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Cosmo Pharma NV ORD (CMOPF) is a pharmaceutical company focused on developing and commercializing products to treat gastrointestinal disorders, aid in colonic lesion detection, and address dermatological conditions. The company's core products include Lialda/Mezavant/Mesavancol, Uceris/Cortiment, Aemcolo/Relafalk, Lumeblue, and Winlevi. Cosmo's partnership with Medtronic for GI Genius, an AI-based system for colon cancer detection, has resulted in significant advancements in the healthcare sector. The company's commitment to responsible and regulated AI in healthcare is evident through initiatives like the AI Access program and integration of the NVIDIA IGX platform into GI Genius, enabling real-time patient care and innovative medical solutions.
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 Geniusâ„¢ received FDA 510(k) clearance for module 300 hardware; °Â¾±²Ô±ô±ð±¹¾±Â® became the top-prescribed branded topical acne treatment in the U.S. with over 1.2 million prescriptions since 2021; µþ°ù±ð±ð³ú³Ü±ô²¹Â® 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 (SIX: COPN, FSE: C43) has announced the appointment of Dominika Spilarova as Chief Strategy Officer, effective January 10, 2025. This newly created position will report directly to the CEO. Spilarova brings over 15 years of experience in Life Sciences and management consulting, having previously worked with PwC and running her own Life Sciences consulting business. She has a track record of developing strategies that have impacted businesses with revenues ranging from $26 million to $19.5 billion.
In addition to her CSO role, Spilarova will serve as acting Chief of Staff for the executive leadership team until a permanent appointment is made. The appointment comes as Cosmo reports a strong close for Full Year 2024, with the company focusing on strategy-led growth and innovation.
Cosmo Pharmaceuticals N.V. (SIX: COPN, FSE: C43) shareholders approved the appointment of Deloitte Accountants B.V. as the new independent auditor for the financial year ending December 31, 2024, at an Extraordinary General Meeting (EGM) held on October 18, 2024. This decision follows the Board of Directors' proposal to rotate auditors in line with good governance practices. The previous auditor had been in place since 2016.
The EGM saw a representation of 8,367,544 ordinary shares, constituting 47.70% of Cosmo's total outstanding ordinary shares as of the record date. This change in auditors reflects Cosmo's commitment to maintaining strong corporate governance standards.
Cosmo Pharmaceuticals has appointed Svetlana Sigalova as its new Chief Financial Officer, effective November 11, 2024. Sigalova, who previously served as Vice President of Commercial Finance at Moderna, brings extensive experience in managing multibillion-dollar revenue streams and developing financial infrastructure. She succeeds Niall Donnelly, who will transition to a new role as EVP - Corporate Governance & Chief Sustainability Officer.
In her new position, Donnelly will focus on strengthening Cosmo's corporate governance framework and advancing ESG initiatives, including carbon footprint reduction. He will remain an executive member of the Board of Directors. CEO Giovanni Di Napoli expressed confidence that Sigalova's expertise will guide Cosmo's financial strategy and support its global expansion, while Donnelly's new role will reinforce the company's commitment to responsible growth and long-term value.
Cosmo Pharmaceuticals has appointed Egle Gedrimaite as the new Head of Global Business Development, effective October 1, 2024. Egle brings 15 years of experience in business development and alliance management across pharmaceutical, medical device, and nutraceutical industries. She will report to Giovanni Di Napoli, CEO of Cosmo.
Egle's expertise includes developing successful business in both B2B and B2C sectors, and driving development projects from inception to completion. She holds a degree in International Communications and Communication Systems from the Università per Stranieri di Perugia.
Giovanni Di Napoli expressed enthusiasm about the appointment, emphasizing Cosmo's focus on innovation, excellence, and growth. He also reflected on his first three months as CEO, highlighting the company's commitment to expanding its global footprint and creating value for shareholders.
Cosmo Pharmaceuticals has announced the publication of a landmark study in The Lancet, demonstrating the efficacy of their GI Geniusâ„¢ intelligent endoscopy system in colonoscopy procedures. The COLO-DETECT study, a multicentre, open-label, randomised controlled trial, showed that GI Geniusâ„¢ improved the detection of colorectal adenomas in an additional 8.3% of patients compared to standard colonoscopy practices.
This significant advancement in colorectal cancer screening could potentially reduce cancer incidence. The study reinforces the value of integrating AI into routine clinical practice for enhanced accuracy in cancer screening. Cosmo Pharmaceuticals, in partnership with Medtronic for global distribution, remains committed to advancing patient care through AI-assisted healthcare technology.
Cosmo Intelligent Medical Devices (Cosmo IMD), a division of Cosmo Pharmaceuticals, has received FDA 510(k) clearance for its next-generation GI Geniusâ„¢ hardware. This sixth-generation device, exclusively distributed by Medtronic globally, represents a significant advancement in AI-enhanced endoscopy. Key features include:
1. Enhanced AI capabilities
2. Versatile AI app integration
3. Improved connectivity
4. Energy efficiency
5. Reliable performance
The hardware incorporates the FDA-cleared ColonPROâ„¢ software, designed to assist endoscopists in identifying potential polyps during colorectal cancer screenings. Utilizing NVIDIA IGX Orinâ„¢ and NVIDIA Holoscanâ„¢ technologies, the GI Geniusâ„¢ system aims to elevate physician performance and standardize quality metric reporting in healthcare.
Cosmo Pharmaceuticals N.V. (SIX: COPN, FSE: C43) reported robust financial performance for H1 2024, confirming its full-year guidance. Key highlights include:
- Health Tech: $100 million upfront payment from Medtronic, with an additional $100 million expected this year
- Dermatology: °Â¾±²Ô±ô±ð±¹¾±Â® continues as the #1 prescribed topical acne product in the U.S.
- Revenue increased to €136.2 million (H1 2023: €43.7 million)
- EBITDA of €94.2 million
- Operating profit of €87.0 million (H1 2023: €7.1 million)
- Net profit of €76.1 million (H1 2023: €1.5 million)
The company confirmed its 2024 guidance with total revenues expected in the range of €260-270 million and operating profit between €159-169 million.
Cosmo Pharmaceuticals will release its Half-Year 2024 results on Wednesday, 24 July 2024, at 07:00 am CEST. The company invites investors, analysts, and journalists to a live video webcast at 2:00 pm CEST the same day, featuring a Q&A session. The webcast will be hosted by CEO Giovanni Di Napoli, CFO Niall Donnelly, and other members of the leadership team. Participants can join via a provided webcast link or phone, with key numbers for Switzerland/Europe, the UK, and the US. The Half-Year Report and replay of the webcast will be available online for three months post-event.
On July 5, 2024, Cosmo Pharmaceuticals' shareholders approved all resolutions proposed by the Board of Directors at an Extraordinary General Meeting. Key decisions included a 90% increase in dividend distribution to €2.00 per ordinary share, payable on July 12, 2024. The FY2023 annual accounts were adopted, and updates to the company's remuneration policy were approved. A total of 7,173,931 ordinary shares were represented, constituting 40.89% of Cosmo's total outstanding shares.