Lantheus Holdings (LNTH) risk factors, FY2024 10-K

Risks Related to Our Portfolio of Commercial Products

1. 01We depend on some of our PMF partners to generate sales, accept, produce and deliver orders, collect payments and report related information for PYLARIFY
2. 02Potential generic competitors as a result of patent and regulatory exclusivity expirations
3. 03We obtain a substantial portion of our products from third party manufacturers and suppliers
4. 04We can give no assurance that Curium will continue to be successful with its commercialization of piflufolastat F-18 in Europe
5. 05Our just-in-time manufacturing of radiopharmaceutical products relies on the reliability of our equipment and processes, the timely receipt of radioactive raw materials and the timely shipment of finished goods, and any disruption of our supply or distribution networks could have a negative effect on our business
6. 06We face significant competition in our business and may not be able to compete effectively
7. 07Ultrasound enhancing agents may cause side effects which could limit our ability to sell DEFINITY

Risks Related to Reimbursement and Regulation

1. 08Reforms to the U.S. healthcare system may adversely affect our business
2. 09Our business and industry are subject to complex and costly regulations. If government regulations are interpreted or enforced in a manner adverse to us or our business, we may be subject to enforcement actions, penalties, exclusion and other material limitations on our operations
3. 10Our marketing and sales practices may contain risks that could result in significant liability, require us to change our business practices, and restrict our operations in the future

Risks Related to Our Intellectual Property and Legal Proceedings

1. 11We are involved in various legal proceedings that are uncertain, costly and time-consuming and could have a material adverse impact on our business, financial condition and results of operations
2. 12If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products, and demand for our products may decline

Risks Related to Our Business Operations and Financial Results

1. 13If we lose the services of our key personnel, our business could be adversely affected
2. 14Any constraint on the availability of PET scanners could impact our ability to grow PYLARIFY and to successfully launch and commercialize radiodiagnostic products in our pipeline
3. 15Our business depends on our ability to successfully introduce new products and adapt to a changing technology and medical practice landscape
4. 16Our future growth may depend on our ability to identify and acquire or in-license additional products, businesses or technologies, and if we do not successfully do so, we may have limited growth opportunities and it could result in significant impairment charges or other adverse financial consequences
5. 17Challenges with product quality or product performance, including defects, caused by us or our manufacturers or suppliers could result in a decrease in customers and revenues, unexpected expenses and loss of market share
6. 18In the ordinary course of business, we may be subject to product liability claims and lawsuits, including potential class actions, alleging that our products have resulted or could result in an unsafe condition or injury
7. 19We use hazardous materials in our business and must comply with environmental laws and regulations, which can be expensive
8. 20We may be adversely affected by prevailing economic conditions and financial, business and other factors beyond our control
9. 21Our business is subject to international economic, political and other risks that could negatively affect our results of operations or financial position
10. 22We face currency and other risks associated with international sales
11. 23Our business depends on the continued effectiveness and availability of our information technology infrastructure, and failures of this infrastructure could harm our operations
12. 24A disruption in our computer networks, including those related to cybersecurity, could adversely affect our operations or financial position
13. 25We may be limited in our ability to utilize, or may not be able to utilize, net operating loss carryforwards to reduce our future tax liability

Risks Related to our and our Strategic Partners’ Portfolios of Clinical Development Candidates

1. 26We may not, or may take longer to, realize the expected benefits and opportunities related to, investments we have made to develop diagnostic product candidates to be used in diagnosing, staging and monitoring Alzheimer’s disease
2. 27We may not, or may take longer to, realize the expected benefits and opportunities related to, the POINT License Agreements
3. 28In addition, we are dependent on POINT to develop commercial product capacity and manufacture for both PNT2002 and PNT2003
4. 29The process of developing new drugs and obtaining regulatory approval is complex, time-consuming and costly, and the outcome is not certain
5. 30Even if clinical development candidates receive regulatory approval, we can give no assurance that they can be successfully commercialized
6. 31We have been and expect to continue to be dependent on partners for the development of certain product candidates, which expose us to the risk of reliance on these partners

Risks Related to Our Capital Structure

1. 32The conditional conversion feature of the 2.625% Convertible Senior Notes due 2027, if triggered, may adversely affect our financial condition and operating results
2. 33The issuance or sale of shares of our common stock, or rights to acquire shares of our common stock, could depress the trading price of our common stock
3. 34Repurchases by us of our common stock may affect the value of our common stock
4. 35We have indebtedness that may limit our financial and operating activities and may adversely affect our ability to incur additional debt to fund future needs
5. 36We may not be able to generate sufficient cash flow to meet our debt service obligations
6. 37Despite our indebtedness, we may incur more debt, which could exacerbate the risks described above
7. 38Our 2022 Revolving Facility contains restrictions that will limit our flexibility in operating our business
8. 39U.S. credit markets may impact our ability to obtain financing or increase the cost of future financing, including interest rate fluctuations based on macroeconomic conditions that are beyond our control
9. 40Our stock price could fluctuate significantly, which could cause the value of your investment in our common stock to decline, and you may not be able to resell your shares at or above your purchase price
10. 41If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendations regarding our stock, or if our results of operations do not meet their expectations, our stock price and trading volume could decline
11. 42We do not anticipate paying any cash dividends for the foreseeable future, and accordingly, stockholders must rely on stock appreciation for any return on their investment
12. 43Anti-takeover provisions in our charter documents and Delaware law and certain provisions in the Notes and Indenture may make an acquisition of us more difficult