Travere Therapeutics, Inc.

In November 2024, we entered into an arrangement to sublet 26,455 square feet of our San Diego office space beginning in January 2025 and ending in August 2028.

We believe our current facilities are adequate to conduct our business, and that suitable additional alternative spaces will be available in the future on commercially reasonable terms.

For additional information regarding our lease agreements, see Note 18 of the Consolidated Financial Statements included in this report.

• Our clinical trials are expensive and time-consuming and may fail to demonstrate the safety and efficacy of our product candidates.
• Success in nonclinical testing and early clinical trials does not ensure that later clinical trials will be successful.
• Communications and/or feedback from regulatory authorities related to our current or planned future clinical trials does not guarantee any particular outcome from or timeline for regulatory review, and expedited regulatory review pathways may not actually lead to faster development or approval.
• Interim, topline and preliminary data from our clinical trials that we announce or publish may change materially as more patient data become available and audit and verification procedures are complete.
• We and/or a collaborative partner are or will be subject to ongoing regulatory obligations and continued regulatory review for our approved products and any product candidates that receive regulatory approval.
• The third-party clinical investigators and contract research organizations that we rely upon to conduct our clinical trials may not be diligent, careful or timely, and may make mistakes, in the conduct of our trials.
• Risks Related to our Products and Product Candidates
• Our products may not achieve or maintain expected levels of market acceptance or commercial success.
• The market opportunities for our products and product candidates may be smaller than we believe they are.
• Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization.
• We do not currently have patent protection for certain of our commercial products. If we are unable to obtain and maintain protection for the intellectual property relating to our technology and products, their value will be adversely affected.
• We expect to rely on orphan drug status to develop and commercialize certain of our products and product candidates, but our orphan drug designations may not confer marketing exclusivity or other expected commercial benefits.
• Any therapies we develop may become subject to unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, thereby harming our business.
• If we are unable to obtain and maintain coverage and adequate reimbursement from governments or third-party payers for any products that we may develop or if we are unable to obtain acceptable prices for those products, our prospects for generating revenue and achieving profitability will suffer.
• We face potential product liability exposure far in excess of our limited insurance coverage.
• We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do. Our operating results will suffer if we fail to compete effectively.
• Use of third parties to manufacture our products and product candidates may increase the risk that we will not have sufficient quantities of our product and product candidates or such quantities at an acceptable cost, and clinical development and commercialization of our product and product candidates could be delayed, prevented or impaired.
• Materials necessary to manufacture our products and product candidates may not be available on commercially reasonable terms, or at all, which may delay the development and commercialization of our products and product candidates.
• Risks Related to Our Business
• International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
• Our limited operating history makes it difficult to evaluate our future prospects, and our profitability in the future is uncertain.
• We depend on a highly experienced and skilled workforce to grow and operate our business. If we are unable to attract, retain and engage our employees, we may not be able to grow effectively.
• Health epidemics or pandemics could materially adversely affect our business, results of operations and financial condition.
• We will likely experience fluctuations in operating results and could incur substantial losses.
• Negative publicity regarding any of our products could impair our ability to market any such product and may require us to spend time and money to address these issues.
• We may not have sufficient insurance to cover our liability in any current or future litigation claims either due to coverage limits or as a result of insurance carriers seeking to deny coverage of such claims.
• We may need substantial funding and may be unable to raise capital when needed.
• The market price for shares of our common stock may be volatile and purchasers of our common stock could incur substantial losses.
• We may not receive some or all of the potential milestone and/or royalty payments from our corporate and licensing transactions.
• We may be unable to successfully integrate new products or businesses we may acquire.
• Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.
• We may become involved in litigation matters, which could result in substantial costs, divert management's attention and otherwise have a material adverse effect on our business, operating results or financial condition.
• We are subject to significant ongoing regulatory obligations and oversight, which may result in significant additional expense and may limit our commercial success.
• If we are not able to obtain and maintain required regulatory approvals, we will not be able to commercialize our products, and our ability to generate revenue will be materially impaired.
• If our information technology systems or data, or those of third parties with whom we work, are or were compromised, we could experience adverse impacts resulting from such compromise, including, but not limited to, regulatory investigations or actions; litigation; fines and penalties; interruptions to our commercial operations, clinical trials or other operations; harm to our reputation; loss of revenue or profits; loss of sales; and other adverse consequences.
• Risks related to the use of artificial intelligence technologies could adversely affect our business, financial condition and/or operating results.
• Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate.
• Our ability to use net operating loss carryforwards and certain other tax attributes to offset future taxable income and taxes may be subject to limitations.
• Changes in funding for the FDA, the SEC and other government agencies or regulatory authorities could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business.
• Our business could be negatively impacted by environmental, social and corporate governance (ESG) matters or our reporting of such matters.
• The withdrawal of the United Kingdom from the European Union, commonly referred to as “Brexit,” may adversely impact our ability to obtain regulatory approvals of our product candidates in the United Kingdom, result in restrictions or imposition of taxes and duties for importing our product candidates into the United Kingdom, and may require us to incur additional expenses in order to develop, manufacture and commercialize our product candidates in the United Kingdom.
• Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
• If material weaknesses in our internal control over financial reporting are discovered or occur in the future, our consolidated financial statements may contain material misstatements and we could be required to restate our financial results, which could adversely affect our stock price and result in an inability to maintain compliance with applicable stock exchange listing requirements.
• Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial condition and results of operations.
• We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
• Risks Related to our Indebtedness and Financial Condition
• Our indebtedness could adversely affect our financial condition.
• We may be unable to raise the funds necessary to repurchase the 2029 Notes for cash following a fundamental change, or to pay any cash amounts due upon conversion, and our future indebtedness may limit our ability to repurchase the 2029 Notes or pay cash upon their conversion.
• A default under the 2029 Notes may have a material adverse effect on our financial condition.
• Provisions of the 2029 Notes could discourage an acquisition of us by a third party.
• Conversion of the Notes may dilute the ownership interest of existing stockholders, including holders who had previously converted their 2029 Notes.
• General Risk Factors
• Unstable market, economic and geopolitical conditions may have serious adverse consequences on our business, financial condition and stock price.