Financial Performance & Growth - Catalyst Pharmaceuticals experienced a 43.6% increase in total net product revenue in 1Q25 compared to 1Q24[55] - The company's 1Q25 net product revenues reached $141.4 million, up from $98.4 million in 1Q24[61] - Net income (GAAP) for 1Q25 was $56.7 million, significantly higher than the $23.3 million reported in 1Q24[61] - Catalyst forecasts total revenues between $545 million and $565 million for the full year 2025[60] Product Portfolio - FIRDAPSE revenue for 1Q25 was $83.7 million, compared to $66.8 million in 1Q24[56] - AGAMREE revenue for 1Q25 was $30.4 million[56] - FYCOMPA revenue for 1Q25 was $35.6 million, compared to $22.0 million in 1Q24[56] - FIRDAPSE is projected to generate between $355 million and $360 million in revenue for 2025[60] - AGAMREE is projected to generate between $100 million and $110 million in revenue for 2025[60] - FYCOMPA is projected to generate between $90 million and $95 million in revenue for 2025[60] Market & Strategic Focus - The total addressable market for the LEMS population is estimated to be over $1 billion[29] - The total addressable market for the DMD population is estimated to be over $1 billion[39]

Pratteln, Switzerland, May 20, 2025 – Santhera Pharmaceuticals (SIX: SANN) today announces that its shareholders approved all motions by the Board of Directors at the Annual General Meeting (AGM) held today in Pratteln, Switzerland, with a large majority. Participating shareholders represented a total of 5,073,050 shares or 37.5% of the Company’s share capital. Approval of the 2024 Annual Report and discharge of corporate bodies The shareholders approved the Annual Report, the annual financial statements an ...

Catalyst Pharmaceuticals (CPRX) reported adjusted earnings of 68 cents per share for the first quarter of 2025, beating the Zacks Consensus Estimate of 53 cents. The company had recorded adjusted earnings of 38 cents in the year-ago quarter.Total revenues, the majority of which comprised product revenues, amounted to $141.4 million in the reported quarter, representing growth of 44% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $130 million.Catalyst Pharmaceuticals’ top ...

Catalyst Enters 2025 With Strong Momentum; Reiterates Confidence in Full-Year Outlook Delivers Record Q1 2025 Total Revenues of $141.4 Million, a 43.6% YoY Increase FIRDAPSE® and AGAMREE® Drive Sustained Organic Growth, Underscoring Execution Strength Reaffirms Full-Year 2025 Total Revenue Guidance Provided Earlier This Year of Between $545 Million and $565 MillionStrengthens Balance Sheet with Cash and Cash Equivalents of $580.7 Million and No Debt as of March 31, 2025 Conference Call and Webcast to be He ...

Pratteln, Switzerland, April 29, 2025 – Santhera Pharmaceuticals (SIX: SANN) today published the invitation to its Annual General Meeting (AGM), which will be held on May 20, 2025, at 10:00 CEST at Haus der Wirtschaft, Hardstrasse 1, 4133 Pratteln, Switzerland. The invitation to the AGM with agenda items and explanations will be sent to registered shareholders by mail and can be viewed on Santhera’s website at www.santhera.com/investors-and-media/investor-toolbox/share-bondholder-meetings Agenda (Overview) ...

Core Insights - The year 2024 was a transformational period for Santhera Pharmaceuticals, marked by the successful launch of AGAMREE® for Duchenne muscular dystrophy (DMD) in Germany, Austria, and the U.S. [1][4][12] - The company secured financing of up to CHF 69 million, which is expected to support growth initiatives and provide liquidity until cash flow break-even in 2026 [1][10][67] - Santhera aims to expand its product portfolio and establish itself as a leading specialty pharmaceutical company in rare diseases [1][4] Operational Highlights - AGAMREE was launched in Germany and Austria, with over 300 patients on treatment by year-end, representing nearly 30% of those on steroid treatment [4][16] - Catalyst Pharmaceuticals launched AGAMREE in the U.S. in March 2024, achieving USD 46 million in revenue for the year, exceeding guidance [4][19] - The partnership with Sperogenix in China initiated an early access program, with commercial rollout expected in mid-2025 [4][20] Financial Highlights - Total revenue for 2024 was CHF 39.1 million, a decrease from CHF 103.4 million in 2023, primarily due to significant licensing milestones recognized in the previous year [4][49] - Product sales amounted to CHF 14.8 million, driven by the successful launch of AGAMREE in Germany and Austria [4][49] - Operating loss for 2024 was CHF 33.2 million, compared to a profit of CHF 68.8 million in 2023, influenced by the absence of prior out-licensing milestones [10][56] Market Access and Reimbursement - AGAMREE received full reimbursement in Germany and Austria, facilitating patient access [22][23][24] - In the UK, AGAMREE was recommended as a cost-effective treatment by NICE, with availability for prescription starting in April 2025 [25][18] - Ongoing negotiations for pricing and reimbursement in other EU countries are expected to progress through 2025 and 2026 [17][26] Partnerships and Licensing - Santhera's partnership with Catalyst Pharmaceuticals in the U.S. includes tiered royalties and potential milestone payments, enhancing market access [34][66] - The collaboration with Sperogenix in China is set to provide tiered royalties and milestone payments, supporting commercialization efforts [35][66] - Santhera is pursuing a hybrid model of direct commercialization in key markets while establishing distribution agreements in secondary territories [36][38] Manufacturing and Supply Chain - Santhera is validating additional manufacturing sites to meet global demand and improve supply chain efficiencies [39][40] - A secondary manufacturing site in the U.S. is being qualified to support growing demand and mitigate supply risks [41] - The company is also exploring local production options in China to enhance pricing and reimbursement discussions [42] R&D Strategy and Pipeline Development - Santhera will focus on maximizing AGAMREE's potential in DMD and generating long-term safety data, with results from the GUARDIAN study expected in Q4 2025 [46] - The company is actively seeking to expand its late-stage pipeline through licensing and distribution agreements, particularly in the rare disease field [47] Financial Guidance and Outlook - For 2025, Santhera expects total revenues in the range of CHF 65-70 million, driven by continued global rollout of AGAMREE [71] - The company anticipates operating expenses to be between CHF 50-55 million, excluding non-cash share-based compensation [71] - Long-term revenue guidance includes expectations of EUR 150 million by 2028, excluding milestones [72]

Pratteln, Switzerland, April 16, 2025 – Santhera Pharmaceuticals (SIX: SANN) announces the latest progress on the commercial rollout of AGAMREE® for the treatment of Duchenne Muscular Dystrophy (DMD). Funding from National Health Service (NHS) England is now available for AGAMREE for the treatment of DMD, enabling prescribing in England to commence. This follows positive NICE (National Institute for Health and Care Excellence) final guidance for AGAMREE announced on January 16, 2025 and initial sales alread ...