7 unchanged sentences
Our success depends primarily on our ability to successfully commercialize EXPAREL and ZILRETTA.
−Removed: 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.
−Removed: EXPAREL was approved by the EC (which included the U.K.) on November 16, 2020.
+Added: 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.
+Added: EXPAREL was approved by the EC (which included the U.K.) in November 2020.
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.
12 unchanged sentences
• ensure that our entire supply chain efficiently and consistently delivers EXPAREL and ZILRETTA to our customers;
−Removed: • 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.
+Added: • maintain and defend our patent protection and regulatory exclusivity for EXPAREL and ZILRETTA, including our ongoing patent litigation lawsuit against WhiteOak and Qilu.
For more information on this matter, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
1 unchanged sentence
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.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 37
EXPAREL has been a commercialized drug since April 2012.
2 unchanged sentences
If we are unable to effectively train our sales force and equip them with effective materials, including medical and sales literature to help them inform and educate potential customers about the benefits and risks of EXPAREL and its proper administration, our efforts to successfully commercialize EXPAREL could be put in jeopardy, which could have a material adverse effect on our future revenues and profits.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 35
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.
24 unchanged sentences
Further, the availability of inexpensive generic forms of postsurgical pain management products may also limit acceptance of EXPAREL among physicians, patients and third-party payers.
−Removed: If EXPAREL does not achieve a broader level of acceptance among physicians, patients and third-party payers, we may not generate meaningful revenues from EXPAREL, and we may not remain profitable.
+Added: If EXPAREL does not achieve a broader level of acceptance among
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 38
+Added: physicians, patients and third-party payers, we may not generate meaningful revenues from EXPAREL, and we may not remain profitable.
ZILRETTA is only approved for the management of OA pain of the knee for patients in the U.S.
1 unchanged sentence
Market acceptance of ZILRETTA will depend on a number of factors, including:
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 36
• the efficacy and safety as demonstrated in clinical trials;
28 unchanged sentences
Our major competitors include organizations such as major multinational pharmaceutical and medical device companies, established biotechnology companies and specialty pharmaceutical and generic drug companies.
−Removed: 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.
+Added: 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.
As a result, these companies may obtain regulatory approval more rapidly than we are able to and may be more effective in selling and marketing their products.
Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies.
−Removed: 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.
−Removed: 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
+Added: Our competitors may succeed in developing,
Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 37
+Added: | 2025 Annual Report on Form 10-K | 39
+Added: 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.
+Added: 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.
Our competitors may also develop drugs or medical devices that are safer, more effective, useful or less costly than ours and may be more successful than us in manufacturing and marketing their products.
28 unchanged sentences
If our promotional activities fail to comply with the FDA’s regulations or guidelines, we may be subject to warnings from, or enforcement action by, these authorities.
−Removed: 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.
+Added: In addition, our failure to follow
Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 38
+Added: | 2025 Annual Report on Form 10-K | 40
+Added: 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.
If we are unable to establish and maintain effective marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may be unable to generate additional product revenues.
4 unchanged sentences
In addition to our internal marketing and sales efforts, we have entered into agreements with third-party distributors to promote and sell EXPAREL in certain territories.
−Removed: For example, we previously had a co-promotion agreement with DePuy Synthes Sales, Inc.
+Added: For example, in July 2025, we entered into a co-promotion agreement with J&J MedTech to market and promote the use of ZILRETTA for OA knee pain in the U.S.
+Added: We 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.
3 unchanged sentences
In July 2022, we submitted a letter to HK Tainuo associated with this license agreement seeking a mutual decision to end the licensing agreement and made a $13.0 million termination payment to HK Tainuo in January 2023.
−Removed: For more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
+Added: For more information, see Note 19, Commercial Partners and Other Agreements and Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
We may seek additional distribution arrangements in the future, including arrangements with third-party distributors to commercialize and sell our products in certain foreign countries, and there can be no assurance that such distributors and promoters will be successful in marketing and promoting our products.
17 unchanged sentences
If the quality or accuracy of the data maintained by these service providers is insufficient, we could be subject to regulatory sanctions.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 41
Distribution of our pMVL-based products, including EXPAREL, requires cold-chain distribution provided by third parties, whereby the product must be maintained between specified temperatures.
1 unchanged sentence
We have obtained limited inventory and cargo insurance coverage for our products.
−Removed: However, our insurance coverage may not reimburse us or may not be sufficient
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 39
−Removed: to reimburse us for any expenses or losses we may suffer.
+Added: However, our insurance coverage may not reimburse us or may not be sufficient to reimburse us for any expenses or losses we may suffer.
This could have a material adverse effect on our business, financial condition, results of operations and reputation.
9 unchanged sentences
• manage our development efforts and clinical trials effectively;
−Removed: • expand our manufacturing capabilities and effectively manage our co-production arrangements with Thermo Fisher and Carlisle;
+Added: • 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;
5 unchanged sentences
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;
−Removed: San Diego, California;
−Removed: northern New Jersey/New York City metro and Tampa, Florida.
+Added: San Diego, California, northern New Jersey/New York City metro and Luckenwalde, Germany.
If we are not able to attract and retain necessary personnel to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.
6 unchanged sentences
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;
−Removed: San Diego, California;
−Removed: northern New Jersey/New York City metro and Tampa, Florida.
−Removed: 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.
+Added: San Diego, California, northern New Jersey/New York City metro and Luckenwalde, Germany.
+Added: While we offer remote work arrangements, which allows us to recruit
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 42
+Added: 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.
We may not be able to hire or retain such personnel at compensation or flexibility levels consistent with our existing policies.
1 unchanged sentence
We may need to further increase our existing compensation levels and employee benefits in response to competition or labor shortages, which would increase our operating costs and reduce our margins.
−Removed: Furthermore, a sustained labor shortage, lack of skilled labor, increased turnover or labor cost inflation (for example, such as that initially caused by the
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 40
−Removed: 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.
+Added: 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.
Many of the companies with which we compete for experienced employees have greater resources than we have and may be able to offer more attractive terms of employment.
25 unchanged sentences
The FDA or similar foreign regulatory authorities at any time may implement new standards or change their interpretation and enforcement of existing standards for manufacture, packaging or testing of our products.
−Removed: 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.
−Removed: Any manufacturing defect or error discovered after products have been produced and distributed also could result in significant consequences, including costly recall procedures, re-stocking costs, damage to our reputation and the potential for product liability claims.
−Removed: The FDA requires manufacturers of medical devices to adhere to certain regulations, including the FDA’s QSRs, which requires periodic audits, design controls, quality control testing and documentation procedures, as well as complaint evaluations
+Added: 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.
−Removed: | 2024 Annual Report on Form 10-K | Page 41
−Removed: and investigations.
+Added: | 2025 Annual Report on Form 10-K | 43
+Added: 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.
+Added: Any manufacturing defect or error discovered after products have been produced and distributed also could result in significant consequences, including costly recall procedures, re-stocking costs, damage to our reputation and the potential for product liability claims.
+Added: The FDA requires manufacturers of medical devices to adhere to certain regulations, including the FDA’s QSRs, which requires periodic audits, design controls, quality control testing and documentation procedures, as well as complaint evaluations and investigations.
Regulations regarding the development, manufacture and sale of medical products are evolving and are subject to change in the future.
13 unchanged sentences
Therefore, we may experience delays, additional or unexpected costs and other adverse events in connection with our capacity expansion projects, including those associated with potential delays in the procurement of manufacturing equipment required to manufacture EXPAREL or ZILRETTA.
−Removed: 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.
+Added: 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.
Entering into such arrangements requires testing and compliance inspections, regulatory agency approvals and development of the processes and facilities necessary for the production of our products.
4 unchanged sentences
EXPAREL is currently manufactured at our facilities in San Diego, California;
−Removed: 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.
+Added: 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.
These facilities are the only currently approved sites in the world for manufacturing EXPAREL, ZILRETTA and iovera°.
−Removed: 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.
−Removed: Our San Diego facilities in California, the Thermo Fisher facility in Swindon, U.K.
−Removed: 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.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 44
+Added: 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.
+Added: 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.
In addition, we have obtained limited property and business interruption insurance coverage for our manufacturing sites in San Diego, U.K.
However, our insurance coverage may not reimburse us, or may not be sufficient to reimburse us, for any expenses or losses we may suffer.
−Removed: There can be no assurance that we would be able to
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 42
−Removed: meet our requirements for EXPAREL, ZILRETTA or iovera° if there were a catastrophic event or failure of our current manufacturing systems.
+Added: 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.
If we are required to change or add a new manufacturer or supplier, the process would likely require prior FDA and/or equivalent foreign regulatory authority approval, would be very time consuming and could be expensive.
21 unchanged sentences
In addition, we and our third-party suppliers must comply with federal, state and foreign regulations, including CGMP regulations, and any failure to comply with applicable regulations, or failure of government agencies to provide necessary authorizations, may harm our ability to manufacture and commercialize our products on a timely and competitive basis, which could result in decreased product sales and lower revenues.
−Removed: 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.
+Added: 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.
To the extent that our vendors are unable to comply with their obligations under our agreements or cannot deliver goods or services timely, our ability to continue meeting commercial demand for our products or advancing development of our product candidates may become impaired.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 45
Furthermore, raw materials and supplies needed to manufacture COVID-19 vaccines were backed by government mandate orders, which previously impacted our suppliers’ ability to supply critical raw materials for our products.
2 unchanged sentences
We rely on international shipping to receive certain raw materials and to transport our products to their various geographic markets.
−Removed: Delays in shipping may cause us to use more expensive expedited freight methods to ship our products or receive raw
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 43
−Removed: For example, the recent COVID-19 pandemic and related governmental actions caused delays in shipments.
+Added: Delays in shipping may cause us to use more expensive expedited freight methods to ship our products or receive raw materials.
+Added: For example, the COVID-19 pandemic and related governmental actions caused delays in shipments.
During the COVID-19 pandemic, we experienced increased lead-times for obtaining raw materials, including those caused by temporary closures and worker shortages.
5 unchanged sentences
Our operations are dependent on the global supply chain and impacts of supply chain constraints and inflationary pressure could adversely impact our operating results.
−Removed: 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.
+Added: 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.
In addition, current or future governmental policies, including the imposition of tariffs, may increase the risk of inflation, which could further increase the costs of raw materials and components for our business.
17 unchanged sentences
• the difficulty entering markets in which we have limited or no direct experience;
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 46
• the difficulty in managing multiple product development programs;
2 unchanged sentences
We may compete with larger pharmaceutical and medical device companies and other competitors, including public and private research organizations, academic institutions and government agencies, in our efforts to establish new collaborations and in-licensing opportunities.
−Removed: These competitors may have access to greater financial resources, research and development staffs and facilities than us and may have greater expertise in identifying and evaluating new opportunities.
−Removed: We may not be successful in locating and acquiring or in-licensing additional desirable
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 44
−Removed: product candidates on acceptable terms or at all.
+Added: These competitors may have access to greater financial resources and larger R&D staffs and facilities than us and may have greater expertise in identifying and evaluating new opportunities.
+Added: We may not be successful in locating and acquiring or in-licensing additional desirable product candidates on acceptable terms or at all.
We may also not be successful in developing or commercializing our current product candidates.
3 unchanged sentences
The industry in which we compete is characterized by intense competition, rapid technological change, changes in customer requirements, frequent new product introductions and enhancements, evolving industry standards and new therapeutic delivery methods.
−Removed: In order to remain competitive, we have made, and expect to continue to make, significant investments in research and development.
+Added: In order to remain competitive, we have made, and expect to continue to make, significant investments in R&D.
If we fail to develop new and enhanced products and technologies, if we focus on products and technologies that do not become widely adopted, or if new competitive products and technologies that we do not support become widely accepted, demand for our products may be reduced.
−Removed: 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.
+Added: 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.
Our business involves the use of hazardous materials and we must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
18 unchanged sentences
Clinical trials may fail to demonstrate the safety and efficacy of our drug products or medical devices, which could prevent or significantly delay obtaining regulatory approval.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 47
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.
5 unchanged sentences
We may not be able to successfully complete clinical testing within the time frame we have planned, or at all.
−Removed: We may experience
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 45
−Removed: numerous unforeseen events during, or as a result of, the clinical trial process which could delay or prevent us from receiving regulatory approval or commercializing our products.
+Added: We may experience numerous unforeseen events during, or as a result of, the clinical trial process which could delay or prevent us from receiving regulatory approval or commercializing our products.
In addition, the results of preclinical studies and early-stage clinical trials of our products do not necessarily predict the results of later-stage clinical trials.
20 unchanged sentences
For example, if any of our clinical trial sites fail to comply with FDA-approved GCPs, we may be unable to use the data gathered at those sites.
−Removed: 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.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 48
+Added: extended, delayed or terminated, and we may be unable to obtain regulatory approval for, or successfully commercialize, our product candidates.
We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources.
4 unchanged sentences
In addition, if our stock price is volatile, we may become involved in securities class action lawsuits in the future.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 46
For information about our legal proceedings, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
23 unchanged sentences
We took actions to immediately address the FDA’s concerns and minimize further disruption to our business.
−Removed: 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.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 49
+Added: rights to communicate truthful and non-misleading information about EXPAREL.
The complaint outlined our belief that the FDA’s warning letter received in September 2014 and regulations restricting our truthful and non-misleading speech about EXPAREL violated the Administrative Procedure Act and the First and Fifth Amendments of the U.S.
3 unchanged sentences
As part of the resolution of this matter, the FDA confirmed that EXPAREL was broadly approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
−Removed: 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
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 47
−Removed: medication ratios are observed.
+Added: 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.
The Warning Letter and labeling supplement only applied to the infiltration indication that was approved at that time, and does not apply to the interscalene brachial plexus nerve block indication subsequently approved by the FDA in April 2018, the use of EXPAREL in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia that was approved by the FDA in March 2021 and the indications for adductor canal block and sciatic nerve block in the popliteal fossa that were FDA approved in November 2023.
18 unchanged sentences
If the FDA’s policy is successfully challenged administratively or in court, we may be required to seek approval of our products via full NDAs that contain a complete data package demonstrating the safety and effectiveness of our product candidates, which would be time-consuming, expensive and would have a material adverse effect on our business and financial condition.
−Removed: 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.
+Added: 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.
3 unchanged sentences
In October 2023, we received notification from the FDA 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 and in October 2024, we received notification from the FDA that our pediatric studies requirement had been waived for the indications of sciatic nerve block in the popliteal fossa and adductor canal block indications.
+Added: 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 required to conduct these trials even if we believe that the costs and potential benefits of conducting the trials are not warranted from a scientific or financial perspective.
−Removed: The failure to conduct these pediatric trials or to meet applicable deadlines could result in the imposition of sanctions, including, among other things, issuance of warnings letters or imposition of seizures or injunctions.
+Added: The failure to conduct these pediatric trials or to meet applicable deadlines
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 50
+Added: could result in the imposition of sanctions, including, among other things, issuance of warnings letters or imposition of seizures or injunctions.
For more information regarding our pediatric study obligations, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
4 unchanged sentences
also require clearance, approval or compliance with certain standards before a medical device or other product can be marketed.
−Removed: The process of obtaining regulatory clearances and approvals to market a medical device can be costly, time consuming, involve rigorous preclinical and clinical testing, require changes in
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 48
−Removed: products or result in limitations on the indicated uses of products.
+Added: The process of obtaining regulatory clearances and approvals to market a medical device can be costly, time consuming, involve rigorous preclinical and clinical testing, require changes in products or result in limitations on the indicated uses of products.
There can be no assurance that these clearances and approvals will be granted on a timely basis, if at all.
19 unchanged sentences
• our reputation may suffer.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 51
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.
3 unchanged sentences
• 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;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 49
• 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;
11 unchanged sentences
The manufacturing techniques and facilities used for the manufacture and supply of our products must be operated in conformity with CGMP and other FDA, EMA and MHRA regulations, including potentially prior regulatory approval.
−Removed: 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.
+Added: 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.
In complying with these requirements, we, along with our co-production partners and suppliers, must continually expend time, money and effort in production, record keeping and quality assurance and control to ensure that our products meet applicable specifications and other requirements for safety, efficacy and quality.
3 unchanged sentences
If we are unable to manufacture our products in compliance with our highly complex specifications in the future, we may be subject to product exchanges, significant costs and charges, supply constraints or other corrective measures.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 52
If we fail to comply with the extensive regulatory requirements to which we and our products are subject, such products could be subject to restrictions or withdrawal from the market and we could be subject to penalties.
8 unchanged sentences
• reputational concerns of our customers or the medical community;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 50
• operating restrictions;
25 unchanged sentences
Under the PPA, the manufacturer agrees to provide front-end discounts on covered outpatient drugs purchased by specified providers, called “covered entities,” that serve the nation’s most vulnerable patient populations.
−Removed: Any expansion of such covered entities or changes to the Medicaid rebate formula may cause the required 340B discount to increase, resulting in increased revenue leakage.
+Added: Any expansion of such covered entities or
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 53
+Added: changes to the Medicaid rebate formula may cause the required 340B discount to increase, resulting in increased revenue leakage.
Additionally, third-party payers may limit the indications or circumstances for which our products will be reimbursed to a smaller set of indications or circumstances than we believe is appropriate.
5 unchanged sentences
or international markets, which could have a negative effect on our business, results of operations, financial condition and prospects.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 51
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.
17 unchanged sentences
The commercial opportunity for EXPAREL could be significantly harmed if competitors are able to develop and commercialize alternative formulations of bupivacaine that are long-acting but outside the scope of our patents.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 54
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.
8 unchanged sentences
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.
−Removed: Litigation or other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very expensive and time-consuming,
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 52
−Removed: 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.
+Added: 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 example, in October 2021, we received a Notice Letter advising that eVenus Pharmaceutical Laboratories, Inc., or eVenus, of Princeton, New Jersey, submitted to the FDA an ANDA with a Paragraph IV certification seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (266 mg/20 mL) in the U.S.
27 unchanged sentences
11,357,727 and 11,452,691.The parties have subsequently dismissed all patents other than the ’348 patent from this litigation.
+Added: On April 7, 2025, we, along with our operating subsidiary, Pacira Pharmaceuticals, Inc., entered into a settlement agreement with the eVenus ANDA Filers with respect to the litigations noted above.
+Added: Pursuant to the settlement agreement, the eVenus ANDA Filers will be enjoined from marketing a generic bupivacaine liposome injectable suspension before the expiration of the patents-in-suit, except as provided for in the settlement agreement, as described below.
+Added: In settlement of all outstanding claims in the litigations, we agreed to provide the eVenus ANDA Filers with a license to our patents required to
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 55
+Added: manufacture and sell certain volume-limited amounts of a generic bupivacaine liposome injectable suspension in the U.S.
+Added: beginning on a confidential date that is sometime in early 2030.
+Added: While the agreed-upon volume-limited percentages are confidential, they begin at a high single-digit percentage of the total volumes distributed in the U.S.
+Added: market and increase gradually in each 12-month period following the volume-limited entry date until reaching a percentage in the low thirties in 2033 and increasing modestly in each of the next two 12-month periods before reaching a maximum percentage in the high thirties of the total volumes distributed in the U.S.
+Added: for the final three years of the agreement.
+Added: In addition, we have agreed to provide the eVenus ANDA Filers with a license to its patents required to manufacture and sell an unlimited quantity of a generic bupivacaine liposome injectable suspension in the U.S.
+Added: beginning on a confidential date in 2039.
+Added: In addition, in recognition of our expected savings with respect to, among other things, the avoidance of fees, costs, time and resources associated with continuing the litigations, we paid the eVenus ANDA Filers $7.0 million.
+Added: In October 2025, we received two separate Paragraph IV Certifications from two Chinese generic drug manufacturers—WhiteOak and Qilu—each advising that they had submitted an ANDA to the FDA seeking authorization from the FDA to manufacture, use or sell a generic version of EXPAREL in the U.S.
+Added: Each letter alleged that EXPAREL patents listed in the Orange Book are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed products described in these ANDA submissions.
+Added: In November 2025, we filed a patent infringement suit against WhiteOak and Qilu in the U.S.
+Added: District Court of the District of Delaware (25-cv-1445) asserting infringement of U.S.
+Added: 11,033,495 (the ‘495 patent), U.S.
+Added: 11,819,574 (the ‘574 patent) U.S.
+Added: 12,144,890 (the ‘890 patent), U.S.
+Added: 12,151,024 (the ‘024 Patent), U.S.
+Added: 12,156,940 (the ‘940 patent), U.S.
+Added: 12,251,468 (the ‘468 Patent), U.S.
+Added: 12,296,047 (the ’047 Patent), U.S.
+Added: 12,318,483 (the ‘483 Patent), and U.S.
+Added: 12,370,142 (the ‘142 Patent).
+Added: On January 23, 2026 and February 5, 2026, Qilu and WhiteOak, respectively, each answered the complaint and asserted affirmative defenses and counterclaims asserting, inter alia, invalidity, unenforceability and non-infringement.
+Added: 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.
−Removed: We are unable to predict the outcome of these litigations at this time.
The patents and the patent applications that we have covering ZILRETTA are limited to specific injectable formulations, uses and processes of manufacturing and our market opportunity for our product candidate may be limited by the lack of patent protection for the active ingredient itself and other formulations and delivery technologies and systems that may be developed by competitors.
8 unchanged sentences
(iii) the listed patents have not expired, but will expire on a particular date and approval is sought after patent expiration or (iv) the listed patents are invalid or will not be infringed by the manufacture, use or sale of the third-party’s generic drug product.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 53
−Removed: certification that the new product will not infringe the Orange Book-listed patents for ZILRETTA, or that such patents are invalid, is called a Paragraph IV certification.
+Added: A certification that the new product will not infringe the Orange Book-listed patents for ZILRETTA, or that such patents are invalid, is called a Paragraph IV certification.
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.
3 unchanged sentences
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 ZILRETTA.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 56
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.
21 unchanged sentences
government requires that any products embodying the subject invention or produced through the use of the subject invention be manufactured substantially in the U.S.
−Removed: 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
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 54
−Removed: to manufacture substantially in the U.S.
+Added: 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.
5 unchanged sentences
We will only be able to protect our technologies from unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets cover them.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 57
The patent positions of pharmaceutical, medical device and biotechnology companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.
34 unchanged sentences
An existing formulation patent for EXPAREL expired in the U.S.
−Removed: in 2013 and its equivalents in Canada, Germany, France, Spain,
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 55
−Removed: Italy and the U.K.
+Added: in 2013 and its equivalents in Canada, Germany, France, Spain, Italy and the U.K.
expired in 2014.
5 unchanged sentences
While we use reasonable efforts to protect our trade secrets through confidentiality and non-disclosure agreements, our licensors, employees, consultants, contractors, outside scientific collaborators and other advisors may unintentionally or willfully disclose our information to competitors.
−Removed: Policing unauthorized use of our trade secrets or enforcing a claim that a third-party illegally obtained and is using our trade secrets is expensive and time consuming, and the outcome is unpredictable.
+Added: Policing unauthorized use of our trade secrets or enforcing a claim that a third-party illegally obtained and is using our trade secrets is
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 58
+Added: expensive and time consuming, and the outcome is unpredictable.
In addition, trade secret laws in other countries may not be as protective as they are in the U.S.
23 unchanged sentences
As is common in the biotechnology, pharmaceutical and medical device industries, we employ individuals who were previously employed at other biotechnology, pharmaceutical and medical device companies, including our competitors or potential competitors.
−Removed: Although no claims against us are currently pending, we may be subject to claims that these employees or
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 56
−Removed: we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.
+Added: Although no claims against us are currently pending, we may be subject to claims that these employees or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.
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.
−Removed: Risks Related to our Financial Condition, Indebtedness and our Common Stock
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 59
+Added: Risks Related to our Financial Condition and Indebtedness
Servicing our indebtedness requires a significant amount of cash, and we may not have sufficient cash flow from our business to pay our substantial indebtedness.
−Removed: 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.
+Added: 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.
Our business may not generate sufficient cash flow from operations in the future to service our indebtedness and make necessary capital expenditures.
2 unchanged sentences
We may not be able to engage in any of these activities or engage in these activities on desirable terms, which could result in a default on our debt obligations.
−Removed: In December 2021, we entered into a term loan credit agreement (the “TLB Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent and the initial lender.
−Removed: The term loan issued under the TLB Credit Agreement (the “TLB Term Loan”) was issued at a 3.00% discount and allowed for a single-advance term loan B facility in the principal amount of $375.0 million, which was secured by substantially all of the Company’s and each subsidiary guarantor’s assets.
−Removed: On March 31, 2023, we entered into a credit agreement (as amended, the “TLA Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent, and certain lenders, to refinance the indebtedness outstanding under our then-existing TLB Credit Agreement.
−Removed: 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 is scheduled to mature on March 31, 2028, subject to certain exceptions set forth in the TLA Credit Agreement.
−Removed: On July 10, 2020, we completed a private placement of $402.5 million in aggregate principal amount of 2025 Notes, and entered into an indenture, or 2025 Indenture, with respect to the 2025 Notes.
−Removed: In May 2024, we used $191.4 million of the net proceeds of the 2029 Notes (as described below) to repurchase $200.0 million aggregate principal amount of the 2025 Notes.
−Removed: The 2025 Notes accrue interest at a fixed rate of 0.750% per year, payable semiannually in arrears on February 1 and August 1 of each year and mature on August 1, 2025.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: In July 2025, we entered into a credit agreement (the “Credit Agreement”) with Wells Fargo Bank, National Association, as administrative agent, swingline lender and an issuing bank, and certain lenders, to, among other things, refinance the indebtedness outstanding under our then-outstanding TLA Credit Agreement (as defined below) and provide ongoing working capital.
+Added: The Credit Agreement provides for a senior secured revolving credit facility (the “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.
+Added: The credit facility is secured by substantially all of our and each subsidiary guarantor’s assets and matures on July 3, 2030, subject to certain exceptions set forth in the Credit Agreement.
+Added: Subject to certain conditions, we may, at any time, on one or more occasions, add one or more new classes of term facilities and/or increase the principal amount of any existing class of term loans by requesting one or more incremental term facilities in an aggregate principal amount not to exceed the greater of $225.0 million and 100% of Consolidated EBITDA (as defined in the Credit Agreement).
+Added: 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.
Additionally, our subsidiaries had no indebtedness (excluding trade payables, intercompany liabilities and income tax-related liabilities).
−Removed: 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.
−Removed: 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.
−Removed: Our TLA Credit Agreement requires us to maintain certain financial covenants.
+Added: 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.
+Added: 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.
+Added: 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.
−Removed: 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.
+Added: 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.
−Removed: 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.
−Removed: 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:
+Added: 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.
+Added: 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;
−Removed: sell, lease or transfer
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 57
+Added: sell, lease or transfer our assets;
pay dividends on, and make other distributions on, or redeem or repurchase, our common stock;
8 unchanged sentences
Our failure to comply with the restrictive covenants described above as well as other terms of our indebtedness could result in an event of default, which, if not cured or waived, could result in our being required to repay these borrowings before their due date.
−Removed: 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.
−Removed: 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.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 60
+Added: 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.
+Added: 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.
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.
2 unchanged sentences
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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
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.
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
−Removed: 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.
+Added: 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.
8 unchanged sentences
• limiting our flexibility in planning for changes in our business and reacting to changes in the industry in which we compete.
−Removed: 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
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 58
−Removed: our debt, sell important strategic assets at unfavorable prices, incur additional indebtedness or issue common stock or other equity securities.
+Added: 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.
We may not be able to, at any given time, refinance our debt, sell assets, incur additional indebtedness or issue equity securities on terms acceptable to us, in amounts sufficient to meet our needs.
3 unchanged sentences
Any of these factors could have an adverse effect on our business, financial condition and results of operations and our ability to meet our debt payment obligations.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 61
Despite our current level of indebtedness, we may be able to incur substantially more debt, which could increase the risks to our financial condition described above.
3 unchanged sentences
To the extent new debt is added to our current debt levels, the substantial leverage risks described in the immediately preceding risk factor would increase.
−Removed: 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.
+Added: 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 on our indebtedness.
−Removed: 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.
−Removed: Provisions in our restated certificate of incorporation and our bylaws, as well as provisions of the Delaware General Corporation Law, or DGCL, could make it more difficult for a third-party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders, including transactions in which stockholders might otherwise receive a premium for their shares.
−Removed: These provisions include:
−Removed: • authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
−Removed: • prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
−Removed: • eliminating the ability of stockholders to call a special meeting of stockholders;
−Removed: • establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
−Removed: These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
−Removed: 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.
−Removed: This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders.
−Removed: Our common stock price may be subject to significant fluctuations and volatility.
−Removed: 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.
−Removed: Our stock could be subject to wide fluctuations in price in response to various factors, including the following:
−Removed: • the commercial success of EXPAREL, ZILRETTA and iovera°;
−Removed: • our ability to execute on our business strategy;
−Removed: • results of clinical trials of our products, product candidates or those of our competitors;
−Removed: • changes or developments in laws or regulations applicable to our products or product candidates;
−Removed: • introduction of competitive products or technologies;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 59
−Removed: • failure to meet or exceed financial projections we provide to the public;
−Removed: • actual or anticipated variations in quarterly operating results;
−Removed: • failure to meet or exceed the estimates and projections of the investment community;
−Removed: • the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community;
−Removed: • regulatory concerns or government actions;
−Removed: • general economic and market conditions and overall fluctuations in U.S.
−Removed: 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;
−Removed: • increased interest rates and their generally negative effect on U.S.
−Removed: equity markets;
−Removed: • developments concerning our sources of manufacturing supply;
−Removed: • disputes or other developments relating to patents, intellectual property or other proprietary rights;
−Removed: • additions or departures of key scientific or management personnel;
−Removed: • the extent to which we acquire or invest in products, businesses and technologies;
−Removed: • issuances of debt, equity or convertible securities;
−Removed: • changes in the market valuations of similar companies;
−Removed: • evolving investor expectations and concerns regarding environmental, social and corporate governance issues;
−Removed: • the other factors described in this “ Risk Factors ” section.
−Removed: In addition, the stock market in general, and the market for pharmaceutical, biotechnology and medical device companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
−Removed: Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
−Removed: Fluctuations in our stock price could, among other things, adversely impact the trading price of our shares.
−Removed: We do not intend to pay dividends on our common stock for the foreseeable future.
−Removed: We have never declared or paid any dividends on our common stock.
−Removed: 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 cash dividends on our common stock in the foreseeable future.
−Removed: The payment of future dividends, if any, will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in future financing instruments, provisions of applicable law and any other factors our board of directors deems relevant.
−Removed: Future sales in the public market or issuances of our common stock could lower the market price for our common stock.
−Removed: In the future, we may sell additional shares of our common stock to raise capital.
−Removed: Except under limited circumstances, we are not restricted from issuing additional common stock, including securities that are convertible into or exchangeable for, or that represent the right to receive, common stock.
−Removed: The issuance of additional shares of our common stock or convertible securities, including upon exercise of our outstanding options, vesting of our restricted stock units or otherwise, will dilute the ownership interest of our common stockholders.
−Removed: 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.
−Removed: In addition, certain of our executive officers and directors have established or may establish trading plans under Rule 10b5-1 of the Exchange Act (a “10b5-1 trading plan”), which provide for sales of shares of our common stock from time to time.
−Removed: Under a 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the executive officer or director when entering into the plan, without further direction from the executive officer or director.
−Removed: A 10b5-1 trading plan may be amended or terminated in some circumstances.
−Removed: Our executive officers and directors also may buy or sell additional shares outside of a 10b5-1 trading plan when they are not in possession of material, nonpublic information.
−Removed: Refer to Item 9B.
−Removed: Other Information , for more information.
−Removed: We cannot predict the size of future sales or issuances of our common stock or the effect, if any, that they may have on the market price for our common stock.
−Removed: The issuance and/or sale of substantial amounts of common stock, or the perception that such issuances and/or sales may occur, could adversely affect the market price of our common stock and impair our ability to raise capital through the sale or issuance of additional equity or debt securities.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 60
−Removed: Raising additional funds by issuing securities would cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
−Removed: To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership would be diluted.
−Removed: If we raise additional funds through licensing arrangements, it may be necessary to relinquish potentially valuable rights to our potential products or proprietary technologies, or grant licenses on terms that are not favorable to us.
−Removed: Any debt financing we enter into may involve covenants that restrict our operations.
−Removed: These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of our assets as well as prohibitions on our ability to create liens, pay dividends, redeem our stock or make investments.
−Removed: Changes in global economic conditions, including, but not limited to, those driven by inflation and tariffs, may adversely affect spending and the financial health of our customers and others with whom we do business, which may adversely affect our financial condition, results of operations and cash flows.
−Removed: Uncertainty about current and future global economic conditions, inflation and tariffs may cause patients to defer or cancel medical procedures.
−Removed: Our financial success is sensitive to changes in general economic conditions, both globally and in specific markets, that may adversely affect the demand for our products including recessionary economic cycles, higher interest rates, higher fuel and other energy costs, increased labor costs, declines in asset values, inflation, the imposition of tariffs, increases in commodity prices, higher levels of unemployment, higher consumer debt levels, higher tax rates and other changes in tax laws, public health issues (such as the recent COVID-19 pandemic), or other economic factors, certain of which effects, including cost inflation and higher interest rates, we experienced in 2023 and 2024 and expect to continue to experience in 2025.
−Removed: If global economic and financial market conditions deteriorate or remain weak for an extended period of time, the following factors, among others, could have a material adverse effect on our financial condition, results of operations and cash flows:
−Removed: • Changes in foreign currency exchange rates relative to the U.S.
−Removed: • The imposition of tariffs and other import restrictions by the U.S.
−Removed: or foreign governments.
−Removed: • Slower consumer spending that may result in our inability to maintain or increase our sales to new and existing customers, reduce patient volumes, cause reduced product orders or product order delays or cancellations from wholesale accounts that are directly impacted by fluctuations in the broader economy, difficulties managing inventories, higher discounts and lower product margins.
−Removed: • A decrease in liquidity or credit available to our customers, product suppliers and other service providers.
−Removed: • If our customers experience diminished liquidity, we may experience a reduction in product orders, an increase in customer order cancellations, and/or the need to extend customer payment terms, which could lead to larger balances and delayed collection of our accounts receivable, reduced cash flows, greater expenses for collection efforts and increased risk of nonpayment of our accounts receivable.
−Removed: • If we are unable to mitigate the impact of supply chain constraints and inflationary pressure through price increases or other measures, our results of operations and financial condition could be negatively impacted.
−Removed: Furthermore, even if we are able to raise the prices of our products, consumers might react negatively to such price increases, which could have a material adverse effect on, among other things, our brands, reputation, and sales.
−Removed: Certain of the foregoing could also result in lower levels of healthcare insurance coverage and/or depress consume confidence, any of which could limit the ability of some customers to purchase our products and reduce consumer spend on certain elective medical procedures in both the short- and medium-term.
−Removed: Federal Reserve previously raised interest rates multiple times in response to concerns about inflation, though it recently lowered interest rates multiple times and further interest rate changes remain uncertain.
−Removed: If higher interest rates return, this, coupled with reduced government spending and volatility in financial markets may also increase economic uncertainty and negatively affect consumer spending.
−Removed: Similarly, the ongoing war in Ukraine and the Israel-Hamas war have created extreme volatility in the global capital markets and is expected to continue to have further global economic consequences, including disruptions of the global supply chain and energy markets.
−Removed: Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely.
−Removed: If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing (or refinancing) more difficult to obtain in a timely manner, or on favorable terms, more costly or more dilutive.
−Removed: Increased inflation rates have already, and may continue to, adversely affect us by increasing our costs, including labor costs, service costs and employee benefit costs.
−Removed: In addition, higher inflation and macro turmoil and uncertainty could also adversely affect our customers, which could reduce demand for our products.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 61
−Removed: Rising international tariffs, including any tariffs applied to goods traded between the U.S.
−Removed: and China, the U.S.
−Removed: and Mexico and the U.S.
−Removed: and Canada, could materially and adversely affect our business and results of operations.
−Removed: For example, in February 2025, the current U.S.
−Removed: presidential administration imposed tariffs on foreign imports into the United States, including an additional 10% tariff on all imports from China and an additional 25% tariff on all imports from Mexico and Canada (except a 10% Canadian tariff on energy imports which do not apply to us), which tariffs imports from Mexico and Canada were subsequently suspended for 30 days in order to facilitate negotiations.
−Removed: As of the date of this Annual Report, the proposed tariffs on all imports from Mexico remain suspended.
−Removed: Our iovera° tips are made in Mexico, we have suppliers of raw materials for each of our commercialized products from China and some of our manufacturing equipment is fabricated in Canada.
−Removed: These tariffs will increase the cost of these products and equipment and negatively impact our results of operations.
−Removed: At this time, it remains unclear what additional actions, if any, will be taken by the U.S.
−Removed: or other governments with respect to international trade agreements, the imposition of additional tariffs on goods imported into the U.S., tax policy related to international commerce, increased export control, sanctions and investment restrictions, or other trade matters.
−Removed: Although the ultimate scope and timing of any such actions is currently indeterminable, if implemented, they could have a material impact on our financial condition and results of operations.
−Removed: Other effects of these changes, including impacts on the price of raw materials and equipment, responsive or retaliatory actions from governments, such as retaliatory tariffs on imports into China, Mexico or Canada from the U.S.
−Removed: and the opportunity for competitors not subject to such changes to establish a presence in markets where we participate, could also have significant impacts on our results of operations, though whether any of the foregoing actions will be taken remains unclear.
−Removed: Furthermore, we may not be able to increase prices for our products enough to offset tariffs, which could impact our margins.
−Removed: If we raise prices in response to tariffs, the demand for our products may go down, which could have a negative impact on our sales.
−Removed: We cannot predict what further action may be taken with respect to export restrictions, tariffs or trade relations between the U.S.
−Removed: and other governments, and any further changes in U.S.
−Removed: or international trade policy could have an adverse impact on our business, financial condition and results of operations.
Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future.
To date, we have focused primarily on developing and commercializing EXPAREL, and have since acquired ZILRETTA and iovera°.
−Removed: We recorded a net loss of $99.6 million for the year ended December 31, 2024, which includes a goodwill impairment of $163.2 million based upon an assessment that the fair value of goodwill is less than its carrying value (for more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein), and recorded net income of $42.0 million and $15.9 million for the years ended December 31, 2023 and 2022, respectively.
+Added: We recorded net income of $7.0 million for the year ended December 31, 2025, a net loss of $99.6 million for the year ended December 31, 2024, which included a goodwill impairment of $163.2 million based upon an assessment that the fair value of goodwill was less than its carrying value (for more information, see Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein), and net income of $42.0 million for the year ended December 31, 2023.
As of December 31, 2025, we had an accumulated deficit of $199.3 million.
7 unchanged sentences
generally accepted accounting principles, we are required to assess our indefinite-lived intangible assets for impairment.
+Added: Goodwill is not amortized but is subject to impairment testing at least annually or when a triggering event occurs that could indicate a potential impairment exists.
Intangible assets with definite lives are amortized on a straight-line basis over their estimated useful lives and are recorded at cost, net of accumulated amortization.
5 unchanged sentences
changes in assumptions regarding future revenue or cash flow forecasts, increased competition or loss of market share, obsolescence, product claims that result in a significant loss of sales or profitability over the product life, deterioration in macroeconomic conditions or declining financial performance in comparison to projected results.
−Removed: For example, in 2022, we recognized a $26.1 million impairment charge related to an intangible asset for acquired in-process research and development related to ZILRETTA for the treatment of OA pain of the shoulder, driven by facts and circumstances revealed in the fourth quarter of 2022 that suggested the fair value reduction in this intangible asset was driven by later timelines for the completion of clinical trials impacting revenue forecasts, among other factors.
+Added: For example, in 2025, we recognized a $25.9 million impairment charge related to an intangible asset for acquired in-process R&D related to ZILRETTA for the treatment of OA pain of the shoulder, driven by revised completion timelines for clinical trials and commercial availability which directly impacted revenue forecasts, among other factors.
For additional information, see Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 62
−Removed: changes to the assumptions regarding the future fair values of our intangible assets could result in additional impairment charges in the future, which could be significant.
−Removed: Previously, a significant portion of our total assets was comprised of goodwill.
−Removed: Pursuant to U.S.
−Removed: generally accepted accounting principles, we are required to assess our goodwill and indefinite-lived intangible assets for impairment.
−Removed: Goodwill is not amortized but is subject to impairment testing at least annually or when a triggering event occurs that could indicate a potential impairment exists.
−Removed: In July 2024, the FDA approved a generic competitor to EXPAREL and in August 2024, a U.S.
+Added: Further changes to the assumptions regarding the future fair values of our intangible assets could result in additional impairment charges in the future, which could be significant.
+Added: In addition, in July 2024, the FDA approved a generic competitor to EXPAREL and in August 2024, a U.S.
District Court ruled that one of our EXPAREL patents was not valid.
1 unchanged sentence
This quantitative impairment test resulted in our carrying value exceeding the fair value of the Company by more than the goodwill balance.
−Removed: As a result, our goodwill balance of $163.2 million was fully impaired during the three months ended September 30, 2024.
−Removed: For more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
−Removed: In February 2025, we completed the GQ Bio Acquisition and will assess the fair value of goodwill related to this transaction in the first quarter of 2025.
−Removed: For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein.
−Removed: It is possible that we may have goodwill again in the future, and, if so, events and conditions that could result in an impairment include but are not limited to:
+Added: As a result, our then-goodwill balance of $163.2 million was fully impaired during the three months ended September 30, 2024.
+Added: At December 31, 2025, the carrying value of our goodwill was $20.2 million, which arose from the GQ Bio Acquisition in February 2025.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 62
+Added: In the future, events and conditions which could result in an impairment include but are not limited to:
changes in assumptions regarding future revenue or cash flow forecasts, a sustained drop in the market price of our common stock, increased competition or loss of market share, obsolescence, product claims that result in a significant loss of sales or profitability over the product life, deterioration in macroeconomic conditions or declining financial performance in comparison to projected results.
+Added: For more information, see Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
We may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts.
5 unchanged sentences
• acquire, in-license and develop additional product candidates;
−Removed: • refinance our Notes and our TLA Term Loan.
+Added: • refinance our 2029 Notes and our Revolving Credit Facility.
We may not have sufficient financial resources to continue our operations or meet all of our objectives, which could require us to postpone, scale back or eliminate some, or all, of these objectives.
7 unchanged sentences
• the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish;
−Removed: • the potential that we may be required to file a lawsuit to defend our patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of extended-release liposome injections of
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 63
−Removed: bupivacaine, long-acting injections of triamcinolone or a cryoanalgesic device that infringes on the various patents covering iovera°;
+Added: • the potential that we may be required to file a lawsuit to defend our patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of extended-release liposome injections of bupivacaine, long-acting injections of triamcinolone or a cryoanalgesic device that infringes on the various patents covering iovera°;
• restrictions contained in the agreements governing our indebtedness.
3 unchanged sentences
If adequate funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our development programs or our commercialization efforts.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 63
Our quarterly operating results may fluctuate significantly.
8 unchanged sentences
• the impact of macroeconomic developments, such as general political, health and economic conditions, including those resulting from the war in Ukraine and the Israel-Hamas war, economic slowdowns, recessions, inflation, rising interest rates and tightening of credit markets on our business;
+Added: • the potential impact of a government shutdown, including the impact such a shutdown could have on certain federal agencies, such as the FDA and Centers for Medicare Services, or CMS, who have, in the past, furloughed staff and scaled back their operations which could significantly impact the ability of the FDA to timely review and process our regulatory submissions or negatively affect sales of our products if some of our customers do not (or perceive that they will not) receive adequate reimbursement from third-party payors or CMS.
If our quarterly or annual operating results fall below the expectations of our investors or securities analysts, the price of our common stock could substantially decline.
3 unchanged sentences
From time to time, we may complete acquisitions of companies and certain businesses of companies, and we may not realize the expected benefits from such acquisitions because of integration difficulties or other challenges.
−Removed: For example, in April 2019, we completed the MyoScience Acquisition and in November 2021, we completed the Flexion Acquisition.
+Added: For example, in April 2019, we completed the MyoScience Acquisition;
+Added: in November 2021, we completed the Flexion Acquisition;
+Added: and in February 2025, we completed the GQ Bio Acquisition.
The success of any acquisitions will depend, in part, on our ability to realize all or some of the anticipated synergies and other benefits from integrating the acquired businesses with our existing businesses.
2 unchanged sentences
• failure to implement our business plans for the combined businesses and consolidation or expansion of production capacity as planned and where applicable;
−Removed: • unexpected losses of key employees, customers or suppliers of our acquired companies and businesses;
+Added: • unexpected losses of key employees, key customers or key suppliers of our acquired companies and businesses;
• unanticipated issues in conforming our acquired companies’ and businesses’ standards, processes, procedures and internal controls with our operations;
3 unchanged sentences
• adverse effects on our or our acquired companies’ and businesses’ existing business relationships;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 64
• unanticipated changes in applicable laws and regulations;
1 unchanged sentence
• unanticipated expenses and liabilities;
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 64
• potential unfamiliarity with our acquired companies and businesses technology, products and markets, which may place us at a competitive disadvantage;
−Removed: • other difficulties in the assimilation of our acquired companies and businesses operations, technologies, products and systems.
−Removed: If MyoScience, Flexion, or any other acquired companies and businesses have unanticipated or larger than anticipated liabilities for patent and trademark infringement claims, violations of laws, commercial disputes, taxes and other known and unknown types of liabilities, there may be liabilities that we underestimated or did not discover in the course of performing our due diligence investigation of our acquired companies and businesses.
+Added: • other difficulties in the assimilation of our acquired companies and businesses operations, technologies, products, systems and internal controls.
+Added: If MyoScience, Flexion, GQ Bio, or any other acquired companies and businesses have unanticipated or larger than anticipated liabilities for patent and trademark infringement claims, violations of laws, commercial disputes, taxes and other known and unknown types of liabilities, there may be liabilities that we underestimated or did not discover in the course of performing our due diligence investigation of our acquired companies and businesses.
We may have no recourse or limited recourse under the applicable acquisition-related agreement to recover damages relating to the liabilities of our acquired companies and businesses.
We may not be able to maintain or increase the levels of revenue, earnings or operating efficiency that each of the acquired companies and businesses and Pacira had historically achieved or might achieve separately.
+Added: Combining with Pacira may not accelerate the growth and success of any acquired commercial product.
In addition, we may not accomplish the integration of any acquired companies and businesses smoothly, successfully or within the anticipated costs or timeframe.
3 unchanged sentences
and our stock price may decline as a result.
−Removed: Our ability to realize the benefits from the Flexion Acquisition is substantially dependent on the commercial success of ZILRETTA and the cost savings resulting from the timely and effective integration of the operations of Pacira and Flexion.
−Removed: Our ability to realize the benefits from the Flexion Acquisition is substantially dependent on our ability to successfully commercialize ZILRETTA.
−Removed: Combining with Pacira may not accelerate the growth and success of ZILRETTA.
−Removed: If we are unsuccessful at convincing health care providers to increase their rate of adoption of ZILRETTA, our sales could be adversely affected, and our business and financial condition could suffer.
−Removed: Further, our ability to realize the benefits from the Flexion Acquisition is substantially dependent on the cost savings resulting from the timely and effective integration of the operations Pacira and Flexion.
−Removed: The process of integrating the operations of Pacira and Flexion could encounter unexpected costs and delays, which include but are not limited to:
−Removed: the loss of key personnel;
−Removed: the loss of key customers;
−Removed: the loss of key suppliers;
−Removed: integrating the products, services and related assets, as well as internal controls into our business operations;
−Removed: and unanticipated issues in integrating the sales, marketing and administrative functions.
−Removed: If we are unable to timely and effectively integrate the operations of Pacira and Flexion, our results of operations could be adversely affected, and our business could suffer.
−Removed: Further, even if the integration is timely and effective, we may never realize the cost savings expected from the integration and synergies of the operations of the two companies.
The use of our net operating loss carryforwards and research and development tax credits will be limited.
−Removed: We have significant Federal and state net operating loss, or NOL, carryforwards and federal and state research and development tax credit carryforwards.
−Removed: Our NOL carryforwards and research and development tax credits may expire and not be used.
+Added: We have significant Federal and state net operating loss, or NOL, carryforwards and federal and state R&D tax credit carryforwards.
+Added: Our NOL carryforwards and R&D tax credits may expire and not be used.
Our state NOL carryforwards will begin expiring in 2028 if we have not used them prior to that time.
6 unchanged sentences
Such an annual limitation may significantly reduce the utilization of the NOLs before they expire.
+Added: Risks Related to Our Common Stock
+Added: 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.
+Added: Provisions in our restated certificate of incorporation and our bylaws, as well as provisions of the Delaware General Corporation Law, or DGCL, could make it more difficult for a third-party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders, including transactions in which stockholders might otherwise receive a premium for their shares.
+Added: These provisions include:
+Added: • authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
+Added: • prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
+Added: • eliminating the ability of stockholders to call a special meeting of stockholders;
+Added: • establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
+Added: These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors, which is responsible for appointing the members of our management.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 65
+Added: our board of directors.
+Added: This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders.
+Added: Our common stock price may be subject to significant fluctuations and volatility.
+Added: 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.
+Added: Our stock could be subject to wide fluctuations in price in response to various factors, including the following:
+Added: • the commercial success of EXPAREL, ZILRETTA and iovera°;
+Added: • our ability to execute on our business strategy;
+Added: • results of clinical trials of our products, product candidates or those of our competitors;
+Added: • changes or developments in laws or regulations applicable to our products or product candidates;
+Added: • introduction of competitive products or technologies;
+Added: • failure to meet or exceed financial projections we provide to the public;
+Added: • actual or anticipated variations in quarterly operating results;
+Added: • failure to meet or exceed the estimates and projections of the investment community;
+Added: • the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community;
+Added: • regulatory concerns or government actions;
+Added: • general economic and market conditions and overall fluctuations in U.S.
+Added: 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;
+Added: • increased interest rates and their generally negative effect on U.S.
+Added: equity markets;
+Added: • developments concerning our sources of manufacturing supply;
+Added: • disputes or other developments relating to patents, intellectual property or other proprietary rights;
+Added: • additions or departures of key scientific or management personnel;
+Added: • the extent to which we acquire or invest in products, businesses and technologies;
+Added: • issuances of debt, equity or convertible securities;
+Added: • changes in the market valuations of similar companies;
+Added: • securities litigation or stockholder activism;
+Added: • evolving investor expectations and concerns regarding environmental, social and corporate governance issues;
+Added: • the other factors described in this “ Risk Factors ” section.
+Added: In addition, the stock market in general, and the market for pharmaceutical, biotechnology and medical device companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies.
+Added: Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
+Added: Fluctuations in our stock price could, among other things, adversely impact the trading price of our shares.
+Added: We do not intend to pay dividends on our common stock for the foreseeable future.
+Added: We have never declared or paid any dividends on our common stock.
+Added: 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 cash dividends on our common stock in the foreseeable future.
+Added: The payment of future dividends, if any, will be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in future financing instruments, provisions of applicable law and any other factors our board of directors deems relevant.
+Added: Future sales in the public market or issuances of our common stock could lower the market price for our common stock.
+Added: In the future, we may sell additional shares of our common stock to raise capital.
+Added: Except under limited circumstances, we are not restricted from issuing additional common stock, including securities that are convertible into or exchangeable for, or that represent the right to receive, common stock.
+Added: The issuance of additional shares of our common stock or convertible securities, including upon exercise of our outstanding options, vesting of our restricted stock units or otherwise, will dilute the ownership interest of our common stockholders.
+Added: In addition, our stockholders, particularly but not limited to those that own 5%
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 66
+Added: 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.
+Added: In addition, certain of our executive officers and directors have established or may establish trading plans under Rule 10b5-1 of the Exchange Act (a “10b5-1 trading plan”), which provide for sales of shares of our common stock from time to time.
+Added: Under a 10b5-1 trading plan, a broker executes trades pursuant to parameters established by the executive officer or director when entering into the plan, without further direction from the executive officer or director.
+Added: A 10b5-1 trading plan may be amended or terminated in some circumstances.
+Added: Our executive officers and directors also may buy or sell additional shares outside of a 10b5-1 trading plan when they are not in possession of material, nonpublic information.
+Added: Refer to Item 9B.
+Added: Other Information , for more information.
+Added: We cannot predict the size of future sales or issuances of our common stock or the effect, if any, that they may have on the market price for our common stock.
+Added: The issuance and/or sale of substantial amounts of common stock, or the perception that such issuances and/or sales may occur, could adversely affect the market price of our common stock and impair our ability to raise capital through the sale or issuance of additional equity or debt securities.
+Added: Raising additional funds by issuing securities would cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.
+Added: To the extent that we raise additional capital by issuing equity securities, our existing stockholders’ ownership would be diluted.
+Added: If we raise additional funds through licensing arrangements, it may be necessary to relinquish potentially valuable rights to our potential products or proprietary technologies, or grant licenses on terms that are not favorable to us.
+Added: Any debt financing we enter into may involve covenants that restrict our operations.
+Added: These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of our assets as well as prohibitions on our ability to create liens, pay dividends, redeem our stock or make investments.
+Added: Repurchases of our common stock may not result in increased stockholder value and could adversely affect our liquidity or financial flexibility.
+Added: From time to time, we may repurchase shares of our common stock pursuant to authorized share repurchase programs.
+Added: Decisions regarding whether, when, and in what amounts to repurchase such securities are based on a variety of factors, including market conditions, our business, results of operations and financial condition, cash flows, capital resources, contractual restrictions (including those included in debt covenants), regulatory restrictions and alternative uses of capital.
+Added: There can be no assurance that repurchases will be made at prices that reflect the intrinsic value of the common stock repurchased or that such repurchases will result in increased stockholder value.
+Added: For example, in April 2025, our board of directors authorized a $300.0 million share repurchase program which authorizes us to repurchase up to an aggregate of $ 300.0 million of our outstanding common stock.
+Added: 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.
+Added: As of December 31, 2025, $ 150.0 million remains available for future repurchases under this authorization (which excludes the broker fees and excise tax incurred).
+Added: Refer to Part II, Item 2.
+Added: Unregistered Sales of Equity Securities and Use of Proceeds for more information on repurchases occurring during the quarter ended December 31, 2025 and Note 13, Stockholders’ Equity , to our consolidated financial statements included herein for more information.
+Added: Repurchases reduce the amount of cash available for other purposes, including, but not limited to:
+Added: funding our operations, expanding the commercialization of our products and product candidates;
+Added: investing in R&D;
+Added: pursuing business development or strategic transactions;
+Added: servicing or refinancing our indebtedness;
+Added: expanding and maintaining our manufacturing facilities and capabilities and legal matters.
+Added: As a result, our repurchase activities may adversely affect our liquidity, capital resources or financial flexibility.
+Added: Our share repurchase program does not obligate us to repurchase any particular amount of common stock and may be suspended, modified or discontinued at any time.
+Added: Any reduction or cessation of repurchase activity may adversely affect the market price of our common stock.
+Added: In addition, repurchase activity may increase price volatility, reduce the public float or trading liquidity of our common stock or increase ownership concentration among existing stockholders.
+Added: In addition, repurchases may offset dilution from equity compensation programs or issuances of securities, but may not do so at a cost or on a timing that is favorable to stockholders.
+Added: To the extent share repurchases are funded through available cash or future borrowings, such activity could increase our leverage or otherwise affect our credit profile, which may limit our access to capital or increase our borrowing costs.
+Added: Repurchases may also reduce our ability to pursue strategic opportunities or respond to competitive or regulatory developments as they arise.
+Added: Our ability to execute share repurchases is subject to compliance with the agreements governing our indebtedness as well as applicable securities laws and regulations, including restrictions on timing, volume, pricing and disclosure, as well as
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 67
+Added: blackout periods and insider trading limitations.
+Added: Changes in applicable laws, regulations, accounting standards or regulatory interpretations—including evolving regulatory focus on issuer repurchase practices—could increase compliance costs, limit our flexibility or restrict our ability to conduct repurchases as contemplated.
+Added: Any of these factors could adversely affect our business, financial condition, results of operations, liquidity or the market price of our common stock.
+Added: Our business has been, and could in the future be, negatively impacted by the actions of activist stockholders.
+Added: We have been and may continue to be subject to stockholder activism in the future that may not align with our business strategies or that we deem to not be in the best interests of all of our stockholders.
+Added: Our business and operations could also be negatively affected if we become subject to any securities litigation or from continued stockholder activism, which could cause us to incur significant expenses, hinder the execution of our business and growth strategy, constrain our capital deployment opportunities and impact the price of our common stock.
+Added: Stockholder activism has been increasing recently, which can arise in a variety of situations, including, but not limited to, campaigns by activist stockholders advocating corporate actions such as operational, governance, management or social changes, financial restructurings, increased borrowings, special dividends, stock repurchases, or sales of assets or entire companies to third parties or to the activist stockholders themselves.
+Added: Volatility in the price of our common stock, our cash balance, our financial performance or other reasons may cause us to become the target of securities litigation or continue to be the target of stockholder activism.
+Added: Securities litigation and stockholder activism, including potential proxy contests, have in the past and could again in the future result in substantial costs and divert management’s and our board of director’s attention and resources from our business.
+Added: Additionally, such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, strategy or leadership and such uncertainties may be exploited by our competitors or result in the loss of potential business opportunities, adversely affect our relationships with service providers and make it more difficult to attract and retain qualified personnel.
+Added: Also, we have and may be required to incur significant legal and advisory fees and other expenses related to any securities litigation and activist stockholder matters.
+Added: Further, the price of our common stock could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.
+Added: In addition, stockholder activism may constrain our capital deployment opportunities and may limit the types of investments that are available to us.
+Added: If individuals with a specific agenda are elected or appointed to our board of directors, it may adversely affect our ability to effectively and timely implement our strategy.
+Added: Furthermore, if individuals are elected or appointed to the board of directors who do not agree with our strategy, the ability of the board of directors to function effectively could be adversely affected.
+Added: As a result, activist stockholder campaigns could adversely affect our business, results of operations, financial condition and price of our common stock.
Risks Related to Information Technology, Cybersecurity and Data Privacy
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Individuals or organizations, including malicious hackers and insider threats including employees and third-party service providers, or intruders into our physical facilities, at times attempt to gain unauthorized access to our software, network and services.
−Removed: We could also be a target of malicious attackers who attempt to gain
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 65
−Removed: access to our network or data centers;
+Added: We could also be a target of malicious attackers who attempt to gain access to our network or data centers;
steal proprietary information related to our business, products, employees, suppliers and customers;
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Our IT infrastructure also includes services provided by third parties, and these service providers can experience breaches of their systems and products that impact the security of our systems and our proprietary or confidential information.
−Removed: In addition, certain factors, such as growth through acquisitions, rapid technology evolution, including increased adoption of artificial intelligence, and geopolitical events, have increased cybersecurity risks.
+Added: In addition, certain factors, such as growth through acquisitions, rapid technology evolution, including increased adoption of artificial intelligence, or AI, and geopolitical events, have increased cybersecurity risks.
A substantial breach of our or one of our service providers’ systems could result in the loss of revenues, the misuse of confidential data, manufacturing challenges or disruption, diversion of management attention, litigation, regulatory action and damage to our relationships with vendors, business partners and customers, and we may incur significant expenses to resolve such issues.
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We cannot yet predict or estimate the amount of additional costs we will incur in order to comply with these rules or the timing of such costs.
−Removed: These rules and regulations may also require us to report a cybersecurity incident before we have been able to fully assess its impact or remediate the underlying issue.
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 68
+Added: and regulations may also require us to report a cybersecurity incident before we have been able to fully assess its impact or remediate the underlying issue.
Efforts to comply with such reporting requirements could divert management’s attention from our incident response and could potentially reveal system vulnerabilities to threat actors.
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If we do not maintain the privacy and security of personal and business information, we could damage our reputation with customers and employees, incur substantial additional costs and become subject to litigation.
−Removed: We receive, retain and transmit personal information about our customers and employees as well as confidential or proprietary information of ours and our customers, vendors and other business partners, and entrust that information to third-party suppliers, including cloud service-providers, software-as-a-service (“SaaS”) solutions, platform-as-a-service (“PaaS”) solutions, data hosting and processing facilities, artificial intelligence, tools and other hardware, software (including open-source software) technical applications and platforms and managed services, including some that are managed, hosted, provided and/or used by third-party vendors, to operate our business that perform activities for us.
+Added: We receive, retain and transmit personal information about our customers and employees as well as confidential or proprietary information of ours and our customers, vendors and other business partners, and entrust that information to third-party suppliers, including cloud service-providers, software-as-a-service (“SaaS”) solutions, platform-as-a-service (“PaaS”) solutions, data hosting and processing facilities, AI, tools and other hardware, software (including open-source software) technical applications and platforms and managed services, including some that are managed, hosted, provided and/or used by third-party vendors, to operate our business that perform activities for us.
Our business depends upon the secure transmission of encrypted confidential information over public networks, including information permitting payments.
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We are subject to a variety of continuously evolving and developing laws and regulations globally regarding privacy, data protection and data security, including those related to the collection, storage, handling, use, disclosure, transfer and security of personal data.
−Removed: Significant uncertainty exists as privacy and data protection laws may be interpreted and applied differently from
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 66
−Removed: country to country and may create inconsistent or conflicting requirements.
+Added: Significant uncertainty exists as privacy and data protection laws may be interpreted and applied differently from country to country and may create inconsistent or conflicting requirements.
These laws apply to transfers of information among our affiliates, as well as to transactions we enter into with third-party vendors.
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Our efforts to comply with GDPR, the CCPA and other privacy and data protection laws may impose significant costs and challenges that are likely to increase over time and may require us to revise certain of our business practices.
−Removed: These and similar initiatives around the world could increase the cost of developing, implementing or securing our servers and require us to allocate more resources to improved technologies, adding to our information technology and compliance costs.
+Added: These and similar initiatives around the world could increase the cost of developing,
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 69
+Added: implementing or securing our servers and require us to allocate more resources to improved technologies, adding to our information technology and compliance costs.
In addition, enforcement actions and investigations by regulatory authorities related to data security incidents and privacy violations continue to increase.
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To the extent that any disruption or security breach results in a loss or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur liability, reputation damage and harm to our business operations.
+Added: We must maintain and upgrade our enterprise resource planning system and other information technology (“IT”) systems as needed, and our failure to do so could have a material and adverse effect on our business, financial condition and results of operations.
+Added: We have invested and will continue to invest in and implement modifications and upgrades to our IT systems and procedures, including making changes to legacy systems or acquiring new systems with new functionality, and building new policies, procedures, training programs and monitoring tools.
+Added: The implementation and maintenance of a new enterprise resource planning, or ERP, system has required and will continue to require significant investment of human and financial resources.
+Added: The ERP system is designed to efficiently maintain our financial records and provide information important to the operation of our business to our management team.
+Added: In implementing, maintaining and upgrading our ERP system, we may experience significant increases to inherent costs and risks associated with changing and acquiring these systems, policies, procedures and monitoring tools, including capital expenditures, additional operating expenses, demands on management time and other risks and costs of delays or difficulties in transitioning to or integrating new systems policies, procedures or monitoring tools into our current systems.
+Added: Any significant disruption or deficiency in the design, implementation and maintenance of the ERP system may adversely affect our ability to process orders, ship product, send invoices and track payments, fulfill contractual obligations, maintain effective disclosure controls and internal control over financial reporting or otherwise operate our business.
+Added: These implementations, modifications and upgrades may not result in productivity improvements at a level that outweighs the costs of implementation, or at all.
+Added: In addition, difficulties with implementing and maintaining new technology systems, such as an ERP system, delays in our timeline for planned improvements, significant system failures or our inability to successfully modify our IT systems, policies, procedures or monitoring tools to respond to changes in our business needs may cause disruptions in our business operations, increase security risks, and may have a material and adverse effect on our business, financial condition and results of operations.
Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data.
−Removed: Issues in the development and use of artificial intelligence, combined with an uncertain regulatory environment, may result in reputational harm, liability or other adverse consequences to our business operations.
−Removed: As with many technological innovations, artificial intelligence presents risks and challenges that could impact our business.
−Removed: We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security.
−Removed: Our vendors may incorporate generative artificial intelligence tools into their offerings without disclosing this use to us, and the providers of these generative artificial intelligence tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience.
−Removed: If we, our vendors or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative artificial intelligence, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed.
−Removed: Further, bad actors around the world use increasingly sophisticated and rapidly evolving methods, including the use of artificial intelligence, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property.
+Added: Issues in the development and use of AI, combined with an uncertain regulatory environment, may result in reputational harm, liability or other adverse consequences to our business operations.
+Added: There can be no assurance that we will realize the desired or anticipated benefits from AI, if any at all.
+Added: As with many technological innovations, AI presents risks and challenges that could impact our business.
+Added: We may adopt and integrate generative AI tools into our systems for specific use cases reviewed by legal and information security.
+Added: Our use of AI could result in additional compliance costs, regulatory investigations, actions and lawsuits;
+Added: and if as a result, we are unable to properly or effectively use AI, it could make our business less efficient, potentially result in competitive disadvantages, and our business, financial condition, results of operations and cash flows could be adversely affected.
+Added: The unauthorized use of AI tools by employees, contractors and/or third-party service providers could result in the exposure of sensitive data, including our intellectual property or trade secrets or the personal information of our employees, customers or other business partners.
+Added: Our vendors may incorporate generative AI tools into their offerings without disclosing its usage to us, and the providers of these generative AI tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience.
+Added: If we, our vendors or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative AI, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed.
+Added: Further, bad actors
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 70
+Added: around the world use increasingly sophisticated and rapidly evolving methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property.
Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
General Risk Factors
−Removed: A pandemic, epidemic or outbreak of a contagious disease (such as the recent novel coronavirus (COVID-19) pandemic), or fear of such an event, could have a material adverse effect on our business, operating results and financial condition.
−Removed: A pandemic, epidemic or outbreak of an infectious disease, including the lingering impact of the COVID-19 pandemic (despite the end of the federal COVID-19 public health emergency declaration in May of 2023), or other public health crisis, could have a material adverse effect on our business, financial condition and operations, including but not limited to our
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 67
−Removed: revenue and cash flows, including potential decreases in sales, manufacturing issues, supply chain issues, including, but not limited to, staffing shortages, cost inflation and shipping delays, and delays in payments by our customers.
−Removed: For example, during 2020, our net product sales were negatively impacted by the COVID-19 pandemic due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives.
+Added: A pandemic, epidemic or outbreak of a contagious disease, or fear of such an event, could have a material adverse effect on our business, operating results and financial condition.
+Added: A pandemic, epidemic or outbreak of an infectious disease or other public health crisis could have a material adverse effect on our business, financial condition and operations, including but not limited to our revenue and cash flows, including potential decreases in sales, manufacturing issues, supply chain issues, including, but not limited to, staffing shortages, cost inflation and shipping delays, and delays in payments by our customers.
New or prolonged suspensions of elective surgeries by governmental restrictions or action would cause net sales of our products to decrease.
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We may experience significant future cost increases associated with regulatory compliance, including fees, licenses, reporting, auditing, and the cost of capital improvements for our operating facilities to meet sustainability and/or environmental regulatory requirements.
−Removed: If our CSR practices fail to meet regulatory requirements or investor, customer, consumer, employee or other stakeholders’ evolving expectations and standards for responsible corporate citizenship in areas including environmental stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety practices, product quality, supply chain management, corporate governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers may be unwilling to continue to do business with us.
+Added: If our CSR practices fail to meet regulatory requirements or investor, customer, consumer, employee or other stakeholders’ evolving expectations and standards for responsible corporate citizenship in areas including environmental stewardship, support for local communities, board of director and employee diversity, human capital management, employee health and safety practices,
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 71
+Added: product quality, supply chain management, corporate governance and transparency, our reputation, brand and employee retention may be negatively impacted, and our customers and suppliers may be unwilling to continue to do business with us.
From time to time, we communicate certain CSR initiatives and goals to market participants and our customers and business partners.
2 unchanged sentences
Furthermore, some stakeholders may disagree with our goals and there is also a risk that stakeholders may change their views on these topics over time.
−Removed: Our various stakeholders or regulators may also have divergent opinions on these types of matters as well as conflicting expectations regarding our culture, values, goals and business, which
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 68
−Removed: makes it difficult to achieve a consistently positive perception amongst all of our various stakeholders.
+Added: Our various stakeholders or regulators may also have divergent opinions on these types of matters as well as conflicting expectations regarding our culture, values, goals and business, which makes it difficult to achieve a consistently positive perception amongst all of our various stakeholders.
Moreover, we may determine that it is in the best interest of our Company and our stockholders to prioritize other business, social, governance or sustainable investments over the achievement of our current goals based on economic, technological developments, regulatory and social factors, business strategy or pressure from investors, activists or other stakeholders.
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While such conditions cannot be predicted, if such conditions were to impact our manufacturing sites or otherwise alter production schedules, including those of our third-party suppliers of raw materials, our manufacturing equipment, or our distributors, we could experience a disruption in the supply of EXPAREL, ZILRETTA or iovera° to our customers and partners, or we could see an unfavorable impact on the cost or availability of our raw or packaging materials.
+Added: Our manufacturing operations and those of our third-party suppliers may be more sensitive to climate-related disruptions than administrative or office functions due to their reliance on specialized facilities, utilities, water availability, transportation networks and controlled production environments.
Disruptions to the operations of our customers could also adversely impact the demand for our products.
Regulations in response to climate change could result in increased manufacturing costs associated with increased compliance and water and energy costs.
+Added: The measures that we have implemented that are intended to enhance the resilience of our operations and supply chain, including environmental compliance programs and business-continuity planning, may not be able to prevent or fully mitigate the adverse impacts of climate-related events or regulatory developments.
+Added: We face both physical risks from climate change (such as extreme weather events, drought, wildfires or flooding affecting our manufacturing sites, contract manufacturers and distribution networks) and transition risks (such as evolving climate-related disclosure requirements, potential carbon-pricing regimes, changes in insurance markets and shifting customer and investor expectations).
The effects of climate change, natural disasters such as earthquakes, wildfires, hurricanes, tornadoes, droughts, tsunamis or other adverse weather events and climate conditions, whether occurring in the U.S.
4 unchanged sentences
In addition, inconsistent regulations among jurisdictions may also affect our cost to comply with such laws and regulations.
−Removed: Any assessment of the potential impact of future climate change legislation, regulations or industry standards, as well as any international treaties and accords, is uncertain given the wide scope of potential regulatory change in the countries in which we operate.
+Added: Any assessment of the potential impact of future climate change legislation, regulations or
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 72
+Added: industry standards, as well as any international treaties and accords, is uncertain given the wide scope of potential regulatory change in the countries in which we operate.
Our international operations expose us to numerous and sometimes conflicting legal and regulatory requirements, the compliance of which could be costly and time consuming and violation of these regulations could adversely affect our business or operations.
5 unchanged sentences
• difficulties in developing, staffing, and simultaneously managing our foreign operations as a result of geographic distance, language, and cultural differences;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 69
• stringent local labor laws and regulations;
31 unchanged sentences
laws and regulations, including the U.S.
−Removed: Foreign Corrupt Practices Act and the U.K.
+Added: Foreign Corrupt Practices
+Added: Pacira BioSciences, Inc.
+Added: | 2025 Annual Report on Form 10-K | 73
+Added: Act and the U.K.
Bribery Act, there can be no assurance that our employees, business partners, or agents will not violate our policies.
+Added: Changes in global economic conditions, including, but not limited to, those driven by inflation and tariffs, may adversely affect spending and the financial health of our customers and others with whom we do business, which may adversely affect our financial condition, results of operations and cash flows.
+Added: Uncertainty about current and future global economic conditions, inflation and tariffs may cause patients to defer or cancel medical procedures.
+Added: Our financial success is sensitive to changes in general economic conditions, both globally and in specific markets, that may adversely affect the demand for our products including recessionary economic cycles, higher interest rates, higher fuel and other energy costs, increased labor costs, declines in asset values, inflation, the imposition of tariffs, increases in commodity prices, higher levels of unemployment, higher consumer debt levels, higher tax rates and other changes in tax laws, public health issues, or other economic factors, certain of which effects, including cost inflation and higher interest rates, we experienced in 2024 and 2025 and expect to continue to experience in 2026.
+Added: If global economic and financial market conditions deteriorate or remain weak for an extended period of time, the following factors, among others, could have a material adverse effect on our financial condition, results of operations and cash flows:
+Added: • Changes in foreign currency exchange rates relative to the U.S.
+Added: • The imposition of tariffs and other import restrictions by the U.S.
+Added: or foreign governments.
+Added: • Slower consumer spending that may result in our inability to maintain or increase our sales to new and existing customers, reduce patient volumes, cause reduced product orders or product order delays or cancellations from wholesale accounts that are directly impacted by fluctuations in the broader economy, difficulties managing inventories, higher discounts and lower product margins.
+Added: • A decrease in liquidity or credit available to our customers, product suppliers and other service providers.
+Added: • If our customers experience diminished liquidity, we may experience a reduction in product orders, an increase in customer order cancellations, and/or the need to extend customer payment terms, which could lead to larger balances and delayed collection of our accounts receivable, reduced cash flows, greater expenses for collection efforts and increased risk of nonpayment of our accounts receivable.
+Added: • If we are unable to mitigate the impact of supply chain constraints and inflationary pressure through price increases or other measures, our results of operations and financial condition could be negatively impacted.
+Added: Furthermore, even if we are able to raise the prices of our products, consumers might react negatively to such price increases, which could have a material adverse effect on, among other things, our brands, reputation, and sales.
+Added: Certain of the foregoing could also result in lower levels of healthcare insurance coverage and/or depress consume confidence, any of which could limit the ability of some customers to purchase our products and reduce consumer spend on certain elective medical procedures in both the short- and medium-term.
+Added: Federal Reserve previously raised interest rates multiple times in response to concerns about inflation, though it recently lowered interest rates multiple times and further interest rate changes remain uncertain.
+Added: If higher interest rates return, this, coupled with reduced government spending and volatility in financial markets may also increase economic uncertainty and negatively affect consumer spending.
+Added: Similarly, the ongoing war in Ukraine and the Israel-Hamas war have created extreme volatility in the global capital markets and is expected to continue to have further global economic consequences, including disruptions of the global supply chain and energy markets.
+Added: Any such volatility and disruptions may adversely affect our business or the third parties on whom we rely.
+Added: If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing (or refinancing) more difficult to obtain in a timely manner, or on favorable terms, more costly or more dilutive.
+Added: Increased inflation rates have already, and may continue to, adversely affect us by increasing our costs, including labor costs, service costs and employee benefit costs.
+Added: In addition, higher inflation and macro turmoil and uncertainty could also adversely affect our customers, which could reduce demand for our products.
+Added: Rising international tariffs could materially and adversely affect our business and results of operations.
+Added: government may in the future pause, reimpose or increase tariffs and foreign governments have, and in the future may, impose retaliatory trade protection measures.
+Added: We may be impacted by ongoing risks associated with global macroeconomic conditions, including international relations and trade disputes.
+Added: For example, and most notably for us, the active pharmaceutical ingredient for both EXPAREL and ZILRETTA are sourced from outside the U.S.
+Added: In July 2025, the U.S.
+Added: agreed to a trade deal that sets a 15% tariff on most imports from the E.U.—including branded pharmaceuticals—and effectively exempts the E.U.
+Added: from higher tariffs that may be imposed on pharmaceutical imports from other countries pursuant to a pending investigation of such imports under Section 232 of the Trade Expansion Act of 1962.
+Added: In December 2025, the U.S.
Pacira BioSciences, Inc.
−Removed: | 2024 Annual Report on Form 10-K | Page 70
+Added: | 2025 Annual Report on Form 10-K | 74
+Added: Switzerland reached a similar agreement, setting a 15% tariff on Swiss origin goods—including branded pharmaceuticals—and likewise exempting Switzerland from potential higher tariffs under the same Section 232 investigation.
+Added: Pharmaceuticals imported from countries outside the E.U.
+Added: and Switzerland may face higher tariffs, including tariffs that may be imposed pursuant to the pending Section 232 investigation.
+Added: However, on February 20, 2026, the Supreme Court of the U.S.
+Added: ruled against the country-specific tariffs, including the E.U.
+Added: and Swiss specific tariffs mentioned above, imposed by U.S.
+Added: President Donald Trump under his asserted executive authority.
+Added: The Supreme Court held that the President did not have the authority under the International Emergency Economic Powers Act (“IEEPA”) to impose such tariffs, rendering them unlawful and no longer in effect.
+Added: The Supreme Court ruling does not directly address whether, and if so how, the U.S.
+Added: Government would go about returning any tariffs collected under these IEEPA tariffs.
+Added: Following the Supreme Court’s ruling, President Trump implemented a blanket 10% ad valorem tariff on imports into the U.S.
+Added: under Section 122, effective February 24, 2026.
+Added: These tariffs are authorized to remain in effect for a period of up to 150 days.
+Added: However, in an exemption list released by the White House on February 22, 2026, pharmaceuticals and pharmaceutical ingredients were excluded from the 10% ad valorem duties.
+Added: At this time, it remains unclear what additional actions, if any, will be taken by the U.S.
+Added: or other governments with respect to international trade agreements, the imposition of additional tariffs on goods imported into the U.S., tax policy related to international commerce, increased export control, sanctions and investment restrictions, or other trade matters.
+Added: Although the ultimate scope and timing of any such actions is currently indeterminable, if implemented, they could have a material impact on our financial condition and results of operations.
+Added: Other effects of these changes, including impacts on the price of raw materials and equipment, responsive or retaliatory actions from governments, such as retaliatory tariffs on imports into China, Mexico or Canada from the U.S.
+Added: and the opportunity for competitors not subject to such changes to establish a presence in markets where we participate, could also have significant impacts on our results of operations, though whether any of the foregoing actions will be taken remains unclear.
+Added: Furthermore, we may not be able to increase prices for our products enough to offset tariffs, which could impact our margins.
+Added: If we raise prices in response to tariffs, the demand for our products may go down, which could have a negative impact on our sales.
+Added: We cannot predict what further action may be taken with respect to export restrictions, tariffs or trade relations between the U.S.
+Added: and other governments, and any further changes in U.S.
+Added: or international trade policy could have an adverse impact on our business, financial condition and results of operations.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.