18 unchanged sentences
• implement and maintain agreements with wholesalers and distributors on commercially reasonable terms;
−Removed: • appropriately prepare the market to take advantage of EXPAREL reimbursement for Medicare patients receiving surgery in the outpatient setting beginning in 2025;
+Added: • appropriately help the market to take advantage of EXPAREL reimbursement at ASP plus 6 percent for Medicare patients receiving surgery in the outpatient setting;
• receive adequate levels of coverage and reimbursement for EXPAREL and ZILRETTA from commercial health plans and governmental health programs;
2 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.
+Added: • 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: For more information on this matter, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
Any disruption in our ability to generate revenues from the sale of EXPAREL and ZILRETTA will have a material and adverse impact on our results of operations and financial condition.
4 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.
+Added: Pacira BioSciences, Inc.
+Added: | 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.
1 unchanged sentence
Generally, before we can attempt to sell EXPAREL in a hospital, EXPAREL must be approved for addition to that hospital’s list of approved drugs, or formulary list, by the hospital’s P&T committee.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 36
−Removed: Table of Content s
−Removed: hospital’s P&T committee typically governs all matters pertaining to the use of medications within the institution, including the review of medication formulary data and recommendations for the appropriate use of drugs within the institution to the medical staff.
+Added: A hospital’s P&T committee typically governs all matters pertaining to the use of medications within the institution, including the review of medication formulary data and recommendations for the appropriate use of drugs within the institution to the medical staff.
The frequency of P&T committee meetings at hospitals varies considerably, and P&T committees often require additional information to aid in their decision-making process.
1 unchanged sentence
Additionally, hospital pharmacists may be concerned that the cost of acquiring EXPAREL for use in their institutions will adversely impact their overall pharmacy budgets, which could cause pharmacists to resist efforts to add EXPAREL to the formulary, or to implement restrictions on the usage of EXPAREL or to encourage use of a lower cost dose than a surgeon or anesthesiologist would otherwise choose in order to control costs.
−Removed: Implementation of the NOPAIN Act in January 2025, which will provide for separate reimbursement of qualifying non-opioids, like EXPAREL, administered during surgical procedures in the outpatient environment, is a significant policy advancement aimed at alleviating cost concerns for the Medicare population;
+Added: Implementation of the NOPAIN Act in January 2025 now provides for separate reimbursement of qualifying non-opioids, like EXPAREL, administered during surgical procedures in the outpatient environment, is a significant policy advancement aimed at alleviating cost concerns for the Medicare population;
however, we cannot guarantee that we will be successful in obtaining the approvals we need from enough P&T committees quickly enough to optimize hospital sales of EXPAREL.
6 unchanged sentences
• the cost of treatment versus economic and clinical benefit, both in absolute terms and in relation to alternative treatments;
−Removed: • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payers, and by government healthcare programs, including Medicare and Medicaid, although implementation of the NOPAIN Act in January 2025 will provide Medicare coverage for separate reimbursement of qualifying opioids like EXPAREL;
+Added: • the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payers, and by government healthcare programs, including Medicare and Medicaid, although implementation of the NOPAIN Act in January 2025 now provides Medicare coverage for separate reimbursement of qualifying non-opioids like EXPAREL in addition to its HCPCS J-code (J0666);
• the extent and strength of our marketing and distribution of EXPAREL;
• the safety, efficacy and other potential advantages over, and availability of, alternative treatments, including, in the case of EXPAREL, a number of products already used to treat pain in the hospital setting;
+Added: • potential future entrance into the market of a generic version of EXPAREL;
• distribution and use restrictions imposed by regulatory agencies or to which we agree as part of a mandatory risk evaluation and mitigation strategy or voluntary risk management plan.
1 unchanged sentence
We will also need to demonstrate acceptable evidence of safety and efficacy, as well as relative convenience and ease of administration.
−Removed: Market acceptance could be further limited depending on the prevalence and severity of any expected or unexpected adverse side effects associated with our product candidates.
+Added: Market acceptance could be further limited depending on the prevalence and severity of any expected or unexpected adverse side effects associated with our product candidates, as well as products and therapies of competitors.
In addition, our approved labels for EXPAREL do not contain claims that EXPAREL is safer or more effective than competitive products and do not permit us to promote EXPAREL as being superior to competing products.
4 unchanged sentences
Market acceptance of ZILRETTA will depend on a number of factors, including:
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 36
• the efficacy and safety as demonstrated in clinical trials;
4 unchanged sentences
• the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 37
−Removed: Table of Content s
• the convenience of prescribing, administrating and initiating patients on the product;
26 unchanged sentences
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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 37
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.
3 unchanged sentences
from several manufacturers, and Caldolor (ibuprofen for injection), an NSAID, has been approved by the FDA for pain management and fever in adults.
−Removed: EXPAREL also faces competition from currently marketed non-opioid products such as bupivacaine, marcaine, ropivacaine and other
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 38
−Removed: Table of Content s
−Removed: anesthetics/analgesics, all of which are also used in the treatment of postsurgical pain and are available as either oral tablets, injectable dosage forms or administered using novel delivery systems.
+Added: EXPAREL also faces competition from currently marketed non-opioid products such as bupivacaine, marcaine, ropivacaine and other anesthetics/analgesics, all of which are also used in the treatment of postsurgical pain and are available as either oral tablets, injectable dosage forms or administered using novel delivery systems.
+Added: We are aware of at least one FDA-approved oral, non-opioid, highly selective Na V 1.8 pain signal inhibitor that utilizes suzetrigine for the treatment of moderate-to-severe pain in adults.
EXPAREL also competes with elastomeric pumps and catheter devices intended to provide bupivacaine over several days and with off-label combinations of other approved analgesics, called “cocktails”, that are combined by compound pharmacies in an attempt to extend the duration of pain control.
22 unchanged sentences
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: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 38
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.
6 unchanged sentences
to market and promote the use of EXPAREL for orthopedic procedures in the U.S.
−Removed: market which we
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 39
−Removed: Table of Content s
−Removed: terminated effective January 2021.
+Added: market which we terminated effective January 2021.
Additionally, in March 2020, Flexion entered into an exclusive license agreement with Hong Kong Tainuo Pharma Ltd., or HK Tainuo, and Jiangsu Tainuo Pharmaceutical Co.
2 unchanged sentences
For more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
−Removed: There can be no assurance that such distributors and promoters will be successful in marketing and promoting our products.
−Removed: 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.
+Added: 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.
The use of distributors involves certain risks, including risks that such distributors will:
6 unchanged sentences
• cease operations.
−Removed: Any such failure may result in decreased sales, which would have an adverse effect on our business.
+Added: Any such failure may result in decreased sales and could lead us to incur other additional costs, which would have an adverse effect on our business.
We rely on third parties to perform many essential services for EXPAREL, ZILRETTA and iovera° and will rely on third parties for any other products that we commercialize.
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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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 39
+Added: 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.
1 unchanged sentence
As of December 31, 2024, we had 790 employees.
−Removed: We may need to expand our personnel resources in order to manage our operations and sales of EXPAREL, ZILRETTA, iovera° or any of our product candidates or products we acquire or in-license.
+Added: We may need to expand our personnel resources in order to manage our operations and sales of EXPAREL, ZILRETTA, iovera°, any of our product candidates or products we acquire or in-license.
Our management, personnel, systems and facilities currently in place may not be adequate to support this future growth.
−Removed: In addition, we may not be able to recruit and retain qualified personnel in the future, particularly in marketing positions, due to competition for personnel among pharmaceutical and medical device businesses, and the failure to do so could have a significant negative impact on our future product revenues and business results.
+Added: In addition, we may not be able to recruit and retain qualified personnel in the future, particularly in sales and marketing positions, due to competition for personnel among pharmaceutical and medical device businesses, and the failure to do so could have a significant negative impact on our future product revenues and results of operations.
Our need to effectively manage our operations, growth and various projects requires that we:
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 40
−Removed: Table of Content s
• continue the hiring and training of an effective commercial organization for the commercialization of EXPAREL, ZILRETTA and iovera°, and establish appropriate systems, policies and infrastructure to support that organization;
9 unchanged sentences
We may not be able to manage our business effectively if we are unable to attract and retain key personnel.
−Removed: 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 Tampa, Florida;
+Added: We may not be able to attract or retain qualified management and commercial, scientific and clinical personnel due to the intense competition for qualified personnel among biotechnology, pharmaceutical, medical device and other businesses, as well as universities, non-profit research organizations and government entities, particularly in and around the San Francisco Bay Area;
San Diego, California;
−Removed: northern New Jersey/New York City metro and Houston, Texas.
+Added: northern New Jersey/New York City metro and Tampa, Florida.
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.
Our industry has experienced a high rate of turnover of management personnel in recent years.
−Removed: We are highly dependent on the development and manufacturing expertise for our products and pMVL drug delivery technology and the commercialization expertise of certain members of our senior management.
+Added: We are highly dependent on the development and manufacturing expertise for our products and pMVL drug delivery technology and the commercialization expertise of management.
In particular, we are highly dependent on the skills and leadership of our senior management team.
If we lose one or more of these key employees, our ability to successfully implement our business strategy could be seriously harmed.
−Removed: Replacing key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully.
+Added: Replacing key employees may be difficult, costly and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to develop, gain regulatory approval of and commercialize products successfully.
Competition to hire from this limited talent pool is intense, and we may be unable to hire, train, retain or motivate additional key personnel.
−Removed: Competition for highly skilled personnel, including management and commercial, scientific and clinical personnel, is extremely competitive, particularly in and around Tampa, Florida;
+Added: Competition for highly skilled personnel, including management and commercial, scientific and clinical personnel, is extremely competitive, particularly in and around the San Francisco Bay Area;
San Diego, California;
−Removed: northern New Jersey/New York City metro and Houston, Texas.
+Added: northern New Jersey/New York City metro and Tampa, Florida.
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.
2 unchanged sentences
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, 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.
−Removed: 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.
−Removed: In particular, candidates making employment decisions, specifically in our industry, often consider the value of any stock-based compensation they may receive in connection with their employment.
−Removed: Any significant volatility in the price of our common stock may adversely affect our ability to attract or retain highly skilled and technical personnel.
+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
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 41
−Removed: Table of Content s
−Removed: If we fail to successfully execute the transition of David Stack, our former Chief Executive Officer and Chairman, and the integration of Frank D.
−Removed: Lee, our new Chief Executive Officer, we may not be able to execute our business strategy.
−Removed: In September 2023, David Stack, our former Chief Executive Officer and Chairman, announced that he intended to retire as Chief Executive Officer and as a member of the Board effective immediately upon the appointment of his successor as Chief Executive Officer in order to ensure a smooth transition of leadership.
−Removed: On December 21, 2023, we announced that Frank D.
−Removed: Lee would succeed Mr.
−Removed: Stack as our Chief Executive Officer effective January 2, 2024.
−Removed: Our success depends in a large part upon the leadership of our Chief Executive Officer, which is critical to, among other things, our mission, strategic direction, culture, products and technologies.
−Removed: Leadership transitions can be inherently difficult to manage.
−Removed: An inadequate transition to a new Chief Executive Officer may cause disruption within the Company, adversely affecting our financial performance and ability to meet our operational goals and strategic plans.
−Removed: In addition, the departure of Mr.
−Removed: Stack will result in a loss of institutional knowledge.
−Removed: This loss of knowledge and experience can be mitigated through successful hiring and transition, but there can be no assurance that we will be successful in such efforts.
−Removed: The ability of our new Chief Executive Officer, Frank D.
−Removed: Lee, to quickly adapt to and understand our business, operations and strategic plans will be critical to our ability to make informed decisions about our strategic direction and operations.
−Removed: Management turnover also inherently causes some loss of institutional knowledge, which can negatively affect strategy and execution.
−Removed: In addition, to the extent we experience additional management turnover, competition for top management is high and it may take time to find a candidate or multiple candidates that meet our requirements.
−Removed: If we are unable to attract and retain qualified management personnel, our business could suffer.
−Removed: Furthermore, while we have succession plans in place and we have employment arrangements with certain key executives, these do not guarantee the services of these executives will continue to be available to us.
+Added: | 2024 Annual Report on Form 10-K | Page 40
+Added: 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: 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.
+Added: In particular, candidates making employment decisions, specifically in our industry, often consider the value of any long-term incentive compensation, including stock-based compensation they may receive in connection with their employment.
+Added: Any significant volatility in the price of our common stock may adversely affect our ability to attract or retain experienced, highly skilled and technical personnel.
We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for EXPAREL, ZILRETTA, iovera° or any product candidates that we may develop and may have to limit their commercialization.
17 unchanged sentences
A successful product liability claim or series of claims brought against us could cause the price of our common stock to fall and, if judgments exceed our insurance coverage, could decrease our cash balance and adversely affect our business.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 42
−Removed: Table of Content s
If we fail to manufacture our products in sufficient quantities and at acceptable quality and pricing levels, or to fully comply with CGMP regulations, we may face delays in the commercialization of these products or be unable to meet market demand, and may lose potential revenues.
5 unchanged sentences
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 and investigations.
+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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 41
+Added: and investigations.
Regulations regarding the development, manufacture and sale of medical products are evolving and are subject to change in the future.
1 unchanged sentence
We may need to expand our manufacturing operations or outsource such operations to third parties.
−Removed: To successfully meet future customer demand for EXPAREL, ZILRETTA and iovera°, we may need to expand our existing commercial manufacturing facilities or establish large-scale commercial manufacturing capabilities.
+Added: To successfully meet future customer demand for EXPAREL, ZILRETTA and iovera°, we may need to expand our existing commercial manufacturing facilities or establish larger-scale commercial manufacturing capabilities.
+Added: For example, in February 2024 the FDA approved our new, larger-scale manufacturing suite at our Science Center Campus in San Diego, California.
In addition, as our drug development pipeline increases and matures, we will have a greater need for clinical trial and commercial manufacturing capacity.
−Removed: As a result, we must continue to improve our manufacturing processes to allow us to reduce our production costs.
+Added: As a result, we must continuously improve our manufacturing processes to allow us to reduce our production costs.
We may not be able to manufacture our drugs and/or medical devices at a cost or in quantities necessary to be commercially successful.
−Removed: The build-up or other expansion of our internal manufacturing capabilities for EXPAREL production at our Science Center Campus in San Diego, California and co-production capabilities for EXPAREL and ZILRETTA at Thermo Fisher’s Swindon, England site, exposes us to significant up-front fixed costs.
−Removed: If market demand for our products does not align with our expanded manufacturing capacity, we may be unable to offset these costs or achieve economies of scale, and our operating results may be adversely affected as a result of high operating expenses.
+Added: The build-up or other expansion of our internal manufacturing capabilities for EXPAREL production at our Science Center Campus in San Diego, California and co-production capabilities for EXPAREL and ZILRETTA at Thermo Fisher’s Swindon, U.K.
+Added: site, exposes us to significant up-front fixed costs.
+Added: If market demand for our products does not align with our expanded manufacturing capacity, we may be unable to offset these costs or achieve economies of scale, and our operating results may be adversely affected as a result of high operating expenses, including overhead.
Alternatively, if we experience demand for our products in excess of our estimates, our facilities may be insufficient to support higher production volumes, which could harm our customer relationships and overall reputation.
−Removed: Our ability to meet such excess demand could also depend on our ability to raise additional capital and effectively scale our manufacturing operations.
+Added: Our ability to meet such excess demand could also depend on our ability to raise additional capital on terms acceptable to us and effectively scale our manufacturing operations.
In addition, the procurement time for the equipment that we use to manufacture EXPAREL and ZILRETTA requires long lead times.
3 unchanged sentences
Such arrangements also involve additional risks, many of which would be outside of our control.
−Removed: Such risks include disruptions or delays in production, manufactured products that do not meet our required specifications, the failure of such third-party manufacturers to comply with CGMP regulations or other regulatory requirements, protection of our intellectual property and manufacturing processes, loss of control of our complex manufacturing processes, inabilities to fulfill our commercial needs and financial risks in connection with our investment in setting up a third-party manufacturing process, such as the substantial capital outlays that were required by us to assist in setting up our manufacturing process at Thermo Fisher’s facility in Swindon, England.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 43
−Removed: Table of Content s
+Added: Such risks include disruptions or delays in production, manufactured products that do not meet our required specifications, the failure of such third-party manufacturers to comply with CGMP regulations or other regulatory requirements, protection of our intellectual property and manufacturing processes, loss of control of our complex manufacturing processes, inabilities to fulfill our commercial needs and financial risks in connection with our investment in setting up a third-party manufacturing process, such as the substantial capital outlays that were required by us to assist in setting up our manufacturing process at Thermo Fisher’s facility in Swindon, U.K.
If we are unable to timely achieve and maintain satisfactory production yields and quality, whether through our internal manufacturing capabilities or arrangements with contract manufacturers, our relationships with customers and our reputation may be harmed and our revenues could decrease.
1 unchanged sentence
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, England and iovera° is currently manufactured at our facilities in San Diego, California and at the Carlisle 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 and iovera° Smart Tips are currently manufactured at Carlisle’s facility in Tijuana, Mexico.
These facilities are the only currently approved sites in the world for manufacturing EXPAREL, ZILRETTA and iovera°.
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, England and the Carlisle facility in Tijuana, Mexico are also subject to the risks of a natural or man-made disaster, including storms, earthquakes, floods and fires, or other business disruptions.
−Removed: In addition, we have obtained limited property and business interruption insurance coverage for our manufacturing sites in San Diego, England and Mexico.
+Added: Our San Diego facilities in California, the Thermo Fisher facility in Swindon, U.K.
+Added: 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: 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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 42
+Added: 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.
2 unchanged sentences
We and Thermo Fisher have entered into a Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing and Supply Agreement.
−Removed: Under these agreements, Thermo Fisher undertook certain technical transfer activities and construction services to prepare their Swindon, England facility for the manufacture of EXPAREL.
+Added: Under these agreements, Thermo Fisher undertook certain technical transfer activities and construction services to prepare their Swindon, U.K.
+Added: facility for the manufacture of EXPAREL.
We agreed with Thermo Fisher, among other things, to provide them with the process equipment necessary to manufacture EXPAREL at this facility.
−Removed: Prior to the Flexion Acquisition, Flexion and Thermo Fisher entered into the ZILRETTA Manufacturing and Supply Agreement and the ZILRETTA Technical Transfer and Service Agreement related to the manufacture of ZILRETTA at the same Thermo Fisher site in Swindon, England where our EXPAREL suites are located.
+Added: Prior to the Flexion Acquisition, Flexion and Thermo Fisher entered into the ZILRETTA Manufacturing and Supply Agreement and the ZILRETTA Technical Transfer and Service Agreement related to the manufacture of ZILRETTA at the same Thermo Fisher site in Swindon, U.K.
+Added: where our EXPAREL suites are located.
Thermo Fisher agreed to undertake certain transfer activities and construction services needed to prepare its facility for the commercial manufacture of ZILRETTA in dedicated manufacturing suites.
3 unchanged sentences
Further, the production under these agreements involve additional risks, many of which would be outside of our control, such as disruptions or delays in production, manufactured products that do not meet our required specifications, the failure of Thermo Fisher to comply with CGMP regulations or other regulatory requirements, protection of our intellectual property and manufacturing processes, loss of control of our complex manufacturing processes and inabilities to fulfill our commercial needs.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 44
−Removed: Table of Content s
We rely on third parties for the timely supply of specified raw materials and equipment for the manufacture of EXPAREL, ZILRETTA and iovera°.
7 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 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 recent 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.
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.
−Removed: There can be no assurances that future government mandates will not occur or that critical raw materials will not be prioritized for other products.
+Added: There can be no assurances that similar government mandates will not occur in the future or that critical raw materials will not be prioritized for other products.
Supply chain disruptions could interrupt product manufacturing and global logistics and increase product costs.
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 materials.
−Removed: For example, the COVID-19 pandemic and related governmental actions had also caused delays in shipments, which may persist despite the end of the federal COVID-19 public health emergency declaration in May of 2023.
+Added: Delays in shipping may cause us to use more expensive expedited freight methods to ship our products or receive raw
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 43
+Added: For example, the recent 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.
In addition, global inflation has contributed to already higher incremental freight costs and such inflation may continue to result in further increases in freight costs.
+Added: Any tariffs imposed on imported goods may also raise the cost of certain raw materials and other property, plant and equipment costs.
Failure to adequately produce and timely ship our products to customers could lead to lost potential revenue, failure to meet customer demand and strained relationships with customers—including wholesalers.
2 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 caused, in part, by the recent COVID-19 pandemic, the uncertain economic environment and macroeconomic trends.
−Removed: In addition, current or future governmental policies may increase the risk of inflation, which could further increase the costs of raw materials and components for our business.
−Removed: Similarly, if costs of goods continue to increase, our suppliers may seek price increases from us.
+Added: 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: 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.
+Added: Tariffs can increase our manufacturing costs and if costs of goods continue to increase, our suppliers may seek price increases from us.
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.
2 unchanged sentences
We expect the situation to remain fluid as foreign exchange rates fluctuate and as inflationary pressure continues.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 45
−Removed: Table of Content s
Our future growth depends—in part—on our ability to identify, develop, acquire or in-license products and if we do not successfully identify, develop, acquire or in-license related product candidates or integrate them into our operations, we may have limited growth opportunities.
2 unchanged sentences
• significant capital expenditures;
−Removed: • difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies;
−Removed: • incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products;
+Added: • the difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies;
+Added: • the incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products and any related milestone or earn-out payments;
• the successful integration of acquired products, businesses or technologies into our operations, and achieving the expected benefits and synergies from such acquisitions;
−Removed: • disruption of our business and diversion of our management’s time and attention;
+Added: • the disruption of our business and diversion of our management’s time and attention;
• higher than expected development, acquisition or in-license and integration costs;
• exposure to unknown liabilities;
−Removed: • difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
−Removed: • inability to retain key employees of any acquired businesses;
−Removed: • difficulty entering markets in which we have limited or no direct experience;
−Removed: • difficulty in managing multiple product development programs;
−Removed: • inability to successfully develop new products or clinical failure.
+Added: • the difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
+Added: • the inability to retain key employees of any acquired businesses;
+Added: • the difficulty entering markets in which we have limited or no direct experience;
+Added: • the difficulty in managing multiple product development programs;
+Added: • the inability to successfully develop new products or clinical failure.
We have limited resources to identify and execute the development, acquisition or in-licensing of products, businesses and technologies and integrate them into our current infrastructure.
1 unchanged sentence
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 product candidates on acceptable terms or at all.
+Added: We may not be successful in locating and acquiring or in-licensing additional desirable
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 44
+Added: product candidates on acceptable terms or at all.
We may also not be successful in developing or commercializing our current product candidates.
−Removed: Such efforts may require the dedication of significant financial and personnel resources, and any diversion of resources may also disrupt our management from expanding on EXPAREL, ZILRETTA or iovera° sales.
+Added: Such efforts may require the dedication of significant financial and personnel resources, and any diversion of resources may also disrupt our management from expanding on EXPAREL, ZILRETTA or iovera° net product sales.
Moreover, we may devote resources to potential development, acquisitions or in-licensing opportunities that are never completed, or we may fail to realize the anticipated benefits of such efforts.
We make substantial investments in research and development and unsuccessful investments could materially adversely affect our business, financial condition and results of operations.
−Removed: The industry in which we compete is characterized by rapid technological change, changes in customer requirements, frequent new product introductions and enhancements, evolving industry standards and new delivery methods.
+Added: 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.
In order to remain competitive, we have made, and expect to continue to make, significant investments in research and development.
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 demand for our products, which would have a negative impact on our financial results.
+Added: 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.
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.
2 unchanged sentences
Violation of these laws and regulations could lead to substantial fines and penalties.
−Removed: Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials or unintended failure to
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 46
−Removed: Table of Content s
−Removed: comply with these laws and regulations.
+Added: Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials or unintended failure to comply with these laws and regulations.
In the event of an accident or failure to comply with these laws and regulations, federal, state or local authorities may curtail our use of these materials and interrupt our business operations.
2 unchanged sentences
Our business model is to commercialize our products in the U.S.
−Removed: and abroad, occasionally seeking collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our products in other countries.
+Added: while seeking collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our products in other countries.
Accordingly, we may enter into collaboration arrangements in the future on a selective basis.
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We may not be able to successfully complete clinical testing within the time frame we have planned, or at all.
−Removed: 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.
+Added: We may experience
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 45
+Added: 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.
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If the CROs that we hire to perform our preclinical testing and clinical trials or our collaborators or licensees do not meet deadlines, do not follow proper procedures or a conflict arises between us and our CROs, our preclinical testing and clinical trials may take longer than expected, may be delayed or may be terminated.
−Removed: If we were forced to find a replacement CRO to perform any of our preclinical testing or clinical trials, we may not be able to find a
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 47
−Removed: Table of Content s
−Removed: suitable replacement on favorable terms, if at all.
+Added: If we were forced to find a replacement CRO to perform any of our preclinical testing or clinical trials, we may not be able to find a suitable replacement on favorable terms, if at all.
Even if we were able to find another CRO to perform a preclinical test or clinical trial, any material delay in a test or clinical trial may result in significant additional expenditures that could adversely affect our operating results.
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We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources.
−Removed: From time to time, we are called upon to defend ourselves against lawsuits relating to our business.
+Added: From time to time, we are called upon to defend ourselves against lawsuits relating to our business and intellectual property.
Due to the inherent uncertainties of litigation, we cannot accurately predict the ultimate outcome of any such proceedings.
−Removed: See Note 20, Commitments and Contingencies , to our consolidated financial statements included herein for information about our legal proceedings.
An unfavorable outcome in these or other proceedings could have an adverse impact on our business, financial condition and results of operations.
1 unchanged sentence
In addition, if our stock price is volatile, we may become involved in securities class action lawsuits in the future.
−Removed: For more information about our legal proceedings, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 46
+Added: For information about our legal proceedings, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
Guidelines and recommendations published by various organizations could reduce the demand for or use of our products.
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According to these regulations, companies may not promote drugs or medical devices for “off-label” uses—that is—uses that are not consistent with the product’s labeling and that differ from those that were approved by the FDA, EMA, MHRA or other regulatory agency.
−Removed: For example, the FDA-
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 48
−Removed: Table of Content s
−Removed: approved label for EXPAREL does not include an indication in obstetrical paracervical block anesthesia.
+Added: For example, the FDA-approved label for EXPAREL does not include an indication in obstetrical paracervical block anesthesia.
In addition to the FDA approval required for new formulations or device enhancements, any new indication for an approved product also requires FDA approval.
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The lawsuit sought a declaration and injunctive relief to permit us to promote EXPAREL consistent with its approved indication and pivotal trials that supported FDA approval.
−Removed: On December 15, 2015, we announced that the FDA had formally withdrawn the September 2014 Warning Letter via a “Rescission Letter,” and that the FDA and Pacira had reached an amicable resolution of the lawsuit.
+Added: In December 2015, we announced that the FDA had formally withdrawn the September 2014 Warning Letter via a “Rescission Letter,” and that the FDA and Pacira had reached an amicable resolution of the lawsuit.
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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 47
+Added: 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.
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As part of the settlement, we admitted to no wrongdoing and explicitly denied the Plaintiffs’ allegations.
−Removed: We have been given assurances that this concluded the investigation that originated from the U.S.
+Added: We have been given assurances that this settlement concluded the investigation that originated from the U.S.
Department of Justice subpoena in April 2015.
2 unchanged sentences
As noted above, any regulatory violation or allegations of a violation may have a material adverse effect on our reputation and business.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 49
−Removed: Table of Content s
We may not receive regulatory approval for any of our product candidates, or the approval may be delayed for various reasons, including successful challenges to the FDA’s interpretation of Section 505(b)(2), which would have a material adverse effect on our business and financial condition.
6 unchanged sentences
Those positive results provided the foundation for an sNDA submission which was approved by the FDA in March 2021.
−Removed: Additionally, we are in negotiations with the FDA and EMA for clarity on other pediatric study obligations for children aged zero to less than six years old, and in October 2023, 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.
+Added: Additionally, we are in negotiations with the FDA and EMA for clarity on other pediatric study obligations for children aged zero to less than six years old.
+Added: 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.
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.
1 unchanged sentence
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.
−Removed: For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
+Added: For more information regarding our pediatric study obligations, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
For iovera° and any other potential medical device, we must obtain clearance or approval from the FDA or other regulatory authorities prior to introducing a new product or a modification to an existing product.
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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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 48
+Added: 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.
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In addition, the class of drugs that EXPAREL belongs to has been associated with nervous system and cardiovascular toxicities at high doses.
−Removed: We cannot be certain that these side effects and others will not be observed in the future, or that regulatory
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 50
−Removed: Table of Content s
−Removed: authorities will not require additional trials or impose more severe labeling restrictions due to these side effects or other concerns.
+Added: We cannot be certain that these side effects and others will not be observed in the future, or that regulatory authorities will not require additional trials or impose more severe labeling restrictions due to these side effects or other concerns.
The active component of EXPAREL is bupivacaine, and bupivacaine infusions have been associated with the destruction of articular cartilage, or chondrolysis.
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• 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;
+Added: Pacira BioSciences, Inc.
+Added: | 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;
6 unchanged sentences
Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses, divert our management’s attention from the operation of our business and damage our reputation.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 51
−Removed: Table of Content s
The design, development, manufacture, supply and distribution of our products are highly regulated and technically complex.
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• reputational concerns of our customers or the medical community;
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 50
• operating restrictions;
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• unanticipated expenditures.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 52
−Removed: Table of Content s
If the government or third-party payers fail to provide adequate coverage and payment rates for EXPAREL, ZILRETTA, iovera° or any future products, or if hospitals or ASCs choose to use alternative therapies that are less expensive, our revenue and prospects for profitability will be limited.
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Therefore, coverage and reimbursement for drug products can differ significantly from payer to payer.
−Removed: Further, barring separate reimbursement for qualifying non-opioids administered to Medicare surgical patients in the outpatient setting as mandated by NOPAIN beginning in January 2025, we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the U.S.
+Added: Further, barring separate reimbursement for qualifying non-opioids administered to Medicare surgical patients in the outpatient setting as mandated by NOPAIN, we believe that future coverage and reimbursement will likely be subject to increased restrictions both in the U.S.
and in international markets, as federal, state and foreign governments continue to propose and pass new legislation designed to reduce or contain the cost of healthcare.
1 unchanged sentence
or international markets, which could have a negative effect on our business, results of operations, financial condition and prospects.
+Added: Pacira BioSciences, Inc.
+Added: | 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.
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Data from clinical trials may receive greater scrutiny, particularly with respect to safety, which may make the FDA or other regulatory authorities more likely to require additional preclinical studies or clinical trials.
−Removed: If the FDA or any other regulatory agency requires us to provide
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 53
−Removed: Table of Content s
−Removed: additional clinical or preclinical data for EXPAREL, ZILRETTA or iovera°, the indications for which these products were approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize EXPAREL, ZILRETTA or iovera° may be otherwise adversely impacted.
+Added: If the FDA or any other regulatory agency requires us to provide additional clinical or preclinical data for EXPAREL, ZILRETTA or iovera°, the indications for which these products were approved may be limited or there may be specific warnings or limitations on dosing, and our efforts to commercialize EXPAREL, ZILRETTA or iovera° may be otherwise adversely impacted.
Risks Related to Intellectual Property
7 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.
−Removed: For instance, because EXPAREL has been approved by the FDA, one or more third parties may challenge the patents covering this product, which could result in the invalidation or unenforceability of some or all of the relevant patent claims.
+Added: 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.
For example, if a third-party files an ANDA for a generic drug product containing bupivacaine and relies in whole or in part on studies conducted by or for us, the third-party will be required to certify to the FDA that either:
7 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, 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.
−Removed: 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.
+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,
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 52
+Added: 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: 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.
prior to the expiration of U.S.
11,033,495 (the ’495 patent).
−Removed: In November 2021, we filed a patent infringement suit against eVenus and its parent company in the U.S.
+Added: In November 2021, we filed a patent infringement suit against eVenus and its parent company (Jiangsu Hengrui Pharmaceuticals Co.
+Added: Ltd., or Jiangsu Hengrui) in the U.S.
District Court for the District of New Jersey (21-cv-19829) asserting infringement of the ’495 patent.
This triggered an automatic 30-month stay of final approval of the eVenus ANDA.
−Removed: On January 6, 2022, eVenus filed an Answer with counterclaims to the Complaint, alleging the ’495 patent is invalid and/or not infringed through the manufacture, sale, or offer for sale of the product described in product described in eVenus’s ANDA submission.
+Added: In January 2022, eVenus filed an Answer with counterclaims to the Complaint, alleging the ’495 patent is invalid and/or not infringed through the manufacture, sale, or offer for sale of the product described in product described in eVenus’s ANDA submission.
In December 2021, we received a second Notice Letter advising that eVenus submitted to the FDA an amendment to its ANDA with a Paragraph IV Certification seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (133 mg/10 mL) in the U.S.
4 unchanged sentences
eVenus further alleges in the Notice Letter that both the ’495 patent and the ’336 patent are invalid and/or not infringed.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 54
−Removed: Table of Content s
−Removed: In February 2022, we filed a second patent infringement suit against eVenus and its parent company in the U.S.
+Added: In February 2022, we filed a second patent infringement suit against eVenus and Jiangsu Hengrui in the U.S.
District Court for the District of New Jersey (22-cv-00718) asserting that the 133 mg/10 mL ANDA product will infringe the ’495 and ’336 patents and that the 266 mg/20 mL ANDA product will infringe the ’336 patent.
3 unchanged sentences
We have subsequently voluntarily dismissed our claims with respect to the ’336 Patent.
−Removed: The trial on the remaining claim occurred in February 2024 with a decision expected to be reached late in the first half of 2024.
−Removed: In April 2023, we filed a third patent infringement suit against eVenus, its parent company, and Fresenius Kabi USA, LLC, in the U.S.
+Added: The trial on the remaining patent was conducted in February 2024, and in August 2024, the U.S.
+Added: District Court for the District of New Jersey issued its ruling in the patent infringement suit for the ‘495 patent.
+Added: The ruling found that claim 7 of the ‘495 patent is not valid on the grounds of obviousness and anticipation.
+Added: A notice of appeal was filed in September 2024 and is ongoing.
+Added: In April 2023, we filed a third patent infringement suit against eVenus, Jiangsu Hengrui, and Fresenius Kabi USA, LLC, in the U.S.
District Court for the District of New Jersey (23-cv-2367) asserting that the 133 mg/10 mL and 266 mg/20 mL ANDA products will infringe U.S.
2 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: For more information on these litigations and other legal proceedings we are involved in, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
We are unable to predict the outcome of these litigations at this time.
+Added: 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.
+Added: The active ingredient in ZILRETTA is triamcinolone acetonide, or TCA.
+Added: Patent protection for TCA has expired and generic immediate-release products are available.
+Added: As a result, competitors who obtain the requisite regulatory approval can offer products with the same active ingredient as ZILRETTA so long as the competitors do not infringe any process, use or formulation patents covering ZILRETTA.
+Added: The commercial opportunity for ZILRETTA could be significantly harmed if competitors are able to develop and commercialize alternative extended release formulations of TCA that are outside the scope of our patents.
+Added: Furthermore, because ZILRETTA has been approved by the FDA, one or more third parties may challenge the patents covering this product, which could result in the invalidation or unenforceability of some or all of the relevant patent claims.
+Added: For example, if a third-party files an ANDA for a generic version of ZILRETTA and relies in whole or in part on studies conducted by or for us, the third-party will be required to certify to the FDA that either:
+Added: (i) there is no patent information listed in the FDA’s Orange Book with respect to our NDA for ZILRETTA;
+Added: (ii) the patents listed in the Orange Book have expired;
+Added: (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.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 53
+Added: 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: 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.
+Added: We may then initiate a lawsuit to defend the patents identified in the notice.
+Added: The filing of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third-party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled or the court reaches a decision in the infringement lawsuit in favor of the third-party.
+Added: 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.
+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 ZILRETTA.
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.
7 unchanged sentences
The commercial opportunity for iovera° could be significantly harmed if competitors are able to develop and commercialize alternative designs and methods outside the scope of our patents.
−Removed: Furthermore, the earliest patent family for iovera° is scheduled to expire in December 2025, thereby opening the door for competitors to copy some of our early technology.
+Added: Furthermore, the earliest patent family for iovera° is scheduled to expire in December 2025, thereby opening the door for competitors to copy some of our early iovera° technology.
This early patent family is primarily focused on treating cosmetic defects that are no longer the focus of iovera°, but the underlying technology is nonetheless relevant enough for there to be appreciable overlap.
1 unchanged sentence
Litigation or other proceedings to defend or enforce 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.
+Added: The patents and the patent applications that we have covering PCRX-201 are limited to composition of matter and uses of an adenoviral vector containing a nucleic acid encoding specific gene and our market opportunity for our product candidate may be limited by the patent protection and other gene therapies for treating OA that may be developed by competitors.
+Added: We reply upon a combination of intellectual property rights, including patent rights, trade secret protection, know-how and confidentiality agreements to protect intellectual property related to PCRX-201.
+Added: We have in-licensed certain issued patents covering PCRX-201 from BCM that expire between 2032 and 2033.
+Added: If we are unable to obtain additional patent protection with later expiration dates, we may not be able to compete effectively in our markets.
+Added: The intellectual property landscape around adenoviral vector delivery and expression systems is highly dynamic, and third parties may initiate and prevail in legal proceedings alleging that the patents that we in-license or owned are invalid or that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business.
+Added: Furthermore, certain inventions which we have in-licensed from BCM may have been discovered through government funded programs and thus may be subject to federal regulations under the Bayh-Dole Act of 1980.
+Added: government has certain rights also referred to as “march-in rights.” In addition, the U.S.
+Added: government also has the right to take title to these inventions if certain disclosure and reporting requirements were not met.
+Added: In addition, the U.S.
+Added: 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.
+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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 54
+Added: to manufacture substantially in the U.S.
+Added: or that under the circumstances domestic manufacture is not commercially feasible.
+Added: This preference for U.S.
+Added: manufacturers may limit our ability to contract with non-U.S.
+Added: product manufacturers for products covered by such intellectual property.
Because it is difficult and costly to protect our proprietary rights, we may not be able to ensure their protection and all patents will eventually expire.
8 unchanged sentences
Accordingly, we cannot predict the breadth of claims that may be allowed or enforced in our patents or in third-party patents.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 55
−Removed: Table of Content s
The degree of future protection for our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage.
27 unchanged sentences
An existing formulation patent for EXPAREL expired in the U.S.
−Removed: in 2013 and its equivalents in Canada, Germany, France, Spain, Italy and the U.K.
+Added: in 2013 and its equivalents in Canada, Germany, France, Spain,
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 55
+Added: Italy and the U.K.
expired in 2014.
11 unchanged sentences
In order to protect the goodwill associated with our company and product names, we rely on trademark protection for our marks.
−Removed: We have registered the “Pacira,” “EXPAREL,” “ZILRETTA” and “iovera°” marks with the USPTO.
−Removed: A third-party may assert a claim that one of our marks is confusingly similar to its mark, and such claims or the failure to timely register a mark or
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 56
−Removed: Table of Content s
−Removed: objections by the FDA or other regulatory agency could force us to select a new name for one of our product candidates, which could cause us to incur additional expense or delay the commercialization of such product.
+Added: We have registered the “Pacira,” “EXPAREL,” “ZILRETTA,” “iovera°” and other marks with the USPTO.
+Added: A third-party may assert a claim that one of our marks is confusingly similar to its mark, and such claims or the failure to timely register a mark or objections by the FDA or other regulatory agency could force us to select a new name for one of our product candidates, which could cause us to incur additional expense or delay the commercialization of such product.
If we fail to obtain or maintain patent, trade secret and/or trademark protection for EXPAREL, ZILRETTA, iovera°, our pMVL drug delivery technology or any product candidate that we may develop, license or acquire, third parties could use our proprietary information, which could impair our ability to compete in the market and adversely affect our ability to generate revenues and remain profitable.
16 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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 56
+Added: 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.
2 unchanged sentences
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 Flexion’s 3.375% Convertible Senior Notes due 2024, or Flexion 2024 Notes, 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 Flexion 2024 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 TLA Term Loan (as defined below), the 0.750% convertible senior notes due 2025, or 2025 Notes, issued in our private offering completed on July 10, 2020, and the 2.125% convertible senior notes due 2029, or 2029 Notes, issued in our private offering completed on May 14, 2024, and, together with the 2025 Notes, the Notes, each as described below, or to make cash payments in connection with any conversion of the 2025 Notes or 2029 Notes (if applicable) depends on our future performance, which is subject to economic, financial, competitive and other factors beyond our control.
Our business may not generate sufficient cash flow from operations in the future to service our indebtedness and make necessary capital expenditures.
If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such as selling assets, restructuring indebtedness or obtaining additional equity capital on terms that may be onerous or highly dilutive.
−Removed: Our ability to refinance our indebtedness will depend on the
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 57
−Removed: Table of Content s
−Removed: capital markets and our financial condition at such time.
+Added: Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time.
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: On March 31, 2023, we entered into a credit agreement (the “TLA Credit Agreement”) with JPMorgan Chase Bank, N.A., as administrative agent, and certain lenders, to refinance the indebtedness outstanding under our TLB Credit Agreement (as defined and discussed below).
+Added: 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.
+Added: 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.
+Added: 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.
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.
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: 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.
−Removed: The 2025 Notes mature on August 1, 2025.
−Removed: On May 2, 2017, Flexion issued an aggregate of $201.3 million principal amount of Flexion 2024 Notes, and entered into an indenture, or Flexion 2024 Notes Indenture, as supplemented to date, with respect to the Flexion 2024 Notes, and, together with the 2025 Indenture, the Indentures.
−Removed: The Flexion 2024 Notes accrue interest at a fixed rate of 3.375% per year, payable semiannually in arrears on May 1 and November 1 of each year.
−Removed: As a result of the Flexion Acquisition, holders of the Flexion 2024 Notes became entitled to certain Flexion Acquisition-related conversion and repurchase rights.
−Removed: Following the expiration of a Fundamental Change Company Notice and Offer to Purchase the Flexion 2024 Notes in January 2022, there were $8.6 million aggregate principal amount of Flexion 2024 Notes outstanding.
−Removed: For more information, see Note 11, Debt , to our consolidated financial statements included herein.
−Removed: In addition, as a result of the Flexion Acquisition and as discussed in more detail below, any future conversion rights are subject to the occurrence of any future events giving rise to such conversion rights under the Flexion 2024 Notes Indenture.
−Removed: The Flexion 2024 Notes mature on May 1, 2024.
−Removed: As of December 31, 2023, our total consolidated gross indebtedness was $411.1 million, which consisted of $402.5 million of principal outstanding on the 2025 Notes, $116.6 million of principal outstanding on the TLA Term Loan and $8.6 million of principal outstanding on the Flexion 2024 Notes.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: 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.
+Added: As of December 31, 2024, our total consolidated gross indebtedness was $595.3 million, which consisted of $202.5 million of principal outstanding on the 2025 Notes, $287.5 million of principal outstanding on the 2029 Notes and $105.3 million of principal outstanding on the TLA Term Loan.
See Note 10, Debt , to our consolidated financial statements included herein for more information.
9 unchanged sentences
incur additional debt or issue preferred stock;
−Removed: sell, lease or transfer our assets;
+Added: sell, lease or transfer
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 57
pay dividends on, and make other distributions on, or redeem or repurchase, our common stock;
9 unchanged sentences
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: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 58
−Removed: Table of Content s
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.
9 unchanged sentences
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, 2023, our total consolidated gross indebtedness was $411.1 million, which consisted of $402.5 million of principal outstanding on the 2025 Notes, $116.6 million of principal outstanding on the TLA Term Loan and $8.6 million of principal outstanding on the Flexion 2024 Notes.
+Added: As of December 31, 2024, our total consolidated gross indebtedness was $595.3 million, which consisted of $202.5 million of principal outstanding on the 2025 Notes, $287.5 million of principal outstanding on the 2029 Notes and $105.3 million of principal outstanding on the TLA Term Loan.
See Note 10, Debt , to our consolidated financial statements included herein for more information.
10 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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 58
+Added: 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.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 59
−Removed: Table of Content s
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, 2023, our total consolidated gross indebtedness was $411.1 million, which consisted of $402.5 million of principal outstanding on the 2025 Notes, $116.6 million of principal outstanding on the TLA Term Loan and $8.6 million of principal outstanding on the Flexion 2024 Notes.
+Added: As of December 31, 2024, our total consolidated gross indebtedness was $595.3 million, which consisted of $202.5 million of principal outstanding on the 2025 Notes, $287.5 million of principal outstanding on the 2029 Notes and $105.3 million of principal outstanding on the TLA Term Loan.
See Note 10, Debt , to our consolidated financial statements included herein for more information on our indebtedness.
13 unchanged sentences
• the commercial success of EXPAREL, ZILRETTA and iovera°;
+Added: • our ability to execute on our business strategy;
• results of clinical trials of our products, product candidates or those of our competitors;
1 unchanged sentence
• introduction of competitive products or technologies;
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 59
• failure to meet or exceed financial projections we provide to the public;
1 unchanged sentence
• failure to meet or exceed the estimates and projections of the investment community;
−Removed: • the perception of the pharmaceutical and medical device industry by the public, legislatures, regulators and the investment community;
+Added: • the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community;
• regulatory concerns or government actions;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 60
−Removed: Table of Content s
• general economic and market conditions and overall fluctuations in U.S.
3 unchanged sentences
• developments concerning our sources of manufacturing supply;
−Removed: • disputes or other developments relating to patents or other proprietary rights;
+Added: • disputes or other developments relating to patents, intellectual property or other proprietary rights;
• additions or departures of key scientific or management personnel;
4 unchanged sentences
• the other factors described in this “ Risk Factors ” section.
−Removed: In addition, the stock market in general, and the market for pharmaceutical and biotechnology 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: 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.
Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.
2 unchanged sentences
We have never declared or paid any dividends on our common stock.
−Removed: We currently intend to retain our 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: 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.
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.
3 unchanged sentences
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 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.
+Added: In addition, our stockholders, particularly but not limited to those that own 5% or more of the Company may sell a substantial number of their shares in the public market, which could also affect the market price for our common stock.
In addition, 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.
6 unchanged sentences
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: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 60
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.
3 unchanged sentences
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: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 61
−Removed: Table of Content s
−Removed: Changes in global economic conditions, including, but not limited to, those driven by inflation, 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 and inflation 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, 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 COVID-19 pandemic), or other economic factors, certain of which effects, including cost inflation and higher interest rates, we experienced in 2022 and 2023 and expect to continue to experience in 2024.
+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 (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.
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:
• 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.
• 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.
4 unchanged sentences
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 recently raised interest rates multiple times in response to concerns about inflation and it may raise them again.
−Removed: Higher interest rates, coupled with reduced government spending and volatility in financial markets may also increase economic uncertainty and negatively affect consumer spending.
+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.
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.
3 unchanged sentences
In addition, higher inflation and macro turmoil and uncertainty could also adversely affect our customers, which could reduce demand for our products.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 61
+Added: Rising international tariffs, including any tariffs applied to goods traded between the U.S.
+Added: and China, the U.S.
+Added: and Mexico and the U.S.
+Added: and Canada, could materially and adversely affect our business and results of operations.
+Added: For example, in February 2025, the current U.S.
+Added: 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.
+Added: As of the date of this Annual Report, the proposed tariffs on all imports from Mexico remain suspended.
+Added: 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.
+Added: These tariffs will increase the cost of these products and equipment and negatively impact our results of operations.
+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.
Cumulatively, we have incurred significant losses since our inception and may incur additional losses in the future.
−Removed: To date, we have focused primarily on developing and commercializing EXPAREL, and have since acquired iovera° and ZILRETTA.
−Removed: We recorded net income of $42.0 million, $15.9 million and $42.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: To date, we have focused primarily on developing and commercializing EXPAREL, and have since acquired ZILRETTA and iovera°.
+Added: 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.
As of December 31, 2024, we had an accumulated deficit of $206.4 million.
1 unchanged sentence
We incurred significant pre-commercialization expenses as we prepared for the commercial launch of EXPAREL, and we continue to incur significant sales, marketing and manufacturing expenses, as well as ongoing development expenses related to the commercialization of EXPAREL, ZILRETTA and iovera°.
−Removed: As a result, we had not been profitable prior to 2015 and were not again until 2020.
+Added: As a result, we had not been profitable prior to 2015 and incurred net losses from 2016 through 2019 and again in 2024.
Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products and medical devices, we are unable to predict the extent of future losses, if any.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 62
−Removed: Table of Content s
−Removed: A material impairment in the carrying value of our goodwill or intangible assets could negatively affect our results of operation and financial condition.
−Removed: A significant portion of our total assets is comprised of goodwill and other intangible assets.
+Added: A material impairment in the carrying value of our intangible assets or goodwill could negatively affect our results of operation and financial condition.
+Added: A significant portion of our total assets is comprised of intangible assets.
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.
+Added: generally accepted accounting principles, we are required to assess our indefinite-lived intangible assets for impairment.
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.
1 unchanged sentence
Impairment charges are recognized to the extent the carrying value exceeds its fair value.
−Removed: At December 31, 2023, the carrying value of our goodwill was $163.2 million and the carrying value of our intangible assets, net of accumulated amortization, was $483.3 million.
+Added: At December 31, 2024, the carrying value of our intangible assets, net of accumulated amortization, was $426.0 million.
If the carrying value of these assets exceeds their current estimated fair value, the assets would be considered impaired, and this would result in a noncash charge to our statement of operations, which could be material.
Events and conditions that could result in an impairment include but are not limited to:
−Removed: 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: 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.
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.
For additional information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
−Removed: Further changes to the assumptions regarding the future fair values of our goodwill and intangible assets could result in additional impairment charges in the future, which could be significant.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 62
+Added: 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: Previously, a significant portion of our total assets was comprised of goodwill.
+Added: Pursuant to U.S.
+Added: generally accepted accounting principles, we are required to assess our goodwill and 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.
+Added: In July 2024, the FDA approved a generic competitor to EXPAREL and in August 2024, a U.S.
+Added: District Court ruled that one of our EXPAREL patents was not valid.
+Added: We determined that these events, combined with a subsequent decrease in our common stock price, indicated that it was more likely than not that the fair value of goodwill may be less than its carrying value, which required us to perform a quantitative impairment test.
+Added: This quantitative impairment test resulted in our carrying value exceeding the fair value of the Company by more than the goodwill balance.
+Added: As a result, our goodwill balance of $163.2 million was fully impaired during the three months ended September 30, 2024.
+Added: For more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
+Added: 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.
+Added: For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein.
+Added: 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: 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.
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.
4 unchanged sentences
• qualify, outsource or build additional commercial-scale manufacturing of our products in accordance with CGMP;
−Removed: • in-license and develop additional product candidates;
−Removed: • refinance our Notes and Term Loan.
+Added: • acquire, in-license and develop additional product candidates;
+Added: • refinance our Notes and our TLA Term Loan.
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.
6 unchanged sentences
• the effect of competing technological and market developments;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 63
−Removed: Table of Content s
• 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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 63
+Added: bupivacaine, long-acting injections of triamcinolone or a cryoanalgesic device that infringes on the various patents covering iovera°;
+Added: • restrictions contained in the agreements governing our indebtedness.
Future capital requirements will also depend on the extent to which we acquire or invest in additional complementary businesses, products and technologies.
−Removed: Unless and until we can generate sufficiently more revenue from our products, we expect to finance or supplement future cash needs through public or private equity offerings, debt financings, stock option exercises, royalties, collaboration and licensing arrangements, as well as through interest income earned on our cash and investment balances.
+Added: Unless and until we can generate sufficiently more revenue from our products, we expect to primarily finance or supplement future cash needs through public or private equity offerings, debt financings, stock option exercises, royalties, collaboration and licensing arrangements, as well as through interest income earned on our cash and investment balances.
If needed, we cannot be certain that additional funding will be available on acceptable terms, or at all.
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• any product liability or intellectual property infringement lawsuit in which we may become involved;
−Removed: • regulatory developments, lawsuits and investigations affecting EXPAREL, ZILRETTA, iovera° or the product candidates of our competitors;
+Added: • regulatory developments, lawsuits and investigations affecting EXPAREL, ZILRETTA, iovera°, our product candidates or the products and product candidates of our competitors;
• 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.
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• increasing the scope, geographic diversity and complexity of our operations;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 64
−Removed: Table of Content s
• diversion of management’s attention from other business concerns;
• adverse effects on our or our acquired companies’ and businesses’ existing business relationships;
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 64
• unanticipated changes in applicable laws and regulations;
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The use of our net operating loss carryforwards and research and development tax credits will be limited.
−Removed: We have significant state net operating loss, or NOL, carryforwards and federal and state research and development tax credit carryforwards.
+Added: We have significant Federal and state net operating loss, or NOL, carryforwards and federal and state research and development tax credit carryforwards.
Our NOL carryforwards and research and development 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.
−Removed: We do not have any remaining Federal NOLs carried forward.
−Removed: NOLs do not expire.
+Added: We have non-U.S.
+Added: NOLs that do not expire.
Additionally, our ability to use certain NOLs to offset taxable income in the future will be limited under Internal Revenue Code Section 382 because we experienced cumulative changes in ownership of more than 50% within a three-year period.
Such ownership changes were triggered by the cumulative ownership changes arising as a result of the initial acquisition of the Company’s stock in 2007 and the completion of our initial public offering in February 2011 and our other financing transactions.
−Removed: Additionally, on November 19, 2021, we completed the Flexion Acquisition which also triggered an ownership change.
+Added: Additionally, in November 2021, we completed the Flexion Acquisition which also triggered an ownership change.
Because of these ownership changes, we will be limited regarding the amount of NOL carryforwards that we can utilize annually in the future to offset taxable income.
Such an annual limitation may significantly reduce the utilization of the NOLs before they expire.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 65
−Removed: Table of Content s
Risks Related to Information Technology, Cybersecurity and Data Privacy
2 unchanged sentences
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 access to our network or data centers;
+Added: We could also be a target of malicious attackers who attempt to gain
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 65
+Added: access to our network or data centers;
steal proprietary information related to our business, products, employees, suppliers and customers;
1 unchanged sentence
or demand a ransom to return control of such systems and services.
−Removed: Such attempts—including but not limited to—social engineering or “phishing” attempts, denial of service attacks and malware (including viruses, trojans and keyloggers) are increasing in number and in technical sophistication, and, if successful, expose us and any affected parties to risk of loss or misuse of proprietary or confidential information or disruptions of our business operations, including our manufacturing operations.
+Added: Such attempts—including but not limited to—social engineering or “phishing” attempts, denial of service attacks and malware (including viruses, trojans and keyloggers) are increasing in number, intensity and in technical sophistication, and are increasingly difficult to detect for periods of time, especially as they relate to attacks on third-party vendors, and, if successful, expose us and any affected parties to risk of loss or misuse of proprietary or confidential information or disruptions of our business operations, including our manufacturing operations.
+Added: These attacks are often carried out by motivated and highly skilled actors, who are increasingly well-resourced.
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: A substantial breach of our or one of our service providers’ systems could damage our reputation and result in the loss of revenues or the misuse of confidential data, and we may incur significant expenses to resolve such issues.
−Removed: Finally, the SEC has adopted new rules that require us to provide greater disclosures around cybersecurity risk management, strategy and governance, as well as disclose the occurrence of material cybersecurity incidents.
−Removed: We cannot predict or estimate the amount of additional costs we will incur in order to comply with these rules or the timing of such costs.
+Added: 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: 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.
+Added: Finally, the SEC has adopted rules that require us to provide greater disclosures around cybersecurity risk management, strategy and governance, as well as disclose the occurrence of material cybersecurity incidents.
+Added: 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.
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.
2 unchanged sentences
This regulatory environment is increasingly challenging and may present material obligations and risks to our business, including significantly expanded compliance burdens, costs and enforcement risks.
−Removed: 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 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.
−Removed: Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.
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 and entrust that information to third-party suppliers, including cloud service-providers 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, 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.
Our business depends upon the secure transmission of encrypted confidential information over public networks, including information permitting payments.
−Removed: A compromise of our security systems or defects within our hardware or software, or those of our suppliers, that results in our customers’ or employees’ information being obtained by unauthorized persons, could adversely affect our reputation with our customers and others, as well as our operations, results of operations, financial condition and liquidity, and could result in litigation, government actions, or the imposition of penalties.
+Added: A compromise of our security systems or defects within our hardware or software, or those of our suppliers, that results in our customers’ or our employees’ information being obtained by unauthorized persons, could adversely affect our reputation with our customers and others, as well as our operations, results of operations, financial condition and liquidity, and could result in litigation, government actions, or the imposition of penalties.
In addition, a breach could disrupt our operations and require that we expend significant additional resources related to the security of our information systems.
1 unchanged sentence
Privacy and information-security laws and regulations change, and compliance with them may result in cost increases due to, among other things, systems changes and the development of new processes.
−Removed: If we or those with whom we share information
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 66
−Removed: Table of Content s
−Removed: fail to comply with these laws and regulations, our reputation could be damaged, possibly resulting in lost future business, and we could be subjected to additional legal risk as a result of non-compliance.
+Added: If we or those with whom we share information fail to comply with these laws and regulations, our reputation could be damaged, possibly resulting in lost future business, and we could be subjected to additional legal risk as a result of non-compliance.
We have security measures and controls to protect personal and business information and continue to make investments to secure access to our information technology network.
4 unchanged sentences
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 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 66
+Added: 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.
18 unchanged sentences
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: 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.
+Added: 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.
+Added: As with many technological innovations, artificial intelligence presents risks and challenges that could impact our business.
+Added: We may adopt and integrate generative artificial intelligence tools into our systems for specific use cases reviewed by legal and information security.
+Added: 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.
+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 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.
+Added: 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: 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 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 revenue and cash flows, including potential decreases in sales, manufacturing issues, supply chain issues, including, but not
+Added: 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.
+Added: 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
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 67
−Removed: Table of Content s
−Removed: limited to, staffing shortages, cost inflation and shipping delays, and delays in payments by our customers.
+Added: | 2024 Annual Report on Form 10-K | Page 67
+Added: 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.
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.
2 unchanged sentences
Business disruptions could include disruptions or restrictions to our workforce, including the ability of our sales teams to interact with our customers and healthcare professionals to educate them on the benefits of our products and perform typical sales activities.
−Removed: For example, the COVID-19 pandemic had significantly impacted the ability of our sales representatives to access customers and healthcare professionals through personal interactions within the healthcare setting, including hospitals and ASCs.
−Removed: With the reopening of many states, the ability of our sales representatives to renew their in-person engagement efforts, in conjunction with remote efforts, has occurred across all sites of care, with more focus on physician offices and ASCs.
−Removed: In addition, any temporary closures of our manufacturing facilities or the facilities of our suppliers and contract manufacturers (and the resulting impact on production or our products) or the workforce at such facilities, could cause delays in the shipment or production of our products.
+Added: For example, the COVID-19 pandemic previously had significantly impacted the ability of our sales representatives to access customers and healthcare professionals through personal interactions within the healthcare setting, including hospitals and ASCs.
+Added: In addition, any temporary closures of our manufacturing facilities, the facilities of our suppliers and contract manufacturers (and the resulting impact on production or our products) or the workforce at such facilities, or those of our distributors, could cause delays in the shipment or production of our products.
If our customers experience disruptions to their businesses and cash flows, we could experience delays or difficulties with the collection of our accounts receivable.
Any sustained impacts and business disruptions to our facilities or workforce, our customers, our suppliers, or our contract manufacturers would likely adversely impact our cash flows, sales and operating results.
−Removed: The significant increase in the number of our employees who are working remotely as a result of the pandemic, and an extended period of remote work arrangements and subsequent reintroduction into the workplace could introduce operational risk, strain our business continuity plans, negatively impact productivity and/or collaboration, and give rise to claims by employees or otherwise adversely affect our business.
+Added: The significant increase in the number of our employees who may return to working remotely as a result of a future pandemic, and an extended period of remote work arrangements and subsequent reintroduction into the workplace could introduce operational risk, strain our business continuity plans, negatively impact productivity and/or collaboration, and give rise to claims by employees or otherwise adversely affect our business.
Additionally, a pandemic or other public health emergencies could require new or modified processes, procedures and controls to respond to changes in our business environment.
3 unchanged sentences
Ultimately, the extent to which future public health crises could impact our business is difficult to predict and will depend on many factors beyond our control, including the speed of contagion, the development and implementation of effective preventative measures and possible treatments, the scope of governmental and other restrictions on elective surgeries, travel and other activity through quarantines/social distancing and other measures, the timing of effective vaccines becoming widely available and accepted by the public, public reactions to these factors and more.
−Removed: Environmental, social and corporate governance, or ESG, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation.
−Removed: There is an increasing focus from certain investors, customers, consumers, employees, lawmakers, regulators (such as the SEC) and other stakeholders concerning ESG matters, including particular focus on climate-related risks.
−Removed: Additionally, public interest and legislative pressure related to public companies’ ESG practices continue to grow.
−Removed: If our ESG 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.
−Removed: From time to time, we communicate certain ESG initiatives and goals to market participants and our customers and business partners.
+Added: Corporate social responsibility, or CSR, issues may have an adverse effect on our business, financial condition and results of operations and damage our reputation.
+Added: There is an increasing focus from certain investors, customers, consumers, employees, lawmakers, regulators (such as the SEC) and other stakeholders concerning CSR matters, including particular focus on climate-related risks.
+Added: Additionally, public interest and legislative pressure related to public companies’ CSR practices continue to grow.
+Added: The landscape related to such regulation, compliance and reporting is constantly evolving, including expanding in scope and complexity.
+Added: 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.
+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, 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: From time to time, we communicate certain CSR initiatives and goals to market participants and our customers and business partners.
Any corporate responsibility disclosure we make may include our policies, practices, initiatives and goals on a variety of social and ethical matters, corporate governance, environmental compliance, sustainability, employee health and safety practices, human capital management, product quality, supply chain management and workforce inclusion and diversity.
−Removed: Although we have undertaken significant efforts to improve and implement our ESG initiatives, it is possible that the aforementioned parties may not be satisfied with such disclosures, our ESG practices or the speed with which we adopt, implement and/or disclose our plans.
−Removed: If our ESG practices do not meet investor or other stakeholder expectations and standards, which continue to evolve, or if we are perceived or deemed to have not appropriately responded to the growing concern for ESG issues, regardless of whether there is a legal requirement to do so, we may suffer from reputational damage from stakeholders and consumers and our business and financial condition could be materially and adversely affected.
+Added: Although we have undertaken significant efforts to improve and implement our CSR initiatives, it is possible that the aforementioned parties may not be satisfied with such disclosures, our CSR practices or the speed with which we adopt, implement and/or disclose our plans.
+Added: 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.
+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
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 68
−Removed: Table of Content s
−Removed: incur additional costs or require additional resources to monitor such stakeholder expectations and standards and to meet our targets and commitments.
+Added: | 2024 Annual Report on Form 10-K | Page 68
+Added: makes it difficult to achieve a consistently positive perception amongst all of our various stakeholders.
+Added: 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.
+Added: If our CSR practices do not meet investor or other stakeholder expectations and standards, which continue to evolve, or if we are perceived or deemed to have not appropriately responded to the growing concern for CSR issues, regardless of whether there is a legal requirement to do so, we may suffer from reputational damage from stakeholders and consumers and our business and financial condition could be materially and adversely affected.
+Added: We may also incur additional costs or require additional resources to monitor such stakeholder expectations and standards and to meet our targets and commitments.
Significant changes in the global climate, extreme weather conditions, water availability and other climate related risks could adversely affect our business or operations.
18 unchanged sentences
• difficulties in developing, staffing, and simultaneously managing our foreign operations as a result of geographic distance, language, and cultural differences;
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 69
• stringent local labor laws and regulations;
2 unchanged sentences
• import or export regulations;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 69
−Removed: Table of Content s
+Added: • trade barriers and changes in trade regulations;
+Added: including impositions of tariffs on imported raw materials and property, plant and equipment;
• compliance with the U.S.
5 unchanged sentences
• potentially adverse tax developments;
−Removed: • trade barriers and changes in trade regulations;
• political or social unrest, including but not limited to the war in Ukraine and the Israel-Hamas war, economic instability, repression, or human rights issues;
6 unchanged sentences
In addition, changes to U.S.
−Removed: trade laws may adversely impact our operations.
+Added: trade laws or the imposition of tariffs may adversely impact our operations.
These changes and any changes to the trade laws of other countries may add additional compliance costs and obligations and subject us to significant fines and penalties for non-compliance.
11 unchanged sentences
Bribery Act, there can be no assurance that our employees, business partners, or agents will not violate our policies.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 70
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.