénica en hombres con 1.495 pacientes
- GI Genius™ recibió la autorización de la FDA para el hardware del Módulo 300
- Winlevi® mantiene su posición como el tratamiento tópico para el acné con receta número 1 en EE. UU.
Para 2025, Cosmo proyecta ingresos totales de 102-107 millones de euros, con ingresos recurrentes de 85-90 millones de euros. La compañía planea invertir 40 millones de euros en I+D y propone un aumento del dividendo a 2,05 euros por acción.
Cosmo Pharmaceuticals는 2024 회계연도에 대한 감사되지 않은 기록적인 결과를 발표했으며, 수익은 2억 6,680만 유로에 도달하여 전년 대비 188% 증가했습니다. 회사는 1억 4,890만 유로의 운영 이익과 1억 6,120만 유로의 EBITDA를 기록하여 전년 대비 1,517% 증가했습니다.
주요 하이라이트는 다음과 같습니다:
- 현금 보유액이 239% 증가하여 1억 7,040만 유로에 도달하며 부채는 없음
- 남성의 안드로겐 탈모 치료를 위한 3상 등록을 1,495명의 환자로 완료
- GI Genius™는 모듈 300 하드웨어에 대한 FDA 승인을 받음
- Winlevi®는 미국에서 1위 브랜드 처방 전용 여드름 치료제로 자리 유지
2025년을 위해 Cosmo는 총 수익을 1억 2천만에서 1억 7천만 유로로 예상하며, 반복 수익은 8천5백만에서 9천만 유로로 예상합니다. 회사는 R&D에 4천만 유로를 투자할 계획이며, 주당 배당금을 2.05 유로로 인상할 것을 제안합니다.
Cosmo Pharmaceuticals a annoncé des résultats records non vérifiés pour l'exercice 2024, avec un chiffre d'affaires atteignant 266,8 millions d'euros, soit une augmentation de 188 % par rapport à l'année précédente. L'entreprise a réalisé un bénéfice d'exploitation de 148,9 millions d'euros et un EBITDA de 161,2 millions d'euros, en hausse de 1.517 % par rapport à l'année précédente.
Les points clés incluent :
- La position de trésorerie a augmenté de 239 % pour atteindre 170,4 millions d'euros sans aucune dette
- Inscription de la Phase III pour le traitement de l'alopécie androgénique chez les hommes avec 1.495 patients
- GI Genius™ a reçu l'approbation de la FDA pour le matériel du Module 300
- Winlevi® maintient sa position de traitement topique de l'acné sur ordonnance numéro 1 aux États-Unis.
Pour 2025, Cosmo prévoit des revenus totaux de 102 à 107 millions d'euros, avec des revenus récurrents de 85 à 90 millions d'euros. L'entreprise prévoit d'investir 40 millions d'euros en R&D et propose une augmentation du dividende à 2,05 euros par action.
Cosmo Pharmaceuticals hat für das Geschäftsjahr 2024 Rekordzahlen ohne Prüfung veröffentlicht, mit einem Umsatz von 266,8 Millionen Euro, was einem Anstieg von 188 % im Vergleich zum Vorjahr entspricht. Das Unternehmen erzielte einen Betriebsgewinn von 148,9 Millionen Euro und ein EBITDA von 161,2 Millionen Euro, was einem Anstieg von 1.517 % im Vergleich zum Vorjahr entspricht.
Wichtige Höhepunkte sind:
- Die Liquiditätsposition stieg um 239 % auf 170,4 Millionen Euro bei null Schulden
- Abschluss der Phase-III-Studie zur Behandlung der androgenetischen Alopezie bei Männern mit 1.495 Patienten
- GI Genius™ erhielt die FDA-Zulassung für die Hardware des Moduls 300
- Winlevi® behält die Position als das #1 verschreibungspflichtige topische Aknebehandlung in den USA.
Für 2025 prognostiziert Cosmo einen Gesamtumsatz von 102-107 Millionen Euro, mit wiederkehrenden Einnahmen von 85-90 Millionen Euro. Das Unternehmen plant, 40 Millionen Euro in Forschung und Entwicklung zu investieren und schlägt eine Erhöhung der Dividende auf 2,05 Euro pro Aktie vor.
- Record revenue of €266.8M (+188% YoY)
- EBITDA increased 1,517% to €161.2M
- Strong cash position of €170.4M with zero debt
- Winlevi maintains #1 market position with 1.3M+ prescriptions
- Completed enrollment for largest clinical trial to date
- 2.5% dividend increase to €2.05 per share
- 2025 revenue guidance shows significant decrease to €102-107M
- EBITDA expected to drop to €1-3M in 2025
- €18.6M increase in operating expenses due to accounting policy change
- R&D costs of €40M will impact 2025 profitability
Ad hoc announcement pursuant to Art. 53 LR
- FY 2024 Revenue of €266.8 million (unaudited) reaching upper end of guidance
- FY 2024 Operating Profit (unaudited) of €148.9 million, exceeding guidance, when adjusted for an accounting policy change
- Outlook for 2025
Dublin, Ireland--(Newsfile Corp. - March 6, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) today reported its unaudited results for the fiscal year ending December 31, 2024. The consolidated and audited 2024 Full-Year results along with the 2024 Annual Report and ESG Report will be published on March 21, 2025.
2024 Unaudited Financial Highlights
- Record revenue: €266.8 million, a
188% year-over-year increase and at the upper range of €260 - €270 million guidance. This includes significant project-based revenues from GI Genius™ and Winlevi® milestones of €190.2 million. - In 2024 Cosmo adopted a change in accounting policy regarding the treatment of internal development costs, namely that it will no longer capitalize clinical phase III costs. As a result, operating expenses for 2024 now include €18.6 million in development costs that were previously anticipated would be capitalized (mainly Phase III costs for Clascoterone solution for Androgenetic Alopecia in males). Accordingly, the figures for 2023 have been restated to include €10.9 million in development costs.
- Operational excellence: EBITDA increased 1,
517% year-over-year to €161.2 million. - Solid financial performance: Operating Profit of €148.9 million, compared to a restated operating loss of €1.9 million in 2023.
- Robust financial position: Cash, equivalents, and investments increased
239% to €170.4 million, compared to €50.3 million in 2023, with zero debt. - Treasury shares: market value of €103.4 million as of December 31, 2024, versus €81.9 million at the end of 2023.
Giovanni Di Napoli, CEO of Cosmo, stated: "2024 has been a landmark year for Cosmo, marked by exceptional growth and transformation. We have achieved the highest revenue and profit in our history, welcomed new leadership, and seen remarkable performance from our key growth drivers, GI Genius™ and Winlevi®. Our strong cash position and zero-debt structure allow us to remain strategically focused on advancing treatments for diseases with significant unmet needs. Additionally, we are progressing in our sustainability journey, with a commitment to achieving net zero by 2040."
Svetlana Sigalova, CFO, added: "2024 has been a great year, demonstrating the strength of our business model and operational execution. Our results reflect not only significant growth but also a disciplined approach to financial management. As we look to 2025, we are well-positioned to drive double-digit growth in our core business while self-funding and advancing our R&D pipeline."
New Date: Investor Day, Zurich, July 1, 2025
Cosmo will now be hosting an Investor Day in Zurich on July 1, 2025 and not on April 9, 2025 as previously announced. The hybrid event will be held at the Park Hyatt Hotel in Zurich. Registration and all other details will be announced later this month.
2025 Financial Guidance
- Going forward, Cosmo has decided that, for competitive and commercially sensitive reasons, it will not provide revenue guidance for unpartnered pipeline assets, including project-based revenues from upfront and milestone payments from potential licensing deals.
- Total Revenues: €102 – €107 million, of which recurring revenues (royalties and manufacturing revenues) are €85 – €90 million, reflecting strong performance and double-digit growth of
11% –17% year-over-year; and project-based revenues of €17 million. - EBITDA from Core Business: €40 – €42 million, inclusive of cost of sales and SG&A expenses.
- Strategic R&D investment: €40 million, focusing on late- and early-stage pipeline assets and AI-driven innovations.
- Overall EBITDA, including R&D investments: Expected in a range of €1 – €3 million.
- Cash, equivalents, and investments: expected to remain above €110 million.
Business and Pipeline Updates
GI Genius™: Revolutionizing AI in Endoscopy
- The installed base continued to grow in 2024, and now that the U.S. FDA has granted 510(k) clearance for the latest generation Module 300 hardware, powered by Nvidia IGX technology, the devices are ready to be launched in the U.S.
- The latest version of Cosmo’s polyp detection software is now even more accurate - providing AI-generated insights post-procedure, reaffirming Cosmo’s leadership in AI-enhanced endoscopy.
- The newest update also includes a medical-grade tablet for easier interaction with GI Genius, allowing real-time AI insights and capturing of notes during procedures. The new software interfaces with the patient’s electronic medical record, so doctors can automatically save and transfer AI-generated notes into their preferred reporting system.
- The AI access platform is progressing with the release of a first third-party application in the first half of 2025, specifically focused on upper gastrointestinal (GI) procedures. Further enhancements to the platform are planned for the second half of 2025 and throughout 2026.
Winlevi®: Expanding Global Reach
- Market leader: Continues to dominate as the #1 branded prescription topical acne treatment in the U.S., with over 1.3 million prescriptions written by 17,900+ prescribers since launch.
- Global expansion: Regulatory approvals secured in Australia, Singapore and New Zealand in 2024, with the most recent approvals received in the United Kingdom and Malaysia this year. EMA approval is anticipated in first half of 2025.
- Commercial growth: Planned launches in 38 countries by end of 2027.
Clascoterone Solution for Androgenetic Alopecia (AGA) in Males
- Pipeline Progress: Phase III enrollment is now complete, with 1,495 patients randomized —marking the largest randomized trial conducted by Cosmo to date.
- Key Milestone: Top-line six-month results are anticipated early in the second half of 2025.
- Breakthrough Innovation: Clascoterone solution represents the first new mechanism of action (MOA) for AGA in 30 years and is the only topical androgen receptor inhibitor developed for this condition.
- Significant Market Potential: Male AGA affects 30 –
50% of men by age 50 and represents a potential market size of hundreds of millions of treatments per year. Strategic market research is underway to determine the maximum commercial opportunities.
Other R&D Programs:
- Bile Acid Diarrhea (BAD): A Phase II proof-of-concept study on the efficacy and safety of Colesevelam MMX is ongoing in the UK and will expand to the EU. BAD is a significant unmet medical need, affecting an estimated 95 million people worldwide, with around
30% of Irritable Bowel Syndrome with Diarrhea (IBS-D) patients suffering from BAD. - Distal Ulcerative Colitis (UC) & Ulcerative Proctitis: A Phase II study is underway across 24 sites in seven EU countries to evaluate Rifamycin
1% enema for inducing clinical remission in mild to moderate cases. These conditions affect approximately 3.5 million people globally, with70% of UC patients experiencing distal UC or ulcerative proctitis. - Solid Tumors: A Phase I study is progressing well, with completion expected in second half of 2025. Following this, Cosmo will explore partnerships to align its R&D portfolio with strategic priorities.
Key figures
| In EUR 1’000 | 2024 (unaudited) | 2023 (restated) |
| Income statement | ||
| Revenue | 266,788 | 92,780 |
| Cost of sales | (45,359) | (39,340) |
| Gross profit | 221,429 | 53,440 |
| Other income | 3,662 | 1,917 |
| R&D costs | (39,927) | (27,296) |
| SG&A costs | (36,282) | (29,936) |
| Net operating expenses | (72,547) | (55,315) |
| Operating profit / (loss) | 148,882 | (1,875) |
| Net financial expenses | 4,485 | (4,614) |
| Profit / (loss) before taxes | 153,367 | (6,489) |
| Profit / (loss) after taxes for the period | 133,191 | (10,703) |
| In EUR 1’000 | 2024 (unaudited) | 2023 (restated) |
| Statement of financial position | ||
| Non-current assets | 444,514 | 423,819 |
| Cash and cash equivalents | 44,296 | 50,275 |
| Other current assets | 157,962 | 51,951 |
| Liabilities | 141,681 | 122,422 |
| Equity attributable to owners of the Company | 498,330 | 396,817 |
| Non-controlling interests | 6,761 | 6,806 |
| Equity ratio (%) | | |
| Shares | ||
| Weighted average of shares issued | 16,358,809 | 16,105,126 |
| Earnings per share (in EUR) | 8.145 | (0.670) |
Live conference call and video webcast presentation
Cosmo invites investors, financial analysts and business and life sciences journalists to a live webcast presentation today at 3:00pm CET.
Participant Link: Live Webcast
Please note that there is a function to type in your questions via webcast.
Via phone:
Participants wishing to ask verbal questions via phone may call the following numbers below. To ensure prompt access, please call approximately ten minutes prior to the scheduled start of the call.
| Switzerland / Europe | +41 (0) 58 310 50 00 |
| United Kingdom | +44 (0) 207 107 06 13 |
| United States | +1 (1) 631 570 56 13 |
Replay:
The webcast, along with the presentation, will be available online shortly after the event and accessible for three months.
2024 Annual Report and ESG Report
The 2024 Annual Report of Cosmo Pharmaceuticals including consolidated and audited financial results for the fiscal year ending on December 31, 2024 and ESG Report will be published on March 21, 2025, and will be made available on the Company’s website under https://www.cosmopharma.com/investors/financial-reports as of 7:00am CET.
2024 Dividend
2024 dividend of €2.05 per share, a
About Cosmo
Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.
Upcoming Events
| J.P. Morgan European Opportunities Forum, London | March 12, 2025 |
| 26th Kepler Cheuvreux Swiss Seminar, Zurich | March 20, 2025 |
| 2024 Annual Report and ESG Report Publication Life Sciences Conference, Amsterdam Ordinary Annual General Meeting of Shareholders | March 21, 2025 April 2-3, 2025 May 30, 2025 |
| Investor Day, Zurich | July 1, 2025 |
| 2025 Half-Year Results and Report | July 23, 2025 |
For further information, please contact
Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
hwinchester@cosmopharma.com
Disclaimer
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.
Attachments
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FAQ
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