UNITED Therapeutics (UTHR) risk factors, 2025 10-K

Risks Related to Our Products and Our Operations

1. 01We rely heavily on sales of our treprostinil-based therapies to generate revenues and support our operations
2. 02If our products fail in clinical trials, we will be unable to sell those products
3. 03We may not compete successfully with established or newly developed drugs or products
4. 04significant number of additional therapies being developed for the treatment of IPF, which would compete with Tyvaso DPI and nebulized Tyvaso if either of them is ultimately approved for that indication
5. 05The successful commercialization of our products depends on the availability of coverage and adequacy of reimbursement from third-party payers, including governmental authorities and private health insurers. Pharmaceutical pricing and reimbursement pressures may negatively impact our sales
6. 06Our manufacturing strategy exposes us to significant risks
7. 07United Therapeutics, a public benefit corporation
8. 08We rely in part on third parties to perform activities that are critical to our business
9. 09Reports of actual or perceived side effects and other adverse effects associated with our products could cause our sales to decrease or regulatory approvals to be revoked
10. 10Negative attention from special interest groups may impair our business
11. 11We may not maintain adequate insurance coverage to protect us against significant product liability claims
12. 12If we fail to attract and retain key management and qualified scientific and technical personnel, we may not be able to achieve our business objectives

Risks Related to Legal Compliance

1. 13We must comply with extensive laws and regulations in the United States and other countries. Failure to obtain approvals on a timely basis or to comply with these requirements could delay, disrupt, or prevent commercialization of our products
2. 14Regulatory approval for our currently marketed products is limited by the FDA and other regulators to those specific indications and conditions for which clinical safety and efficacy have been demonstrated
3. 15We must comply with various laws in jurisdictions around the world that restrict certain marketing practices
4. 16Government healthcare reform and other reforms could adversely affect our revenue, costs, and results of operations
5. 17It is difficult to predict the impact, if any, that future legislation or executive actions might have on the use of and reimbursement for our products in the United States, including the potential for the importation of generic versions of our products
6. 18We may be subject to enforcement action or penalties in connection with the contract pharmacy policy we have implemented pursuant to the 340B program
7. 19contract pharmacy policy. In November 2021, the court granted our motion for summary judgment, ruling that the letters threatening enforcement action “contain legal reasoning that rests upon an erroneous reading of Section 340B.” HRSA appealed, and the appellate court affirmed the lower court’s decision in our favor
8. 20Improper handling of hazardous materials used in our activities could expose us to significant remediation liabilities
9. 21The increasing use of social media platforms and artificial intelligence-based software presents new risks and challenges
10. 22fail to comply with applicable regulations, we could incur liability, face overly restrictive regulatory actions, or incur other harm to our business

Risks Related to Our Intellectual Property and Data Privacy

1. 23If any of the agreements under which we license or acquired intellectual property rights are breached or terminated, we could lose our rights to continue to develop, manufacture, and sell the products covered by such agreements
2. 24Our intellectual property rights may not effectively deter competitors from developing competing products that, if successful, could have a material adverse effect on our revenues and profits
3. 25Third parties may allege that our products or services infringe their patents and other intellectual property rights, which could result in the payment of royalties that negatively affect our profits, subject us to costly and time-consuming litigation, or cause us to lose the ability to sell the related products
4. 26Cybersecurity incidents and other disruptions impacting our networks, systems, or data may have a material adverse effect on our business

Risks Related to Our Financing Capacity, Indebtedness, and Investments

1. 27If we need additional financing and cannot obtain it, our product development and sales efforts may be limited
2. 28We may not be able to generate sufficient cash to service or repay our indebtedness, which may have a material adverse effect on our financial position, results of operations, and cash flows
3. 29Our portfolio of investments is subject to market, interest, operational, and credit risk that may reduce its value
4. 30If we are not able to successfully identify, finance, consummate, and/or integrate acquisitions, our business operations and financial position could be adversely affected

Risks Related to Our Common Stock

1. 31The price of our common stock can be highly volatile and may decline
2. 32Provisions of Delaware law, our charter, bylaws and employment and license agreements, among other things, could prevent or delay a change of control or change in management that may be beneficial to our public shareholders
3. 33Our shareholders must rely on stock appreciation for any return on their investment in us
4. 34Our exclusive forum bylaw may limit our shareholders’ ability to bring a claim in a forum that they find favorable for disputes with us or our directors, officers, or other employees
5. 35We may not be able to achieve our public benefit purpose or realize the expected positive impacts from being a PBC
6. 36As a Delaware PBC, we may be subject to increased litigation risk