Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo Pharmaceuticals has maintained its 2025 financial guidance despite receiving a negative CHMP opinion for Winlevi® (clascoterone cream 1%) in Europe. The company expressed disappointment but emphasized that this development will not materially impact their financial expectations for the year.

Key points:

• Company remains confident in Winlevi's clinical profile
• Management sees Winlevi as addressing an important unmet need in dermatology
• Team is preparing a re-examination submission
• Commitment to securing European patient access remains strong

The company will continue to provide updates throughout the re-examination process, maintaining transparency with stakeholders.

Cosmo Pharmaceuticals faces a setback as the European Medicines Agency's CHMP adopts a negative opinion on Winlevi (clascoterone cream 1%) for acne treatment. The decision primarily stems from concerns about the benefit-risk assessment in adolescents aged 12-17, despite positive results in adults over 18.

The company plans to request a re-examination, citing:

• Strong evidence from two multi-center, randomized, double-blind clinical trials
• Successful real-world usage, particularly in the United States
• No emerging safety concerns in hundreds of thousands of adolescent patients

Prof. Andrea Lania of Humanitas University expressed difficulty understanding the negative opinion given robust clinical data. CEO Giovanni Di Napoli voiced disappointment but remains confident in Winlevi's science, emphasizing their decision to maintain adolescent inclusion was based on data, not tactics. The company will continue engaging with EMA during the re-examination process.

Cosmo Pharmaceuticals has announced its Annual General Meeting (AGM) 2025, scheduled for May 30, 2025, at 12:00 CEST in Amsterdam, Netherlands. The meeting agenda includes several key items:

• Review of the Board's report for FY2024
• Approval of Annual Report 2024
• Proposed dividend distribution of €2.05 per ordinary share
• Board member discharge and elections
• Articles of association amendments

Chairman Alessandro Della Chà emphasized that the AGM will provide shareholders an opportunity to review achievements and discuss priorities for the ongoing year. The convening notice, explanatory notes, and written proxy have been published on the company's website, with the 2024 Annual Report available in the Financial Reports section.

Cosmo Pharmaceuticals (SIX: COPN, FSE: C43) has announced the appointment of Federico Sommariva as Chief Legal Counsel, reporting directly to the CEO and joining the management team. Sommariva brings extensive legal and management experience from the Lifesciences industry, most recently serving as Director and Global Legal Business Partner Oncology at Gilead Sciences in Milan since 2013. He also held the position of interim Head of Legal and Compliance for Gilead Sciences Romania for 1.5 years.

Sommariva, a University of Milan law graduate, began his career as Legal Counsel Secondee at H&M in Rome. CEO Giovanni Di Napoli expressed confidence that Sommariva's expertise in corporate law and industry knowledge will support the company's long-term growth and help navigate the evolving regulatory landscape.

Cosmo Pharmaceuticals has released its Annual Report for fiscal year 2024, following the unaudited results announcement on March 6, 2025. The report highlights a year of strong financial performance and exceptional revenue growth, accompanied by significant strategic advancements.

The Board of Directors has proposed a dividend distribution of €2.05 per share, an increase from €2.00 in the previous year. The Ordinary Annual General Meeting of Shareholders is scheduled for May 30, 2025, with the invitation and proposed resolutions to be available on April 29, 2025.

The company will host an Investor Day in Zurich on July 1, providing an opportunity for engagement with investors, analysts, and media professionals. The comprehensive report includes consolidated and audited financial results, corporate governance details, compensation information, and ESG topics.

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 has announced it will host an Investor Day on Wednesday, April 9, 2025, at the Park Hyatt Hotel in Zurich, Switzerland. The event will commence at 11:00am CET, featuring presentations followed by lunch.

The program will include detailed presentations from the Management team covering the company's R&D pipeline, long-term strategic initiatives, and growth opportunities. CEO Giovanni Di Napoli and the executive team will conduct a Q&A session with investors, analysts, and media representatives.

Registration details for in-person attendance and live webcast information will be available in the Events & Presentations section of Cosmo's website. A replay of the webcast will be provided after the event.

Cosmo Pharmaceuticals has appointed Andrea Cherubini as Chief AI Officer, marking a strategic move to integrate AI across its portfolio. Cherubini, who previously served as Senior Vice President - Science, AI, and Data since 2018, was instrumental in developing GI Genius™, the first AI-powered polyp detection system in gastroenterology.

In his new role, Cherubini will expand AI applications beyond endoscopy into multiple areas including:

• Gastroenterology pipeline, focusing on Bile Acid Diarrhea (BAD)
• Dermatology pipeline, optimizing clinical trials for Breezula®
• Drug discovery and development

CEO Giovanni Di Napoli emphasized AI's role as a core growth pillar, while Cherubini expressed commitment to advancing AI-driven healthcare solutions across drug development, diagnostics, and personalized medicine.

Cosmo Pharmaceuticals and Glenmark Pharmaceuticals announced that Glenmark has received MHRA approval to market Winlevi® in the United Kingdom for treating acne vulgaris in patients aged 12 and older. Winlevi® is the first topical acne treatment in nearly 40 years with a novel mechanism of action, featuring clascoterone as its active ingredient.

The treatment is the first commercially available topical androgen receptor inhibitor, targeting sebaceous glands without systemic anti-androgen effects, making it safe for both males and females. Two phase III studies showed that clascoterone cream 1%, applied twice daily for 12 weeks, outperformed vehicle cream in achieving Investigator's Global Assessment success and reducing lesion counts.

This approval stems from a September 2023 agreement where Glenmark in-licensed the product from Cosmo for distribution in Europe and South Africa. The treatment addresses a significant market, as acne affects over 90% of the global population at some point in their lives.