Cosmo Pharmaceuticals Nv Stock Price, News & Analysis

Cosmo Pharmaceuticals (CMOPF) has received a positive CHMP opinion recommending European approval for Winlevi® (clascoterone 1% cream) for treating facial acne vulgaris in both adults and adolescents aged 12 to <18 years. This follows a successful re-examination of an initial negative opinion from April.

The approval marks a significant milestone as Winlevi® becomes the first-in-class topical anti-androgen therapy for Europe's largest acne treatment segment. The drug works by inhibiting androgen receptors in the skin, reducing sebum production and inflammation. The treatment is already approved in several markets including the United States, Canada, and the UK.

Cosmo is preparing to launch Winlevi® across 20 European markets, targeting a significant expansion of its addressable market, particularly in the adolescent population.

Cosmo Pharmaceuticals (OTC:CMOPF) has renewed its strategic manufacturing agreement with Takeda (NYSE:TAK) for the production of Mesalazine MMX 1200 mg, marketed as Lialda in the USA and Mezavant in Europe, for ulcerative colitis treatment.

The multi-year agreement will be executed at Cosmo's 18,000 m² manufacturing facility in Lainate, Italy, which is ISO 13485 certified and approved by multiple regulatory authorities worldwide. The facility has been supporting global pharmaceutical production for over 30 years.

This renewal aligns with Cosmo's Vision 2030 strategy to expand trusted partnerships and strengthen its Contract Development and Manufacturing Organization (CDMO) leadership globally.

Cosmo Pharmaceuticals (OTC:CMOPF) has addressed market concerns regarding potential U.S. tariffs on Swiss pharmaceutical companies, confirming that its operations and revenue streams remain unaffected. The company emphasized that it does not export products from Switzerland to the United States and operates through long-term contracts with global partners.

The company has reported increased EBITDA in its latest half-year results and maintains a positive outlook on its growth trajectory, supported by strong fundamentals and continued execution of its strategic plan.

Cosmo Pharmaceuticals (OTC:CMOPF), a leader in AI-powered healthcare and specialty pharma, reported strong H1 2025 results and raised its EBITDA guidance by €4.5 million. The company achieved total revenues of €51.7 million, including €41.9 million in recurring revenues.

Key growth drivers include GI Genius™ recurring revenues up 128% YoY and Winlevi® recurring revenues up 23% YoY. The company maintains a strong financial position with €133.3 million in cash and investments. Updated FY2025 guidance projects total revenues of €102-107 million and EBITDA of €5.5-7.5 million.

Operating expenses were controlled with R&D at €18.0 million (-6% YoY) and SG&A at €14.3 million (-13% YoY). The company operates across four strategic platforms: AI-powered MedTech, Dermatology, GI innovation, and CDMO services.

Cosmo Pharmaceuticals (OTC:CMOPF) has launched Winlevi® (clascoterone) cream 1% in Singapore and Malaysia through its partnership with Hyphens Pharma, marking its first entry into Southeast Asia. Winlevi® is the first topical androgen receptor inhibitor for acne treatment in over 40 years, approved for patients aged 12 and older.

The treatment demonstrated superior efficacy in two Phase III studies, showing significant improvements in both non-inflammatory and inflammatory lesion counts. Hyphens Pharma has in-licensed the product for distribution across ten Southeast Asian countries, with progressive rollout planned for other markets in the region.

This launch aligns with Cosmo's 2030 vision for sustainable revenue growth through geographic expansion, addressing a market where acne affects over 90% of the population at some point in their lives.

Cosmo Pharmaceuticals (OTC:CMOPF), a global AI-powered healthcare and specialty pharma company, has announced significant progress in its ESG initiatives. The company achieved an MSCI ESG rating upgrade from "BBB" to "A" and saw its LSEG ESG score double to 62.98, ranking #42 globally among peers.

Key developments include becoming a signatory to the UN Global Compact and committing to the Science Based Targets initiative (SBTi) for emissions reduction. These achievements align with Cosmo's Vision 2030 strategy, positioning the company to attract investments from ESG-focused funds, particularly those aligned with SFDR Articles 8 and 9.

Cosmo N.V. (SIX: COPN) unveiled its ambitious 2030 vision and strategic roadmap during its Investor Day 2025 in Zurich. The company aims to achieve €480 million in recurring revenues by 2030, representing a five-year CAGR of 39%, with €260 million expected from core business and €220 million from late-stage assets and Digital AI platforms.

The company targets an EBITDA of €195 million by 2030, representing a 40% margin. The core business growth (23% CAGR) will be driven by the expansion of GI Genius™ platform, global adoption of Winlevi®, and stable growth from Gastroenterology and CDMO businesses.

The Investor Day event featured presentations on the company's strategic roadmap across Medtech AI, Dermatology, Gastro, and CDMO franchises, along with insights from KOLs and technology demonstrations. Cosmo also revealed its refreshed corporate identity, positioning itself as a digitally native, patient-impact-focused company.

Cosmo (OTC:CMOPF) has announced the sale of its "Digital Trust" business to Tinexta InfoCert for €8.3 million. The transaction, expected to close by end of June 2025, involves the divestment of digital security services focused on identity protection and process dematerialization for healthcare organizations.

This strategic move is part of Cosmo's portfolio streamlining initiative, allowing the company to focus on core business areas including AI-powered medical devices, gastrointestinal therapeutics, dermatology, and high-value CDMO services. The company aims to strengthen its position as a focused, innovation-driven healthcare organization with global reach.

Cosmo Pharmaceuticals (OTC:CMOPF) has announced a groundbreaking clinical study integrating their GI Genius™ AI endoscopy module with Apple Vision Pro, set to begin in July 2025 at Rush University Medical Center. The first-of-its-kind usability study will evaluate a new software application that enables physicians to view AI-generated insights during live colonoscopy procedures through Apple Vision Pro.

The GI Genius™ system has demonstrated the ability to increase adenoma detection rates by 14.4%. The study results will support Cosmo's upcoming FDA submission. The technology is commercially distributed globally through Cosmo's partnership with Medtronic, their exclusive distributor since 2019.