Pacira BioSciences, Inc.

We believe that our R&D facilities and manufacturing facilities at our Science Center Campus, Thermo Fisher and Amphenol sites (as discussed in Item 1—Business above) will be sufficient for our current commercial and pipeline development needs. We also may add new facilities or expand existing facilities as we add employees, expand our geographic markets and if demand for EXPAREL, ZILRETTA and iovera° increases and we believe that suitable additional or substitute space will be available as needed to accommodate any such expansion of our operations.

• We may need to expand our manufacturing operations or outsource such operations to third parties.
• Our 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.
• Our co-production and other agreements with Thermo Fisher may involve unanticipated expenses and delays.
• We rely on third parties for the timely supply of specified raw materials and equipment for the manufacture of EXPAREL, ZILRETTA and iovera°. Although we actively manage these third-party relationships to provide continuity and quality, some events which are beyond our control could result in the complete or partial failure of these goods and services. Any such failure could have a material adverse effect on our financial condition and operations.
• Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs.
• Our operations are dependent on the global supply chain and impacts of supply chain constraints and inflationary pressure could adversely impact our operating results.
• Our 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.
• We make substantial investments in research and development and unsuccessful investments could materially adversely affect our business, financial condition and results of operations.
• Our 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.
• Any 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.
• Clinical trials are expensive, lengthy and have uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results. Clinical trials may fail to demonstrate the safety and efficacy of our drug products or medical devices, which could prevent or significantly delay obtaining regulatory approval.
• Our dependence on contract research organizations could result in delays in and additional costs for our drug or medical device development efforts.
• We 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.
• We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources.
• Guidelines and recommendations published by various organizations could reduce the demand for or use of our products.
• Regulatory Risks
• Our 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.
• We 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.
• For iovera° and any other potential medical device, we must obtain clearance or approval from the FDA or other regulatory authorities prior to introducing a new product or a modification to an existing product. The regulatory clearance process may result in substantial delays, unexpected or additional costs and other unforeseen factors and limitations on the types and uses of products we would be able to commercialize, any of which could have a material adverse effect on our business and financial condition.
• A regulatory authority may determine that our products or any of our product candidates have undesirable side effects.
• If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties.
• The design, development, manufacture, supply and distribution of our products are highly regulated and technically complex.
• If 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.
• If 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.
• Public 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
• The patents and the patent applications that we have covering our pMVL products are limited to specific injectable formulations, processes and uses of drugs encapsulated in our pMVL drug delivery technology and our market opportunity for our product candidates may be limited by the lack of patent protection for the active ingredient itself and other formulations and delivery technologies and systems that may be developed by competitors.
• The patents and the patent applications that we have covering ZILRETTA are limited to specific injectable formulations, uses and processes of manufacturing and our market opportunity for our product candidate may be limited by the lack of patent protection for the active ingredient itself and other formulations and delivery technologies and systems that may be developed by competitors.
• The patents and the patent applications that we have covering our iovera° products are primarily limited to specific handheld cryogenic needle devices that are cooled by a cryogen and methods for applying cryotherapy to nerve tissue using the cryogenic devices. Our market opportunity for our product candidates may be limited by gaps in patent coverage for the cryogenic devices, methods of use and other cryotherapy technology and systems that may be developed by competitors.
• The patents and the patent applications that we have covering PCRX-201 are limited to composition of matter and uses of an adenoviral vector containing a nucleic acid encoding specific gene and our market opportunity for our product candidate may be limited by the patent protection and other gene therapies for treating OA that may be developed by competitors.
• Because 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.
• If 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.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
• Risks Related to our Financial Condition and Indebtedness
• Servicing our indebtedness requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial indebtedness.
• Our Credit Agreement and the Indenture each impose significant operating and financial restrictions on us and certain of our subsidiaries, which may prevent us from capitalizing on business opportunities. A breach of any of those restrictive covenants may cause us to be in default under the Credit Agreement and/or the Indenture, and our lenders could foreclose on our assets.
• We may not have the ability to raise the funds necessary to settle conversions of the 2029 Notes in cash to the extent elected or to repurchase the 2029 Notes upon a fundamental change, and that our indebtedness may contain limitations on our ability to pay cash upon conversion of the 2029 Notes or limitations on our ability to repurchase the 2029 Notes.
• Our indebtedness could adversely affect our business, financial condition, and results of operations, as well as the ability to meet payment obligations under our Credit Agreement and the 2029 Notes.
• Despite 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.
• Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future.
• A material impairment in the carrying value of our intangible assets or goodwill could negatively affect our results of operation and financial condition.
• We 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.
• Our quarterly operating results may fluctuate significantly.
• We 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.
• The use of our net operating loss carryforwards and research and development tax credits will be limited.
• Risks Related to Our Common Stock
• Some 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.
• Our common stock price may be subject to significant fluctuations and volatility.
• We do not intend to pay dividends on our common stock for the foreseeable future.
• Future sales in the public market or issuances of our common stock could lower the market price for our common stock.
• Raising 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.
• Repurchases of our common stock may not result in increased stockholder value and could adversely affect our liquidity or financial flexibility.
• Our business has been, and could in the future be, negatively impacted by the actions of activist stockholders.
• Risks Related to Information Technology, Cybersecurity and Data Privacy
• We face risks related to cybersecurity threats and incidents.
• If 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.
• Changes 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.
• Our business and operations would suffer in the event of system failures.
• We must maintain and upgrade our enterprise resource planning system and other information technology (“IT”) systems as needed, and our failure to do so could have a material and adverse effect on our business, financial condition and results of operations.
• Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
• General Risk Factors
• A pandemic, epidemic or outbreak of a contagious disease, or fear of such an event, could have a material adverse effect on our business, operating results and financial condition.
• Corporate social responsibility, or CSR, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation.
• Significant changes in the global climate, extreme weather conditions, water availability and other climate related risks could adversely affect our business or operations.
• Our 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.
• Changes 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.