Pacira BioSciences (PCRX) risk factors, FY2024 10-K

Risks Related to the Development and Commercialization of our Products and Product Candidates

1. 01Our success depends primarily on our ability to successfully commercialize EXPAREL and ZILRETTA
2. 02Our efforts to successfully commercialize EXPAREL and ZILRETTA are subject to many internal and external challenges and if we cannot overcome these challenges in a timely manner, our future revenues and profits could be materially and adversely impacted
3. 03Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 35
4. 04Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 36
5. 05If we are unable to achieve and maintain adequate levels of third-party payer coverage and reimbursement for any product we may offer, on reasonable pricing terms, that product’s commercial success may be severely hindered
6. 06We face significant competition from other pharmaceutical, medical device and biotechnology companies. Our operating results will suffer if we fail to compete effectively
7. 07candidates. Our competitors may also develop drugs or medical devices that are safer, more effective, useful or less costly than ours and may be more successful than us in manufacturing and marketing their products
8. 08Regulatory approval for any approved product is limited to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and allegations of our failure to comply with such approved indications could limit our sales efforts and have a material adverse effect on our business
9. 09If we are unable to establish and maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may be unable to generate additional product revenues
10. 10Any such failure may result in decreased sales and could lead us to incur other additional costs, which would have an adverse effect on our business
11. 11We may need to increase the size of our organization and effectively manage our sales force, and we may experience difficulties in managing growth
12. 12We may not be able to manage our business effectively if we are unable to attract and retain key personnel
13. 13Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 40
14. 14We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for EXPAREL, ZILRETTA, iovera° or any product candidates that we may develop and may have to limit their commercialization
15. 15If we fail to manufacture our products in sufficient quantities and at acceptable quality and pricing levels, or to fully comply with CGMP regulations, we may face delays in the commercialization of these products or be unable to meet market demand, and may lose potential revenues
16. 16and investigations. Regulations regarding the development, manufacture and sale of medical products are evolving and are subject to change in the future
17. 17We may need to expand our manufacturing operations or outsource such operations to third parties
18. 18Our inability to continue manufacturing adequate quantities of our products could result in a disruption in the supply to our customers and partners, which could have a material adverse impact on our business and results of operations
19. 19Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 42
20. 20Our co-production and other agreements with Thermo Fisher may involve unanticipated expenses and delays
21. 21Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs
22. 22Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 43
23. 23Our operations are dependent on the global supply chain and impacts of supply chain constraints and inflationary pressure could adversely impact our operating results
24. 24Our future growth depends—in part—on our ability to identify, develop, acquire or in-license products and if we do not successfully identify, develop, acquire or in-license related product candidates or integrate them into our operations, we may have limited growth opportunities
25. 25Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 44
26. 26We make substantial investments in research and development and unsuccessful investments could materially adversely affect our business, financial condition and results of operations
27. 27Our business involves the use of hazardous materials and we must comply with environmental laws and regulations, which can be expensive and restrict how we do business
28. 28Any collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates
29. 29Collaborations with pharmaceutical and/or medical device companies and other third parties often are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect us financially and could harm our business reputation
30. 30Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 45
31. 31Our dependence on contract research organizations could result in delays in and additional costs for our drug or medical device development efforts
32. 32We depend on clinical investigators and clinical sites to enroll patients in our clinical trials and sometimes other third parties to manage the trials and to perform related data collection and analysis, and, as a result, we may face costs and delays outside of our control
33. 33We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources
34. 34Guidelines and recommendations published by various organizations could reduce the demand for or use of our products

Regulatory Risks

1. 35Our business could be materially adversely affected if a regulatory or enforcement agency determines that we are promoting or have in the past promoted the “off-label” use of our products
2. 36Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 47
3. 37We may not receive regulatory approval for any of our product candidates, or the approval may be delayed for various reasons, including successful challenges to the FDA’s interpretation of Section 505(b)(2), which would have a material adverse effect on our business and financial condition
4. 38Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 48
5. 39A regulatory authority may determine that our products or any of our product candidates have undesirable side effects
6. 40If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties
7. 41Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 49
8. 42The design, development, manufacture, supply and distribution of our products are highly regulated and technically complex
9. 43Any failure to comply with regulatory and other legal requirements applicable to the manufacture, supply and distribution of our products could lead to remedial action (such as recalls), civil and criminal penalties and delays in manufacture, supply and distribution of our products
10. 44If we fail to comply with the extensive regulatory requirements to which we and our products are subject, such products could be subject to restrictions or withdrawal from the market and we could be subject to penalties
11. 45Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 50
12. 46If the government or third-party payers fail to provide adequate coverage and payment rates for EXPAREL, ZILRETTA, iovera° or any future products, or if hospitals or ASCs choose to use alternative therapies that are less expensive, our revenue and prospects for profitability will be limited
13. 47Public concern regarding the safety of drug products such as EXPAREL and ZILRETTA and medical device products such as iovera° could result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs

Risks Related to Intellectual Property

1. 48may divert our management’s attention from our core business and may result in unfavorable results that could adversely impact our ability to prevent third parties from competing with our products
2. 49We are unable to predict the outcome of these litigations at this time
3. 50Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 53
4. 51The commercial opportunity for iovera° could be significantly harmed if competitors are able to develop and commercialize alternative designs and methods outside the scope of our patents
5. 52Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 54
6. 53Because it is difficult and costly to protect our proprietary rights, we may not be able to ensure their protection and all patents will eventually expire
7. 54Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 55
8. 55If we are sued for infringing the intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in any litigation would harm our business
9. 56We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
10. 57Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 56

Risks Related to our Financial Condition, Indebtedness and our Common Stock

1. 58Servicing our indebtedness requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial indebtedness
2. 59Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 57
3. 60Our indebtedness could adversely affect our business, financial condition, and results of operations, as well as the ability to meet payment obligations under our TLA Credit Agreement and the Notes
4. 61Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 58
5. 62Despite our current level of indebtedness, we may be able to incur substantially more debt, which could increase the risks to our financial condition described above
6. 63Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current management
7. 64Our stock price is volatile, and from February 3, 2011, the first day of trading of our common stock, to February 26, 2025, the trading prices of our stock have ranged from $6.16 to $121.95 per share
8. 65Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 59
9. 66We do not intend to pay dividends on our common stock for the foreseeable future
10. 67Future sales in the public market or issuances of our common stock could lower the market price for our common stock
11. 68Raising additional funds by issuing securities would cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights
12. 69Changes in global economic conditions, including, but not limited to, those driven by inflation and tariffs, may adversely affect spending and the financial health of our customers and others with whom we do business, which may adversely affect our financial condition, results of operations and cash flows
13. 70Certain of the foregoing could also result in lower levels of healthcare insurance coverage and/or depress consume confidence, any of which could limit the ability of some customers to purchase our products and reduce consumer spend on certain elective medical procedures in both the short- and medium-term
14. 71Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 61
15. 72Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future
16. 73A material impairment in the carrying value of our intangible assets or goodwill could negatively affect our results of operation and financial condition
17. 74changes to the assumptions regarding the future fair values of our intangible assets could result in additional impairment charges in the future, which could be significant
18. 75We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts
19. 76Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies
20. 77Our quarterly operating results may fluctuate significantly
21. 78We may be unable to successfully integrate the businesses and personnel of acquired companies and businesses, and may not realize the anticipated synergies and benefits of such acquisitions
22. 79Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 64
23. 80Our ability to realize the benefits from the Flexion Acquisition is substantially dependent on the commercial success of ZILRETTA and the cost savings resulting from the timely and effective integration of the operations of Pacira and Flexion
24. 81The use of our net operating loss carryforwards and research and development tax credits will be limited

Risks Related to Information Technology, Cybersecurity and Data Privacy

1. 82We face risks related to cybersecurity threats and incidents
2. 83Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 65
3. 84If we do not maintain the privacy and security of personal and business information, we could damage our reputation with customers and employees, incur substantial additional costs and become subject to litigation
4. 85Changes in data privacy and protection laws and regulations, particularly in Europe and the State of California, or any failure to comply with such laws and regulations, could adversely affect our business and financial results
5. 86country to country and may create inconsistent or conflicting requirements. These laws apply to transfers of information among our affiliates, as well as to transactions we enter into with third-party vendors
6. 87Our business and operations would suffer in the event of system failures
7. 88Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data
8. 89A pandemic, epidemic or outbreak of a contagious disease (such as the recent novel coronavirus (COVID-19) pandemic), or fear of such an event, could have a material adverse effect on our business, operating results and financial condition
9. 90Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 67
10. 91In addition, a pandemic or other public health emergency could, among other things, cause global macroeconomic uncertainty, disrupt consumer spending and supply chains, contribute to various global shipping delays and port congestions and create significant volatility and disruption of financial markets
11. 92Corporate social responsibility, or CSR, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation
12. 93Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 68
13. 94Significant changes in the global climate, extreme weather conditions, water availability and other climate related risks could adversely affect our business or operations
14. 95Our international operations expose us to numerous and sometimes conflicting legal and regulatory requirements, the compliance of which could be costly and time consuming and violation of these regulations could adversely affect our business or operations
15. 96Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 69