Jacobus Pharmaceutical Co., Inc.

Achieved Record Q3 2022 FIRDAPSE® Net Revenue of $57.2 Million, a 59.3% YoY Increase Company Increases Full Year 2022 Total Revenue Guidance to $205-210 Million Q3 2022 GAAP Net Income of $22.7 Million ($0.22 per basic and $0.20 per diluted share), which Includes a One Time Charge of $4.1 Million Related to the Acquisition of Ruzurgi® Cash and Short-Term Investments Increased in Q3 2022 by $35.3 Million to $256.1 Million Non-GAAP Net Income for Q3 2022 of $28.6 Million ($0.28 per basic share and $0.26 per diluted share) Company to Host a Conference Call and Webcast on November 10, 2022, at 8:30 AM ET CORAL GABLES, Fla., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today reported financial results and provided a corporate update for the third quarter of 2022. "Catalyst delivered another solid quarter driven by record net revenues that exceeded expectations, marking this as another strong quarter of sequential growth of our FIRDAPSE® brand. These results reflect our exceptional commercial execution and continued commitment to the patient community that we serve," said Patrick J. McEnany, Chairman and CEO of Catalyst. "Coupled with sustained organic growth, several significant milestones were achieved during the quarter that further enhance the commercial runway and long-term growth potential for FIRDAPSE®. The extraordinary execution across all segments of our business underscores our core competencies and adds further confidence that we are on the right path to achieving our long-term goals. With robust year-to-date performance and continued momentum going into the fourth quarter, we are raising our 2022 full year total revenue guidance to $205-210 million." McEnany continued, "During the quarter, our priorities continued to be focused on commercial execution, preparing for the launch of our thoracic oncology programs to reach small-cell lung cancer patients with LEMS and diversifying our product portfolio with the acquisition of innovative therapies that address unmet medical needs in rare diseases. Moving ahead, we are well positioned to continue to drive organic growth as we look to strengthen our business with strategic opportunities that translate into added long-term value creation for all of our stakeholders." RECENT BUSINESS HIGHLIGHTS Achieved all-time high net FIRDAPSE® product revenue of $57.2 million for Q3 2022, representing robust growth of 59.3% year-over-year increase and a 7.8% increase compared to Q2 2022.In July 2022, completed the acquisition of Ruzurgi®, including the acquisition of intellectual property and inventory and a license for commercial rights in the U.S. and Mexico, which settled U.S. patent litigation and pending disputes in the U.S. between Catalyst and Jacobus Pharmaceutical Company, Inc.In September 2022, received FDA approval of the supplemental New Drug Application for FIRDAPSE®, expanding the indicated age range to include pediatric patients six years of age and older for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS").Enhanced intellectual property portfolio with an additional patent listed in the Orange Book with an expiry date of February 25, 2037, bringing the total number of U.S. patents listed to six.Advanced Environmental, Social, and Governance ("ESG") initiatives through the launch of a comprehensive assessment of key ESG topics to identify appreciable targets for sustainability activities. Expect inaugural ESG Report in the first half of next year.On September 15th Catalyst was added to the S&P SmallCap 600 Index. For inclusion in the index, a stock must have a market cap that ranges from $850 million to $3.7 billion.In the third quarter of 2022 we were ranked #39 in the 2022 Fortune 100 Fastest Growing Companies List.Recently awarded the BioFlorida 2022 "David J. Gury Company of the Year” for the achievement of significant milestones and contributions to the growth of Florida's life science industry.Advanced strategic growth initiatives to diversify our product portfolio with innovative therapies that address unmet needs in rare diseases. Third Quarter 2022 Financial Results Revenue: Product revenue, net in the third quarter of 2022, was $57.2 million, compared to $35.9 million for the third quarter of 2021, representing an increase of 59.3% year-over-year. Total revenue for the third quarter of 2022 was $57.2 million, compared to $36.0 million for the third quarter of 2021, representing an increase of 59.2% year-over-year. Research and development expenses: Research and development expenses in the third quarter of 2022 were $8.3 million, compared to $4.5 million in the third quarter of 2021. In connection with the Q3-22 Ruzurgi® acquisition, a one-time expense of $4.1 million related to the write-off of acquired inventory was included in R&D. Selling, general, and administrative expenses: Selling, general, and administrative expenses for the third quarter of 2022 were $14.2 million, compared to $12.2 million in the third quarter of 2021. Operating income: Operating income for the third quarter of 2022 was $25.1 million, compared to $14.0 million in the third quarter of 2021, representing an increase of 79.2% year-over-year. GAAP net income: GAAP net income for the third quarter of 2022 was $22.7 million ($0.22 per basic and $0.20 per diluted share), compared to $10.3 million ($0.10 per basic and diluted share) for the third quarter of 2021. Non-GAAP Financial Measures Non-GAAP1 net income for the third quarter of 2022 was $28.6 million ($0.28 per basic and $0.26 per diluted share), which excludes from GAAP net income of $22.7 million (i) stock-based compensation expense of $2.1 million, (ii) depreciation of $35 thousand, (iii) amortization of $518 thousand, and (iv) the provision for income taxes of $3.3 million. This compares to Non-GAAP1 net income for the third quarter of 2021 of $15.6 million ($0.15 per basic and $0.14 per diluted share), which excludes from GAAP net income of $10.3 million (i) stock-based compensation of $1.5 million, (ii) depreciation of $31 thousand, and (iii) the provision for income taxes of $3.7 million. Cash and investments: Cash and investments were $256.1 million as of September 30, 2022. Share repurchase program: The Company implemented a share repurchase program in March 2021. As of September 30, 2022, the Company had repurchased approximately 3.2 million shares of Catalyst common stock in the open market, at an average price of $5.92 per share, for a total purchase price of approximately $19.0 million. As of now the Company has suspended share repurchases to conserve cash for business development activities. More detailed financial information and analysis regarding the Company's financial position at September 30, 2022, and its results of operations for the three and nine months ended on that date can be found in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, which was filed with the U.S. Securities and Exchange Commission ("SEC") on November 9, 2022. 2022 Financial Guidance: The Company has increased its forecast for the full year 2022 total revenues to be in the range of between $205 million and $210 million, representing a 46% - 49% increase in total revenues compared to 2021, with cash operating expenses for the full year 2022 expected to be in the range of $65 million to $70 million and non-GAAP net income expected to be in the range of $100-105 million. Key guidance assumptions included in these forecasts reflect, among other risks, continued recovery in healthcare activity throughout 2022 as it relates to the current COVID-19 environment. 1 Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with the U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies. The non-GAAP financial measure in this press release excludes from the calculation of net income (i) the expense associated with non-cash, stock-based compensation, (ii) non-cash depreciation and amortization expense, and (iii) the provision for income taxes. Non-GAAP income per share is calculated by dividing non-GAAP income by the weighted average common shares outstanding. Conference Call & Webcast DetailsThe Company will host a conference call and webcast on Thursday, November 10, 2022, at 8:30 AM ET to discuss the financial results and provide a business update. US/Canada Dial-in Number: (866) 682-6100International Dial-in Number: (862) 298-0702 A webcast and accompanying materials will be accessible under the investor section on the Company's website at www.catalystpharma.com. A webcast replay will be available on the Catalyst website for 30 days following the date of the event. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA") and FIRDAPSE® is commercially available in the United States as a treatment for adults and children ages six to seventeen with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE® for the treatment of adult patients in Canada with LEMS. For additional information about the Company, please visit www.catalystpharma.com. Forward-Looking StatementsThis press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the effect of the COVID-19 pandemic on Catalyst's business and results of operations, (ii) Catalyst's ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst's ability to sell products acquired that are already approved and to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst's total revenue, cash operating expense, and non-GAAP net income forecasts for 2022 will prove to be accurate, (v) whether Catalyst's patents listed in the Orange Book will be sufficient to eliminate generic competition for FIRDAPSE® after our orphan drug exclusivity for FIRDAPSE® for LEMS expires in late November 2025, (vi) whether legislative changes currently being considered by Congress that are intended to reduce the cost of prescription drug products will adversely affect Catalyst, and (vii) those factors described in Catalyst's Annual Report on Form 10-K for the 2021 fiscal year and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc. CATALYST PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share data) For the Three MonthsEnded September 30, For the Nine MonthsEnded September 30, 2022 2021 2022 2021Product revenue, net $57,173 $35,890 $153,255 $99,731License and other revenue 71 64 191 2,793Total revenues 57,244 35,954 153,446 102,524 Operating costs and expenses: Cost of sales 9,665 5,310 23,198 14,536Research and development 8,310 4,487 15,696 11,944Selling, general and administrative 14,167 12,153 43,515 36,401Total operating costs and expenses 32,142 21,950 82,409 62,881Operating income 25,102 14,004 71,037 39,643Other income (expense), net 905 68 674 211Net income before income taxes 26,007 14,072 71,711 39,854Income tax provision 3,259 3,743 14,103 9,681Net income $22,748 $10,329 $57,608 $30,173 Net income per share: Basic$0.22 $0.10 $0.56 $0.29Diluted$0.20 $0.10 $0.52 $0.28 Weighted average shares outstanding: Basic 103,318,572 103,196,550 102,967,280 103,470,762Diluted 111,986,025 107,843,196 110,352,214 107,476,175 CATALYST PHARMACEUTICALS, INC. RECONCILIATION OF NON-GAAP METRICS (unaudited) (in thousands, except share data) For the Three MonthsEnded September 30, For the Nine MonthsEnded September 30, 2022 2021 2022 2021GAAP net income$ 22,748 $ 10,329 $ 57,608 $ 30,173 Non-GAAP adjustments: Stock-based compensation expense 2,055 1,512 5,981 4,601Depreciation 35 31 106 159Amortization 518 -- 518 --Income tax provision 3,259 3,743 14,103 9,681Non-GAAP net income $28,615 $15,615 $78,316 $44,614 Non-GAAP net income per share: Basic$0.28 $0.15 $0.76 $0.43Diluted$0.26 $0.14 $0.71 $0.42 Weighted average shares outstanding: Basic 103,318,572 103,196,550 102,967,280 103,470,762Diluted 111,986,025 107,843,196 110,352,214 107,476,175 CATALYST PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands) September 30,2022 December 31, 2021 (unaudited) ASSETS Current Assets: Cash and cash equivalents $256,065 $171,445Short-term investments -- 19,821Accounts receivable, net 9,337 6,619Inventory 7,132 7,870Prepaid expenses and other current assets 3,776 4,351Total current assets 276,310 210,106Operating lease right-of-use asset 2,833 3,017Property and equipment, net 882 959License and acquired intangibles, net 33,051 --Deferred tax assets, net 20,029 23,697Deposits 9 9Total assets $333,114 $237,788 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $2,529 $2,768Accrued expenses and other liabilities 42,152 24,295Total current liabilities 44,681 27,063Operating lease liability, net of current portion 3,643 3,894Other non-current liabilities 14,749 --Total liabilities 63,073 30,957Total stockholders’ equity 270,041 206,831Total liabilities and stockholders’ equity $333,114 $237,788

Achieved Record Q2 2022 FIRDAPSE® Net Product Revenues of $53.0 Million, a 57.7% YoY Increase Cash and Short-Term Investments at June 30, 2022 were $220.8 Million, with No Funded Debt Completed Acquisition of Ruzurgi® U.S. and Mexico Commercial Rights Advanced Plans to Diversify Portfolio and Invest in Innovative Rare Disease Opportunities Provides Guidance that Full-Year 2022 Adjusted EBITDA to be Between $100-105 Million Listing New Orange Book Patent Potentially Extends FIRDAPSE Patent Protection to 2037 Company to Host a Conference Call and Webcast on August 10, 2022, at 8:30 AM EDT CORAL GABLES, Fla., Aug. 09, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc.("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today reported financial results for the second quarter 2022 and provided a corporate update. These results marked a quarter of record revenues from FIRDAPSE net sales and reflect the 5th period of consecutive quarter-over-quarter growth for Catalyst. "Catalyst's performance in the first half of the year and into the third quarter continues to be on a strong footing, and we have gained great momentum toward achieving our key strategic objectives for the year,” stated Patrick J. McEnany, Chairman and CEO of Catalyst. “We are pleased with the continued uptake of FIRDAPSE and patient demand, partially resulting from the favorable Appellate Court ruling that removed Ruzurgi from the market on February 1, 2022, as well as robust organic growth, which is providing strong operational growth in line with our total revenue guidance for 2022. In fact, at this time we are comfortable stating that our revenue guidance for the year is expected to be at the upper end of our previous total revenue forecast.” McEnany continued, “We intend to build on our momentum with a clear priority to diversify our product portfolio with innovative therapies that address unmet medical needs in other rare diseases. Looking ahead, we are optimistic about our future as we remain committed to the patient community we serve and confident in our full-year outlook to drive sustainable growth and create long-term value for our various stakeholders. These efforts along with our continued fiscal discipline, uniquely position Catalyst to deliver sustainable value for our stockholders while supporting our mission for people living with rare diseases.” RECENT BUSINESS HIGHLIGHTS Achieved record net product revenue of $53.0 million for Q2 2022, representing a significant 57.7% year-over-year increase and a 23.3% increase compared to Q1 2022, driven by the transition of Ruzurgi patients converting to FIRDAPSE treatment and robust organic growth. Settled our U.S. disputes with Jacobus Pharmaceuticals, which included a settlement of our U.S. patent infringement litigation against Jacobus and a resolution of our litigation challenging the Ruzurgi approval. As part of the settlement, we acquired the U.S. and Mexico rights to develop and commercialize Ruzurgi, the existing inventory of Ruzurgi, and certain know-how and intellectual property, including two U.S. patents. We intend to list one of these patents in the FDA’s Orange Book to add to our patent protection for FIRDAPSE, potentially extending our patent protection for FIRDAPSE until February 25, 2037, and bringing the total number of U.S. patents that we have listed in the Orange Book seeking to protect FIRDAPSE to six. FDA accepted for review our supplemental New Drug Application seeking approval for the use of FIRDAPSE as a treatment for pediatric LEMS patients. Continued to advance on strategic growth initiatives to diversify our product portfolio with innovative therapies that address unmet needs in other rare diseases. Established a framework for our initial Environmental, Social, and Governance report. Second Quarter 2022 Financial Results Revenue: Product revenue, net in the second quarter of 2022 was $53.0 million, compared to $33.6 million for the second quarter of 2021, representing an increase of 57.7% year-over-year. Total revenue for the second quarter of 2022 was $53.1 million, compared to $36.4 million for the second quarter of 2021, representing an increase of 46.1% year-over-year. Research and development expenses: R&D expenses in the second quarter of 2022 were $4.0 million, compared to R&D expenses of $4.5 million in the second quarter of 2021. Selling, general, and administrative expenses: Selling, general, and administrative expenses for the second quarter of 2022 were $12.9 million, compared to $11.5 million in the second quarter of 2021. Operating income: Operating income for the second quarter of 2022 was $28.6 million, compared to $15.8 million in the second quarter of 2021, representing an increase of 80.4% year-over-year. GAAP Net Income for the second quarter of 2022 was $21.6 million ($0.21 per basic and $0.20 per diluted share), compared to $12.2 million ($0.12 per basic and $0.11 per diluted share) for the second quarter of 2021. Non-GAAP Financial Measures Non-GAAP1 net income for the second quarter of 2022 was $30.3 million ($0.29 per basic and $0.28 per diluted share), which excludes from GAAP net income of $21.6 million (i) stock-based compensation expense of $2.0 million, (ii) depreciation of $37 thousand, and (iii) the provision for income taxes of $6.6 million. This compares to non-GAAP1 net income for the second quarter of 2021 of $17.4 million ($0.17 per basic and $0.16 per diluted share), which excludes from GAAP net income of $12.2 million (i) stock-based compensation of $1.5 million, (ii) depreciation of $31 thousand, and (iii) the provision for income taxes of $3.7 million. Cash and investments were $220.8 million as of June 30, 2022, with no funded debt. Share repurchase program: The Company implemented a share repurchase program in March 2021. As of June 30, 2022, the Company had repurchased approximately 3.2 million shares of Catalyst common stock in the open market, at an average price of $5.92 per share, for a total purchase price of approximately $19.0 million. More detailed financial information and analysis regarding the Company's financial position at June 30, 2022 and its results of operations for the three and six months ended on that date can be found in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 that was filed with the U.S. Securities and Exchange Commission (“SEC”) on August 9, 2022. 2022 Financial Guidance: The Company continues to forecast that its full year 2022 total revenues will be in the range of between $195 million and $205 million, representing a 38% - 45% increase in total revenues compared to 2021, with cash operating expenses for the full year 2022 expected to be in the range of $65 million to $70 million and adjusted EBITDA (calculated in the same manner as non-GAAP net income) expected to be in the range of $100-105 million. Key guidance assumptions included in these forecasts reflect, among other risks, continued recovery in healthcare activity throughout 2022 as it relates to the current COVID-19 environment. 1 Statements made in this press release include non-GAAP financial measures. Such information is provided as additional information and not as an alternative to Catalyst's financial statements presented in accordance with the U.S. generally accepted accounting principles (GAAP). These non-GAAP financial measures are intended to enhance an overall understanding of Catalyst's current financial performance. Catalyst believes that the non-GAAP financial measures presented in this press release provide investors and prospective investors with an alternative method for assessing Catalyst's operating results in a manner that Catalyst believes is focused on the performance of ongoing operations and provides a more consistent basis for comparison between periods. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP accounting. Further, non-GAAP measures of net income used by Catalyst may be different from and not directly comparable to similarly titled measures used by other companies. The non-GAAP financial measure in this press release excludes from the calculation of net income (i) the expense associated with non-cash, stock-based compensation, (ii) depreciation expense, and (iii) the provision for income taxes. Non-GAAP income per share is calculated by dividing non-GAAP income by the weighted average common shares outstanding. Conference Call & Webcast Details The Company will host a conference call and webcast on Wednesday, August 10, 2022, at 8:30 AM ET to discuss the financial results and provide a business update. US/Canada Dial-in Number: (877) 407-8912 International Dial-in Number: (201) 689-8059 A webcast and accompanying materials will be accessible under the investor section on the Company's website at . A webcast replay will be available on the Catalyst website for 30 days following the date of the event. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) the effect of the COVID-19 pandemic on Catalyst's business and results of operations, (ii) Catalyst's ability to locate and acquire new product candidates through acquisition or in-licensing, (iii) Catalyst's ability to successfully develop any new product candidates acquired or in-licensed, (iv) whether Catalyst's total revenue, cash operating expense, and adjusted EBITDA forecasts for 2022 will prove to be accurate, (v) whether Catalyst's patents listed in the Orange Book will be sufficient to eliminate generic competition for FIRDAPSE after our orphan drug exclusivity for FIRDAPSE for LEMS expires in late November 2025, (vi) whether legislative changes currently being considered by Congress that are intended to reduce the cost of prescription drug products will adversely affect Catalyst, and (vii) those factors described in Catalyst's Annual Report on Form 10-K for the 2021 fiscal year and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc. FOR FURTHER INFORMATION, CONTACT: Media Contact Investor Contact David Schull Mary Coleman Russo Partners Catalyst Pharmaceuticals, Inc. (858) 717-2310 (305) 420-3200 david.schull@russopartnersllc.com mcoleman@catalystpharma.com CATALYST PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except share data) For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 Product revenue, net $ 53,049 $ 33,636 $ 96,082 $ 63,841 License and other revenue 64 2,729 120 2,729 Total revenues 53,113 36,365 96,202 66,570 Operating costs and expenses: Cost of sales 7,643 4,545 13,533 9,226 Research and development 3,983 4,450 7,386 7,457 Selling, general and administrative 12,918 11,532 29,348 24,248 Total operating costs and expenses 24,544 20,527 50,267 40,931 Operating income 28,569 15,838 45,935 25,639 Other income (expense), net (324 ) 62 (231 ) 143 Net income before income taxes 28,245 15,900 45,704 25,782 Income tax provision 6,626 3,719 10,844 5,938 Net income $ 21,619 $ 12,181 $ 34,860 $ 19,844 Net income per share: Basic $ 0.21 $ 0.12 $ 0.34 $ 0.19 Diluted $ 0.20 $ 0.11 $ 0.32 $ 0.18 Weighted average shares outstanding: Basic 102,795,600 103,407,803 102,788,719 103,610,138 Diluted 109,264,730 107,734,924 109,149,185 107,299,262 CATALYST PHARMACEUTICALS, INC. RECONCILIATION OF NON-GAAP METRICS (unaudited) (in thousands, except share data) For the Three Months Ended June 30, For the Six Months Ended June 30, 2022 2021 2022 2021 GAAP net income $ 21,619 $ 12,181 $ 34,860 $ 19,844 Non-GAAP adjustments: Stock-based compensation expense 2,023 1,518 3,926 3,089 Depreciation 37 31 71 128 Income tax provision 6,626 3,719 10,844 5,938 Non-GAAP net income $ 30,305 $ 17,449 $ 49,701 $ 28,999 Non-GAAP net income per share: Basic $ 0.29 $ 0.17 $ 0.48 $ 0.28 Diluted $ 0.28 $ 0.16 $ 0.46 $ 0.27 Weighted average shares outstanding: Basic 102,795,600 103,407,803 102,788,719 103,610,138 Diluted 109,264,730 107,734,924 109,149,185 107,299,262 CATALYST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2022 December 31, 2021 (unaudited) ASSETS Current Assets: Cash and cash equivalents $ 210,912 $ 171,445 Short-term investments 9,876 19,821 Accounts receivable, net 9,587 6,619 Inventory 7,850 7,870 Prepaid expenses and other current assets 4,333 4,351 Total current assets 242,558 210,106 Operating lease right-of-use asset 2,895 3,017 Property and equipment, net 917 959 Deferred tax assets, net 20,930 23,697 Deposits 9 9 Total assets $ 267,309 $ 237,788 LIABILITIES AND STOCKHOLDERS’ EQUITY Current Liabilities: Accounts payable $ 2,315 $ 2,768 Accrued expenses and other liabilities 20,173 24,295 Total current liabilities 22,488 27,063 Operating lease liability, net of current portion 3,729 3,894 Total liabilities 26,217 30,957 Total stockholders’ equity 241,092 206,831 Total liabilities and stockholders’ equity $ 267,309 $ 237,788

As Part of the Settlement, Catalyst has Acquired Certain of Jacobus’ Intellectual Property Rights, Including the U.S. and Mexico Rights to Ruzurgi®CORAL GABLES, Fla., July 12, 2022 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has settled its ongoing patent infringement litigation with Jacobus Pharmaceutical Company, Inc., ("Jacobus") and PANTHERx Rare LLC ("PANTHERx"). Catalyst had asserted in its patent litigation that Jacobus and PANTHERx induced infringement by third parties of FIRDAPSE® related patent rights in their marketing and distribution of Ruzurgi®. As part of the settlement, Catalyst will dismiss all claims related to the patent litigation between the companies and has acquired certain of Jacobus’ intellectual property rights, including the rights to develop and commercialize Ruzurgi in the U.S. and Mexico. Ruzurgi is not currently approved for distribution in the United States as a result of the FDA decision to convert the Ruzurgi approval for pediatric use to a tentative approval following a decision of the U.S. Circuit Court of Appeals for the 11th Circuit. The Appellate Court determined that the approval of the Jacobus NDA for Ruzurgi for pediatric patients violated Catalyst's orphan drug exclusivity for FIRDAPSE for the treatment of LEMS. Jacobus has also agreed to dismiss its pending Petition for a Writ of Certiorari before the U.S. Supreme Court seeking to overturn the 11th Circuit Court of Appeals decision. “We are pleased to have reached a mutually agreeable resolution to this litigation, as it removes any further litigation costs and related distractions for Catalyst. Having achieved this meaningful milestone, the plan is to address our ongoing focus on patient’s needs by continuing to supply those patients with other neuromuscular conditions currently being treated with Ruzurgi under investigator-sponsored INDs. At the same time, we will also continue to concentrate our resources on addressing the needs of the LEMS patient community while further evaluating other rare disease opportunities,” said Patrick McEnany, Chairman and Chief Executive Officer of Catalyst. "We also believe that this settlement underscores the strength of the FIRDAPSE intellectual property portfolio as well as our commitment to safeguard that patent estate which includes five Orange Book-listed patents with expiries through 2034.” “Our mission has always been to bring life-changing therapies to patients and families affected by rare diseases, and we are pleased to have reached a favorable outcome with Catalyst, which shares that same commitment,” stated Laura R. Jacobus, President of Jacobus Pharmaceutical. “We believe that this agreement represents the opportunity to build upon our accomplishments to further serve our patients.” Pursuant to the terms of the settlement, Catalyst will make a cash payment to Jacobus plus pay Jacobus a low single digit royalty on Catalyst's U.S. net sales of amifampridine. About Catalyst Pharmaceuticals Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst's New Drug Application for FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA"), and FIRDAPSE is commercially available in the United States as a treatment for adults with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. For more information, visit the Company's website at www.catalystpharma.com. Forward-Looking Statements This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including the outcome of any post-closing review of the transaction with Jacobus Pharmaceutical by regulators focused on competition concerns, and those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2021 and Catalyst's other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc.