NASDAQ false 0001369568 0001369568 2021-08-09 2021-08-09





Washington, D.C. 20549









Date of Report (Date of Earliest Event Reported): August 9, 2021




(Exact Name Of Registrant As Specified In Its Charter)




Delaware   001-33057   76-0837053

(State or other jurisdiction

of incorporation)



File Number)


(I.R.S. Employer

Identification No.)


355 Alhambra Circle  
Suite 801  
Coral Gables, Florida   33134
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (305) 420-3200

Not Applicable

Former Name or Former address, if changed since last report



Securities registered pursuant to Section 12(b) of the Act:


Title of Each Class


Name of Exchange

on Which Registered




Common Stock, par value $0.001 per share   NASDAQ Capital Market   CPRX

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this Chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging Growth Company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐




Item 8.01

Other Events

On August 9, 2021, the Company issued a press release announcing its results of operations for the three and six months ended June 30, 2021 and providing a corporate update. A copy of the press release is attached hereto as Exhibit 99.1.


Item 9.01

Financial Statements and Exhibits.

(d)    Exhibits


99.1    Press release issued by the Company on August 9, 2021.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).




Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.


Catalyst Pharmaceuticals, Inc.

                    /s/ Alicia Grande


Alicia Grande


Vice President, Treasurer and CFO

Dated: August 9, 2021




Exhibit 99.1



Catalyst Pharmaceuticals Announces Second Quarter 2021 Financial Results and Provides Corporate Update

-Q2 2021 Total Net Revenues of $36.4 Million Reflect Strong Quarter over Quarter Growth

-Q2 2021 GAAP Net Income of $12.2 Million; Non-GAAP Net Income of $17.4 Million

-$155.3 Million in Cash and Investments and no Funded Debt at End of Q2-2021

-Catalyst to Host Quarterly Conference Call at 8:30 AM ET Tomorrow

CORAL GABLES, Fla., August 9, 2021 (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 reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

“I am very pleased that our operational plan for 2021 and year to date financial results continue to deliver as originally planned, despite not yet being back to pre-Covid conditions. I believe that this portends well for the balance of the year, as we anticipate that patient access to physician practices will continue to improve. This should lead to abbreviated diagnostic times for new Lambert-Eaton Myasthenic Syndrome (LEMS) patients, which will mean that these patients will have access to Firdapse® much sooner,” said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst Pharmaceuticals. “Additionally, in line with our strategic objectives we have recently expanded our senior leadership team with highly regarded pharmaceutical executives to help us accelerate our business and portfolio development activities and continue the transformation of the company.”

Q2-21 Financial Results



Total revenues in Q2 2021 were $36.4 million, a 23% increase from $29.6 million for Q2 2020.



Total Firdapse® product revenue, net in Q2 2021 was $33.6 million, a 14% increase from $29.6 million, net for Q2 2020.



Operating income in Q2 2021 was $15.8 million, up from $10.3 million in Q2 2020.



GAAP net income in Q2 2021 was $12.2 million, or $0.12 per basic and $0.11 per diluted share, compared with GAAP net income in Q2 2020 of $9.8 million, or $0.09 per basic and diluted share.



Research and development expenses were $4.5 million for Q2 2021 compared to $4.4 million for Q2 2020.



Selling, general and administrative expenses for Q2 2021 totaled $11.5 million compared to $10.8 million for Q2 2020.



During Q2 2021, repurchased 732,951 shares of the Company’s common stock for approximately $3.7 million.



Ended Q2 2021 with $155.3 million in cash and investments and no funded debt.

Corporate Milestones



Announced exclusive license and supply agreement with DyDo Pharma for the development and commercialization of Firdapse® in Japan.



During July 2021, strengthened our senior leadership team with onboarding of Dr. Preethi Sundaram as Chief Product Development Officer, who will lead our product portfolio development and management.



Expanded our strategic focus to include acquiring or in-licensing innovative, technology platforms and earlier stage programs in all therapeutic categories with the exclusion of oncology.



Actively engaged in evaluation of potential acquisitions and partnerships of innovative products or companies.



Second Firdapse® patent issued, further strengthening our intellectual property portfolio.



Added Molly Harper, a seasoned pharmaceutical executive, to our board of directors.



Hired a new Vice President to lead investor relations. This executive will join us on August 16, 2021.

Balance Sheet and Key Activities in 2021

The Company plans to continue investing in the following key activities in 2021:



Expansion of U.S. commercialization of Firdapse®.



Continue support for our Firdapse® long-acting formulation and other development programs.



Expanding, prosecuting and protecting our portfolio of intellectual property.



Expansion of investments in research and development, including acquiring earlier stage rare disease opportunities and innovative technology.

More detailed financial information and analysis can be found in the Company’s Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission (SEC) on August 9, 2021.

Non-GAAP Financial Measures

Non-GAAP1 net income for Q2-21 was $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 expense of $1.5 million, (ii) depreciation of $31 thousand, and (iii) the provision for income taxes of $3.7 million. This compares to non-GAAP1 net income for Q2-20 of $12.2 million ($0.12 per basic and $0.11 per diluted share), which excludes from GAAP net income of $9.8 million (i) stock-based compensation expense of $1.8 million, (ii) depreciation of $29 thousand, and (iii) the provision for income taxes of $0.6 million. A tabular presentation of non-GAAP1 net income for the three months and six months ended June 30, 2021 and 2020 is included on page 5 of this press release.




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 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 provides 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 measures in this press release exclude 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

Catalyst management will host an investment-community conference call and webcast at 8:30 a.m. ET, tomorrow, Tuesday, August 10, 2021 to discuss the financial results and provide a corporate update. Investors who wish to participate in the conference call may do so by dialing (877) 407-8912 for domestic and Canadian callers or (201) 689-8059 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the Investors page of the company’s website at www.catalystpharma.com and clicking on the webcast link on the Investors home page. A webcast replay will be available on the Catalyst website for 30 days following the call by visiting the Investor page of the company’s website at www.catalystpharma.com.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing and commercializing novel high-quality medicines for patients living with rare diseases. With exceptional patient focus, Catalyst is committed to developing a robust pipeline of cutting-edge, first- or best-in-class medicines for rare diseases. Catalyst’s New Drug Application for Firdapse® (amifampridine) Tablets 10 mg for the treatment of adults with 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, approved the use of Firdapse® (amifampridine) for the treatment of adult patients in Canada with LEMS.

Firdapse® is currently being evaluated in clinical trials for the treatment of MuSK-MG and has received Orphan Drug Designation from the FDA for myasthenia gravis.

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 net product revenues and net income, (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) Catalyst’s ability to successfully develop Firdapse® for other indications and to successfully develop and commercialize a long acting formulation of Firdapse®, and (v) those factors described in Catalyst’s Annual Report on Form 10-K for fiscal year 2020 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.


Media Contact

David Schull

Russo Partners

(212) 845-4271



Company Contact

Patrick J. McEnany

Catalyst Pharmaceuticals

Chief Executive Officer

(305) 420-3200






(in thousands, except share data)


     For the Three Months
Ended June 30,
     For the Six Months
Ended June 30,
     2021      2020      2021      2020  

Product revenue, net

   $ 33,636      $ 29,605    $ 63,841    $ 58,741

License and other revenue

     2,729      —        2,729      —  













Total revenues

     36,365      29,605      66,570      58,741

Operating costs and expenses:


Cost of sales

     4,545      4,140      9,226      8,291

Research and development

     4,450      4,350      7,457      8,573

Selling, general and administrative

     11,532      10,833      24,248      20,896













Total operating costs and expenses

     20,527      19,323      40,931      37,760













Operating income

     15,838      10,282      25,639      20,981

Other income, net

     62      111      143      448













Net income before income taxes

     15,900      10,393      25,782      21,429

Provision for income taxes

     3,719      613      5,938      1,223













Net income

   $ 12,181    $ 9,780    $ 19,844    $ 20,206













Net income per share:



   $ 0.12    $ 0.09    $ 0.19    $ 0.20














   $ 0.11    $ 0.09    $ 0.18    $ 0.19













Weighted average shares outstanding:



     103,407,803        103,414,523        103,610,138        103,410,881  














     107,734,924        106,730,423        107,299,262        106,433,862  

















(in thousands, except share data)


     For the Three Months
Ended June 30,
     For the Six Months
Ended June 30,
     2021      2020      2021      2020  

GAAP net income

   $ 12,181    $ 9,780    $ 19,844    $ 20,206

Non-GAAP adjustments:


Stock-based compensation expense

     1,518      1,794      3,089      3,314


     31      29      128      43

Income tax provision

     3,719      613      5,938      1,223













Non-GAAP net income

   $ 17,449    $ 12,216    $ 28,999    $ 24,786













Non-GAAP net income per share:



   $ 0.17    $ 0.12    $ 0.28    $ 0.24














   $ 0.16    $ 0.11    $ 0.27    $ 0.23













Weighted average shares outstanding – basic

     103,407,803        103,414,523        103,610,138        103,410,881  













Weighted average shares outstanding – diluted

     107,734,924        106,730,423        107,299,262        106,433,862  

















(in thousands)


     June 30,
     December 31,



Current Assets:


Cash and cash equivalents

   $ 135,295      $ 130,237  

Short-term investments

     19,980        10,041  

Accounts receivable, net

     6,292        5,987  


     7,097        4,651  

Prepaid expenses and other current assets

     7,641        8,328  







Total current assets

     176,305        159,244  

Operating lease right-of-use asset

     3,201        —    

Property and equipment, net

     914        130  

Deferred tax assets

     28,701        32,971  


     9        9  







Total assets

   $ 209,130      $ 192,354  









Current Liabilities:


Accounts payable

   $ 2,924      $ 4,256  

Accrued expenses and other liabilities

     13,211        18,500  







Total current liabilities

     16,135        22,756  

Operating lease liability, net of current portion

     4,051        —    







Total liabilities

     20,186        22,756  

Total stockholders’ equity

     188,944        169,598  







Total liabilities and stockholders’ equity

   $ 209,130      $ 192,354