CORAL GABLES, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today announced that it will release its fourth quarter and full-year 2023 financial results after the market close on February 28, 2024. Catalyst's management team will host a conference call and webcast the f ...

CORAL GABLES, Fla., Feb. 14, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst”) (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today announced that it will release its fourth quarter and full-year 2023 financial results after the market close on February 28, 2024. Catalyst's management team will host a conference call and webcast the f ...

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q3 2023 Results Conference Call November 9, 2023 8:30 AM ET Company Participants Ali Grande - Chief Financial Officer Patrick McEnany - Chairman and Chief Executive Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Jeffrey Del Carmen - Chief Commercial Officer Conference Call Participants Les Sulewski - Truist Securities Charles Duncan - Cantor Fitzgerald Joe Catanzaro - Piper Sandler Scott Henry - ROTH Capital Partners Operator Hello, ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The financial statements show a Q3 2023 net loss due to a significant IPR&D expense, despite strong revenue growth from recent acquisitions, and a decrease in cash from acquisition funding [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) This section presents the company's financial position, highlighting changes in assets, liabilities, and equity due to recent acquisitions - **Consolidated Balance Sheet Highlights (in thousands)** | Balance Sheet Item | Sep 30, 2023 (unaudited) | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $120,971 | $298,395 | | Accounts receivable, net | $48,049 | $10,439 | | License and acquired intangibles, net | $167,108 | $32,471 | | Total assets | $413,211 | $375,630 | | Total liabilities | $64,663 | $75,209 | | Total stockholders' equity | $348,548 | $300,421 | - The significant decrease in cash and cash equivalents is primarily due to cash used for acquisitions, while the increase in license and acquired intangibles reflects the addition of FYCOMPA® to the company's portfolio[9](index=9&type=chunk) [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) This section details the company's revenues, expenses, and net income (loss) over specific periods, reflecting the impact of recent strategic transactions - **Statement of Operations Summary (in thousands, except per share data)** | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $102,688 | $57,244 | $287,636 | $153,446 | | Research and development | $83,662 | $8,310 | $91,178 | $15,696 | | Operating income (loss) | $(37,188) | $25,102 | $45,120 | $71,037 | | Net income (loss) | $(30,764) | $22,748 | $36,566 | $57,608 | | Diluted EPS | $(0.29) | $0.20 | $0.32 | $0.52 | - The company reported a net loss in Q3 2023 despite a **79% increase in revenue**, driven by a massive surge in R&D expenses, primarily due to the immediate expensing of acquired in-process research and development (IPR&D) for vamorolone[12](index=12&type=chunk)[151](index=151&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This section summarizes the cash inflows and outflows from operating, investing, and financing activities, highlighting the impact of recent acquisitions on liquidity - **Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands)** | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $87,952 | $75,970 | | Net cash provided by (used in) investing activities | $(255,184) | $9,209 | | Net cash provided by (used in) financing activities | $(10,192) | $(559) | | Net increase (decrease) in cash | $(177,424) | $84,620 | - Investing activities show a significant cash outflow of **$255.2 million** in the first nine months of 2023, primarily for asset acquisitions including FYCOMPA® (**$162.3 million**) and the IPR&D for vamorolone (**$79.3 million**)[21](index=21&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail the company's business, accounting policies, and the financial impact of recent strategic moves, including asset acquisitions, a significant IPR&D charge, ongoing patent litigation, and subsequent FDA approval of AGAMREE® - The company's product portfolio has expanded with the acquisition of U.S. rights to FYCOMPA® in January 2023 and an exclusive North American license for vamorolone in July 2023[26](index=26&type=chunk)[27](index=27&type=chunk) - **Net Product Revenue by Product (in thousands)** | Product | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | FIRDAPSE® | $66,224 | $57,173 | $188,648 | $153,255 | | FYCOMPA® | $36,393 | $— | $98,750 | $— | | **Total** | **$102,617** | **$57,173** | **$287,398** | **$153,255** | - The acquisition of vamorolone rights from Santhera was accounted for as an asset acquisition, with the purchase price allocated to IPR&D (**$81.5 million**) and an investment in Santhera (**$13.5 million**), with the IPR&D immediately expensed to R&D as the product had not yet received regulatory approval[150](index=150&type=chunk)[151](index=151&type=chunk) - Subsequent to the quarter's end, on October 26, 2023, AGAMREE® (vamorolone) was approved by the FDA for treating Duchenne muscular dystrophy (DMD), triggering a milestone payment obligation[171](index=171&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes Q3 2023 revenue growth to FYCOMPA® and FIRDAPSE® sales, explains the net loss by a one-time IPR&D expense, and confirms sufficient liquidity despite acquisition-related cash outflows [Overview](index=34&type=section&id=Overview) This section provides a high-level summary of the company's business, strategic focus, and key developments, including product portfolio and intellectual property defense - The company is a commercial-stage biopharmaceutical firm focused on rare diseases, with three key products: FIRDAPSE® (for LEMS), FYCOMPA® (for epilepsy), and the newly licensed AGAMREE® (vamorolone) for Duchenne muscular dystrophy (DMD)[173](index=173&type=chunk)[174](index=174&type=chunk) - The company is actively defending its intellectual property for FIRDAPSE® and FYCOMPA® against multiple generic drug manufacturers that have filed Abbreviated New Drug Applications (ANDAs), with lawsuits filed triggering a 30-month stay on FDA approval for the generics[181](index=181&type=chunk)[192](index=192&type=chunk) - Following the FDA approval of AGAMREE® (vamorolone) on October 26, 2023, the company is planning a commercial launch in the U.S. during the first quarter of 2024[174](index=174&type=chunk)[199](index=199&type=chunk) [Results of Operations](index=39&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's financial performance, explaining the drivers behind revenue, cost of sales, and operating expenses - **Q3 2023 vs Q3 2022 Operating Results (in thousands)** | Item | Q3 2023 | Q3 2022 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | $102,617 | $57,173 | $45,444 | 79.5% | | Cost of Sales | $14,167 | $9,665 | $4,502 | 46.6% | | R&D Expenses | $83,662 | $8,310 | $75,352 | 906.8% | | SG&A Expenses | $33,560 | $13,649 | $19,911 | 145.9% | | Net Income (Loss) | $(30,764) | $22,748 | $(53,512) | -235.2% | - The increase in net product revenue was driven by the acquisition of FYCOMPA® (contributing **$36.4 million** in Q3 2023) and a **9% increase** in FIRDAPSE® sales volume[218](index=218&type=chunk)[219](index=219&type=chunk) - The primary driver for the increase in R&D expenses was the **$81.5 million** IPR&D charge for the vamorolone license acquisition in Q3 2023[223](index=223&type=chunk) - SG&A expenses increased significantly due to commercialization costs for FYCOMPA®, including transition service fees and the hiring of a dedicated sales force[226](index=226&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's ability to meet its financial obligations, detailing cash position, working capital, and significant cash flow activities - As of September 30, 2023, the company had cash and cash equivalents of **$121.0 million** and working capital of **$134.2 million**, down from **$298.4 million** and **$263.2 million**, respectively, at year-end 2022[235](index=235&type=chunk) - Major cash outflows in 2023 included approximately **$162 million** for the FYCOMPA® acquisition, approximately **$95 million** for the vamorolone license and Santhera equity investment, and a **$10 million** payment to Jacobus for the RUZURGI® acquisition[235](index=235&type=chunk) - The company filed a **$500 million** shelf registration statement on September 8, 2023, providing flexibility for future capital raises, though no offerings have been completed under it yet[241](index=241&type=chunk) - A regulatory milestone payment of **$36 million** for AGAMREE® became due upon its FDA approval on October 26, 2023, and will be paid in the fourth quarter of 2023[250](index=250&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=46&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's primary market risk is interest rate exposure on its cash and cash equivalents, managed through investments in highly liquid instruments without derivatives - The company's market risk is confined to interest rate risk on its cash and cash equivalents[257](index=257&type=chunk)[258](index=258&type=chunk) [Item 4. Controls and Procedures](index=46&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal controls - As of September 30, 2023, the company's disclosure controls and procedures were deemed effective by management[262](index=262&type=chunk) [PART II. OTHER INFORMATION](index=47&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in significant patent litigation, having filed lawsuits against generic manufacturers for FIRDAPSE® and FYCOMPA®, triggering 30-month FDA approval stays - The company has initiated patent infringement lawsuits against three generic manufacturers for FIRDAPSE® and one manufacturer for FYCOMPA® following their Paragraph IV ANDA filings[264](index=264&type=chunk)[266](index=266&type=chunk) - These legal actions have triggered a statutory **30-month stay**, preventing the FDA from approving the generic versions of FIRDAPSE® until at least May 2026, and also staying the approval for the FYCOMPA® generics, absent an earlier court decision[264](index=264&type=chunk)[266](index=266&type=chunk) [Item 1A. Risk Factors](index=48&type=section&id=Item%201A.%20Risk%20Factors) This section refers readers to the 2022 Form 10-K for detailed risk factors, noting no material changes to previously disclosed risks - The report directs investors to the Risk Factors section of the 2022 Form 10-K for a comprehensive discussion of potential risks[268](index=268&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=48&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company did not repurchase common stock in Q3 2023, prioritizing cash for business development, with $21 million remaining under the repurchase program - No shares were repurchased during the three months ended September 30, 2023[269](index=269&type=chunk) - The company is prioritizing cash for business development over share repurchases at present[269](index=269&type=chunk) [Item 5. Other Information](index=49&type=section&id=Item%205.%20Other%20Information) The company announced a CEO transition, with Richard R. Daly appointed to succeed retiring Patrick J. McEnany, effective January 1, 2024 - A CEO transition is underway, with Richard R. Daly appointed to take over from the retiring Patrick J. McEnany on January 1, 2024[271](index=271&type=chunk)

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q2 2023 Earnings Conference Call August 10, 2023 8:30 AM ET Company Participants Alicia Grande - Vice President, Chief Financial Officer and Treasurer Patrick McEnany - Chairman and Chief Executive Officer Jeffrey Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer and Chief Scientific Officer Conference Call Participants Joe Catanzaro - Piper Sandler Les Sulewski - Truist Securities Charles Duncan - Cantor Fitzgerald Operator Hello, and ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [Mark One] ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File No. 001-33057 CATALYST PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 76-0837053 (State or other jurisdiction of incorporat ...

Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Patrick McEnany - Chairman, Chief Executive Officer Alicia Grande - Vice President, Chief Financial Officer Jeff Del Carmen - Chief Commercial Officer Steven Miller - Chief Operating Officer, Chief Scientific Officer Conference Call Participants Les Sulewski - Truist Securities Joe Catanzaro - Piper Sandler Pete Stavropoulos - Cantor Fitzgerald Operator Greetings and welcome to the Catal ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20FINANCIAL%20STATEMENTS) This section presents the unaudited consolidated financial statements for Catalyst Pharmaceuticals, Inc. as of March 31, 2023, and for the three months ended March 31, 2023, and 2022 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) Total assets increased to **$407.2 million**, primarily due to the FYCOMPA® acquisition, with stockholders' equity rising to **$333.7 million** Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $148,247 | $298,395 | | Total current assets | $198,911 | $320,806 | | License and acquired intangibles, net | $184,083 | $32,471 | | **Total assets** | **$407,227** | **$375,630** | | **Liabilities & Equity** | | | | Total current liabilities | $56,709 | $57,588 | | **Total liabilities** | **$73,566** | **$75,209** | | **Total stockholders' equity** | **$333,661** | **$300,421** | [Consolidated Statements of Operations and Comprehensive Income](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income) Revenues nearly doubled to **$85.4 million**, with net income more than doubling to **$29.6 million**, primarily due to the FYCOMPA® acquisition Q1 2023 vs Q1 2022 Statement of Operations (in thousands, except per share data) | Metric | Q1 2023 (unaudited) | Q1 2022 (unaudited) | | :--- | :--- | :--- | | Product revenue, net | $85,304 | $43,033 | | Total revenues | $85,366 | $43,089 | | Total operating costs and expenses | $49,757 | $25,723 | | Operating income | $35,609 | $17,366 | | **Net income** | **$29,568** | **$13,241** | | **Diluted EPS** | **$0.26** | **$0.12** | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Operating cash flow was **$12.1 million**, with **$162.4 million** used for the FYCOMPA® acquisition, reducing cash to **$148.2 million** Cash Flow Summary for Three Months Ended March 31 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $12,070 | $8,478 | | Net cash used in investing activities | ($162,367) | $0 | | Net cash provided by (used in) financing activities | $149 | ($1,551) | | **Net decrease in cash** | **($150,148)** | **$6,927** | | **Cash at end of period** | **$148,247** | **$178,372** | [Notes to Unaudited Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) Notes detail the FYCOMPA® acquisition, revenue recognition for FIRDAPSE® and FYCOMPA®, and contractual obligations - The company is a commercial-stage biopharmaceutical firm focused on rare neurological and epileptic diseases, with main products FIRDAPSE® and FYCOMPA®[55](index=55&type=chunk) - On January 24, 2023, the company acquired the U.S. rights to FYCOMPA® from Eisai Co., Ltd. and is now marketing it in the United States[29](index=29&type=chunk) - The company sells FIRDAPSE® through an exclusive U.S. distributor and sells FYCOMPA® directly to major wholesalers and distributors[64](index=64&type=chunk) Net Product Revenue by Product (in thousands) | Product | For the Three Months Ended March 31, 2023 | For the Three Months Ended March 31, 2022 | | :--- | :--- | :--- | | FIRDAPSE® | $57,526 | $43,033 | | FYCOMPA® | $27,778 | — | | **Total product revenue, net** | **$85,304** | **$43,033** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=31&type=section&id=Item%202.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Management discusses Q1 2023 financial performance, highlighting revenue and net income growth from the FYCOMPA® acquisition [Overview](index=31&type=section&id=Overview) Catalyst, a biopharmaceutical company, expanded its portfolio with the FYCOMPA® acquisition for rare neurological diseases - The company's flagship U.S. commercial product is FIRDAPSE® for LEMS, and it recently acquired the U.S. rights to FYCOMPA® for epilepsy from Eisai, closing the deal on **January 24, 2023**[153](index=153&type=chunk) - The company is pursuing a strategy to broaden and diversify its drug portfolio through acquisitions of early or late-stage products, companies, or technology platforms in rare disease and CNS therapeutic categories[203](index=203&type=chunk) [Results of Operations](index=36&type=section&id=Results%20of%20Operations) Total revenues increased **98%** to **$85.4 million**, driven by FIRDAPSE® and FYCOMPA® sales, leading to a **124%** net income increase Q1 2023 vs Q1 2022 Revenue Breakdown (in millions) | Product | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | FIRDAPSE® Sales | $57.5 | $43.0 | | FYCOMPA® Sales | $27.8 | $0.0 | | **Total Product Revenue** | **$85.3** | **$43.0** | - The increase in net revenues was due to the acquisition of FYCOMPA® and a **21%** increase in FIRDAPSE® sales volumes, which included patients transferred from RUZURGI® in 2022[238](index=238&type=chunk) - Amortization of intangible assets was **$6.5 million** in Q1 2023, a new expense related to the FYCOMPA® and RUZURGI® rights acquisitions, compared to **$0** in Q1 2022[192](index=192&type=chunk) - Selling, general and administrative (SG&A) expenses increased by **$13.3 million**, primarily due to **$8.5 million** in transition service fees for FYCOMPA® and a **$1.5 million** increase in employee compensation[219](index=219&type=chunk) Net Income Comparison (in millions, except per share data) | Metric | Q1 2023 | Q1 2022 | | :--- | :--- | :--- | | Net Income | $29.6 | $13.2 | | Diluted EPS | $0.26 | $0.12 | [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) Cash decreased to **$148.2 million** due to the **$162 million** FYCOMPA® acquisition, but remains sufficient for future operations - Cash and cash equivalents decreased to **$148.2 million** at March 31, 2023, from **$298.4 million** at December 31, 2022, mainly because the company used approximately **$162 million** to acquire the U.S. rights to FYCOMPA®[246](index=246&type=chunk) - Net cash from operating activities was **$12.1 million** for Q1 2023, with an increase in accounts receivable from FYCOMPA® sales partially offsetting cash generated from net income[250](index=250&type=chunk) - Contractual obligations include royalties on FIRDAPSE® sales, deferred payments and future royalties for the RUZURGI® settlement, and potential milestone and royalty payments for the FYCOMPA® acquisition[252](index=252&type=chunk)[268](index=268&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=42&type=section&id=Item%203.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURE%20ABOUT%20MARKET%20RISK) Market risk is limited to interest rate fluctuations on cash and equivalents, with a focus on capital preservation - The company's primary market risk is interest rate fluctuations affecting its cash and cash equivalents invested in money market funds and U.S. Treasuries[273](index=273&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20CONTROLS%20AND%20PROCEDURES) Disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal controls - Management concluded that as of **March 31, 2023**, the company's disclosure controls and procedures were effective[274](index=274&type=chunk) - No material changes were made to the company's internal control over financial reporting during the first quarter of 2023[274](index=274&type=chunk) [PART II. OTHER INFORMATION](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20LEGAL%20PROCEEDINGS) The company initiated patent lawsuits against generic manufacturers for FIRDAPSE® and FYCOMPA®, triggering 30-month FDA approval stays - In January 2023, the company received Paragraph IV notice letters from three generic drug manufacturers seeking to market a generic version of FIRDAPSE®[118](index=118&type=chunk)[174](index=174&type=chunk) - The company filed patent infringement lawsuits against the three generic manufacturers on **March 1, 2023**, triggering an automatic **30-month** stay of FDA approval for the generic FIRDAPSE® products until **May 2026** or a court decision[118](index=118&type=chunk)[261](index=261&type=chunk) - In February 2023, the company received Paragraph IV notice letters for generic versions of FYCOMPA® tablets and oral suspension, and subsequently filed lawsuits on **April 5, 2023**, triggering a **30-month** stay for those applications as well[202](index=202&type=chunk)[262](index=262&type=chunk)[297](index=297&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20RISK%20FACTORS) No material changes to risk factors were reported, referring readers to the 2022 Annual Report on Form 10-K for details - The company refers to its **2022 Annual Report on Form 10-K** for a description of significant risk factors affecting the business[280](index=280&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20UNREGISTERED%20SALES%20OF%20EQUITY%20SECURITIES%20AND%20USE%20OF%20PROCEEDS) No shares were repurchased under the **$40 million** program in Q1 2023, as cash is being retained for business development Issuer Purchases of Equity Securities (Q1 2023) | Period | Total Number of Shares Purchased | Average Price Paid Per Share | Dollar Value of Shares that May Yet Be Purchased (in thousands) | | :--- | :--- | :--- | :--- | | Jan 2023 | — | $ — | $21,003 | | Feb 2023 | — | $ — | $21,003 | | Mar 2023 | — | $ — | $21,003 | - The company is not currently purchasing shares under its repurchase program, instead opting to retain cash for business development[281](index=281&type=chunk)

Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) Q4 2022 Earnings Conference Call March 16, 2023 8:30 AM ET Company Participants Alicia Grande - VP, CFO, and Treasurer Patrick J. McEnany - Chairman, President, and CEO Jeff Del Carmen - Chief Commercial Officer Steven R. Miller - COO and CSO Conference Call Participants Joseph Catanzaro - Piper Sandler Pete Stavropoulos - Cantor Fitzgerald Unidentified Analyst - Truist Securities Scott Henry - ROTH Capital Partners Operator Greetings and welcome to the Catalyst ...

Financial Performance - For the year ended December 31, 2022, the company recognized $213.9 million in net revenue from product sales of FIRDAPSE®, a 55% increase from $138.0 million in 2021, driven by a 49% increase in sales volume [46]. - Selling, general and administrative expenses increased to approximately $58.2 million in 2022, up from $49.6 million in 2021, accounting for 52% of total operating costs [31]. - Other income for 2022 was $2.9 million, up from $0.3 million in 2021, attributed to higher yields on investments and increased invested balances [50]. - Total selling, general, and administrative expenses for 2022 were $58.2 million, a 17.2% increase from $49.6 million in 2021 [58]. - Employee stock-based compensation increased to $7.9 million in 2022 from $6.1 million in 2021, reflecting a 29.5% rise [59]. - As of December 31, 2022, the company had cash and investments of approximately $298 million, which decreased to $136 million after the FYCOMPA® acquisition [92]. Research and Development - The company incurred total research and development expenses of $19.8 million for the year ended December 31, 2022, representing a 16.8% increase from $16.9 million in 2021 [30]. - Research and development expenses for 2022 were approximately $19.8 million, representing about 18% of total operating costs, an increase of $2.9 million from 2021 [48]. - The increase in research and development expenses was primarily due to a one-time acquisition of RUZURGI® inventory costing approximately $4.1 million [48]. - The company expects substantial research and development expenses to continue in 2023 as it seeks to acquire innovative technology platforms in rare disease categories [48]. Acquisitions and Partnerships - The acquisition of FYCOMPA® included an upfront payment of $160 million and a potential additional payment of $25 million if a patent extension is approved [34]. - The company is exploring additional opportunities to acquire companies with commercial drug products or products in development to diversify its portfolio [34]. - The company has entered into a definitive agreement with Endo for the development and commercialization of generic Sabril® tablets, with an upfront payment of $500,000 and a potential milestone payment of $2.0 million [61]. - The company is exploring additional acquisition opportunities in rare disease and CNS therapeutic categories to diversify its product portfolio [91]. Product Development and Marketing - FYCOMPA® is the first and only AED targeting the AMPA receptor, with ongoing efforts to market this product [54]. - The company expects to hire approximately 34 sales and marketing personnel to support the marketing of FYCOMPA® [34]. - FYCOMPA® is expected to be marketed by the company through its own sales team starting May 2023, with plans to hire approximately 34 sales and marketing personnel [89]. - The company plans to expand FIRDAPSE® commercialization efforts into Japan and other Asian territories upon approval [93]. Regulatory and Legal Matters - The company filed lawsuits against three generic drug manufacturers to protect its patents for FIRDAPSE® following Paragraph IV Certification Notice Letters received in January 2023 [33]. - The company has filed lawsuits against three generic drug manufacturers following Paragraph IV Certification Notice Letters received in January 2023, which challenge the validity of six patents listed in the FDA Orange Book for FIRDAPSE® [128]. - The company is required to conduct a pediatric safety study and has established a pregnancy surveillance program for FIRDAPSE® [112]. Market and Competitive Landscape - The pharmaceutical industry is highly competitive, with many organizations having greater resources than the company [66]. - The company faces significant competition in the biotechnology and pharmaceutical industries, with competitors having greater financial resources and experience [204]. - The commercial success of the company's drug products will depend on third-party payor coverage and reimbursement, which may not be sufficient to ensure profitability [212]. Patient Access and Support Programs - The company has a co-pay assistance program that reduces out-of-pocket costs for LEMS patients to no more than $10.00 per month, currently averaging less than $2.00 per month [88]. - The company is committed to patient access programs to ensure no LEMS patient is denied access to FIRDAPSE® for financial reasons [93]. - Catalyst Pathways® is a personalized treatment support program that assists patients in managing the dosing and titration regimen for FIRDAPSE® [82]. Intellectual Property and Patent Protection - The company aims to maintain its patent protection for FIRDAPSE® to prevent generic competition after orphan drug exclusivity expires [86]. - The company holds patent rights for FIRDAPSE® with a patent expiration date of April 7, 2034, protecting specific dosing regimens [127]. - Catalyst Pharmaceuticals emphasizes the importance of protecting its intellectual property and regulatory exclusivities as a strategic priority for future success [128]. Operational Challenges - The company is reliant on third-party contract manufacturers for production, which poses risks related to compliance with current good manufacturing practices (cGMP) and potential disruptions in supply [209]. - The ongoing COVID-19 pandemic may adversely affect the company's business operations and financial results [219]. - The company may encounter difficulties in managing growth, which could adversely affect its financial condition and operational results [211].