Repligen (RGEN) risk factors, FY2024 10-K

Other

1. 01Investors should carefully consider the risk factors described below before making an investment decision

Risks Related to Our Business

1. 02The bioprocessing market is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants
2. 03If we are unable to continue to hire and retain skilled personnel, then we will have trouble developing and marketing our products
3. 04Despite our increasingly diversified client base, we have historically depended on a limited number of customers for a high percentage of our revenues
4. 05customers may place fewer orders with us or cease placing orders with us, which would negatively affect our revenues and operating results

Risks Related to Product Development and Acquisitions

1. 06If we are unable to expand our product portfolio, our ability to generate revenue could be adversely affected
2. 07Our acquisitions expose us to risks that could adversely affect our business, and we may not achieve the anticipated benefits of acquisitions of businesses or technologies
3. 08risks associated with acquiring intellectual property, including potential disputes regarding acquired companies’ intellectual property
4. 09If intangible assets and goodwill that we recorded in connection with our acquisitions become impaired, we may have to take significant charges against earnings

Risks Related to Manufacturing and Supply

1. 10If we are unable to manufacture our products in sufficient quantities and in a timely manner, our operating results will be harmed, our ability to generate revenue could be diminished and our gross margin may be negatively impacted
2. 11We rely on a limited number of suppliers or, for certain of our products, one supplier, and we may not be able to find replacements or immediately transition to alternative suppliers, which could have a material adverse effect on our financial condition, results of operations and reputation

Risks Related to Our Financial Position and Need for Additional Capital

1. 12place us at a disadvantage compared to our competitors who have less debt; and
2. 13limit our ability to borrow additional amounts for working capital and other general corporate purposes, including to fund possible acquisitions of, or investments in, complementary businesses, products, services and technologies
3. 14The conditional conversion feature of the Notes, if triggered, may adversely affect our financial condition and liquidity
4. 15Future strategic transactions or acquisitions may require us to seek additional financing, which we may not be able to secure on favorable terms, if at all
5. 16Our corporate restructuring and the associated headcount reduction may not result in anticipated savings, could result in total costs and expenses that are greater than expected and could disrupt our business
6. 17Our exposure to political, economic and other risks that arise from operating a multinational business has and may continue to increase
7. 18being subject to longer payment cycles from customers and experiencing greater difficulties in timely accounts receivable collections; and
8. 19Our business success depends in part on our ability to anticipate and effectively manage these and other related factors. We cannot assure you that these and other related factors will not materially adversely affect our international operations or business as a whole
9. 20We may be unable to efficiently manage our growth as a larger and more geographically expansive organization
10. 21Our results of operations could be negatively affected by potential fluctuations in foreign currency exchange rates
11. 22Natural disasters, geopolitical unrest, war, terrorism, public health issues or other catastrophic events could disrupt the supply, delivery or demand of products, which could negatively affect our operations and performance
12. 23Our business, financial condition and results from operations could be adversely affected by disruptions in the global economy caused by geopolitical events, such as the ongoing conflicts between Russia and Ukraine and Israel and Palestine

Risks Related to Investment in Our Securities

1. 24Our operating results may fluctuate significantly, our customers’ future purchases are difficult to predict and any failure to meet financial expectations may result in a decline in our stock price
2. 25Securities or industry analysts may not publish favorable research or reports about our business or may publish no information, which could cause our stock price or trading volume to decline
3. 26Our stock price could be volatile, which could cause shareholders to lose part or all of their investment
4. 27Increased education for internal resources on accounting for contracts within the scope of ASC 606 and deploying enablers to facilitate documentation of accounting analyses and conclusions
5. 28Expanding the management and governance over IT system controls
6. 29Assessing the frequency of our control monitoring activities to ensure that they are conducted in a timely manner; and

Risks Related to Our Charter and Bylaws

1. 30Anti-takeover provisions in our charter documents, certain of our contracts with third parties, and under Delaware law could make an acquisition of us, even one that may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management

Risks Related to Tax Matters

1. 31The enactment of legislation implementing changes in taxation of international business activities, the adoption of other corporate tax reform policies, or changes in tax legislation or policies, or interpretations thereof, could materially impact our financial position and results of operations

Risks Related to Regulations and Compliance

1. 32We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations
2. 33Our business is subject to a number of environmental risks
3. 34Climate change, climate change-related regulation and sustainability concerns could adversely affect our businesses and the operations of our subsidiaries, and any actions we take or fail to take in response to such matters could damage our reputation
4. 35Health care reform measures could adversely affect our business
5. 36We may be exposed to liabilities under the Foreign Corrupt Practices Act, and any determination that we violated the Foreign Corrupt Practices Act could have a material adverse effect on our business
6. 37Changes in accounting standards and subjective assumptions, estimates, and judgments by management related to complex accounting matters could significantly affect our financial results or financial condition

Risks Related to Data and Privacy

1. 38Our internal computer systems, or those of our customers, collaborators or other contractors, may be subject to cyber-attacks or security incidents or compromises, which could result in a material disruption of our product development programs
2. 39Changes in laws and regulations governing the privacy and protection of data and personal information could adversely affect our business
3. 40The use of new and evolving technologies, such as artificial intelligence (“AI”), in our offerings may present risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data

Risks Related to Our Intellectual Property

1. 41If we are unable to obtain or maintain our intellectual property, we may not be able to succeed commercially
2. 42secure any necessary licenses from others on acceptable terms
3. 43Patents that may be granted to us in certain foreign countries may be subject to opposition proceedings brought by third parties or result in suits by us, which may be costly and result in adverse consequences for us
4. 44While we continue to obtain patent grants directed towards Protein A, other patent grants directed towards Protein A have expired, and as a result, we may face increased competition, which could harm our results of operations, financial condition, cash flow and future prospects
5. 45There has been substantial litigation and other proceedings regarding the complex patent and other intellectual property rights in the life sciences industry. We have been a party to, and in the future may become a party to, patent litigation or other proceedings regarding intellectual property rights
6. 46If third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we will need to defend against such claims