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What changed in Pacira BioSciences, Inc.'s 10-K2024 vs 2025

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Paragraph-level year-over-year comparison of Pacira BioSciences, Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+607 added476 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-27)

Top changes in Pacira BioSciences, Inc.'s 2025 10-K

607 paragraphs added · 476 removed · 374 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

158 edited+91 added36 removed282 unchanged
Biggest changeAlthough we have numerous controls to protect against common cybersecurity attacks, some attacks may still be effective. Our controls are designed to detect, triage and eradicate these attacks. Over the past three years, there have been no known material breaches, and no expenses related to the investigation of such breaches. For more information on our cybersecurity program, see Item 1C.
Biggest changeOver the past three years, there have been no known material breaches, and no expenses related to the investigation of such breaches. For more information on our cybersecurity program, see Item 1C. Cybersecurity . Corporate Citizenship We are the industry leader in our commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients.
In April 2019, we acquired MyoScience, Inc., a privately held medical technology company (the “MyoScience Acquisition”), in November 2021, we acquired Flexion Therapeutics, Inc., or Flexion, a publicly traded biopharmaceutical company (the “Flexion Acquisition”) and in February 2025, we acquired GQ Bio Therapeutics GmbH, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”).
In April 2019, we acquired MyoScience, Inc., a privately held medical technology company (the “MyoScience Acquisition”), in November 2021, we acquired Flexion Therapeutics, Inc., or Flexion, a publicly traded biopharmaceutical company (the “Flexion Acquisition”) and in February 2025, we acquired GQ Bio Therapeutics GmbH, or GQ Bio, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”).
In December 2012, we entered into an Exclusive License, Development and Commercialization Agreement and related Supply Agreement with Aratana Therapeutics, Inc., a wholly owned subsidiary of Elanco Animal Health, Inc., or Aratana.
Aratana Therapeutics In December 2012, we entered into an Exclusive License, Development and Commercialization Agreement and related Supply Agreement with Aratana Therapeutics, Inc., a wholly owned subsidiary of Elanco Animal Health, Inc., or Aratana.
Based on our clinical data, EXPAREL: provides long-lasting local or regional analgesia; is a ready-to-use formulation; expands easily with saline or lactated Ringer’s solution to reach a desired volume; can be administered for local analgesia via infiltration and for regional analgesia via field block, as well as brachial plexus nerve block, sciatic nerve block in the popliteal fossa and adductor canal block; and facilitates treatment of a variety of surgical sites.
Based on our clinical data, EXPAREL: provides long-lasting local or regional analgesia; is a ready-to-use formulation; expands easily with saline or lactated Ringer’s solution to reach a desired volume; can be administered for local analgesia via infiltration and for regional analgesia via field block, as well as brachial plexus nerve block, sciatic nerve block in the popliteal fossa and adductor canal block; and facilitates treatment across a variety of surgical sites.
While we believe we are in compliance with applicable environmental regulations, the failure to fully comply with any such regulations could result in the imposition of penalties, fines and/or sanctions which could have a material adverse effect on our business. It is also possible that environmental issues may arise in the future which we cannot now predict.
While we are in compliance with applicable environmental regulations, the failure to fully comply with any such regulations could result in the imposition of penalties, fines and/or sanctions which could have a material adverse effect on our business. It is also possible that environmental issues may arise in the future which we cannot now predict.
Unless the context requires otherwise, references to “Pacira,” “we,” the “Company,” “us” and “our” in this Annual Report refers to Pacira BioSciences, Inc., a Delaware corporation, and its subsidiaries. Corporate Information We were incorporated in Delaware under the name Blue Acquisition Corp. in December 2006 and changed our name to Pacira, Inc. in June 2007.
Unless the context requires otherwise, references to “Pacira,” “we,” the “Company,” the “Registrant,” “us” and “our” in this Annual Report refers to Pacira BioSciences, Inc., a Delaware corporation, and its subsidiaries. Corporate Information We were incorporated in Delaware under the name Blue Acquisition Corp. in December 2006 and changed our name to Pacira, Inc. in June 2007.
PCRX-201 In December 2017, Flexion acquired the global rights to PCRX-201 from GQ, including a direct exclusive license of certain foundational patents, patent applications, and other proprietary rights owned by the Baylor College of Medicine, or BCM, that are related to PCRX-201 for human applications.
Patents and Patent Applications for PCRX-201 In December 2017, Flexion acquired the global rights to PCRX-201 from GQ Bio, including a direct exclusive license of certain foundational patents, patent applications, and other proprietary rights owned by the Baylor College of Medicine, or BCM, that are related to PCRX-201 for human applications.
In our Phase 3 trial as an interscalene brachial plexus nerve block for upper extremity surgeries, EXPAREL: decreased total opioid consumption by 78% (p Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 7 Table of Contents reduced pain scores by 46% versus placebo (p allowed 13% of patients who received EXPAREL to remain opioid-free for 48 hours after surgery (p In our Phase 3 trial as an adductor canal block in patients undergoing total knee arthroplasty, or TKA, EXPAREL: achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p achieved its secondary endpoint with a statistically significant reduction in postsurgical opioid consumption through 96 hours (p In our Phase 3 trial as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, EXPAREL: achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p achieved its secondary endpoints with statistically significant reductions in postsurgical opioid consumption through 96 hours (p EXPAREL can improve patient satisfaction and outcomes.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 7 Table of Contents In our Phase 3 trial as an interscalene brachial plexus nerve block for upper extremity surgeries, EXPAREL: decreased total opioid consumption by 78% (p reduced pain scores by 46% versus placebo (p allowed 13% of patients who received EXPAREL to remain opioid-free for 48 hours after surgery (p In our Phase 3 trial as an adductor canal block in patients undergoing total knee arthroplasty, or TKA, EXPAREL: achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p achieved its secondary endpoint with a statistically significant reduction in postsurgical opioid consumption through 96 hours (p In our Phase 3 trial as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, EXPAREL: achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p achieved its secondary endpoints with statistically significant reductions in postsurgical opioid consumption through 96 hours (p EXPAREL can improve patient satisfaction and outcomes.
Trade Secrets and Proprietary Information Trade secrets play an important role in protecting our pMVL-based products (including EXPAREL) and pipeline, ZILRETTA and iovera° and provide protection beyond patents and regulatory exclusivity. The scale-up and commercial manufacture of each of our products involve processes, custom equipment and in-process and release analytical techniques that we believe are unique to us.
Trade Secrets and Proprietary Information Trade secrets play an important role in protecting our pMVL-based products (including EXPAREL) and pipeline, ZILRETTA and iovera° and provide protection beyond patents and regulatory exclusivity. The scale-up and commercial manufacture of each of our products involves processes, custom equipment and in-process and release analytical techniques that we believe are unique to us.
Patent Nos. 11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, and 12,151,024 are currently listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).
Patent Nos. 11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, 12,151,024 and 12,296,047 are currently listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).
We funded the cash portion of the purchase price with cash on hand, and the consideration is subject to adjustments based on the estimated fair value of the potential milestone payments. As of December 31, 2024, these contingent value rights could aggregate up to a total of $372.3 million if certain regulatory and commercial milestones are met.
We funded the cash portion of the purchase price with cash on hand, and the consideration is subject to adjustments based on the estimated fair value of the potential milestone payments. As of December 31, 2025, these contingent value rights could aggregate up to a total of $372.3 million if certain regulatory and commercial milestones are met.
Because of the disagreement over the interpretation of this agreement, in December 2021, we filed a declaratory judgment lawsuit in the U.S. District Court for the District of Nevada (21-cv-02241). The lawsuit seeks a declaration from the court that we owe no royalties to RDF with respect to our EXPAREL product after December 24, 2021.
Because of the disagreement over the interpretation of this agreement, in December 2021, we filed a declaratory judgment lawsuit in the U.S. District Court for the District of Nevada (21-cv-02241). The lawsuit seeks a declaration from the court that we owe no royalties to RDF with respect to our EXPAREL product after December 24, 2021. In August 2023, the U.S.
We received notification from the FDA in October 2023 that our pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients as well as sciatic nerve block in the popliteal fossa and adductor canal block indications in October 2024. Global activities.
We received notification from the FDA in October 2023 that our pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients as well as sciatic nerve block in the popliteal fossa and adductor canal block indications in October 2024.
These patents are set to expire between 2025 and 2032. An important patent family specifically directed to systems and methods of treating pain offers both broad and variable coverage of cryogenic device features and methods of using the same for pain management, including single-use needle probes, particular needle sizes and shapes.
These patents are set to expire between 2026 and 2032. An important patent family specifically directed to systems and methods of treating pain offers both broad and variable coverage of cryogenic device features and methods of using the same for pain management, including single-use needle probes, particular needle sizes and shapes.
Two important patient groups are driving the spine market: first, pediatric cases, like adolescent scoliosis patients, who are undergoing highly invasive surgeries and who until very recently Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 8 Table of Contents only had opioids available to treat their pain, and second, adult degenerative patients who are often coming into surgery opioid-tolerant and who may have already had multiple back surgeries.
Two important patient groups are driving the spine market: first, pediatric cases, like adolescent scoliosis patients, who are undergoing highly invasive surgeries and who until very recently only had opioids available to treat their pain, and second, adult degenerative patients who are often coming into surgery opioid- Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 8 Table of Contents tolerant and who may have already had multiple back surgeries.
EXPAREL is redefining the paradigm of care for postsurgical pain management in children as the market’s only clinically proven safe alternative for long-acting, non-opioid postsurgical pain control in children aged 6 and over. There are approximately one million pediatric procedures per year in the U.S.
EXPAREL is redefining the paradigm of care for postsurgical pain management in children as the market’s only clinically proven safe alternative for long-acting, non-opioid postsurgical pain control in children aged six and over. There are approximately one million pediatric procedures per year in the U.S.
EXPAREL is the only product indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block in adults (safety and efficacy have not been established in other nerve blocks).
It is the only product indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block in adults (safety and efficacy have not been established in other nerve blocks).
Other Agreements Flexion Acquisition On November 19, 2021, we completed the Flexion Acquisition pursuant to an Agreement and Plan of Merger (the “Flexion Merger Agreement”), dated as of October 11, 2021, by and among us, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of Pacira (“Purchaser”), and Flexion.
Flexion Acquisition On November 19, 2021, we completed the Flexion Acquisition pursuant to an Agreement and Plan of Merger (the “Flexion Merger Agreement”), dated as of October 11, 2021, by and among us, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of Pacira (“Purchaser”), and Flexion.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 5 Table of Contents Product Portfolio and Product Candidate Pipeline Our current product portfolio and product candidate pipeline, along with anticipated milestones over the next 12 to 18 months, are summarized in the table below: Our Commercial Products EXPAREL (bupivacaine liposome injectable suspension) EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S. in April 2012.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 5 Table of Contents Product Portfolio and Product Candidate Pipeline Our current product portfolio and product candidate pipeline, along with anticipated milestones over the next 12 to 18 months, are summarized in the table below: Our Commercial Products EXPAREL (bupivacaine liposome injectable suspension) EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S. in April 2012.
The prevalence of symptomatic knee OA increases with each decade of life, with the annual incidence of knee OA being highest between age 55 and 64 years old. There are 14 million individuals in the U.S. who have symptomatic knee OA, and nearly two million are under the age of 45.
The prevalence of symptomatic knee OA increases with each decade of life, with the annual incidence of knee OA being highest between age 55 and 64 years old. There are 15 million individuals in the U.S. who have symptomatic knee OA, and nearly two million are under the age of 45.
We are currently sponsoring a prospective, real-world registry called the Innovations in Genicular Outcomes Registry, or iGOR, which is a patient focused registry governed in collaboration with a steering committee of scientific experts that evaluates clinical, economic- and health-related patient-reported outcomes in patients who have received any treatment for knee OA pain, including TKA, for a minimum of 18 months.
We are currently sponsoring a prospective, real-world registry called the Innovations in Genicular Outcomes Registry, or IGOR, which is a patient-focused registry governed in collaboration with a steering committee of scientific experts that evaluates clinical, economic- and health-related patient-reported outcomes in patients who have received any treatment for knee OA pain, including TKA.
As of December 31, 2024, we have four granted patents in China, one granted patent in Europe, one granted patent in Japan and one granted patent in Israel, protecting various aspects of the alternative process, including the methods of using the apparatus and the apparatus itself.
As of December 31, 2025, we have four granted patents in China, one granted patent in Europe, one granted patent in Japan and one granted patent in Israel, protecting various aspects of the alternative process, including the methods of using the apparatus and the apparatus itself.
Patents in this family are set to expire between 2025 and 2028. Another important patent family has broad disclosure and coverage of a variety of indications for treatment by cryogenic devices, including joint function and stiffness, OA, occipital neuralgia, spasticity, neuroma and other nerve entrapment indications and is set to expire between 2033 and 2037.
Patents in this family are set to start expiring in 2028. Another important patent family has broad disclosure and coverage of a variety of indications for treatment by cryogenic devices, including joint function and stiffness, OA, occipital neuralgia, spasticity, neuroma and other nerve entrapment indications and is set to expire between 2033 and 2037.
We list our job postings on state job banks and distribute them to community engaged veteran, minority, women and diversity organizations as well as other targeted diversity sites. We are committed to evaluating our people processes to ensure we are attracting, developing, promoting and retaining diverse talent. In 2018, we established P.O.W.E.R.
We list our job postings on state job banks and distribute them to community engaged veteran, minority, women and diversity organizations as well as other targeted diversity sites. We are committed to evaluating our people processes to ensure we are attracting, developing, promoting and retaining diverse talent. Our P.O.W.E.R.
We encourage our employees to give back in their communities and offer one paid day off per year to volunteer through our Community Day benefit. We regularly benchmark our rewards programs, adjusting as needed, to ensure our total rewards are competitive. We are committed to paying all our employees a fair and living wage.
We encourage our employees to give back in their communities and offer one paid day off per year to volunteer through our Community Day benefit. We regularly benchmark our rewards programs, adjusting as needed, to ensure our total rewards are competitive. We are steadfast in our commitment to paying all our employees a fair and living wage.
Our customer-facing team, consisting of sales representatives, account managers, scientific and medical affairs personnel and reimbursement and market access professionals, executes on a full range of activities to broaden the use of our non-opioid products for pain management, including: providing publications and abstracts showing clinical efficacy and safety, health outcomes and review articles; working in tandem with hospital staff, such as anesthesiologists, surgeons, heads of quality, pharmacists, executives and registered nurses, to provide access and resources for drug utilization or medication use evaluations and health outcomes studies, which provide retrospective and prospective analyses for our hospital customers using their own hospital data to demonstrate the true cost of opioid-based postsurgical pain control; working with KOLs and advisory boards to address topics of best practice techniques as well as guidelines and protocols for the use of our products, meeting the educational and training needs of our physician, surgeon, anesthesiologist, pharmacist and registered nurse customers; undertaking education initiatives such as center of excellence programs; preceptorship programs; opioid-sparing and ERAS pain protocols and predictive models for enhanced patient care; interactive discussion forums; patient education platforms leveraging public relations, advocacy partnerships and public affairs efforts where appropriate; web-based training and virtual launch programs; collaborating with healthcare providers towards improving the knowledge and management of pain in surgical and OA patients with a focus on opioid risk and non-opioid alternatives and engaging our field-based medical teams in system-wide partnerships to address the national opioid epidemic, with a goal of studying alternative postsurgical pain management options that focus on optimization and opioid alternative strategies; and facilitating reimbursement and the shift of procedures to hospital outpatient and ambulatory surgical center, or ASC, sites of care.
Our customer-facing team, consisting of sales representatives, account managers, scientific and medical affairs personnel and reimbursement and market access professionals, executes on a full range of activities to broaden the use of our non-opioid products for pain management, including: providing publications and abstracts showing clinical efficacy and safety, health outcomes and review articles; working in tandem with hospital staff, such as anesthesiologists, surgeons, heads of quality, pharmacists, executives and registered nurses, to provide access and resources for drug utilization or medication use evaluations and health outcomes studies, which provide retrospective and prospective analyses for our hospital customers using their own hospital data to demonstrate the true cost of opioid-based postsurgical pain control; working with KOLs and advisory boards to address topics of best practice techniques as well as guidelines and protocols for the use of our products, meeting the educational and training needs of our physician, surgeon, anesthesiologist, pharmacist and registered nurse customers; undertaking education initiatives such as center of excellence programs; preceptorship programs; opioid-sparing and ERAS pain protocols and predictive models for enhanced patient care; interactive discussion forums; patient education platforms leveraging public relations, advocacy partnerships and public affairs efforts where appropriate; web-based training and virtual launch programs; collaborating with healthcare providers towards improving the knowledge and management of pain in surgical and OA patients with a focus on opioid risk and non-opioid alternatives and engaging our field-based medical teams in system-wide partnerships to address the national opioid epidemic, with a goal of studying alternative postsurgical pain management options that focus on optimization and opioid alternative strategies; and Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 16 Table of Contents facilitating reimbursement and the shift of procedures to hospital outpatient and ASC sites of care.
This building also houses our Science Center related research and development activities and general and administrative functions, as it includes both laboratories and the building infrastructure necessary to support the formulation, analytical testing, clinical and process development activities for manufacturing additional commercial product indications and new pipeline products.
This building also houses our Science Center related R&D activities and general and administrative functions, as it includes both laboratories and the building infrastructure necessary to support the formulation, analytical testing, clinical and process development activities for manufacturing additional commercial product indications and new pipeline products.
Thermo Fisher undertook certain technical transfer activities and construction services to prepare Thermo Fisher’s Swindon, United Kingdom, or U.K., facility for the manufacture of EXPAREL in a dedicated manufacturing suite. We provided Thermo Fisher with the equipment necessary to manufacture EXPAREL and paid fees to Thermo Fisher based on Thermo Fisher’s achievement of certain technical transfer and construction milestones.
Thermo Fisher undertook certain technical transfer activities and construction services to prepare Thermo Fisher’s Swindon, U.K. facility for the manufacture of EXPAREL in a dedicated manufacturing suite. We provided Thermo Fisher with the equipment necessary to manufacture EXPAREL and paid fees to Thermo Fisher based on Thermo Fisher’s achievement of certain technical transfer and construction milestones.
With 5x30, we intend to achieve the following five key objectives by 2030: (i) deliver our products to more than three million patients annually; (ii) grow product revenues by a double-digit compounded annual growth rate; (iii) achieve a five percentage-point improvement in gross margins over 2024; (iv) advance an innovative pipeline with at least five programs in clinical development and (v) establish five partnerships—including pipeline and commercial agreements.
The 5x30 plan focuses on five key objectives that we intend to achieve by 2030: (i) deliver our products to more than three million patients annually; (ii) grow product revenues by a double-digit compounded annual growth rate; (iii) achieve a five percentage-point improvement in gross margins over 2024; (iv) advance an innovative pipeline with at least five programs in clinical development and (v) establish five partnerships—including pipeline and commercial agreements.
This enhanced, large-scale manufacturing suite received FDA approval in February 2024. Our 90,000 square-foot mixed-use research and development, manufacturing and office facility is located adjacent to our EXPAREL manufacturing facility and was completely renovated in 2020 to meet our specifications. We manufacture all of the iovera° handpieces at this facility.
This enhanced, large-scale manufacturing suite received FDA approval in February 2024. Our 90,000 square-foot mixed-use R&D, manufacturing and office facility is located adjacent to our EXPAREL manufacturing facility and was completely renovated in 2020 to meet our specifications. We manufacture all of the iovera° handpieces at this facility.
Many of our competitors in our space have greater financial and other resources than we have, such as more commercial resources, larger research and development staffs and more extensive marketing and manufacturing organizations. As a result, these companies may obtain marketing approval more rapidly than we are able and may be more effective in developing, selling and marketing their products.
Many of our competitors in our space have greater financial and other resources than we have, such as more commercial resources, larger R&D staffs and more extensive marketing and manufacturing organizations. As a result, these companies may obtain marketing approval more rapidly than we are able and may be more effective in developing, selling and marketing their products.
Net product sales of ZILRETTA were $118.1 million, $111.1 million and $105.5 million, for the years ended December 31, 2024, 2023 and 2022, respectively. iovera° The iovera° system is a non-opioid handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature to targeted nerves to produce an immediate, long-lasting neurolytic block that interrupts the pain-transmitting signals of a peripheral nerve.
Net product sales of ZILRETTA were $116.6 million, $118.1 million and $111.1 million, for the years ended December 31, 2025, 2024 and 2023, respectively. iovera° The iovera° system is a non-opioid handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature to targeted nerves to produce an immediate, long-lasting neurolytic block that interrupts the pain-transmitting signals of a peripheral nerve.
In some cases, it also causes reduced function and disability—some people are no longer able to do daily tasks or work. According to the CDC, OA affects over 32.5 million adults in the U.S. The lifetime risk of developing symptomatic knee OA is 45 percent according to the Arthritis Foundation.
OA can cause pain, stiffness and swelling. In some cases, it also causes reduced function and disability—some people are no longer able to do daily tasks or work. According to the CDC, OA affects over 32.5 million adults in the U.S. The lifetime risk of developing symptomatic knee OA is 45 percent according to the Arthritis Foundation.
As a result, the desired effect can be achieved with much smaller doses. The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors. Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals. Lower dose levels and efficient delivery of genes into cells means that thousands of doses can potentially be produced in a single batch.
As a result, the desired effect can be achieved with much smaller doses; The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors; and Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals. Lower dose levels mean that thousands of doses can be produced in a single batch.
Key EXPAREL Markets Orthopedics EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. In November 2023, the FDA approved our sNDA to expand the EXPAREL label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Key EXPAREL Markets Orthopedics EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. In November 2023, the FDA approved our supplementary New Drug Application, or sNDA, to expand the EXPAREL label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Our competitors include organizations such as major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and generic drug companies. Many of our competitors have greater financial and other resources than we have, such as more commercial resources, larger research and development staffs and more extensive marketing and manufacturing organizations.
Our competitors include organizations such as major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies and generic drug companies. Many of our competitors have greater financial and other resources than we have, such as more commercial resources, larger R&D staffs and more extensive marketing and manufacturing organizations.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 17 Table of Contents We also occupy a 21,000 square-foot warehouse that serves as the main CGMP warehouse for our Science Center Campus operations, primarily being used for the storage of production materials.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 19 Table of Contents We also occupy a 21,000 square-foot warehouse that serves as the main CGMP warehouse for our Science Center Campus operations, primarily being used for the storage of production materials.
It is FDA 510(k) cleared in the U.S., has a CE mark in the E.U. and is cleared for marketing in Canada for the blocking of pain.
It is FDA 510(k) cleared in the U.S., has a CE mark in the European Union, or E.U., and is cleared for marketing in Canada for the blocking of pain.
This process generally involves: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 23 Table of Contents completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations; submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.; approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated; performance of adequate and well-controlled human clinical trials in accordance with the FDA’s Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug product for each intended use; completion of process validation, quality product release and stability; submission of a New Drug Application, or NDA, to the FDA; satisfactory completion of an FDA pre-approval inspection of the product’s manufacturing facility or facilities to assess compliance with CGMP requirements and to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, quality and purity; satisfactory completion of an FDA advisory committee review, if applicable; and review and approval by the FDA of the NDA.
This process generally involves: completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations; submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.; approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated; performance of adequate and well-controlled human clinical trials in accordance with the FDA’s Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug product for each intended use; completion of process validation, quality product release and stability; submission of a New Drug Application, or NDA, to the FDA; satisfactory completion of an FDA pre-approval inspection of the product’s manufacturing facility or facilities to assess compliance with CGMP requirements and to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, quality and purity; satisfactory completion of an FDA advisory committee review, if applicable; and review and approval by the FDA of the NDA.
As a result, we expect to receive $14.5 million from RDF, representing the royalties that we paid to RDF under protest after December 24, 2021 for EXPAREL made from the 45-liter manufacturing process. In November 2023, the United States District Court, District of Nevada conducted a mediation that did not result in a settlement.
As a result, we expect to receive $14.5 million from RDF, representing the royalties that we paid to RDF under protest after December 24, 2021 for EXPAREL made from the 45-liter manufacturing process. In November 2023, the U.S. District Court, District of Nevada conducted a mediation that did not result in a settlement. In June 2025, the U.S.
Patent No. 11,426,348, claiming EXPAREL batch compositions. In September 2022, the USPTO issued U.S. Patent No. 11,452,691, claiming EXPAREL batch compositions. In November 2023, the USPTO issued U.S. Patent Nos. 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by the improved U.K. manufacturing process and compositions of EXPAREL, respectively. In March 2024, the USPTO issued U.S.
In September 2022, the USPTO issued U.S. Patent No. 11,452,691, claiming EXPAREL batch compositions. In November 2023, the USPTO issued U.S. Patent Nos. 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by the improved U.K. manufacturing process and compositions of EXPAREL, respectively. In March 2024, the USPTO issued U.S. Patent No. 11,925,706, claiming composition of EXPAREL.
Our 84,000 square-foot EXPAREL manufacturing facility at the Science Center Campus is located on a five-acre site. It was custom built as a pharmaceutical research and development and manufacturing facility.
Our 84,000 square-foot EXPAREL manufacturing facility at the Science Center Campus is located on a five-acre site. It was custom built as a pharmaceutical R&D and manufacturing facility.
For more information, see Note 11, Financial Instruments , to our consolidated financial statements included herein.
For more information, see Note 12, Financial Instruments , to our consolidated financial statements included herein.
Any drug or device that qualifies for reimbursement under the NOPAIN Act must have demonstrated the ability to reduce or avoid intraoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. The NOPAIN Act took effect on January 1, 2025.
In order to qualify for reimbursement under the NOPAIN Act, a device must have demonstrated the ability to reduce or avoid intraoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. The NOPAIN Act took effect on January 1, 2025.
Significant Customers We had three wholesalers each comprising 10 percent or more of our total revenue for the year ended December 31, 2024: McKesson Drug Company, Cardinal Health, Inc. and AmerisourceBergen Health Corporation, which accounted for 34%, 23% and 20% of our total revenues, respectively. These wholesalers process orders for EXPAREL under a drop-ship program.
Significant Customers We had three wholesalers each comprising 10 percent or more of our total revenue for the year ended December 31, 2025: McKesson Drug Company, Cardinal Health, Inc. and AmerisourceBergen Health Corporation, which accounted for 31%, 26% and 22% of our total revenues, respectively. These wholesalers process orders for EXPAREL under a drop-ship program.
As of December 31, 2024, there are over 13 families of patents and patent applications relating to various aspects of the pMVL drug delivery technology and 29 families of patents and patent applications relating to various aspects of the technology used by iovera°.
As of December 31, 2025, there are over 15 families of patents and patent applications relating to various aspects of the pMVL drug delivery technology and 29 families of patents and patent applications relating to various aspects of the technology used by iovera°.
Patent No. 11,033,495. The ruling found that this patent is not valid on the grounds of obviousness and anticipation. A notice of appeal was filed in September 2024 and remains pending.
The ruling found that this patent is not valid on the grounds of obviousness and anticipation. A notice of appeal was filed in September 2024 and remains pending.
It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days. Net product sales of iovera° were $22.8 million, $19.7 million and $15.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days. Net product sales of iovera° were $24.2 million, $22.8 million and $19.7 million for the years ended December 31, 2025, 2024 and 2023, respectively.
We also make available free of charge through our corporate website our Annual Report, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and any amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act.
We also make available free of charge through our corporate website our Annual Report, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and any amendments to those reports filed or furnished pursuant to Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 36 Table of Contents Sections 13(a) and 15(d) of the Exchange Act.
On August 8, 2023, the United States District Court, District of Nevada, granted our motion for partial summary judgment in respect to our claim for a declaration that we no longer owe royalties for EXPAREL made under the 45-liter manufacturing process as of December 24, 2021.
District Court, District of Nevada, granted our motion for partial summary judgment in respect to our claim for a declaration that we no longer owe royalties for EXPAREL made under the 45-liter manufacturing process as of December 24, 2021.
In October 2010, we changed our name to Pacira Pharmaceuticals, Inc. and in April 2019, we changed our name to Pacira BioSciences, Inc. Our principal executive offices and corporate headquarters are located in Tampa, Florida.
In October 2010, we changed our name to Pacira Pharmaceuticals, Inc. and in April 2019, we changed our name to Pacira BioSciences, Inc. Our principal executive offices and corporate headquarters are located in Brisbane, California.
As a result, people develop chronic IL-1-driven inflammation that eventually causes joint damage and pain. It has been well established that chronic IL-1 activation is an underlying driver of knee inflammation, joint degeneration and pain. By targeting it, we are able to target a root cause of disease rather than just alleviating only the symptoms of OA.
It has been well established that chronic IL-1 activation is an underlying driver of knee inflammation, joint degeneration and pain. By targeting it, we are able to target a root cause of disease rather than just alleviating only the symptoms of OA.
We changed the name of Flexion to Pacira Therapeutics, Inc. after completing the merger. As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, IA (meaning in the joint) injection indicated for the management of OA knee pain. ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.
As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, IA (meaning in the joint) injection indicated for the management of OA knee pain. ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 21 Table of Contents Additional Intellectual Property We have entered the national phase in Brazil, China, Europe and the U.S. based on a PCT application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.
Additional Intellectual Property We have entered the national phase in Brazil, China, Europe and the U.S. based on a PCT application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.
Surgical intervention is typically a last resort for patients suffering from OA of the knee. With ZILRETTA, we now offer clinicians the flexibility to individualize OA knee pain treatment with either ZILRETTA or a drug-free nerve block with iovera° based on patient factors and preference, physician training, site of care and reimbursement considerations. Label and Global Activities EXPAREL Pediatrics.
Surgical intervention is typically a last resort for patients suffering from OA of the knee. Clinicians have the flexibility to individualize OA knee pain treatment with either ZILRETTA or a drug-free nerve block with iovera° based on patient factors and preference, physician training, site of care and reimbursement considerations.
Through Pacira Gives Back, employees can also make a donation to a not-for-profit organization of their choice with a dollar-for-dollar company match of up to $200 per employee annually. Human Capital Pacira Core Values We are a team of dedicated and highly talented professionals focused on delivering innovative, non-opioid pain therapies to transform the lives of patients.
Through Pacira Gives Back, employees can also make a donation to a not-for-profit organization of their choice. Human Capital Pacira Core Values We are a team of dedicated and highly talented professionals focused on delivering innovative, non-opioid pain therapies to transform the lives of patients.
Patent No. 11,278,494, claiming EXPAREL composition. In April 2022, the USPTO issued U.S. Patent Nos. 11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by an improved manufacturing process and EXPAREL composition, respectively. In June 2022, the USPTO issued U.S. Patent No. 11,357,727, claiming composition of EXPAREL prepared by the improved U.K. manufacturing process. In August 2022, the USPTO issued U.S.
Patent Nos. 11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by an improved manufacturing process and EXPAREL composition, respectively. In June 2022, the USPTO issued U.S. Patent No. 11,357,727, claiming composition of EXPAREL prepared by the improved U.K. manufacturing process. In August 2022, the USPTO issued U.S. Patent No. 11,426,348, claiming EXPAREL batch compositions.
With RFA, patients may not get the effects of pain relief until 1-2 weeks after treatment, further the intense heat can damage surrounding tissue and blood vessels, and tissue damage may lead to painful neuritis (inflammation in the nerves). The Osteoarthritis Market OA is the most common form of arthritis.
With RFA, patients may not get the effects of pain relief until 1-2 weeks after treatment, further the intense heat can damage surrounding tissue and blood vessels, and tissue damage may lead to painful neuritis (inflammation in the nerves).
Patent No. 11,925,706, claiming composition of EXPAREL. In November 2024, the USPTO issued U.S. Patent Nos. 12,144,890 and 12,151,024, claiming composition of EXPAREL prepared by the improved UK manufacturing process, and both composition of EXPAREL and composition of EXPAREL prepared by the improved UK manufacturing process, respectively. In December 2024, the USPTO issued U.S.
In November 2024, the USPTO issued U.S. Patent Nos. 12,144,890 and 12,151,024, claiming composition of EXPAREL prepared by the improved U.K. manufacturing process, and both composition of EXPAREL and composition of EXPAREL prepared by the improved U.K. manufacturing process, respectively. In December 2024, the USPTO issued U.S. Patent No. 12,178,909, claiming the improved EXPAREL U.K. manufacturing process.
Patent No. 11,033,495. In August 2024, the U.S. District Court for the District of New Jersey issued its ruling in our patent infringement suit against eVenus and its parent company (Jiangsu Hengrui Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 19 Table of Contents Pharmaceuticals, Co. Ltd., or Jiangsu Hengrui) for infringement of EXPAREL U.S.
District Court for the District of New Jersey issued its ruling in our patent infringement suit against eVenus and its parent company (Jiangsu Hengrui) for Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 21 Table of Contents infringement of EXPAREL U.S. Patent No. 11,033,495.
Beyond treatment for pain, observational data has been presented at multiple congresses showing the effectiveness of iovera° for the treatment of upper limb spasticity over 90 days by targeting motor nerves. We currently have a pivotal trial underway to demonstrate the efficacy and safety of iovera° for treating spasticity.
Beyond treatment for pain, observational data has been presented at multiple congresses showing the effectiveness of iovera° for the treatment of upper limb spasticity over 90 days by targeting motor nerves. We are advancing a registration trial to evaluate the efficacy and safety of iovera° for treating spasticity.
Medical Devices The FDA has broad post‑market and regulatory obligations that we must adhere to. We are subject to unannounced inspections by the FDA to determine our compliance with QSRs and other rules and regulations. After a medical device is placed on the market, numerous regulatory requirements apply.
We are subject to unannounced inspections by the FDA to determine our compliance with QSRs and other rules and regulations. After a medical device is placed on the market, numerous regulatory requirements apply.
Early outcomes from iGOR have shown that patients who receive iovera° prior to TKA have less pain, improved function and improved sleep for six months after surgery versus patients who do not receive iovera°. As of November 2024, more than 2,000 patients have enrolled in the iGOR registry across 12 participating sites in the U.S.
Early outcomes from IGOR have shown that patients who receive iovera° prior to undergoing TKA have less pain, improved function and improved sleep for six months after surgery versus patients who do not receive iovera°. As of February 2026, more than 3,200 patients have enrolled in the IGOR registry across 15 participating sites in the U.S.
A regenerative medicine advanced therapy that is granted accelerated approval and is subject to post-approval requirements may fulfill such requirements through the submission of clinical evidence, clinical studies, patient registries, or other sources of real-world evidence, such as electronic health records; the collection of larger confirmatory data sets; or post-approval monitoring of all patients treated with such therapy prior to its approval.
A regenerative medicine advanced therapy that is granted accelerated approval and is subject to post-approval requirements may fulfill such requirements through the submission of clinical evidence, clinical studies, patient Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 33 Table of Contents registries, or other sources of real-world evidence, such as electronic health records; the collection of larger confirmatory data sets; or post-approval monitoring of all patients treated with such therapy prior to its approval.
Our products are currently only marketed in the U.S. We believe there is an opportunity in certain key markets outside of the U.S. where our products can be financially viable and deliver value. We are actively seeking potential commercial partners to realize that potential.
Our products are currently only marketed in the U.S. We believe there is an opportunity in certain key markets outside of the U.S. where our products can be financially viable and deliver value.
Patent Nos. 11,185,506 and 11,179,336, claiming the improved U.K. EXPAREL manufacturing process and EXPAREL composition, respectively. Eight U.S. patents relating to product and product-by-process in connection with the improved U.K. manufacturing process for EXPAREL were issued between March 2022 and November 2023, providing additional patent protection through 2041. In March 2022, the USPTO issued U.S.
Eight U.S. patents relating to product and product-by-process in connection with the improved U.K. manufacturing process for EXPAREL were issued between March 2022 and November 2023, providing additional patent protection through 2041. In March 2022, the USPTO issued U.S. Patent No. 11,278,494, claiming EXPAREL composition. In April 2022, the USPTO issued U.S.
Pacira Gives Back As part of our ongoing commitment to support the communities where we live and work, we support a corporate giving campaign— Pacira Gives Back —which allows our employees to find local volunteer opportunities in their communities and help encourage use of a paid day off per year, known as our Community Day.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 34 Table of Contents Pacira Gives Back As part of our ongoing commitment to support the communities where we live and work, we support a corporate giving campaign— Pacira Gives Back —which allows our employees to find local volunteer opportunities in their communities and help encourage use of a paid day off per year, known as our Community Day.
Over the past three years we provided support for charitable medical missions in Honduras, Ghana, Zambia, Guatemala, Ecuador, Mexico, India, Guyana, Palau, Nigeria and the Dominican Republic by donating EXPAREL to help support surgeries for patients in need; have supported the Louisiana State University Opioid Minimization Initiative as well as made a three-year commitment beginning in 2022 to donate EXPAREL to not-for-profit children’s hospitals each year.
Over the past five years we have provided support for charitable medical missions in Honduras, Ghana, Zambia, Guatemala, Ecuador, Mexico, India, Guyana, Palau, Nigeria, Belize and the Dominican Republic by donating EXPAREL to help support surgeries for patients in need; have supported the Louisiana State University Opioid Minimization Initiative, and have donated EXPAREL to not-for-profit children’s hospitals each year since 2022 with a commitment to do so through 2027.
It is our policy that everyone is entitled to a safe and healthful place to work. We recognize that accident prevention, employee wellness and efficiency of operations are directly related to quality, production and cost. Pacira operates its facilities in a manner that protects the health of its employees and minimizes the impact of its operations on the environment.
We recognize that accident prevention, employee wellness and efficiency of operations are directly related to quality, production and cost. Pacira operates its facilities in a manner that protects the health of its employees and minimizes the impact of its operations on the environment.
It is also called degenerative joint disease and occurs most frequently in the hands, hips and knees. With OA, the cartilage within a joint begins to break down and the underlying bone begins to change. These changes usually develop slowly and worsen over time. OA can cause pain, stiffness and swelling.
The Osteoarthritis Market OA is the most common form of arthritis. It is also called degenerative joint disease and occurs most frequently in the hands, hips and knees. With OA, the cartilage within a joint begins to break down and the underlying bone begins to change. These changes usually develop slowly and worsen over time.
Review processes may sometimes extend beyond these target completion dates due to FDA requests for additional information or clarification, difficulties scheduling an advisory committee meeting, negotiations regarding REMS or FDA workload issues, but in general under PDUFA the FDA is supposed to complete its reviews within the target timeframes despite these factors.
Review processes may sometimes extend beyond these target completion dates due to FDA requests for additional information or clarification, Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 27 Table of Contents difficulties scheduling an advisory committee meeting, negotiations regarding REMS or FDA workload issues, but in general under PDUFA the FDA is supposed to complete its reviews within the target timeframes despite these factors.
If the study is successful, we plan to seek approval to expand the ZILRETTA label to include OA pain of the shoulder. iovera° Clinical Benefits There is a growing body of clinical data demonstrating success with iovera° treatment for a wide range of chronic pain conditions.
An interim analysis later this year will inform next steps for our study. If the study is successful, we plan to seek approval to expand the ZILRETTA label to include OA pain of the shoulder. iovera° Clinical Benefits There is a growing body of clinical data demonstrating success with iovera° treatment for a wide range of chronic pain conditions.
In addition, a pilot randomized control trial evaluating iovera° for the treatment of lower back pain showed that it had significantly greater improvements in pain and disability, and required fewer injections over a year, compared to patients who were treated with radiofrequency ablation.
A pilot randomized control trial evaluating iovera° versus radiofrequency ablation for the treatment of lower back pain showed that iovera° had significantly greater improvements in pain and disability and required fewer injections over a year.
EXPAREL Our competitors may succeed in developing, acquiring or licensing on an exclusive basis technologies and drug products that are more effective or less costly than EXPAREL or any other products that we are currently selling through partners or developing or that we may develop, which could render our products obsolete and noncompetitive.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 24 Table of Contents EXPAREL Our competitors may succeed in developing, acquiring or licensing on an exclusive basis technologies and drug products that are more effective or less costly than EXPAREL or any other products that we are currently selling through partners or developing or that we may develop, which could render our products obsolete and noncompetitive.
The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 29 Table of Contents The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion.
Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, oral Na V 1.8 pain signal inhibitors, novel opioids, new formulations of currently Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 22 Table of Contents available opioids and NSAIDs, long-acting local anesthetics and new chemical entities as well as alternative delivery forms of various opioids and NSAIDs.
Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, oral Na V 1.8 pain signal inhibitors, novel opioids, new formulations of currently available opioids and NSAIDs, long-acting local anesthetics and new chemical entities as well as alternative delivery forms of various opioids and NSAIDs.
Specifically, findings demonstrated reductions in opioids, including: The daily morphine equivalent consumption in the per protocol group analysis was significantly lower at 72 hours (p Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.
Specifically, findings demonstrated reductions in opioids, including: The daily morphine equivalent consumption in the per protocol group analysis was significantly lower at 72 hours (p Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 10 Table of Contents Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.
There are also eight utility and design patent families covering various features of commercial and developing next-generation technology, which are issued or pending in the North American, European, Japanese, Chinese and Brazilian markets, which could potentially prevent others from using commercial and/or next-generation cryogenic devices until at least 2040 for utility patents and 2046 for design patents.
There are also 11 utility and design patent families covering various features of commercial and developing next-generation technology, which are issued or pending in the North American, Asia, Middle East, New Zealand, Australia, South African and Brazilian markets, which could potentially prevent others from using commercial and/or next-generation cryogenic devices until at least 2046 for utility patents and 2050 for design patents.
The CGMP provisions include requirements relating to the organization of personnel, buildings and facilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products.
The CGMP provisions include requirements relating to the organization of personnel, buildings and facilities, equipment, control of Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 32 Table of Contents components and drug product containers and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls, records and reports and returned or salvaged products.
We currently have a pivotal trial underway to demonstrate the efficacy and safety of iovera° for treating spasticity.
We currently have a pivotal trial underway to demonstrate the efficacy and safety of iovera° for treating spasticity, which is expected to be completed in 2026.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAdditionally, in March 2020, Flexion entered into an exclusive license agreement with Hong Kong Tainuo Pharma Ltd., or HK Tainuo, and Jiangsu Tainuo Pharmaceutical Co. Ltd. for the development and commercialization (other than manufacturing) of ZILRETTA in Greater China.
Biggest changeWe previously had a co-promotion agreement with DePuy Synthes Sales, Inc. to market and promote the use of EXPAREL for orthopedic procedures in the U.S. market which we terminated effective January 2021. Additionally, in March 2020, Flexion entered into an exclusive license agreement with Hong Kong Tainuo Pharma Ltd., or HK Tainuo, and Jiangsu Tainuo Pharmaceutical Co.
If the third-party submits a Paragraph IV certification to the FDA, a notice of the Paragraph IV certification must also be sent to us once the third-party’s ANDA is accepted for filing by the FDA. We may then initiate a lawsuit to defend the patents identified in the notice.
If the third-party submits a Paragraph IV certification to the FDA, a notice of the Paragraph IV certification must also be sent to us once the third-party’s ANDA is accepted for filing by the FDA. We may then initiate a lawsuit to defend the patents identified in the notice.
The filing of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third-party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled or the court reaches a decision in the infringement lawsuit in favor of the third-party.
The filing of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third-party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled or the court reaches a decision in the infringement lawsuit in favor of the third-party.
If we do not file a patent infringement lawsuit within the required 45-day period, the third-party’s ANDA will not be subject to the 30-month stay.
If we do not file a patent infringement lawsuit within the required 45-day period, the third-party’s ANDA will not be subject to the 30-month stay.
Our need to effectively manage our operations, growth and various projects requires that we: continue the hiring and training of an effective commercial organization for the commercialization of EXPAREL, ZILRETTA and iovera°, and establish appropriate systems, policies and infrastructure to support that organization; continue to establish and maintain effective relationships with distributors and commercial partners for the promotion and sale of our products; ensure that our distributors, partners, suppliers, consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines; manage our development efforts and clinical trials effectively; expand our manufacturing capabilities and effectively manage our co-production arrangements with Thermo Fisher and Carlisle; continue to carry out our own contractual obligations to our licensors and other third parties; and continue to improve our operational, financial and management controls, reporting systems and procedures.
Our need to effectively manage our operations, growth and various projects requires that we: continue the hiring and training of an effective commercial organization for the commercialization of EXPAREL, ZILRETTA and iovera°, and establish appropriate systems, policies and infrastructure to support that organization; continue to establish and maintain effective relationships with distributors and commercial partners for the promotion and sale of our products; ensure that our distributors, partners, suppliers, consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines; manage our development efforts and clinical trials effectively; expand our manufacturing capabilities and effectively manage our co-production arrangements with Thermo Fisher and Amphenol; continue to carry out our own contractual obligations to our licensors and other third parties; and continue to improve our operational, financial and management controls, reporting systems and procedures.
If we breach any of these restrictive covenants, the lenders could either refuse to lend funds to us or accelerate the repayment of any outstanding borrowings under the TLA Credit Agreement. We may not have sufficient funds to repay such indebtedness upon a default or be unable to receive a waiver of the default from the lenders.
If we breach any of these restrictive covenants, the lenders could either refuse to lend funds to us or accelerate the repayment of any outstanding borrowings under the Credit Agreement. We may not have sufficient funds to repay such indebtedness upon a default or be unable to receive a waiver of the default from the lenders.
While it is our intention to pay the principal in cash, upon conversion of the Notes we will be required to make cash payments for each $1,000 in principal amount of Notes converted of at least the lesser of $1,000 and the sum of the daily conversion values.
While it is our intention to pay the principal in cash, upon conversion of the 2029 Notes we will be required to make cash payments for each $1,000 in principal amount of 2029 Notes converted of at least the lesser of $1,000 and the sum of the daily conversion values.
If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the Notes or make cash payments upon conversions thereof.
If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the 2029 Notes or make cash payments upon conversions thereof.
We may also experience additional disruptions that could severely impact our supply chain, such as those caused by the recent COVID-19 pandemic, which would disrupt our clinical trials and commercialization efforts.
We may also experience additional disruptions that could severely impact our supply chain, such as those caused by the COVID-19 pandemic, which would disrupt our clinical trials and commercialization efforts.
If we are unable to repay the indebtedness, the lenders could initiate a bankruptcy proceeding or collection proceedings with respect to our assets, all of which secure our indebtedness under the TLA Credit Agreement.
If we are unable to repay the indebtedness, the lenders could initiate a bankruptcy proceeding or collection proceedings with respect to our assets, all of which secure our indebtedness under the Credit Agreement.
However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of Notes surrendered therefor or Notes being converted.
However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of 2029 Notes surrendered therefor or 2029 Notes being converted.
The 2029 Notes accrue interest at a fixed rate of 2.125% per year, payable semiannually in arrears on May 15 and November 15 of each year and mature on May 15, 2029.
The 2029 Notes accrue interest at a fixed rate of 2.125% per year, payable semiannually in arrears on May 15 th and November 15 th of each year and mature on May 15, 2029.
A notice of appeal was filed in September 2024 and is ongoing. In April 2023, we filed a third patent infringement suit against eVenus, Jiangsu Hengrui, and Fresenius Kabi USA, LLC, in the U.S. District Court for the District of New Jersey (23-cv-2367) asserting that the 133 mg/10 mL and 266 mg/20 mL ANDA products will infringe U.S.
A notice of appeal was filed in September 2024 and is ongoing. In April 2023, we filed a third patent infringement suit against eVenus, Jiangsu Hengrui, and Fresenius Kabi USA, LLC, in the U.S. District Court for the District of New Jersey (23-cv-02367) asserting that the 133 mg/10 mL and 266 mg/20 mL ANDA products will infringe U.S.
For more information on this matter, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein. 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.
For more information on this matter, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein. 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.
In addition to expanding our internal manufacturing facilities, we may enter into arrangements with third parties to supply, manufacture, package, test and/or store EXPAREL, ZILRETTA, iovera° or our product candidates, such as our manufacturing arrangements with Thermo Fisher and Carlisle.
In addition to expanding our internal manufacturing facilities, we may enter into arrangements with third parties to supply, manufacture, package, test and/or store EXPAREL, ZILRETTA, iovera° or our product candidates, such as our manufacturing arrangements with Thermo Fisher and Amphenol.
The FDA, as a condition of the EXPAREL NDA approval on October 28, 2011, has required us to study EXPAREL in pediatric patients as a post-marketing requirement. We have agreed to a trial timeline where we will study successive pediatric patient subpopulations.
The FDA, as a condition of the EXPAREL NDA approval in October 2011, has required us to study EXPAREL in pediatric patients as a post-marketing requirement. We have agreed to a trial timeline where we will study successive pediatric patient subpopulations.
The TLA Credit Agreement limits—and any credit facility or other agreement that we may enter into may limit—our ability to make cash payments at the time of a fundamental change or upon conversion of the Notes.
The Credit Agreement limits—and any credit facility or other agreement that we may enter into may limit—our ability to make cash payments at the time of a fundamental change or upon conversion of the 2029 Notes.
In addition, any expansion of our existing manufacturing facilities or the introduction of any new manufacturing facilities, including the manufacturing suites at the Thermo Fisher and Carlisle facilities, also require conformity with CGMP and other FDA, EMA and MHRA regulations.
In addition, any expansion of our existing manufacturing facilities or the introduction of any new manufacturing facilities, including the manufacturing suites at the Thermo Fisher and Amphenol facilities, also require conformity with CGMP and other FDA, EMA and MHRA regulations.
Our ability to effectively generate revenues from EXPAREL and ZILRETTA will depend on our ability to, among other things: create further market demand for EXPAREL and ZILRETTA through our marketing and sales activities and other arrangements established for their promotion; train, deploy and support a qualified sales force; secure formulary approvals for EXPAREL at a substantial number of targeted hospitals and ASCs; manufacture EXPAREL and ZILRETTA in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand; implement and maintain agreements with wholesalers and distributors on commercially reasonable terms; appropriately help the market to take advantage of EXPAREL reimbursement at ASP plus 6 percent for Medicare patients receiving surgery in the outpatient setting; receive adequate levels of coverage and reimbursement for EXPAREL and ZILRETTA from commercial health plans and governmental health programs; maintain compliance with regulatory requirements; obtain regulatory approvals for additional indications and geographic expansion for the use of EXPAREL and ZILRETTA; ensure that our entire supply chain efficiently and consistently delivers EXPAREL and ZILRETTA to our customers; and maintain and defend our patent protection and regulatory exclusivity for EXPAREL and ZILRETTA, including our ongoing patent litigation lawsuits against eVenus, Jiangsu Hengrui and Fresenius.
Our ability to effectively generate revenues from EXPAREL and ZILRETTA will depend on our ability to, among other things: create further market demand for EXPAREL and ZILRETTA through our marketing and sales activities and other arrangements established for their promotion; train, deploy and support a qualified sales force; secure formulary approvals for EXPAREL at a substantial number of targeted hospitals and ASCs; manufacture EXPAREL and ZILRETTA in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand; implement and maintain agreements with wholesalers and distributors on commercially reasonable terms; appropriately help the market to take advantage of EXPAREL reimbursement at ASP plus 6 percent for Medicare patients receiving surgery in the outpatient setting; receive adequate levels of coverage and reimbursement for EXPAREL and ZILRETTA from commercial health plans and governmental health programs; maintain compliance with regulatory requirements; obtain regulatory approvals for additional indications and geographic expansion for the use of EXPAREL and ZILRETTA; ensure that our entire supply chain efficiently and consistently delivers EXPAREL and ZILRETTA to our customers; and maintain and defend our patent protection and regulatory exclusivity for EXPAREL and ZILRETTA, including our ongoing patent litigation lawsuit against WhiteOak and Qilu.
Our failure to repurchase Notes at a time when the repurchase is required by the applicable indenture or to pay any cash payable on future conversions of the Notes as required by the Indenture would constitute a default under the applicable indenture.
Our failure to repurchase 2029 Notes at a time when the repurchase is required by the Indenture or to pay any cash payable on future conversions of the 2029 Notes as required by the Indenture would constitute a default under the Indenture.
We may not be able to attract or retain qualified management and commercial, scientific and clinical personnel due to the intense competition for qualified personnel among biotechnology, pharmaceutical, medical device and other businesses, as well as universities, non-profit research organizations and government entities, particularly in and around the San Francisco Bay Area; San Diego, California; northern New Jersey/New York City metro and Tampa, Florida.
We may not be able to attract or retain qualified management and commercial, scientific and clinical personnel due to the intense competition for qualified personnel among biotechnology, pharmaceutical, medical device and other businesses, as well as universities, non-profit research organizations and government entities, particularly in and around the San Francisco Bay Area; San Diego, California, northern New Jersey/New York City metro and Luckenwalde, Germany.
A breach of any of those restrictive covenants may cause us to be in default under the TLA Credit Agreement and/or the Indentures, and our lenders could foreclose on our assets. Our TLA Credit Agreement requires us to maintain certain financial covenants. A decline in our operating performance could negatively impact our ability to meet these financial covenants.
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. Our Credit Agreement requires us to maintain certain financial covenants. A decline in our operating performance could negatively impact our ability to meet these financial covenants.
We have invested a significant portion of our efforts and financial resources in the development and commercialization of our lead product, EXPAREL, which was first approved by the FDA on October 28, 2011 and commercially launched in April 2012. EXPAREL was approved by the EC (which included the U.K.) on November 16, 2020.
We have invested a significant portion of our efforts and financial resources in the development and commercialization of our lead product, EXPAREL, which was first approved by the FDA in October 2011 and commercially launched in April 2012. EXPAREL was approved by the EC (which included the U.K.) in November 2020.
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.
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.
Additionally, our subsidiaries had no indebtedness (excluding trade payables, intercompany liabilities and income tax-related liabilities). Our TLA Credit Agreement and the Indentures each impose significant operating and financial restrictions on us and certain of our subsidiaries, which may prevent us from capitalizing on business opportunities.
Additionally, our subsidiaries had no indebtedness (excluding trade payables, intercompany liabilities and income tax-related liabilities). 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.
Further, our ability to repurchase the Notes or to pay cash upon conversions of the Notes may be limited by law, by regulatory authority or by agreements governing our future indebtedness.
Further, our ability to repurchase the 2029 Notes or to pay cash upon conversions of the 2029 Notes may be limited by law, by regulatory authority or by agreements governing our indebtedness.
We may not have the ability to raise the funds necessary to settle conversions of the Notes in cash to the extent elected or to repurchase the Notes upon a fundamental change, and our future indebtedness may contain limitations on our ability to pay cash upon conversion of the Notes or limitations on our ability to repurchase the Notes.
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.
Subject to the limits contained in the TLA Credit Agreement and the Indentures, we may be able to incur substantial additional debt from time to time. If we do so, the risks related to our level of debt could increase.
Subject to the limits contained in the Credit Agreement and the Indenture, we may be able to incur substantial additional debt from time to time. If we do so, the risks related to our level of debt could increase.
Our stock could be subject to wide fluctuations in price in response to various factors, including the following: the commercial success of EXPAREL, ZILRETTA and iovera°; our ability to execute on our business strategy; results of clinical trials of our products, product candidates or those of our competitors; changes or developments in laws or regulations applicable to our products or product candidates; introduction of competitive products or technologies; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 59 Table of Contents failure to meet or exceed financial projections we provide to the public; actual or anticipated variations in quarterly operating results; failure to meet or exceed the estimates and projections of the investment community; the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community; regulatory concerns or government actions; general economic and market conditions and overall fluctuations in U.S. equity markets and the impact of macroeconomic developments, such as general political, health and economic conditions, economic slowdowns, recessions, inflation, rising interest rates and the tightening of credit markets; increased interest rates and their generally negative effect on U.S. equity markets; developments concerning our sources of manufacturing supply; disputes or other developments relating to patents, intellectual property or other proprietary rights; additions or departures of key scientific or management personnel; the extent to which we acquire or invest in products, businesses and technologies; issuances of debt, equity or convertible securities; changes in the market valuations of similar companies; evolving investor expectations and concerns regarding environmental, social and corporate governance issues; and the other factors described in this Risk Factors section.
Our stock could be subject to wide fluctuations in price in response to various factors, including the following: the commercial success of EXPAREL, ZILRETTA and iovera°; our ability to execute on our business strategy; results of clinical trials of our products, product candidates or those of our competitors; changes or developments in laws or regulations applicable to our products or product candidates; introduction of competitive products or technologies; failure to meet or exceed financial projections we provide to the public; actual or anticipated variations in quarterly operating results; failure to meet or exceed the estimates and projections of the investment community; the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community; regulatory concerns or government actions; general economic and market conditions and overall fluctuations in U.S. equity markets and the impact of macroeconomic developments, such as general political, health and economic conditions, economic slowdowns, recessions, inflation, rising interest rates and the tightening of credit markets; increased interest rates and their generally negative effect on U.S. equity markets; developments concerning our sources of manufacturing supply; disputes or other developments relating to patents, intellectual property or other proprietary rights; additions or departures of key scientific or management personnel; the extent to which we acquire or invest in products, businesses and technologies; issuances of debt, equity or convertible securities; changes in the market valuations of similar companies; securities litigation or stockholder activism; evolving investor expectations and concerns regarding environmental, social and corporate governance issues; and the other factors described in this Risk Factors section.
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.
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.
Increased investments in research and development or unsuccessful research and development efforts could cause our cost structure to fall out of alignment with the demand for our products, which would have a negative impact on our business, financial condition and results of operations.
Increased investments in R&D or unsuccessful R&D efforts could cause our cost structure to fall out of alignment with the demand for our products, which would have a negative impact on our business, financial condition and results of operations.
In the U.S., the laws that directly or indirectly affect our ability to operate our business include the following: the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration—directly or indirectly—in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 49 Table of Contents other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment; the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government; the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
In the U.S., the laws that directly or indirectly affect our ability to operate our business include the following: the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration—directly or indirectly—in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid; other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment; the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government; the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
Our San Diego facilities in California, the Thermo Fisher facility in Swindon, U.K. and the Carlisle facility in Tijuana, Mexico are also subject to the risks of a natural or man-made disaster, including, but not limited to, storms, earthquakes, floods, fires or other business disruptions.
Our San Diego facilities in California, the Thermo Fisher facility in Swindon, U.K., the Amphenol facility in Tijuana, Mexico, and the Jubilant facility in Spokane, Washington, are also subject to the risks of a natural or man-made disaster, including, but not limited to, storms, earthquakes, floods, fires or other business disruptions.
Many of our competitors have greater financial and other resources than we have, such as larger research and development staff, more extensive marketing, distribution, sales and manufacturing organizations and experience, more extensive clinical trial and regulatory experience, expertise in prosecution of intellectual property rights and access to development resources like personnel and technology.
Many of our competitors have greater financial and other resources than we have, such as larger R&D staffs, more extensive marketing, distribution, sales and manufacturing organizations and experience, more extensive clinical trial and regulatory experience, expertise in prosecution of intellectual property rights and access to development resources like personnel and technology.
Competition for highly skilled personnel, including management and commercial, scientific and clinical personnel, is extremely competitive, particularly in and around the San Francisco Bay Area; San Diego, California; northern New Jersey/New York City metro and Tampa, Florida.
Competition for highly skilled personnel, including management and commercial, scientific and clinical personnel, is extremely competitive, particularly in and around the San Francisco Bay Area; San Diego, California, northern New Jersey/New York City metro and Luckenwalde, Germany.
Market acceptance of ZILRETTA will depend on a number of factors, including: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 36 Table of Contents the efficacy and safety as demonstrated in clinical trials; the ability to demonstrate the impact of real-world evidence; the timing and market introduction of competitive products; the product label and clinical indications for which the product is approved; acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies; the convenience of prescribing, administrating and initiating patients on the product; the potential and perceived advantages or value of the product over alternative treatments; the cost of treatment in relation to alternative treatments, including any similar generic treatments; the economics of a buy-and-bill product and discounts and rebates we offer; the availability of coverage and adequate reimbursement by third-party payers and government authorities to support pricing; the prevalence and severity of adverse side effects; and the effectiveness of sales and marketing efforts.
Market acceptance of ZILRETTA will depend on a number of factors, including: the efficacy and safety as demonstrated in clinical trials; the ability to demonstrate the impact of real-world evidence; the timing and market introduction of competitive products; the product label and clinical indications for which the product is approved; acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies; the convenience of prescribing, administrating and initiating patients on the product; the potential and perceived advantages or value of the product over alternative treatments; the cost of treatment in relation to alternative treatments, including any similar generic treatments; the economics of a buy-and-bill product and discounts and rebates we offer; the availability of coverage and adequate reimbursement by third-party payers and government authorities to support pricing; the prevalence and severity of adverse side effects; and the effectiveness of sales and marketing efforts.
However, these business activities may entail numerous operational and financial risks, including: significant capital expenditures; the difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies; the incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products and any related milestone or earn-out payments; the successful integration of acquired products, businesses or technologies into our operations, and achieving the expected benefits and synergies from such acquisitions; the disruption of our business and diversion of our management’s time and attention; higher than expected development, acquisition or in-license and integration costs; exposure to unknown liabilities; the difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; the inability to retain key employees of any acquired businesses; the difficulty entering markets in which we have limited or no direct experience; the difficulty in managing multiple product development programs; and the inability to successfully develop new products or clinical failure.
However, these business activities may entail numerous operational and financial risks, including: significant capital expenditures; the difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies; the incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products and any related milestone or earn-out payments; the successful integration of acquired products, businesses or technologies into our operations, and achieving the expected benefits and synergies from such acquisitions; the disruption of our business and diversion of our management’s time and attention; higher than expected development, acquisition or in-license and integration costs; exposure to unknown liabilities; the difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; the inability to retain key employees of any acquired businesses; the difficulty entering markets in which we have limited or no direct experience; Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 46 Table of Contents the difficulty in managing multiple product development programs; and the inability to successfully develop new products or clinical failure.
Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
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.
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.
Our failure, or the failure of any contract manufacturers with whom we may work in the future, to comply with the laws administered by the FDA, EMA, the MHRA or other governmental authorities could result in, among other things, any of the following: product recall or seizure; suspension or withdrawal of an approved product from the market; interruption of production; reputational concerns of our customers or the medical community; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 50 Table of Contents operating restrictions; warning letters; injunctions; refusal to permit import or export of an approved product; refusal to approve pending applications or supplements to approved applications that we submit; denial of permission to file an application or supplement in a jurisdiction; consent decrees; suspension or termination of ongoing clinical trials; fines and other monetary penalties; criminal prosecutions; and unanticipated expenditures.
Our failure, or the failure of any contract manufacturers with whom we may work in the future, to comply with the laws administered by the FDA, EMA, the MHRA or other governmental authorities could result in, among other things, any of the following: product recall or seizure; suspension or withdrawal of an approved product from the market; interruption of production; reputational concerns of our customers or the medical community; operating restrictions; warning letters; injunctions; refusal to permit import or export of an approved product; refusal to approve pending applications or supplements to approved applications that we submit; denial of permission to file an application or supplement in a jurisdiction; consent decrees; suspension or termination of ongoing clinical trials; fines and other monetary penalties; criminal prosecutions; and unanticipated expenditures.
On May 14, 2024, we completed a private placement of $287.5 million in aggregate principal amount of 2029 Notes, and entered into an indenture, or 2029 Indenture, and, together with the 2025 Indenture, the Indentures, with respect to the 2029 Notes.
In May 2024, we completed a private placement of $287.5 million in aggregate principal amount of 2029 Notes, and entered into an indenture, or 2029 Indenture, with respect to the 2029 Notes.
During 2024, sales of EXPAREL accounted for 78% of our total revenue, and we expect EXPAREL sales will remain of primary importance for the foreseeable future. We added ZILRETTA to our product portfolio upon completing the Flexion Acquisition in November 2021 and it accounted for 17% of our total revenue in 2024.
During 2025, sales of EXPAREL accounted for 79% of our total revenue, and we expect EXPAREL sales will remain of primary importance for the foreseeable future. We added ZILRETTA to our product portfolio upon completing the Flexion Acquisition in November 2021 and it accounted for 16% of our total revenue in 2025.
The FDA also approved a labeling supplement for EXPAREL that further clarified that EXPAREL was not limited to any specific surgery type or site, that the proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, that there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy trial and that EXPAREL may be admixed with bupivacaine, provided certain Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 47 Table of Contents medication ratios are observed.
The FDA also approved a labeling supplement for EXPAREL that further clarified that EXPAREL was not limited to any specific surgery type or site, that the proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, that there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy trial and that EXPAREL may be admixed with bupivacaine, provided certain medication ratios are observed.
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. EXPAREL has been a commercialized drug since April 2012.
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.
These trials will be expensive and time consuming and we are required to meet the timelines for submission of protocols and data and for completion as agreed with the FDA and EMA, and we may be delayed in meeting such timelines.
The EMA waived our pediatric studies requirement in March 2025. These trials will be expensive and time consuming and we are required to meet the timelines for submission of protocols and data and for completion as agreed with the FDA and EMA, and we may be delayed in meeting such timelines.
We are continuing to build our commercial infrastructure for the marketing, sale and distribution of pharmaceutical products. In order to continue commercializing our products effectively, we must continue to build our marketing, sales and distribution capabilities. The establishment, development and training of our sales force and related compliance plans to market our products is expensive and time consuming.
In order to continue commercializing our products effectively, we must continue to build our marketing, sales and distribution capabilities. The establishment, development and training of our sales force and related compliance plans to market our products is expensive and time consuming.
Our competitors may succeed in developing, acquiring or licensing on an exclusive basis technologies, drug products and medical devices that are more effective or less costly than EXPAREL, ZILRETTA, iovera° or any product candidate that we are currently developing or that we may develop, license or acquire, which could render our products obsolete and noncompetitive or significantly harm the commercial opportunity for EXPAREL, ZILRETTA, iovera° or any of our product candidates.
Our competitors may succeed in developing, Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 39 Table of Contents acquiring or licensing on an exclusive basis technologies, drug products and medical devices that are more effective or less costly than EXPAREL, ZILRETTA, iovera° or any product candidate that we are currently developing or that we may develop, license or acquire, which could render our products obsolete and noncompetitive or significantly harm the commercial opportunity for EXPAREL, ZILRETTA, iovera° or any of our product candidates.
In addition, our failure to follow FDA rules and guidelines relating to promotion and advertising may cause the FDA to issue warning letters or untitled letters, bring an enforcement action against us, suspend or withdraw an approved product from the market, require a recall or institute fines or civil fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our reputation and our business.
In addition, our failure to follow Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 40 Table of Contents FDA rules and guidelines relating to promotion and advertising may cause the FDA to issue warning letters or untitled letters, bring an enforcement action against us, suspend or withdraw an approved product from the market, require a recall or institute fines or civil fines, or could result in disgorgement of money, operating restrictions, injunctions or criminal prosecution, any of which could harm our reputation and our business.
We may be able to incur substantial additional indebtedness in the future. Although certain of the agreements governing our existing indebtedness contain restrictions on the incurrence of additional indebtedness and entering into certain types of other transactions, these restrictions are subject to a number of qualifications and exceptions, including compliance with various financial conditions.
Although certain of the agreements governing our existing indebtedness contain restrictions on the incurrence of additional indebtedness and entering into certain types of other transactions, these restrictions are subject to a number of qualifications and exceptions, including compliance with various financial conditions. Additional indebtedness incurred in compliance with our existing debt instruments could be substantial.
If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our product candidates.
If these clinical investigators, clinical sites or other third parties do not carry out their contractual duties or obligations or fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to their failure to adhere to our clinical protocols or for other reasons, our clinical trials may be Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 48 Table of Contents extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our product candidates.
EXPAREL is currently manufactured at our facilities in San Diego, California; both EXPAREL and ZILRETTA are currently manufactured at the Thermo Fisher facility in Swindon, U.K., iovera° handpieces are currently manufactured at our facility in San Diego, California and iovera° Smart Tips are currently manufactured at Carlisle’s facility in Tijuana, Mexico.
EXPAREL is currently manufactured at our facilities in San Diego, California; both EXPAREL and ZILRETTA are currently manufactured at the Thermo Fisher facility in Swindon, U.K., iovera° handpieces are currently manufactured at our facility in San Diego, California, iovera° Smart Tips are currently manufactured at Amphenol’s facility in Tijuana, Mexico, and the diluent for ZILRETTA is currently manufactured at Jubilant’s facility in Spokane, Washington.
Our ability to make payments of the principal of, to pay interest on or to refinance our indebtedness, including the TLA Term Loan (as defined below), the 0.750% convertible senior notes due 2025, or 2025 Notes, issued in our private offering completed on July 10, 2020, and the 2.125% convertible senior notes due 2029, or 2029 Notes, issued in our private offering completed on May 14, 2024, and, together with the 2025 Notes, the Notes, each as described below, or to make cash payments in connection with any conversion of the 2025 Notes or 2029 Notes (if applicable) depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
Our ability to make payments of the principal of, to pay interest on or to refinance our indebtedness, including the Revolving Credit Facility (as defined below) and the 2.125% convertible senior notes due 2029, or 2029 Notes, issued in our private offering completed in May 2024 (each as described below), or to make cash payments in connection with any conversion of the 2029 Notes (if applicable) depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
A default under the applicable indenture or the fundamental change itself could also lead to a default under agreements governing our TLA Credit Agreement or future indebtedness.
A default under the Indenture or the fundamental change itself could also lead to a default under agreements governing our Revolving Credit Facility or future indebtedness.
We may experience temporary or prolonged suspensions in production of our products due to issues in our manufacturing process that must be remediated or in 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.
We may experience temporary or prolonged suspensions in production of our products due to issues in our manufacturing process that must be remediated or in Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 44 Table of Contents 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.
Furthermore, a sustained labor shortage, lack of skilled labor, increased turnover or labor cost inflation (for example, such as that initially caused by the Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 40 Table of Contents recent COVID-19 pandemic), or as a result of general macroeconomic factors, could lead to increased costs, which could negatively affect our ability to efficiently operate our overall business and have other adverse effects on our results of operations and financial condition.
Furthermore, a sustained labor shortage, lack of skilled labor, increased turnover or labor cost inflation (for example, such as that initially caused by the COVID-19 pandemic), or as a result of general macroeconomic factors, could lead to increased costs, which could negatively affect our ability to efficiently operate our overall business and have other adverse effects on our results of operations and financial condition.
In addition, we are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our board of directors.
In addition, we are subject to Section 203 of the DGCL, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 65 Table of Contents our board of directors.
Our operations have been, and may continue to be, impacted by supply chain constraints and raw material shortages, resulting in increased material costs, longer lead times and increased freight costs first caused, in part, by the recent COVID-19 pandemic, the uncertain economic environment and macroeconomic trends.
Our operations have in the past been, and may continue to be in the future, impacted by supply chain constraints and raw material shortages, resulting in increased material costs, longer lead times and increased freight costs, the uncertain economic environment and macroeconomic trends.
Furthermore, if we are unable to meet our debt service obligations or should we fail to comply with our financial and other negative covenants contained in the agreements governing our indebtedness, we may be required to refinance all or part of Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 58 Table of Contents our debt, sell important strategic assets at unfavorable prices, incur additional indebtedness or issue common stock or other equity securities.
Furthermore, if we are unable to meet our debt service obligations or should we fail to comply with our financial and other negative covenants contained in the agreements governing our indebtedness, we may be required to refinance all or part of our debt, sell important strategic assets at unfavorable prices, incur additional indebtedness or issue common stock or other equity securities.
The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 54 Table of Contents to manufacture substantially in the U.S. or that under the circumstances domestic manufacture is not commercially feasible.
The manufacturing preference requirement can be waived if the owner of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the U.S. or that under the circumstances domestic manufacture is not commercially feasible.
In addition, professional societies, practice management groups, private health and science foundations and other organizations from time to time may publish papers, guidelines or recommendations to the healthcare and patient communities with respect to specific products or classes of products.
Government agencies promulgate regulations and guidelines directly applicable to us and to our products and product candidates. In addition, professional societies, practice management groups, private health and science foundations and other organizations from time to time may publish papers, guidelines or recommendations to the healthcare and patient communities with respect to specific products or classes of products.
The TLA Credit Agreement and the Indentures also contain certain restrictive covenants that limit, and in some circumstances prohibit, our ability to, among other things: incur additional debt or issue preferred stock; sell, lease or transfer Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 57 Table of Contents our assets; pay dividends on, and make other distributions on, or redeem or repurchase, our common stock; make certain capital expenditures and investments; guarantee debt or obligations; create certain liens; enter into transactions with our affiliates; and enter into certain merger, consolidation or other reorganization transactions.
The Credit Agreement and the Indenture also contain certain restrictive covenants that limit, and in some circumstances prohibit, our ability to, among other things: incur additional debt or issue preferred stock; sell, lease or transfer our assets; pay dividends on, and make other distributions on, or redeem or repurchase, our common stock; make certain capital expenditures and investments; guarantee debt or obligations; create certain liens; enter into transactions with our affiliates; and enter into certain merger, consolidation or other reorganization transactions.
Any failure by us or our manufacturing partners to comply with applicable regulations may result in fines and civil penalties, suspension of production, product seizure or recall, operating restrictions, imposition of a consent decree, modification or withdrawal of product approval or criminal prosecution and would limit the availability of our product.
Any failure by us or our manufacturing partners to comply with applicable regulations may result in fines and civil penalties, suspension of production, Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 43 Table of Contents product seizure or recall, operating restrictions, imposition of a consent decree, modification or withdrawal of product approval or criminal prosecution and would limit the availability of our product.
Prior to receiving approval to commercialize any of our drug products or medical devices, we must demonstrate with scientifically appropriate and statistically sound evidence from well-controlled clinical trials, and to the satisfaction of the FDA and other regulatory authorities, that each of the products are both safe and effective.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 47 Table of Contents Prior to receiving approval to commercialize any of our drug products or medical devices, we must demonstrate with scientifically appropriate and statistically sound evidence from well-controlled clinical trials, and to the satisfaction of the FDA and other regulatory authorities, that each of the products are both safe and effective.
For more information on these litigations and other legal proceedings we are involved in, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein. We are unable to predict the outcome of these litigations at this time.
We intend to vigorously defend our intellectual property rights relating to EXPAREL and are unable to predict the outcome of this litigation at this time. 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.
While we offer remote work arrangements, which allows us to recruit employees residing outside of the geographic areas we operate in, we have experienced—and may continue to experience—some difficulty identifying and hiring qualified personnel, especially as we pursue our growth strategy.
While we offer remote work arrangements, which allows us to recruit Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 42 Table of Contents employees residing outside of the geographic areas we operate in, we have experienced—and may continue to experience—some difficulty identifying and hiring qualified personnel, especially as we pursue our growth strategy.
Litigation or other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming, Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 52 Table of Contents 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.
Litigation or other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming, 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.
For instance, because EXPAREL has been approved by the FDA, one or more third parties may challenge the patents covering this product, as described below, which could result in the invalidation or unenforceability of some or all of the relevant patent claims.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 54 Table of Contents For instance, because EXPAREL has been approved by the FDA, one or more third parties may challenge the patents covering this product, as described below, which could result in the invalidation or unenforceability of some or all of the relevant patent claims.
In addition, our stockholders, particularly but not limited to those that own 5% 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.
In addition, our stockholders, particularly but not limited to those that own 5% Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 66 Table of Contents 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.
Ultimately, however, in September 2015, we, along with two independent physicians, filed a lawsuit in federal court against the FDA and other governmental defendants seeking to exercise our lawful rights to communicate truthful and non-misleading information about EXPAREL.
Ultimately, however, in September 2015, we, along with two independent physicians, filed a lawsuit in federal court against the FDA and other governmental defendants seeking to exercise our lawful Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 49 Table of Contents rights to communicate truthful and non-misleading information about EXPAREL.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 51 Table of Contents 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.
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.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 35 Table of Contents In addition to our extensive internal efforts, the successful commercialization of EXPAREL requires many third parties, over whom we have no control, to continue to utilize EXPAREL. These third parties include physicians and hospital pharmacy and therapeutics committees (“P&T committees”).
In addition to our extensive internal efforts, the successful commercialization of EXPAREL requires many third parties, over whom we have no control, to continue to utilize EXPAREL. These third parties include physicians and hospital pharmacy and therapeutics committees (“P&T committees”).
Any of these events could prevent us from achieving or maintaining market acceptance of our products or any of our product candidates and could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from its sale.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 51 Table of Contents Any of these events could prevent us from achieving or maintaining market acceptance of our products or any of our product candidates and could substantially increase our commercialization costs and expenses, which in turn could delay or prevent us from generating significant revenues from its sale.
Holders of the Notes will have the right to require us to repurchase their Notes upon the occurrence of a fundamental change at a repurchase price equal to 100% of their principal amount, plus accrued and unpaid interest, if any. We have the option to pay the principal in cash, shares of our common stock, or any combination thereof.
Holders of the 2029 Notes will have the right to require us to repurchase their 2029 Notes upon the occurrence of a fundamental change at a repurchase price equal to 100% of their principal amount, plus accrued and unpaid interest, if any.
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.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 56 Table of Contents 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.
In the case of EXPAREL, the European and U.S. patents protecting the formulation of EXPAREL expired in 2018. An existing formulation patent for EXPAREL expired in November 2013.
In the case of EXPAREL, the European and U.S. patents protecting the formulation of EXPAREL expired in 2018. An existing formulation patent for EXPAREL expired in November 2013. An existing formulation patent for EXPAREL expired in the U.S. in 2013 and its equivalents in Canada, Germany, France, Spain, Italy and the U.K. expired in 2014.
As a result of these factors, our competitors may obtain patent protection or other intellectual property rights that may limit our ability to develop other indications for, or commercialize, EXPAREL, ZILRETTA, iovera° or any of our product Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 37 Table of Contents candidates.
As a result of these factors, our competitors may obtain patent protection or other intellectual property rights that may limit our ability to develop other indications for, or commercialize, EXPAREL, ZILRETTA, iovera° or any of our product candidates.
As of December 31, 2024, our total consolidated gross indebtedness was $595.3 million, which consisted of $202.5 million of principal outstanding on the 2025 Notes, $287.5 million of principal outstanding on the 2029 Notes and $105.3 million of principal outstanding on the TLA Term Loan. See Note 10, Debt , to our consolidated financial statements included herein for more information.
As of December 31, 2025, our total consolidated gross indebtedness was $378.5 million, which consisted of $287.5 million of principal outstanding on the 2029 Notes and $91.0 million of principal outstanding on the Revolving Credit Facility. See Note 11, Debt , to our consolidated financial statements included herein for more information.
If we are 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.
If we are Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 60 Table of Contents 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.
There can be no assurance that we would be able to Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 42 Table of Contents meet our requirements for EXPAREL, ZILRETTA or iovera° if there were a catastrophic event or failure of our current manufacturing systems.
There can be no assurance that we would be able to meet our requirements for EXPAREL, ZILRETTA or iovera° if there were a catastrophic event or failure of our current manufacturing systems.
As of December 31, 2024, our total consolidated gross indebtedness was $595.3 million, which consisted of $202.5 million of principal outstanding on the 2025 Notes, $287.5 million of principal outstanding on the 2029 Notes and $105.3 million of principal outstanding on the TLA Term Loan. See Note 10, Debt , to our consolidated financial statements included herein for more information.
As of December 31, 2025, our total consolidated gross indebtedness was $378.5 million, which consisted of $287.5 million of principal outstanding on the 2029 Notes and $91.0 million outstanding under the Revolving Credit Facility. See Note 11, Debt , to our consolidated financial statements included herein for more information.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeFor more information about the cybersecurity risks and other information technology and data privacy risks we face, see Item 1A. Risk Factors and the subsection titled Risks Related to Information Technology, Cybersecurity and Data Privacy. Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 71 Table of Contents
Biggest changeFor more information about the cybersecurity risks and other information technology and data privacy risks we face, see Item 1A. Risk Factors and the subsection titled Risks Related to Information Technology, Cybersecurity and Data Privacy.
Members of management that possess information security certifications and many years of experience work with our legal, finance and corporate governance functions to identify, define and report cybersecurity risks, policies and procedures and incident response plans.
Members of management that possess information security certifications and many years of experience work with our legal, finance and corporate governance Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 75 Table of Contents functions to identify, define and report cybersecurity risks, policies and procedures and incident response plans.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn addition, we maintain two administrative, commercial and business development offices—one in Parsippany, New Jersey, where we occupy approximately 53,000 square feet under a lease expiring in March 2028 and one in Brisbane, California, where we occupy approximately 20,000 square feet under a lease expiring in May 2026.
Biggest changeIn addition, we maintain two administrative, commercial and business development offices in the U.S.—one in Parsippany, New Jersey, where we occupy approximately 53,000 square feet under a lease expiring in March 2028 and one in Brisbane, California, where our principal executive offices and corporate headquarters are located.
Item 2. Properties We occupy three facilities totaling approximately 195,000 square feet at our Science Center Campus in San Diego, California. We use these facilities for research and development, manufacturing, general and administrative purposes and the storage of inventory and raw materials.
Item 2. Properties We occupy three facilities totaling approximately 195,000 square feet at our Science Center Campus in San Diego, California. We use these facilities for R&D, manufacturing, general and administrative purposes and the storage of inventory and raw materials.
Our manufacturing facility on this site where we produce EXPAREL and the handpieces for iovera° and our mixed-use research and development property leases both expire in June 2030 and our warehouse lease expires in August 2030.
Our manufacturing facility on this site where we produce EXPAREL and the handpieces for iovera° and our mixed-use R&D property leases both expire in June 2030 and our warehouse lease expires in August 2030.
We believe that our research and development and manufacturing facilities at our Science Center Campus, Thermo Fisher and Carlisle sites (as discussed in Item 1—Business above) will be sufficient for our current commercial and pipeline development needs.
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.
Removed
Our Pacira Innovation and Training Center in Tampa, Florida, is an approximately 13,000 square-foot facility that supports a full range of educational events to advance clinician understanding of the latest local, regional and field block approaches for managing pain and reducing or eliminating exposure to opioids.
Added
The Brisbane office is approximately 41,000 square feet and our lease expires in June 2036. We also lease an R&D lab and office space in Luckenwalde, Germany focused on our HCAd vector platform which consists of approximately 8,500 square feet under a lease expiring in November 2032.
Removed
Our principal executive offices and corporate headquarters are also located here, and our lease expires in December 2026.
Removed
In February 2025, Pacira Therapeutics, Inc., a wholly-owned subsidiary of the Company, entered into a securities purchase agreement to acquire the remaining 81% of GQ Bio that was not already owned by us.
Removed
GQ Bio maintains its main administrative office in Hamburg, Germany, has a research and development lab in Luckenwalde, Germany and maintains smaller administrative offices in each of Eupen and Liège, Belgium. For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changePacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 72 Table of Contents PART II
Biggest changePacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 76 Table of Contents PART II
Item 3. Legal Proceedings We are subject to legal proceedings and claims that have not been fully resolved and that have arisen in the ordinary course of business. For information related to Item 3. Legal Proceedings, refer to Note 19, Commitments and Contingencies , to our consolidated financial statements included herein. Item 4. Mine Safety Disclosures Not applicable.
Item 3. Legal Proceedings We are subject to legal proceedings and claims that have not been fully resolved and that have arisen in the ordinary course of business. For information related to Item 3. Legal Proceedings, refer to Note 20, Commitments and Contingencies , to our consolidated financial statements included herein. Item 4. Mine Safety Disclosures Not applicable.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(PCRX) $ 100.00 $ 132.10 $ 132.83 $ 85.23 $ 74.48 $ 41.59 Nasdaq Composite Index (^IXIC) $ 100.00 $ 143.64 $ 174.36 $ 116.65 $ 167.30 $ 215.22 Nasdaq Biotechnology Index (^NBI) $ 100.00 $ 125.69 $ 124.89 $ 111.27 $ 115.42 $ 113.84 S&P Pharmaceuticals Select Index (^SPSIPH) $ 100.00 $ 113.59 $ 100.83 $ 89.53 $ 90.76 $ 93.69 Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 73 Table of Contents Dividend Policy We have never declared or paid any dividends on our common stock.
Biggest change(PCRX) $ 100.00 $ 100.55 $ 64.52 $ 56.38 $ 31.48 $ 43.25 Nasdaq Composite Index (^IXIC) $ 100.00 $ 121.39 $ 81.21 $ 116.47 $ 149.83 $ 180.33 Nasdaq Biotechnology Index (^NBI) $ 100.00 $ 99.37 $ 88.53 $ 91.84 $ 90.58 $ 119.92 S&P Pharmaceuticals Select Index (^SPSIPH) $ 100.00 $ 88.76 $ 78.82 $ 79.90 $ 82.47 $ 107.22 Dividend Policy We have never declared or paid any dividends on our common stock.
Performance Graph The following graph and table shows the value of an investment of $100.00 made on December 31, 2019—the last trading day of 2019—in each of Pacira BioSciences, Inc. (PCRX), the Nasdaq Composite Index (^IXIC), the Nasdaq Biotechnology Index (^NBI) and the S&P Pharmaceuticals Select Index (^SPSIPH).
Performance Graph The following graph and table shows the value of an investment of $100.00 made on December 31, 2020—the last trading day of 2020—in each of Pacira BioSciences, Inc. (PCRX), the Nasdaq Composite Index (^IXIC), the Nasdaq Biotechnology Index (^NBI) and the S&P Pharmaceuticals Select Index (^SPSIPH).
Comparison of Five-Year Cumulative Total Returns Among Pacira BioSciences, Inc., the Nasdaq Composite Index, the Nasdaq Biotechnology Index and the S&P Pharmaceuticals Select Index Cumulative Total Return as of December 31, 2019 2020 2021 2022 2023 2024 Pacira BioSciences, Inc.
Comparison of Five-Year Cumulative Total Returns Among Pacira BioSciences, Inc., the Nasdaq Composite Index, the Nasdaq Biotechnology Index and the S&P Pharmaceuticals Select Index Cumulative Total Return as of December 31, 2020 2021 2022 2023 2024 2025 Pacira BioSciences, Inc.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed and traded under the ticker symbol “PCRX” on the Nasdaq Global Select Market. As of February 26, 2025, we had nine holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed and traded under the ticker symbol “PCRX” on the Nasdaq Global Select Market. As of February 25, 2026, we had nine holders of record of our common stock.
The payment of any future dividends would be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in the agreements governing our indebtedness, provisions of applicable law and any other factors our board of directors deems relevant. Purchases of Equity Securities by the Registrant None. Item 6.
The payment of any future dividends would be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in the agreements governing our indebtedness, provisions of applicable law and any other factors our board of directors deems relevant.
We currently intend to retain any future earnings to finance the future development and expansion of our business, and as such we do not expect to pay any dividends on our common stock in the foreseeable future.
We currently intend to retain any future earnings to finance the future development and expansion of our business, and as such we do not expect to pay any dividends on our Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 77 Table of Contents common stock in the foreseeable future.
Added
Purchases of Equity Securities by the Registrant The following table provides information on our share repurchases during the quarter ended December 31, 2025: Issuer Purchases of Equity Securities Period Total Number of Shares Purchased Average Price Paid Per Share (1) Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2) Approximate Dollar Value of Shares that May Yet be Purchased Under the Plans or Programs (1) October 1, 2025 – October 31, 2025 — $ — — $ 199,998,530 November 1, 2025 – November 30, 2025 768,164 $ 23.41 768,164 $ 182,014,229 December 1, 2025 –December 31, 2025 1,236,528 $ 25.89 1,236,528 $ 150,001,371 Total 2,004,692 $ 24.94 2,004,692 $ 150,001,371 (1) The average price paid per share excludes less than $0.1 million of broker fees and $1.0 million of excise tax incurred on share repurchases for the three months ended December 31, 2025.
Added
The remaining authorization outstanding for repurchases of common stock also excludes broker fees and the excise tax incurred. (2) Our Board of Directors has authorized the repurchase of common stock under a share repurchase program adopted and announced in April 2025.
Added
The share repurchase program authorizes the Company to purchase up to an aggregate of $300.0 million of the Company’s outstanding common stock. Repurchases under this program may be made at management’s discretion on the open market or through privately negotiated transactions, including plans that comply with Rule 10b5-1 under the Exchange Act.
Added
The share repurchase program may be suspended or discontinued at any time by the Company and has an expiration date of December 31, 2026.
Added
The timing of any repurchases and the actual number of shares repurchased will depend on a variety of factors, including our stock price, corporate and regulatory requirements, tax implications, restrictions under our debt obligations, other uses for capital, impacts on the value of remaining shares, and market and economic conditions.
Added
Refer to Note 13, Stockholders’ Equity , to our consolidated financial statements included herein for more information on our share repurchases. Item 6. [Reserved]

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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Biggest changeSee Note 11, Financial Instruments , to our consolidated financial statements included herein for more information; the impact of global economic conditions—including the impact of inflation and tariffs—on our product, material and labor costs, supply chain, longer lead-times, an inability to secure a sufficient supply of materials, our operating expenses and our business strategy; the timing of and extent to which the holders of our 2025 Notes and 2029 Notes elect to convert their 2025 Notes and 2029 Notes, the timing of principal and interest payments on our TLA Term Loan and the timing and impact of increases to the variable interest rate on our TLA Term Loan borrowings in accordance with the terms of the TLA Credit Agreement; the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°; the cost and timing of expanding and maintaining our manufacturing facilities; the cost and timing of additional strategic investments, including additional investments under existing agreements; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 83 Table of Contents the costs related to legal and regulatory matters, including those to develop and defend our intellectual property; the costs of performing additional clinical trials for our products, including the additional pediatric trials required by the FDA and EMA as a condition of the approval of EXPAREL; the costs for the development and commercialization of other product candidates; the costs and timing of future payments under our employee benefit plans, including but not limited to our cash long-term incentive plan and non-qualified deferred compensation plan; the timing and the number of shares of our common stock repurchased through our share repurchase program; and the extent to which we acquire or invest in products, businesses and technologies.
Biggest changeSee Note 12, Financial Instruments , to our consolidated financial statements included herein for more information; the impact of global economic conditions—including the impact of inflation and tariffs—on our products, material and labor costs, supply chain, longer lead-times, an inability to procure a sufficient supply of materials, our operating expenses and our business strategy; the timing of and extent to which the holders of our 2029 Notes elect to convert their 2029 Notes, and the amount of borrowings and interest payments on our Revolving Credit Facility; the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°; the cost and timing of expanding and maintaining our manufacturing and administrative facilities and capabilities; Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 89 Table of Contents the cost and timing of additional strategic investments, including additional investments under existing agreements; the costs related to legal and regulatory matters, including those to develop and defend our intellectual property; the costs of performing additional clinical trials for our products and product candidates, including the additional pediatric trials required by the FDA and EMA as a condition of the approval of EXPAREL and clinical trials for PCRX-201; the costs for the development and commercialization of other product candidates; the costs and timing of future payments under our employee benefit plans, including but not limited to our cash long-term incentive plan and non-qualified deferred compensation plan; the extent to which we acquire or invest in products, businesses and technologies; and the timing and the number of shares of our common stock either repurchased through our $300.0 million share repurchase program announced in April 2025, which has an expiration date of December 31, 2026 or withheld to cover employee tax withholding obligations on restricted stock unit vests.
Financing Activities In 2024, net cash provided by financing activities was $17.4 million, which primarily consisted of $287.5 million in proceeds from the issuance of the 2029 Notes.
In 2024, net cash provided by financing activities was $17.4 million, which primarily consisted of $287.5 million in proceeds from the issuance of the 2029 Notes.
See Note 10, Debt , to our condensed consolidated financial statements included herein for further discussion on the Flexion 2024 Notes, 2025 Notes, 2029 Notes, the capped call transaction and the TLA Term Loan. There was also $2.3 million of proceeds from the issuance of common stock through our ESPP.
See Note 10, Debt, to our consolidated financial statements included herein for further discussion on the Flexion 2024 Notes, 2025 Notes, 2029 Notes, the capped call transaction and the TLA Term Loan. There was also $2.3 million of proceeds from the issuance of common stock through our ESPP.
We also expanded the size of our sales force in the second half of 2024 in order to better extend our reach on each of our commercial products.
We also expanded the size of our sales force in the second half of 2024 in order to better extend our reach on our commercial products.
Such impacts may include the effect of prolonged periods of inflation or the imposition of tariffs, which could, among other things, result in higher costs for labor, raw materials, equipment and other goods and services; cause our patients to defer or cancel medical procedures, thereby adversely impacting our revenues; and negatively impact our suppliers which could cause longer lead-times or the inability to secure a sufficient supply of materials.
Such impacts may include the effect of prolonged periods of inflation or the imposition of tariffs, which could, among other things, result in higher costs for raw materials, equipment and other goods and services; cause patients to defer or cancel medical procedures, thereby adversely impacting our revenues; and negatively impact our suppliers which could result in longer lead-times or the inability to procure a sufficient supply of materials.
Research and Development Expense Research and development expenses primarily consist of costs related to clinical trials and related outside services, product development and other research and development costs, including trials that we are conducting to generate new data for EXPAREL, ZILRETTA and iovera°, clinical trials for PCRX-201 and stock-based compensation expense.
Research and Development Expenses R&D expenses primarily consist of costs related to clinical trials and related outside services, product development and other R&D costs, including trials that we are conducting to generate new data for EXPAREL, ZILRETTA and iovera°, clinical trials for PCRX-201 and stock-based compensation expense.
We have omitted discussion of the year ended December 31, 2022 (the earliest of the three years covered by our consolidated financial statements presented in this Annual Report) as permitted by SEC regulations.
We have omitted discussion of the year ended December 31, 2023 (the earliest of the three years covered by our consolidated financial statements presented in this Annual Report) as permitted by SEC regulations.
Certain defined terms have been brought forward from Part I of this Annual Report. This section of this Annual Report discusses year-to-year comparisons between 2024 and 2023, as well as other discussions of 2024 and 2023 items.
Certain defined terms have been brought forward from Part I of this Annual Report. This section of this Annual Report discusses year-to-year comparisons between 2025 and 2024, as well as other discussions of 2025 and 2024 items.
Contingent Consideration Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as contingent consideration gains, restructuring charges and other. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales and regulatory approvals.
Contingent Consideration Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as contingent consideration gains, acquisition-related expenses, restructuring and other. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales and regulatory approvals.
The complete Management’s Discussion and Analysis of Financial Condition and Results of Operations for year-to-year comparisons between 2023 and 2022 and other discussions of 2022 items can be found within Part II , Item 7 , to our Annual Report for the year ended December 31, 2023, filed with the SEC on February 29, 2024 , which is available on the SEC’s website at www.sec.gov and our corporate website at www.pacira.com.
The complete Management’s Discussion and Analysis of Financial Condition and Results of Operations for year-to-year comparisons between 2024 and 2023 and other discussions of 2023 items can be found within Part II , Item 7 , to our Annual Report for the year ended December 31, 2024, filed with the SEC on February 27, 2025 , which is available on the SEC’s website at www.sec.gov and our corporate website at www.pacira.com.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 78 Table of Contents Amortization of Acquired Intangible Assets The following table provides a summary of the amortization of acquired intangible assets during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Amortization of acquired intangible assets $ 57,288 $ 57,288 —% As part of the Flexion Acquisition and the MyoScience Acquisition, we acquired intangible assets consisting of developed technology intangible assets and customer relationships, with estimated useful lives between 9 and 14 years.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 83 Table of Contents Amortization of Acquired Intangible Assets The following table provides a summary of the amortization of acquired intangible assets during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Amortization of acquired intangible assets $ 57,288 $ 57,288 —% As part of the Flexion Acquisition and the MyoScience Acquisition, we acquired intangible assets consisting of developed technology intangible assets and customer relationships, with estimated useful lives between 9 and 14 years.
Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material. The summary of activity with respect to our sales related allowances and accruals for the years ended December 31, 2024, 2023 and 2022 appears in Note 4, Revenue , to our consolidated financial statements included herein.
Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material. The summary of activity with respect to our sales related allowances and accruals for the years ended December 31, 2025, 2024 and 2023 appears in Note 5, Revenue , to our consolidated financial statements included herein.
The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions. As of December 31, 2024, we were in compliance with all financial covenants under the TLA Credit Agreement.
The Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions. As of December 31, 2025, we were in compliance with all covenants under the Credit Agreement.
In the normal course of business, we enter into various lease agreements for manufacturing, research and development and corporate activities, which are typically classified as operating leases under the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 842, Leases .
In the normal course of business, we enter into various lease agreements for manufacturing, R&D and corporate activities, which are typically classified as operating leases under the provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 842, Leases .
The following table includes the key assumptions used in the valuation of our contingent consideration milestones: Assumption Ranges Utilized as of December 31, 2024 Discount rates 7.8% to 8.1% Probability of payment for remaining regulatory milestones 0% The maximum remaining potential payments related to contingent consideration from the Flexion Acquisition is $372.3 million as of December 31, 2024.
The following table includes the key assumptions used in the valuation of our contingent consideration milestones: Assumption Ranges Utilized as of December 31, 2025 Discount rates 7.3% to 7.5% Probability of payment for remaining regulatory milestones 0% The maximum remaining potential payments related to contingent consideration from the Flexion Acquisition is $372.3 million as of December 31, 2025.
For more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
For more information, see Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
The term loan issued under the TLA Credit Agreement (the “TLA Term Loan”) was issued at a 0.30% discount and provides for a single-advance term loan A facility in the principal amount of $150.0 million, which is secured by substantially all of our and any subsidiary guarantor’s assets and matures on March 31, 2028.
The term loan issued under the TLA Credit Agreement (the “TLA Term Loan”) was issued at a 0.30% discount and provides for a single-advance term loan A facility in the principal amount of $150.0 million, which is secured by substantially all of our and any subsidiary guarantor’s assets.
The impact of a hypothetical 10 percent increase in the forecasted annual growth rates would have increased the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2024 by $6.3 million.
The impact of a hypothetical 10 percent increase in the forecasted annual growth rates would have increased the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2025 by $6.9 million.
The impact of a hypothetical 100 basis point increase in the discount rate would have reduced the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2024 by $0.9 million.
The impact of a hypothetical 100 basis point increase in the discount rate would have reduced the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2025 by $0.3 million.
The effective tax rate of (58)% for the year ended December 31, 2024 differed from the U.S. statutory tax rate of 21% primarily due to non-deductible goodwill impairment charges during the three months ended September 30, 2024 and costs related to non-deductible executive compensation and stock-based compensation, mainly related to expired stock options.
The effective tax rate of (58)% for the year ended December 31, 2024 differed from the U.S. statutory tax rate of 21% primarily due to non-deductible goodwill impairment charges and costs related to non-deductible executive compensation and stock-based compensation, mainly related to expired stock options.
See Note 10, Debt, to our consolidated financial statements included herein for further discussion. 2025 Convertible Senior Notes In July 2020, we completed a private placement of $402.5 million in aggregate principal amount of our 2025 Notes, and entered into an indenture with respect to the 2025 Notes.
See Note 11, Debt, to our consolidated financial statements included herein for further discussion. 2025 Convertible Senior Notes In July 2020, we completed a private placement of $402.5 million in aggregate principal amount of our 0.750% convertible senior notes due 2025, or 2025 Notes, and entered into an indenture with respect to the 2025 Notes.
Investing Activities In 2024, net cash used in investing activities was $83.3 million, which reflected $72.6 million of available-for-sale investment purchases (net of sales) and $10.6 million of capital expenditures for manufacturing product fill lines and our EXPAREL capacity expansion project at our Science Center Campus in San Diego, California, partially offset by an increased investment in inventory levels.
In 2024, net cash used in investing activities was $83.3 million, which reflected $72.6 million of available-for-sale investment purchases (net of sales) and $10.6 million of capital expenditures for manufacturing product fill lines and our EXPAREL capacity expansion project at our Science Center Campus in San Diego, California.
Future Capital Requirements We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our TLA Term Loan, 2025 Notes and 2029 Notes through the next 12 months.
Future Capital Requirements We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our Revolving Credit Facility and 2029 Notes through the next 12 months.
Accordingly, we performed a quantitative assessment through a discounted cash flow model (or income approach), which resulted in the carrying value of the Company exceeding its fair value by more than the goodwill balance. As a result, the goodwill balance of $163.2 million was recorded as fully impaired during the three months ended September 30, 2024.
Accordingly, we performed a quantitative assessment through a discounted cash flow model (or income approach), which resulted in the carrying value of the Company exceeding its fair value by more than the goodwill balance. As a result, the then-goodwill balance of $163.2 million was recorded as fully impaired during the year ended December 31, 2024.
Due to these events and a subsequent decrease in our common stock price, it was determined these qualitative factors indicated it was more likely than not that the fair value of goodwill may be less than its carrying value.
District Court ruled that one of our EXPAREL patents was not valid. Due to these events and a subsequent decrease in our common stock price, it was determined these qualitative factors indicated it was more likely than not that the fair value of goodwill may be less than its carrying value.
Goodwill Impairment The following table provides a summary of goodwill impairments during the periods indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Goodwill impairment $ 163,243 $ N/A During the three months ended September 30, 2024, the FDA approved a generic competitor to EXPAREL and a U.S.
Goodwill Impairment The following table provides a summary of goodwill impairments during the periods indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Goodwill impairment $ $ 163,243 (100)% During the year ended December 31, 2024, the FDA approved a generic competitor to EXPAREL and a U.S.
Selling, General and Administrative Expense Sales and marketing expenses primarily consist of compensation and benefits for our sales force and personnel that support our sales, marketing, medical and scientific affairs operations, expenses related to communicating the health outcome benefits of our products, investments in provider-level market access and patient reimbursement support and educational programs for our customers.
Selling, General and Administrative Expenses Sales and marketing expenses primarily consist of compensation and benefits for our sales force and personnel that support our sales, marketing, medical and scientific affairs operations, expenses related to health outcome communications, provider-level market access, patient reimbursement support and customer educational programs.
The effective tax rate of 32% for the year ended December 31, 2023 differed from the U.S. statutory tax rate of 21% primarily due to non-deductible stock-based and executive compensation and non-U.S. valuation allowances, partially offset by tax credits.
The effective tax rate of 58% for the year ended December 31, 2025 differed from the U.S. statutory tax rate of 21% primarily due to costs related to non-deductible stock-based compensation and non-deductible executive compensation, partially offset by tax credits.
For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein. Global Economic Conditions, Inflation and Tariffs Direct and indirect effects of global economic conditions have in the past, and may continue to, negatively impact our business, financial condition and results of operations.
For more information, see Note 13, Stockholders’ Equity , to our consolidated financial statements included herein. Global Economic Conditions, Inflation and Tariffs Direct and indirect effects of global economic conditions have in the past, and may continue to, negatively impact our business, financial condition and results of operations.
Each term loan borrowing which is an alternate base rate borrowing bears interest at a rate per annum equal to (i) the Alternate Base Rate (as defined in the TLA Credit Agreement), plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 2.00% to 2.75%.
Each revolving loan borrowing which is an alternate base rate borrowing will bear interest at a rate per annum equal to (i) a base rate, plus (ii) a spread based on our Senior Secured Net Leverage Ratio (as defined in the Credit Agreement) ranging from 1.50% to 2.25%.
Overview Our stated corporate mission is to deliver innovative, non-opioid pain therapies to transform the lives of patients. We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 78 Table of Contents Overview Our stated corporate mission is to deliver innovative, non-opioid pain therapies to transform the lives of patients. We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
As part of the Flexion Acquisition, there are up to $372.3 million in potential payments if all regulatory and commercial milestones are met. For more information, see Note 11, Financial Instruments , to our consolidated financial statements included herein. In February 2025, we completed the GQ Bio Acquisition.
As part of the Flexion Acquisition, there are up to $372.3 million in potential payments if all regulatory and commercial milestones are met prior to December 31, 2030. For more information, see Note 12, Financial Instruments , to our consolidated financial statements included herein.
Each term loan borrowing which is a term benchmark borrowing or daily simple SOFR borrowing bears interest at a rate per annum equal to (i) the Adjusted Term SOFR Rate or Adjusted Daily Simple SOFR (as each is defined in the TLA Credit Agreement), plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 3.00% to 3.75%.
Each revolving loan borrowing which is a term benchmark borrowing or daily simple SOFR (as defined in the Credit Agreement) borrowing will bear interest at a rate per annum equal to (i) a forward-looking term rate based on SOFR or a rate determined by reference to the daily simple SOFR, plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 2.50% to 3.25%.
The 2029 Notes accrue interest at a fixed rate of 2.125% per annum, payable semiannually in arrears on May 15 th and November 15 th of each year, and mature on May 15, 2029.
The 2029 Notes accrue interest at a fixed rate of 2.125% per year, payable semiannually in arrears on May 15 th and November 15 th of each year. The 2029 Notes mature on May 15, 2029. At December 31, 2025, all $287.5 million of principal was outstanding on the 2029 Notes.
In 2024, we recognized a $7.5 million gain on early extinguishment of debt in conjunction with the repurchase of $200.0 million aggregate principal of our 2025 Notes (as defined below). The partial repurchase of the 2025 Notes was completed with our net proceeds from the issuance of the 2029 Notes (as defined below).
In 2024, we recognized a $7.5 million gain on early extinguishment of debt in conjunction with the repurchase of $200.0 million aggregate principal of our 2025 Notes. The partial repurchase of the 2025 Notes was completed with our net proceeds from the issuance of the 2029 Notes. For more information, See Note 11, Debt, to our consolidated financial statements herein.
Our significant accounting policies are more fully discussed in Note 2, Summary of Significant Accounting Policies , to our consolidated financial statements included herein. The following accounting policies, which may include significant judgments and estimates, were used in the preparation of our consolidated financial statements.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 90 Table of Contents Our significant accounting policies are more fully discussed in Note 2, Summary of Significant Accounting Policies , to our consolidated financial statements included herein. The following accounting policies, which may include significant judgments and estimates, were used in the preparation of our consolidated financial statements.
Contingent Consideration Gains, Restructuring Charges and Other The following table provides a summary of the costs (gains) related to contingent consideration, restructuring charges, acquisition-related charges and other activities during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Contingent consideration $ (4,457) $ (3,424) 30% Acquisition-related charges 1,462 1,963 (26)% Restructuring charges 8,532 1,109 100%+ Loss on lease termination 2,165 N/A Total contingent consideration gains, restructuring charges and other $ 7,702 $ (352) N/A In 2024, we recognized contingent consideration gains of $4.5 million due to adjustments reflecting the probability of achieving the remaining Flexion regulatory milestone by December 31, 2030—the milestone expiration date, partially offset by revisions to our weighted average cost of capital and the latest discount rates.
Contingent Consideration Gains, Acquisition-related Expenses, Restructuring and Other The following table provides a summary of the costs (gains) related to contingent consideration, restructuring charges, acquisition-related charges and other activities during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Contingent consideration gains $ (2,175) $ (4,457) (51)% Restructuring charges 3,674 8,532 (57)% Acquisition-related expenses 2,895 1,462 98% Legal settlement 7,000 N/A Legal judgment (23,148) N/A Impairment of acquired IPR&D 25,866 N/A Loss on lease termination 2,165 (100)% Total contingent consideration gains, acquisition-related expenses, restructuring and other $ 14,112 $ 7,702 83% In 2025 and 2024, we recognized contingent consideration gains of $2.2 million and $4.5 million, respectively, due to adjustments reflecting the probability of achieving the remaining Flexion sales-based milestones by December 31, 2030—the milestone expiration date, partially offset by revisions to our weighted average cost of capital and discount rates.
The 2025 Notes accrue interest at a fixed rate of 0.750% per annum, payable semiannually in arrears on February 1 st and August 1 st of each year, and mature on August 1, 2025. At December 31, 2024, the outstanding principal on the 2025 Notes was $202.5 million.
The 2025 Notes accrued interest at a fixed rate of 0.750% per annum, which was payable semiannually in arrears on February 1 st and August 1 st of each year.
Other Income (Expense), Net The following table provides information regarding other income (expense), net during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Interest income $ 19,689 $ 11,444 72% Interest expense (16,569) (20,306) (18)% Gain (loss) on early extinguishment of debt 7,518 (16,926) N/A Other, net (373) (186) 100%+ Total other income (expense), net $ 10,265 $ (25,974) N/A Total other income, net was $10.3 million in 2024 versus total other expense, net of $26.0 million in 2023.
Other (Expense) Income, Net The following table provides information regarding other income (expense), net during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Interest income $ 22,732 $ 19,689 15% Interest expense (17,446) (16,569) 5% (Loss) gain on early extinguishment of debt (983) 7,518 N/A Other, net (6,620) (373) 100%+ Total other (expense) income, net $ (2,317) $ 10,265 N/A Total other expense, net was $2.3 million in 2025 versus total other income, net of $10.3 million in 2024.
Equity Financings From our inception in December 2006 through December 31, 2024, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 87 Table of Contents Equity Financings From our inception in December 2006 through December 31, 2025, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
We base our estimates on historical experience, contract Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 84 Table of Contents terms and on other factors we believe to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
We base our estimates on historical experience, contract terms and on other factors we believe to be appropriate under the circumstances. Actual results may differ from these estimates under different assumptions or conditions.
In addition, we have approximately $59.9 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2024, of which $20.3 million is due in each of 2025 and 2026, $17.9 million is due in 2027 and the remaining $1.4 million is due in 2028.
In addition, we have approximately $37.2 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2025, of which $19.5 million is due in 2026, $16.0 million is due in 2027 and the remaining $1.7 million is due in 2028.
The following table provides a breakout of our research and development expenses during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Clinical and preclinical development $ 33,696 $ 24,471 38% Product development and manufacturing capacity expansion 30,803 33,365 (8)% Regulatory and other 9,697 9,727 (0)% Stock-based compensation 7,381 8,694 (15)% Total research and development expense $ 81,577 $ 76,257 7% % of total revenue 12% 11% Total research and development expense increased 7% in 2024 versus 2023.
The following table provides a breakout of our R&D expenses during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Clinical and preclinical development $ 52,861 $ 33,696 57% Product development 44,233 30,803 44% Regulatory and other 11,030 9,697 14% Stock-based compensation 9,188 7,381 24% Total research and development expense $ 117,312 $ 81,577 44% % of total revenue 16% 12% Total R&D expense increased 44% in 2025 versus 2024.
In 2024, we recognized a loss of $2.2 million associated with exiting a lease to a training center located in Houston, Texas. See Note 7, Leases , to our consolidated financial statements included herein.
In 2024, we recognized a loss of $2.2 million associated with exiting a lease to a training center located in Houston, Texas.
See Note 10, Debt, to our consolidated financial statements included herein for further discussion. 2029 Convertible Senior Notes In May 2024, we completed a private placement of $287.5 million in aggregate principal amount of our 2.125% convertible senior notes due 2029, or 2029 Notes, and entered into an indenture with respect to the 2029 Notes.
Prior to the TLA Credit Agreement extinguishment, we made voluntary principal prepayments of $6.6 million during the year ended December 31, 2025 and $11.3 million during the year ended December 31, 2024.See Note 11, Debt, to our consolidated financial statements included herein for further discussion. 2029 Convertible Senior Notes In May 2024, we completed a private placement of $287.5 million in aggregate principal amount of its 2.125% convertible senior notes due 2029, or 2029 Notes, and entered into an indenture with Computershare Corporate Trust, National Association, or 2029 Indenture, with respect to the 2029 Notes.
The following table provides information regarding our revenues during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Net product sales: EXPAREL $ 548,962 $ 538,120 2% ZILRETTA 118,089 111,098 6% iovera° 22,813 19,685 16% Bupivacaine liposome injectable suspension 7,322 3,342 100%+ Total net product sales 697,186 672,245 4% Royalty revenue 3,780 2,733 38% Total revenues $ 700,966 $ 674,978 4% EXPAREL revenue increased 2% in 2024 versus 2023.
The following table provides information regarding our revenues during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Net product sales: EXPAREL $ 575,130 $ 548,962 5% ZILRETTA 116,633 118,089 (1)% iovera° 24,178 22,813 6% Bupivacaine liposome injectable suspension 6,913 7,322 (6)% Total net product sales 722,854 697,186 4% Royalty revenue 3,557 3,780 (6)% Total revenues $ 726,411 $ 700,966 4% EXPAREL revenue increased 5% in 2025 versus 2024.
Contractual Obligations We had two convertible senior notes outstanding as of December 31, 2024, for which $202.5 million in aggregate principal amount is due on our 2025 Notes in August 2025 and $287.5 million in aggregate principal amount is due on our 2029 Notes in May 2029.
Contractual Obligations We had one convertible senior note outstanding as of December 31, 2025, for which $287.5 million in aggregate principal amount is due on our 2029 Notes in May 2029. The remaining interest payments on our 2029 Notes is $21.2 million, of which $6.1 million is due in 2026.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 80 Table of Contents Income Tax Expense The following table provides information regarding our income tax expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 (Loss) income before income taxes $ (63,106) $ 61,701 N/A Income tax expense $ 36,454 $ 19,746 85% Effective tax rate (58)% 32% We recorded income tax expense of $36.5 million and $19.7 million for the years ended December 31, 2024 and 2023, respectively.
Income Tax Expense The following table provides information regarding our income tax expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Income (loss) before income taxes $ 16,874 $ (63,106) N/A Income tax expense $ 9,840 $ 36,454 (73)% Effective tax rate 58% (58)% We recorded income tax expense of $9.8 million and $36.5 million for the years ended December 31, 2025 and 2024, respectively.
Liquidity and Capital Resources Since our inception in 2006, we have devoted most of our cash resources to manufacturing, research and development and selling, general and administrative activities related to the development and commercialization of EXPAREL.
Liquidity and Capital Resources Since our inception in 2006, we have devoted most of our cash resources to manufacturing, R&D and selling, general and administrative activities related to the development and commercialization of EXPAREL. We acquired ZILRETTA as part of the Flexion Acquisition in November 2021 and iovera° as part of the MyoScience Acquisition in April 2019.
The fair value of the Company would be calculated through an income approach. Under the income approach, we calculate the fair value based on the present value of estimated future cash flows. Considerable management judgment is necessary to evaluate the impact of operating and macroeconomic changes and to estimate the future cash flows used to assume fair value.
Under the income approach, we calculate the fair value based on the present Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 91 Table of Contents value of estimated future cash flows. Considerable management judgment is necessary to evaluate the impact of operating and macroeconomic changes and to estimate the future cash flows used to assume fair value.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 Revenues Net product sales consist of sales of (i) EXPAREL in the U.S., E.U., and U.K.; (ii) ZILRETTA in the U.S.; (iii) iovera° in the U.S., Canada and the E.U. and (iv) sales of our bupivacaine liposome injectable suspension product for veterinary use.
Results of Operations Comparison of the Years Ended December 31, 2025 and 2024 Revenues Our net product sales are primarily within the U.S. and consist of EXPAREL, ZILRETTA, iovera° and sales of bupivacaine liposome injectable suspension for veterinary use. Royalty revenues are related to the sale of bupivacaine liposome injectable suspension for veterinary use.
The following table provides information regarding selling, general and administrative expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Sales and marketing $ 172,015 $ 153,040 12% General and administrative 87,227 82,737 5% Stock-based compensation 34,857 33,664 4% Total selling, general and administrative expense $ 294,099 $ 269,441 9% % of total revenue 42% 40% Total selling, general and administrative expense increased 9% in 2024 versus 2023.
The following table provides information regarding selling, general and administrative expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Sales and marketing $ 226,616 $ 172,015 32% General and administrative 100,277 87,227 15% Stock-based compensation 41,866 34,857 20% Total selling, general and administrative expense $ 368,759 $ 294,099 25% % of total revenue 51% 42% Total selling, general and administrative expense increased 25% in 2025 versus 2024.
In February 2025, we acquired Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 74 Table of Contents GQ Bio Therapeutics GmbH, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”). PCRX-201 is the lead program from this platform.
In February 2025, we acquired GQ Bio Therapeutics GmbH, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”). PCRX-201 is the lead program from this platform.
We have approximately $6.5 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2024, all of which are due in 2025. We had $1.8 million of other minimum, non-cancelable contractual commitments as of December 31, 2024, of which $1.4 million is due in 2025, and the remaining $0.4 million is due thereafter.
We have approximately $9.1 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2025, of which $3.1 million is due in each of 2026 and 2027, $1.7 million in 2028, and $0.6 million in each of 2028 and 2029.
Clinical and preclinical development expense increased 38% in 2024 versus 2023 due to site start-up and ongoing enrollment in a ZILRETTA shoulder trial, an iovera° spasticity trial and an EXPAREL pediatric trial, as well as start-up expenses related to the PCRX-201 Phase 2 trial for knee OA.
Clinical and preclinical development expense increased 57% in 2025 versus 2024 due to site start-up expenses and the completed patient enrollment in Part A of our PCRX-201 Phase 2 ASCEND trial for knee OA, the ongoing enrollment in our ZILRETTA shoulder trial and an iovera° spasticity trial, as well as increased Investigator Initiated Trial (IIT) milestones achieved and additional personnel to support clinical initiatives.
This quantitative impairment test resulted in our carrying value exceeding the fair value of the Company by more than the goodwill balance. As a result, the goodwill balance of $163.2 million was fully impaired during the three months ended September 30, 2024. For more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
This quantitative impairment test resulted in our carrying value exceeding the fair value of the Company by more than the goodwill balance. As a result, our then-goodwill balance of $163.2 million was fully impaired during the year ended December 31, 2024.
In 2023, in conjunction with the entry into the TLA Credit Agreement (as defined below), we incurred a $16.9 million loss on early extinguishment of debt recognized as a result of the retirement of $287.5 million aggregate principal of our TLB Term Loan. For more information, See Note 10, Debt, to our consolidated financial statements herein.
For more information, see Note 11, Debt , to our consolidated financial statements herein. In 2025, we recognized a $1.0 million loss on early extinguishment of debt in conjunction with the repayment of a credit agreement (the TLA Term Loan).
Summary of Cash Flows The following table summarizes our cash flows from operating, investing and financing activities for the years ended December 31, 2024 and 2023 (in thousands): Year Ended December 31, Consolidated Statements of Cash Flows Data: 2024 2023 Net cash provided by (used in): Operating activities $ 189,389 $ 154,649 Investing activities (83,276) 77,541 Financing activities 17,363 (183,031) Net increase in cash and cash equivalents $ 123,476 $ 49,159 Operating Activities In 2024, net cash provided by operating activities was $189.4 million compared to $154.6 million in 2023.
Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 86 Table of Contents Summary of Cash Flows The following table summarizes our cash flows from operating, investing and financing activities for the years ended December 31, 2025 and 2024 (in thousands): Year Ended December 31, Consolidated Statements of Cash Flows Data: 2025 2024 Net cash provided by (used in): Operating activities $ 151,994 $ 189,389 Investing activities 99,481 (83,276) Financing activities (369,627) 17,363 Effect of exchange rate changes on cash and cash equivalents (77) Net (decrease) increase in cash and cash equivalents $ (118,229) $ 123,476 Operating Activities In 2025, net cash provided by operating activities was $152.0 million compared to $189.4 million in 2024.
See Note 10, Debt , to our consolidated financial statements included herein for further discussion.
For more information, see Note 12, Financial Instruments, to our consolidated financial statements included herein.
A 4% increase in gross vial volume was partially offset by a shift in vial mix. EXPAREL revenue was also impacted by a 1% increase in selling price per unit related to a price increase, net of increases in sales related allowances as a result of group purchasing organization contracting.
The decrease in net selling price per unit relates to increases in sales-related allowances as a result of group purchasing organization (GPO) contracting, partially offset by a January 2025 price increase. ZILRETTA revenue decreased 1% in 2025 versus 2024, primarily due to a 4% decrease in kit volume, partially offset by a 3% increase in net selling price per unit.
The partial repurchase of the 2025 Notes resulted in a $7.5 million gain on early extinguishment of debt. At December 31, 2024, all $287.5 million of principal was outstanding on the 2029 Notes.
The partial repurchase of the 2025 Notes resulted in a $7.5 million gain on early extinguishment of debt during the year ended December 31, 2024. On August 1, 2025, the 2025 Notes matured and we settled the remaining outstanding principal balance of $202.5 million in cash.
We are also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel gene therapy vector platform enabling local administration of genetic medicines with the potential to treat large prevalent diseases like OA.
We are also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy for the treatment of OA of the knee. PCRX-201 is the lead program from our HCAd vector platform, which enables local administration of genetic medicines and has the potential to unlock gene therapy for large prevalent diseases affecting millions of people.
Stock Repurchase Program In May 2024, we announced that our board of directors approved a share repurchase program which was effective immediately and authorizes us to repurchase up to an aggregate of $150.0 million of our outstanding common stock. Repurchases under this program may be made at management’s discretion on the open market or through privately negotiated transactions.
In April 2025, we announced that our board of directors approved a new share repurchase program, which replaced the previously authorized share repurchase program and was effective immediately, which authorizes us to repurchase up to an aggregate of $300.0 million of our outstanding common stock.
Bupivacaine liposome injectable suspension revenue increased more than 100% in 2024 versus 2023, and the related royalties increased 38%, primarily due to the sales mix of vial sizes and the timing of orders placed for veterinary use.
Bupivacaine liposome injectable suspension revenue and its related royalties both decreased 6% in 2025 versus 2024, primarily due to the sales mix of vial sizes and the timing of orders placed by our partner for veterinary use. Cost of Goods Sold Cost of goods sold primarily relates to the costs to produce, package and deliver our products to customers.
District Court ruled that one of our patents was not valid (for more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein).
For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements herein.
Net product sales of iovera° increased 16% in 2024 versus 2023 primarily due to a 20% increase in Smart Tip volume, partially offset by increased sales related allowances and accruals.
The increase in net selling price per unit is related to two price increases in 2025, partially offset by higher gross-to-net adjustments. Net product sales of iovera° increased 6% in 2025 versus 2024 primarily due to a 7% increase in Smart Tip volume.
The share repurchase program may be suspended or discontinued at any time by us and has an expiration date of December 31, 2026.
Repurchases under this program may be made at management’s discretion on the open market or through privately negotiated transactions, including plans that comply with Rule 10b5-1 under the Exchange Act. The share repurchase program may be suspended or discontinued at any time by us and has an expiration date of December 31, 2026.
If the Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 85 Table of Contents estimated fair value of the reporting unit is less than the carrying amount of the reporting unit, impairment is indicated, requiring recognition of a goodwill impairment charge up to the carrying value of goodwill.
If the estimated fair value of the reporting unit is less than the carrying amount of the reporting unit, impairment is indicated, requiring recognition of a goodwill impairment charge up to the carrying value of goodwill. The fair value of the Company would be calculated through an income approach.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 79 Table of Contents In 2024 and 2023, we recognized acquisition-related charges of $1.5 million and $2.0 million, respectively, primarily related to vacant and underutilized Flexion leases that were assumed from the Flexion Acquisition.
In 2025, we recognized acquisition-related charges of $2.9 million, primarily related to third-party services and legal fees associated with the GQ Bio Acquisition. In 2024, we recognized acquisition-related charges of $1.5 million, primarily related to vacant and underutilized Flexion leases that were assumed from the Flexion Acquisition.
Product development and manufacturing capacity expansion expense decreased 8% in 2024 versus 2023, primarily attributable to the completion of pre-commercial scale-up activities of our larger-scale EXPAREL manufacturing capacity at Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 77 Table of Contents our Science Center Campus in San Diego, California, which the FDA approved in February 2024 and was subsequently placed into service in July 2024.
These increases were partially offset by the completion of pre-commercial scale-up activities of our enhanced, larger-scale EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California. This manufacturing suite was approved by the FDA in February 2024 and placed into service in July 2024.
Debt 2028 Term Loan A Facility On March 31, 2023, we entered into a credit agreement (as amended, the “TLA Credit Agreement”) to refinance the indebtedness outstanding under our TLB Credit Agreement.
Upon entering into the Credit Agreement, we borrowed $101.0 million under the Revolving Credit Facility, of which $91.0 million is outstanding as of December 31, 2025 after we made repayments of $10.0 million during the year ended December 31, 2025. 2028 Term Loan A Facility On March 31, 2023, we entered into a credit agreement (as amended, the “TLA Credit Agreement”).
As of December 31, 2024, we had net minimum commitments of $64.0 million, of which $12.3 million are due in 2025. For more information, refer to Note 7, Leases , to our consolidated financial statements included herein.
As of December 31, 2025, we also entered into a lease for additional office space at our principal executive offices in Brisbane, California that will commence in 2026 and has net minimum commitments of $22.5 million, of which none is due in 2026. For more information, refer to Note 8, Leases , to our consolidated financial statements included herein.
The following table provides information regarding cost of goods sold and gross margin during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Cost of goods sold $ 170,428 $ 184,669 (8)% Gross margin 76% 73% Gross margin increased three percentage points in 2024 versus 2023 primarily due to lower EXPAREL product costs as a result of higher production volumes and the absence of a step-up of ZILRETTA fixed assets and inventory to fair value in accordance with purchase accounting that existed in the prior period, partially offset by higher EXPAREL and ZILRETTA inventory reserves.
The following table provides information regarding cost of goods sold and gross margin during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2025 2024 Cost of goods sold $ 149,749 $ 170,428 (12)% Gross margin 79% 76% Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 81 Table of Contents Gross margin increased three percentage points in 2025 versus 2024 primarily due to lower EXPAREL inventory reserves and improved ZILRETTA product costs due to higher volumes manufactured in order to enhance the level of inventory on hand, partially offset by accelerated depreciation of fixed assets impacted by the decommissioning of our 45-liter EXPAREL batch manufacturing suite at our Science Center Campus in San Diego, California (for more information, see Note 7, Fixed Assets , to our consolidated financial statements included herein).
During the year ended December 31, 2023, we did not repurchase any shares of our common stock. As of December 31, 2024, we had remaining authorization to repurchase approximately $125.0 million of our common stock, subject to restrictions under the TLA Credit Agreement and the Indentures.
During the year ended December 31, 2025, we repurchased 5,936,798 shares of our common stock through open market transactions for $151.4 million which included $0.1 million of broker fees and $1.3 million of accrued excise tax. As of December 31, 2025, we had remaining authorization to repurchase approximately $150.0 million of our common stock, subject to restrictions under the Indenture.
Sales and marketing expense increased 12% in 2024 versus 2023, driven by investments in programs to drive awareness and education for our customers and enhance our marketing, market access and reimbursement teams and value creation for the implementation of separate Medicare reimbursement for EXPAREL at average sales price plus 6 percent in HOPD settings and iovera° at up to an additional $255.85 when providers administer iovera° in ASC and HOPD settings beginning in January 2025 as part of the NOPAIN Act.
Sales and marketing expense increased 32% in 2025 versus 2024, driven by investing in programs to drive awareness and education for our customers and enhancing our marketing, market access and reimbursement teams and value creation to strengthen our key commercial capabilities and expand EXPAREL utilization.
We have financed our operations primarily with the proceeds from the sale of convertible senior notes and other debt, common stock, product sales and collaborative licensing and milestone revenue. As of December 31, 2024, we had an accumulated deficit of $206.4 million, cash and cash equivalents and available-for-sale investments of $484.6 million and working capital of $435.2 million.
As of December 31, 2025, we had an accumulated deficit of $199.3 million, cash and cash equivalents and available-for-sale investments of $238.4 million and working capital of $427.4 million.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 76 Table of Contents Cost of Goods Sold Cost of goods sold primarily relates to the costs to produce, package and deliver our products to customers. These expenses include labor, raw materials, manufacturing overhead and occupancy costs, depreciation of facilities, royalty payments, quality control and engineering.
These expenses include labor, raw materials, manufacturing overhead and occupancy costs, depreciation of facilities, quality control and engineering.
As of December 31, 2024, there are contractually obligated principal payments of $4.1 million in 2026, $15.0 million in 2027 and $86.3 million in 2028. The remaining interest payments of the TLA Term Loan are approximately $25.0 million based on the current interest rate, of which $7.9 million is due in 2025.
We had $8.3 million of other minimum, non-cancelable contractual commitments as of December 31, 2025, of which $6.3 million is due in 2026 $0.8 million in 2027, $0.7 million in 2028 and the remaining $0.5 million is due thereafter.
Stock-based compensation decreased 15% in 2024 versus 2023 primarily due to fewer equity awards granted to research and development personnel and headcount vacancies as well as the acceleration of stock-based compensation awards related to a terminated executive in 2023.
Stock-based compensation increased 24% in 2025 versus 2024 primarily due to increased R&D personnel as well as the shifting of our annual equity grant to the first quarter in 2025.
These increases were partially offset by the impact of a February 2024 restructuring plan designed to ensure we are well positioned for long-term growth (for more information, see Note 17, Contingent Consideration Gains, Restructuring Charges and Other , to our consolidated financial statements included herein) .
For more information, see Note 6, Inventories , Note 7, Fixed Assets and Note 18, Contingent Consideration Gains, Acquisition-Related Expenses, Restructuring and Other, to our consolidated financial statements included herein.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

6 edited+4 added5 removed3 unchanged
Biggest changeDollar, subject to an annual adjustment based on changes in currency exchange rates. Additionally, our accounts receivable are primarily concentrated with three large wholesalers of pharmaceutical products. In the event of non-performance or non-payment, there may be a material adverse impact on our financial condition, results of operations or net cash flow.
Biggest changeDollar, subject to an annual adjustment based on changes in currency exchange rates. While we conduct operations in Europe, we are subject to foreign currency risk which is not expected to be material. Additionally, our accounts receivable are primarily concentrated with three large wholesalers of pharmaceutical products.
A hypothetical 100 basis point increase in interest rates would increase interest expense over the next 12 months by approximately $1.1 million, based on the balances outstanding for these borrowings as of December 31, 2024. We have agreements with certain vendors and partners that operate in foreign jurisdictions. The more significant transactions are primarily denominated in the U.S.
A hypothetical 100 basis point increase in interest rates would increase interest expense over the next 12 months by approximately $0.9 million based on the balance outstanding for these borrowings as of December 31, 2025. We have agreements with certain vendors and partners that operate in foreign jurisdictions. The more significant transactions are primarily denominated in the U.S.
A hypothetical 100 basis point increase in interest rates would have reduced the fair value of our available-for-sale securities at December 31, 2024 by approximately $0.8 million. The fair value of our 2025 Notes is impacted by both the fair value of our common stock and interest rate fluctuations.
A hypothetical 100 basis point increase in interest rates would have increased the fair value of our available-for-sale securities at December 31, 2025 by approximately $0.4 million. The fair value of our 2029 Notes is impacted by both the fair value of our common stock and interest rate fluctuations.
As of December 31, 2024, the estimated fair value of the 2025 Notes was $971 per $1,000 principal amount. See Note 10, Debt , to our consolidated financial statements included herein for further discussion of our 2025 Notes, which bears interest at a fixed rate. At December 31, 2024, $202.5 million of principal remains outstanding on the 2025 Notes.
As of December 31, 2025, the estimated fair value of the 2029 Notes was $1,010 per $1,000 principal amount. See Note 11, Debt , to our consolidated financial statements included herein for further discussion of our 2029 Notes, which bears interest at a fixed rate. At December 31, 2025, all $287.5 million of principal remains outstanding on the 2029 Notes.
Each term loan borrowing that is a term benchmark borrowing or daily simple SOFR borrowing bears interest at a rate per annum equal to (i) the Adjusted Term SOFR Rate or Adjusted Daily Simple SOFR (as each is defined in the TLA Credit Agreement), plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 3.00% to 3.75%.
Each revolving loan borrowing which is a term benchmark borrowing or daily simple SOFR (as defined in the Credit Agreement) borrowing will bear interest at a rate per annum equal to (i) a forward-looking term rate based on SOFR or a rate determined by reference to the daily simple SOFR, plus (ii) a spread based on our Senior Secured Net Leverage Ratio ranging from 2.50% to 3.25%.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 86 Table of Contents Item 8. Financial Statements and Supplementary Data Our consolidated financial statements required by this item, together with the report of our independent registered public accounting firm, begin on page F-1 of this Annual Report. Item 9.
Financial Statements and Supplementary Data Our consolidated financial statements required by this item, together with the report of our independent registered public accounting firm, begin on page F-1 of this Annual Report. Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.
Removed
The fair value of our 2029 Notes is impacted by both the fair value of our common stock and interest rate fluctuations. As of December 31, 2024, the estimated fair value of the 2029 Notes was $861 per $1,000 principal amount.
Added
The Revolving Credit Facility provides for a senior secured revolving credit facility in an aggregate commitment amount of $300.0 million, with a letter of credit sublimit of $10.0 million and swingline loan sublimit of $15.0 million.
Removed
See Note 10, Debt , to our consolidated financial statements included herein for further discussion of our 2029 Notes, which bears interest at a fixed rate. At December 31, 2024, all $287.5 million of principal remains outstanding on the 2029 Notes.
Added
Each revolving loan borrowing which is an alternate base rate borrowing will bear interest at a rate per annum equal to (i) a base rate, plus (ii) a spread based on our Senior Secured Net Leverage Ratio (as defined in the Credit Agreement) ranging from 1.50% to 2.25%.
Removed
The TLA Term Loan provides for a single-advance term loan in the principal amount of $150.0 million and is scheduled to mature on March 31, 2028.
Added
Upon entering into the Credit Agreement, we borrowed $101.0 million under the Revolving Credit Facility, of which $91.0 million is outstanding as of December 31, 2025. As of December 31, 2025, borrowings under the Revolving Credit Facility consisted entirely of term SOFR borrowings at an approximate all-in rate of 6.47%.
Removed
At December 31, 2024, the outstanding principal on the TLA Term Loan was $105.3 million. As of December 31, 2024, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 7.43%.
Added
In the event of non-performance or non-payment, there may be a material adverse impact on our financial condition, results of operations or net cash flow. Pacira BioSciences, Inc. | 2025 Annual Report on Form 10-K | 92 Table of Contents Item 8.
Removed
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.

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