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Catalyst Pharmaceuticals Reports Record First Quarter 2022 Financial Results And Provides Corporate Update Achieved Record Revenues of more than $43 Million, a 42.7% Increase YoY Three New Patents Issued; Now Five Orange

Key Takeaway: Catalyst Pharmaceuticals Reports Record First Quarter 2022 Financial Results And Provides Corporate Update Achieved Record Revenues of more than $43 Million, a 42.7% Increase YoY Three New Patents Issued; Now Five Orange-Book Listed Patents for FIRDAPSE Significant Cash Positi

Full Press Release Details

Catalyst Pharmaceuticals Reports Record First Quarter 2022 Financial Results And Provides Corporate Update
Achieved Record Revenues of more than $43 Million, a 42.7% Increase YoY
Three New Patents Issued; Now Five Orange-Book Listed Patents for FIRDAPSE
Significant Cash Position of $198 Million and No Funded Debt
Advanced Plans to Diversify and Invest in Innovative Rare Disease Opportunities
Reaffirms FY 2022 Total Revenue Guidance of $195 Million to $205 Million
Company to Host a Conference Call and Webcast on May 11, 2022, at 8:30 AM ET
CORAL GABLES, Fla., May 10, 2022 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 first
quarter 2022 and provided a corporate update.
I am proud of Catalyst s solid progress in the first quarter of 2022, where we delivered
record revenues, driven in part, by new patients converting to FIRDAPSE following the removal of Ruzurgi from the U. S. market in
February 2022. Our accomplishments exemplify our exceptional commercial and patient services capabilities and steadfast commitment to the LEMS patient community that we serve, said Patrick J. McEnany, Chairman and Chief Executive Officer of
Catalyst. We also achieved several meaningful milestones during the quarter, including the issuance of three new patents that we believe position us to deliver sustainable long-term growth for FIRDAPSE. We anticipate this to be a
transformative year for Catalyst, as we work with increased momentum to diversify and invest in innovative therapeutic opportunities for rare diseases. We approach these objectives from a position of strength and look forward to enhancing our growth
potential near-term, as well as adding long-term value for all of our stakeholders.
RECENT BUSINESS HIGHLIGHTS
First Quarter 2022 Financial Results
Total revenue: Total revenue in the first quarter of 2022 was $43.1 million, compared to $30.2 million for the first quarter of
2021, representing an increase of 42.7% year-over-year.
Research and development expenses: R&D expenses in the first quarter of 2022 were
$3.4 million, compared to R&D expenses of $3.0 million in the first quarter of 2021.
Selling, general, and administrative expenses:
Selling, general, and administrative expenses for the first quarter of 2022 were $16.4 million, compared to $12.7 million in the first quarter of 2021.
Operating income: Operating income for the first quarter of 2022 was $17.4 million, compared to $9.8 million in the first
quarter of 2021, representing an increase of 77.2% year-over-year.
GAAP Net Income for the first quarter of 2022 was $13.2 million ($0.13 per
basic and $0.12 per diluted share), compared to $7.7 million ($0.07 per basic and diluted share) for the first quarter of 2021, representing a year-over-year increase of 72.8%.
Non-GAAP Financial Measures
Non-GAAP1 net income for the first quarter of 2022 was
$19.4 million ($0.19 per basic and $0.18 per diluted share), which excludes from GAAP net income of $13.2 million (i) stock-based compensation expense of $1.9 million, (ii) depreciation of $34 thousand, and
(iii) the provision for income taxes of $4.2 million. This compares to non-GAAP1 net income for the first quarter of 2021 of $11.6 million
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.
basic and diluted share), which excludes from GAAP net income of $7.7 million (i) stock-based compensation expense of $1.6 million, (ii) depreciation of $97 thousand, and
(iii) a provision for income taxes of $2.2 million. A tabular presentation of non-GAAP1 net income for the three months ended March 31, 2022
and 2021 is included below.
More detailed financial information and analysis can be found in the Company s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, which was filed with the Securities and Exchange Commission ( SEC ) on May 10, 2022.
Cash and investments were $198 million as of March 31, 2022, with no funded debt.
Share repurchase program: The Company implemented a share repurchase program in March 2021. As of March 31, 2022, the Company had repurchased
2.6 million shares of Catalyst common stock in the open market, at an average price of $5.61 per share, for a total purchase price of $14.6 million.
2022 Financial Guidance: The Company continues to forecast full year 2022 total revenues to be in the range of between $195 million and
$205 million, representing a 38% - 45% increase in total revenues as compared to 2021, with cash operating expenses for the full year 2022 expected to be in the range of $65 million to $70 million. Key guidance assumptions included in
these forecasts reflect a continued recovery in macroeconomic and healthcare activity throughout 2022 as it relates to the current COVID-19 environment.
Conference Call & Webcast Details
will host a conference call and webcast on Wednesday, May 11, 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 www.catalystpharma.com. A replay of
the webcast 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 continuing 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 and cash operating expenses forecasts for 2022 will prove to be accurate, and (v) 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.
Catalyst Pharmaceuticals, Inc.
CATALYST PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)
(in thousands, except share data)
For the Three Months Ended March 31,
2022 2021
Revenues:
Product revenue, net $ 43,033 $ 30,205
License and other revenue 56
Total revenues 43,089 30,205
Operating costs and expenses:
Cost of sales 5,890 4,681
Research and development 3,403 3,007
Selling, general and administrative 16,430 12,716
Total operating costs and expenses 25,723 20,404
Operating income 17,366 9,801
Other income, net 93 81
Net income before income taxes 17,459 9,882
Income tax provision 4,218 2,219
Net income $ 13,241 $ 7,663
Net income per share:
Basic $ 0.13 $ 0.07
Diluted $ 0.12 $ 0.07
Weighted average shares outstanding:
Basic 102,781,771 103,814,725
Diluted 109,041,096 106,680,344
CATALYST PHARMACEUTICALS, INC.
RECONCILIATION OF NON-GAAP METRICS (unaudited)
(in thousands, except share data)
For the Three Months Ended March 31,
2022 2021
GAAP net income $ 13,241 $ 7,663
Non-GAAP adjustments:
Stock-based compensation expense 1,903 1,571
Depreciation 34 97
Income tax provision 4,218 2,219
Non-GAAP net income $ 19,396 $ 11,550
Non-GAAP net income per share:
Basic $ 0.19 $ 0.11
Diluted $ 0.18 $ 0.11
Weighted average shares outstanding:
Basic 102,781,771 103,814,725
Diluted 109,041,096 106,680,344
CATALYST PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2022 December 31, 2021
(unaudited)
ASSETS
Current Assets:
Cash and cash equivalents $ 178,372 $ 171,445
Short-term investments 19,424 19,821
Accounts receivable, net 10,552 6,619
Inventory 7,827 7,870
Prepaid expenses and other current assets 5,016 4,351
Total current assets 221,191 210,106
Operating lease right-of-use asset 2,957 3,017
Property and equipment, net 925 959
Deferred tax assets, net 21,890 23,697
Deposits 9 9
Total assets $ 246,972 $ 237,788
LIABILITIES AND STOCKHOLDERS EQUITY
Current Liabilities:
Accounts payable $ 5,139 $ 2,768
Accrued expenses and other liabilities 17,799 24,295
Total current liabilities 22,938 27,063
Operating lease liability, net of current portion 3,813 3,894
Total liabilities 26,751 30,957
Total stockholders equity 220,221 206,831
Total liabilities and stockholders equity $ 246,972 $ 237,788
Last updated: May 11, 2022