Travere Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Travere Therapeutics, Inc. has filed its annual report detailing its 2023 financial performance and business operations.</b>

AI Summary

Travere Therapeutics, Inc. (TVTX) filed a Annual Report (10-K) with the SEC on February 20, 2024. Travere Therapeutics, Inc. filed its 2023 Form 10-K on February 20, 2024. The company's fiscal year ends on December 31st. Travere Therapeutics, Inc. was formerly known as Retrophin, Inc. and Desert Gateway, Inc. The company's business address is 3611 Valley Centre Dr, Suite 300, San Diego, CA 92130. The filing covers the fiscal year ending December 31, 2023.

Why It Matters

For investors and stakeholders tracking Travere Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Travere Therapeutics' financial health, operational activities, and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. Understanding the company's historical financial data, including revenue streams and equity changes, as presented in this filing, is essential for making informed investment decisions and evaluating its market position.

Risk Assessment

Risk Level: medium — Travere Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, clinical trial risks, and market competition, as indicated by the nature of a 10-K filing for a biotech firm.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Travere Therapeutics' operational performance and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-02-20 — Filing Date (Date of submission)
• 2023-01-01 — Fiscal Year Start (Reporting period)
• 2022-12-31 — Prior Year End (Comparative period)

Key Players & Entities

• Travere Therapeutics, Inc. (company) — Filer name
• Retrophin, Inc. (company) — Former company name
• Desert Gateway, Inc. (company) — Former company name
• 2024-02-20 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end
• San Diego, CA (location) — Business address city and state
• 001-36257 (other) — SEC file number
• 262383102 (other) — IRS number

FAQ

Industry Context

Travere Therapeutics operates in the pharmaceutical and biotechnology sector, focusing on developing therapies for rare diseases.

Regulatory Implications

As a pharmaceutical company, Travere Therapeutics is subject to stringent regulations from bodies like the FDA regarding drug development, approval, and marketing.

What Investors Should Do

1. Review Travere Therapeutics' financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section to understand potential challenges and uncertainties.
3. Examine any disclosures related to product development pipelines and regulatory milestones.

Key Dates

• 2024-02-20: 10-K Filing — Annual report submission date
• 2023-12-31: Fiscal Year End — End of the reporting period

Year-Over-Year Comparison

This filing is the 2023 annual report, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.0001 — ich registered Common Stock, par value $0.0001 per share TVTX The Nasdaq Global Marke

Filing Documents

• tvtx-20231231.htm (10-K) — 2533KB
• ex108-1231202310k.htm (EX-10.8) — 16KB
• ex1010-1231202310k.htm (EX-10.10) — 32KB
• ex1025-1231202310k.htm (EX-10.25) — 121KB
• ex1028-1231202310k.htm (EX-10.28) — 29KB
• ex1029-1231202310k.htm (EX-10.29) — 84KB
• ex1030-1231202310k.htm (EX-10.30) — 109KB
• ex1032-1231202310k.htm (EX-10.32) — 62KB
• ex211-1231202310k.htm (EX-21.1) — 5KB
• ex231-1231202310k.htm (EX-23.1) — 5KB
• ex232-1231202310k.htm (EX-23.2) — 3KB
• ex311-1231202310k.htm (EX-31.1) — 11KB
• ex312-1231202310k.htm (EX-31.2) — 11KB
• ex321-1231202310k.htm (EX-32.1) — 6KB
• ex322-1231202310k.htm (EX-32.2) — 6KB
• ex97-1231202310k.htm (EX-97) — 35KB
• image_0.jpg (GRAPHIC) — 47KB
• image_01.jpg (GRAPHIC) — 3KB
• tvtx-20231231_g1.jpg (GRAPHIC) — 170KB
• tvtx-20231231_g2.jpg (GRAPHIC) — 253KB
• 0001438533-24-000005.txt (&nbsp;) — 15087KB
• tvtx-20231231.xsd (EX-101.SCH) — 84KB
• tvtx-20231231_cal.xml (EX-101.CAL) — 154KB
• tvtx-20231231_def.xml (EX-101.DEF) — 535KB
• tvtx-20231231_lab.xml (EX-101.LAB) — 1149KB
• tvtx-20231231_pre.xml (EX-101.PRE) — 816KB
• tvtx-20231231_htm.xml (XML) — 1867KB

Business

Business 7 Item 1A.

Risk Factors

Risk Factors 29 Item 1B. Unresolved Staff Comments 63 Item 1C. Cybersecurity 63 Item 2.

Properties

Properties 64 Item 3.

Legal Proceedings

Legal Proceedings 64 Item 4. Mine Safety Disclosures 64 PART II Item 5. Market For Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 65 Item 6. [Reserved] 66 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 66 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 81 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 82 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 82 Item 9A.

Controls and Procedures

Controls and Procedures 82 Item 9B. Other Information 85 Item 9C . Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 85 PART III Item 10. Directors, Executive Officers, and Corporate Governance 86 Item 11.

Executive Compensation

Executive Compensation 89 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 89 Item 13. Certain Relationships and Related Transactions, and Director Independence 89 Item 14. Principal Accountant Fees and Services 89 PART IV Item 15. Exhibits, Financial Statement Schedules 90 Item 16. Form 10-K Summary 92 2 Table of Contents CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS Certain information contained in this Annual Report on Form 10-K of Travere Therapeutics, Inc., a Delaware corporation (the "Company") include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements herein which are not historical reflect our current expectations and projections about the Company's future results, performance, liquidity, financial condition, prospects and opportunities and are based upon information currently available to the Company's management and is subject to its interpretation of what are believed to be significant factors affecting the Company's business, including many assumptions regarding future events. Such forward-looking statements include statements regarding, among other things: the potential full regulatory approval of FILSPARI for Immunoglobulin A nephropathy (IgAN); the estimated addressable U.S. patient population for FILSPARI under the indication approved via accelerated approval; and the estimated addressable patient populations if full approval is granted; estimated patient populations related to our other products and products in development; the anticipated opinion by the EMA's Committee for Human Medicinal Products ("CHMP") on the conditional marketing authorization ("CMA") application for sparsentan for the treatment of IgAN, and the timing thereof; expectations regarding our pivotal Phase 3 HARMONY Study to support the potential approval of pegtibatinase for the treatment of classical homocystinuria (HCU);

BUSINESS

ITEM 1. BUSINESS Those statements in the following discussion that are not historical in nature should be considered forward-looking statements that are inherently uncertain. Actual results and the timing of the events may differ materially from those contained in these forward-looking statements due to a number of factors, including those discussed in the "Cautionary Statement Regarding Forward-Looking Statements" and "Risk Factors" set forth elsewhere in this Annual Report. Overview We are a biopharmaceutical company headquartered in San Diego, California, focused on identifying, developing and delivering life-changing therapies to people living with rare kidney and metabolic diseases. Our approach centers on advancing our innovative pipeline with multiple late-stage clinical programs targeting rare diseases with significant unmet medical needs. In February 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to our first development program, FILSPARI (sparsentan), which is indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression. Sparsentan is also in late-stage development for focal segmental glomerulosclerosis (FSGS). IgAN and FSGS are rare kidney disorders that lead to kidney failure. We are also advancing pegtibatinase, a novel investigational enzyme replacement therapy for the treatment of classical homocystinuria (HCU), a genetic disorder caused by a deficiency in a pivotal enzyme essential to the body. In December 2023, we initiated the pivotal Phase 3 HARMONY Study to support the potential approval of pegtibatinase as the first disease modifying therapy for HCU. Our early research efforts include partnering with patient advocacy groups and government researchers to identify potential therapeutics for Alagille syndrome (ALGS), a condition with no approved treatment options. In addition, we continue to evaluate potential opportunities to expand our pipeline and approved products through li

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View this 10-K filing on SEC EDGAR