Cosmo Pharmaceuticals Announces Strong Full Year 2024 Revenue and Cash and Provides Business and Pipeline Updates
Cosmo Pharmaceuticals reported strong preliminary unaudited 2024 results with revenue of €265.7 million, representing a 186% increase from €92.8 million in 2023. The growth includes €185 million in non-recurring revenues from Medtronic. Year-end cash position strengthened to €170.4 million from €50.3 million in 2023, with zero debt.
Key pipeline updates include: GI Genius™ received FDA 510(k) clearance for module 300 hardware; Winlevi® became the top-prescribed branded topical acne treatment in the U.S. with over 1.2 million prescriptions since 2021; Breezula® phase III clinical program for androgenetic alopecia progressing with results expected in 2025. Additional programs include Phase II studies for Bile Acid Diarrhea and Distal Ulcerative Colitis, plus a Phase I study for Solid Tumors.
Cosmo Pharmaceuticals ha riportato risultati preliminari non verificati molto solidi per il 2024, con un fatturato di €265,7 milioni, che rappresenta un aumento del 186% rispetto ai €92,8 milioni del 2023. Questa crescita include €185 milioni di ricavi straordinari provenienti da Medtronic. La posizione di cassa a fine anno è migliorata a €170,4 milioni rispetto ai €50,3 milioni del 2023, con zero debito.
Le principali novità pipeline includono: GI Genius™ ha ricevuto l'approvazione FDA 510(k) per l'hardware del modulo 300; Winlevi® è diventato il trattamento acneico topico a marchio più prescritto negli Stati Uniti con oltre 1,2 milioni di prescrizioni dal 2021; il programma clinico di fase III di Breezula® per l'alopecia androgenetica è in corso, con risultati attesi nel 2025. Altri programmi includono studi di fase II per la diarrea da acidi biliari e la colite ulcerativa distale, oltre a uno studio di fase I per i tumori solidi.
Cosmo Pharmaceuticals informó resultados preliminares no auditados muy sólidos para 2024, con ingresos de €265,7 millones, lo que representa un aumento del 186% en comparación con los €92,8 millones de 2023. Este crecimiento incluye €185 millones en ingresos no recurrentes de Medtronic. La posición de efectivo a fin de año se fortaleció a €170,4 millones desde €50,3 millones en 2023, sin deudas.
Las actualizaciones clave del pipeline incluyen: GI Genius™ recibió la aprobación FDA 510(k) para el hardware del módulo 300; Winlevi® se convirtió en el tratamiento tópico antiacné de marca más recetado en EE. UU. con más de 1,2 millones de recetas desde 2021; el programa clínico de etapa III de Breezula® para la alopecia androgenética avanza con resultados esperados para 2025. Programas adicionales incluyen estudios de fase II para la diarrea por ácidos biliares y la colitis ulcerativa distal, además de un estudio de fase I para tumores sólidos.
Cosmo Pharmaceuticals는 2024년의 강력한 비공식 초기 결과를 보고했으며, 수익은 €265.7백만으로 2023년 €92.8백만에 비해 186% 증가했습니다. 이 성장은 Medtronic으로부터의 비정기적 수익 €185백만을 포함합니다. 연말 현금 위치는 2023년 €50.3백만에서 €170.4백만으로 강화되었으며, 부채는 없습니다.
주요 파이프라인 업데이트는 다음과 같습니다: GI Genius™가 모듈 300 하드웨어에 대해 FDA 510(k) 승인을 받았습니다; Winlevi®는 2021년 이후 120만 건 이상의 처방으로 미국에서 가장 많이 처방된 브랜드 국소 여드름 치료제가 되었습니다; Breezula®의 안드로겐 탈모에 대한 3상 임상 프로그램이 진행 중이며, 결과는 2025년에 예상됩니다. 추가 프로그램으로는 담즙산 설사와 원위 대장염에 대한 2상 연구, 고형종양에 대한 1상 연구가 포함됩니다.
Cosmo Pharmaceuticals a rapporté de solides résultats préliminaires non audités pour 2024, avec un chiffre d'affaires de 265,7 millions d'euros, représentant une augmentation de 186 % par rapport à 92,8 millions d'euros en 2023. Cette croissance inclut 185 millions d'euros de revenus non récurrents provenant de Medtronic. La position de trésorerie en fin d'année a été renforcée à 170,4 millions d'euros contre 50,3 millions d'euros en 2023, avec aucune dette.
Les principales mises à jour du pipeline comprennent : GI Genius™ a reçu l'agrément FDA 510(k) pour le matériel du module 300 ; Winlevi® est devenu le traitement topique contre l'acné à marque le plus prescrit aux États-Unis avec plus de 1,2 million d'ordonnances depuis 2021 ; le programme clinique de phase III de Breezula® pour l'alopécie androgénétique progresse, avec des résultats attendus en 2025. Des programmes supplémentaires incluent des études de phase II pour la diarrhea acides biliaires et la colite ulcéreuse distale, ainsi qu'une étude de phase I pour les tumeurs solides.
Cosmo Pharmaceuticals hat starke vorläufige, nicht testierte Ergebnisse für 2024 berichtet, mit einem Umsatz von €265,7 Millionen, was einem Anstieg von 186 % gegenüber €92,8 Millionen im Jahr 2023 entspricht. Das Wachstum umfasst €185 Millionen an einmaligen Einnahmen von Medtronic. Die Cash-Position zum Jahresende hat sich auf €170,4 Millionen gegenüber €50,3 Millionen im Jahr 2023 verbessert, bei null Schulden.
Wichtige Pipeline-Updates sind: GI Genius™ erhielt die FDA 510(k) Zulassung für die Hardware-Modul 300; Winlevi® wurde das meistverschriebene markenbezogene topische Akne-Mittel in den USA mit über 1,2 Millionen Rezepten seit 2021; das Phase-III-Programm von Breezula® zur androgenetischen Alopezie schreitet voran, Ergebnisse werden für 2025 erwartet. Weitere Programme umfassen Phase-II-Studien zu Gallensäuredurchfall und distaler ulzerativer Kolitis sowie eine Phase-I-Studie zu soliden Tumoren.
- Revenue increased 186% to €265.7 million in 2024
- Cash position grew to €170.4 million with zero debt
- Secured €185 million non-recurring revenue from Medtronic agreement
- Winlevi® achieved top-prescribed branded topical acne treatment status in U.S.
- FDA 510(k) clearance obtained for GI Genius™ module 300
- Significant portion of revenue (€185M) is non-recurring
- Multiple clinical trials still in early/mid stages with uncertain outcomes
Ad hoc announcement pursuant to Art. 53 LR
- Revenue Growth: Full-year 2024 revenue of €265.7 million (unaudited), marking a
186% increase compared to 2023. - Financial Strength: Year-end cash and short-term investments of €170.4 million, reflecting a robust balance sheet with zero debt.
- Pipeline Progress: Advancements in one late-stage and three mid- and early-stage programs, with key milestones anticipated in 2025 and 2026.
Dublin, Ireland--(Newsfile Corp. - January 9, 2025) - Cosmo Pharmaceuticals N.V. (SIX: COPN) (FSE: C43) (“Cosmo”) reports strong preliminary unaudited 2024 revenue and year end cash, reflecting exceptional revenue growth and a solid cash position. Cosmo will publish 2024 audited consolidated financial statements and Annual Report 2024 on March 20, 2025.
Preliminary Unaudited Revenue and Cash
- Revenue: €265.7 million, representing a
186% year-over-year increase from €92.8 million in 2023. This includes €185 million in non-recurring revenues from Medtronic linked to the December 2023 expanded agreement and milestones related to the delivery of AI advancements in the GI Genius™ platform. - Cash Position: Year-end cash, equivalents, and short-term investments of €170.4 million, compared to €50.3 million at the end of 2023, reflecting a very strong operational performance.
Business and pipeline update
GI Genius™
- The installed base continued to grow in 2024, and the U.S. FDA granted 510(k) clearance for the latest generation module 300 hardware, powered by Nvidia IGX technology, reaffirming its leadership in AI-enhanced endoscopy.
- The latest iteration of Cosmo’s polyp detection SaMD (Software as a Medical Device) features significantly improved performances, and for the first time includes post-procedural insights generated by advanced AI, further enhancing its value in clinical practice.
- Expanded features and new applications are planned for release in 2025 and 2026.
Winlevi®
- The top-prescribed branded topical acne treatment in the U.S. has generated over 1.2 million prescriptions since its launch in 2021. Regulatory approvals in Singapore, Australia, and New Zealand in 2024 underscore its global growth, with an approval by EMA anticipated in H1 2025.
Breezula®
- The phase III clinical program for androgenetic alopecia (AGA) in males is progressing on schedule, with top line six-month results expected in 2025. Ongoing comprehensive market research will support the strategic launch planning for this potential blockbuster lifestyle drug.
Other Programs:
- Bile Acid Diarrhea: The phase II proof-of-concept-study was approved in the UK at the end of 2024, with activities initiated to activate the first clinical site. The first patient is expected to be enrolled by the end of January 2025. Bile Acid Diarrhea (BAD) represents a significant target market and unmet medical need, affecting an estimated 95 million people globally. Studies suggest that approximately
30% of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) suffer from BAD. - Distal Ulcerative Colitis: The phase II study is progressing with active patient recruitment across 24 sites. Distal Ulcerative Colitis (Distal UC) represents a large target market and unmet medical need, affecting an estimated 3.5 million people globally. Studies suggest that approximately
70% of Ulcerative Colitis patients are experiencing Distal UC. - Solid Tumors: The ongoing Phase I study evaluating safety and efficacy is progressing well. Following the completion of Part I of the study in H2 2025, the Company plans to explore partnership opportunities for this asset to better align its R&D portfolio with strategic priorities.
Giovanni Di Napoli, CEO of Cosmo, stated: “2024 has been a transformative year for Cosmo, marked by innovation, achievement, and significant progress across all fronts. Through strategic investments and a commitment to operational excellence, we are driving growth and redefining market leadership. This year, we strengthened our foundation for future success by fostering a culture of collaboration and welcoming exceptional leaders, including a new Chief Financial Officer, Head of Business Development, and Chief Strategy Officer. Together, we are executing an ambitious roadmap to position Cosmo for sustained top-line growth. As we look to the future, 2024 is just the beginning of an exciting new chapter for Cosmo, with even greater achievements ahead.”
Svetlana Sigalova, CFO, added: “Our robust cash position and debt-free balance sheet enable us to advance our pipeline and deliver value to patients and shareholders alike. We look forward to engaging with our stakeholders at the upcoming J.P. Morgan Healthcare Conference.”
Connect with Cosmo at JPM 2025
Cosmos’ senior leadership team is available from January 13-15 in San Francisco and would welcome the opportunity to connect. Please email us at investor.relations@cosmopharma.com to schedule a meeting.
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
Baader Swiss Equities Conference, Bad Ragaz January 9, 2025
J.P: Morgan 43rd Annual Healthcare Conference, San Francisco January 13-15, 2025
J.P. Morgan European Opportunities Forum, London March 12, 2025
Audited 2024 Full Year Results and Annual Report Publication March 20, 2025
26th Kepler Cheuvreux Swiss Seminar, Zurich March 20, 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
250109_Cosmo Pharma_Media Release_Preliminary Results 2024_EN_Final
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FAQ
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