Core Viewpoint - Catalyst Pharmaceuticals and SERB have reached a settlement with Lupin regarding the patent litigation over FIRDAPSE, allowing Lupin to market a generic version starting February 25, 2035, if approved by the FDA [1][2]. Group 1: Settlement Agreement Details - The settlement prohibits Lupin from marketing its generic version of FIRDAPSE in the U.S. before February 25, 2035, unless specific circumstances arise [2]. - All ongoing patent litigation between Catalyst/SERB and Lupin concerning FIRDAPSE patents will be terminated as part of the agreement [2]. - Catalyst has previously settled similar litigation regarding ANDA applications for FIRDAPSE with Teva Pharmaceuticals and Inventia Healthcare Limited [2]. Group 2: Company Overview - Catalyst Pharmaceuticals is focused on developing and commercializing treatments for rare diseases and has a strong commitment to patient care [4]. - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4].

Core Viewpoint - Catalyst Pharmaceuticals (CPRX) has entered into a settlement agreement with Lupin Pharmaceuticals regarding patent litigation over Firdapse, which protects the company's sales from generic competition until February 25, 2035 [1][5][6]. Group 1: Firdapse Overview - Firdapse is approved in the U.S., EU, and Japan for treating Lambert-Eaton Myasthenic Syndrome (LEMS) in adults and has recently expanded its label to include pediatric patients aged six and older [2]. - In 2024, Firdapse accounted for 62% of Catalyst Pharmaceuticals' sales, generating $168.6 million in revenue in the first half of 2025 [5][8]. Group 2: Settlement Details - The settlement prohibits Lupin from marketing its generic version of Firdapse in the U.S. before February 25, 2035, unless specific exceptions arise [6]. - The agreement also resolves all ongoing patent litigation between Catalyst Pharmaceuticals/SERB and Lupin in the U.S. District Court in New Jersey [6][7]. Group 3: Other Products and Market Position - Catalyst Pharmaceuticals markets two additional drugs in the U.S.: Fycompa for epilepsy and Agamree for Duchenne muscular dystrophy, which provide incremental revenue [9]. - The patents for Fycompa are set to expire in 2025 and 2026, leading to anticipated declines in sales due to increased competition from generics [10].

Core Viewpoint - Catalyst Pharmaceuticals and SERB have reached a settlement with Lupin regarding the patent litigation over FIRDAPSE, allowing Lupin to market a generic version starting February 25, 2035, pending FDA approval [1][2]. Group 1: Settlement Agreement Details - The settlement agreement resolves ongoing patent litigation between Catalyst/SERB and Lupin concerning FIRDAPSE [2]. - Lupin is prohibited from marketing its generic version of FIRDAPSE in the U.S. before February 25, 2035, unless specific circumstances arise [2]. - The agreement includes the termination of all ongoing patent litigation related to FIRDAPSE patents in the U.S. District Court for the District of New Jersey [2]. Group 2: Company Background - Catalyst Pharmaceuticals is focused on developing and commercializing treatments for rare diseases and has a strong commitment to patient care [4]. - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4].

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 reached $146.6 million, a 19.4% increase year over year, while total revenue for 2025 grew 30.2% to $288 million [5][29] - The company ended Q2 2025 with a cash position of $652.8 million, reinforcing its ability to invest strategically for long-term growth [5][29] - GAAP net income for Q2 2025 was $52.1 million, or $0.41 per diluted share, reflecting a 27.7% increase year over year [30] Business Line Data and Key Metrics Changes - Firdapse generated net product revenue of $84.8 million in Q2 2025, a 9.7% increase year over year, with year-to-date revenue of $168.6 million, representing a 16.9% increase over 2024 [6][29] - GammaRy achieved net product revenue of $27.4 million in Q2 2025, a 213% increase year over year, with first half revenues reaching $49.4 million, up 398% from the prior year [10][29] - Fycompa reported revenue of $34.3 million in Q2 2025, a 6% decrease year over year, with full year guidance remaining unchanged at $90 million to $95 million [11][29] Market Data and Key Metrics Changes - The company is focusing on expanding its reach in the oncology market, where it believes potentially 90% of cancer-associated LEMS patients remain undiagnosed, representing a significant growth opportunity [9][24] - The updated NCCN guidelines for small cell lung cancer, published on July 25, now include VGCC antibody testing and recommend amifampridine for treatment, which is expected to enhance market access [22] Company Strategy and Development Direction - The company is advancing a focused expansion strategy for Firdapse, centered on educating healthcare providers and improving diagnostic access [9][21] - The company remains committed to disciplined business development, actively evaluating opportunities that align with its long-term growth strategy [16][98] - The leadership changes, including the appointment of a new Chief Medical Officer, are aimed at ensuring scientific rigor and operational excellence [12][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full year 2025 revenue guidance of $545 million to $565 million, supported by strong leading indicators [6][35] - The company anticipates sustained growth driven by the strong performance of its commercial portfolio and the successful execution of its strategic initiatives [35] Other Important Information - The company is awaiting a trial date in ongoing patent litigation for Firdapse, expected in Q4 2025 or Q1 2026 [17] - The company published its 2024 ESG report, underscoring its commitment to sustainable growth and responsible innovation [18] Q&A Session Summary Question: Can you speak more about your strategy for educating oncologists on the LEMS opportunity? - The company is focused on increasing frictionless testing for patients and has implemented digital marketing and educational initiatives to engage oncologists [38][41] Question: What impact are you seeing on Firdapse and GammaRy uptake following the increase in sales force size? - Early indicators show increased engagements and deeper relationships with healthcare providers, with strong performance in enrollments for both products [49][51] Question: How do you view the potential for PTCT's Translarna FDA approval for DMD treatment? - The company believes that GammaRy will continue to retain market share as it is viewed as a differentiated treatment option for DMD [93][95] Question: What is your current stance on near-term strategic initiatives to offset Fycompa's loss of exclusivity? - The company is actively assessing multiple opportunities for business development and lifecycle management to offset potential revenue loss from Fycompa [96][98]

Financial Data and Key Metrics Changes - Catalyst Pharmaceuticals reported total revenue of $146.6 million for Q2 2025, a 19.4% increase year over year, and total revenue for 2025 reached $288 million, reflecting a 30.2% growth [5][28] - The company ended Q2 2025 with a cash position of $652.8 million, indicating strong financial health and capacity for strategic investments [5][28] - GAAP net income for Q2 2025 was $52.1 million, or $0.41 per diluted share, representing a 27.7% increase year over year [29] Business Line Data and Key Metrics Changes - Firdapse generated net product revenue of $84.8 million in Q2 2025, a growth of $7.5 million compared to Q2 2024, with year-to-date revenue of $168.6 million, a 16.9% increase over the previous year [6][28] - GammaRy achieved net product revenue of $27.4 million in Q2 2025, a 213% increase year over year, with first half revenues reaching $49.4 million, up 398% from the prior year [10][28] - Fycompa reported revenue of $34.3 million in Q2 2025, reflecting a 6% decrease year over year, with full year guidance remaining unchanged at $90 million to $95 million [11][28] Market Data and Key Metrics Changes - The company noted that approximately 90% of cancer-associated LEMS patients remain undiagnosed, presenting a significant opportunity for market expansion [9][23] - Prescription approval rates for Firdapse remained above 90%, indicating strong patient adherence and a solid foundation for sustained performance [20] Company Strategy and Development Direction - Catalyst Pharmaceuticals is focused on expanding Firdapse's market presence in oncology, supported by updated NCCN guidelines that recommend its use for cancer patients with LEMS [9][22] - The company is actively pursuing a three-step strategy to enhance diagnostic access and improve patient outcomes, which includes frictionless testing, educational initiatives, and partnerships with oncology practices [21][23] - The leadership team has been strengthened with the addition of new executives, enhancing the company's strategic capabilities [12][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full year 2025 revenue guidance of $545 million to $565 million, supported by strong leading indicators and a balanced commercial portfolio [6][33] - The company remains committed to disciplined financial management and strategic growth, with a focus on long-term value creation [16][33] Other Important Information - Catalyst Pharmaceuticals is awaiting a trial date for ongoing patent litigation related to Firdapse, with expectations for clarity following a scheduled Markman hearing [16] - The company published its 2024 ESG report, emphasizing its commitment to sustainable growth and responsible innovation [17] Q&A Session Summary Question: Can you speak more about your strategy for educating oncologists on the LEMS opportunity? - The company is focused on increasing frictionless testing for patients and enhancing education through digital marketing, congresses, and publications. Success will be tracked through increased VGCC antibody testing and a growing mix of cancer-associated LEMS patients [36][39][41] Question: What impact are you seeing on Firdapse and GammaRy uptake following the increase in sales force size? - Early indicators show increased engagements and deeper relationships with healthcare providers, with strong performance in enrollments and a solid pipeline for both products [47][50][51] Question: How do you view the potential for PTCT's Translarna FDA approval for DMD treatment? - The company believes that GammaRy will continue to retain market share as it is viewed as a differentiated steroid treatment for DMD, unaffected by Translarna's approval [88][90] Question: What is your current stance on near-term strategic initiatives to offset Fycompa's loss of exclusivity? - The company is actively assessing multiple opportunities for business development and lifecycle management to offset potential revenue loss from Fycompa [92][93]

Group 1 - Catalyst Pharmaceutical (CPRX) reported quarterly earnings of $0.68 per share, exceeding the Zacks Consensus Estimate of $0.58 per share, and showing an increase from $0.56 per share a year ago, resulting in an earnings surprise of +17.24% [1] - The company achieved revenues of $146.56 million for the quarter ended June 2025, surpassing the Zacks Consensus Estimate by 5.30%, and up from $122.71 million in the same quarter last year [2] - Catalyst has consistently surpassed consensus EPS estimates for the last four quarters, indicating strong performance [2] Group 2 - The stock has gained approximately 6.5% since the beginning of the year, compared to the S&P 500's gain of 7.1%, suggesting a slight underperformance relative to the broader market [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The Zacks Rank for Catalyst is currently 2 (Buy), indicating expectations for the stock to outperform the market in the near future [6] Group 3 - The current consensus EPS estimate for the upcoming quarter is $0.56 on revenues of $138.29 million, while for the current fiscal year, the estimate is $2.25 on revenues of $559.96 million [7] - The Medical - Drugs industry, to which Catalyst belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable industry outlook [8]

Core Insights - Catalyst Pharmaceuticals reported record financial results for Q2 and the first half of 2025, with total revenues of $146.6 million for Q2, reflecting a 19.4% year-over-year increase, and $288.0 million for the first half, a 30.2% increase over the prior year [1][6][8] - The company reaffirmed its full-year 2025 revenue guidance of $545 million to $565 million, indicating broad-based growth and sustained demand across its product portfolio [1][6] Financial Performance - Q2 2025 net product revenue reached $146.5 million, a 19.5% increase year-over-year, driven by strong demand across the portfolio [4][8] - FIRDAPSE net product revenue for Q2 2025 was $84.8 million, up 9.7% year-over-year, while the first half revenue was $168.6 million, a 16.9% increase [1][8] - AGAMREE achieved remarkable growth with Q2 2025 net product revenue of $27.4 million, a 212.9% increase year-over-year, and $49.4 million for the first half, a 398.0% increase [1][8] - FYCOMPA's Q2 2025 net product revenue was $34.3 million, reflecting a slight decrease of 6.0% year-over-year due to generic competition [1][8] Profitability Metrics - GAAP net income for Q2 2025 was $52.1 million, representing a 27.7% increase from $40.8 million in Q2 2024 [15] - Non-GAAP net income for Q2 2025 was $86.4 million, a 24.0% increase from $69.6 million in the same quarter of the previous year [16] - Operating income for Q2 2025 was $66.3 million, up 22.2% from $54.2 million in Q2 2024 [14] Cash Position - As of June 30, 2025, the company reported a strong cash position of $652.8 million with no funded debt [1][18] Strategic Developments - The National Comprehensive Cancer Network® updated guidelines to include VGCC antibody testing for cancer-associated Lambert-Eaton myasthenic syndrome (LEMS) and the use of FIRDAPSE in treatment, which is expected to enhance clinical awareness and diagnostic rates [8] - The company appointed Daniel J. Curran, MD, to its Board of Directors on August 4, 2025, and published its 2024 ESG Report on June 30, 2025 [8][17]

PART I. FINANCIAL INFORMATION [Item 1. FINANCIAL STATEMENTS](index=3&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) Unaudited consolidated financial statements and notes for Catalyst Pharmaceuticals, Inc. for periods ended June 30, 2025, and December 31, 2024 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets and stockholders' equity increased from December 2024 to June 2025, driven by higher cash and retained earnings Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (unaudited, in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :-------------------------------------- | :------------------------------- | | Cash and cash equivalents | $652,800 | $517,553 | | Total current assets | $758,739 | $623,609 | | Total assets | $971,915 | $851,411 | | Total current liabilities | $113,007 | $120,678 | | Total liabilities | $115,888 | $123,779 | | Total stockholders' equity | $856,027 | $727,632 | [Consolidated Statements of Operations and Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) Total revenues and net income grew significantly for Q2 and H1 2025 compared to 2024, primarily driven by product revenue Consolidated Statements of Operations and Comprehensive Income (in thousands) | Metric | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Total revenues | $146,563 | $122,710 | $287,984 | $221,219 | | Operating income | $66,298 | $54,246 | $129,665 | $81,372 | | Net income | $52,108 | $40,794 | $108,845 | $64,069 | | Basic EPS | $0.43 | $0.35 | $0.89 | $0.55 | | Diluted EPS | $0.41 | $0.33 | $0.86 | $0.52 | - Product revenue, net, increased by **$23,887 thousand (19.5%)** for the three months and **$66,846 thousand (30.2%)** for the six months ended June 30, 2025, compared to the same periods in 2024[12](index=12&type=chunk) [Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity) Stockholders' equity significantly increased from December 2024 to June 2025, driven by net income and stock-based compensation, partially offset by other comprehensive losses Consolidated Statements of Changes in Stockholders' Equity (in thousands) | Metric | Balance at Dec 31, 2024 (in thousands) | Balance at June 30, 2025 (in thousands) | | :-------------------------------- | :------------------------------------- | :------------------------------------ | | Common Stock (Shares) | 120,879 | 122,386 | | Common Stock (Amount) | $121 | $122 | | Additional Paid-in Capital | $442,286 | $461,868 | | Retained Earnings | $285,161 | $394,006 | | Accumulated Other Comprehensive Income (Loss) | $64 | $31 | | Total Stockholders' Equity | $727,632 | $856,027 | - Net income contributed **$52,108 thousand** to retained earnings for the three months ended June 30, 2025, and **$56,737 thousand** for the period from December 31, 2024, to March 31, 2025[15](index=15&type=chunk) - Stock-based compensation added **$7,597 thousand** for the three months ended June 30, 2025, and **$5,850 thousand** for the period from December 31, 2024, to March 31, 2025, to additional paid-in capital[15](index=15&type=chunk) [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Substantial cash generated from operating activities led to a significant increase in cash and cash equivalents for H1 2025 compared to the prior year Cash Flow Activity (in thousands) | Cash Flow Activity | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | | Net cash provided by operating activities | $131,341 | $96,060 | | Net cash used in investing activities | $(26) | $(209) | | Net cash provided by financing activities | $3,932 | $142,206 | | Net increase in cash and cash equivalents | $135,247 | $238,057 | | Cash and cash equivalents – end of period | $652,800 | $375,693 | - Net cash provided by operating activities increased by **$35,281 thousand (36.7%)** for the six months ended June 30, 2025, driven by higher net income and non-cash adjustments[17](index=17&type=chunk)[252](index=252&type=chunk) - Financing activities in 2024 included **$141,000 thousand** from the issuance of common stock, which was not present in 2025[17](index=17&type=chunk)[254](index=254&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Detailed notes provide essential context for the consolidated financial statements, covering organization, accounting policies, assets, liabilities, agreements, and legal proceedings [Note 1. Organization and Description of Business](index=8&type=section&id=1.%20Organization%20and%20Description%20of%20Business.) Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare diseases, marketing FIRDAPSE®, AGAMREE®, and FYCOMPA®, with plans for portfolio expansion - Catalyst Pharmaceuticals markets three commercial-stage drug products: **FIRDAPSE® (amifampridine)**, **AGAMREE® (vamorolone)**, and **FYCOMPA® (perampanel)**[19](index=19&type=chunk) - FIRDAPSE®'s label was expanded in 2024 to include pediatric patients and an increased maximum daily dose, becoming commercially available in Japan in January 2025[20](index=20&type=chunk) - AGAMREE® was approved by the FDA in October 2023 for Duchenne muscular dystrophy (DMD) and commercially launched in the U.S. in March 2024[22](index=22&type=chunk) - A public offering of **10 million shares** in January 2024 raised approximately **$140.7 million** in net proceeds for new product acquisitions and general corporate purposes[26](index=26&type=chunk) [Note 2. Basis of Presentation and Significant Accounting Policies](index=10&type=section&id=2.%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies.) Outlines accounting principles, including U.S. GAAP compliance, consolidation, estimates, and specific policies for assets, liabilities, revenue, expenses, and recent accounting standard updates - Product revenue is recognized when customers obtain control of products, recorded net of variable consideration like discounts, rebates, and returns[49](index=49&type=chunk)[53](index=53&type=chunk) Net Product Revenue by Product (in thousands) | Product | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | FIRDAPSE® | $84,845 | $77,372 | $168,576 | $144,214 | | FYCOMPA® | $34,332 | $36,535 | $69,959 | $66,960 | | AGAMREE®* | $27,363 | $8,746 | $49,405 | $9,920 | | Total | $146,540 | $122,653 | $287,940 | $221,094 | *AGAMREE® net product revenue for the six months ended June 30, 2024 is for the period between March 13, 2024 (date of commercial launch) and June 30, 2024. - The company operates in one reportable segment: the development and commercialization of drug products, with the CEO reviewing consolidated financial information[83](index=83&type=chunk) - ASU 2024-03, requiring more detailed expense disaggregation disclosures, is effective for fiscal years beginning after December 15, 2026, and the company is evaluating its impact[86](index=86&type=chunk) [Note 3. Investments](index=25&type=section&id=3.%20Investments.) Investments primarily comprise available-for-sale U.S. Treasuries and an equity investment in Santhera, with gains/losses recognized in AOCI or other income Available-for-sale Investments (in thousands) | Security Type | Estimated Fair Value (June 30, 2025, in thousands) | Amortized Cost (June 30, 2025, in thousands) | Estimated Fair Value (Dec 31, 2024, in thousands) | Amortized Cost (Dec 31, 2024, in thousands) | | :-------------------------- | :------------------------------------------------- | :------------------------------------------- | :------------------------------------------------- | :------------------------------------------- | | U.S. Treasuries | $407,687 | $407,646 | $329,457 | $329,373 | Net Gains (Losses) on Equity Securities (in thousands) | Period | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Net gains (losses) on equity securities | $(2,952) | $(2,262) | $(308) | $(3,406) | [Note 4. Accumulated Other Comprehensive Income (Loss)](index=26&type=section&id=4.%20Accumulated%20Other%20Comprehensive%20Income%20%28Loss%29.) AOCI primarily reflects unrealized gains/losses on available-for-sale securities, shifting from a gain at December 2024 to a smaller gain at June 2025 due to current period losses Changes in Accumulated Other Comprehensive Income (Loss) (in thousands) | Metric | Balance at March 31, 2025 (in thousands) | Other comprehensive gain (loss) before reclassifications (in thousands) | Balance at June 30, 2025 (in thousands) | | :-------------------------------- | :--------------------------------------- | :------------------------------------------------------ | :-------------------------------------- | | Total Accumulated Other Comprehensive Income (Loss) | $(17) | $48 | $31 | - The balance of accumulated other comprehensive income (loss) was **$64 thousand** at December 31, 2024, and **$31 thousand** at June 30, 2025[92](index=92&type=chunk) [Note 5. Inventory, Net](index=26&type=section&id=5.%20Inventory%2C%20Net.) Net inventory slightly decreased from December 2024 to June 2025, with work-in-process increasing while raw materials and finished goods decreased, and write-offs recorded Inventory, Net (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------- | :--------------------------- | :------------------------------- | | Raw materials | $5,186 | $6,518 | | Work-in-process | $5,345 | $3,445 | | Finished goods | $8,119 | $9,578 | | Total inventory, net | $18,650 | $19,541 | - Inventory write-offs were approximately **$0.5 million** as of June 30, 2025, expected to be reimbursed by the contract manufacturer[93](index=93&type=chunk) - An inventory reserve of approximately **$0.2 million** was recorded during the three and six months ended June 30, 2025, related to slow-moving FYCOMPA® inventory[93](index=93&type=chunk) [Note 6. Prepaid Expenses and Other Current Assets](index=27&type=section&id=6.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets.) Prepaid expenses and other current assets remained stable, with increases in prepaid tax and manufacturing costs offset by decreases in commercialization and co-pay assistance programs Prepaid Expenses and Other Current Assets (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Prepaid manufacturing costs | $463 | $206 | | Prepaid tax | $10,215 | $7,959 | | Prepaid commercialization expenses | $4,198 | $4,957 | | Prepaid co-pay assistance program | $755 | $1,561 | | Total prepaid expenses and other current assets | $21,426 | $21,039 | [Note 7. Operating Leases](index=28&type=section&id=7.%20Operating%20Leases.) The company holds an operating lease for its corporate office with a 5.8-year remaining term, recognizing lease liabilities and right-of-use assets based on future payments Operating Lease Information (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Operating lease right-of-use assets, net | $2,084 | $2,230 | | Total operating lease liabilities | $2,991 | $3,188 | | Weighted average remaining lease term | 5.8 years | 6.3 years | | Weighted average discount rate | 4.51% | 4.51% | - Total remaining lease payments as of June 30, 2025, are **$3,420 thousand**, with **$270 thousand** due in the remaining six months of 2025[96](index=96&type=chunk) [Note 8. Property and Equipment, Net](index=29&type=section&id=8.%20Property%20and%20Equipment%2C%20Net.) Net property and equipment decreased from December 2024 to June 2025, primarily due to accumulated depreciation Property and Equipment, Net (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------- | :--------------------------- | :------------------------------- | | Furniture and equipment | $1,076 | $1,050 | | Leasehold improvements | $991 | $991 | | Software | $433 | $433 | | Less: Accumulated depreciation | $(1,351) | $(1,120) | | Total property and equipment, net | $1,149 | $1,354 | [Note 9. License and Acquired Intangibles, Net](index=29&type=section&id=9.%20License%20and%20Acquired%20Intangibles%2C%20Net.) Net license and acquired intangibles decreased from December 2024 to June 2025 due to ongoing amortization of RUZURGI®, FYCOMPA®, and AGAMREE® assets Intangible Assets, Net (in thousands) | Intangible Asset | Net Carrying Value (June 30, 2025, in thousands) | Net Carrying Value (Dec 31, 2024, in thousands) | | :-------------------------------- | :----------------------------------------------- | :---------------------------------------------- | | RUZURGI® | $26,670 | $27,830 | | FYCOMPA® | $81,027 | $96,842 | | AGAMREE® | $30,286 | $32,000 | | Total | $137,983 | $156,672 | - Amortization expense for FYCOMPA® was approximately **$7.9 million** for both the three and six months ended June 30, 2025, and 2024, respectively, recorded in cost of sales[99](index=99&type=chunk) - The weighted average amortization period remaining for intangible assets was **4.9 years** at June 30, 2025[100](index=100&type=chunk) [Note 10. Accrued Expenses and Other Liabilities](index=31&type=section&id=10.%20Accrued%20Expenses%20and%20Other%20Liabilities.) Total accrued expenses and other liabilities increased from December 2024 to June 2025, driven by higher gross-to-net revenue liabilities, partially offset by lower professional and license fees Accrued Expenses and Other Liabilities (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------------------- | :--------------------------- | :------------------------------- | | Accrued professional fees | $8,315 | $11,011 | | Accrued license fees | $22,742 | $30,991 | | Accrued gross-to-net revenue liabilities | $62,736 | $44,939 | | Current accrued expenses and other liabilities | $107,479 | $104,085 | | Total accrued expenses and other liabilities | $110,360 | $107,186 | [Note 11. Collaborative and Licensing Arrangements](index=31&type=section&id=11.%20Collaborative%20and%20Licensing%20Arrangements.) Details collaborative and licensing agreements with KYE Pharmaceuticals for FIRDAPSE® and AGAMREE® in Canada, and DyDo Pharma for FIRDAPSE® in Japan, involving payments and royalty sharing - In July 2024, the company entered a license agreement with KYE for exclusive Canadian commercial rights to AGAMREE®[105](index=105&type=chunk) - DyDo Pharma launched FIRDAPSE® in Japan in January 2025 following MHLW approval in September 2024[112](index=112&type=chunk) - Revenue from the DyDo arrangement for the six months ended June 30, 2025, was **$1.1 million**, included in product revenue, net[113](index=113&type=chunk) [Note 12. Commitments and Contingencies](index=34&type=section&id=12.%20Commitments%20and%20Contingencies.) Details the Jacobus settlement, ongoing FIRDAPSE® patent litigation against Hetero and Lupin, settlements with Teva and Inventia, and a **$5.4 million** purchase commitment - The company settled FIRDAPSE® patent litigation with Inventia in July 2024, preventing Inventia's commercialization until February 2037 or another ANDA product entry[118](index=118&type=chunk) - A settlement with Teva in January 2025 prevents them from marketing a generic FIRDAPSE® version in the U.S. before February 25, 2035[120](index=120&type=chunk) - FIRDAPSE® patent litigation against Hetero and Lupin (for the 2037 patent) remains ongoing, with a Markman hearing scheduled for October 7, 2025[122](index=122&type=chunk) - A FYCOMPA® patent litigation settlement in June 2024 prevents a Paragraph IV filer from commercializing generic FYCOMPA® oral suspension and tablets until at least December 15, 2025[124](index=124&type=chunk) [Note 13. Agreements](index=37&type=section&id=13.%20Agreements.) Outlines key license and acquisition agreements for FIRDAPSE®, RUZURGI®, FYCOMPA®, and AGAMREE®, detailing payment terms, royalties, accounting treatment, and manufacturing agreements - The FIRDAPSE® license agreement with BioMarin (now SERB S.A.) includes tiered royalties on net sales in North America and Japan, with territory expansion in 2019 and 2023[128](index=128&type=chunk) - The RUZURGI® license agreement with Jacobus involves **$30 million** in cash payments and tiered annual royalties (**1.5% for 2022-2025, 2.5% thereafter**) on U.S. amifampridine net sales, with minimum annual royalties[129](index=129&type=chunk)[130](index=130&type=chunk)[121](index=121&type=chunk) - The FYCOMPA® acquisition from Eisai involved a **$160 million** upfront cash payment and future tiered royalty payments after patent protection expires, accounted for as an asset acquisition[134](index=134&type=chunk)[135](index=135&type=chunk)[138](index=138&type=chunk) - The AGAMREE® license from Santhera included a **$75 million** initial cash payment, a **$36 million** regulatory milestone payment in Q4 2023, and potential future sales-based milestones and royalties, alongside a strategic equity investment in Santhera[139](index=139&type=chunk)[140](index=140&type=chunk)[143](index=143&type=chunk) [Note 14. Income Taxes](index=43&type=section&id=14.%20Income%20Taxes.) The effective income tax rate for H1 2025 was **22.6%**, influenced by state income taxes, investment fluctuations, and equity compensation deductions, with future fluctuations expected - The effective income tax rate was **22.6%** for the six months ended June 30, 2025, compared to **24.5%** for the same period in 2024[145](index=145&type=chunk) - The company is evaluating the impact of the recently passed OBBBA legislation on corporate taxation but does not expect a material impact on its effective tax rate[146](index=146&type=chunk) [Note 15. Stockholders' Equity](index=43&type=section&id=15.%20Stockholders%27%20Equity.) Details authorized and outstanding common/preferred stock, the expiration of the share repurchase program, and the **$140.7 million** raised in January 2024 under the 2023 shelf registration - As of June 30, 2025, **122,385,569 shares** of common stock were issued and outstanding[148](index=148&type=chunk) - The **$40 million** share repurchase program expired in March 2025, with no shares repurchased during the three and six months ended June 30, 2025, and 2024[149](index=149&type=chunk) - A public offering in January 2024 raised approximately **$140.7 million** in net proceeds from the sale of **10 million common shares** under the 2023 Shelf Registration Statement[150](index=150&type=chunk) [Note 16. Stock Compensation](index=43&type=section&id=16.%20Stock%20Compensation.) Stock-based compensation expense increased for Q2 and H1 2025 but remained stable for H1, primarily due to stock options, restricted stock unit grants, and executive retirement charges Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Research and development | $904 | $403 | $1,329 | $912 | | Selling, general and administrative | $6,693 | $4,005 | $12,118 | $11,744 | | Total stock-based compensation | $7,597 | $4,408 | $13,447 | $12,656 | - As of June 30, 2025, approximately **$36.7 million** of unrecognized compensation expense for non-vested stock option awards is expected to be recognized over **2.5 years**[156](index=156&type=chunk) - Approximately **$7.1 million** of unrecognized compensation expense related to non-vested restricted stock units is expected to be recognized over **2.7 years**[158](index=158&type=chunk) [Note 17. Subsequent Events](index=45&type=section&id=17.%20Subsequent%20Events.) Subsequent events include Daniel J. Curran, MD's board appointment on August 1, 2025, and NCCN guideline updates for Small Cell Lung Cancer to include LEMS and amifampridine - Daniel J. Curran, MD, was appointed to the Board of Directors on August 1, 2025[159](index=159&type=chunk) - NCCN Clinical Practice Guidelines for Small Cell Lung Cancer now include LEMS, amifampridine, and specific antibody tests, as announced on August 6, 2025[160](index=160&type=chunk) [Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=33&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management's discussion and analysis of financial condition and results of operations, covering business overview, product developments, accounting policies, estimates, revenues, expenses, and liquidity [Overview](index=46&type=section&id=OVERVIEW) Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company, markets FIRDAPSE®, AGAMREE®, and FYCOMPA®, with strategic field force splits, portfolio expansion, and ongoing patent litigation - The company split its commercial and medical field-based forces into two units for FIRDAPSE® and AGAMREE® effective April 1, 2025, to improve product focus[164](index=164&type=chunk)[186](index=186&type=chunk) - FIRDAPSE® received FDA approval for an expanded age range (pediatric patients six and older) in September 2022 and an increased maximum daily dose (from **80 mg to 100 mg**) in May 2024[165](index=165&type=chunk) - AGAMREE® was commercially launched in the U.S. on March 13, 2024, for Duchenne muscular dystrophy (DMD) patients aged two years and older[185](index=185&type=chunk) - Patent protection for FYCOMPA® tablets expired on May 23, 2025, and for the oral suspension, it is expected to expire on December 15, 2025, leading to generic competition[202](index=202&type=chunk) - Daniel J. Curran, MD, was appointed to the Board of Directors on August 1, 2025, bringing over **25 years** of pharmaceutical experience[205](index=205&type=chunk) [Basis of Presentation](index=56&type=section&id=Basis%20of%20Presentation) Reiterates key financial statement components, including revenue recognition, cost of sales, R&D, SG&A, intangible asset amortization, stock-based compensation, and income taxes, emphasizing their impact on financial performance - Revenues are primarily generated from product sales of **FIRDAPSE®**, **AGAMREE®**, and **FYCOMPA®**, with immaterial contributions from Canadian and Japanese collaboration agreements in 2025[207](index=207&type=chunk)[209](index=209&type=chunk) - Cost of sales includes third-party manufacturing, freight, royalties, and milestone payments, with royalties based on net revenue as defined in license agreements[210](index=210&type=chunk)[231](index=231&type=chunk) - Research and development expenses are expensed as incurred and are expected to be principally attributable to FIRDAPSE® and AGAMREE® development[211](index=211&type=chunk)[212](index=212&type=chunk) - Selling, general and administrative expenses are substantial due to commercialization efforts for all three products, with FYCOMPA® expenses expected to decline post-patent expiration[214](index=214&type=chunk) [Critical Accounting Policies and Estimates](index=58&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies and estimates, requiring significant management judgment, include revenue recognition, intangible asset valuation, stock-based compensation, and deferred tax asset valuation allowance, with no material changes reported - Key critical accounting policies and estimates include revenue recognition, valuation of intangible assets, stock-based compensation, and valuation allowance for deferred tax assets[220](index=220&type=chunk) - Management continually evaluates judgments, estimates, and assumptions based on underlying agreements, expected development, historical experience, and other reasonable factors[220](index=220&type=chunk) [Results of Operations](index=60&type=section&id=Results%20of%20Operations) Significant revenue growth for Q2 and H1 2025, driven by AGAMREE® and FIRDAPSE® sales, led to substantial net income increase, while operating expenses rose due to commercialization and stock-based compensation [Revenues](index=60&type=section&id=Revenues.) Total revenues significantly increased for Q2 and H1 2025, driven by AGAMREE® launch and FIRDAPSE® sales, partially offset by a slight decrease in FYCOMPA® revenue in the three-month period Total Revenues (in millions) | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :---------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Total revenues | $146.6 | $122.7 | $288.0 | $221.2 | | Net product revenues | $146.5 | $122.7 | $287.9 | $221.1 | - FIRDAPSE® net product revenue increased by **9.7% ($7.5 million)** for the three months and **16.9% ($24.4 million)** for the six months ended June 30, 2025, driven by sales volume increases[225](index=225&type=chunk)[228](index=228&type=chunk) - AGAMREE® net product revenue grew substantially to **$27.4 million** for the three months and **$49.4 million** for the six months ended June 30, 2025, from **$8.7 million** and **$9.9 million** respectively in 2024, following its commercial launch[226](index=226&type=chunk)[228](index=228&type=chunk) - FYCOMPA® net product revenue decreased by **6.0% ($2.2 million)** for the three months but increased by **4.5% ($3.0 million)** for the six months ended June 30, 2025, with future decreases expected due to patent expiration[227](index=227&type=chunk)[228](index=228&type=chunk)[229](index=229&type=chunk) [Cost of Sales](index=60&type=section&id=Cost%20of%20Sales.) Cost of sales increased for Q2 and H1 2025, primarily due to higher royalty payments tied to increased net product revenues, particularly for AGAMREE® Cost of Sales (in millions) | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :---------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Cost of sales | $20.6 | $15.4 | $38.5 | $27.9 | - Cost of sales increased by **$5.2 million (33.8%)** for the three months and **$10.6 million (38.0%)** for the six months ended June 30, 2025, compared to the same periods in 2024[12](index=12&type=chunk)[231](index=231&type=chunk) - Royalties payable under license agreements for **FIRDAPSE®** and **AGAMREE®** were the principal components of cost of sales[231](index=231&type=chunk) [Amortization of Intangible Assets](index=60&type=section&id=Amortization%20of%20Intangible%20Assets.) Amortization expense for intangible assets remained consistent, reflecting straight-line amortization of FYCOMPA®, RUZURGI®, and AGAMREE® product rights over their estimated useful lives Amortization of Intangible Assets (in millions) | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :-------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Amortization of intangible assets | $9.3 | $9.3 | $18.7 | $18.7 | - Intangible assets for **FYCOMPA®** are amortized over **5 years**, **RUZURGI®** over **14.5 years**, and **AGAMREE®** over **10.5 years**[232](index=232&type=chunk) [Research and Development Expenses](index=62&type=section&id=Research%20and%20Development%20Expenses.) R&D expenses increased for Q2 and H1 2025, driven by higher employee compensation, clinical trial expenses, and a charge related to a former executive's retirement Research and Development Expenses (in thousands) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Salary and benefit expense | $1,668 | $1,356 | $2,780 | $2,099 | | Employee stock-based compensation expense | $904 | $403 | $1,329 | $912 | | Research and clinical trial expense | $1,697 | $857 | $3,787 | $1,995 | | Total research and development expenses | $4,358 | $2,985 | $8,245 | $5,566 | - Research and development expenses increased by **46.0% ($1.373 million)** for the three months and **48.1% ($2.679 million)** for the six months ended June 30, 2025[234](index=234&type=chunk) - The increase in stock-based compensation expense includes a charge related to the retirement of a former executive officer in Q2 2025[234](index=234&type=chunk) [Selling, General and Administrative Expenses](index=62&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses.) SG&A expenses increased for Q2 and H1 2025, driven by higher selling expenses from increased headcount and compensation, and stock-based compensation, partially offset by lower general and administrative expenses Selling, General and Administrative Expenses (in thousands) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Selling | $28,284 | $26,247 | $58,185 | $51,568 | | General and administrative | $10,972 | $10,478 | $22,557 | $24,356 | | Employee stock-based compensation | $6,693 | $4,005 | $12,118 | $11,744 | | Total SG&A expenses | $45,949 | $40,730 | $92,860 | $87,668 | - Total SG&A expenses increased by **12.8% ($5.219 million)** for the three months and **5.9% ($5.192 million)** for the six months ended June 30, 2025[236](index=236&type=chunk)[237](index=237&type=chunk) - The increase in selling expenses was primarily due to annual merit increases and increased headcount from FYCOMPA® and AGAMREE® acquisitions[237](index=237&type=chunk) [Stock-Based Compensation](index=63&type=section&id=Stock-Based%20Compensation.) Total stock-based compensation increased for Q2 2025 but remained stable for H1, primarily due to stock options, restricted stock unit grants, and executive retirement charges Total Stock-Based Compensation (in millions) | Metric | 3 Months Ended June 30, 2025 (in millions) | 3 Months Ended June 30, 2024 (in millions) | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :-------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | :----------------------------------------- | | Total stock-based compensation | $7.6 | $4.4 | $13.4 | $12.7 | - The 2025 and 2024 periods include charges related to the retirement of three former executive officers[239](index=239&type=chunk) [Other Income, Net](index=63&type=section&id=Other%20Income%2C%20Net.) Other income, net, significantly increased for Q2 and H1 2025, driven by higher interest income from invested cash, partially offset by net losses on equity securities Other Income, Net (in thousands) | Category | 3 Months Ended June 30, 2025 (in thousands) | 3 Months Ended June 30, 2024 (in thousands) | 6 Months Ended June 30, 2025 (in thousands) | 6 Months Ended June 30, 2024 (in thousands) | | :-------------------------------- | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | :------------------------------------------ | | Interest income, net | $5,947 | $3,804 | $11,222 | $6,911 | | Net gains (losses) on equity securities | $(2,952) | $(2,262) | $(308) | $(3,406) | | Total other income, net | $2,995 | $1,542 | $10,914 | $3,505 | - The increase in other income, net, was primarily due to higher invested balances, despite a decrease in the share price of the investment in Santhera[240](index=240&type=chunk) [Income Taxes](index=63&type=section&id=Income%20Taxes.) The effective income tax rate for H1 2025 was **22.6%**, influenced by state income taxes, investment fluctuations, and equity compensation deductions, with future fluctuations expected - The effective income tax rate was approximately **22.6%** for the six months ended June 30, 2025, compared to **24.5%** for the same period in 2024[242](index=242&type=chunk) - Differences from the statutory federal income tax rate of **21%** are driven by state income taxes, investment value fluctuations, and equity compensation deductions[242](index=242&type=chunk) [Net Income](index=65&type=section&id=Net%20Income.) Net income and diluted earnings per share increased substantially for Q2 and H1 2025, reflecting strong financial performance Net Income and EPS | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :---------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net income | $52.1 million | $40.8 million | $108.8 million | $64.1 million | | Basic EPS | $0.43 | $0.35 | $0.89 | $0.55 | | Diluted EPS | $0.41 | $0.33 | $0.86 | $0.52 | [Liquidity and Capital Resources](index=65&type=section&id=Liquidity%20and%20Capital%20Resources) Strong liquidity with significant cash from product sales and securities offerings; sufficient funds for 12 months, but future funding may be needed for acquisitions and development, potentially causing dilution Cash and Working Capital (in millions) | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :---------------- | :-------------------------- | :------------------------------ | | Cash and cash equivalents | $652.8 | $517.6 | | Working capital | $645.7 | $502.9 | - The company believes it has sufficient funds to support operations for at least the next **12 months**, absent the use of cash for potential business development opportunities[247](index=247&type=chunk) - Future funding requirements depend on factors such as acquisition costs, clinical trial expenses, regulatory approvals, product sales, competition, intellectual property enforcement, and the extent of new product acquisitions[249](index=249&type=chunk)[250](index=250&type=chunk) [Cash Flows](index=67&type=section&id=Cash%20Flows.) Net cash from operating activities significantly increased for H1 2025 due to higher net income; investing was minimal, and financing decreased without prior year's large stock issuance Cash Flow Summary (in millions) | Cash Flow Activity | 6 Months Ended June 30, 2025 (in millions) | 6 Months Ended June 30, 2024 (in millions) | | :-------------------------------- | :----------------------------------------- | :----------------------------------------- | | Net cash provided by operating activities | $131.3 | $96.1 | | Net cash used in investing activities | $(0.026) | $(0.2) | | Net cash provided by financing activities | $3.9 | $142.2 | - Net cash provided by operating activities increased by **$35.2 million (36.7%)** for the six months ended June 30, 2025, primarily due to net income of **$108.8 million**[252](index=252&type=chunk) - Financing activities in 2024 included **$141.0 million** from the issuance of common stock, which was not a factor in 2025[254](index=254&type=chunk) [Contractual Obligations and Arrangements](index=67&type=section&id=Contractual%20Obligations%20and%20Arrangements.) Details contractual obligations, including tiered royalty payments for FIRDAPSE®, RUZURGI®, FYCOMPA®, and AGAMREE®, Jacobus settlement cash payments, and a significant purchase commitment - Royalties payable under FIRDAPSE® license agreements totaled approximately **$13.8 million** for the three months and **$25.4 million** for the six months ended June 30, 2025[256](index=256&type=chunk) - Payments to Jacobus for RUZURGI® include **$30 million** in cash (paid in installments through July 2024) and annual royalties of **1.5% (2022-2025)** to **2.5% (2026 onwards)** on U.S. amifampridine net sales, with minimum annual royalties[258](index=258&type=chunk) - Royalties payable for AGAMREE® totaled approximately **$3.2 million** for the three months and **$5.7 million** for the six months ended June 30, 2025[260](index=260&type=chunk) - The company has a purchase commitment of approximately **$5.4 million** with a contract manufacturing organization, expected to be fulfilled within the next **twelve months**[264](index=264&type=chunk) [Off-Balance Sheet Arrangements](index=71&type=section&id=Of%20-Balance%20Sheet%20Arrangements.) The company does not have any off-balance sheet arrangements as defined by SEC rules [Caution Concerning Forward-Looking Statements](index=71&type=section&id=Caution%20Concerning%20Forward-Looking%20Statements) Highlights inherent uncertainties in forward-looking statements, emphasizing that actual results may differ due to risks like commercialization success, regulatory compliance, market estimates, competition, intellectual property, and healthcare policy changes - Factors affecting future success include the ability to successfully market **FIRDAPSE®**, **AGAMREE®**, and **FYCOMPA®**, attract and retain qualified personnel, and accurately estimate market size and patient adherence[263](index=263&type=chunk)[265](index=265&type=chunk) - Risks involve generic competition for **FYCOMPA®**, potential impairment of intangible assets, payor coverage and reimbursement policies, and the outcome of patent litigation for **FIRDAPSE®** and **AGAMREE®**[265](index=265&type=chunk)[266](index=266&type=chunk) - External factors such as tariffs on pharmaceutical imports, potential Most Favored Nation (MFN) pricing policies, and general economic conditions could adversely affect the business[266](index=266&type=chunk) PART II. OTHER INFORMATION [Item 1. LEGAL PROCEEDINGS](index=76&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) Details ongoing Paragraph IV patent litigation for FIRDAPSE® against Hetero and Lupin, noting outcome uncertainty and potential generic market entry; other litigation is not material - Ongoing Paragraph IV patent litigation for **FIRDAPSE®** against Hetero and Lupin (for the 2037 patent) continues, with the outcome uncertain regarding generic market entry before February 25, 2035[274](index=274&type=chunk) [Item 1A. RISK FACTORS](index=76&type=section&id=Item%201A.%20RISK%20FACTORS) Highlights specific risks, including potential tariffs on pharmaceutical imports and Most Favored Nation (MFN) pricing policies, which could adversely affect the company's financial condition and results of operations - A U.S. Department of Commerce probe into pharmaceutical imports could lead to tariffs, increasing costs and potentially delaying clinical trials and manufacturing, as the company sources ingredients and supplies from foreign manufacturers[277](index=277&type=chunk)[278](index=278&type=chunk) - The potential implementation of Most Favored Nation (MFN) pricing for drug products in the U.S. could adversely affect the company's financial condition and results of operations[279](index=279&type=chunk)[280](index=280&type=chunk) [Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS](index=76&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) The **$40 million** share repurchase program expired in March 2025, with no shares repurchased during the three and six months ended June 30, 2025, and 2024 - No shares were repurchased under the **$40 million** share repurchase program during the three and six months ended June 30, 2025, and 2024, and the program expired in March 2025[281](index=281&type=chunk) [Item 3. DEFAULTS UPON SENIOR SECURITIES](index=77&type=section&id=Item%203.%20DEFAULTS%20UPON%20SENIOR%20SECURITIES) No defaults upon senior securities were reported [Item 4. MINE SAFETY DISCLOSURE](index=77&type=section&id=Item%204.%20MINE%20SAFETY%20DISCLOSURE) This item is not applicable to the company [Item 5. OTHER INFORMATION](index=77&type=section&id=Item%205.%20OTHER%20INFORMATION) No other information was reported under this item [Item 6. EXHIBITS](index=78&type=section&id=Item%206.%20EXHIBITS) Lists exhibits filed with Form 10-Q, including a license agreement amendment, Sarbanes-Oxley Act certifications, and XBRL documents - Exhibits include Amendment No. 1 to License and Collaboration Agreement with Santhera Pharmaceuticals, certifications of principal executive and financial officers under Sections 302 and 906 of the Sarbanes-Oxley Act, and Inline XBRL documents[286](index=286&type=chunk) [SIGNATURES](index=79&type=section&id=SIGNATURES) The report is signed by Michael W. Kalb, Executive Vice President and Chief Financial Officer of Catalyst Pharmaceuticals, Inc., on August 6, 2025 - The report was signed by Michael W. Kalb, Executive Vice President and Chief Financial Officer, on August 6, 2025[289](index=289&type=chunk)

Core Insights - Catalyst Pharmaceuticals announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Small Cell Lung Cancer (SCLC) now include new recommendations regarding Lambert Eaton myasthenic syndrome (LEMS) and the use of amifampridine (FIRDAPSE) [1][2] Group 1: NCCN Guidelines Update - The updated NCCN guidelines for SCLC now specify symptoms of LEMS, including proximal muscle weakness and autonomic dysfunction, and recommend diagnosis through neurological evaluation and testing for PQ- and N-type VGCC antibodies [2] - Amifampridine is recommended as a treatment option in consultation with neurology under the principles of supportive care [2] Group 2: LEMS and SCLC Connection - Approximately 50% of LEMS cases are associated with an underlying malignancy, most commonly SCLC, with literature indicating that LEMS is observed in 3% of SCLC patients [3] - An internal healthcare database analysis suggests that potentially 90% of LEMS patients with SCLC remain undiagnosed, which may lead to untreated symptoms during SCLC treatment [3] Group 3: Importance of Early Diagnosis - Early diagnosis of LEMS in SCLC is critical for improving patient outcomes, as effective treatment of LEMS symptoms can enhance the overall management of SCLC [4] - Accurate identification through VGCC antibody testing and comprehensive neurological evaluation is emphasized as essential for patient care [4] Group 4: Company Overview - Catalyst Pharmaceuticals is focused on improving the lives of patients with rare diseases and has a proven track record in bringing life-changing treatments to market [5] - The company prioritizes accessibility and support services to ensure patients receive necessary care, maintaining a strong U.S. presence while exploring global expansion opportunities [5] - Catalyst was recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [5]

Core Insights - Catalyst Pharmaceuticals, Inc. has appointed Dr. Daniel Curran to its Board of Directors, bringing over 25 years of pharmaceutical experience [1][2] - Dr. Curran's expertise includes strategy, business development, and rare disease knowledge, which will support Catalyst's growth strategy [3][4] - The company has a strong foundation in delivering innovative therapies for rare diseases and aims to expand its global presence [7] Company Overview - Catalyst Pharmaceuticals is focused on improving the lives of patients with rare diseases through innovative therapies [7] - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list [7] - Catalyst emphasizes patient care and accessibility, providing comprehensive support services to ensure patients receive necessary treatments [7] Leadership Background - Dr. Curran has held significant roles at Takeda Pharmaceutical Company, including Senior Vice President and Head of the Rare Genetics and Hematology Therapeutic Area Unit [3][4] - He has also served in leadership positions at Millennium Pharmaceuticals and DuPont Merck Pharmaceuticals [4][5] - Dr. Curran holds an M.D. from the University of Pennsylvania, an M.B.A. from The Wharton School, and a B.S. in chemistry from King's College [6]