Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo (CMOPF) is participating in Digestive Disease Week® (DDW) 2025 in San Diego, California from May 3-6. The company's leadership team is conducting strategic meetings with key opinion leaders, innovators, and potential partners in AI and gastrointestinal (GI) drug development. DDW, attracting over 13,000 gastroenterologists, researchers, and industry leaders annually, serves as a platform for Cosmo to advance its position in AI-powered endoscopy and GI therapeutics.

CEO Giovanni Di Napoli emphasized DDW's importance as the epicenter of GI innovation. The company has also convened its AI Advisory Board at the event to guide strategic priorities and accelerate development across its AI platform. Cosmo's participation demonstrates its commitment to advancing GI care through technology integration and strategic partnerships.

Cosmo (CMOPF) announces that Endovision Limited has received EU MDR certification for Cerebro, an AI-powered guide for Esophagogastroduodenoscopy (EGD) procedures. Cerebro will be distributed through the AI Access platform integrated into the Medtronic GI Genius endoscopy system. The software uses deep learning algorithms to analyze real-time endoscopic imaging across multiple modalities, highlighting anatomical landmarks and identifying quality issues during procedures. This expansion extends Cosmo's AI capabilities to the upper gastrointestinal tract, complementing their existing lower GI solutions. The system generates detailed photo documentation with coverage scores and procedural reports, developed in collaboration with the Chinese University of Hong Kong's Faculty of Medicine.

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.