0001193125-24-195950.txt : 20240807 0001193125-24-195950.hdr.sgml : 20240807 20240807163204 ACCESSION NUMBER: 0001193125-24-195950 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20240807 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240807 DATE AS OF CHANGE: 20240807 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CATALYST PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001369568 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33057 FILM NUMBER: 241184352 BUSINESS ADDRESS: STREET 1: 355 ALHAMBRA CIRCLE STREET 2: SUITE 801 CITY: CORAL GABLES STATE: FL ZIP: 33134 BUSINESS PHONE: (305) 529-2522 MAIL ADDRESS: STREET 1: 355 ALHAMBRA CIRCLE STREET 2: SUITE 801 CITY: CORAL GABLES STATE: FL ZIP: 33134 FORMER COMPANY: FORMER CONFORMED NAME: CATALYST PHARMACEUTICAL PARTNERS, INC. DATE OF NAME CHANGE: 20110215 FORMER COMPANY: FORMER CONFORMED NAME: Catalyst Pharmaceutical Partners, Inc. DATE OF NAME CHANGE: 20060719 8-K 1 d873312d8k.htm 8-K 8-K
NASDAQ false 0001369568 0001369568 2024-08-07 2024-08-07

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of Earliest Event Reported): August 7, 2024

 

 

CATALYST PHARMACEUTICALS, INC.

(Exact Name Of Registrant As Specified In Its Charter)

 

 

 

Delaware   001-33057   76-0837053

(State or other jurisdiction

of incorporation)

  

(Commission

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

 

 

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))

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

 

Title of Each Class

  

Name of Exchange

on Which Registered

  

Ticker

Symbol

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

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 7, 2024, the Company issued a press release announcing its results of operations for the three and six months ended June 30, 2024 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 7, 2024.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

2

SIGNATURES

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.
By:  

/s/ Michael Kalb

    Michael Kalb
    Executive Vice President and CFO

Dated: August 7, 2024

 

3

EX-99.1 2 d873312dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Catalyst Pharmaceuticals Reports Strong Second Quarter 2024 Financial Results and Provides Corporate Update

Delivered Robust Revenue Performance, Fueled by Exceptional Commercial Execution and Early Success of the U.S. AGAMREE® Product Launch

Reported Record Q2 2024 Total Revenues of $122.7 Million, Representing a 23.2% YoY Increase

FIRDAPSE® Q2 2024 Net Product Revenues of $77.4 Million, Reflecting Strong Organic 19.2% YoY Growth

AGAMREE® Q2 2024 Net Product Revenues of $8.7 Million Demonstrates a Strong Start to U.S. Commercialization

FYCOMPA® Q2 2024 Net Product Revenues of $36.5 Million, Representing a 5.7% YoY Increase

Q2 2024 GAAP Net Income of $40.8 Million, $0.33 Per Share Diluted

Q2 2024 Non-GAAP Net Income of $69.6 Million, $0.56 Per Share Diluted

Reaffirming 2024 Total Revenue Guidance of $455 Million – $475 Million, Expecting Results in the Upper

Range of the Guidance

Conference Call and Webcast to be Held on August 8, 2024, at 8:30 AM ET

CORAL GABLES, Fla., August 7, 2024- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “Company”) (Nasdaq: CPRX) today reported financial results for the second quarter of 2024 and provided a corporate update.

“Since the onset of this year, we have advanced with continued momentum, propelled by the strong performance of our established product portfolio and the successful U.S. commercial launch of AGAMREE. Our accomplishments have significantly strengthened our financial position, aligning with our revenue guidance for the year, and we believe that we are on track to achieve the upper end of our previously provided total revenue forecast,” stated Richard J. Daly, President and CEO of Catalyst. “With unwavering confidence in our ability to execute our strategic objectives, we remain steadfast in our plans to capitalize on new opportunities to broaden our rare orphan portfolio with innovative and differentiated products and expand our market presence, as exemplified by our recent license agreement for AGAMREE in Canada. As we continue to execute our business strategy, we remain focused on enhancing our growth potential and delivering value to our stakeholders, while prioritizing the needs of our patient communities. Backed by our proven track record and dedicated team, we believe that we are well-positioned for sustained success.”

Financial Highlights

 

For the Three Months Ended June 30,    2024      2023      % Change  

(In thousands, except per share data)

         

Product Revenue, Net

    $ 122,653      $ 99,477        23.3 % 

FIRDAPSE Product Revenue, Net

    $ 77,372      $ 64,898        19.2 % 

FYCOMPA Product Revenue, Net

    $ 36,535      $ 34,579        5.7 % 

AGAMREE Product Revenue, Net

    $ 8,746        N/A        N/A  

GAAP Net Income

    $ 40,794      $ 37,762        8.0 % 

Non-GAAP Net Income **

    $ 69,631      $ 60,380        15.3 % 

GAAP Net Income Per Share - Basic

    $ 0.35      $ 0.36        (2.8 %) 

Non-GAAP Net Income Per Share – Basic**

    $ 0.59      $ 0.57        3.5 % 

GAAP Net Income Per Share – Diluted

    $ 0.33      $ 0.33        0 % 

Non-GAAP Net Income Per Share – Diluted**

    $ 0.56      $ 0.53        5.7 % 

As of June 30, 2024, and December 31, 2023

         

(In thousands)

         

Cash and Cash Equivalents

    $ 375,693      $ 137,636        173.0 % 

 

**

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 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.

Recent Business Highlights

 

  •  

Achieved strong results with total net product revenues amounting to $122.7 million for Q2 2024, reflecting a robust 23.3% YoY increase.

 

  •  

Delivered outstanding FIRDAPSE net product revenues of $77.4 million for Q2 2024, evidenced by impressive 19.2% YoY growth.

  •  

Successfully executed the U.S. commercial launch of AGAMREE, a novel corticosteroid treatment for Duchenne Muscular Dystrophy, yielding solid results and surpassing our initial expectations.

 

  •  

Reported AGAMREE net product revenues of $8.7 million for Q2 2024, marking the first full quarter of U.S. commercial availability.

 

  •  

Achieved Q2 2024 FYCOMPA net product revenues of $36.5 million, representing a 5.7% YoY performance.

 

  •  

On May 30, 2024, the FDA approved the 100 mg maximum daily dose of FIRDAPSE, enhancing treatment flexibility for healthcare providers treating LEMS patients.

 

  •  

In July 2024, Catalyst secured an exclusive license, supply, and commercialization agreement with KYE Pharmaceuticals, Inc., for AGAMREE in Canada, marking a pivotal strategic milestone in expanding the product’s North American footprint.

 

  •  

Published the Company’s 2023 ESG Report in June 2024, highlighting key achievements and initiatives.

 

  •  

We currently believe that our total revenue for the year ending December 31, 2024 will be in the upper half of our previously reported total revenue guidance of between $455 million and $475 million.

 

  •  

We are reaffirming our full-year 2024 FIRDAPSE net product revenue guidance to be approximately $295 million to $310 million and our 2024 FYCOMPA net product revenue guidance to be approximately $130 million to $135 million, respectively.

 

  •  

We are increasing our full-year 2024 net product revenue guidance for AGAMREE to be approximately $35 million to $40 million, based on the promising demand trend and an encouraging payer landscape.

Second Quarter 2024 Financial Results

Total revenues: In the second quarter of 2024, total revenues were $122.7 million, compared to $99.6 million for the second quarter of 2023, representing an increase of approximately 23.2%.

Product revenue, net: Product revenue, net for the second quarter of 2024 was $122.7 million, compared to $99.5 million for the second quarter of 2023, representing an increase of approximately 23.3%.

Research and development expenses: Research and development expenses for the second quarter of 2024 were $3.0 million, compared to $4.0 million for the second quarter of 2023, representing a decrease of approximately 24.5%.

Selling, general, and administrative expenses: Selling, general, and administrative expenses for the second quarter of 2024 were $40.7 million, compared to $28.4 million for the second quarter of 2023, representing an increase of approximately 43.4%, primarily relating to our preparation for and commercial launch of AGAMREE.

Amortization of intangible assets: Amortization of intangible assets was $9.3 million in the second quarter of 2024, compared to $8.5 million in the second quarter of 2023, representing an increase of approximately 10.1%.

Operating income: Operating income for the second quarter of 2024 was $54.2 million, compared to $46.7 million for the second quarter of 2023, representing an increase of approximately 16.2%.

GAAP net income: GAAP net income for the second quarter of 2024 was $40.8 million ($0.35 per basic and $0.33 per diluted share), compared to GAAP net income of $37.8 million ($0.36 per basic and $0.33 per diluted share) for the second quarter of 2023.

Non-GAAP net income: Non-GAAP net income for the second quarter of 2024 was $69.6 million ($0.59 per basic and $0.56 per diluted share), compared to non-GAAP net income of $60.4 million ($0.57 per basic and $0.53 per diluted share) for the second quarter of 2023.

Cash and cash equivalents: Cash and cash equivalents were $375.7 million as of June 30, 2024.

Our Form 10-Q for the second quarter of 2024, filed with the U.S. Securities and Exchange Commission on August 7, 2024, provides more detailed financial information and analysis of our financial condition and results of operations.

Conference Call & Webcast Details

The Company will host a conference call and webcast on Thursday, August 8, 2024, at 8:30 AM ET to discuss the financial results and provide a business update.

 

U.S./Canada Dial-in Number:

    (877) 407-8912

International Dial-in Number:

    (201) 689-8059

A webcast 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 after the event.

About Catalyst Pharmaceuticals

With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare and difficult-to-treat diseases. Catalyst’s flagship U.S. commercial product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”) in adults and pediatric patients 6 years of age and older. 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. Most recently, on May 30, 2024, the FDA approved an increased maximum daily dose of 100 mg for FIRDAPSE for adults and pediatric patients weighing more than 45 kg.

In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.

On July 18, 2023, Catalyst acquired an exclusive license for North America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and Fast Track designations and was approved by the FDA for commercialization in the U.S. on October 26, 2023. AGAMREE became commercially available by prescription in the U.S. on March 13, 2024. Further, in July 2024, Catalyst entered into an exclusive license, supply, and commercialization agreement for AGAMREE in Canada.

For more information about Catalyst, please visit the Company’s website at www.catalystpharma.com. For Full Prescribing and Safety Information for FIRDAPSE®, please visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.fycompa.com. For Full Prescribing Information for AGAMREE®, please visit www.agamree.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 (i) whether the launch of AGAMREE® will continue to surpass initial expectations and exceed 2024 full-year revenue forecasts for sales of the product that were previously published by the Company (ii) whether AGAMREE’s commercialization will ultimately be profitable, cash flow positive, and accretive to Catalyst, (iii) Catalyst’s ability to continue to successfully sell its current products and continue to be profitable and cash flow positive, (iv) whether Catalyst’s total revenue forecast for 2024 included in this press release will prove to be accurate, (v) whether Catalyst will complete additional acquisitions of products, and the timing of any such acquisitions; (vi) the impact of pending Paragraph IV litigation relating to FIRDAPSE® if the results of these litigation matters are adverse, (vii) whether AGAMREE will be approved for commercialization in Canada, and (viii) those factors described in Catalyst’s Annual Report on Form 10-K for the 2023 fiscal year, Catalyst’s Quarterly Report on Form 10-Q for the second quarter of 2024, 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 obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

CATALYST PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited)

(in thousands, except share and per share data)

 

     For the Three Months
Ended June 30,		      For the Six Months
Ended June 30,		  
     2024      2023      2024      2023  

Product revenue, net

    $ 122,653      $ 99,477      $ 221,094    $ 184,781

License and other revenue

      57      105      125      167  
  

 

 

     

 

 

     

 

 

     

 

 

  

Total revenues

      122,710      99,582      221,219      184,948
  

 

 

     

 

 

     

 

 

     

 

 

  

Operating costs and expenses:

            

Cost of sales (a)

      15,405      12,045      27,925      21,991

Research and development

      2,985      3,954      5,566      7,516

Selling, general and administrative (a)

      40,730      28,396      87,668      58,114

Amortization of intangible assets

      9,344      8,488      18,688      15,019
  

 

 

     

 

 

     

 

 

     

 

 

  

Total operating costs and expenses

      68,464      52,883      139,847      102,640
  

 

 

     

 

 

     

 

 

     

 

 

  

Operating income

      54,246      46,699      81,372      82,308

Other income, net

      1,542      1,813        3,505      3,517  
  

 

 

     

 

 

     

 

 

     

 

 

  

Net income before income taxes

      55,788      48,512      84,877      85,825

Income tax provision

      14,994      10,750      20,808      18,495
  

 

 

     

 

 

     

 

 

     

 

 

  

Net income

    $ 40,794    $ 37,762    $ 64,069    $ 67,330
  

 

 

     

 

 

     

 

 

     

 

 

  

Net income per share:

            

Basic

    $ 0.35    $ 0.36    $ 0.55    $ 0.64
  

 

 

     

 

 

     

 

 

     

 

 

  

Diluted

    $ 0.33    $ 0.33    $ 0.52    $ 0.59
  

 

 

     

 

 

     

 

 

     

 

 

  

Weighted average shares outstanding:

            

Basic

      118,180,396        106,258,790        117,493,257        105,911,936  
  

 

 

     

 

 

     

 

 

     

 

 

  

Diluted

      124,655,999        113,673,534        124,028,752        113,840,155  
  

 

 

     

 

 

     

 

 

     

 

 

  

 

(a)

exclusive of amortization of intangible assets

CATALYST PHARMACEUTICALS, INC.

RECONCILIATION OF NON-GAAP METRICS (unaudited)

(in thousands, except share and per share data)

 

     For the Three Months
Ended June 30,		      For the Six Months
Ended June 30,		  
     2024      2023      2024      2023  

GAAP net income

    $ 40,794      $ 37,762      $ 64,069      $ 67,330  

Non-GAAP adjustments:

            

Stock-based compensation expense

      4,408      3,298      12,656        6,190  

Depreciation

      91      82      177        151  

Amortization of intangible assets

      9,344      8,488      18,688        15,019  

Income tax provision

      14,994      10,750      20,808        18,495  
  

 

 

     

 

 

     

 

 

     

 

 

  

Non-GAAP net income

    $ 69,631    $ 60,380      $ 116,398      $ 107,185  
  

 

 

     

 

 

     

 

 

     

 

 

  

Non-GAAP net income per share:

            

Basic

    $ 0.59    $ 0.57      $ 0.99      $ 1.01
  

 

 

     

 

 

     

 

 

     

 

 

  

Diluted

    $ 0.56      $ 0.53      $ 0.94      $ 0.94  
  

 

 

     

 

 

     

 

 

     

 

 

  

Weighted average shares outstanding:

            

Basic

      118,180,396        106,258,790        117,493,257        105,911,936  
  

 

 

     

 

 

     

 

 

     

 

 

  

Diluted

      124,655,999        113,673,534        124,028,752        113,840,155  
  

 

 

     

 

 

     

 

 

     

 

 

  

CATALYST PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

     June 30,
2024
(unaudited)		      December 31,
2023		  

Assets

      

Current Assets:

      

Cash and cash equivalents

    $ 375,693      $ 137,636  

Accounts receivable, net

      57,172        53,514  

Inventory

      18,014        15,644  

Prepaid expenses and other current assets

      23,550        12,535  
  

 

 

     

 

 

  

Total current assets

      474,429        219,329  

Operating lease right-of-use asset

      2,371        2,508  

Property and equipment, net

      1,227        1,195  

License and acquired intangibles, net

      175,361        194,049  

Deferred tax assets, net

      39,889        36,544  

Investment in equity securities

      13,083        16,489  
  

 

 

     

 

 

  

Total assets

    $ 706,360      $ 470,114  
  

 

 

     

 

 

  

Liabilities and Stockholders’ Equity

      

Current Liabilities:

      

Accounts payable

    $ 7,116      $ 14,795  

Accrued expenses and other liabilities

      85,202        61,268  
  

 

 

     

 

 

  

Total current liabilities

      92,318        76,063  

Operating lease liability, net of current portion

      2,991        3,188  

Other non-current liabilities

      2,396        2,982  
  

 

 

     

 

 

  

Total liabilities

      97,705        82,233  

Total stockholders’ equity

      608,655        387,881  
  

 

 

     

 

 

  

Total liabilities and stockholders’ equity

    $ 706,360      $ 470,114  
  

 

 

     

 

 

  

Source: Catalyst Pharmaceuticals, Inc.

Contact information:

Investor Contact

Mary Coleman

Catalyst Pharmaceuticals, Inc.

(305) 420-3200

mcoleman@catalystpharma.com

Media Contact

David Schull

Russo Partners

(858) 717-2310

david.schull@russopartnersllc.com

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