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New Date: Investor Day, Zurich, July 1, 2025

Cosmo will now be hosting an Investor Day in Zurich on July 1, 2025 and not on April 9, 2025 as previously announced. The hybrid event will be held at the Park Hyatt Hotel in Zurich. Registration and all other details will be announced later this month.

2025 Financial Guidance

• Going forward, Cosmo has decided that, for competitive and commercially sensitive reasons, it will not provide revenue guidance for unpartnered pipeline assets, including project-based revenues from upfront and milestone payments from potential licensing deals.

• Total Revenues: €102 – €107 million, of which recurring revenues (royalties and manufacturing revenues) are €85 – €90 million, reflecting strong performance and double-digit growth of 11% – 17% year-over-year; and project-based revenues of €17 million.

• EBITDA from Core Business: €40 – €42 million, inclusive of cost of sales and SG&A expenses.

• Strategic R&D investment: €40 million, focusing on late- and early-stage pipeline assets and AI-driven innovations.

• Overall EBITDA, including R&D investments: Expected in a range of €1 – €3 million.

• Cash, equivalents, and investments: expected to remain above €110 million.

Business and Pipeline Updates

GI Genius™: Revolutionizing AI in Endoscopy

• The installed base continued to grow in 2024, and now that the U.S. FDA has granted 510(k) clearance for the latest generation Module 300 hardware, powered by Nvidia IGX technology, the devices are ready to be launched in the U.S.

• The latest version of Cosmo’s polyp detection software is now even more accurate - providing AI-generated insights post-procedure, reaffirming Cosmo’s leadership in AI-enhanced endoscopy.

• The newest update also includes a medical-grade tablet for easier interaction with GI Genius, allowing real-time AI insights and capturing of notes during procedures. The new software interfaces with the patient’s electronic medical record, so doctors can automatically save and transfer AI-generated notes into their preferred reporting system.

• The AI access platform is progressing with the release of a first third-party application in the first half of 2025, specifically focused on upper gastrointestinal (GI) procedures. Further enhancements to the platform are planned for the second half of 2025 and throughout 2026.

Winlevi®: Expanding Global Reach

• Market leader: Continues to dominate as the #1 branded prescription topical acne treatment in the U.S., with over 1.3 million prescriptions written by 17,900+ prescribers since launch.

• Global expansion: Regulatory approvals secured in Australia, Singapore and New Zealand in 2024, with the most recent approvals received in the United Kingdom and Malaysia this year. EMA approval is anticipated in first half of 2025.

• Commercial growth: Planned launches in 38 countries by end of 2027.

Clascoterone Solution for Androgenetic Alopecia (AGA) in Males

• Pipeline Progress: Phase III enrollment is now complete, with 1,495 patients randomized —marking the largest randomized trial conducted by Cosmo to date.

• Key Milestone: Top-line six-month results are anticipated early in the second half of 2025.

• Breakthrough Innovation: Clascoterone solution represents the first new mechanism of action (MOA) for AGA in 30 years and is the only topical androgen receptor inhibitor developed for this condition.

• Significant Market Potential: Male AGA affects 30 – 50% of men by age 50 and represents a potential market size of hundreds of millions of treatments per year. Strategic market research is underway to determine the maximum commercial opportunities.

Other R&D Programs:

• Bile Acid Diarrhea (BAD): A Phase II proof-of-concept study on the efficacy and safety of Colesevelam MMX is ongoing in the UK and will expand to the EU. BAD is a significant unmet medical need, affecting an estimated 95 million people worldwide, with around 30% of Irritable Bowel Syndrome with Diarrhea (IBS-D) patients suffering from BAD.

• Distal Ulcerative Colitis (UC) & Ulcerative Proctitis: A Phase II study is underway across 24 sites in seven EU countries to evaluate Rifamycin 1% enema for inducing clinical remission in mild to moderate cases. These conditions affect approximately 3.5 million people globally, with 70% of UC patients experiencing distal UC or ulcerative proctitis.

• Solid Tumors: A Phase I study is progressing well, with completion expected in second half of 2025. Following this, Cosmo will explore partnerships to align its R&D portfolio with strategic priorities.

Key figures

Live conference call and video webcast presentation

Cosmo invites investors, financial analysts and business and life sciences journalists to a live webcast presentation today at 3:00pm CET.

Participant Link: Live Webcast

Please note that there is a function to type in your questions via webcast.

Via phone:

Participants wishing to ask verbal questions via phone may call the following numbers below. To ensure prompt access, please call approximately ten minutes prior to the scheduled start of the call.

Replay:

The webcast, along with the presentation, will be available online shortly after the event and accessible for three months.

2024 Annual Report and ESG Report

The 2024 Annual Report of Cosmo Pharmaceuticals including consolidated and audited financial results for the fiscal year ending on December 31, 2024 and ESG Report will be published on March 21, 2025, and will be made available on the Company’s website under https://www.cosmopharma.com/investors/financial-reports as of 7:00am CET.

2024 Dividend

2024 dividend of €2.05 per share, a 2.5% increase vs. prior year, will be proposed at the upcoming Annual General Meeting on May 30, 2025.

About Cosmo

Cosmo Pharmaceuticals N.V. is committed to revolutionizing healthcare and transforming people’s lives by researching and developing innovative products that tackle unfulfilled healthcare demands. As a pharmaceutical company, Cosmo is active in the areas of Healthtech/AI, dermatology, gastroenterology and contract manufacturing & development. For the commercialization and distribution of its products, Cosmo collaborates with leading partners worldwide, including Medtronic and Sun Pharma. Founded in 1997, Cosmo is headquartered in Dublin (Ireland) and has offices also in San Diego (USA), and Lainate/Rome/Catania (Italy). The Company has approximately 330 employees at the end of 2024, all dedicated to making a significant impact in the field of healthcare. For more information, please visit www.cosmopharma.com.

Upcoming Events

For further information, please contact
Hazel Winchester
Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
hwinchester@cosmopharma.com

Disclaimer                                                                                      
Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. Cosmo does not make any representation or warranty, express or implied, as to the accuracy, completeness or updated status of such statements. Therefore, in no case whatsoever will Cosmo and its affiliate companies be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.

Attachments

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