10-K: Pacira BioSciences Reports 2025 Profit Amidst Strategic Growth & Pipeline Expansion
Annual Report
Pacira BioSciences achieved profitability in 2025 with increased product revenues, new strategic partnerships, and significant pipeline advancements, despite legal challenges and an IPR&D impairment.
Summary
- Total revenues increased 4% to $726.4 million in 2025 from $701.0 million in 2024.
- Net product sales of EXPAREL grew 5% to $575.1 million in 2025, driven by a 6% increase in gross vial volume.
- Net product sales of ZILRETTA decreased 1% to $116.6 million in 2025, primarily due to a 4% decrease in kit volume.
- Net product sales of iovera increased 6% to $24.2 million in 2025, with a 7% increase in Smart Tip volume.
- Gross margin improved by three percentage points to 79% in 2025, attributed to lower EXPAREL inventory reserves and improved ZILRETTA product costs.
- Reported a net income of $7.0 million in 2025, a significant turnaround from a net loss of $99.6 million in 2024, which included a $163.2 million goodwill impairment.
- Research and development expenses increased 44% to $117.3 million in 2025, largely due to the PCRX-201 Phase 2 trial, ZILRETTA shoulder trial, iovera spasticity trial, and a $5.0 million upfront payment for PCRX-2002.
- Selling, general and administrative expenses rose 25% to $368.8 million in 2025, reflecting increased marketing, sales force expansion, and legal fees.
- A $25.9 million impairment charge was recognized for the ZILRETTA shoulder OA in-process research and development (IPR&D) asset due to revised completion timelines and revenue forecasts.
- Received a $28.3 million cash payment from the Research Development Foundation (RDF), comprising $23.1 million in repaid royalties and $5.2 million in statutory interest, following a favorable court judgment.
- Settled patent infringement suits with eVenus ANDA Filers for $7.0 million, granting a volume-limited license for generic bupivacaine liposome injectable suspension starting in early 2030.
- New patent infringement suits were filed against WhiteOak and Qilu in November 2025 for EXPAREL patents.
- Launched the 5x30 strategic growth plan in January 2025, targeting over three million patients annually, double-digit compounded annual growth rate in product revenues, a five percentage-point improvement in gross margins, at least five pipeline programs in clinical development, and five partnerships by 2030.
- Acquired the remaining 81% of GQ Bio Therapeutics GmbH for $30.6 million in February 2025, securing full ownership of the HCAd vector platform and PCRX-201.
- Entered a co-promotion agreement with Johnson & Johnson MedTech in July 2025 for ZILRETTA in the U.S.
- Signed an exclusive worldwide license agreement with AmacaThera, Inc. in November 2025 for PCRX-2002, a long-acting ropivacaine formulation.
- Partnered with LG Chem in January 2026 for exclusive commercialization rights of EXPAREL in select Asian-Pacific markets, including a $2.0 million upfront payment.
- The NOPAIN Act, effective January 1, 2025, mandates Medicare reimbursement for qualifying non-opioid products like EXPAREL and iovera in outpatient settings.
- A new product-specific HCPCS J-code (J0666) for EXPAREL became effective January 1, 2025, standardizing and streamlining billing and reimbursement.
Sentiment
Score: 8
Explanation: StockSavvy.ai views this as a strong positive report, reflecting significant operational improvements, strategic execution, and favorable regulatory developments that position the company for sustained growth and profitability, despite some increased expenses and ongoing legal challenges.
Positives
- Total revenues increased 4% year-over-year to $726.4 million.
- EXPAREL net product sales increased 5% to $575.1 million, with a 6% increase in gross vial volume.
- iovera net product sales increased 6% to $24.2 million, driven by a 7% increase in Smart Tip volume.
- Gross margin improved by three percentage points to 79% due to lower EXPAREL inventory reserves and improved ZILRETTA product costs.
- Achieved net income of $7.0 million in 2025, a significant turnaround from a $99.6 million net loss in 2024.
- A favorable legal judgment against Research Development Foundation (RDF) resulted in a $28.3 million cash payment, including $23.1 million in repaid royalties and $5.2 million in statutory interest.
- Settled eVenus patent infringement suits, granting a volume-limited license for generic bupivacaine liposome injectable suspension starting early 2030, avoiding further litigation costs.
- Acquired full ownership of GQ Bio Therapeutics GmbH for $30.6 million, securing the HCAd vector platform and PCRX-201, and eliminating future milestone/royalty payments to GQ Bio.
- Launched the 5x30 strategic growth plan, showing early progress towards patient reach (2.5 million patients reached), double-digit topline growth, and gross margin improvement.
- Established a co-promotion agreement with Johnson & Johnson MedTech for ZILRETTA, expanding market reach.
- Secured an exclusive worldwide license agreement with AmacaThera, Inc. for PCRX-2002, adding a new long-acting ropivacaine to the pipeline.
- Partnered with LG Chem for exclusive commercialization rights of EXPAREL in select Asian-Pacific markets, including a $2.0 million upfront payment.
- The NOPAIN Act, effective January 1, 2025, mandates Medicare reimbursement for non-opioid products like EXPAREL and iovera in outpatient settings, eliminating cost burdens for institutions.
- A new product-specific HCPCS J-code (J0666) for EXPAREL became effective January 1, 2025, standardizing and streamlining billing and reimbursement.
- iovera received a separate add-on payment of up to $255.85 for Medicare reimbursement in ASC and HOPD settings (C9809).
- FDA cleared a new iovera Smart Tip for medial branch blocks to manage chronic low back pain, with a pilot study showing significantly greater improvements in pain and disability compared to RFA.
- PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the EMA, expediting development and review.
- Positive two-year safety and efficacy data for PCRX-201 in Phase 1 knee OA trial, showing sustained pain relief.
- Expanded EXPAREL label to include adductor canal block and sciatic nerve block in the popliteal fossa, increasing utility for lower extremity procedures.
- FDA waived pediatric studies requirement for EXPAREL brachial plexus interscalene nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block indications.
- Completed Part 1 of Phase 1 pediatric pharmacokinetic study for EXPAREL and initiated enrollment for Part 2.
- Achieved zero hazardous waste to landfill certification at San Diego Science Center Campus in 2024.
- Supreme Court ruling against country-specific tariffs and exclusion of pharmaceuticals from new blanket tariffs mitigate potential cost increases.
Negatives
- ZILRETTA net product sales decreased 1% to $116.6 million, primarily due to a 4% decrease in kit volume.
- Research and development expenses increased significantly by 44% to $117.3 million.
- Selling, general and administrative expenses increased significantly by 25% to $368.8 million.
- A $25.9 million impairment charge was recognized for the ZILRETTA shoulder OA IPR&D asset due to revised completion timelines and revenue forecasts.
- Incurred a $7.0 million legal settlement cost for the eVenus patent infringement suits.
- Incurred a $1.0 million loss on early extinguishment of debt related to the TLA Term Loan repayment.
- Experienced a $6.6 million other net loss, primarily due to an $11.0 million impairment of an equity investment and convertible note receivable.
- The U.S. District Court for the District of New Jersey ruled in August 2024 that one of EXPAREL's patents (11,033,495) was not valid on grounds of obviousness and anticipation, though an appeal is pending.
- New patent infringement suits filed against WhiteOak and Qilu for EXPAREL patents, indicating ongoing legal challenges and potential costs.
- A reduction in force impacted 71 employees (approximately 8% of total workforce) due to manufacturing efficiencies, incurring $3.7 million in employee termination benefits and $5.5 million in accelerated depreciation.
- Cash and cash equivalents decreased significantly from $276.8 million in 2024 to $158.5 million in 2025.
- Net cash used in financing activities was $369.6 million in 2025, primarily due to debt repayments and share repurchases.
- The earliest patent family for iovera is scheduled to expire in December 2025, potentially opening the door for competitors.
- A shareholder derivative suit was filed in June 2025 alleging breach of fiduciary duties by officers and directors related to EXPAREL patents.
- RDF filed two notices of appeal regarding the favorable court judgment, indicating continued litigation risk.
Risks
- Success depends primarily on the ability to successfully commercialize EXPAREL and ZILRETTA.
- Efforts to commercialize EXPAREL and ZILRETTA are subject to many internal and external challenges, including market demand, sales force training, formulary approvals, manufacturing capacity, and distribution.
- Inability to achieve and maintain adequate levels of third-party payer coverage and reimbursement for products, on reasonable pricing terms, may hinder commercial success.
- Significant competition from other pharmaceutical, medical device, and biotechnology companies could adversely affect operating results.
- Regulatory approval for any approved product is limited to specific indications and conditions, and allegations of failure to comply with approved indications could limit sales efforts.
- Inability to establish and maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell products may limit revenue generation.
- Reliance on third parties to perform many essential services for EXPAREL, ZILRETTA, and iovera, and for any other commercialized products, poses risks if these parties fail to perform or comply with regulations.
- Need to increase the size of the organization and effectively manage the sales force, with potential difficulties in managing such growth.
- Inability to attract and retain key personnel could adversely affect business management.
- Potential product liability exposure, which could result in substantial liability and limit commercialization.
- Failure to manufacture products in sufficient quantities and at acceptable quality and pricing levels, or to fully comply with CGMP regulations, may lead to delays or inability to meet market demand.
- Need to expand manufacturing operations or outsource, which may involve unanticipated expenses and delays.
- Inability to continue manufacturing adequate quantities of products could disrupt supply to customers and partners.
- Reliance on third parties for the timely supply of specified raw materials and equipment for manufacturing EXPAREL, ZILRETTA, and iovera.
- Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs.
- Operations are dependent on the global supply chain, and impacts of supply chain constraints and inflationary pressure could adversely impact operating results.
- Future growth depends in part on the ability to identify, develop, acquire, or in-license products; failure to do so may limit growth opportunities.
- Substantial investments in research and development (R&D) may be unsuccessful, materially adversely affecting business, financial condition, and results of operations.
- Business involves the use of hazardous materials and compliance with environmental laws and regulations, which can be expensive and restrict business operations.
- Collaboration arrangements that may be entered into in the future may not be successful.
- Clinical trials are expensive, lengthy, and have uncertain outcomes; failure to demonstrate safety and efficacy could prevent or significantly delay obtaining regulatory approval.
- Dependence on contract research organizations could result in delays and additional costs for drug or medical device development efforts.
- Dependence on clinical investigators and clinical sites to enroll patients in clinical trials and sometimes other third parties to manage trials and perform data collection and analysis.
- 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 products.
- Business could be materially adversely affected if a regulatory or enforcement agency determines off-label use of products is being promoted.
- Failure to receive regulatory approval for any product candidates, or delays in approval, would have a material adverse effect on business and financial condition.
- Regulatory clearance process for medical devices may result in substantial delays, unexpected or additional costs, and limitations on product commercialization.
- A regulatory authority may determine that products or product candidates have undesirable side effects.
- Failure to comply with federal, state, and foreign laws and regulations relating to the healthcare business could result in substantial penalties.
- Design, development, manufacture, supply, and distribution of products are highly regulated and technically complex.
- Patents and patent applications covering pMVL products are limited to specific injectable formulations, processes, and uses, and market opportunity may be limited by lack of patent protection for the active ingredient itself.
- Patents and patent applications covering ZILRETTA are limited to specific injectable formulations, uses, and processes of manufacturing, and market opportunity may be limited by lack of patent protection for the active ingredient itself.
- Patents and patent applications covering iovera products are primarily limited to specific handheld cryogenic needle devices and methods, and market opportunity may be limited by gaps in patent coverage.
- Patents and patent applications covering PCRX-201 are limited to composition of matter and uses of an adenoviral vector, and market opportunity may be limited by other gene therapies for treating OA.
- Difficulty and cost in protecting proprietary rights, and all patents will eventually expire.
- Being sued for infringing the intellectual property rights of third parties would be costly and time-consuming.
- May be subject to claims that employees have wrongfully used or disclosed alleged trade secrets of their former employers.
- Servicing indebtedness requires a significant amount of cash, and there may not be sufficient cash flow to pay substantial indebtedness.
- Credit Agreement and Indenture impose significant operating and financial restrictions, which may prevent capitalizing on business opportunities.
- May not have the ability to raise funds necessary to settle conversions of the 2029 Notes in cash or to repurchase the 2029 Notes upon a fundamental change.
- Ability to incur substantially more debt despite current levels, which could increase financial risks.
- Cumulatively incurred significant losses since inception and may incur additional losses in the future.
- A material impairment in the carrying value of intangible assets or goodwill could negatively affect results of operation and financial condition.
- May need additional funding and may be unable to raise capital when needed, forcing delays, reductions, or elimination of product development programs or commercialization efforts.
- Quarterly operating results may fluctuate significantly.
- Inability to successfully integrate the businesses and personnel of acquired companies and businesses, and failure to realize anticipated synergies and benefits.
- Use of net operating loss carryforwards and R&D tax credits will be limited.
- Provisions of charter documents and Delaware law may have anti-takeover effects.
- Common stock price may be subject to significant fluctuations and volatility.
- No intention to pay dividends on common stock for the foreseeable future.
- Future sales in the public market or issuances of common stock could lower the market price and cause dilution.
- Repurchases of common stock may not result in increased stockholder value and could adversely affect liquidity or financial flexibility.
- Business has been, and could in the future be, negatively impacted by the actions of activist stockholders.
- Risks related to cybersecurity threats and incidents.
- Failure to maintain the privacy and security of personal and business information could damage reputation, incur costs, and lead to litigation.
- Changes in data privacy and protection laws and regulations, particularly in Europe and California, or any failure to comply, could adversely affect business and financial results.
- Inability to maintain and upgrade enterprise resource planning system and other information technology (IT) systems as needed.
- Artificial intelligence presents risks and challenges that can impact business, including security risks to confidential information and an uncertain regulatory environment.
- A pandemic, epidemic, or outbreak of a contagious disease, or fear of such an event, could have a material adverse effect on business, operating results, and financial condition.
- Corporate social responsibility (CSR) issues may have an adverse effect on business, financial condition, results of operations, and damage reputation.
- Significant changes in the global climate, extreme weather conditions, water availability, and other climate-related risks could adversely affect business or operations.
- International operations expose to numerous and sometimes conflicting legal and regulatory requirements, with compliance being costly and violations adversely affecting business.
- Changes in global economic conditions, including those driven by inflation and tariffs, may adversely affect spending and the financial health of customers and others.
Future Outlook
The 5x30 strategic growth plan aims to deliver products to over three million patients annually, grow product revenues by a double-digit compounded annual growth rate, achieve a five percentage-point improvement in gross margins over 2024, advance an innovative pipeline with at least five programs in clinical development, and establish five partnerships by 2030. The company expects to continue pursuing expanded use of EXPAREL, ZILRETTA, and iovera in additional procedures, progress its product candidate pipeline including PCRX-201 development, and advance regulatory activities. A Phase 2 program for PCRX-2002 is expected to initiate in 2026, and LG Chem plans to file for EXPAREL marketing authorizations in South Korea and Thailand in 2026. Results from a pre-specified interim analysis of Part A of the PCRX-201 Phase 2 ASCEND study are expected before the end of 2026, with Part B initiating in the second half of 2026. The investigational device exemption (IDE) study for iovera in spasticity is expected to complete in 2026. The company anticipates continued cost inflation and higher interest rates in 2026 but does not expect tariffs to have a material adverse impact. Existing cash and investments are believed to be adequate for short-term liquidity needs.
Management Comments
- Our mission is to deliver innovative, non-opioid pain therapies to transform the lives of patients.
- In January 2025, we launched our new 5x30 strategic growth plan (5x30) to accelerate our transition into an innovative biopharmaceutical and therapeutic area leader in musculoskeletal pain and adjacencies.
- Since 5x30 was introduced, we have already made significant progress towards our long-term objectives. In 2025, we reached 2.5 million patients; volume trends show we are moving towards our goal of double-digit topline growth; we are on track for a five-percentage point improvement in gross margins through enhanced manufacturing efficiencies; progress has been made in the pipeline with new preclinical programs; and we have added two strategic partnerships, one for each of EXPAREL and ZILRETTA.
- We believe EXPAREL addresses a significant medical need for a safe and effective long-acting non-opioid postsurgical analgesic and plays a significant role in opioid minimization strategies.
- We believe that ZILRETTA holds the potential to become the corticosteroid of choice given its high patient satisfaction, with up to four months of reliable OA knee pain relief and fewer office visits.
- We believe these data validate iovera as a clinically meaningful non-opioid alternative for patients with knee OA as well as those undergoing TKA, and that iovera offers the opportunity to provide patients with non-opioid pain control well in advance of any necessary surgical intervention.
- With the introduction of this new iovera Smart Tip, Pacira aims to address these gaps and elevate the standard of care.
- PCRX-201 is the lead program from our HCAd platform and we believe it underscores its promise for treating common diseases given its encouraging data in OA.
- While other therapies typically provide relief for three to six months, PCRX-201 has already set a new standard with a year or more of sustained pain relief from a single injection.
- We are a team of dedicated and highly talented professionals focused on delivering innovative, non-opioid pain therapies to transform the lives of patients.
- We are an organization built on high ethical standards, an unwavering commitment to patients and transparent communications.
- We have a drive and a desire to improve the world around us and make a meaningful difference in the lives of patients, families, communities and society.
- We are deeply invested in the welfare of our patients, employees, the environment and the communities where we live and work.
- We are committed to intentionally cultivating a culture of inclusion where all feel welcomed and valued for their backgrounds, perspectives and experiences.
- We expect that our cash and cash equivalents and available-for-sale investments on hand will be adequate to cover our short-term liquidity needs, and that we would be able to access other sources of financing should the need arise.
Industry Context
StockSavvy.ai notes that Pacira BioSciences is strategically positioning itself as a leader in musculoskeletal pain and adjacencies, aligning with the broader healthcare trend of reducing opioid dependence. The company's focus on non-opioid therapies like EXPAREL, ZILRETTA, and iovera directly addresses the ongoing opioid crisis and patient demand for safer pain management alternatives. The acquisition of GQ Bio and the advancement of the HCAd gene therapy platform for OA knee pain demonstrate a forward-looking approach to addressing prevalent diseases with innovative, potentially disease-modifying treatments, differentiating Pacira from competitors primarily offering symptomatic relief. The new partnerships with J&J MedTech and LG Chem indicate a strategy to leverage established distribution networks for market expansion, a common tactic in the competitive pharmaceutical landscape. The NOPAIN Act and the new J-code for EXPAREL are significant regulatory tailwinds, reflecting a supportive policy environment for non-opioid alternatives, which could provide a competitive advantage.
Comparison to Industry Standards
- EXPAREL is positioned as a long-acting, non-opioid alternative to traditional opioids (e.g., morphine, fentanyl) and short-acting local anesthetics (e.g., bupivacaine, marcaine, ropivacaine). Clinical data shows EXPAREL delayed median time to opioid rescue to 15 hours versus 1 hour for placebo in hemorrhoidectomy, and reduced opioid consumption by 45% through 72 hours, demonstrating superior pain management compared to traditional approaches.
- ZILRETTA is the first and only extended-release, single-shot corticosteroid intra-articular (IA) injection for OA knee pain, offering relief for 12-16 weeks. This provides a significant advantage over immediate-release steroids and hyaluronic acid (HA) injections, which are current IA standards of care but typically offer shorter durations of relief. Competitors like stem cell and PRP injections have questionable efficacy in controlled trials and lack broad reimbursement.
- iovera provides immediate, long-lasting (months) drug-free pain control via cryoanalgesia. A pilot study for chronic low back pain showed significantly greater improvements in pain and disability compared to radiofrequency ablation (RFA), which can have delayed effects and potential tissue damage. This positions iovera as a potentially superior alternative to RFA for certain nerve blocks.
- PCRX-201, a gene therapy for OA knee pain, has shown potential for pain relief lasting at least 2 years from a single injection in Phase 1 data. This aims to set a new standard for durability, substantially exceeding the typical 3-6 months of relief offered by other therapies. Its Regenerative Medicine Advanced Therapy (RMAT) and Advanced Therapy Medicinal Products (ATMP) designations highlight its potential to offer a major advantage over existing treatments for a significant unmet need.
Management Changes
| Role | Previous Person | New Person | Effective Date | Reason |
|---|---|---|---|---|
| Director | NA | Samit Hirawat, M.D. | January 2026 | Appointment to the board of directors, increasing board size to 10 members. Also appointed to the Science and Technology Committee. |
Corporate Governance
| Change Type | Description | Effective Date | Impact Assessment |
|---|---|---|---|
| Board Composition | Appointed Samit Hirawat, M.D., to the board of directors, increasing the board size to 10 members and adding expertise in clinical development and industry. | January 2026 | Enhances board's expertise and oversight, particularly in scientific and technological areas. |
| Committee Appointment | Samit Hirawat, M.D., appointed to the Science and Technology Committee of the board of directors. | January 2026 | Strengthens the committee's ability to guide and oversee R&D and technological advancements. |
| Cybersecurity Oversight | Audit Committee assists the board in oversight of cyber and information security risks, receiving quarterly updates. The full board receives a cybersecurity program update at least annually. | Ongoing | Maintains robust oversight of cybersecurity risks, crucial in an increasingly digital and threat-prone environment. |
| Employee Training | Executive team and senior leaders received Unconscious Bias and Inclusive Leadership training. All employees receive annual information security training. | Ongoing | Fosters a more inclusive culture and strengthens internal controls against cybersecurity threats. |
| Diversity, Equity, and Inclusion (DEI) Initiatives | Established a cross-functional DEI employee council and the P.O.W.E.R. (Preparing Our Women for Excellence and Results) organization, an employee resource group. | Ongoing | Promotes a culture of inclusion, supports leadership development, and enhances employee engagement and retention. |
Legal Proceedings
- MyoScience Milestone Litigation: Court ruled in January 2025 that disputed milestones were not met, granting judgment to Pacira. Pacira received a $5.2 million payment for attorney fees in April 2025.
- eVenus Pharmaceutical Laboratories Litigations: Pacira settled patent infringement suits with eVenus ANDA Filers in April 2025. Pacira granted a volume-limited license for generic bupivacaine liposome injectable suspension starting early 2030. Pacira paid eVenus ANDA Filers $7.0 million.
- Paragraph IV Certification Notices (WhiteOak and Qilu): In October 2025, received notices from WhiteOak and Qilu regarding Abbreviated New Drug Applications (ANDAs) for generic EXPAREL. Pacira filed patent infringement suits against them in November 2025, asserting infringement of multiple EXPAREL patents. Litigation is ongoing.
- Argentum Request for Ex Parte Reexamination of 495 Patent: Argentum filed a request in October 2024. The USPTO issued a Reexamination Certificate in August 2025, agreeing with Pacira's position after claim 7 was withdrawn and claim 1 canceled.
- Securities Class Action (Alvarez v. Pacira BioSciences, Inc.): Filed January 2025, alleging false/misleading statements about EXPAREL patents. Dismissed with prejudice in February 2026.
- Shareholder Derivative Action (Young v. Lee, et al): Filed June 2025, alleging breach of fiduciary duties by officers/directors related to EXPAREL patents. The case is in the pleadings stage.
- Research Development Foundation (RDF): U.S. District Court, District of Nevada, ruled in April 2025 that Pacira was no longer obligated to pay royalties for EXPAREL. In June 2025, the court ordered RDF to repay Pacira $23.1 million in royalties plus $5.2 million in statutory interest. Pacira received a $28.3 million cash payment in July 2025. RDF filed two notices of appeal in May and September 2025; a consolidated appeal is pending.
Stakeholder Impact
- Shareholders: Positive impact from increased net income, improved gross margin, favorable legal judgment (RDF), and share repurchase program. Potential negative impact from ongoing patent litigation (WhiteOak/Qilu, RDF appeal), IPR&D impairment, and increased R&D/SG&A expenses. Dilution risk from future equity raises.
- Patients: Positive impact from continued commercialization of non-opioid pain therapies (EXPAREL, ZILRETTA, iovera), expanded indications, and pipeline advancements (PCRX-201, PCRX-2002). The NOPAIN Act and new J-code improve access to non-opioid options.
- Employees: Reduction in force impacted 71 employees, leading to termination benefits. Overall commitment to employee wellbeing, health, safety, diversity, equity, and inclusion. Opportunities for professional development and long-term incentives.
- Customers (Hospitals, ASCs, Physicians): Benefits from expanded product labels, new Smart Tips (iovera), and improved reimbursement policies (NOPAIN Act, J-code). Co-promotion with J&J MedTech expands ZILRETTA reach.
- Suppliers/Partners: New partnerships (LG Chem, AmacaThera) create new business opportunities. Continued reliance on third-party manufacturers and suppliers for raw materials and services.
- Creditors: Indebtedness levels and covenants impose restrictions. Repayment of 2025 Notes and refinancing of TLA Term Loan impact debt profile.
Next Steps
- Initiate enrollment for Part 2 of the EXPAREL Phase 1 pharmacokinetic pediatric study in children aged six months to less than two years of age.
- Discuss regulatory strategy for EXPAREL nerve block in pediatric setting with FDA, EMA, and MHRA.
- Conduct a Phase 3 registration study for ZILRETTA to evaluate safety and efficacy for OA pain of the shoulder, with an interim analysis later this year (2026).
- Seek approval to expand the ZILRETTA label to include OA pain of the shoulder if the study is successful.
- Develop new iovera Smart Tips for certain procedures, including a specific tip for medial branch block for chronic low-back pain.
- Launch an investigational device exemption (IDE) study to evaluate iovera as an alternative treatment for spasticity.
- Develop new iovera Smart Tips to expand use to other chronic and acute pain applications (foot and ankle, elbow and wrist, pediatric care).
- Initiate a Phase 2 program for PCRX-2002 in 2026.
- LG Chem plans to file for marketing authorizations for EXPAREL in South Korea and Thailand in 2026.
- Report results from a pre-specified interim analysis of Part A of the PCRX-201 Phase 2 ASCEND study before the end of 2026.
- Initiate Part B of the PCRX-201 Phase 2 clinical study in the second half of 2026.
- Conduct Investigational New Drug (IND) enabling studies of PCRX-1002 for Dry Eye Disease and PCRX-1003 for Degenerative Disc Disease.
- Conduct animal studies for PCRX-1001, which has out-licensing potential for OA in dogs and other companion animals.
- Continue to monitor developments and assess potential impact of Supreme Court decision and related trade measures on business and supply chain.
- Continue to implement the 5x30 strategic growth plan objectives.
- Vigorously defend intellectual property rights relating to EXPAREL in ongoing litigation against WhiteOak and Qilu.
- Address the consolidated appeal filed by RDF regarding the $28.3 million repayment.
- Address the shareholder derivative suit (Young v. Lee, et al).
Key Dates
| Date | Description |
|---|---|
| December 2006 | Pacira BioSciences, Inc. (then Blue Acquisition Corp.) incorporated. |
| March 2007 | Acquired Pacira Pharmaceuticals, Inc. from SkyePharma Holdings, Inc. |
| October 2010 | Name changed to Pacira Pharmaceuticals, Inc. |
| February 2011 | Completed initial public offering. |
| October 2011 | EXPAREL approved by FDA. |
| April 2012 | EXPAREL commercially launched in U.S. |
| December 2012 | Entered license agreement with Aratana Therapeutics, Inc. |
| April 4, 2014 | Entered Strategic Co-Production, Technical Transfer, and Manufacturing and Supply Agreements with Thermo Fisher Scientific Pharma Services. |
| April 2014 | Amended and Restated 2014 Inducement Plan approved by Board. |
| June 2014 | Amended and Restated 2011 Stock Incentive Plan and 2014 Employee Stock Purchase Plan approved by stockholders. |
| July 31, 2015 | Flexion and Thermo Fisher entered Manufacturing and Supply Agreement and Technical Transfer and Service Agreement for ZILRETTA. |
| August 2016 | FDA's Center for Veterinary Medicine approved NOCITA (bupivacaine liposome injectable suspension) for dogs. |
| October 2017 | ZILRETTA approved by FDA and launched in U.S. |
| May 2018 | FDA approval of first dedicated EXPAREL manufacturing suite at Thermo Fisher. |
| April 2019 | Acquired MyoScience, Inc. |
| November 2020 | European Commission granted marketing authorization for EXPAREL. |
| March 2021 | FDA approved sNDA to expand EXPAREL label for pediatric use (6 years and older). |
| August 2021 | American Association of Orthopaedic Surgeons (AAOS) updated guidelines, finding ZILRETTA can improve patient outcomes. |
| November 2021 | Acquired Flexion Therapeutics, Inc. |
| November 2021 | USPTO issued U.S. Patent Nos. 11,185,506 and 11,179,336 for EXPAREL manufacturing process and composition. |
| December 2021 | Filed declaratory judgment lawsuit against Research Development Foundation (RDF). |
| April 2022 | All iovera Smart Tips produced by Amphenol. |
| November 2022 | EMA's CHMP and MHRA approved expanded EXPAREL indication for pediatric use (6 years and older) in Europe/U.K. |
| March 31, 2023 | Entered TLA Credit Agreement. |
| August 2023 | U.S. District Court, District of Nevada, granted partial summary judgment in favor of Pacira against RDF regarding EXPAREL royalties. |
| November 2023 | FDA approved sNDA to expand EXPAREL label for adductor canal block and sciatic nerve block. |
| November 2023 | U.S. District Court, District of Nevada, mediation with RDF did not result in settlement. |
| December 2023 | FASB issued ASU 2023-09, adopted by Pacira for annual reporting. |
| February 2024 | FDA approved enhanced, large-scale EXPAREL manufacturing suite in San Diego. |
| February 2024 | FDA granted PCRX-201 Regenerative Medicine Advanced Therapy (RMAT) designation. |
| May 2024 | Completed private placement of $287.5 million in 2029 Notes. |
| August 2024 | U.S. District Court for the District of New Jersey ruled EXPAREL patent 11,033,495 invalid. |
| September 2024 | Appeal filed regarding invalidation of EXPAREL patent 11,033,495. |
| October 2024 | Argentum filed Request for Ex Parte Reexamination of 495 patent. |
| October 2024 | CMS established permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J-code (J0666) for EXPAREL, effective January 1, 2025. |
| November 2024 | CMS confirmed EXPAREL and iovera qualify for NOPAIN Act reimbursement, effective January 1, 2025. |
| November 2024 | Presented two-year safety and efficacy data for PCRX-201 at American College of Rheumatology's annual ACR Convergence meeting. |
| November 2024 | USPTO issued U.S. Patent Nos. 12,144,890 and 12,151,024 for EXPAREL composition/process. |
| December 2024 | FDA cleared new iovera Smart Tip for medial branch blocks. |
| December 2024 | USPTO issued U.S. Patent No. 12,156,940 for EXPAREL manufacturing process. |
| December 2024 | Announced results from pilot study evaluating iovera versus radiofrequency ablation (RFA) for chronic low back pain. |
| January 1, 2025 | NOPAIN Act took effect. |
| January 2025 | Launched 5x30 strategic growth plan. |
| January 2025 | Court issued decision in MyoScience Milestone Litigation, finding milestones not met. |
| January 2025 | Entered Manufacturing and Supply Agreement with Jubilant Hollisterstier, LLC for ZILRETTA diluent. |
| February 2025 | Acquired remaining 81% of GQ Bio Therapeutics GmbH. |
| February 2025 | USPTO issued U.S. Patent No. 12,226,610 for EXPAREL adductor canal block use. |
| March 2025 | EMA waived pediatric studies requirement for EXPAREL. |
| March 2025 | USPTO issued U.S. Patent Nos. 12,246,092, 12,251,468 and 12,251,472 for EXPAREL manufacturing process/composition. |
| April 7, 2025 | Entered settlement agreement with eVenus ANDA Filers. |
| April 2025 | Board authorized new $300.0 million share repurchase program. |
| April 2025 | U.S. District Court for the District of Nevada issued judgment in favor of Pacira against RDF. |
| April 2025 | USPTO issued U.S. Patent No. 12,285,435 for dexamethasone sodium phosphate-pMVL product. |
| April 2025 | USPTO issued U.S. Patent No. 12,285,419 for high-potency bupivacaine-pMVL product. |
| May 2025 | USPTO issued U.S. Patent No. 12,296,047 for EXPAREL manufacturing process. |
| May 2025 | RDF filed notice of appeal regarding court judgment. |
| June 2025 | U.S. District Court for the District of Nevada issued judgment for $23.1 million repayment from RDF plus $5.2 million in statutory interest. |
| June 16, 2025 | Shareholder Derivative suit, Young v. Lee, et al, filed. |
| July 3, 2025 | Entered Credit Agreement with Wells Fargo Bank, N.A. |
| July 2025 | Entered co-promotion agreement with Johnson & Johnson MedTech for ZILRETTA. |
| July 2025 | Instituted reduction in force at Science Center Campus. |
| July 2025 | Received $28.3 million cash payment from RDF. |
| August 1, 2025 | 2025 Notes matured and repaid. |
| August 2025 | USPTO issued Reexamination Certificate for 495 patent (Argentum). |
| September 2025 | RDF filed second notice of appeal. |
| October 2025 | USPTO issued U.S. Patent No. 12,433,878 for EXPAREL stellate ganglion block use. |
| October 2025 | Received Paragraph IV Certifications from WhiteOak and Qilu. |
| November 2025 | Filed patent infringement suit against WhiteOak and Qilu. |
| November 2025 | Entered exclusive worldwide license agreement with AmacaThera, Inc. for PCRX-2002. |
| November 2025 | Completed enrollment for Part A of PCRX-201 Phase 2 ASCEND study. |
| December 2025 | USPTO issued U.S. Patent No. 12,508,062 for iovera stellate ganglion block use. |
| January 2026 | Samit Hirawat, M.D., appointed to board of directors. |
| January 2026 | Entered partnership agreement with LG Chem for EXPAREL in Asian-Pacific markets. |
| February 2026 | Securities class action suit (Alvarez v. Pacira BioSciences, Inc.) dismissed with prejudice. |
| February 26, 2026 | Filing date of this Annual Report on Form 10-K. |
Recommendation
buyThe company demonstrated a strong financial turnaround in 2025, moving from a significant net loss to profitability, driven by increased product sales and improved gross margins. Strategic initiatives like the 5x30 plan, coupled with new partnerships (J&J MedTech, AmacaThera, LG Chem) and pipeline advancements (PCRX-201, PCRX-2002), indicate robust future growth potential. Favorable regulatory changes (NOPAIN Act, EXPAREL J-code) are expected to further boost product adoption and reimbursement. While there are ongoing legal challenges and increased R&D/SG&A expenses, the overall trajectory and strategic positioning suggest a positive outlook for long-term investors.
Keywords
Pacira BioSciences, EXPAREL, ZILRETTA, iovera, Non-opioid pain therapy, Postsurgical pain management, Osteoarthritis knee pain, Cryoanalgesia, Gene therapy, PCRX-201, HCAd vector platform, Pharmaceuticals, Medical devices, 10-K, Financial results, Clinical trials, Regulatory approval, Intellectual property, Manufacturing, Strategic partnerships, NOPAIN Act, RMAT designation, Biotechnology, Healthcare, Pain management, Corporate governance, Risk factors, Stock repurchase, Debt, Acquisition, GQ Bio, AmacaThera, LG Chem, SEC filing
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