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What changed in Pacira BioSciences, Inc.'s 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of Pacira BioSciences, Inc.'s 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+549 added−468 removedSource: 10-K (2025-02-27) vs 10-K (2024-02-29)

Top changes in Pacira BioSciences, Inc.'s 2024 10-K

549 paragraphs added · 468 removed · 364 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

131 edited+83 added−47 removed262 unchanged
Biggest changeThe Centers for Medicare and Medicaid Services (CMS) requires time to implement the NOPAIN Act, which will take effect on January 1, 2025. Once effectuated, this policy with eliminate the cost burden associated with providing Medicare patients best-in-class opioid-sparing strategies, allowing institutions the financial flexibility to treat more patients with no- and low-opioid pain management strategies.
Biggest changeThis policy eliminates the cost burden associated with providing Medicare patients best-in-class opioid-sparing strategies, allowing institutions the financial flexibility to treat more patients with no- and low-opioid pain management strategies. In October 2024, the Centers for Medicare and Medicaid Services, or CMS, established a permanent product-specific Healthcare Common Procedure Coding System, or HCPCS, J-code for EXPAREL.
In addition, the BCM patents related to PCRX-201 are issued in Europe, with an expiry date in 2032, and in Australia, Canada, China, India, Japan and Eurasia with expiry dates in 2033. We are continuing to prosecute one U.S. BCM patent application related to PCRX-201.
In addition, the BCM patents related to PCRX-201 are issued in Europe, with an expiry date in 2032, and in Australia, Canada, China, India, Japan and Eurasia with expiry dates in 2033. We are continuing to prosecute one BCM U.S. patent application related to PCRX-201.
Total Rewards In order to attract and retain talent, we maintain broad-based benefits that are provided to all employees, including our 401(k) retirement plan with an employer matching contribution made each pay period, employee stock purchase plan, flexible spending accounts, medical, dental and vision care plans, healthcare and dependent care savings accounts, life insurance, short- and long-term disability policies, paid vacation, paid sick time and paid company holidays.
Total Rewards In order to attract and retain talent, we maintain broad-based benefits that are provided to all employees, including our 401(k) retirement plan with an employer matching contribution made each pay period, an employee stock purchase plan, flexible spending accounts, medical, dental and vision care plans, healthcare and dependent care savings accounts, life insurance, short- and long-term disability policies, paid vacation, paid sick time and paid company holidays.
The foregoing references to our corporate website are not intended to, nor shall they be deemed to, incorporate information on our corporate website into this Annual Report by reference, and the inclusion of our website address in this Annual Report is an inactive textual reference only and is not intended to be an active link to our corporate website.
The foregoing references to our corporate website are not intended to, nor shall they be deemed to, incorporate information on our corporate website into this Annual Report by reference, and the inclusion of our corporate website address in this Annual Report is an inactive textual reference only and is not intended to be an active link to our corporate website.
In March 2010, President Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “Affordable Care Act”), a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
In March 2010, President Barack Obama signed into law the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act (collectively, the “Affordable Care Act”), a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms.
Over the past three years we provided support for charitable medical missions in Honduras, Ghana, Zambia, Guatemala, Ecuador, Mexico, India, Guyana, Palau and the Dominican Republic by donating EXPAREL to help support surgeries for patients in need; have supported the Louisiana State University Opioid Minimization Initiative as well as made a three-year commitment beginning in 2022 to donate EXPAREL to not-for-profit children’s hospitals each year.
Over the past three years we provided support for charitable medical missions in Honduras, Ghana, Zambia, Guatemala, Ecuador, Mexico, India, Guyana, Palau, Nigeria and the Dominican Republic by donating EXPAREL to help support surgeries for patients in need; have supported the Louisiana State University Opioid Minimization Initiative as well as made a three-year commitment beginning in 2022 to donate EXPAREL to not-for-profit children’s hospitals each year.
Furthermore, we maintain a recognition program based on our core values, known as Celebrate , through which we recognize each other’s commitment to making a meaningful difference for our patients and communities and create a shared culture where everyone is responsible for living up to and sustaining our core values.
Furthermore, we maintain a recognition program based on our core values, known as Celebrate , through which we recognize each other’s commitment to making a meaningful difference for our patients and communities and create a shared culture where everyone is responsible for living and sustaining our core values.
Based on the direct manufacturing cost, we would pay GQ a success fee within a scale of €0.5 million up to €7.5 million, plus royalties within a scale of 0.25% to 3.75% of net sales associated with PCRX-201.
Based on the direct manufacturing cost, we would pay GQ Bio a success fee within a scale of €0.5 million up to €7.5 million, plus royalties within a scale of 0.25% to 3.75% of net sales associated with PCRX-201.
We funded the cash portion of the purchase price with cash on hand, and the consideration is subject to adjustments based on the estimated fair value of the potential milestone payments. As of December 31, 2023, these contingent value rights could aggregate up to a total of $372.3 million if certain regulatory and commercial milestones are met.
We funded the cash portion of the purchase price with cash on hand, and the consideration is subject to adjustments based on the estimated fair value of the potential milestone payments. As of December 31, 2024, these contingent value rights could aggregate up to a total of $372.3 million if certain regulatory and commercial milestones are met.
Sponsors of clinical trials generally must register at the National Institutes of Health (NIH)-maintained website (www.clinicaltrials.gov) and report key findings and parameters.
Sponsors of clinical trials generally must register at the National Institutes of Health-maintained website (www.clinicaltrials.gov) and report key findings and parameters.
The number of patients taking opioids six weeks after TKA in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14 percent vs. 44 percent, p • Patients in the iovera° group demonstrated a statistically significant reduction in pain scores from their baseline pain scores at 72 hours (p We believe these data validate iovera° as a clinically meaningful non-opioid alternative for patients undergoing TKA, and that iovera° offers the opportunity to provide patients with non-opioid pain control well in advance of any necessary surgical intervention through a number of key product attributes: • iovera° is safe and effective with immediate pain relief that can last for months as the nerve regenerates over time; • iovera° is repeatable, with no diminishing effectiveness over time and repeat use; • The iovera° technology does not risk damage to the surrounding tissue; • iovera° is a convenient handheld device with a single-use procedure-specific Smart Tip; and • iovera° can be delivered precisely using ultrasound guidance or an anatomical landmark.
The number of patients taking opioids six weeks after TKA in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14 percent vs. 44 percent, p • Patients in the iovera° group demonstrated a statistically significant reduction in pain scores from their baseline pain scores at 72 hours (p We believe these data validate iovera° as a clinically meaningful non-opioid alternative for patients with knee OA as well as those undergoing TKA, and that iovera° offers the opportunity to provide patients with non-opioid pain control well in advance of any necessary surgical intervention through a number of key product attributes: • iovera° is safe and effective with immediate pain relief that can last for months as the nerve regenerates over time; • iovera° is repeatable, with no diminishing effectiveness over time and repeat use; • The iovera° technology does not risk damage to the surrounding tissue; • iovera° is a convenient handheld device with a single-use procedure-specific Smart Tip; and • iovera° can be delivered precisely using imaging guidance or an anatomical landmark.
A study published in 2021 that included 267 patients (169 who underwent cryoneurolysis with iovera° compared to 98 patients who did not receive iovera° treatment) showed that patients who were treated with iovera° had 51% lower daily morphine milligram equivalents during their hospital stay and a 22% lower mean pain score versus those who were not.
A study published in 2021 that included 267 patients undergoing TKA (169 who underwent cryoneurolysis with iovera° compared to 98 patients who did not receive iovera° treatment) showed that patients who were treated with iovera° had 51% lower daily morphine milligram equivalents during their hospital stay and a 22% lower mean pain score versus those who were not.
Orthopedics EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. In November 2023, the FDA approved our sNDA to expand the EXPAREL label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Key EXPAREL Markets Orthopedics EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. In November 2023, the FDA approved our sNDA to expand the EXPAREL label to include administration in adults as an adductor canal block and a sciatic nerve block in the popliteal fossa.
Preliminary findings demonstrated reductions in opioids, including: • The daily morphine equivalent consumption in the per protocol group analysis was significantly lower at 72 hours (p • Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.
Specifically, findings demonstrated reductions in opioids, including: • The daily morphine equivalent consumption in the per protocol group analysis was significantly lower at 72 hours (p • Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.
In our Phase 3 hemorrhoidectomy trial, EXPAREL: • delayed the median time to rescue analgesic use (opioids) to 15 hours for patients treated with EXPAREL versus one hour for patients treated with placebo; • significantly increased the percentage of patients requiring no opioid rescue medication through 72 hours post-surgery to 28%, compared to 10% for placebo; • resulted in 45% less opioid usage through 72 hours post-surgery compared to placebo; and • increased the percentage of patients who were pain free at 24 hours post-surgery compared to placebo.
In our Phase 3 hemorrhoidectomy trial, EXPAREL: • delayed the median time to opioid rescue medication to 15 hours for patients treated with EXPAREL versus one hour for patients treated with placebo; • significantly increased the percentage of patients requiring no opioid rescue medication through 72 hours post-surgery to 28%, compared to 10% for placebo; • resulted in 45% less opioid usage through 72 hours post-surgery compared to placebo; and • increased the percentage of patients who were pain free at 24 hours post-surgery compared to placebo.
This process generally involves: • completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations; • submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.; • approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated; • performance of adequate and well-controlled human clinical trials in accordance with the FDA’s Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug product for each intended use; • completion of process validation, quality product release and stability; • submission of a New Drug Application, or NDA, to the FDA; • satisfactory completion of an FDA pre-approval inspection of the product’s manufacturing facility or facilities to assess compliance with CGMP requirements and to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, quality and purity; Pacira BioSciences, Inc. | 2023 Form 10-K | Page 23 Table of Content s • satisfactory completion of an FDA advisory committee review, if applicable; and • review and approval by the FDA of the NDA.
This process generally involves: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 23 Table of Contents • completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations; • submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.; • approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated; • performance of adequate and well-controlled human clinical trials in accordance with the FDA’s Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug product for each intended use; • completion of process validation, quality product release and stability; • submission of a New Drug Application, or NDA, to the FDA; • satisfactory completion of an FDA pre-approval inspection of the product’s manufacturing facility or facilities to assess compliance with CGMP requirements and to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, quality and purity; • satisfactory completion of an FDA advisory committee review, if applicable; and • review and approval by the FDA of the NDA.
Our issued patents expire at various dates in the future, as discussed below, with the last currently issued patent for the pMVL drug delivery technology expiring in 2041, the last currently issued patent for ZILRETTA expiring in 2031 and the last currently issued utility patent for the iovera° technology expiring in 2040.
Our issued patents expire at various dates in the future, as discussed below, with the last currently issued patent for the pMVL drug delivery technology expiring in 2044, the last currently issued patent for ZILRETTA expiring in 2031 and the last currently issued utility patent for the iovera° technology expiring in 2040.
Patents and Patent Applications for our pMVL and pMVL Products In June 2021, the United States Patent and Trademark Office, or USPTO, issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, “ Manufacturing of Bupivacaine Multivesicular Liposomes ,” claims composition of EXPAREL prepared by an improved manufacturing process. In November 2021, the USPTO issued U.S.
Patents and Patent Applications for our pMVL and pMVL Products In June 2021, the United States Patent and Trademark Office, or USPTO, issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, “ Manufacturing of Bupivacaine Multivesicular Liposomes ,” claims composition of EXPAREL prepared by an improved manufacturing process developed in Swindon, U.K. In November 2021, the USPTO issued U.S.
As of December 31, 2023, we have four granted patents in China, one granted patent in Europe, one granted patent in Japan and one granted patent in Israel, protecting various aspects of the alternative process, including the methods of using the apparatus and the apparatus itself.
As of December 31, 2024, we have four granted patents in China, one granted patent in Europe, one granted patent in Japan and one granted patent in Israel, protecting various aspects of the alternative process, including the methods of using the apparatus and the apparatus itself.
As of December 31, 2023, there are over 13 families of patents and patent applications relating to various aspects of the pMVL drug delivery technology and 29 families of patents and patent applications relating to various aspects of the technology used by iovera°.
As of December 31, 2024, there are over 13 families of patents and patent applications relating to various aspects of the pMVL drug delivery technology and 29 families of patents and patent applications relating to various aspects of the technology used by iovera°.
Prior to the Flexion Acquisition, in July 2015, Flexion and Thermo Fisher entered into a Manufacturing and Supply Agreement (the “ZILRETTA Manufacturing and Supply Agreement”) and a Technical Transfer and Service Agreement related to the manufacture of ZILRETTA at the same Thermo Fisher site in Swindon, England where our EXPAREL suite is located.
Prior to the Flexion Acquisition, in July 2015, Flexion and Thermo Fisher entered into a Manufacturing and Supply Agreement (the “ZILRETTA Manufacturing and Supply Agreement”) and a Technical Transfer and Service Agreement related to the manufacture of ZILRETTA at the same Thermo Fisher site in Swindon, U.K. where our EXPAREL suite is located.
Total joint arthroplasties are expected to grow rapidly in the coming years with a significant migration of these procedures from the inpatient hospital setting to outpatient sites of care. EXPAREL-based regional analgesia as part of multimodal pain management protocols in enhanced ERAS pathways is supporting this surgical migration.
Total joint arthroplasties are expected to grow rapidly in the coming years with a significant migration of these procedures from the inpatient hospital setting to outpatient sites of care. EXPAREL-based regional analgesia as part of multimodal pain management protocols in enhanced recovery after surgery, or ERAS, pathways is supporting this surgical migration.
Activities in this facility include the manufacture of EXPAREL bulk product on dedicated production lines and its fill/finish into vials, microbiological and quality control testing, product storage, development of analytical methods and manufacturing of development products. We are expanding our EXPAREL manufacturing capacity at our Science Center Campus as we expect the demand for EXPAREL will increase.
Activities in this facility include the manufacture of EXPAREL bulk product on dedicated production lines and its fill/finish into vials, microbiological and quality control testing, product storage, development of analytical methods and manufacturing of development products. We recently expanded our EXPAREL manufacturing capacity at our Science Center Campus as we expect the future demand for EXPAREL will increase.
There are also certain requirements of state, local and foreign governments that must be complied with in the manufacture and marketing of our products. A new indication for 510(k) clearance may or may not require a clinical trial. Expanding the iovera° label to include the treatment of spasticity requires a clinical trial, which we expect to begin in 2023.
There are also certain requirements of state, local and foreign governments that must be complied with in the manufacture and marketing of our products. A new indication for 510(k) clearance may or may not require a clinical trial. Expanding the iovera° label to include the treatment of spasticity requires a clinical trial.
For example, we provide access to free biometric screenings, an employee assistance program, or EAP, and host in-person and webinar trainings on stress management and other EAP benefits, access to telemedicine including mental health visits and confidential counseling sessions for a number of needs, a health advocate service to help employees and their families navigate the healthcare system, a free consultation with an attorney for personal legal matters and discounted legal fees thereafter, activity challenges and more.
For example, we provide access to free biometric screenings, voluntary genetic testing (including enhanced support for cancer diagnoses), an employee assistance program, or EAP, and host in-person and webinar trainings on stress management and other EAP benefits, access to telemedicine including mental health visits and confidential counseling sessions for a number of needs, a health advocate service to help employees and their families navigate the healthcare system, a free consultation with an attorney for personal legal matters and discounted legal fees thereafter, activity challenges and more.
NOCITA is a registered trademark of Aratana. We are eligible to receive up to $40.0 million upon the achievement of commercial milestones. Aratana is required to pay us a tiered double-digit royalty on certain net sales made in the U.S.
NOCITA is a registered trademark of Aratana. Aratana pays us a tiered double-digit royalty on certain net sales made in the U.S., and we are eligible to receive up to $40.0 million upon the achievement of commercial milestones.
Patent Nos. 11,185,506 and 11,179,336, claiming an improved EXPAREL manufacturing process and EXPAREL composition, respectively. Eight U.S. patents relating to product and product-by-process in connection with an improved manufacturing process for EXPAREL were issued between March 2022 and November 2023, providing additional patent protection through 2041. In March 2022, the USPTO issued U.S. Patent No. 11,278,494, claiming EXPAREL composition.
Patent Nos. 11,185,506 and 11,179,336, claiming the improved U.K. EXPAREL manufacturing process and EXPAREL composition, respectively. Eight U.S. patents relating to product and product-by-process in connection with the improved U.K. manufacturing process for EXPAREL were issued between March 2022 and November 2023, providing additional patent protection through 2041. In March 2022, the USPTO issued U.S.
Item 1. Business References Pacira BioSciences, Inc., a Delaware corporation, is the holding company for our California operating subsidiary named Pacira Pharmaceuticals, Inc. In March 2007, we acquired Pacira Pharmaceuticals, Inc. from SkyePharma Holdings, Inc. (now a subsidiary of Vectura Group plc), or Skyepharma (the “Skyepharma Acquisition”).
Item 1. Business References Pacira BioSciences, Inc., a Delaware corporation, is the holding company for our California operating subsidiary named Pacira Pharmaceuticals, Inc. In March 2007, we acquired Pacira Pharmaceuticals, Inc. from SkyePharma Holdings, Inc. (now Vectura Group Limited, a subsidiary of Molex Asia Holdings, Ltd.), or Skyepharma (the “Skyepharma Acquisition”).
During the pendency of the remaining lawsuit, we will continue to pay royalties associated with the 200-liter manufacturing process to RDF under protest. We are unable to predict the outcome of this action at this time. For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein. Aratana Therapeutics, Inc.
During the pendency of the remaining lawsuit, we will continue to pay royalties associated with our enhanced larger-scale manufacturing process to RDF under protest. We are unable to predict the outcome of this action at this time. For more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein. Aratana Therapeutics, Inc.
In our Phase 3 trial as an interscalene brachial plexus nerve block for upper extremity surgeries, EXPAREL: • decreased total opioid consumption by 78% (p • reduced pain scores by 46% versus placebo (p • allowed 13% of patients who received EXPAREL to remain opioid-free for 48 hours after surgery (p In our Phase 3 trial as an adductor canal block in patients undergoing total knee arthroplasty, or TKA, EXPAREL: • achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p • achieved its secondary endpoint with a statistically significant reduction in postsurgical opioid consumption through 96 hours (p In our Phase 3 trial as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, EXPAREL: • achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p • achieved its secondary endpoints with statistically significant reductions in postsurgical opioid consumption through 96 hours (p EXPAREL can improve patient satisfaction and outcomes.
In our Phase 3 trial as an interscalene brachial plexus nerve block for upper extremity surgeries, EXPAREL: • decreased total opioid consumption by 78% (p Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 7 Table of Contents • reduced pain scores by 46% versus placebo (p • allowed 13% of patients who received EXPAREL to remain opioid-free for 48 hours after surgery (p In our Phase 3 trial as an adductor canal block in patients undergoing total knee arthroplasty, or TKA, EXPAREL: • achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p • achieved its secondary endpoint with a statistically significant reduction in postsurgical opioid consumption through 96 hours (p In our Phase 3 trial as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, EXPAREL: • achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p • achieved its secondary endpoints with statistically significant reductions in postsurgical opioid consumption through 96 hours (p EXPAREL can improve patient satisfaction and outcomes.
Thermo Fisher undertook certain technical transfer activities and construction services to prepare Thermo Fisher’s Swindon, England facility for the manufacture of EXPAREL in a dedicated manufacturing suite. We provided Thermo Fisher with the equipment necessary to manufacture EXPAREL and paid fees to Thermo Fisher based on Thermo Fisher’s achievement of certain technical transfer and construction milestones.
Thermo Fisher undertook certain technical transfer activities and construction services to prepare Thermo Fisher’s Swindon, United Kingdom, or U.K., facility for the manufacture of EXPAREL in a dedicated manufacturing suite. We provided Thermo Fisher with the equipment necessary to manufacture EXPAREL and paid fees to Thermo Fisher based on Thermo Fisher’s achievement of certain technical transfer and construction milestones.
Any drug or device that qualifies for reimbursement under the NOPAIN Act must have demonstrated the ability to reduce or avoid intraoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.
Any drug or device that qualifies for reimbursement under the NOPAIN Act must have demonstrated the ability to reduce or avoid intraoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal. The NOPAIN Act took effect on January 1, 2025.
These foreign patents cover the composition of matter, methods of manufacturing, and methods of using ZILRETTA and are similar in scope to the protection in the U.S. described above. In March 2023, we filed a provisional application relating to use ZILRETTA to treat OA pain in subpopulations of diabetic patients.
These foreign patents cover the composition of matter, methods of manufacturing, and methods of using ZILRETTA and are similar in scope to the protection in the U.S. described above. In February 2024, we filed a PCT application relating to use ZILRETTA to treat OA pain in subpopulations of diabetic patients.
Pacira Gives Back In October 2023, as part of our ongoing commitment to support the communities where we live and work, we launched our Pacira Gives Back corporate giving program, which allows our employees to find local volunteer opportunities in their communities, to encourage use of their paid day off per year, known as our Community Day.
Pacira Gives Back As part of our ongoing commitment to support the communities where we live and work, we support a corporate giving campaign— Pacira Gives Back —which allows our employees to find local volunteer opportunities in their communities and help encourage use of a paid day off per year, known as our Community Day.
Pain may persist for prolonged periods following surgery with 35 percent of patients reporting persistent thoracic pain one year post cardiac surgery. Opioids are used extensively after cardiothoracic surgery and nearly one in ten patients will continue to use opioids over 90 days after surgery.
As a result, opioids are widely used but are often inadequate. Pain may persist for prolonged periods following surgery with 35 percent of patients reporting persistent thoracic pain one year post cardiac surgery. Opioids are used extensively after cardiothoracic surgery and nearly one in ten patients will continue to use opioids over 90 days after surgery.
In September 2022, the USPTO issued U.S. Patent No. 11,452,691, claiming EXPAREL batch compositions. In November 2023, the USPTO issued U.S. Patent Nos. 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by an improved manufacturing process and compositions of EXPAREL respectively.
Patent No. 11,426,348, claiming EXPAREL batch compositions. In September 2022, the USPTO issued U.S. Patent No. 11,452,691, claiming EXPAREL batch compositions. In November 2023, the USPTO issued U.S. Patent Nos. 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by the improved U.K. manufacturing process and compositions of EXPAREL, respectively. In March 2024, the USPTO issued U.S.
There are eight utility and design patent families covering now-commercial and developing next-generation technology, which are issued or pending in the North American, European, Japanese, Chinese and Brazilian markets, which could potentially prevent others from using this now-commercial next-generation cryogenic device until at least 2040 for utility patents and 2046 for design patents.
There are also eight utility and design patent families covering various features of commercial and developing next-generation technology, which are issued or pending in the North American, European, Japanese, Chinese and Brazilian markets, which could potentially prevent others from using commercial and/or next-generation cryogenic devices until at least 2040 for utility patents and 2046 for design patents.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 6 Table of Content s Product Portfolio and Product Candidate Pipeline Our current product portfolio and product candidate pipeline, along with anticipated milestones over the next 12 to 18 months, are summarized in the table below: Pacira BioSciences, Inc. | 2023 Form 10-K | Page 7 Table of Content s Our Commercial Products EXPAREL (bupivacaine liposome injectable suspension) EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S. in April 2012.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 5 Table of Contents Product Portfolio and Product Candidate Pipeline Our current product portfolio and product candidate pipeline, along with anticipated milestones over the next 12 to 18 months, are summarized in the table below: Our Commercial Products EXPAREL (bupivacaine liposome injectable suspension) EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S. in April 2012.
This federal mandate requires Medicare to reimburse for non-opioid products, such as EXPAREL, used during all surgeries conducted in the ASC or hospital outpatient department (HOPD) setting.
This federal mandate requires Medicare to reimburse for non-opioid products, such as EXPAREL and iovera°, used during all surgeries conducted in the ASC or HOPD setting.
Although we have numerous controls to protect against common cybersecurity attacks, some attacks may still be effective. Our controls are designed to detect, triage and eradicate these attacks. Over the past three years, there have been no known material breaches, and no expenses related to the investigation of such breaches.
Although we have numerous controls to protect against common cybersecurity attacks, some attacks may still be effective. Our controls are designed to detect, triage and eradicate these attacks. Over the past three years, there have been no known material breaches, and no expenses related to the investigation of such breaches. For more information on our cybersecurity program, see Item 1C.
As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, IA (meaning in the joint) injection indicated for the management of OA knee pain. ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.
We changed the name of Flexion to Pacira Therapeutics, Inc. after completing the merger. As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, IA (meaning in the joint) injection indicated for the management of OA knee pain. ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.
Additional Intellectual Property We have entered the national phase in Brazil, China, Europe and the U.S. based on a PCT application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 21 Table of Contents Additional Intellectual Property We have entered the national phase in Brazil, China, Europe and the U.S. based on a PCT application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 15 Table of Content s Initially, the total consideration for the Flexion Acquisition was approximately $578.8 million consisting of (i) $448.5 million of cash paid to Flexion shareholders and to settle restricted stock units and certain stock options; (ii) an $85.1 million cash payment of Flexion debt not assumed by us and (iii) $45.2 million of estimated fair value of contingent consideration related to contingent value rights that were issued to Flexion shareholders and certain equity award holders in conjunction with the Flexion Acquisition.
Initially, the total consideration for the Flexion Acquisition was approximately $578.8 million consisting of: (i) $448.5 million of cash paid to Flexion shareholders and to settle restricted stock units and certain stock options; (ii) an $85.1 million cash payment of Flexion debt not assumed by Pacira and (iii) $45.2 million of estimated fair value of contingent consideration related to contingent value rights that were issued to Flexion shareholders and certain equity award holders in conjunction with the Flexion Acquisition.
We offer targeted selection training for interviewers to ensure a consistent methodology applied in identifying and hiring the best candidates for open positions and offer critical skills trainings in live and virtual settings, along with online courses available through our learning platform, including management skills training for people managers, project management and communications training.
We offer targeted selection training for interviewers to ensure a consistent methodology applied in identifying and hiring the best candidates for open positions and offer management skills trainings in live and virtual settings, along with online courses available to all employees through our learning platform.
In April 2022, the USPTO issued U.S. Patent Nos. 11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by an improved manufacturing process and EXPAREL composition, respectively. In June 2022, the USPTO issued U.S. Patent No. 11,357,727, claiming composition of EXPAREL prepared by an improved manufacturing process. In August 2022, the USPTO issued U.S. Patent No. 11,426,348, claiming EXPAREL batch compositions.
Patent No. 11,278,494, claiming EXPAREL composition. In April 2022, the USPTO issued U.S. Patent Nos. 11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by an improved manufacturing process and EXPAREL composition, respectively. In June 2022, the USPTO issued U.S. Patent No. 11,357,727, claiming composition of EXPAREL prepared by the improved U.K. manufacturing process. In August 2022, the USPTO issued U.S.
Both the PDMA and state laws limit the distribution of prescription Pacira BioSciences, Inc. | 2023 Form 10-K | Page 27 Table of Content s pharmaceutical product samples and impose requirements to ensure accountability in distribution, including a drug pedigree which tracks the distribution of prescription drugs.
Both the PDMA and state laws limit the distribution of prescription Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 27 Table of Contents pharmaceutical product samples and impose requirements to ensure accountability in distribution, including a drug pedigree which tracks the distribution of prescription drugs.
In April 2019, we acquired MyoScience, Inc., a privately held medical technology company (the “MyoScience Acquisition”) and in November 2021, we acquired Flexion Therapeutics, Inc., or Flexion, a publicly traded biopharmaceutical company (the “Flexion Acquisition”).
In April 2019, we acquired MyoScience, Inc., a privately held medical technology company (the “MyoScience Acquisition”), in November 2021, we acquired Flexion Therapeutics, Inc., or Flexion, a publicly traded biopharmaceutical company (the “Flexion Acquisition”) and in February 2025, we acquired GQ Bio Therapeutics GmbH, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”).
Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing or distribution would apply to any product that is approved in Europe, the U.K., Canada and Latin America, and Pacira BioSciences, Inc. | 2023 Form 10-K | Page 28 Table of Content s failure to comply with such obligations could have a material adverse effect on our ability to successfully commercialize any product.
Additionally, as in the U.S., post-approval regulatory requirements, such as those regarding product manufacture, marketing or distribution would apply to any product that is approved in Europe, the U.K., Canada and Latin America, and failure to comply with such obligations could have a material adverse effect on our ability to successfully commercialize any product.
Our 90,000 square-foot mixed-use research and development, manufacturing and office facility is located adjacent to our EXPAREL manufacturing facility and was completely renovated in 2020 to meet our specifications. We manufacture all of the iovera° handpieces at this facility.
This enhanced, large-scale manufacturing suite received FDA approval in February 2024. Our 90,000 square-foot mixed-use research and development, manufacturing and office facility is located adjacent to our EXPAREL manufacturing facility and was completely renovated in 2020 to meet our specifications. We manufacture all of the iovera° handpieces at this facility.
We may Pacira BioSciences, Inc. | 2023 Form 10-K | Page 18 Table of Content s terminate this agreement upon one month’s notice if a regulatory authority causes the withdrawal of ZILRETTA from the U.S. or any other market that represents 80 percent of our overall sales, or at any time for convenience by providing 24 months’ notice.
We may terminate this agreement upon one month’s notice if a regulatory authority causes the withdrawal of ZILRETTA from the U.S. or any other market that represents 80 percent of our overall sales, or at any time for convenience by providing 24 months’ notice.
Phase 1-Ready CX-011, a small molecule modulator of gp130 formulated as an intra-articular injection designed to slow joint degeneration by mediating IL-6 cytokines Knee OA Genascence Corporation Phase 1b Adeno-associated virus (AAV) based gene therapy engineered to deliver Interleukin-1 Receptor Antagonist (IL-1Ra) to target cells in joint(s) Knee OA GQ Bio Therapeutics GmbH Preclinical High-capacity adenovirus (HCAd) based gene therapy engineered to deliver DNA to target cells in joint(s) and intervertebral disc(s) Knee OA and degenerative disc disease (DDD) Spine BioPharma, LLC Phase 3 SB-01, a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1) Degenerative disc disease (DDD) Pacira BioSciences, Inc. | 2023 Form 10-K | Page 14 Table of Content s Customer-Facing Organization We have built our sales and marketing organization to commercialize our products.
Phase 1-Ready CX-011, a small molecule modulator of gp130 formulated as an IA injection designed to slow joint degeneration by mediating IL-6 cytokines Knee OA Genascence Corporation Phase 1b Adeno-associated virus (AAV) based gene therapy engineered to deliver Interleukin-1 Receptor Antagonist (IL-1Ra) to target cells in joint(s) Knee OA Spine BioPharma, LLC Phase 3 SB-01, a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1) Degenerative disc disease (DDD) Customer-Facing Organization We have built our sales and marketing organization to commercialize our products.
We recognize that accident prevention, employee wellness and efficiency of operations are directly related to quality, production and cost. Pacira operates its facilities in a manner that protects the health of its employees and minimizes the impact of its operations on the environment.
It is our policy that everyone is entitled to a safe and healthful place to work. We recognize that accident prevention, employee wellness and efficiency of operations are directly related to quality, production and cost. Pacira operates its facilities in a manner that protects the health of its employees and minimizes the impact of its operations on the environment.
If new safety issues are identified following approval, the FDA can require the NDA sponsor to revise the approved labeling to reflect the new safety information; conduct post-market studies or clinical trials to assess the new safety information and implement a REMS program to mitigate newly identified risks.
Similar reporting and pharmacovigilance obligations exist with regulatory agencies outside the U.S. If new safety issues are identified following approval, the FDA can require the NDA sponsor to revise the approved labeling to reflect the new safety information; conduct post-market studies or clinical trials to assess the new safety information and implement a REMS program to mitigate newly identified risks.
There also can be no assurance that approval or utilization of our products will be identical in different jurisdictions. Pacira BioSciences, Inc. | 2023 Form 10-K | Page 24 Table of Content s Medical Devices In the U.S., the Medical Device Amendments of 1976 to the FDCA and its subsequent amendments regulate the design, manufacture and marketing of medical devices.
There also can be no assurance that approval or utilization of our products will be identical in different jurisdictions. Medical Devices In the U.S., the Medical Device Amendments of 1976 to the FDCA and its subsequent amendments regulate the design, manufacture and marketing of medical devices.
The FDA also may approve an NDA contingent on, among other things, changes to proposed Pacira BioSciences, Inc. | 2023 Form 10-K | Page 25 Table of Content s labeling, a commitment to conduct one or more post-market studies or clinical trials and the correction of identified manufacturing deficiencies, including the development of adequate controls and specifications.
The FDA also may approve an NDA contingent on, among other things, changes to proposed labeling, a commitment to conduct one or more post-market studies or clinical trials and the correction of identified manufacturing deficiencies, including the development of adequate controls and specifications.
Two important patient groups are driving the spine market: first, pediatric cases, like adolescent scoliosis patients, who are undergoing highly invasive surgeries and who until very recently only had opioids available to treat their pain, and second, adult degenerative patients who are often coming into surgery opioid-tolerant and who may have already had multiple back surgeries.
Two important patient groups are driving the spine market: first, pediatric cases, like adolescent scoliosis patients, who are undergoing highly invasive surgeries and who until very recently Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 8 Table of Contents only had opioids available to treat their pain, and second, adult degenerative patients who are often coming into surgery opioid-tolerant and who may have already had multiple back surgeries.
Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to Pacira BioSciences, Inc. | 2023 Form 10-K | Page 31 Table of Content s “business associates”—independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.
Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to “business associates”—independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.
Either party has the right to terminate the license agreement in connection with certain Pacira BioSciences, Inc. | 2023 Form 10-K | Page 16 Table of Content s events and unless terminated earlier pursuant to its terms, the license agreement is effective until July 2033, after which Aratana has the option to extend the agreement for an additional five-year term, subject to certain requirements.
Either party has the right to terminate the license agreement in connection with certain events and unless terminated earlier pursuant to its terms, the license agreement is effective until July 2033, after which Aratana has the option to extend the agreement for an additional five-year term, subject to certain requirements.
These utility patents generally have a term of 20 years from the date of the non-provisional filing unless claiming priority to an earlier filed non-provisional application. Some of our expired U.S. patents had a term of 17 years from the grant date.
These utility patents generally have a term of 20 years from the date of the non-provisional filing unless claiming priority to an earlier filed non-provisional application.
Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, oral Na V 1.8 pain signal inhibitors, novel opioids, new formulations of currently available opioids and NSAIDs, long-acting local anesthetics and new chemical entities as well as alternative delivery forms of various opioids and NSAIDs.
Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, oral Na V 1.8 pain signal inhibitors, novel opioids, new formulations of currently Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 22 Table of Contents available opioids and NSAIDs, long-acting local anesthetics and new chemical entities as well as alternative delivery forms of various opioids and NSAIDs.
In addition, we also filed a provisional application in 2023 covering compositions and method of use of PCRX-201 in combination with a corticosteroid.
In February 2024, we also filed a PCT application covering compositions and method of use of PCRX-201 in combination with a corticosteroid.
ZILRETTA is also manufactured using custom equipment and proprietary processes with respect to certain of the formulation and manufacturing Pacira BioSciences, Inc. | 2023 Form 10-K | Page 21 Table of Content s techniques related to the TA-formulated PLGA microspheres in ZILRETTA, including those that relate to its precise pharmaceutical release profile.
ZILRETTA is also manufactured using custom equipment and proprietary processes with respect to certain of the formulation and manufacturing techniques related to the TA-formulated PLGA microspheres in ZILRETTA, including those that relate to its precise pharmaceutical release profile.
In addition, we Pacira BioSciences, Inc. | 2023 Form 10-K | Page 34 Table of Content s regularly use our corporate website to post information regarding our business, product development programs and corporate governance, and we encourage investors to use our website, particularly the information in the sections entitled “Investors” and “News,” as a source of information about us.
In addition, we regularly use our corporate website to post information regarding our business, product development programs and corporate governance, and we encourage investors to use our website, particularly the information in the sections entitled “Investors” and “News,” as a source of information about us.
Some of our strongest data relates directly to the improvement of OA pain of the knee. Surgical intervention is typically a last resort for patients suffering from OA pain of the knee. In one study, the majority of the patients suffering from OA pain of the knee experienced pain relief up to 150 days after being treated with iovera°.
Some of our strongest data relates directly to the improvement of OA pain of the knee. In a pivotal trial evaluating iovera° for knee OA pain, the majority of the patients suffering from OA pain of the knee experienced pain relief up to 150 days after being treated with iovera°.
We have also in-licensed intellectual property, owned by the Southwest Research Institute, or SwRI, which gives us exclusive rights to SwRI patents covering our proprietary microsphere manufacturing technology used in the production of ZILRETTA. These patents are scheduled to expire in September 2025.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 20 Table of Contents We have also in-licensed intellectual property, owned by the Southwest Research Institute, or SwRI, which gives us exclusive rights to SwRI patents covering our proprietary microsphere manufacturing technology used in the production of ZILRETTA. These patents are scheduled to expire in September 2025.
Employees As of December 31, 2023, we had 712 employees, of which 711 are full-time and one is part-time. All of our employees are based in the U.S. except for 11 employees based in England. None of our employees are represented by a labor union, and we consider our current employee relations to be good.
Employees As of December 31, 2024, we had 790 employees, of which 788 are full-time and two are part-time. All of our employees are based in the U.S. except for seven employees based in the U.K. None of our employees are represented by a labor union, and we consider our current employee relations to be good.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 33 Table of Content s Employee Wellbeing, Health and Safety Pacira is committed to the total wellbeing of our employees and their families. We offer a range of benefits designed to meet individual needs and help employees and their families live healthy lives.
Employee Wellbeing, Health and Safety Pacira is committed to the total wellbeing of our employees and their families. We offer a range of benefits designed to meet individual needs and help employees and their families live healthy lives.
In December 2022, the NOPAIN Act was signed into law as part of the Biden Administration’s Consolidated Appropriations Act of 2023. The NOPAIN Act is preventative legislation aimed at tackling the opioid crisis by incentivizing the use of non-opioids to manage surgical pain for Medicare patients treated in ASC and hospital outpatient department, or HOPD, settings.
The NOPAIN Act is preventative legislation aimed at tackling the opioid crisis by incentivizing the use of non-opioids to manage surgical pain for Medicare patients treated in ASC and hospital outpatient department, or HOPD, settings.
External Innovation In parallel to our internal clinical programs, we are pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 14 Table of Contents External Innovation In parallel to our internal clinical programs, we are pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.
Environmental Matters Our research and development processes and our manufacturing processes involve the controlled use of hazardous materials and chemicals and produce waste products, including pharmaceutical residues. We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products, including those related to pharmaceutical residues.
We are subject to federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous materials and waste products, including those related to pharmaceutical residues.
Furthermore, the American Association of Hip & Knee Surgeons (AAHKS) issued a position statement indicating that it cannot recommend biologic therapies, including stem cell and PRP injections, for the treatment of advanced hip or knee arthritis.
Furthermore, the American Association of Hip & Knee Surgeons (AAHKS) issued a position statement indicating that it cannot recommend biologic therapies, including stem cell and PRP injections, for the treatment of advanced hip or knee arthritis. iovera° The medical device industry is intensely competitive and subject to rapid and significant technological change.
Considerable expertise and effort were required to carry out the large body of original work underlying the formulation of ZILRETTA, including experimenting with, and observing the effects of over 50 steroid and poly lactic-co-glycolic acid, or PLGA, formulations.
The USPTO has also issued two patents directed at the methods of manufacturing and using ZILRETTA with patent terms into 2031. Considerable expertise and effort were required to carry out the large body of original work underlying the formulation of ZILRETTA, including experimenting with, and observing the effects of over 50 steroid and poly lactic-co-glycolic acid, or PLGA, formulations.
De-identified data from 300 patients who received EXPAREL were compared to data from 300 patients who did not receive an infiltration of EXPAREL. Data from two outpatient oral surgery centers were included in this analysis.
In this retrospective analysis, researchers reviewed data from 600 patients who underwent third molar extractions between 2012 and 2018. De-identified data from 300 patients who received EXPAREL were compared to data from 300 patients who did not receive an infiltration of EXPAREL. Data from two outpatient oral surgery centers were included in this analysis.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 17 Table of Content s Our 84,000 square-foot EXPAREL manufacturing facility at the Science Center Campus is located on a five-acre site. It was custom built as a pharmaceutical research and development and manufacturing facility.
Our 84,000 square-foot EXPAREL manufacturing facility at the Science Center Campus is located on a five-acre site. It was custom built as a pharmaceutical research and development and manufacturing facility.
We received notification from the FDA in October 2023 that our pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients. • Stellate ganglion block.
We received notification from the FDA in October 2023 that our pediatric studies requirement had been waived for the indication of brachial plexus interscalene nerve block to produce postsurgical regional analgesia in pediatric patients as well as sciatic nerve block in the popliteal fossa and adductor canal block indications in October 2024. • Global activities.
The iovera° system is highly complementary to EXPAREL and ZILRETTA as a non-opioid therapy that alleviates pain using a non-pharmacological nerve block to disrupt pain signals being transmitted to the brain from the site of injury or surgery. It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days.
The iovera° system is highly complementary to EXPAREL and ZILRETTA as a locally administered, non-opioid therapy that alleviates pain using a non-pharmacological nerve block to disrupt pain signals being transmitted to the brain from the site of injury or surgery.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 8 Table of Content s EXPAREL Clinical Benefits We believe EXPAREL can replace the use of bupivacaine delivered via elastomeric pumps as the foundation of a multimodal regimen for long-acting postsurgical pain management.
EXPAREL Clinical Benefits We believe EXPAREL can replace the use of bupivacaine delivered via elastomeric pumps as the foundation of a multimodal regimen for long-acting postsurgical pain management.
Women’s Health is a key target market as anesthesia-driven EXPAREL-based TAP and pectoralis blocks take hold as institutional protocol for Cesarean section, abdominoplasty, gynecologic oncology, mastectomy and breast reconstruction procedures.
Women’s Health is a key target market as anesthesia-driven EXPAREL-based TAP and pectoralis blocks take hold as institutional protocol for Cesarean section, abdominoplasty, gynecologic oncology, mastectomy and breast reconstruction procedures. Cardiothoracic Cardiothoracic surgery is considered one of the most painful types of surgical procedures for both open and minimally invasive procedures.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 11 Table of Content s ZILRETTA Clinical Benefits ZILRETTA combines a commonly administered steroid, TA, with a proprietary, extended-release microsphere technology to administer extended therapeutic concentrations in the joint and persistent analgesic effect.
ZILRETTA Clinical Benefits ZILRETTA combines a commonly administered steroid, TA, with a proprietary, extended-release microsphere technology to administer extended therapeutic concentrations in the joint and persistent analgesic effect.
After the FDA evaluates the NDA and the manufacturing facilities, it may issue an approval letter or a Complete Response Letter, or CRL, to indicate that the review cycle for an application is complete and that the application is not ready for approval.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 25 Table of Contents After the FDA evaluates the NDA and the manufacturing facilities, it may issue an approval letter or a Complete Response Letter, or CRL, to indicate that the review cycle for an application is complete and that the application is not ready for approval.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeOur business model is to commercialize our products in the U.S. and abroad, occasionally 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. Any future collaboration arrangements that we enter into may not be successful.
Biggest changeAny collaboration arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our product candidates. Our business model is to commercialize our products in the U.S. while seeking collaboration arrangements with pharmaceutical or biotechnology companies for the development or commercialization of our products in other countries.
There can be no assurance that such distributors and promoters will be successful in marketing and promoting our products. 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.
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.
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. Our management, personnel, systems and facilities currently in place may not be adequate to support this future growth.
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.
As part of the settlement, we admitted to no wrongdoing and explicitly denied the Plaintiffs’ allegations. We have been given assurances that this concluded the investigation that originated from the U.S. Department of Justice subpoena in April 2015.
As part of the settlement, we admitted to no wrongdoing and explicitly denied the Plaintiffs’ allegations. We have been given assurances that this settlement concluded the investigation that originated from the U.S. Department of Justice subpoena in April 2015.
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. 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.
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. 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.
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.
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.
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.
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.
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.
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.
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.
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.
Any significant volatility in the price of our common stock may adversely affect our ability to attract or retain highly skilled and technical personnel.
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.
In July 2022, we submitted a letter to HK Tainuo associated with this license agreement seeking a mutual decision to end the licensing agreement and made a $13.0 million termination payment to HK Tainuo in January 2023. For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
In July 2022, we submitted a letter to HK Tainuo associated with this license agreement seeking a mutual decision to end the licensing agreement and made a $13.0 million termination payment to HK Tainuo in January 2023. For more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
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.
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.
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.
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.
We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources. From time to time, we are called upon to defend ourselves against lawsuits relating to our business. Due to the inherent uncertainties of litigation, we cannot accurately predict the ultimate outcome of any such proceedings.
We are subject to periodic litigation, which could result in losses or unexpected expense of time and resources. 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.
However, these business activities may entail numerous operational and financial risks, including: • significant capital expenditures; • difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies; • incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products; • the successful integration of acquired products, businesses or technologies into our operations, and achieving the expected benefits and synergies from such acquisitions; • 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; • difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; • inability to retain key employees of any acquired businesses; • difficulty entering markets in which we have limited or no direct experience; • difficulty in managing multiple product development programs; and • inability to successfully develop new products or clinical failure.
However, these business activities may entail numerous operational and financial risks, including: • significant capital expenditures; • the difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies; • the incurrence of substantial debt or dilutive issuances of securities to pay for the development, acquisition or in-licensing of new products and any related milestone or earn-out payments; • the successful integration of acquired products, businesses or technologies into our operations, and achieving the expected benefits and synergies from such acquisitions; • the disruption of our business and diversion of our management’s time and attention; • higher than expected development, acquisition or in-license and integration costs; • exposure to unknown liabilities; • the difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel; • the inability to retain key employees of any acquired businesses; • the difficulty entering markets in which we have limited or no direct experience; • the difficulty in managing multiple product development programs; and • the inability to successfully develop new products or clinical failure.
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.
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.
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. 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.
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.
In July 2023, eVenus filed its answer with claims for declaratory judgment, alleging patent invalidity, non-infringement and inequitable conduct with respect to the ’348 patent as well as our other patents, U.S. Patent Nos. 11,278,494; 11,304,904; 11,311,486; 11,357,727 and 11,452,691.The parties have subsequently dismissed all patents other than the ’348 patent from this litigation.
Patent No. 11,426,348 (the ’348 patent). In July 2023, eVenus filed its answer with claims for declaratory judgment, alleging patent invalidity, non-infringement and inequitable conduct with respect to the ’348 patent as well as our other patents, U.S. Patent Nos. 11,278,494; 11,304,904; 11,311,486; 11,357,727 and 11,452,691.The parties have subsequently dismissed all patents other than the ’348 patent from this litigation.
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.
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.
Thus, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. In order to protect the goodwill associated with our company and product names, we rely on trademark protection for our marks. We have registered the “Pacira,” “EXPAREL,” “ZILRETTA” and “iovera°” marks with the USPTO.
Thus, courts outside the U.S. are sometimes less willing to protect trade secrets. Moreover, our competitors may independently develop equivalent knowledge, methods and know-how. In order to protect the goodwill associated with our company and product names, we rely on trademark protection for our marks. We have registered the “Pacira,” “EXPAREL,” “ZILRETTA,” “iovera°” and other marks with the USPTO.
We may need to expand our manufacturing operations or outsource such operations to third parties. 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.
We may need to expand our manufacturing operations or outsource such operations to third parties. 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.
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. Our ability to meet such excess demand could also depend on our ability to raise additional capital and effectively scale our manufacturing operations.
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. 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.
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; 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.
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.
We will also need to demonstrate acceptable evidence of safety and efficacy, as well as relative convenience and ease of administration. 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.
We will also need to demonstrate acceptable evidence of safety and efficacy, as well as relative convenience and ease of administration. 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.
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. There can be no assurances that future government mandates will not occur or that critical raw materials will not be prioritized for other products.
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. 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.
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. In particular, we are highly dependent on the skills and leadership of our senior management team.
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.
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.
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. site, exposes us to significant up-front fixed costs.
Market acceptance of ZILRETTA will depend on a number of factors, including: • the efficacy and safety as demonstrated in clinical trials; • the ability to demonstrate the impact of real-world evidence; • the timing and market introduction of competitive products; • the product label and clinical indications for which the product is approved; • acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; • the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies; Pacira BioSciences, Inc. | 2023 Form 10-K | Page 37 Table of Content s • the convenience of prescribing, administrating and initiating patients on the product; • the potential and perceived advantages or value of the product over alternative treatments; • the cost of treatment in relation to alternative treatments, including any similar generic treatments; • the economics of a buy-and-bill product and discounts and rebates we offer; • the availability of coverage and adequate reimbursement by third-party payers and government authorities to support pricing; • the prevalence and severity of adverse side effects; and • the effectiveness of sales and marketing efforts.
Market acceptance of ZILRETTA will depend on a number of factors, including: Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 36 Table of Contents • the efficacy and safety as demonstrated in clinical trials; • the ability to demonstrate the impact of real-world evidence; • the timing and market introduction of competitive products; • the product label and clinical indications for which the product is approved; • acceptance by physicians, the medical community and patients of the product as a safe and effective treatment; • the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies; • the convenience of prescribing, administrating and initiating patients on the product; • the potential and perceived advantages or value of the product over alternative treatments; • the cost of treatment in relation to alternative treatments, including any similar generic treatments; • the economics of a buy-and-bill product and discounts and rebates we offer; • the availability of coverage and adequate reimbursement by third-party payers and government authorities to support pricing; • the prevalence and severity of adverse side effects; and • the effectiveness of sales and marketing efforts.
We and Thermo Fisher have entered into a Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing and Supply Agreement. Under these agreements, Thermo Fisher undertook certain technical transfer activities and construction services to prepare their Swindon, England facility for the manufacture of EXPAREL.
We and Thermo Fisher have entered into a Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing and Supply Agreement. Under these agreements, Thermo Fisher undertook certain technical transfer activities and construction services to prepare their Swindon, U.K. facility for the manufacture of EXPAREL.
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. 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.
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. 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.
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.
For instance, because EXPAREL has been approved by the FDA, one or more third parties may challenge the patents covering this product, as described below, which could result in the invalidation or unenforceability of some or all of the relevant patent claims.
In addition, we have obtained limited property and business interruption insurance coverage for our manufacturing sites in San Diego, England and Mexico. However, our insurance coverage may not reimburse us, or may not be sufficient to reimburse us, for any expenses or losses we may suffer.
In addition, we have obtained limited property and business interruption insurance coverage for our manufacturing sites in San Diego, U.K. and Mexico. However, our insurance coverage may not reimburse us, or may not be sufficient to reimburse us, for any expenses or losses we may suffer.
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.
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. where our EXPAREL suites are located.
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; San Diego, California; northern New Jersey/New York City metro and Houston, Texas.
We may not be able to attract or retain qualified management and commercial, scientific and clinical personnel due to the intense competition for qualified personnel among biotechnology, pharmaceutical, medical device and other businesses, as well as universities, non-profit research organizations and government entities, particularly in and around the San Francisco Bay Area; San Diego, California; northern New Jersey/New York City metro and Tampa, Florida.
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.
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 stock could be subject to wide fluctuations in price in response to various factors, including the following: • the commercial success of EXPAREL, ZILRETTA and iovera°; • results of clinical trials of our products, product candidates or those of our competitors; • changes or developments in laws or regulations applicable to our products or product candidates; • introduction of competitive products or technologies; • failure to meet or exceed financial projections we provide to the public; • actual or anticipated variations in quarterly operating results; • failure to meet or exceed the estimates and projections of the investment community; • the perception of the pharmaceutical and medical device industry by the public, legislatures, regulators and the investment community; • regulatory concerns or government actions; Pacira BioSciences, Inc. | 2023 Form 10-K | Page 60 Table of Content s • general economic and market conditions and overall fluctuations in U.S. equity markets and the impact of macroeconomic developments, such as general political, health and economic conditions, economic slowdowns, recessions, inflation, rising interest rates and the tightening of credit markets; • increased interest rates and their generally negative effect on U.S. equity markets; • developments concerning our sources of manufacturing supply; • disputes or other developments relating to patents or other proprietary rights; • additions or departures of key scientific or management personnel; • the extent to which we acquire or invest in products, businesses and technologies; • issuances of debt, equity or convertible securities; • changes in the market valuations of similar companies; • evolving investor expectations and concerns regarding environmental, social and corporate governance issues; and • the other factors described in this “ Risk Factors ” section.
Our stock could be subject to wide fluctuations in price in response to various factors, including the following: • the commercial success of EXPAREL, ZILRETTA and iovera°; • our ability to execute on our business strategy; • results of clinical trials of our products, product candidates or those of our competitors; • changes or developments in laws or regulations applicable to our products or product candidates; • introduction of competitive products or technologies; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 59 Table of Contents • failure to meet or exceed financial projections we provide to the public; • actual or anticipated variations in quarterly operating results; • failure to meet or exceed the estimates and projections of the investment community; • the perception of the pharmaceutical, biotechnological and medical device industry by the public, legislatures, regulators and the investment community; • regulatory concerns or government actions; • general economic and market conditions and overall fluctuations in U.S. equity markets and the impact of macroeconomic developments, such as general political, health and economic conditions, economic slowdowns, recessions, inflation, rising interest rates and the tightening of credit markets; • increased interest rates and their generally negative effect on U.S. equity markets; • developments concerning our sources of manufacturing supply; • disputes or other developments relating to patents, intellectual property or other proprietary rights; • additions or departures of key scientific or management personnel; • the extent to which we acquire or invest in products, businesses and technologies; • issuances of debt, equity or convertible securities; • changes in the market valuations of similar companies; • evolving investor expectations and concerns regarding environmental, social and corporate governance issues; and • the other factors described in this “ Risk Factors ” section.
In the U.S., the laws that directly or indirectly affect our ability to operate our business include the following: • the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration—directly or indirectly—in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid; • other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment; • the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government; • the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and • various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
In the U.S., the laws that directly or indirectly affect our ability to operate our business include the following: • the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration—directly or indirectly—in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 49 Table of Contents • other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment; • the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government; • the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and • various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
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.
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.
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. For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
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. For more information regarding our pediatric study obligations, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
See Note 11, Debt , to our consolidated financial statements included herein for more information on our indebtedness.
See Note 10, Debt , to our consolidated financial statements included herein for more information on our indebtedness.
The degree of market acceptance of EXPAREL also depends on a number of other factors, including: • changes in the standard of care for the targeted indications for EXPAREL, which could reduce the marketing impact of any claims that we can make; • the relative efficacy, convenience and ease of administration of EXPAREL; • the prevalence and severity of adverse events associated with EXPAREL; • the cost of treatment versus economic and clinical benefit, both in absolute terms and in relation to alternative treatments; • 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; • 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; and • 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.
The degree of market acceptance of EXPAREL also depends on a number of other factors, including: • changes in the standard of care for the targeted indications for EXPAREL, which could reduce the marketing impact of any claims that we can make; • the relative efficacy, convenience and ease of administration of EXPAREL; • the prevalence and severity of adverse events associated with EXPAREL; • the cost of treatment versus economic and clinical benefit, both in absolute terms and in relation to alternative treatments; • 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; • potential future entrance into the market of a generic version of EXPAREL; and • 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.
Patent No. 11,033,495 (the ’495 patent). In November 2021, we filed a patent infringement suit against eVenus and its parent company 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.
Patent No. 11,033,495 (the ’495 patent). In November 2021, we filed a patent infringement suit against eVenus and its parent company (Jiangsu Hengrui Pharmaceuticals Co. 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.
Our need to effectively manage our operations, growth and various projects requires that we: Pacira BioSciences, Inc. | 2023 Form 10-K | Page 40 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; • continue to establish and maintain effective relationships with distributors and commercial partners for the promotion and sale of our products; • ensure that our distributors, partners, suppliers, consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines; • manage our development efforts and clinical trials effectively; • expand our manufacturing capabilities and effectively manage our co-production arrangements with Thermo Fisher and Carlisle; • continue to carry out our own contractual obligations to our licensors and other third parties; and • continue to improve our operational, financial and management controls, reporting systems and procedures.
Our need to effectively manage our operations, growth and various projects requires that we: • continue the hiring and training of an effective commercial organization for the commercialization of EXPAREL, ZILRETTA and iovera°, and establish appropriate systems, policies and infrastructure to support that organization; • continue to establish and maintain effective relationships with distributors and commercial partners for the promotion and sale of our products; • ensure that our distributors, partners, suppliers, consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines; • manage our development efforts and clinical trials effectively; • expand our manufacturing capabilities and effectively manage our co-production arrangements with Thermo Fisher and Carlisle; • continue to carry out our own contractual obligations to our licensors and other third parties; and • continue to improve our operational, financial and management controls, reporting systems and procedures.
Our 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.
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 stock price is volatile, and from February 3, 2011, the first day of trading of our common stock, to February 28, 2024, the trading prices of our stock have ranged from $6.16 to $121.95 per share.
Our stock price is volatile, and from February 3, 2011, the first day of trading of our common stock, to February 26, 2025, the trading prices of our stock have ranged from $6.16 to $121.95 per share.
Our ability to effectively generate revenues from EXPAREL and ZILRETTA will depend on our ability to, among other things: • create further market demand for EXPAREL and ZILRETTA through our marketing and sales activities and other arrangements established for their promotion; • train, deploy and support a qualified sales force; • secure formulary approvals for EXPAREL at a substantial number of targeted hospitals and ASCs; • manufacture EXPAREL and ZILRETTA in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand; • implement and maintain agreements with wholesalers and distributors on commercially reasonable terms; • appropriately prepare the market to take advantage of EXPAREL reimbursement for Medicare patients receiving surgery in the outpatient setting beginning in 2025; • receive adequate levels of coverage and reimbursement for EXPAREL and ZILRETTA from commercial health plans and governmental health programs; • maintain compliance with regulatory requirements; • obtain regulatory approvals for additional indications and geographic expansion for the use of EXPAREL and ZILRETTA; • ensure that our entire supply chain efficiently and consistently delivers EXPAREL and ZILRETTA to our customers; and • maintain and defend our patent protection and regulatory exclusivity for EXPAREL and ZILRETTA.
Our ability to effectively generate revenues from EXPAREL and ZILRETTA will depend on our ability to, among other things: • create further market demand for EXPAREL and ZILRETTA through our marketing and sales activities and other arrangements established for their promotion; • train, deploy and support a qualified sales force; • secure formulary approvals for EXPAREL at a substantial number of targeted hospitals and ASCs; • manufacture EXPAREL and ZILRETTA in sufficient quantities in compliance with requirements of regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand; • implement and maintain agreements with wholesalers and distributors on commercially reasonable terms; • appropriately help the market to take advantage of EXPAREL reimbursement at ASP plus 6 percent for Medicare patients receiving surgery in the outpatient setting; • receive adequate levels of coverage and reimbursement for EXPAREL and ZILRETTA from commercial health plans and governmental health programs; • maintain compliance with regulatory requirements; • obtain regulatory approvals for additional indications and geographic expansion for the use of EXPAREL and ZILRETTA; • ensure that our entire supply chain efficiently and consistently delivers EXPAREL and ZILRETTA to our customers; and • maintain and defend our patent protection and regulatory exclusivity for EXPAREL and ZILRETTA, including our ongoing patent litigation lawsuits against eVenus, Jiangsu Hengrui and Fresenius.
Any such failure may result in decreased sales, 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.
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.
Our failure, or the failure of any contract manufacturers with whom we may work in the future, to comply with the laws administered by the FDA, EMA, the MHRA or other governmental authorities could result in, among other things, any of the following: • product recall or seizure; • suspension or withdrawal of an approved product from the market; • interruption of production; • reputational concerns of our customers or the medical community; • operating restrictions; • warning letters; • injunctions; • refusal to permit import or export of an approved product; • refusal to approve pending applications or supplements to approved applications that we submit; • denial of permission to file an application or supplement in a jurisdiction; • consent decrees; • suspension or termination of ongoing clinical trials; • fines and other monetary penalties; • criminal prosecutions; and • unanticipated expenditures.
Our failure, or the failure of any contract manufacturers with whom we may work in the future, to comply with the laws administered by the FDA, EMA, the MHRA or other governmental authorities could result in, among other things, any of the following: • product recall or seizure; • suspension or withdrawal of an approved product from the market; • interruption of production; • reputational concerns of our customers or the medical community; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 50 Table of Contents • operating restrictions; • warning letters; • injunctions; • refusal to permit import or export of an approved product; • refusal to approve pending applications or supplements to approved applications that we submit; • denial of permission to file an application or supplement in a jurisdiction; • consent decrees; • suspension or termination of ongoing clinical trials; • fines and other monetary penalties; • criminal prosecutions; and • unanticipated expenditures.
Our 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.
Our San Diego facilities in California, the Thermo Fisher facility in Swindon, U.K. and the Carlisle facility in Tijuana, Mexico are also subject to the risks of a natural or man-made disaster, including, but not limited to, storms, earthquakes, floods, fires or other business disruptions.
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.
We have never declared or paid any dividends on our common stock. 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.
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. Similarly, if costs of goods continue to increase, our suppliers may seek price increases from us.
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. Tariffs can increase our manufacturing costs and if costs of goods continue to increase, our suppliers may seek price increases from us.
During 2023, sales of EXPAREL accounted for 80% of our total revenue, and we expect EXPAREL sales will remain of primary importance for the foreseeable future. We added ZILRETTA to our product portfolio upon completing the Flexion Acquisition in November 2021 and it accounted for 16% of our total revenue in 2023.
During 2024, sales of EXPAREL accounted for 78% of our total revenue, and we expect EXPAREL sales will remain of primary importance for the foreseeable future. We added ZILRETTA to our product portfolio upon completing the Flexion Acquisition in November 2021 and it accounted for 17% of our total revenue in 2024.
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).
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.
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.
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.
The FDA also approved a labeling supplement for EXPAREL that further clarified that EXPAREL was not limited to any specific surgery type or site, that the proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, that there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy trial and that EXPAREL may be admixed with bupivacaine, provided certain medication ratios are observed.
The FDA also approved a labeling supplement for EXPAREL that further clarified that EXPAREL was not limited to any specific surgery type or site, that the proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, that there was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy trial and that EXPAREL may be admixed with bupivacaine, provided certain Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 47 Table of Contents medication ratios are observed.
In order to continue commercializing our products effectively, we must continue to build our marketing, sales and distribution capabilities. The establishment, development and training of our sales force and related compliance plans to market our products is expensive and time consuming.
We are continuing to build our commercial infrastructure for the marketing, sale and distribution of pharmaceutical products. In order to continue commercializing our products effectively, we must continue to build our marketing, sales and distribution capabilities. The establishment, development and training of our sales force and related compliance plans to market our products is expensive and time consuming.
Although certain of the agreements governing our existing indebtedness contain restrictions on the incurrence of additional indebtedness and entering into certain types of other transactions, these restrictions are subject to a number of qualifications and exceptions, including compliance with various financial conditions. Additional indebtedness incurred in compliance with our existing debt instruments could be substantial.
We may be able to incur substantial additional indebtedness in the future. Although certain of the agreements governing our existing indebtedness contain restrictions on the incurrence of additional indebtedness and entering into certain types of other transactions, these restrictions are subject to a number of qualifications and exceptions, including compliance with various financial conditions.
The TLA Credit Agreement and the Indentures also contain certain restrictive covenants that limit, and in some circumstances prohibit, our ability to, among other things: incur additional debt or issue preferred stock; sell, lease or transfer our assets; pay dividends on, and make other distributions on, or redeem or repurchase, our common stock; make certain capital expenditures and investments; guarantee debt or obligations; create certain liens; enter into transactions with our affiliates; and enter into certain merger, consolidation or other reorganization transactions.
The TLA Credit Agreement and the Indentures also contain certain restrictive covenants that limit, and in some circumstances prohibit, our ability to, among other things: incur additional debt or issue preferred stock; sell, lease or transfer Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 57 Table of Contents our assets; pay dividends on, and make other distributions on, or redeem or repurchase, our common stock; make certain capital expenditures and investments; guarantee debt or obligations; create certain liens; enter into transactions with our affiliates; and enter into certain merger, consolidation or other reorganization transactions.
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 Pacira BioSciences, Inc. | 2023 Form 10-K | Page 56 Table of Content s 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.
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.
We are unable to predict the outcome of these litigations at this time. 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.
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.
EXPAREL also faces competition from currently marketed non-opioid products such as bupivacaine, marcaine, ropivacaine and other Pacira BioSciences, Inc. | 2023 Form 10-K | Page 38 Table of Content s 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.
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.
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.
Furthermore, if we are unable to meet our debt service obligations or should we fail to comply with our financial and other negative covenants contained in the agreements governing our indebtedness, we may be required to refinance all or part of Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 58 Table of Contents our debt, sell important strategic assets at unfavorable prices, incur additional indebtedness or issue common stock or other equity securities.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 49 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.
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.
If the FDA or any other regulatory agency requires us to provide Pacira BioSciences, Inc. | 2023 Form 10-K | Page 53 Table of Content s 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.
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.
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.
Furthermore, a sustained labor shortage, lack of skilled labor, increased turnover or labor cost inflation (for example, such as that initially caused by the Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 40 Table of Contents recent COVID-19 pandemic), or as a result of general macroeconomic factors, could lead to increased costs, which could negatively affect our ability to efficiently operate our overall business and have other adverse effects on our results of operations and financial condition.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 42 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.
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.
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.
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. For example, the FDA-approved label for EXPAREL does not include an indication in obstetrical paracervical block anesthesia.
See Note 11, Debt , to our consolidated financial statements included herein for more information. Additionally, our subsidiaries had no indebtedness (excluding trade payables, intercompany liabilities and income tax-related liabilities). Our TLA Credit Agreement and the Indentures each impose significant operating and financial restrictions on us and certain of our subsidiaries, which may prevent us from capitalizing on business opportunities.
Additionally, our subsidiaries had no indebtedness (excluding trade payables, intercompany liabilities and income tax-related liabilities). Our TLA Credit Agreement and the Indentures each impose significant operating and financial restrictions on us and certain of our subsidiaries, which may prevent us from capitalizing on business opportunities.
We purchase certain raw materials and equipment from various suppliers in order to manufacture our products. The acquisition of certain materials may require considerable lead times, and our ability to source such materials is also dependent on logistics providers.
Any such failure could have a material adverse effect on our financial condition and operations. We purchase certain raw materials and equipment from various suppliers in order to manufacture our products. The acquisition of certain materials may require considerable lead times, and our ability to source such materials is also dependent on logistics providers.
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.
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. The design, development, manufacture, supply and distribution of our products are highly regulated and technically complex.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 52 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.
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.
EXPAREL is currently manufactured at our facilities in San Diego, California; both EXPAREL and ZILRETTA are currently manufactured at the Thermo Fisher facility in Swindon, England and iovera° is currently manufactured at our facilities in San Diego, California and at the Carlisle facility in Tijuana, Mexico.
EXPAREL is currently manufactured at our facilities in San Diego, California; both EXPAREL and ZILRETTA are currently manufactured at the Thermo Fisher facility in Swindon, U.K., iovera° handpieces are currently manufactured at our facility in San Diego, California and iovera° Smart Tips are currently manufactured at Carlisle’s facility in Tijuana, Mexico.
See Note 11, Debt , to our consolidated financial statements included herein for more information. Subject to the limits contained in the TLA Credit Agreement and the Indentures, we may be able to incur substantial additional debt from time to time. If we do so, the risks related to our level of debt could increase.
Subject to the limits contained in the TLA Credit Agreement and the Indentures, we may be able to incur substantial additional debt from time to time. If we do so, the risks related to our level of debt could increase.
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 Pacira BioSciences, Inc. | 2023 Form 10-K | Page 46 Table of Content s comply with these laws and regulations.
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.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 58 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.
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.
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.
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. Our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time.
Public concern regarding the safety of drug products such as EXPAREL and ZILRETTA and medical device products such as iovera° could result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 51 Table of Contents Public concern regarding the safety of drug products such as EXPAREL and ZILRETTA and medical device products such as iovera° could result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 43 Table of Content s 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.
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.
In addition to our extensive internal efforts, the successful commercialization of EXPAREL requires many third parties, over whom we have no control, to continue to utilize EXPAREL. These third parties include physicians and hospital pharmacy and therapeutics committees (“P&T committees”).
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 35 Table of Contents In addition to our extensive internal efforts, the successful commercialization of EXPAREL requires many third parties, over whom we have no control, to continue to utilize EXPAREL. These third parties include physicians and hospital pharmacy and therapeutics committees (“P&T committees”).
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 45 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.
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.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe take input from industry activities, third party assessments and internal simulations and continuously adjust our protection mechanisms to be effective. We also assess operational and data security risks associated with our use of third-party service providers, understanding where failure points may exist within our supply chain operations and data protections.
Biggest changeWe also assess operational and data security risks associated with our use of third-party service providers, understanding where failure points may exist within our supply chain operations and data protections.
Finally, in the event a material cybersecurity incident were to occur, the CAO and Vice President of Information Technology would brief the Audit Committee which would then be responsible for assessing the materiality of the incident and making the determination of materiality and any related disclosure. We face a number of cybersecurity risks in connection with our business.
Finally, in the event a material cybersecurity incident were to occur, the CAO and Vice President of Information Technology would brief the Audit Committee which would then be responsible for assessing the materiality of the incident and making the determination of materiality and any related disclosure. We face a number of cybersecurity risks and threats in connection with our business.
Our CAO reports directly to our Chief Executive Officer and our Vice President of Information Technology reports directly to our CAO. We utilize a layered approach in assessing, identifying, evaluating and managing material risks from cybersecurity threats, and leverage outside partners to gain intelligence on threats.
Our CAO reports directly to our Chief Executive Officer and our Vice President of Information Technology reports directly to our CAO and has over 15 years of experience in cybersecurity. We utilize a layered approach in assessing, identifying, evaluating and managing material risks from cybersecurity threats, and leverage outside partners to gain intelligence on threats.
The Audit Committee receives updates on our cybersecurity program from management on a quarterly basis and more frequently as determined to be necessary or advisable.
The Audit Committee receives updates on our cybersecurity program from management on a quarterly basis and more frequently as determined to be necessary or advisable, and the full board receives a cybersecurity program update at least annually.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 70 Table of Content s Our board of directors has the ultimate oversight of the Company’s risks—including cybersecurity risks—with our Audit Committee assisting the board in their oversight of cyber and information security risks.
Our board of directors has the ultimate oversight of the Company’s risks—including cybersecurity risks—with our Audit Committee assisting the board in their oversight of cyber and information security risks.
For more information about the cybersecurity risks and other information technology and data privacy risks we face, see Item 1A. Risk Factors and the subsection titled Risks Related to Information Technology, Cybersecurity and Data Privacy.
For more information about the cybersecurity risks and other information technology and data privacy risks we face, see Item 1A. Risk Factors and the subsection titled Risks Related to Information Technology, Cybersecurity and Data Privacy. Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 71 Table of Contents
Added
Highlighted risks are integrated into our Enterprise Risk Management process. We take input from industry activities, third party assessments and internal simulations and continuously adjust our protection mechanisms to be effective.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeThe lease for the PIT of Houston expires in October 2027. In addition, we maintain an administrative, commercial and business development office in Parsippany, New Jersey, where we occupy approximately 53,000 square feet under a lease expiring in March 2028.
Biggest changeIn addition, we maintain two administrative, commercial and business development offices—one in Parsippany, New Jersey, where we occupy approximately 53,000 square feet under a lease expiring in March 2028 and one in Brisbane, California, where we occupy approximately 20,000 square feet under a lease expiring in May 2026.
We believe that our research and development and manufacturing facilities at our Science Center Campus, Thermo Fisher and Carlisle sites (as discussed in Item 1—Business above) will be sufficient for our commercial and pipeline development needs.
We believe that our research and development and manufacturing facilities at our Science Center Campus, Thermo Fisher and Carlisle sites (as discussed in Item 1—Business above) will be sufficient for our current commercial and pipeline development needs.
Our PIT of Tampa in Tampa, Florida, is an approximately 13,000 square-foot facility that supports a full range of educational events to advance clinician understanding of the latest local, regional and field block approaches for managing pain and reducing or eliminating exposure to opioids.
Our Pacira Innovation and Training Center in Tampa, Florida, is an approximately 13,000 square-foot facility that supports a full range of educational events to advance clinician understanding of the latest local, regional and field block approaches for managing pain and reducing or eliminating exposure to opioids.
Our manufacturing facility where we produce EXPAREL and iovera° handpieces and our mixed-use research and development property leases both expire in June 2030 and our warehouse lease expires in August 2030.
Our manufacturing facility on this site where we produce EXPAREL and the handpieces for iovera° and our mixed-use research and development property leases both expire in June 2030 and our warehouse lease expires in August 2030.
Our principal executive offices and corporate headquarters are also located at the PIT of Tampa, and our lease expires in December 2026.
Our principal executive offices and corporate headquarters are also located here, and our lease expires in December 2026.
Removed
The PIT of Houston, in Houston, Texas, is an approximately 19,000 square-foot facility similar to the PIT of Tampa, but that also features advanced ultrasound machines equipped with artificial intelligence, 3-D training software and professional medical lighting and in-ceiling cameras, both wet and dry laboratory space and a 125-seat lecture hall.
Added
In February 2025, Pacira Therapeutics, Inc., a wholly-owned subsidiary of the Company, entered into a securities purchase agreement to acquire the remaining 81% of GQ Bio that was not already owned by us.
Removed
As part of the Flexion Acquisition, we assumed leases for approximately 42,000 square feet of office space in Burlington, Massachusetts under a lease that expires in April 2025 and is being partially subleased.
Added
GQ Bio maintains its main administrative office in Hamburg, Germany, has a research and development lab in Luckenwalde, Germany and maintains smaller administrative offices in each of Eupen and Liège, Belgium. For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changePacira BioSciences, Inc. | 2023 Form 10-K | Page 71 Table of Content s PART II
Biggest changePacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 72 Table of Contents PART II
Item 3. Legal Proceedings We are subject to legal proceedings and claims that have not been fully resolved and that have arisen in the ordinary course of business. For information related to Item 3. Legal Proceedings, refer to Note 20, Commitments and Contingencies , to our consolidated financial statements included herein. Item 4. Mine Safety Disclosures Not applicable.
Item 3. Legal Proceedings We are subject to legal proceedings and claims that have not been fully resolved and that have arisen in the ordinary course of business. For information related to Item 3. Legal Proceedings, refer to Note 19, Commitments and Contingencies , to our consolidated financial statements included herein. Item 4. Mine Safety Disclosures Not applicable.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest change(PCRX) $ 100.00 $ 105.30 $ 139.10 $ 139.87 $ 89.75 $ 70.39 Nasdaq Composite Index (^IXIC) $ 100.00 $ 135.23 $ 194.24 $ 235.78 $ 157.74 $ 205.57 Nasdaq Biotechnology Index (^NBI) $ 100.00 $ 124.41 $ 156.36 $ 155.37 $ 138.42 $ 127.49 S&P Pharmaceuticals Select Index (^SPSIPH) $ 100.00 $ 124.75 $ 141.71 $ 125.78 $ 111.70 $ 100.63 Dividend Policy We have never declared or paid any dividends on our common stock.
Biggest change(PCRX) $ 100.00 $ 132.10 $ 132.83 $ 85.23 $ 74.48 $ 41.59 Nasdaq Composite Index (^IXIC) $ 100.00 $ 143.64 $ 174.36 $ 116.65 $ 167.30 $ 215.22 Nasdaq Biotechnology Index (^NBI) $ 100.00 $ 125.69 $ 124.89 $ 111.27 $ 115.42 $ 113.84 S&P Pharmaceuticals Select Index (^SPSIPH) $ 100.00 $ 113.59 $ 100.83 $ 89.53 $ 90.76 $ 93.69 Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 73 Table of Contents Dividend Policy We have never declared or paid any dividends on our common stock.
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.
We currently intend to retain any future earnings to finance the future development and expansion of our business, and as such we do not expect to pay any dividends on our common stock in the foreseeable future.
Comparison of Five-Year Cumulative Total Returns Among Pacira BioSciences, Inc., the Nasdaq Composite Index, the Nasdaq Biotechnology Index and the S&P Pharmaceuticals Select Index Cumulative Total Return as of December 31, 2018 2019 2020 2021 2022 2023 Pacira BioSciences, Inc.
Comparison of Five-Year Cumulative Total Returns Among Pacira BioSciences, Inc., the Nasdaq Composite Index, the Nasdaq Biotechnology Index and the S&P Pharmaceuticals Select Index Cumulative Total Return as of December 31, 2019 2020 2021 2022 2023 2024 Pacira BioSciences, Inc.
Performance Graph The following graph shows the value of an investment of $100.00 made on December 31, 2018—the last trading day of 2018—in each of Pacira BioSciences, Inc. (PCRX), the Nasdaq Composite Index (^IXIC), the Nasdaq Biotechnology Index (^NBI) and the S&P Pharmaceuticals Select Index (^SPSIPH).
Performance Graph The following graph and table shows the value of an investment of $100.00 made on December 31, 2019—the last trading day of 2019—in each of Pacira BioSciences, Inc. (PCRX), the Nasdaq Composite Index (^IXIC), the Nasdaq Biotechnology Index (^NBI) and the S&P Pharmaceuticals Select Index (^SPSIPH).
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed and traded under the ticker symbol “PCRX” on the Nasdaq Global Select Market. As of February 28, 2024, we had 11 holders of record of our common stock.
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock is listed and traded under the ticker symbol “PCRX” on the Nasdaq Global Select Market. As of February 26, 2025, we had nine holders of record of our common stock.
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 the agreements governing our indebtedness, provisions of applicable law and any other factors our board of directors deems relevant.
The payment of any future dividends would be at the discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements, restrictions contained in the agreements governing our indebtedness, provisions of applicable law and any other factors our board of directors deems relevant. Purchases of Equity Securities by the Registrant None. Item 6.
Removed
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 72 Table of Content s Item 6. Reserved

Item 7. Management's Discussion & Analysis

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

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Biggest changePacira BioSciences, Inc. | 2023 Form 10-K | Page 77 Table of Content s Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other The following table provides a summary of the costs related to contingent consideration, restructuring charges, acquisition-related charges and other activities during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Contingent consideration gains $ (3,424) $ (29,476) (88)% Acquisition-related charges 1,963 11,245 (83)% Impairment of acquired in-process research & development — 26,134 (100)% Other 1,109 3,000 (63)% Total contingent consideration (gains) charges, acquisition-related charges and other $ (352) $ 10,903 N/A In 2023, we recognized contingent consideration gains of $3.4 million due to a decrease in the fair value of the Flexion contingent consideration.
Biggest changeContingent Consideration Gains, Restructuring Charges and Other The following table provides a summary of the costs (gains) related to contingent consideration, restructuring charges, acquisition-related charges and other activities during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Contingent consideration $ (4,457) $ (3,424) 30% Acquisition-related charges 1,462 1,963 (26)% Restructuring charges 8,532 1,109 100%+ Loss on lease termination 2,165 — N/A Total contingent consideration gains, restructuring charges and other $ 7,702 $ (352) N/A In 2024, we recognized contingent consideration gains of $4.5 million due to adjustments reflecting the probability of achieving the remaining Flexion regulatory milestone by December 31, 2030—the milestone expiration date, partially offset by revisions to our weighted average cost of capital and the latest discount rates.
The foregoing reference to our corporate website is not intended to, nor shall it be deemed to, incorporate information on our corporate website into this Annual Report by reference, and the inclusion of our website address in this Annual Report is an inactive textual reference only and is not intended to be an active link to our corporate website.
The foregoing reference to our corporate website is not intended to, nor shall it be deemed to, incorporate information on our corporate website into this Annual Report by reference, and the inclusion of our corporate website address in this Annual Report is an inactive textual reference only and is not intended to be an active link to our corporate website.
With the acquisition of Flexion Therapeutics, Inc. in November 2021 (the “Flexion Acquisition”), we acquired ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular therapy that can provide major relief for OA knee pain for three months and has the potential to become an alternative to hyaluronic acid, or HA, and platelet rich plasma, or PRP, injections or other early intervention treatments.
With the acquisition of Flexion Therapeutics, Inc. in November 2021 (the “Flexion Acquisition”), we acquired ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injectable therapy that can provide major relief for OA knee pain for three months and has the potential to become an alternative to hyaluronic acid, or HA, and platelet rich plasma, or PRP, injections or other early intervention treatments.
Financing Activities In 2023, net cash used in financing activities was $183.0 million, which consisted of a $296.9 million repayment of TLB Term Loan principal as well as a $5.8 million prepayment penalty in connection with the retirement of the TLB Term Loan facility and $33.4 million repayments of TLA Term Loan principal, partially offset by the net proceeds from the TLA Term Loan of $149.6 million, $2.8 million from the issuance of common stock through our ESPP and proceeds from the exercise of stock options of $1.9 million.
In 2023, net cash used in financing activities was $183.0 million, which consisted of a $296.9 million repayment of TLB Term Loan principal as well as a $5.8 million prepayment penalty in connection with the retirement of the TLB Term Loan facility and $33.4 million repayments of TLA Term Loan principal, partially offset by the net proceeds from the TLA Term Loan of $149.6 million, $2.8 million from the issuance of common stock through our ESPP and proceeds from the exercise of stock options of $1.9 million.
Selling, General and Administrative Expenses Sales and marketing expenses primarily consist of compensation and benefits for our sales force and personnel that support our sales, marketing, medical and scientific affairs operations, expenses related to communicating the health outcome benefits of our products, investments in provider-level market access and patient reimbursement support and educational programs for our customers.
Selling, General and Administrative Expense Sales and marketing expenses primarily consist of compensation and benefits for our sales force and personnel that support our sales, marketing, medical and scientific affairs operations, expenses related to communicating the health outcome benefits of our products, investments in provider-level market access and patient reimbursement support and educational programs for our customers.
In conjunction with the entry into the TLA Credit Agreement (as defined below), we incurred a $16.9 million loss on early extinguishment of debt recognized as a result of the retirement of $287.5 million aggregate principal of our TLB Term Loan in 2023. For more information, See Note 11, Debt, to our consolidated financial statements herein.
In 2023, in conjunction with the entry into the TLA Credit Agreement (as defined below), we incurred a $16.9 million loss on early extinguishment of debt recognized as a result of the retirement of $287.5 million aggregate principal of our TLB Term Loan. For more information, See Note 10, Debt, to our consolidated financial statements herein.
The TLA Credit Agreement requires the Company to maintain an unrestricted cash and cash equivalents balance of at least $500.0 million less any prepayments of the 2025 Notes at any time from 91 days prior to the maturity date through the earlier of (i) the latest maturity date of the 2025 Notes and (ii) the date on which there is no outstanding principal amount of the 2025 Notes.
The TLA Credit Agreement requires us to maintain an unrestricted cash and cash equivalents balance of at least $500.0 million less any prepayments of the 2025 Notes at any time from 91 days prior to the maturity date through the earlier of (i) the latest maturity date of the 2025 Notes and (ii) the date on which there is no outstanding principal amount of the 2025 Notes.
Contingent Consideration Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as contingent consideration (gains) charges, acquisition-related charges and other. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales and regulatory approvals.
Contingent Consideration Subsequent to an acquisition, we measure contingent consideration arrangements at fair value for each period with changes in fair value recognized in the consolidated statements of operations as contingent consideration gains, restructuring charges and other. Changes in contingent consideration can result from changes in the assumed achievement and timing of estimated sales and regulatory approvals.
Research and Development Expenses Research and development expenses primarily consist of costs related to clinical trials and related outside services, product development and other research and development costs, including trials that we are conducting to generate new data for EXPAREL, ZILRETTA and iovera° and stock-based compensation expense.
Research and Development Expense Research and development expenses primarily consist of costs related to clinical trials and related outside services, product development and other research and development costs, including trials that we are conducting to generate new data for EXPAREL, ZILRETTA and iovera°, clinical trials for PCRX-201 and stock-based compensation expense.
The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions. As of December 31, 2023, we were in compliance with all financial covenants under the TLA Credit Agreement.
The TLA Credit Agreement also contains customary affirmative and negative covenants, financial covenants, representations and warranties, events of default and other provisions. As of December 31, 2024, we were in compliance with all financial covenants under the TLA Credit Agreement.
We have omitted discussion of the year ended December 31, 2021 (the earliest of the three years covered by our consolidated financial statements presented in this Annual Report) as permitted by SEC regulations.
We have omitted discussion of the year ended December 31, 2022 (the earliest of the three years covered by our consolidated financial statements presented in this Annual Report) as permitted by SEC regulations.
Certain defined terms have been brought forward from Part I of this Annual Report. This section of this Annual Report discusses year-to-year comparisons between 2023 and 2022, as well as other discussions of 2023 and 2022 items.
Certain defined terms have been brought forward from Part I of this Annual Report. This section of this Annual Report discusses year-to-year comparisons between 2024 and 2023, as well as other discussions of 2024 and 2023 items.
The complete Management’s Discussion and Analysis of Financial Condition and Results of Operations for year-to-year comparisons between 2022 and 2021 and other discussions of 2021 items can be found within Part II , Item 7 , to our Annual Report for the year ended December 31, 2022, filed with the SEC on February 28, 2023 , which is available on the SEC’s website at www.sec.gov and our corporate website at www.pacira.com.
The complete Management’s Discussion and Analysis of Financial Condition and Results of Operations for year-to-year comparisons between 2023 and 2022 and other discussions of 2022 items can be found within Part II , Item 7 , to our Annual Report for the year ended December 31, 2023, filed with the SEC on February 29, 2024 , which is available on the SEC’s website at www.sec.gov and our corporate website at www.pacira.com.
Such impacts may include the effect of prolonged periods of inflation which could, among other things, result in higher costs for labor, raw materials and services; cause our patients to defer or cancel medical procedures, thereby adversely impacting our revenues; and negatively impact our suppliers which could cause longer lead-times or the inability to secure a sufficient supply of materials.
Such impacts may include the effect of prolonged periods of inflation or the imposition of tariffs, which could, among other things, result in higher costs for labor, raw materials, equipment and other goods and services; cause our patients to defer or cancel medical procedures, thereby adversely impacting our revenues; and negatively impact our suppliers which could cause longer lead-times or the inability to secure a sufficient supply of materials.
Future Capital Requirements We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our TLA Term Loan, Flexion 2024 Notes and 2025 Notes (collectively, the “Notes”) through the next 12 months.
Future Capital Requirements We believe that our existing cash and cash equivalents, available-for-sale investments and cash received from product sales will be sufficient to enable us to fund our operating expenses, capital expenditure requirements and payment of the interest and principal on our TLA Term Loan, 2025 Notes and 2029 Notes through the next 12 months.
Regulatory and other expenses include regulatory activities related to unapproved products and indications, medical information expenses, registry expenses and related personnel. Stock-based compensation expense relates to the costs of stock option grants, awards of restricted stock units, or RSUs, and our employee stock purchase plan, or ESPP.
Regulatory and other expenses include regulatory activities related to unapproved products and indications, medical information and scientific communication expenses, expenses related to our iGOR registry study and related personnel. Stock-based compensation expense relates to the costs of stock option grants, awards of restricted stock units, or RSUs, and our employee stock purchase plan, or ESPP.
See Note 11, Debt , to our consolidated financial statements included herein for further discussion of the TLB Term Loan. 2025 Convertible Senior Notes In July 2020, we completed a private placement of $402.5 million in aggregate principal amount of our 2025 Notes, and entered into an indenture with respect to the 2025 Notes.
See Note 10, Debt, to our consolidated financial statements included herein for further discussion. 2025 Convertible Senior Notes In July 2020, we completed a private placement of $402.5 million in aggregate principal amount of our 2025 Notes, and entered into an indenture with respect to the 2025 Notes.
During the year ended December 31, 2023, we made a scheduled principal payment of $2.8 million as well as $30.6 million of voluntary principal prepayments.
During the year ended December 31, 2024, we made $11.3 million of voluntary principal prepayments. During the year ended December 31, 2023, we made a scheduled principal payment of $2.8 million as well as $30.6 million of voluntary principal prepayments.
We expect to continue to pursue the expanded use of EXPAREL, ZILRETTA and iovera° in additional procedures; progress our earlier-stage product candidate pipeline; advance regulatory activities for EXPAREL, ZILRETTA, iovera° and our other product candidates; invest in sales and marketing resources for EXPAREL, ZILRETTA and iovera°; expand and enhance our manufacturing capacity for EXPAREL, ZILRETTA and iovera°; invest in products, businesses and technologies; and support legal matters.
We expect to continue to pursue the expanded use of EXPAREL, ZILRETTA and iovera° in additional procedures; progress our product candidate pipeline, including the development of PCRX-201; advance regulatory activities for EXPAREL, ZILRETTA, iovera° and our other product candidates; invest in sales and marketing resources for EXPAREL, ZILRETTA and iovera°; expand and enhance our manufacturing capacity for EXPAREL, ZILRETTA and iovera°; invest in products, businesses and technologies; and support legal matters.
The 2025 Notes accrue interest at a fixed rate of 0.750% per annum, payable semiannually in arrears on February 1 and August 1 of each year. The 2025 Notes mature on August 1, 2025. At December 31, 2023, the outstanding principal on the 2025 Notes was $402.5 million.
The 2025 Notes accrue interest at a fixed rate of 0.750% per annum, payable semiannually in arrears on February 1 st and August 1 st of each year, and mature on August 1, 2025. At December 31, 2024, the outstanding principal on the 2025 Notes was $202.5 million.
Debt 2028 Term Loan A Facility On March 31, 2023, we entered into a credit agreement (the “TLA Credit Agreement”) to refinance the indebtedness outstanding under our TLB Credit Agreement (as defined and discussed below).
Debt 2028 Term Loan A Facility On March 31, 2023, we entered into a credit agreement (as amended, the “TLA Credit Agreement”) to refinance the indebtedness outstanding under our TLB Credit Agreement.
The impact of a hypothetical 10 percent increase in the forecasted annual growth rates would have increased the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2023 by $5.7 million.
The impact of a hypothetical 10 percent increase in the forecasted annual growth rates would have increased the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2024 by $6.3 million.
Amortization of Acquired Intangible Assets The following table provides a summary of the amortization of acquired intangible assets during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Amortization of acquired intangible assets $ 57,288 $ 57,288 —% As part of the Flexion Acquisition and the MyoScience Acquisition, we acquired intangible assets consisting of developed technology intangible assets and customer relationships, with estimated useful lives between 9 and 14 years.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 78 Table of Contents Amortization of Acquired Intangible Assets The following table provides a summary of the amortization of acquired intangible assets during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Amortization of acquired intangible assets $ 57,288 $ 57,288 —% As part of the Flexion Acquisition and the MyoScience Acquisition, we acquired intangible assets consisting of developed technology intangible assets and customer relationships, with estimated useful lives between 9 and 14 years.
Investing Activities In 2023, net cash provided by investing activities was $77.5 million, which reflected $99.5 million of available-for-sale investment maturities (net of purchases), purchases of fixed assets of $15.2 million for fill lines for our products and equipment for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of debt investments of $6.8 million in external complementary development stage product candidates.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 81 Table of Contents In 2023, net cash provided by investing activities was $77.5 million, which reflected $99.5 million of available-for-sale investment maturities (net of purchases), purchases of fixed assets of $15.2 million for manufacturing product fill lines for our products and equipment for our EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of debt investments of $6.8 million in external complementary development stage product candidates.
General and administrative expenses consist of compensation and benefits for legal, finance, regulatory activities related to approved products and indications, compliance, information technology, human resources, business development, executive management and other supporting personnel. It also includes professional fees for legal, audit, Pacira BioSciences, Inc. | 2023 Form 10-K | Page 76 Table of Content s tax and consulting services.
General and administrative expenses consist of compensation and benefits for legal, finance, regulatory activities related to approved products and indications, compliance, information technology, human resources, business development, executive management and other supporting personnel. It also includes professional fees for legal, audit, tax and consulting services.
See Note 5, Flexion Acquisition , and Note 12, Financial Instruments , to our consolidated financial statements included herein for more information; • the impact of global economic conditions—including the impact of inflation—on our product, material and labor costs, supply chain, longer lead-times, an inability to secure a sufficient supply of materials, our operating expenses and our business strategy; • the timing of and extent to which the holders of our Notes elect to convert their Notes, the timing of principal and interest payments on our TLA Term Loan and the timing and impact of increases to the variable interest rate on our TLA Term Loan borrowings in accordance with the terms of the TLA Credit Agreement; • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°, including markets outside of the U.S.; • the cost and timing of expanding and maintaining our manufacturing facilities; • the cost and timing of additional strategic investments, including additional investments under existing agreements; • the costs related to legal and regulatory matters; • the costs of performing additional clinical trials for our products, including the additional pediatric trials required by the FDA and EMA as a condition of the approval of EXPAREL; • the costs for the development and commercialization of other product candidates; • the costs and timing of future payments under our employee benefit plans, including but not limited to our cash long-term incentive plan and non-qualified deferred compensation plan; and • the extent to which we acquire or invest in products, businesses and technologies.
See Note 11, Financial Instruments , to our consolidated financial statements included herein for more information; • the impact of global economic conditions—including the impact of inflation and tariffs—on our product, material and labor costs, supply chain, longer lead-times, an inability to secure a sufficient supply of materials, our operating expenses and our business strategy; • the timing of and extent to which the holders of our 2025 Notes and 2029 Notes elect to convert their 2025 Notes and 2029 Notes, the timing of principal and interest payments on our TLA Term Loan and the timing and impact of increases to the variable interest rate on our TLA Term Loan borrowings in accordance with the terms of the TLA Credit Agreement; • the costs and our ability to successfully continue to expand the commercialization of EXPAREL, ZILRETTA and iovera°; • the cost and timing of expanding and maintaining our manufacturing facilities; • the cost and timing of additional strategic investments, including additional investments under existing agreements; Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 83 Table of Contents • the costs related to legal and regulatory matters, including those to develop and defend our intellectual property; • the costs of performing additional clinical trials for our products, including the additional pediatric trials required by the FDA and EMA as a condition of the approval of EXPAREL; • the costs for the development and commercialization of other product candidates; • the costs and timing of future payments under our employee benefit plans, including but not limited to our cash long-term incentive plan and non-qualified deferred compensation plan; • the timing and the number of shares of our common stock repurchased through our share repurchase program; and • the extent to which we acquire or invest in products, businesses and technologies.
For more information, see Note 5, Flexion Acquisition, and Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
For more information, see Note 8, Goodwill and Intangible Assets , to our consolidated financial statements included herein.
We have financed our operations primarily with the proceeds from the sale of convertible senior notes and other debt, common stock, product sales and collaborative licensing revenue. As of December 31, 2023, we had an accumulated deficit of $106.8 million, cash and cash equivalents and available-for-sale investments of $281.0 million and working capital of $412.6 million.
We have financed our operations primarily with the proceeds from the sale of convertible senior notes and other debt, common stock, product sales and collaborative licensing and milestone revenue. As of December 31, 2024, we had an accumulated deficit of $206.4 million, cash and cash equivalents and available-for-sale investments of $484.6 million and working capital of $435.2 million.
Actual results may differ from these estimates under different assumptions or conditions. Our significant accounting policies are more fully discussed in Note 2, Summary of Significant Accounting Policies , to our consolidated financial statements included herein. The following accounting policies, which may include significant judgments and estimates, were used in the preparation of our consolidated financial statements.
Our significant accounting policies are more fully discussed in Note 2, Summary of Significant Accounting Policies , to our consolidated financial statements included herein. The following accounting policies, which may include significant judgments and estimates, were used in the preparation of our consolidated financial statements.
The following table includes the key assumptions used in the valuation of our contingent consideration milestones: Assumption Flexion Ranges Utilized as of December 31, 2023 Discount rates 7.9% to 9.7% Probability of payment for achievement of regulatory milestones 0% to 12.5% Projected year of achieving or expiration of regulatory milestones 2030 The maximum remaining potential payments related to contingent consideration from the Flexion Acquisition is $372.3 million as of December 31, 2023.
The following table includes the key assumptions used in the valuation of our contingent consideration milestones: Assumption Ranges Utilized as of December 31, 2024 Discount rates 7.8% to 8.1% Probability of payment for remaining regulatory milestones 0% The maximum remaining potential payments related to contingent consideration from the Flexion Acquisition is $372.3 million as of December 31, 2024.
The impact of this assumption on the fair value was partially offset by a decrease to the assumed discount rate based on a significant improvement in our incremental borrowing rate resulting from the TLA Credit Agreement entered into in March 2023.
The impact of this assumption on the fair value was partially offset by a decrease to the assumed discount rate based on a significant improvement in our incremental borrowing rate resulting from the TLA Credit Agreement entered into in March 2023. For more information, see Note 11, Financial Instruments, to our consolidated financial statements included herein.
On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, contingent consideration, impairment of intangible assets, inventory costs, liabilities and accruals, clinical trial expenses, stock-based compensation and the valuation of deferred tax assets. We base our estimates on historical experience, contract terms and on other factors we believe to be appropriate under the circumstances.
On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognition, contingent consideration, impairment of intangible assets and goodwill, inventory costs, liabilities and accruals, clinical trial expenses, stock-based compensation and the valuation of deferred tax assets.
The decrease was primarily due to adjustments in the assumption for the long-term forecasts which reduced the probability of meeting the sales-based contingent consideration milestones by December 31, 2030, the expiration date for achieving the milestones.
In 2023, we recognized contingent consideration gains of $3.4 million due to a decrease in the fair value of the Flexion contingent consideration. The decrease was primarily due to adjustments in the assumption for the long-term forecasts which reduced the probability of meeting the sales-based contingent consideration milestones by December 31, 2030—the expiration date for achieving the milestones.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 74 Table of Contents Results of Operations Comparison of the Years Ended December 31, 2023 and 2022 Revenues Net product sales consist of sales of (i) EXPAREL in the U.S., E.U. and U.K.; (ii) ZILRETTA in the U.S.; (iii) iovera° in the U.S., Canada and Europe and (iv) sales of, and royalties on, our bupivacaine liposome injectable suspension for veterinary use.
Results of Operations Comparison of the Years Ended December 31, 2024 and 2023 Revenues Net product sales consist of sales of (i) EXPAREL in the U.S., E.U., and U.K.; (ii) ZILRETTA in the U.S.; (iii) iovera° in the U.S., Canada and the E.U. and (iv) sales of our bupivacaine liposome injectable suspension product for veterinary use.
As of December 31, 2023, we had net minimum commitments of $78.6 million, of which $13.0 million is due in 2024. For more information, refer to Note 8, Leases , to our consolidated financial statements included herein.
As of December 31, 2024, we had net minimum commitments of $64.0 million, of which $12.3 million are due in 2025. For more information, refer to Note 7, Leases , to our consolidated financial statements included herein.
For more information, see Note 5, Flexion Acquisition , to our consolidated financial statements included herein. Critical Accounting Estimates We have based our Management’s Discussion and Analysis of our Financial Condition and Results of Operations on our financial statements that have been prepared in accordance with GAAP in the U.S.
Critical Accounting Estimates We have based our Management’s Discussion and Analysis of our Financial Condition and Results of Operations on our financial statements that have been prepared in accordance with GAAP in the U.S.
As of December 31, 2023, there are contractually obligated principal payments of $1.3 million in 2025, $15.0 million in both 2026 and 2027 and $85.3 million in 2028. The remaining interest payments of the TLA Term Loan are approximately $39.6 million based on the current interest rate.
As of December 31, 2024, there are contractually obligated principal payments of $4.1 million in 2026, $15.0 million in 2027 and $86.3 million in 2028. The remaining interest payments of the TLA Term Loan are approximately $25.0 million based on the current interest rate, of which $7.9 million is due in 2025.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 79 Table of Content s Liquidity and Capital Resources Since our inception in 2006, we have devoted most of our cash resources to manufacturing, research and development and selling, general and administrative activities related to the development and commercialization of EXPAREL.
Liquidity and Capital Resources Since our inception in 2006, we have devoted most of our cash resources to manufacturing, research and development and selling, general and administrative activities related to the development and commercialization of EXPAREL.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 80 Table of Content s Equity Financings From our inception in December 2006 through December 31, 2023, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
Equity Financings From our inception in December 2006 through December 31, 2024, we have raised $344.5 million of net proceeds from the sale of common stock and other equity securities via public offerings.
Summary of Cash Flows The following table summarizes our cash flows from operating, investing and financing activities for the years ended December 31, 2023 and 2022 (in thousands): Year Ended December 31, Consolidated Statements of Cash Flows Data: 2023 2022 Net cash provided by (used in): Operating activities $ 154,649 $ 145,274 Investing activities 77,541 (225,185) Financing activities (183,031) (401,528) Net increase (decrease) in cash and cash equivalents $ 49,159 $ (481,439) Operating Activities In 2023, net cash provided by operating activities was $154.6 million compared to $145.3 million in 2022.
Summary of Cash Flows The following table summarizes our cash flows from operating, investing and financing activities for the years ended December 31, 2024 and 2023 (in thousands): Year Ended December 31, Consolidated Statements of Cash Flows Data: 2024 2023 Net cash provided by (used in): Operating activities $ 189,389 $ 154,649 Investing activities (83,276) 77,541 Financing activities 17,363 (183,031) Net increase in cash and cash equivalents $ 123,476 $ 49,159 Operating Activities In 2024, net cash provided by operating activities was $189.4 million compared to $154.6 million in 2023.
Overview As the therapeutic area leader in non-opioid pain management, our stated corporate mission is providing non-opioid pain management options to as many patients as possible and redefining the role of opioids for rescue therapy only. We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
Overview Our stated corporate mission is to deliver innovative, non-opioid pain therapies to transform the lives of patients. We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.
The following table provides a breakout of our research and development expenses during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Clinical and preclinical development $ 24,471 $ 45,615 (46)% Product development and manufacturing capacity expansion 33,365 24,635 35% Regulatory and other 9,727 7,953 22% Stock-based compensation 8,694 6,594 32% Total research and development expense $ 76,257 $ 84,797 (10)% % of total revenue 11% 13% Total research and development expense decreased 10% in 2023 as compared to 2022.
The following table provides a breakout of our research and development expenses during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Clinical and preclinical development $ 33,696 $ 24,471 38% Product development and manufacturing capacity expansion 30,803 33,365 (8)% Regulatory and other 9,697 9,727 (0)% Stock-based compensation 7,381 8,694 (15)% Total research and development expense $ 81,577 $ 76,257 7% % of total revenue 12% 11% Total research and development expense increased 7% in 2024 versus 2023.
The following table provides information regarding selling, general and administrative expenses during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Sales and marketing $ 153,040 $ 144,996 6% General and administrative 82,737 73,989 12% Stock-based compensation 33,664 35,531 (5)% Total selling, general and administrative expenses $ 269,441 $ 254,516 6% % of total revenue 40% 38% Total selling, general and administrative expenses increased 6% in 2023 as compared to 2022.
The following table provides information regarding selling, general and administrative expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Sales and marketing $ 172,015 $ 153,040 12% General and administrative 87,227 82,737 5% Stock-based compensation 34,857 33,664 4% Total selling, general and administrative expense $ 294,099 $ 269,441 9% % of total revenue 42% 40% Total selling, general and administrative expense increased 9% in 2024 versus 2023.
We have approximately $14.2 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2023, of which $7.7 million is due within one year, and the remaining $6.5 million is due in one to two years. As of December 31, 2023, we had $4.9 million of other minimum, non-cancelable contractual commitments.
We have approximately $6.5 million of minimum, non-cancelable contractual commitments for the purchase of certain raw materials as of December 31, 2024, all of which are due in 2025. We had $1.8 million of other minimum, non-cancelable contractual commitments as of December 31, 2024, of which $1.4 million is due in 2025, and the remaining $0.4 million is due thereafter.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 82 Table of Content s Contractual Obligations We had two convertible senior notes outstanding as of December 31, 2023, for which $8.6 million in aggregate principal amount is due on the Flexion 2024 Notes in May 2024 and $402.5 million in aggregate principal amount is due on our 2025 Notes in August 2025.
Contractual Obligations We had two convertible senior notes outstanding as of December 31, 2024, for which $202.5 million in aggregate principal amount is due on our 2025 Notes in August 2025 and $287.5 million in aggregate principal amount is due on our 2029 Notes in May 2029.
Since its initial approval in 2011, more than 14 million patients have been treated with EXPAREL. We drop-ship EXPAREL directly to end-users based on orders placed to wholesalers or directly to us, and there is no product held by wholesalers.
We drop-ship EXPAREL directly to end-users based on orders placed to wholesalers or directly to us, and there is no product held by wholesalers.
Global Economic Conditions and Inflation Direct and indirect effects of global economic conditions have in the past, and may continue to, negatively impact our business, financial condition and results of operations.
For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein. Global Economic Conditions, Inflation and Tariffs Direct and indirect effects of global economic conditions have in the past, and may continue to, negatively impact our business, financial condition and results of operations.
In addition, we have approximately $71.4 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2023, of which $21.1 million is due within one year, and the remaining $50.3 million is due in one to five years.
In addition, we have approximately $59.9 million of minimum, non-cancelable contractual commitments for contract manufacturing services as of December 31, 2024, of which $20.3 million is due in each of 2025 and 2026, $17.9 million is due in 2027 and the remaining $1.4 million is due in 2028.
The impact of a hypothetical 100 basis point increase in the discount rate would have reduced the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2023 by $1.2 million. Recent Accounting Pronouncements See Note 3, Recent Accounting Pronouncements , to our consolidated financial statements included herein for further discussion of recent accounting pronouncements.
The impact of a hypothetical 100 basis point increase in the discount rate would have reduced the value of our contingent consideration liability associated with the Flexion Acquisition as of December 31, 2024 by $0.9 million.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 78 Table of Content s Other Expense, Net The following table provides information regarding other expense, net during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Interest expense $ (20,306) $ (39,976) (49)% Interest income 11,444 4,542 100% + Loss on early extinguishment of debt (16,926) — N/A Other, net (186) (11,288) (98)% Total other expense, net $ (25,974) $ (46,722) (44)% Total other expense, net decreased 44% in 2023 versus 2022.
Other Income (Expense), Net The following table provides information regarding other income (expense), net during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Interest income $ 19,689 $ 11,444 72% Interest expense (16,569) (20,306) (18)% Gain (loss) on early extinguishment of debt 7,518 (16,926) N/A Other, net (373) (186) 100%+ Total other income (expense), net $ 10,265 $ (25,974) N/A Total other income, net was $10.3 million in 2024 versus total other expense, net of $26.0 million in 2023.
Bupivacaine liposome injectable suspension revenue decreased 48% in 2023 versus 2022, and its related royalties increased 2%, primarily due to the sales mix of vial sizes and the timing of orders placed for veterinary use. Cost of Goods Sold Cost of goods sold primarily relates to the costs to produce, package and deliver our products to customers.
Bupivacaine liposome injectable suspension revenue increased more than 100% in 2024 versus 2023, and the related royalties increased 38%, primarily due to the sales mix of vial sizes and the timing of orders placed for veterinary use.
For more information, see Note 20, Commitments and Contingencies , to our consolidated financial statements included herein.
District Court ruled that one of our patents was not valid (for more information, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein).
Income Tax Expense (Benefit) The following table provides information regarding our income tax expense (benefit) during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Income tax expense (benefit) $ 19,746 $ (2,607) N/A Effective tax rate 32% (20)% We recorded income tax expense of $19.7 million for the year ended December 31, 2023 and an income tax benefit of $2.6 million for the year ended December 31, 2022.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 80 Table of Contents Income Tax Expense The following table provides information regarding our income tax expense during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 (Loss) income before income taxes $ (63,106) $ 61,701 N/A Income tax expense $ 36,454 $ 19,746 85% Effective tax rate (58)% 32% We recorded income tax expense of $36.5 million and $19.7 million for the years ended December 31, 2024 and 2023, respectively.
In 2023, we recognized other operating expenses of $1.1 million that included a restructuring plan in an effort to improve our operational efficiencies and recognized one-time employee termination benefits through a reduction of headcount. In 2022, we recognized other operating expense of $3.0 million related to the termination of a license agreement.
In 2023, we recognized restructuring charges of $1.1 million that included a restructuring plan in an effort to improve our operational efficiencies and recognized one-time employee termination benefits through a reduction of headcount. For more information, see Note 17, Contingent Consideration Gains, Restructuring Charges and Other , to our consolidated financial statements included herein.
Net product sales of iovera° increased 29% in 2023 versus 2022 primarily due to a 33% increase in Smart Tip volume and a 1% increase in selling price per Smart Tip.
Net product sales of iovera° increased 16% in 2024 versus 2023 primarily due to a 20% increase in Smart Tip volume, partially offset by increased sales related allowances and accruals.
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 83 Table of Content s The summary of activity with respect to our sales related allowances and accruals for the years ended December 31, 2023, 2022 and 2021 appears in Note 4, Revenue , to our consolidated financial statements included herein.
Historically, adjustments to these estimates to reflect actual results or updated expectations have not been material. The summary of activity with respect to our sales related allowances and accruals for the years ended December 31, 2024, 2023 and 2022 appears in Note 4, Revenue , to our consolidated financial statements included herein.
The remaining interest payments on our Notes is $6.1 million, of which an estimated $3.1 million is due in 2024. We also have the TLA Term Loan with $116.6 million in outstanding principal. Due to voluntary principal prepayments of $30.6 million made during the year ended December 31, 2023, we are not contractually obligated to make principal payments in 2024.
Due to voluntary principal prepayments of $30.6 million made during the year ended December 31, 2023 and $11.3 million made during December 31, 2024, we are not contractually obligated to make principal payments in 2025, although we retain the option to do so.
The following table provides information regarding our revenues during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Net product sales: EXPAREL $ 538,120 $ 536,899 0% ZILRETTA 111,098 105,517 5% iovera° 19,685 15,258 29% Bupivacaine liposome injectable suspension 3,342 6,476 (48)% Total net product sales 672,245 664,150 1% Royalty revenue 2,733 2,673 2% Total revenues $ 674,978 $ 666,823 1% EXPAREL revenue remained flat in 2023 compared to 2022, primarily due to an increase in gross vial volume of 4% versus 2022 and reduced by 1% due to a shift in sales mix.
The following table provides information regarding our revenues during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Net product sales: EXPAREL $ 548,962 $ 538,120 2% ZILRETTA 118,089 111,098 6% iovera° 22,813 19,685 16% Bupivacaine liposome injectable suspension 7,322 3,342 100%+ Total net product sales 697,186 672,245 4% Royalty revenue 3,780 2,733 38% Total revenues $ 700,966 $ 674,978 4% EXPAREL revenue increased 2% in 2024 versus 2023.
Stock-based compensation increased 32% in 2023 versus 2022 primarily due to the acceleration of stock compensation awards related to a terminated executive in 2023.
Stock-based compensation decreased 15% in 2024 versus 2023 primarily due to fewer equity awards granted to research and development personnel and headcount vacancies as well as the acceleration of stock-based compensation awards related to a terminated executive in 2023.
The following table provides information regarding cost of goods sold and gross margin during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2023 2022 Cost of goods sold $ 184,669 $ 199,295 (7)% Gross margin 73% 70% Gross margin increased three percentage points in 2023 as compared to 2022 mainly due to lower inventory reserves, accelerated depreciation recorded in 2022 for certain machinery and equipment and lower royalty expense as discussed below, partially offset by a lower net selling price for EXPAREL largely as a result of enrolling in the 340B drug pricing program.
The following table provides information regarding cost of goods sold and gross margin during the years indicated, including percent changes (dollar amounts in thousands): Year Ended December 31, % Increase / (Decrease) 2024 2023 Cost of goods sold $ 170,428 $ 184,669 (8)% Gross margin 76% 73% Gross margin increased three percentage points in 2024 versus 2023 primarily due to lower EXPAREL product costs as a result of higher production volumes and the absence of a step-up of ZILRETTA fixed assets and inventory to fair value in accordance with purchase accounting that existed in the prior period, partially offset by higher EXPAREL and ZILRETTA inventory reserves.
The increase of $9.4 million was attributable to an improved gross margin, increased interest income and reduced interest expense, partially offset by a $13.0 million termination fee relating to a licensing agreement and a negative impact on the changes in working capital.
The increase of $34.7 million was primarily attributable to increased revenue with favorable gross margins, lower interest paid and the impact of a $13.0 million payment made in the prior year for a termination fee relating to a licensing agreement, partially offset by an increased investment in inventory levels.
See Note 11, Debt , to our consolidated financial statements included herein for further discussion. 2024 Convertible Senior Notes In November 2021, as part of the Flexion Acquisition, we assumed $201.3 million in aggregate principal amount of the Flexion 2024 Notes.
See Note 10, Debt, to our consolidated financial statements included herein for further discussion. 2029 Convertible Senior Notes In May 2024, we completed a private placement of $287.5 million in aggregate principal amount of our 2.125% convertible senior notes due 2029, or 2029 Notes, and entered into an indenture with respect to the 2029 Notes.
Product development and manufacturing capacity expansion expense increased 35% in 2023 versus 2022, primarily attributable to new product development costs related to PCRX-201 and the continued significant scale-up activities of our EXPAREL manufacturing capacity at our Science Center Campus in San Diego, California, for which an sNDA for a 200-liter EXPAREL manufacturing suite was approved by the FDA in February 2024.
Product development and manufacturing capacity expansion expense decreased 8% in 2024 versus 2023, primarily attributable to the completion of pre-commercial scale-up activities of our larger-scale EXPAREL manufacturing capacity at Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 77 Table of Contents our Science Center Campus in San Diego, California, which the FDA approved in February 2024 and was subsequently placed into service in July 2024.
ZILRETTA revenue increased 5% in 2023 compared to 2022, primarily due to an increase of 3% in kit volume and 2% in selling price per unit, net of customer discounting due to expanded contracting efforts.
ZILRETTA revenue increased 6% in 2024 versus 2023, primarily due to a 4% increase in net selling price per unit and a 2% increase in kit volume. The increase in net selling price per unit is related to two price increases and favorable sales related allowances.
These expenses include labor, raw materials, manufacturing overhead and occupancy costs, depreciation of facilities, royalty payments, quality control and engineering.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 76 Table of Contents Cost of Goods Sold Cost of goods sold primarily relates to the costs to produce, package and deliver our products to customers. These expenses include labor, raw materials, manufacturing overhead and occupancy costs, depreciation of facilities, royalty payments, quality control and engineering.
EXPAREL revenue was also impacted by a decrease of 3% in net selling price per unit related to enrolling EXPAREL in the 340B drug pricing program and expanding other contracting activities, partially offset by a January 2023 price increase.
A 4% increase in gross vial volume was partially offset by a shift in vial mix. EXPAREL revenue was also impacted by a 1% increase in selling price per unit related to a price increase, net of increases in sales related allowances as a result of group purchasing organization contracting.
For more information, See Note 11, Debt, to our consolidated financial statements herein. Interest income significantly increased in 2023 versus 2022 due to higher interest rates and overall investment balances.
Interest income increased 72% in 2024 versus 2023 due to higher overall investment balances.
For more information, see Note 12, Financial Instruments and Note 18, Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other , to our consolidated financial statements included herein. In 2023, we recognized acquisition-related charges of $2.0 million related to vacant and underutilized leases assumed as part of the Flexion Acquisition.
As part of the Flexion Acquisition, there are up to $372.3 million in potential payments if all regulatory and commercial milestones are met. For more information, see Note 11, Financial Instruments , to our consolidated financial statements included herein. In February 2025, we completed the GQ Bio Acquisition.
See Note 20, Commitments and Contingencies , to our consolidated financial statements included herein for more information. For more information, see Note 18, Contingent Consideration (Gains) Charges, Acquisition-related Charges and Other , to our consolidated financial statements included herein.
These increases were partially offset by the impact of a February 2024 restructuring plan designed to ensure we are well positioned for long-term growth (for more information, see Note 17, Contingent Consideration Gains, Restructuring Charges and Other , to our consolidated financial statements included herein) .
During the year ended December 31, 2023, we made a scheduled principal payment of $9.4 million and repaid the outstanding $287.5 million principal on the TLB Term Loan, which resulted in a $16.9 million loss on early extinguishment of debt.
The partial repurchase of the 2025 Notes resulted in a $7.5 million gain on early extinguishment of debt. At December 31, 2024, all $287.5 million of principal was outstanding on the 2029 Notes.
In 2022, net cash used in investing activities was $225.2 million, which reflected $150.1 million of available-for-sale investment purchases (net of maturities), a $32.0 million contingent consideration milestone payment that had been achieved in the fourth quarter of 2021 associated with our 2007 acquisition of Pacira Pharmaceuticals, Inc. from Skyepharma, purchases of fixed assets of $30.1 million for fill lines for our products and equipment for an EXPAREL capacity expansion project at our Science Center Campus in San Diego, California and purchases of equity and debt investments of $13.0 million in external complementary development stage product candidates.
Investing Activities In 2024, net cash used in investing activities was $83.3 million, which reflected $72.6 million of available-for-sale investment purchases (net of sales) and $10.6 million of capital expenditures for manufacturing product fill lines and our EXPAREL capacity expansion project at our Science Center Campus in San Diego, California, partially offset by an increased investment in inventory levels.
Each of these EXPAREL patents are listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”).
Additionally, the ‘940 patent is listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”). Patents that are eligible for Orange Book listing are those that have claims covering the active ingredient, the drug product (formulation and composition) or the approved method of use. Additionally, the USPTO recently issued U.S.
The effective tax rate of (20)% for the year ended December 31, 2022 differed from the U.S. statutory tax rate of 21% due to non-taxable contingent consideration fair value gains, tax deductible interest for a Skyepharma milestone payment and tax credits, partially offset by valuation allowances recorded against capital loss carryforwards and non-deductible executive compensation.
The effective tax rate of (58)% for the year ended December 31, 2024 differed from the U.S. statutory tax rate of 21% primarily due to non-deductible goodwill impairment charges during the three months ended September 30, 2024 and costs related to non-deductible executive compensation and stock-based compensation, mainly related to expired stock options.
In January 2022, we repurchased $192.6 million aggregate principal amount of the Flexion 2024 Notes. At December 31, 2023, the outstanding principal on the Flexion 2024 Notes was $8.6 million. See Note 11, Debt , to our consolidated financial statements included herein for further discussion.
See Note 10, Debt , to our condensed consolidated financial statements included herein for further discussion on the Flexion 2024 Notes, 2025 Notes, 2029 Notes, the capped call transaction and the TLA Term Loan. There was also $2.3 million of proceeds from the issuance of common stock through our ESPP.
Removed
Pacira BioSciences, Inc. | 2023 Form 10-K | Page 73 Table of Content s Recent Highlights • In December 2023, our Board of Directors appointed Frank D. Lee as Chief Executive Officer and a member of the Board. Mr.
Added
We are also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel gene therapy vector platform enabling local administration of genetic medicines with the potential to treat large prevalent diseases like OA.
Removed
Lee brings more than three decades of global experience and a strong track record of product development and commercial leadership success across a wide range of therapeutic areas within the biotech and pharmaceutical industry.
Added
In February 2025, we acquired Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 74 Table of Contents GQ Bio Therapeutics GmbH, a privately-held biopharmaceutical company (the “GQ Bio Acquisition”). PCRX-201 is the lead program from this platform.
Removed
Most recently he served as Chief Executive Officer and member of the board of directors of Forma Therapeutics, Inc., or Forma, from March 2019 through its acquisition by Novo Nordisk A/S in October 2022. During his tenure at Forma, Mr.
Added
Recent Highlights • In November 2024, we presented two-year safety and efficacy data at the American College of Rheumatology’s annual ACR Convergence meeting in Washington, DC.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

7 edited+2 added−2 removed5 unchanged
Biggest changeWe have agreements with certain vendors and partners that operate in foreign jurisdictions. The more significant transactions are primarily denominated in the U.S. Dollar, subject to an annual adjustment based on changes in currency exchange rates. Additionally, our accounts receivable are primarily concentrated with three large wholesalers of pharmaceutical products.
Biggest changeDollar, subject to an annual adjustment based on changes in currency exchange rates. Additionally, our accounts receivable are primarily concentrated with three large wholesalers of pharmaceutical products. In the event of non-performance or non-payment, there may be a material adverse impact on our financial condition, results of operations or net cash flow.
A hypothetical 100 basis point increase in interest rates would have reduced the fair value of our available-for-sale securities at December 31, 2023 by approximately $0.5 million. The fair value of our Notes is impacted by both the fair value of our common stock and interest rate fluctuations.
A hypothetical 100 basis point increase in interest rates would have reduced the fair value of our available-for-sale securities at December 31, 2024 by approximately $0.8 million. The fair value of our 2025 Notes is impacted by both the fair value of our common stock and interest rate fluctuations.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure None.
As of December 31, 2023, the estimated fair value of the 2025 Notes was $924 per $1,000 principal amount. See Note 11, Debt , to our consolidated financial statements included herein for further discussion of our 2025 Notes, which bears interest at a fixed rate.
As of December 31, 2024, the estimated fair value of the 2025 Notes was $971 per $1,000 principal amount. See Note 10, Debt , to our consolidated financial statements included herein for further discussion of our 2025 Notes, which bears interest at a fixed rate. At December 31, 2024, $202.5 million of principal remains outstanding on the 2025 Notes.
At December 31, 2023, the outstanding principal on the TLA Term Loan was $116.6 million. As of December 31, 2023, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 8.46%.
At December 31, 2024, the outstanding principal on the TLA Term Loan was $105.3 million. As of December 31, 2024, borrowings under the TLA Term Loan consisted entirely of term benchmark borrowings at a rate of 7.43%.
A Pacira BioSciences, Inc. | 2023 Form 10-K | Page 84 Table of Content s hypothetical 100 basis point increase in interest rates would increase interest expense over the next 12 months by approximately $1.2 million, based on the balances outstanding for these borrowings as of December 31, 2023.
A hypothetical 100 basis point increase in interest rates would increase interest expense over the next 12 months by approximately $1.1 million, based on the balances outstanding for these borrowings as of December 31, 2024. We have agreements with certain vendors and partners that operate in foreign jurisdictions. The more significant transactions are primarily denominated in the U.S.
In the event of non-performance or non-payment, there may be a material adverse impact on our financial condition, results of operations or net cash flow. Item 8. Financial Statements and Supplementary Data Our consolidated financial statements required by this item, together with the report of our independent registered public accounting firm, begin on page F-1 of this Annual Report.
Pacira BioSciences, Inc. | 2024 Annual Report on Form 10-K | Page 86 Table of Contents Item 8. Financial Statements and Supplementary Data Our consolidated financial statements required by this item, together with the report of our independent registered public accounting firm, begin on page F-1 of this Annual Report. Item 9.
Removed
At December 31, 2023, all $402.5 million of principal remains outstanding on the 2025 Notes and $8.6 million of principal remains outstanding on the Flexion 2024 Notes.
Added
The fair value of our 2029 Notes is impacted by both the fair value of our common stock and interest rate fluctuations. As of December 31, 2024, the estimated fair value of the 2029 Notes was $861 per $1,000 principal amount.
Removed
As a result of the Flexion Acquisition and as discussed in more detail in Note 11, Debt , to our consolidated financial statements included herein, any future conversion rights for the Flexion 2024 Notes are subject to the occurrence of any future events giving rise to such conversion rights under the indenture governing the Flexion 2024 Notes.
Added
See Note 10, Debt , to our consolidated financial statements included herein for further discussion of our 2029 Notes, which bears interest at a fixed rate. At December 31, 2024, all $287.5 million of principal remains outstanding on the 2029 Notes.

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