Cosmo Pharmaceuticals Announces Strong Full Year 2024 Revenue and Cash and Provides Business and Pipeline Updates

Catalysts

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

Assumptions

Risks

• A lack of information regarding any future partners or acquisitions.
• Increased competition.
• Cosmo’s ability to finance expansion plans.
• The results of Cosmo’s research and development activities.
• The success of Cosmo’s products and partnerships.
• Regulatory, legislative and judicial developments or changes in market and/or overall economic conditions.

Valuation

• Where do you think the business will be in 5 years time?450M$ (20% y)
• What do you think revenue and profit margins will be?40%
• What do you think the valuation multiple will be in the future?30