Catalyst Pharmaceuticals, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Catalyst Pharmaceuticals filed its 2023 10-K, detailing financial performance and strategic investments, including a $5.9 million cash payment related to its Santhera investment.</b>

AI Summary

CATALYST PHARMACEUTICALS, INC. (CPRX) filed a Annual Report (10-K) with the SEC on February 28, 2024. Catalyst Pharmaceuticals, Inc. filed its annual report for the fiscal year ending December 31, 2023. The company's business address is 355 Alhambra Circle, Suite 801, Coral Gables, FL 33134. The fair value of the investment in Santhera was determined based on market price (CHF 8.25) and exchange rate (1.1537 CHF to USD) on July 19, 2023. As of December 31, 2023, the full $5.9 million investment payment was made in cash. The filing includes financial data for the fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking CATALYST PHARMACEUTICALS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Catalyst Pharmaceuticals' financial health and operational activities for the fiscal year 2023, crucial for investors assessing the company's stability and growth prospects. Details on the Santhera investment valuation and payment clarify the financial commitment and its basis, offering insight into the company's strategic partnerships and asset management.

Risk Assessment

Risk Level: low — CATALYST PHARMACEUTICALS, INC. shows low risk based on this filing. The filing is a standard 10-K annual report, which typically contains routine financial and operational disclosures without immediate, significant new risks or opportunities.

Analyst Insight

Review the detailed financial statements and management discussion in the 10-K to understand Catalyst Pharmaceuticals' 2023 performance and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-28 — Filing Date (Date of submission)
• $5.9 million — Santhera Investment Payment (Cash paid for investment)
• CHF 8.25 — Santhera Share Price (Valuation basis)
• 1.1537 — CHF to USD Exchange Rate (Valuation basis)

Key Players & Entities

• CATALYST PHARMACEUTICALS, INC. (company) — Filer name
• Santhera (company) — Investment mentioned
• 355 Alhambra Circle, Suite 801, Coral Gables, FL 33134 (company) — Business address
• CHF 8.25 (dollar_amount) — Santhera share price
• 1.1537 (dollar_amount) — CHF to USD exchange rate
• July 19, 2023 (date) — Date of Santhera share transfer
• $5.9 million (dollar_amount) — Investment payment
• December 31, 2023 (date) — Fiscal year end and reporting date

FAQ

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-02-28: Filing Date — Date the 10-K was officially submitted to the SEC.

Key Financial Figures

• $0.001 — ch Registered Common Stock , par value $0.001 per share CPRX NASDAQ Capital Market
• $10 — ep out-of-pocket costs to not more than $10 per month (currently less than $2 per m
• $2 — than $10 per month (currently less than $2 per month) is available for all LEMS pa
• $160 million — , in exchange for an upfront payment of $160 million in cash. We also agreed to pay Eisai an
• $25 million — pay Eisai an additional cash payment of $25 million if a requested patent extension for FYC
• $1,300 — COMPA co-pay (with a maximum savings of $1,300 per year). The FYCOMPA Instant Savings

Filing Documents

• d723690d10k.htm (10-K) — 2155KB
• d723690dex101a.htm (EX-10.1(A)) — 16KB
• d723690dex101b.htm (EX-10.1(B)) — 15KB
• d723690dex101c.htm (EX-10.1(C)) — 51KB
• d723690dex101d.htm (EX-10.1(D)) — 53KB
• d723690dex104.htm (EX-10.4) — 30KB
• d723690dex231.htm (EX-23.1) — 2KB
• d723690dex311.htm (EX-31.1) — 10KB
• d723690dex312.htm (EX-31.2) — 10KB
• d723690dex321.htm (EX-32.1) — 4KB
• d723690dex322.htm (EX-32.2) — 4KB
• d723690dex971.htm (EX-97.1) — 21KB
• g723690g0216042347602.jpg (GRAPHIC) — 6KB
• g723690g0216043646046.jpg (GRAPHIC) — 6KB
• g723690g0217024458003.jpg (GRAPHIC) — 22KB
• 0001193125-24-050908.txt (&nbsp;) — 9867KB
• cprx-20231231.xsd (EX-101.SCH) — 76KB
• cprx-20231231_cal.xml (EX-101.CAL) — 65KB
• cprx-20231231_def.xml (EX-101.DEF) — 275KB
• cprx-20231231_lab.xml (EX-101.LAB) — 538KB
• cprx-20231231_pre.xml (EX-101.PRE) — 461KB
• d723690d10k_htm.xml (XML) — 1637KB

Business

Business 3 Item1A.

Risk Factors

Risk Factors 34 Item1B. Unresolved Staff Comments 53 Item1C. Cybersecurity 53 Item2.

Properties

Properties 54 Item3.

Legal Proceedings

Legal Proceedings 55 Item4. Mine Safety Disclosure 55 PART II 56 Item5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 56 Item6.

Selected Financial Data

Selected Financial Data 58 Item7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 58 Item7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 73 Item8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 73 Item9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 73 Item9A.

Controls and Procedures

Controls and Procedures 73 Item9B. Other Information 74 PART III 74 Item10. Directors and Executive Officers of the Registrant 74 Item11.

Executive Compensation

Executive Compensation 74 Item12.

Security Ownership of Certain Beneficial Owners and Management

Security Ownership of Certain Beneficial Owners and Management 74 Item13. Certain Relationships and Related Transactions 74 Item14. Principal Accounting Fees and Services 74 PART IV 75 Item15. Exhibits and Financial Statement Schedules 75 EXHIBITS FILED WITH FORM 10-K EX 10.1(a)Offer Letter between the Company and Richard J. Daly EX 10.1(b)Offer Letter between the Company and Michael W. Kalb EX 10.1(c)Separation Agreement between the Company and Patrick J. McEnany EX 10.1(d)Separation Agreement between the Company and Alicia Grande EX 10.4Severance and Change in Control Plan EX 23.1 Consent of Independent Registered Public Accounting Firm EX 31.1 Section 302 Certification of CEO EX 31.2 Section 302 Certification of CFO EX 32.1 Section 906 Certification of CEO EX 32.2 Section 906 Certification of CFO EX 97.1Clawback Policy Table of Contents Index to Financial Statements PART I You are urged to read this Annual Report on Form 10-K (Form 10-K) in its entirety. This Form 10-K contains forward-looking statements that involve risks and uncertainties. Our actual results may differ significantly from the projected results discussed in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those discussed below and in Item 1A, "Risk Factors." "We," "our," "ours," "us," "Catalyst," or the "Company," when used herein, refers to Catalyst Pharmaceuticals, Inc., a Delaware corporation, and its wholly-owned subsidiary, Catalyst Pharmaceuticals Ireland, Ltd., a corporation organized in the Republic of Ireland.

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995. These include statements regarding our expectations, beliefs, plans or objectives for future operations and anticipated results of operations. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, "believes", "anticipates", "proposes", "plans", "expects", "intends", "may", and other similar expressions are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or other achievements to be materially different from any future results, performances or achievements expressed or implied by such forward-looking statements. Factors that might cause such differences include, but are not limited to, those discussed in the section entitled "Risk Factors." The continued successful commercialization of FIRDAPSE (amifampridine), FYCOMPA (perampanel) CIII, and the successful launch and commercialization of AGAMREE (vamorolone) are highly uncertain. Factors that will affect our success include the uncertainty of: Whether we will be able to continue to successfully market and sell FIRDAPSE and FYCOMPA while maintaining full compliance with applicable federal and state laws, rules and regulations; Whether our estimates of the size of the market for FIRDAPSE for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) will prove to be accurate; Whether our supplemental New Drug Application (sNDA) seeking to increase the maximum daily dosage of FIRDAPSE from 80 mg to 100 mg will be approved by the U.S. Food and Drug Administration (FDA); Whether the daily dose of FIRDAPSE taken by patients changes over time and affects our results of operations; Whether we w

Business

Business Overview We are a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult to treat diseases. We utilize concerted diligence efforts in search of therapies that will improve the lives of those who suffer from rare or difficult to treat diseases. With an unwavering patient focus embedded in everything we do, we are committed to providing innovative, best-in-class medications with the hope of making a meaningful impact on those affected by these conditions. Our flagship U.S. commercial product is FIRDAPSE (amifampridine) Tablets 10 mg approved for the treatment of Lambert-Eaton myasthenic syndrome, or LEMS, for adults and for children ages six and up. Further, on January 24, 2023, we closed our acquisition of FYCOMPA and are now also marketing that product in the United States. FYCOMPA (perampanel) CIII is a prescription medication used alone or with other medicines to treat focal onset seizures with or without secondarily generalized seizures in people with epilepsy aged four and older and with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older. Finally, on July 18, 2023, we closed our acquisition of an exclusive license for North America for vamorolone, a novel corticosteroid treatment for patients suffering from Duchenne Muscular Dystrophy (DMD). On October 26, 2023, the FDA approved AGAMREE (vamorolone) oral suspension 40 mg/ml for the treatment of DMD. We are currently planning the commercial launch of AGAMREE in the United States during the first quarter of 2024. FIRDAPSE On November 28, 2018, we received approval from the FDA for our new drug application, or NDA, for FIRDAPSE Tablets 10 mg for the treatment of adult patients (ages 17 and above) with LEMS, and in January 2019, we launched FIRDAPSE in the United States. Further, on September 29, 2022, the F

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View this 10-K filing on SEC EDGAR