Pacira BioSciences (PCRX) risk factors, FY2025 10-K

Pacira BioSciences's FY2025 10-K, filed Feb 26, 2026, lists 99 risk factors in 6 groups. Against the prior year's 96: 12 new, 9 dropped, 58 substantially reworded.

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Risk factors listed
996 groups
New this year
12vs 96 last year
Dropped
9since the prior 10-K
Substantially reworded
58of those kept
Section length
33k wordsItem 1A

What the changes say

  • Pacira faces key risks in commercializing EXPAREL and ZILRETTA against generic and competitive pressures, managing manufacturing and supply chain vulnerabilities, and navigating stringent regulatory environments.

What changed since the prior 10-K

New

  • NewRisks Related to the Development and Commercialization of our Products and Product Candidates

    Any disruption in our ability to generate revenues from the sale of EXPAREL and ZILRETTA will have a material and adverse impact on our results of operations and financial condition

    Any disruption in generating revenues from EXPAREL and ZILRETTA would severely harm our financial condition.

  • NewRisks Related to the Development and Commercialization of our Products and Product Candidates

    physicians, patients and third-party payers, we may not generate meaningful revenues from EXPAREL, and we may not remain profitable

    ZILRETTA is approved only for knee OA pain, and its commercial success faces numerous market and competitive uncertainties.

  • NewRisks Related to the Development and Commercialization of our Products and Product Candidates

    response to inspections conducted by the FDA or similar foreign regulatory authorities, which could have a material adverse effect on our business, financial position and results of operations

    Natural or man-made disasters at manufacturing facilities in San Diego, the U.K., Mexico, and Washington could disrupt EXPAREL, ZILRETTA, or iovera° supply.

  • NewRegulatory Risks

    could result in the imposition of sanctions, including, among other things, issuance of warnings letters or imposition of seizures or injunctions. For more information regarding our pediatric study obligations, see Note 20, Commitments and Contingencies, to our consolidated financial statements included herein

    Medical devices like iovera° require costly and time-consuming FDA clearances or approvals before commercialization or modification.

  • NewRegulatory Risks

    changes to the Medicaid rebate formula may cause the required 340B discount to increase, resulting in increased revenue leakage

    Changes to the Medicaid rebate formula and 340B discounts could increase revenue leakage amid tighter third-party reimbursement restrictions.

  • NewRisks Related to Intellectual Property

    For more information on these litigations and other legal proceedings we are involved in, see Note 20, Commitments and Contingencies, to our consolidated financial statements included herein

    ZILRETTA's active ingredient triamcinolone acetonide lacks patent protection, exposing it to generic competition.

  • NewRisks Related to our Financial Condition and Indebtedness

    forced to refinance these borrowings on less favorable terms or cannot refinance these borrowings, our results of operations and financial condition could be adversely affected

    We may lack sufficient cash or financing to settle conversions or repurchases of the 2029 Notes.

  • NewRisks Related to Our Common Stock

    or more of the Company may sell a substantial number of their shares in the public market, which could also affect the market price for our common stock

    Sales of substantial shares by officers and directors under Rule 10b5-1 trading plans could affect our common stock price.

  • NewRisks Related to Our Common Stock

    Repurchases of our common stock may not result in increased stockholder value and could adversely affect our liquidity or financial flexibility

    Share repurchases under our $300.0 million program may not increase stockholder value and could harm liquidity.

  • NewRisks Related to Our Common Stock

    Our business has been, and could in the future be, negatively impacted by the actions of activist stockholders

    Activist stockholder campaigns and potential securities litigation could cause significant expenses and hinder our strategy.

  • NewRisks Related to Information Technology, Cybersecurity and Data Privacy

    We have invested and will continue to invest in and implement modifications and upgrades to our IT systems and procedures, including making changes to legacy systems or acquiring new systems with new functionality, and building new policies, procedures, training programs and monitoring tools

    Implementing and maintaining a new enterprise resource planning system involves high costs and risks of operational disruption.

  • NewRisks Related to Information Technology, Cybersecurity and Data Privacy

    product quality, supply chain management, corporate governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers may be unwilling to continue to do business with us

    Dissatisfaction with our corporate social responsibility initiatives and disclosures could negatively impact our reputation and brand.

Dropped

  • DroppedRisks Related to the Development and Commercialization of our Products and Product Candidates

    Our 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

  • DroppedRisks Related to the Development and Commercialization of our Products and Product Candidates

    candidates. 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

    Sales force training and execution challenges for EXPAREL.

  • DroppedRisks Related to the Development and Commercialization of our Products and Product Candidates

    and investigations. Regulations regarding the development, manufacture and sale of medical products are evolving and are subject to change in the future

  • DroppedRisks Related to Intellectual Property

    may 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

  • DroppedRisks Related to Intellectual Property

    We are unable to predict the outcome of these litigations at this time

  • DroppedRisks Related to our Financial Condition, Indebtedness and our Common Stock

    changes 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

  • DroppedRisks Related to our Financial Condition, Indebtedness and our Common Stock

    Our 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

    Competition from generic opioids and NSAIDs.

  • DroppedRisks Related to Information Technology, Cybersecurity and Data Privacy

    country 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

  • DroppedRisks Related to Information Technology, Cybersecurity and Data Privacy

    Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 69

Reworded

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 39

    Shifted from listing specific ZILRETTA market acceptance factors to risks of competitors rendering products obsolete by acquiring better technologies.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 36

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 40

    Replaced macroeconomic and stock price retention risks with specific FDA promotion and advertising rule violation penalties.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 40

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 41

    Replaced general manufacturing disruption warnings with specific cold-chain distribution temperature failure risks for pMVL-based products.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 42

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 42

    Replaced COVID-19 pandemic and inflation freight cost discussions with personnel hiring and compensation inflation challenges.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 43

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 43

    Replaced pipeline development diversion risks with detailed FDA QSR manufacturing compliance, audit, and product recall risks.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 44

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 45

    Replaced clinical trial unpredictability with warnings about government mandates prioritizing raw materials for COVID-19 vaccines.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 45

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 46

    Replaced past DOJ subpoena and warning letter history with competition risks from larger pharmaceutical companies in R&D and business development.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 47

  • 100% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 47

    Replaced medical device off-label promotion warnings with general clinical trial safety and efficacy development failure risks.

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 48

  • 100% rewrittenRegulatory Risks

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 49

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 49

  • 100% rewrittenRegulatory Risks

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 51

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 50

  • 100% rewrittenRisks Related to Intellectual Property

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 55

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 54

  • 100% rewrittenRisks Related to Intellectual Property

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 56

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 55

  • 100% rewrittenRisks Related to Intellectual Property

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 57

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 56

  • 100% rewrittenRisks Related to Intellectual Property

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 58

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 57

  • 100% rewrittenRisks Related to our Financial Condition and Indebtedness

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 62

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 58

  • 100% rewrittenRisks Related to our Financial Condition and Indebtedness

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 64

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 59

  • 100% rewrittenRisks Related to Our Common Stock

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 67

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 61

  • 100% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 68

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 64

  • 100% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 69

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 65

  • 100% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 70

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 67

  • 100% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 74

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 68

  • 95% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    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

    Was: A 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

  • 89% rewrittenRisks Related to Intellectual Property

    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

  • 86% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    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

  • 83% rewrittenRisks Related to Intellectual Property

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 54

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 53

  • 82% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    We face risks related to cybersecurity threats and incidents

  • 82% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs

  • 81% rewrittenRisks Related to Our Common Stock

    Our stock price is volatile, and from February 3, 2011, the first day of trading of our common stock, to February 25, 2026, the trading prices of our stock have ranged from $6.16 to $121.95 per share

    Was: Our 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

  • 78% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Collaborations 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

  • 73% rewrittenRisks Related to Our Common Stock

    Future sales in the public market or issuances of our common stock could lower the market price for our common stock

  • 71% rewrittenRegulatory Risks

    If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties

  • 71% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    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

  • 70% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    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

  • 67% rewrittenRisks 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

  • 67% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    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

  • 59% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Corporate social responsibility, or CSR, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation

  • 58% rewrittenRisks Related to our Financial Condition and Indebtedness

    A material impairment in the carrying value of our intangible assets or goodwill could negatively affect our results of operation and financial condition

  • 57% rewrittenRisks Related to Intellectual Property

    We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers

  • 52% rewrittenRisks Related to our Financial Condition and Indebtedness

    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

    Was: Our 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

  • 48% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    We face significant competition from other pharmaceutical, medical device and biotechnology companies. Our operating results will suffer if we fail to compete effectively

  • 46% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    If 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

  • 43% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Certain 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

  • 40% rewrittenRegulatory Risks

    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

  • 39% rewrittenRisks Related to our Financial Condition and Indebtedness

    Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future

  • 38% rewrittenRisks Related to our Financial Condition and Indebtedness

    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

  • 38% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    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

  • 37% rewrittenRegulatory Risks

    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

  • 36% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    We may not be able to manage our business effectively if we are unable to attract and retain key personnel

  • 33% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Any 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

  • 30% rewrittenRegulatory 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

  • 30% rewrittenRisks Related to our Financial Condition and Indebtedness

    Our quarterly operating results may fluctuate significantly

  • 29% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Our success depends primarily on our ability to successfully commercialize EXPAREL and ZILRETTA

  • 29% rewrittenRegulatory Risks

    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

  • 27% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Significant changes in the global climate, extreme weather conditions, water availability and other climate related risks could adversely affect our business or operations

  • 25% rewrittenRisks Related to our Financial Condition and Indebtedness

    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

  • 23% rewrittenRisks Related to Information Technology, Cybersecurity and Data Privacy

    Our business and operations would suffer in the event of system failures

  • 22% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    We make substantial investments in research and development and unsuccessful investments could materially adversely affect our business, financial condition and results of operations

  • 21% rewrittenRisks Related to the Development and Commercialization of our Products and Product Candidates

    Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 37

    Was: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 35

All 99 risk factors

Headings as the filing states them, in filing order.

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 ZILRETTA29% rewritten
  2. 02Any disruption in our ability to generate revenues from the sale of EXPAREL and ZILRETTA will have a material and adverse impact on our results of operations and financial conditionNew
  3. 03Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 3721% rewritten
  4. 04physicians, patients and third-party payers, we may not generate meaningful revenues from EXPAREL, and we may not remain profitableNew
  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 effectively48% rewritten
  7. 07Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 39100% rewritten
  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. 09Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 40100% rewritten
  10. 10If 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
  11. 11Any such failure may result in decreased sales and could lead us to incur other additional costs, which would have an adverse effect on our business33% rewritten
  12. 12Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 41100% rewritten
  13. 13We may need to increase the size of our organization and effectively manage our sales force, and we may experience difficulties in managing growth
  14. 14We may not be able to manage our business effectively if we are unable to attract and retain key personnel36% rewritten
  15. 15Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 42100% rewritten
  16. 16We 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
  17. 17If 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 revenues46% rewritten
  18. 18Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 43100% rewritten
  19. 19We may need to expand our manufacturing operations or outsource such operations to third parties
  20. 20Our 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 operations70% rewritten
  21. 21response to inspections conducted by the FDA or similar foreign regulatory authorities, which could have a material adverse effect on our business, financial position and results of operationsNew
  22. 22Our co-production and other agreements with Thermo Fisher may involve unanticipated expenses and delays
  23. 23Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 45100% rewritten
  24. 24Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs82% rewritten
  25. 25Our operations are dependent on the global supply chain and impacts of supply chain constraints and inflationary pressure could adversely impact our operating results
  26. 26Our 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 opportunities38% rewritten
  27. 27Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 46100% rewritten
  28. 28We make substantial investments in research and development and unsuccessful investments could materially adversely affect our business, financial condition and results of operations22% rewritten
  29. 29Our 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
  30. 30Any 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
  31. 31Collaborations 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 reputation78% rewritten
  32. 32Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 47100% rewritten
  33. 33Our dependence on contract research organizations could result in delays in and additional costs for our drug or medical device development efforts
  34. 34We 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
  35. 35We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources
  36. 36Guidelines and recommendations published by various organizations could reduce the demand for or use of our products

Regulatory Risks

  1. 37Our 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 products30% rewritten
  2. 38Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 49100% rewritten
  3. 39We 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 condition40% rewritten
  4. 40could result in the imposition of sanctions, including, among other things, issuance of warnings letters or imposition of seizures or injunctions. For more information regarding our pediatric study obligations, see Note 20, Commitments and Contingencies, to our consolidated financial statements included hereinNew
  5. 41A regulatory authority may determine that our products or any of our product candidates have undesirable side effects
  6. 42Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 51100% rewritten
  7. 43If we do not comply with federal, state and foreign laws and regulations relating to the health care business, we could face substantial penalties71% rewritten
  8. 44The design, development, manufacture, supply and distribution of our products are highly regulated and technically complex
  9. 45Any 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. 46If 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 penalties29% rewritten
  11. 47If 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 limited37% rewritten
  12. 48changes to the Medicaid rebate formula may cause the required 340B discount to increase, resulting in increased revenue leakageNew
  13. 49Public 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. 50Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 5483% rewritten
  2. 51Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 55100% rewritten
  3. 52For more information on these litigations and other legal proceedings we are involved in, see Note 20, Commitments and Contingencies, to our consolidated financial statements included hereinNew
  4. 53Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 56100% rewritten
  5. 54The 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
  6. 55Because it is difficult and costly to protect our proprietary rights, we may not be able to ensure their protection and all patents will eventually expire89% rewritten
  7. 56Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 57100% rewritten
  8. 57Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 58100% rewritten
  9. 58If 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
  10. 59We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers57% rewritten

Risks Related to our Financial Condition and Indebtedness

  1. 60Servicing our indebtedness requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial indebtedness67% rewritten
  2. 61forced to refinance these borrowings on less favorable terms or cannot refinance these borrowings, our results of operations and financial condition could be adversely affectedNew
  3. 62Our 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 Notes52% rewritten
  4. 63Despite our current level of indebtedness, we may be able to incur substantially more debt, which could increase the risks to our financial condition described above38% rewritten
  5. 64Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future39% rewritten
  6. 65A material impairment in the carrying value of our intangible assets or goodwill could negatively affect our results of operation and financial condition58% rewritten
  7. 66Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 62100% rewritten
  8. 67We 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
  9. 68Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies
  10. 69Our quarterly operating results may fluctuate significantly30% rewritten
  11. 70We 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 acquisitions25% rewritten
  12. 71Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 64100% rewritten
  13. 72The use of our net operating loss carryforwards and research and development tax credits will be limited

Risks Related to Our Common Stock

  1. 73Some 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
  2. 74Our stock price is volatile, and from February 3, 2011, the first day of trading of our common stock, to February 25, 2026, the trading prices of our stock have ranged from $6.16 to $121.95 per share81% rewritten
  3. 75We do not intend to pay dividends on our common stock for the foreseeable future
  4. 76Future sales in the public market or issuances of our common stock could lower the market price for our common stock73% rewritten
  5. 77or more of the Company may sell a substantial number of their shares in the public market, which could also affect the market price for our common stockNew
  6. 78Raising 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
  7. 79Repurchases of our common stock may not result in increased stockholder value and could adversely affect our liquidity or financial flexibilityNew
  8. 80Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 67100% rewritten
  9. 81Our business has been, and could in the future be, negatively impacted by the actions of activist stockholdersNew

Risks Related to Information Technology, Cybersecurity and Data Privacy

  1. 82We face risks related to cybersecurity threats and incidents82% rewritten
  2. 83Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 68100% rewritten
  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 results86% rewritten
  5. 86Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 69100% rewritten
  6. 87Our business and operations would suffer in the event of system failures23% rewritten
  7. 88We have invested and will continue to invest in and implement modifications and upgrades to our IT systems and procedures, including making changes to legacy systems or acquiring new systems with new functionality, and building new policies, procedures, training programs and monitoring toolsNew
  8. 89Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data67% rewritten
  9. 90Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 70100% rewritten
  10. 91A 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 condition95% rewritten
  11. 92In 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
  12. 93Corporate social responsibility, or CSR, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation59% rewritten
  13. 94product quality, supply chain management, corporate governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers may be unwilling to continue to do business with usNew
  14. 95Significant changes in the global climate, extreme weather conditions, water availability and other climate related risks could adversely affect our business or operations27% rewritten
  15. 96Our 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 operations71% rewritten
  16. 97Changes 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
  17. 98Certain 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-term43% rewritten
  18. 99Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 74100% rewritten

Other Pacira BioSciences 10-Ks

  • FY2024 10-K risk factors
    96 risks

    Commercial success depends heavily on flagship products EXPAREL and ZILRETTA. Operations rely on complex third-party manufacturing, global supply chains, and strict regulatory compliance.

    Filed Feb 27, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.