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from SkyePharma Holdings, Inc.
−Removed: (now a subsidiary of Vectura Group plc), or Skyepharma (the “Skyepharma Acquisition”).
−Removed: 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”).
+Added: (now Vectura Group Limited, a subsidiary of Molex Asia Holdings, Ltd.), or Skyepharma (the “Skyepharma Acquisition”).
+Added: 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”).
Unless the context requires otherwise, references to “Pacira,” “we,” the “Company,” “us” and “our” in this Annual Report refers to Pacira BioSciences, Inc., a Delaware corporation, and its subsidiaries.
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Our use of trademarks or trade names of other companies should not suggest any endorsement, sponsorship or other relationship with or by such companies.
−Removed: 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.
+Added: Our mission is to deliver innovative, non-opioid pain therapies to transform the lives of patients.
We have three commercialized non-opioid treatments:
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and iovera ® °, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve.
−Removed: In 2024, we are prioritizing three key strategic initiatives to position the company for long-term success and drive sustainable and significant growth beginning in 2025.
−Removed: • Launching EXPAREL in two new lower extremity nerve block indications.
−Removed: In February 2024, we launched EXPAREL in two key lower extremity nerve blocks, namely an adductor canal block and a sciatic nerve block in the popliteal fossa.
−Removed: We believe these two key nerve blocks provide the opportunity to significantly expand EXPAREL utilization within surgeries of the knee, lower leg, and foot and ankle procedures.
−Removed: The launch is supported by two successful head-to-head Phase 3 studies in which EXPAREL demonstrated four days of superiority to bupivacaine.
−Removed: • Ensuring commercial readiness for the rollout of NOPAIN in 2025.
−Removed: In December 2022, the N on- O pioids P revent A ddiction I n the N ation, or NOPAIN, Act, was signed into law.
−Removed: NOPAIN mandates separate Medicare reimbursement of non-opioid therapies for postsurgical pain relief across all outpatient settings beginning in January 2025.
−Removed: There are roughly six million annual procedures in outpatient settings for Medicare patients.
−Removed: To ensure NOPAIN readiness, we are enhancing our commercial organization with new talent and expertise across critical functions, such as marketing, market access and reimbursement.
−Removed: We will also be investing in programs to drive awareness, education and action across key decision makers including pharmacies, C-suites, clinicians, payers, influencers and patients.
−Removed: We believe NOPAIN will result in accelerated and sustainable growth beginning in 2025.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 5
−Removed: Table of Content s
−Removed: • Expanding market access ahead of NOPAIN.
−Removed: We have been paving the way for NOPAIN through our investment in 340B pricing and new partnerships with group purchasing organizations, or GPOs, such as our recently announced agreement with Premier, Inc., or Premier, whose significant network of hospitals and health systems covers nearly 20 percent of EXPAREL-relevant market procedures.
−Removed: These preferential pricing programs assist healthcare systems in affording the opportunity to improve patient care through best-practice opioid-sparing pain management.
−Removed: Our customers will have a favorable acquisition cost and once NOPAIN takes effect next year, they will be reimbursed at average selling price (ASP), plus 6 percent.
−Removed: The Opioid Epidemic
−Removed: Opioid addiction in the U.S.
−Removed: has reached epidemic proportions, with the U.S.
−Removed: Centers for Disease Control and Prevention, or CDC, reporting that over 112,000 Americans died from a drug overdose in the 12-month period ending August 2023.
−Removed: Opioids were involved in nearly 70% of all drug overdose deaths reported, with Fentanyl and other synthetic opioids being the primary driver of the increase in fatalities.
−Removed: A recent meta-analysis of 33 studies and nearly two million patients who underwent various procedures showed that across a variety of surgical procedures, 7% of patients continued to fill opioid prescriptions more than three months after surgery.
−Removed: The highest rates were observed in orthopedic procedures.
−Removed: Studies have also shown that misuse of prescription opioids is a primary predictor of heroin usage and that 4% to 6% of those who misuse prescription opioids transition to heroin use.
−Removed: Our Commitment to the Athletic Community
−Removed: We are committed to educating and advocating for athletic participants and associations of all levels to choose non-opioid pain management solutions.
−Removed: The Pacira portfolio offers patients and the clinicians who treat them multiple safe and effective non-opioid options to help manage pain in advance of or after surgery, as well as to mitigate chronic pain.
−Removed: We are deeply committed to driving education and awareness among athletes and their health care providers about the range of Pacira options available to decrease, or in some cases eliminate, the need for opioid-based pain control.
−Removed: Our initiatives include partnerships with the Professional Golfers Association of America (PGA), the Ladies Professional Golfers Association (LPGA) and the National Football League Alumni Association.
+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.
+Added: In January 2025, we launched our new 5x30 strategic growth plan (“5x30”) to accelerate our transition into an innovative biopharmaceutical and therapeutic area leader in musculoskeletal pain and adjacencies.
+Added: With 5x30, we intend to achieve the following five key objectives by 2030:
+Added: (i) deliver our products to more than three million patients annually;
+Added: (ii) grow product revenues by a double-digit compounded annual growth rate;
+Added: (iii) achieve a five percentage-point improvement in gross margins over 2024;
+Added: (iv) advance an innovative pipeline with at least five programs in clinical development and (v) establish five partnerships—including pipeline and commercial agreements.
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 6
−Removed: Table of Content s
+Added: | 2024 Annual Report on Form 10-K | Page 5
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:
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 7
−Removed: Table of Content s
Our Commercial Products
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in April 2012.
−Removed: In the U.S., EXPAREL is a long-acting, non-opioid option proven to manage postsurgical pain.
−Removed: EXPAREL is the only product indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block in adults.
−Removed: Safety and efficacy have not been established in other nerve blocks.
+Added: EXPAREL is a long-acting, non-opioid proven to manage postsurgical pain.
+Added: EXPAREL is the only product indicated for local analgesia via infiltration in patients aged six years and older and regional analgesia via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block in adults (safety and efficacy have not been established in other nerve blocks).
In November 2020, the European Commission, or EC, granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults and children aged six years and older.
−Removed: We launched EXPAREL in the United Kingdom, or U.K., and select European Union, or E.U., countries in November 2021.
−Removed: Since its initial approval in 2011, more than 14 million patients have been treated with EXPAREL.
EXPAREL consists of bupivacaine, an amide-type local anesthetic, encapsulated in our pMVL drug delivery technology, which delivers bupivacaine over time for extended analgesia.
−Removed: We believe that EXPAREL addresses a significant medical need for a safe and effective long-acting non-opioid postsurgical analgesic and plays a significant role in opioid minimization strategies.
−Removed: EXPAREL is designed for recovery with minimal opioid use by (i) delivering targeted local analgesia at the surgical site;
+Added: We believe EXPAREL addresses a significant medical need for a safe and effective long-acting non-opioid postsurgical analgesic and plays a significant role in opioid minimization strategies.
+Added: EXPAREL is designed for recovery with minimal opioid use by:
+Added: (i) delivering targeted local analgesia at the surgical site;
(ii) reliably releasing bupivacaine over time for prolonged analgesia;
(iii) eliminating the need for catheters and pumps that may hinder recovery and (iv) providing long-lasting pain control while reducing the need for opioids.
−Removed: Our net product sales of EXPAREL were $538.1 million, $536.9 million and $506.5 million for the years ended December 31, 2023, 2022 and 2021, respectively.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 6
+Added: Net product sales of EXPAREL were $549.0 million, $538.1 million and $536.9 million for the years ended December 31, 2024, 2023 and 2022, respectively.
For the years ended December 31, 2024, 2023 and 2022, net product sales of EXPAREL accounted for 78%, 80% and 81% of our total revenues, respectively.
−Removed: The significant change in the 2022 percentage resulted from the recognition of a full year of ZILRETTA net product sales after completing the Flexion Acquisition in November 2021.
ZILRETTA (triamcinolone acetonide extended-release injectable suspension)
−Removed: ZILRETTA is the first and only extended-release, IA therapy for patients with OA knee pain.
+Added: ZILRETTA is the first and only extended-release, single-shot corticosteroid injection for patients with OA knee pain.
ZILRETTA uses a proprietary extended-release microsphere technology to slowly and continuously releases triamcinolone acetonide, or TA, a commonly administered, immediate-release corticosteroid into the knee for approximately three months to provide significant pain relief for 12 weeks, with some people experiencing pain relief through 16 weeks.
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shortly thereafter.
−Removed: We added ZILRETTA to our commercial offering with the completion of the Flexion Acquisition in November 2021.
−Removed: For the years ended December 31, 2023, 2022 and 2021, ZILRETTA net product sales were $111.1 million , $105.5 million and $12.7 million , respectively.
−Removed: The ZILRETTA net product sales recognized in 2021 reflect the post-closing period of the Flexion Acquisition of November 19, 2021 to December 31, 2021.
−Removed: The iovera° system
−Removed: The iovera° system is a non-opioid handheld cryoanalgesia device used to produce precise, controlled doses of cold temperature to targeted nerves to produce an immediate, long-lasting neurolytic block that interrupts the pain-transmitting signals of a peripheral nerve.
+Added: Net product sales of ZILRETTA were $118.1 million, $111.1 million and $105.5 million, for the years ended December 31, 2024, 2023 and 2022, respectively.
+Added: The iovera° system is a non-opioid handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature to targeted nerves to produce an immediate, long-lasting neurolytic block that interrupts the pain-transmitting signals of a peripheral nerve.
The effect on the nerve is temporary, providing months of pain relief until the nerve regenerates and function is restored over time.
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and is cleared for marketing in Canada for the blocking of pain.
−Removed: 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.
+Added: 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.
It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days.
−Removed: For the years ended December 31, 2023, 2022 and 2021, our net product sales of iovera° were $19.7 million, $15.3 million and $16.2 million, respectively.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 8
−Removed: Table of Content s
+Added: Net product sales of iovera° were $22.8 million, $19.7 million and $15.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
EXPAREL Clinical Benefits
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We believe EXPAREL is a key component of long-acting postsurgical pain management regimens that reduce the need for opioids.
−Removed: Based on the clinical data from our Phase 3 and Phase 4 clinical studies as well as data from retrospective health outcomes studies, EXPAREL significantly reduces opioid usage while improving postsurgical pain management.
+Added: Based on our clinical studies as well as data from robust, retrospective real-world published studies, EXPAREL is associated with significantly reduced opioid use, fewer emergency department visits and shorter length of stay while improving postsurgical pain management.
In our Phase 3 hemorrhoidectomy trial, EXPAREL:
−Removed: • 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;
+Added: • 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;
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• decreased total opioid consumption by 78% (p<0.01) from zero to 48 hours after surgery;
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 7
• reduced pain scores by 46% versus placebo (p<0.01);
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• promotes maintenance of early postsurgical pain management, which may reduce the time to discharge.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 9
−Removed: Table of Content s
Key EXPAREL Markets
−Removed: EXPAREL-based enhanced recovery after surgery, or ERAS, protocols are becoming a cornerstone of opioid-sparing postsurgical pain management and enabling the shifting of many complex, painful procedures to the 23-hour stay environment.
EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures.
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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.
−Removed: EXPAREL-based regional analgesia as part of multimodal pain management protocols in enhanced ERAS pathways is supporting this surgical migration.
+Added: EXPAREL-based regional analgesia as part of multimodal pain management protocols in enhanced recovery after surgery, or ERAS, pathways is supporting this surgical migration.
The clinical and economic benefits of EXPAREL in total joint arthroplasty procedures have been demonstrated in clinical studies with EXPAREL use associated with significant reductions in opioid consumption, well-controlled pain management, shorter recovery time, same-day discharge to home and high patient satisfaction.
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Two important patient groups are driving the spine market:
−Removed: 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.
+Added: first, pediatric cases, like adolescent scoliosis patients, who are undergoing highly invasive surgeries and who until very recently
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 8
+Added: 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.
Managing postsurgical pain in these adult degenerative patients can be challenging due to their established opioid tolerance, but by utilizing EXPAREL, healthcare providers can control their pain with a non-opioid approach, and when feasible based on surgical intervention and patient characteristics, move many historical inpatient procedures to the 23-hour stay environment.
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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.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 10
−Removed: Table of Content s
Cardiothoracic
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A study of the effect of EXPAREL on postoperative opioid prescribing after third molar extraction showed that patients who received EXPAREL were prescribed significantly fewer opioids, including refills, compared to those who did not receive EXPAREL.
−Removed: The study, A Retrospective Cross-Sectional Study of the Effect of Liposomal Bupivacaine on Postoperative Opioid Prescribing After Third Molar Extraction , was published in The Journal of Oral and Maxillofacial Surgery in July 2021.
+Added: The study, A Retrospective Cross-Sectional Study of the Effect of Liposomal Bupivacaine on Postoperative Opioid
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 9
+Added: Prescribing After Third Molar Extraction , was published in The Journal of Oral and Maxillofacial Surgery in July 2021.
In this retrospective analysis, researchers reviewed data from 600 patients who underwent third molar extractions between 2012 and 2018.
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This collaboration, which advances Sevāredent’s goal of improving patient outcomes and reducing exposure to opioids and their associated risks, provides easy access to EXPAREL—including comprehensive product training and onboarding support from Pacira—for more than 1,800 dental offices across the U.S.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 11
−Removed: Table of Content s
+Added: EXPAREL Economic Benefits
+Added: Retrospective, real-world studies highlight EXPAREL’s opioid-sparing and economic benefits:
+Added: • In October 2024, Surgery for Obesity and Related Diseases published a retrospective, cohort study of 4,298 patients undergoing laparoscopic sleeve gastrectomy.
+Added: Patients who received EXPAREL were matched to patients who received non-EXPAREL analgesia.
+Added: The EXPAREL cohort was associated with significantly lower opioid use and opioid related adverse events throughout their hospital stay, as well as a shorter length of hospital stay.
+Added: Further, the odds of 30-day hospital readmission and incidence of opioid use disorder after discharge were significantly lower for the EXPAREL group.
+Added: • In June 2024, Plastic and Reconstructive Surgery Global Open published a retrospective, cohort study of 1,017 patients undergoing abdominal flap breast reconstruction.
+Added: Patients who received EXPAREL were matched 2-to-1 with patients who received bupivacaine.
+Added: The EXPAREL cohort was associated with significantly lower opioid use throughout their hospital stay.
+Added: Further, three-month hospital readmission rates and outpatient clinic or office visits were also lower for the EXPAREL group.
+Added: • In May 2024, Surgery Open Science published results from a real-world study of 8,794 patients undergoing colorectal resection surgery.
+Added: Patients who received EXPAREL were matched 1-to-1 with patients who did not.
+Added: Average opioid utilization through six months after surgery, length of stay, outpatient or emergency department visits and hospital readmissions were all significantly lower in the EXPAREL cohort.
+Added: • In May 2024, The Spine Journal published results from a retrospective, comparative study of 1,524 patients undergoing outpatient spine surgery.
+Added: Patients who received EXPAREL were matched 1-to-3 with patients who did not.
+Added: The use of EXPAREL was associated with reduced opioid use at the hospital with significantly lower emergency department visits for 60 days after discharge.
ZILRETTA Clinical Benefits
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The pivotal Phase 3 trial showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through 16 weeks.
−Removed: Both the magnitude and duration of pain relief provided by ZILRETTA in clinical trials were clinically meaningful with the magnitude of pain relief amongst the largest seen to date in OA clinical trials.
−Removed: The overall frequency of treatment-related adverse events in these trials was similar to those observed with placebo, and no drug-related serious adverse events were reported.
−Removed: We believe that ZILRETTA holds the potential to become the corticosteroid of choice given its safety and efficacy profile, and the fact that it is the first and only extended-release corticosteroid on the market.
+Added: We believe that ZILRETTA holds the potential to become the corticosteroid of choice given its high patient satisfaction, with up to four months of reliable OA knee pain relief and fewer office visits.
+Added: ZILRETTA also has a strong safety and pharmacokinetic profile.
+Added: It remains localized in the knee, which allows for fewer systemic effects, including significantly lower hypoglycemia.
+Added: This represents a meaningful opportunity as 14 percent of patients with OA also have diabetes.
+Added: It is also the first and only extended-release corticosteroid on the market.
In September 2021, the American Association of Orthopaedic Surgeons, or AAOS, updated its evidence-based clinical practice guidelines, finding ZILRETTA can improve patient outcomes over traditional immediate-release corticosteroids.
−Removed: We have launched a Phase 3 registration study in 2024 that will evaluate the safety and efficacy of ZILRETTA for the management of OA pain of the shoulder.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 10
+Added: We launched a Phase 3 registration study in 2024 that evaluates the safety and efficacy of ZILRETTA for the management of OA pain of the shoulder.
If the study is successful, we plan to seek approval to expand the ZILRETTA label to include OA pain of the shoulder.
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Some of our strongest data relates directly to the improvement of OA pain of the knee.
−Removed: Surgical intervention is typically a last resort for patients suffering from OA pain of the knee.
−Removed: 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°.
−Removed: Preliminary findings demonstrated reductions in opioids, including:
+Added: 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°.
+Added: Surgical intervention is typically a last resort for patients suffering from knee OA pain.
+Added: Treatment with iovera° has also demonstrated effectiveness for managing pain associated with knee replacements.
+Added: 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<0.05), 6 weeks (p<0.05) and 12 weeks (p<0.05).
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• Patients in the iovera° group demonstrated a statistically significant reduction in pain scores from their baseline pain scores at 72 hours (p<0.05) and at 12 weeks (p<0.05).
−Removed: 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:
+Added: 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;
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• iovera° is a convenient handheld device with a single-use procedure-specific Smart Tip;
−Removed: • iovera° can be delivered precisely using ultrasound guidance or an anatomical landmark.
−Removed: 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.
+Added: • iovera° can be delivered precisely using imaging guidance or an anatomical landmark.
+Added: 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.
In addition, the iovera° group had greater function at discharge, a shorter length of hospital stay and received significantly fewer opioids, including discharge prescriptions at week 2 and week 6 after surgery.
In September 2021, the AAOS updated its evidence-based clinical practice guidelines, reporting that denervation therapy—including cryoneurolysis—may reduce knee pain and improve function in patients with symptomatic OA of the knee.
+Added: We are currently sponsoring a prospective, real-world registry called the Innovations in Genicular Outcomes Registry, or iGOR, which is a patient focused registry governed in collaboration with a steering committee of scientific experts that evaluates clinical, economic- and health-related patient-reported outcomes in patients who have received any treatment for knee OA pain, including TKA, for a minimum of 18 months.
+Added: A unique feature of iGOR is that if patients receive additional treatments for OA, data capture resets so that outcomes of their treatment journey can be followed over multiple years.
+Added: Unlike in clinical studies, treatment decisions in iGOR are decided by physicians and patients in a shared decision-making manner rather than being driven by treatment assignment, so that outcomes are truly those from real-world applications.
+Added: The iGOR registry is tracking outcomes of iovera°, ZILRETTA and EXPAREL, as well as comparator treatments.
+Added: Early outcomes from iGOR have shown that patients who receive iovera° prior to TKA have less pain, improved function and improved sleep for six months after surgery versus patients who do not receive iovera°.
+Added: As of November 2024, more than 2,000 patients have enrolled in the iGOR registry across 12 participating sites in the U.S.
+Added: In addition, a pilot randomized control trial evaluating iovera° for the treatment of lower back pain showed that it had significantly greater improvements in pain and disability, and required fewer injections over a year, compared to patients who were treated with radiofrequency ablation.
+Added: Beyond treatment for pain, observational data has been presented at multiple congresses showing the effectiveness of iovera° for the treatment of upper limb spasticity over 90 days by targeting motor nerves.
+Added: We currently have a pivotal trial underway to demonstrate the efficacy and safety of iovera° for treating spasticity.
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 12
−Removed: Table of Content s
+Added: | 2024 Annual Report on Form 10-K | Page 11
+Added: In December 2024, the FDA cleared our 510(k) submission to market a new Smart Tip designed to access the medial branch nerves to administer a medial branch block to manage chronic low back pain.
+Added: Before the approval of this new Smart Tip, the iovera° portfolio consisted of either a three-pronged Smart Tip featuring 8.5mm long 27-gauge needles to treat superficial nerves or a single, 90mm long, 20-guage Smart Tip ideally suited to treat deeper nerves.
+Added: It is most commonly used to treat knee pain, but frequently used to manage pain in the hip, shoulder, chest, foot and ankle, and more.
+Added: Now, this new, 25-gauge 180mm Smart Tip allows for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can relieve chronic low back pain associated with facet mediated pain.
+Added: This longer-needle Smart Tip is uniquely designed for use through a cannula or introducer, providing the ability for ice ball formation at deeper peripheral nerves.
+Added: Chronic low back pain remains a pervasive health challenge in the U.S.:
+Added: • Back pain is the leading cause of disability nationwide.
+Added: • Back pain is also the most common reason for extended work absences.
+Added: • Chronic back pain is the number one indication for opioid prescriptions, often leading to dependency and abuse.
+Added: • Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures.
+Added: With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care.
+Added: This FDA-cleared innovation offers a compelling alternative to conventional treatments such as radiofrequency ablation, or RFA, which has substantial limitations.
+Added: With RFA, patients may not get the effects of pain relief until 1-2 weeks after treatment, further the intense heat can damage surrounding tissue and blood vessels, and tissue damage may lead to painful neuritis (inflammation in the nerves).
The Osteoarthritis Market
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We are also discussing with the FDA, EMA and Medicines and Healthcare Products Regulatory Agency (MHRA) our regulatory strategy for EXPAREL administered as a nerve block in the pediatric setting.
−Removed: 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.
−Removed: • Stellate ganglion block.
−Removed: Planning is underway for a multicenter Phase 3 registration study of EXPAREL as a stellate ganglion block for preventing postoperative atrial fibrillation after cardiothoracic surgery.
−Removed: We worked with a steering committee of Key Opinion Leaders, or KOLs, in regional anesthesia and stellate ganglion blocks to design our study protocol and we are awaiting FDA feedback on study design.
−Removed: We believe a stellate ganglion block utilizing EXPAREL will be critical in an unmet need with post-operative atrial fibrillation, or POAF.
−Removed: POAF is a common and costly complication after cardiothoracic surgery, occurring after up to 40% of cardiac procedures and 20% of thoracic procedures, and often results in an extended intensive care unit and/or hospital stay, as well as higher long-term risk.
−Removed: A stellate ganglion block is a sympathetic nerve block which can stabilize the heart.
−Removed: Since POAF typically occurs around the third day after surgery, a long-acting block with EXPAREL provided at the time of surgery may enhance current prophylactic measures.
+Added: 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.
−Removed: In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for treatment of post-operative pain in adults and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults, and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in children aged six years or older.
−Removed: We launched EXPAREL in the U.K.
−Removed: and targeted E.U.
−Removed: countries in 2021.
−Removed: In Latin America, we have a distribution agreement with Eurofarma Laboratories S.A., or Eurofarma, for the development and commercialization of EXPAREL.
−Removed: Eurofarma has the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia and Mexico.
−Removed: In addition, Eurofarma will be responsible for regulatory filings for EXPAREL in these countries.
−Removed: We will receive royalties and are also eligible to receive regulatory- and commercial-based milestone payments that are triggered by the achievement of certain events.
+Added: Our products are currently only marketed in the U.S.
+Added: We believe there is an opportunity in certain key markets outside of the U.S.
+Added: where our products can be financially viable and deliver value.
+Added: We are actively seeking potential commercial partners to realize that potential.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 12
We believe ZILRETTA’s extended-release profile may also provide effective treatment for OA pain of the shoulder, and in 2024 launched a Phase 3 trial investigating ZILRETTA as a treatment for OA pain of the shoulder.
The shoulder study will compare ZILRETTA to immediate release TA.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 13
−Removed: Table of Content s
In 2022, we launched a next-generation iovera° handheld device, which we believe is more efficient, provides more consistent treatment, is easier for providers to use and is more durable.
6 unchanged sentences
Clinical Development Programs
−Removed: PCRX-201 was added to our portfolio as part of the Flexion Acquisition.
−Removed: PCRX-201 is a novel, helper-dependent adenoviral vector expressing interleukin-1 receptor antagonist (IL-1Ra).
−Removed: After injection, the vector enters joint cells and turns them into factories to produce sustained therapeutic levels of IL-1Ra and inhibit the IL-1 pathway to manage pain and mitigate OA-related joint damage while remaining localized to the joint space.
−Removed: In a Phase 1 proof-of-concept study of patients with moderate to severe OA of the knee, PCRX-201 was well tolerated with improvements in knee pain observed across all doses.
−Removed: Based upon compelling initial Phase 1 efficacy and safety data for PCRX-201, we are working with investigators and the FDA to discuss the regulatory pathway forward for OA of the knee.
−Removed: PCRX-201 received an RMAT designation from the FDA in February 2024.
−Removed: pMVL-Based Clinical Program
−Removed: Given the proven safety, flexibility and customizability of our pMVL drug delivery technology platform for acute, sub-acute and chronic pain applications, we have another pMVL-based product in clinical development.
−Removed: Following data readouts from preclinical and feasibility studies, we initiated a second Phase 1 study of EXPAREL for intrathecal analgesia in June 2023.
+Added: PCRX-201 (enekinragene inzadenovec) is our novel gene therapy vector platform in clinical development as a treatment for OA of the knee.
+Added: Its innovative high-capacity adenovirus, or HCAd, design, manufacturing process, and local administration may solve many of the challenges that have made gene therapy inaccessible for common diseases like OA.
+Added: Key features of the HCAd vector that support its use for treatments targeting large prevalent diseases like OA:
+Added: • Medicine where it matters.
+Added: PCRX-201 is injected locally into the knee joint to boost cellular interleukin 1 receptor antagonist (IL-1Ra) production and block IL-1 pathway activation, significantly reducing chronic inflammation.
+Added: • Overcomes gene therapy pitfalls.
+Added: PCRX-201’s innovative HCAd vector is more efficient at delivering genes into cells than other vectors, which means less medication needed to achieve the desired effect.
+Added: • Protein production only when needed.
+Added: PCRX-201 uses an inflammation-responsive promoter to only produce IL-1Ra when needed, mimicking the body’s natural response to inflammation.
+Added: • Attractive cost of goods profile, Smaller doses, localized administration and scalable manufacturing processes translate to an attractive cost of goods profile because we could potentially make many thousands of doses in a single batch.
+Added: IL-1’s Role in Inflammation
+Added: The IL-1 pathway triggers inflammation in response to pathogens and cellular stress.
+Added: IL-1Ra is a core regulator of this pathway and helps keep inflammation in balance by turning off the IL-1 pathway when it is not needed.
+Added: As people age, their bodies have a more challenging time maintaining that balance.
+Added: As a result, people develop chronic IL-1-driven inflammation that eventually causes joint damage and pain.
+Added: It has been well established that chronic IL-1 activation is an underlying driver of knee inflammation, joint degeneration and pain.
+Added: By targeting it, we are able to target a root cause of disease rather than just alleviating only the symptoms of OA.
+Added: FDA-approved drugs, such as anakinra and canakinumab, have successfully targeted the IL-1 pathway in other joint inflammatory conditions, proving that blocking its activation is a well-validated, de-risked strategy for reducing inflammation.
+Added: Existing drugs that target IL-1 are not practical for OA because they would require very high doses or daily injections directly into the joint.
+Added: The PCRX-201 mechanism of action could potentially solve the limitations experienced with existing drugs.
+Added: PCRX-201 Mechanism of Action
+Added: PCRX-201 is a gene therapy that boosts cellular IL-1Ra production, which blocks IL-1 pathway activation and dampens down chronic inflammation in the knee.
+Added: It uses an inflammation-responsive promoter to only produce IL-1Ra when needed,
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 13
+Added: mimicking how the body naturally responds to inflammation.
+Added: It is delivered directly into the knee joint capsule providing durable pain relief where it matters most and with no to minimal systemic exposure.
+Added: PCRX-201 Safety and Efficacy
+Added: 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.
+Added: The new data is derived from an open-label, Phase 1 trial investigating the safety and efficacy of PCRX-201 administered via ultrasound-guided IA injection in 72 patients with moderate to severe osteoarthritis of the knee (OAK) graded at 2, 3, or 4 on the Kellgren-Lawrence scale, a semiquantitative method for evaluating the severity of OA on a scale of 0-4.
+Added: Participants were broken into two cohorts.
+Added: The first cohort received one of three doses of PCRX-201.
+Added: The second cohort received concurrent pretreatment with an IA corticosteroid (methylprednisolone 40 mg), a technique common in gene therapy dosing to improve tolerability and gene transfer.
+Added: Pain and function benefits were observed at all doses and across both cohorts over the full two years studied, with patients in the second cohort achieving greater pain reduction and fewer adverse events, or AEs.
+Added: Additional results in the pretreated cohort, across all doses, included:
+Added: • 48% to 65% improvement in pain from baseline, as measured by the Western Ontario and McMaster Universities Arthritis Index-A (WOMAC-A)
+Added: • 53% to 72% improvement in stiffness from baseline, as measured by WOMAC-B:
+Added: ◦ Improvements in function from baseline, as measured by the KOOS Activities of Daily Living (ADL) scale, that were similar to improvements in WOMAC-A and WOMAC-B
+Added: • By 16 weeks more than 70% of participants achieved greater than 50% reductions from baseline pain.
+Added: No serious treatment-emergent AEs related to the treatment or procedure were reported regardless of steroid pretreatment or dose level administered.
+Added: Treatment-related joint effusions (swelling) were the most common AE, occurring in 36% of patients who received steroid pretreatment versus 61% of patients who were not pretreated.
+Added: The majority of effusions were mild to moderate in severity and resolved in a median of 33 days among patients in the pretreated group.
+Added: While other therapies typically provide relief for three to six months, PCRX-201 has already set a new standard with a year or more of sustained pain relief from a single injection.
+Added: Given these highly encouraging Phase 1 data, we opened enrollment in a randomized, double-blind Phase 2 clinical study in knee OA in February 2025.
+Added: In February 2024, the FDA granted PCRX-201 a Regenerative Medicine Advanced Therapy, or RMAT, designation.
+Added: Established under the 21 st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising therapies, including genetic therapies, that are intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and for which preliminary clinical evidence indicates that the drug or therapy has the potential to address an unmet medical need.
+Added: PCRX-201 is the first gene therapy product candidate to receive RMAT designation for OA.
+Added: HCAd Vector Platform
+Added: The HCAd vector platform solves many of the challenges in the field of genetic medicine that have prevented its utilization in treating common diseases like OA.
+Added: Key features include:
+Added: • The HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that rely on adenovirus associated virus, or AAV, vectors.
+Added: As a result, the desired effect can be achieved with much smaller doses.
+Added: • The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors.
+Added: • Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals.
+Added: • Lower dose levels and efficient delivery of genes into cells means that thousands of doses can potentially be produced in a single batch.
+Added: As a result, therapies built on the HCAd platform are expected to have a commercially attractive and viable cost of goods profile.
+Added: In addition to PCRX-201 which is based on the HCAd vector platform, we have identified other well-validated cytokines that could be the basis for additional locally administered genetic therapies using the HCAd vector platform.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 14
External Innovation
4 unchanged sentences
CarthroniX, Inc.
−Removed: 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
+Added: 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)
−Removed: 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)
−Removed: 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)
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 14
−Removed: Table of Content s
Customer-Facing Organization
13 unchanged sentences
• facilitating reimbursement and the shift of procedures to hospital outpatient and ambulatory surgical center, or ASC, sites of care.
−Removed: Pacira Training Facilities
−Removed: We maintain and operate two Pacira Innovation and Training, or PIT, facilities—one in Tampa, Florida and one in Houston, Texas.
−Removed: These sites were constructed with a singular goal in mind:
−Removed: to advance education on best practice techniques to effectively manage acute pain while reducing or eliminating the need for opioids.
−Removed: These facilities provide clinicians with flexible, state-of-the-art environments for interactive, hands-on instruction on the latest and most innovative local, regional and field block approaches for managing pain, improving patient care and enabling patient migration to the 23-hour stay environment.
−Removed: Each of our PIT facilities feature distinct training spaces, including simulation labs equipped with ultrasound scanning stations;
−Removed: lecture halls that feature liquid crystal display video walls to support live, virtual and global presentations;
−Removed: and green-screen broadcast studios to livestream content with single or multiple hosts.
−Removed: The PIT of Houston has both wet and dry lab space for cadaver and other interactive workshops.
−Removed: The PIT of Tampa also houses our principal executive offices and corporate headquarters.
Other Agreements
1 unchanged sentence
On November 19, 2021, we completed the Flexion Acquisition pursuant to an Agreement and Plan of Merger (the “Flexion Merger Agreement”), dated as of October 11, 2021, by and among us, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of Pacira (“Purchaser”), and Flexion.
−Removed: Following the completion of a successful tender offer for the shares of Flexion’s common stock, Purchaser merged with and into Flexion with Flexion surviving as a wholly owned subsidiary of Pacira.
+Added: Following the completion of a successful tender offer for the shares of Flexion’s common stock, Purchaser merged with and into Flexion with Flexion surviving as a wholly
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 15
+Added: owned subsidiary of Pacira.
We changed the name of Flexion to Pacira Therapeutics, Inc.
2 unchanged sentences
ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.
−Removed: The addition of ZILRETTA to our innovative non-opioid product portfolio directly aligns with our mission to provide an opioid alternative to as many patients as possible and address medical needs along the neural pain pathway.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 15
−Removed: Table of Content s
−Removed: 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;
−Removed: (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.
+Added: The addition of ZILRETTA to our innovative non-opioid product portfolio directly aligned with our mission to deliver innovative, non-opioid pain therapies to transform the lives of patients.
+Added: Initially, the total consideration for the Flexion Acquisition was approximately $578.8 million consisting of:
+Added: (i) $448.5 million of cash paid to Flexion shareholders and to settle restricted stock units and certain stock options;
+Added: (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 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.
−Removed: For more information, see Note 5, Flexion Acquisition and Note 12, Financial Instruments , to our consolidated financial statements included herein.
−Removed: MyoScience Acquisition
−Removed: In April 2019, we completed the MyoScience Acquisition.
−Removed: The total consideration included an initial cash payment of $120.0 million, reduced by $1.0 million for post-closing purchase price adjustments and indemnification obligations, plus contingent milestone payments up to an aggregate of $100.0 million.
−Removed: The expiration date for the achievement of the milestones was December 31, 2023.
−Removed: We changed the name of MyoScience to Pacira CryoTech, Inc.
−Removed: after completing the merger.
−Removed: For more information on the contingent consideration related to the MyoScience Acquisition, refer to Note 12, Financial Instruments , to our consolidated financial statements included herein.
+Added: For more information, see Note 11, Financial Instruments , to our consolidated financial statements included herein.
Research Development Foundation
10 unchanged sentences
In November 2023, the United States District Court, District of Nevada conducted a mediation that did not result in a settlement.
−Removed: During the pendency of the remaining lawsuit, we will continue to pay royalties associated with the 200-liter manufacturing process to RDF under protest.
+Added: 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.
5 unchanged sentences
NOCITA is a registered trademark of Aratana.
−Removed: We are eligible to receive up to $40.0 million upon the achievement of commercial milestones.
−Removed: Aratana is required to pay us a tiered double-digit royalty on certain net sales made in the U.S.
+Added: 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.
If the product is approved by foreign regulatory agencies for sale outside of the U.S., Aratana will be required to pay us a tiered double-digit royalty on such net sales.
Royalty rates will be reduced under certain circumstances.
−Removed: Either party has the right to terminate the license agreement in connection with certain
+Added: 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.
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 16
−Removed: Table of Content s
−Removed: 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.
−Removed: Eurofarma Laboratories S.A.
−Removed: In June 2021, we entered into a distribution agreement with Eurofarma for the development and commercialization of EXPAREL in Latin America.
−Removed: Under the terms of the agreement, Eurofarma obtained the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia, and Mexico.
−Removed: In addition, Eurofarma is responsible for regulatory filings for EXPAREL in these countries.
−Removed: We will receive royalties based on Eurofarma’s future commercialization of EXPAREL and are also eligible to receive milestone payments that are triggered by the achievement of certain regulatory and commercial events.
+Added: | 2024 Annual Report on Form 10-K | Page 16
GQ Bio Therapeutics GmbH
−Removed: In April 2023, we entered into a process development agreement with GQ Bio Therapeutics GmbH (formerly named GeneQuine BioTherapeutics GmbH), or GQ, for the development of a commercially scalable manufacturing process for the production of PCRX-201.
−Removed: The agreement calls for us to pay GQ upon three milestones that can be achieved independently of each other.
−Removed: Milestone 1 includes a €0.5 million payment to GQ for the execution and completion of a feasibility assessment proposal for scalable process to support milestone 2.
−Removed: Achieving milestone 2 is associated with the development of a qualified program process for PCRX-201 where GQ would build a direct manufacturing cost of a PCRX-201 unit.
−Removed: 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.
+Added: In April 2023, we entered into a process development agreement with GQ Bio Therapeutics GmbH, or GQ Bio, for the development of a commercially scalable manufacturing process for the production of PCRX-201.
+Added: The agreement calls for us to pay GQ Bio upon the achievement of three milestones that can be achieved independently of each other.
+Added: Milestone 1 includes a €0.5 million payment to GQ Bio for the execution and completion of a feasibility assessment proposal for scalable process to support milestone 2.
+Added: Achieving milestone 2 is associated with the development of a qualified program process for PCRX-201 where GQ Bio would build a direct manufacturing cost of a PCRX-201 unit.
+Added: 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.
The achievement of milestone 3 requires us to pay GQ €0.5 million for delivering a validatable manufacturing process and validated analytical control package necessary for initiating process validation.
−Removed: Verve Medical Products, Inc.
−Removed: In July 2021, we entered into a licensing agreement with Verve Medical Products, Inc.
−Removed: for the distribution of iovera° in Canada.
−Removed: We began selling iovera° in Canada in the fourth quarter of 2021.
+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.
+Added: For more information on the GQ Bio Acquisition, see Note 21, Subsequent Events , to our consolidated financial statements included herein.
+Added: As of the date of this Annual Report, GQ Bio is a wholly-owned subsidiary of the Company.
Significant Customers
8 unchanged sentences
We manufacture EXPAREL and iovera° handpieces at our facility in San Diego, California.
−Removed: We also have a mixed-use research and development, manufacturing and office facility which sits adjacent to our EXPAREL and iovera° manufacturing facility, and a warehouse located within five miles of these facilities.
−Removed: We refer to these three buildings as the Science Center Campus, and together they consist of approximately 195,000 square feet.
+Added: We also have a mixed-use research and development, manufacturing and office facility which sits adjacent to our EXPAREL and iovera° handpiece manufacturing facility, and a warehouse located within five miles of these facilities.
+Added: We refer to these three buildings as our Science Center Campus, and together they measure approximately 195,000 square feet.
Our manufacturing facilities are inspected regularly and approved by the FDA, EMA, MHRA and the Environmental Protection Agency (EPA).
4 unchanged sentences
All manufacturing of products, initial product release and stability testing are conducted by us and our manufacturing partners in accordance with Current Good Manufacturing Practices, or CGMP.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 17
−Removed: Table of Content s
Our 84,000 square-foot EXPAREL manufacturing facility at the Science Center Campus is located on a five-acre site.
1 unchanged sentence
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.
−Removed: We are expanding our EXPAREL manufacturing capacity at our Science Center Campus as we expect the demand for EXPAREL will increase.
+Added: We recently expanded our EXPAREL manufacturing capacity at our Science Center Campus as we expect the future demand for EXPAREL will increase.
+Added: 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.
2 unchanged sentences
Our pilot plant suite for early-stage clinical product production is located in this building, and there is additional space for future expansion opportunities.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 17
We also occupy a 21,000 square-foot warehouse that serves as the main CGMP warehouse for our Science Center Campus operations, primarily being used for the storage of production materials.
5 unchanged sentences
In April 2014, we entered into a Strategic Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing and Supply Agreement (the “EXPAREL Manufacturing and Supply Agreement”) with Thermo Fisher Scientific Pharma Services, or Thermo Fisher, to collaborate in the manufacture of EXPAREL.
−Removed: 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.
+Added: 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.
8 unchanged sentences
Either party may terminate the EXPAREL Manufacturing and Supply Agreement in the event of the breach or bankruptcy of the other party.
−Removed: 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.
+Added: 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.
+Added: where our EXPAREL suite is located.
Thermo Fisher agreed to undertake certain transfer activities and construction services needed to prepare its facility for the commercial manufacture of ZILRETTA in dedicated manufacturing suites.
5 unchanged sentences
The ZILRETTA Manufacturing and Supply Agreement will remain in full effect unless and until it expires or is terminated.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 18
−Removed: Table of Content s
−Removed: terminate this agreement upon one month’s notice if a regulatory authority causes the withdrawal of ZILRETTA from the U.S.
+Added: 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.
3 unchanged sentences
In January 2020, we and Carlisle Companies, Inc., or Carlisle, entered into a Manufacturing and Supply Agreement (the “Carlisle Agreement”) to collaborate in the manufacture of iovera° Smart Tips at Carlisle’s Tijuana, Mexico facility.
−Removed: The initial term of the Carlisle Agreement is five years with automatic one-year extensions unless either party provides prior notice in writing.
+Added: The initial term of the Carlisle Agreement is five years with automatic one-year extensions unless either party provides prior notice in
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 18
Under the Carlisle Agreement, we pay fees based on the amount of iovera° Smart Tips delivered by Carlisle.
13 unchanged sentences
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.
−Removed: Some of our expired U.S.
−Removed: patents had a term of 17 years from the grant date.
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.
2 unchanged sentences
11,033,495 related to EXPAREL.
−Removed: The patent, “ Manufacturing of Bupivacaine Multivesicular Liposomes ,” claims composition of EXPAREL prepared by an improved manufacturing process.
+Added: 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.
−Removed: 11,185,506 and 11,179,336, claiming an improved EXPAREL manufacturing process and EXPAREL composition, respectively.
−Removed: 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.
+Added: 11,185,506 and 11,179,336, claiming the improved U.K.
+Added: EXPAREL manufacturing process and EXPAREL composition, respectively.
+Added: patents relating to product and product-by-process in connection with the improved U.K.
+Added: 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.
3 unchanged sentences
In June 2022, the USPTO issued U.S.
−Removed: 11,357,727, claiming composition of EXPAREL prepared by an improved manufacturing process.
+Added: 11,357,727, claiming composition of EXPAREL prepared by the improved U.K.
+Added: manufacturing process.
In August 2022, the USPTO issued U.S.
3 unchanged sentences
In November 2023, the USPTO issued U.S.
−Removed: 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by an improved manufacturing process and compositions of EXPAREL respectively.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 19
−Removed: Table of Content s
+Added: 11,819,574 and 11,819,575, claiming batch compositions of EXPAREL prepared by the improved U.K.
+Added: manufacturing process and compositions of EXPAREL, respectively.
+Added: In March 2024, the USPTO issued U.S.
+Added: 11,925,706, claiming composition of EXPAREL.
+Added: In November 2024, the USPTO issued U.S.
+Added: 12,144,890 and 12,151,024, claiming composition of EXPAREL prepared by the improved UK manufacturing process, and both composition of EXPAREL and composition of EXPAREL prepared by the improved UK manufacturing process, respectively.
+Added: In December 2024, the USPTO issued U.S.
+Added: 12,178,909, claiming the improved EXPAREL UK manufacturing process.
All 15 patents issued between 2021 and 2024 have an expiration date of January 22, 2041.
11,033,495, 11,179,336, 11,278,494, 11,304,904, 11,311,486, 11,357,727, 11,426,348, 11,452,691, 11,819,574, 11,819,575, 11,925,706, 12,144,890, and 12,151,024 are currently listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”).
+Added: 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 Abbreviated New Drug Application, or ANDA with a Paragraph IV certification seeking authorization for the manufacturing and marketing of a generic version of EXPAREL (266 mg/20 mL) in the U.S.
+Added: prior to the expiration of U.S.
+Added: In August 2024, the U.S.
+Added: District Court for the District of New Jersey issued its ruling in our patent infringement suit against eVenus and its parent company (Jiangsu Hengrui
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 19
+Added: Pharmaceuticals, Co.
+Added: Ltd., or Jiangsu Hengrui) for infringement of EXPAREL U.S.
+Added: The ruling found that this patent is not valid on the grounds of obviousness and anticipation.
+Added: A notice of appeal was filed in September 2024 and remains pending.
+Added: For information on this matter, as well as other subsequent patent litigation lawsuits against eVenus, Jiangsu Hengrui and Fresenius Kabi USA, LLC, or Fresenius, see Note 19, Commitments and Contingencies , to our consolidated financial statements included herein.
+Added: In December 2024, the USPTO also issued U.S.
+Added: 12,156,940 from a new family of patents related to EXPAREL produced by the Company’s enhanced, large-scale manufacturing process in San Diego, California, which received approval from the FDA in February 2024.
+Added: The ’940 patent, entitled “ Manufacturing of Bupivacaine Multivesicular Liposomes ”, claims batch compositions of EXPAREL prepared the enhanced U.S.
+Added: large-scale manufacturing process.
+Added: The ’940 patent has an expiration date of July 2, 2044 and is currently listed in the FDA’s Orange Book.
+Added: Furthermore, the USPTO also issued U.S.
+Added: 11,918,565 and 11,931,459 in March 2024, relating to use of EXPAREL as a sciatic nerve block and the pediatric use of EXPAREL, respectively.
+Added: 11,918,565 and 11,931,459 have an expiration date of February 2, 2043 and March 17, 2042, respectively, both are currently listed in the FDA’s Orange Book.
We also own a family of U.S.
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nonprovisional applications and PCT applications relating to the use of EXPAREL as a stellate ganglion block for managing cardiac arrhythmia and anxiety disorders, including electrical storm and post-traumatic stress disorder.
+Added: In 2024, we filed a U.S.
+Added: nonprovisional application relating to the use of EXPAREL as a stellate ganglion block for treating disorders associated with the sympathetic nervous system.
Patents and Patent Applications for ZILRETTA
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described above.
−Removed: In March 2023, we filed a provisional application relating to use ZILRETTA to treat OA pain in subpopulations of diabetic patients.
+Added: In February 2024, we filed a PCT application relating to use ZILRETTA to treat OA pain in subpopulations of diabetic patients.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 20
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.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 20
−Removed: Table of Content s
Patents and Patent Applications for iovera°
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Other patents and applications cover methods of using needles with blunt tips and aspects of cryogenic devices coupled with a neurostimulator for locating nerves and are set to expire between 2035 and 2038.
−Removed: 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.
+Added: 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.
In addition, we also filed a U.S.
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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.
−Removed: We are continuing to prosecute one U.S.
−Removed: BCM patent application related to PCRX-201.
+Added: We are continuing to prosecute one BCM U.S.
+Added: patent application related to PCRX-201.
Further, we have entered the national phase in Brazil, China, Europe, Hong Kong, Japan and the U.S.
based on a PCT application covering composition of matter and effective dosages of PCRX-201 in the treatment of OA in humans, which, if granted, are expected to provide protection until 2040.
−Removed: We also have a U.S.
−Removed: application and a PCT application covering composition of matter and method of use of PCRX-201 for the treatment of degenerative disc disease (DDD), which, if granted, are expected to provide protection until 2042.
−Removed: In addition, we also filed a provisional application in 2023 covering compositions and method of use of PCRX-201 in combination with a corticosteroid.
+Added: We also have a family of patent applications pending in the U.S., Australia, Canada, China, Hong Kong, Europe, Japan and South Korea covering composition of matter and method of use of PCRX-201 for the treatment of degenerative disc disease, or DDD, which, if granted, are expected to provide patent protection until 2042.
+Added: In February 2024, we also filed a PCT application covering compositions and method of use of PCRX-201 in combination with a corticosteroid.
+Added: In February 2025, as part of the GQ Bio Acquisition, we acquired an exclusive license of certain foundational patents and patent applications, and other proprietary rights owned by BCM related to an HCAd gene therapy vector encoding PRG4 gene for both human and veterinary applications.
+Added: Issued European patent EP 2948553 B1 generally covers HCAd-PRG4 composition of matter and method of use in treating camptodactyly-arthropathy-coxa vara-pericarditis (CACP) syndrome, a musculoskeletal disorder, or a joint disorder.
+Added: Patent No.11,746,359 generally covers composition of matter comprising HCAd-PRG4 and HCAd-IL-1Ra.
+Added: These patents expire in January 2034.
+Added: In addition, we also acquired a PCT application owned by GQ Bio related to HCAd gene therapy for treating DDD using nucleic acid encoding SOX-9, GDF5, TIMP3, SIRT6, TBXT, GLP-1, ANGPTL3 in combination with nucleic acid encoding IL-1Ra or PRG4.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 21
Additional Intellectual Property
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The expertise and knowledge required to understand the critical aspects of our pMVL manufacturing steps requires knowledge of both traditional and non-traditional emulsion processing and traditional pharmaceutical production, overlaid with all of the challenges presented by aseptic manufacturing.
−Removed: ZILRETTA is also manufactured using custom equipment and proprietary processes with respect to certain of the formulation and manufacturing
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 21
−Removed: Table of Content s
−Removed: techniques related to the TA-formulated PLGA microspheres in ZILRETTA, including those that relate to its precise pharmaceutical release profile.
+Added: 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.
The iovera° system relies on custom manufacturing techniques that are able to provide the precision and tight tolerances required for a self-contained handheld cryogenic device.
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EXPAREL also competes with 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.
−Removed: 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.
+Added: 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
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 22
+Added: available opioids and NSAIDs, long-acting local anesthetics and new chemical entities as well as alternative delivery forms of various opioids and NSAIDs.
Currently EXPAREL also competes with elastomeric pumps and catheter devices intended to provide bupivacaine over several days and with off-label combinations of other approved analgesics, called “cocktails,” that are combined by compound pharmacies in an attempt to extend the duration of pain control.
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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.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 22
−Removed: Table of Content s
The medical device industry is intensely competitive and subject to rapid and significant technological change.
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This process generally involves:
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 23
• completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations;
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• 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;
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 23
−Removed: Table of Content s
• satisfactory completion of an FDA advisory committee review, if applicable;
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Clinical trials involve the administration of the product candidate to healthy volunteers or patients having the disease being studied under the supervision of qualified investigators in accordance with GCP requirements, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.
−Removed: 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.
+Added: Sponsors of clinical trials generally must register at the National Institutes of Health-maintained website (www.clinicaltrials.gov) and report key findings and parameters.
For purposes of an NDA submission and approval, typically, the conduct of human clinical trials occurs in the following three pre-market sequential phases, which may overlap or be combined:
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Some clinical trials may be overseen by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board or committee.
−Removed: This group provides authorization for whether or not a trial may move forward at designated check points based on access to certain data from the trial.
+Added: This group provides authorization for whether or not a trial may move
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 24
+Added: forward at designated check points based on access to certain data from the trial.
The process of completing clinical testing and obtaining FDA approval for a new drug is likely to take a number of years and requires the expenditure of substantial resources.
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There also can be no assurance that approval or utilization of our products will be identical in different jurisdictions.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 24
−Removed: Table of Content s
Medical Devices
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A new indication for 510(k) clearance may or may not require a clinical trial.
−Removed: Expanding the iovera° label to include the treatment of spasticity requires a clinical trial, which we expect to begin in 2023.
+Added: Expanding the iovera° label to include the treatment of spasticity requires a clinical trial.
+Added: We currently have a pivotal trial underway to demonstrate the efficacy and safety of iovera° for treating spasticity.
Review and Approval Process
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Additionally, the FDA will typically inspect one or more clinical sites to ensure compliance with GCP before approving an NDA.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 25
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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If the FDA requires a REMS plan, it could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.
−Removed: The FDA also may approve an NDA contingent on, among other things, changes to proposed
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 25
−Removed: Table of Content s
−Removed: 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.
+Added: 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.
If and when the deficiencies have been addressed to the FDA’s satisfaction, the FDA will typically issue an approval letter.
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If the patent owner or NDA holder brings a patent infringement lawsuit within 45 days of such notice, the 505(b)(2) application cannot be approved for 30 months or until the 505(b)(2) applicant prevails, whichever is sooner.
−Removed: If the 505(b)(2) applicant loses the patent infringement suit, the FDA may not approve the 505(b)(2) application until the patent expires, plus any period of pediatric exclusivity.
−Removed: In any future NDA submissions for our product candidates, we intend to follow the development and approval pathway permitted under the FDCA that we believe will maximize the commercial opportunities for these product candidates.
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 26
−Removed: Table of Content s
+Added: | 2024 Annual Report on Form 10-K | Page 26
+Added: 505(b)(2) applicant loses the patent infringement suit, the FDA may not approve the 505(b)(2) application until the patent expires, plus any period of pediatric exclusivity.
+Added: In any future NDA submissions for our product candidates, we intend to follow the development and approval pathway permitted under the FDCA that we believe will maximize the commercial opportunities for these product candidates.
Post-Approval Requirements
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Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 27
−Removed: Table of Content s
+Added: | 2024 Annual Report on Form 10-K | Page 27
pharmaceutical product samples and impose requirements to ensure accountability in distribution, including a drug pedigree which tracks the distribution of prescription drugs.
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As with FDA, EMA or MHRA approval, we may not be able to secure additional regulatory approvals in a timely manner, if at all.
−Removed: 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
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 28
−Removed: Table of Content s
−Removed: failure to comply with such obligations could have a material adverse effect on our ability to successfully commercialize any product.
+Added: 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.
In addition to regulations in Europe and the U.S., we will be subject to regulations governing clinical trials, product approvals, and commercial distribution in the U.K, Canada, Latin America and any other jurisdictions in which EXPAREL, ZILRETTA, iovera° or any other future product is approved.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 28
Third-Party Payer Coverage and Reimbursement
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Congress and state legislatures from time to time propose and adopt initiatives aimed at cost containment that could impact our ability to sell our products at a price level high enough to realize an appropriate return on our investment, which would materially impact our results of operations.
−Removed: 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.
+Added: 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.
The Affordable Care Act revised the definition of “average manufacturer price” for reporting purposes, which could increase the amount of Medicaid drug rebates owed to states by pharmaceutical manufacturers for covered outpatient drugs.
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Moreover, in the coming years, additional changes could be made to governmental healthcare programs that could significantly impact the success of our products.
−Removed: In December 2022, the NOPAIN Act was signed into law as part of the Biden Administration’s Consolidated Appropriations Act of 2023.
+Added: In December 2022, the N on- O pioids P revent A ddiction I n the N ation (“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.
−Removed: 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.
+Added: 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.
Specifically, the NOPAIN Act covers reimbursement for (i) all non-opioid medications indicated to reduce postoperative pain or produce postsurgical regional analgesia without acting upon the body’s opioid receptors;
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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.
−Removed: The Centers for Medicare and Medicaid Services (CMS) requires time to implement the NOPAIN Act, which will take effect on January 1, 2025.
−Removed: 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.
+Added: The NOPAIN Act took effect on January 1, 2025.
+Added: This 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.
+Added: 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.
+Added: The new J-code for EXPAREL (J0666) became effective January 1, 2025, and supersedes the prior C-code (C9290), which had been in place since 2019.
+Added: In addition to the separate CMS reimbursement EXPAREL will receive in outpatient settings with the implementation of the NOPAIN Act in January 2025, this new J-code will also provide reimbursement when EXPAREL is used in the office setting and for office-based surgeries.
+Added: J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like EXPAREL.
+Added: Claims submission and payment are standardized with a J-code, facilitating and streamlining billing and reimbursement.
+Added: In addition, some commercial insurers require a J-code for payment.
+Added: Additionally, in November 2024, CMS confirmed that both EXPAREL and iovera° qualify as eligible non-opioid pain management products under the NOPAIN Act.
+Added: HOPDs and ASCs, that use these products now receive additional Medicare reimbursement effective January 1, 2025.
+Added: Additionally, separate reimbursement for iovera° will pay up to an additional $255.85 when providers administer iovera° in ASC and HOPD settings, using a new C-code created for iovera° (C9809).
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 29
+Added: Medicare payment is provided in addition to the current reimbursement available to HOPDs and ASCs when they perform a procedure with iovera°.
The marketability of our products may suffer if the government and third-party payers fail to provide adequate coverage and reimbursement.
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has increased, and we expect will continue to increase, the pressure on pharmaceutical and medical device pricing.
−Removed: Some third-party payers require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers that use such therapies, or place limits
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 29
−Removed: Table of Content s
−Removed: on the amount of reimbursement.
+Added: Some third-party payers require pre-approval of coverage for new or innovative devices or drug therapies before they will reimburse healthcare providers that use such therapies, or place limits on the amount of reimbursement.
Coverage policies and third-party payer reimbursement rates may change at any time.
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Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 30
−Removed: Table of Content s
Regulations Pertaining to Sales and Marketing
We are subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws.
−Removed: Anti-kickback laws generally prohibit a prescription drug or medical device manufacturer from soliciting, offering, receiving, or paying any remuneration to generate business, including the purchase or prescription of a particular drug or device.
+Added: Anti-kickback laws generally prohibit a prescription drug or medical device manufacturer from soliciting, offering, receiving, or paying any remuneration to generate business, including the purchase or prescription of a
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 30
+Added: particular drug or device.
Although the specific provisions of these laws vary, their scope is generally broad and there may be no regulations, guidance or court decisions that clarify how the laws apply to particular industry practices.
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The American Recovery and Reinvestment Act of 2009, commonly referred to as the economic stimulus package, included sweeping expansion of HIPAA’s privacy and security standards called the Health Information Technology for Economic and Clinical Health Act, or HITECH, which became effective in February 2010.
−Removed: Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 31
−Removed: Table of Content s
−Removed: “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.
+Added: 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.
HITECH also increased the civil and criminal penalties that may be imposed against covered entities, business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorney’s fees and costs associated with pursuing federal civil actions.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 31
Environmental Matters
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Over the past three years, there have been no known material breaches, and no expenses related to the investigation of such breaches.
−Removed: For more information related to our cybersecurity program, see Item 1C.
+Added: For more information on our cybersecurity program, see Item 1C.
Cybersecurity .
Corporate Citizenship
−Removed: We are the industry leader in our commitment to non-opioid pain management and providing non-opioid pain management options to as many patients as possible to redefine the role of opioids as a rescue therapy only.
+Added: We are the industry leader in our commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients.
We are dedicated to the principles of social responsibility and good corporate governance.
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We conduct our operations and manage our product and pipeline programs in a responsible manner and strive to comply with applicable laws, rules and regulations.
−Removed: 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;
+Added: 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.
Pacira Gives Back
−Removed: 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.
−Removed: Through Pacira Gives Back, employees can also make a donation to a non-profit organization of their choice with a dollar-for-dollar company match up to $200 per employee.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 32
−Removed: Table of Content s
+Added: 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.
+Added: Through Pacira Gives Back, employees can also make a donation to a not-for-profit organization of their choice with a dollar-for-dollar company match of up to $200 per employee annually.
Human Capital
Pacira Core Values
−Removed: We are a team of dedicated and highly talented professionals focused on driving improved patient outcomes with opioid-reducing strategies.
+Added: We are a team of dedicated and highly talented professionals focused on delivering innovative, non-opioid pain therapies to transform the lives of patients.
We are an organization built on high ethical standards, an unwavering commitment to patients and transparent communications.
We have a drive and a desire to improve the world around us and make a meaningful difference in the lives of patients, families, communities and society.
−Removed: The six core values that underpin everything we do are:
−Removed: Their safety and welfare are our top priority at all times
−Removed: Our greatest asset
−Removed: We are passionate about what we do
−Removed: Our thoughts are shared generously
−Removed: Building trust is essential
−Removed: The cornerstone of our business success
+Added: Our core values guide our behaviors, choices and actions;
+Added: foster our collaborative culture and further strengthen our organization.
+Added: The core values that underpin everything we do are:
+Added: • Every day, we are determined to achieve the extraordinary .
+Added: We are bold enough to consistently do what others say cannot be done.
+Added: Guided by our commitment to keep the patient at the center, we recognize that every day matters for a patient suffering in pain.
+Added: • Integrity is the foundation of who we are .
+Added: We have the courage to tackle the biggest problems—and to do that, we know we have to follow the science.
+Added: We believe in transparency, accountability and honesty, and we have the fortitude to make difficult decisions for the greater good.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 32
+Added: • We respect diverse talent and the collective power of a unified team .
+Added: We recognize the role of teamwork toward tackling challenges and we believe in the value of different experiences and perspectives.
+Added: We treat our people well—with fairness, equity and respect.
Corporate Sustainability Report
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Total Rewards
−Removed: 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.
+Added: 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.
Additionally, we reward employees driving significant value creation with a variety of long-term and short-term incentives including a recognition platform, annual performance bonuses, stock options, restricted stock units and a long-term performance cash incentive.
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In addition, we conduct mid-year and annual performance reviews for all employees to ensure regular discussions around performance, progress towards goals and professional development.
−Removed: 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.
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 33
−Removed: Table of Content s
+Added: 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.
Employee Wellbeing, Health and Safety
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This includes a variety of tools to promote total wellbeing in the areas of health, wealth, work and life to keep our employees and their families healthy, lower their healthcare costs and reduce stress.
−Removed: 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.
+Added: 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.
We offer our eligible employees flexible work arrangements—including remote working opportunities, flexible schedules and reduced schedules to help achieve an appropriate work/life balance.
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a paid parental leave benefit, insurance to help protect assets during times of short- and long-term disability, life insurance and accidental death and dismemberment insurance, critical illness and accident insurance, financial education seminars on savings, debt and other financial topics, access to financial specialists, access to discounts on a variety of products and services and incentives to engage in a new or maintain a wellbeing activity.
−Removed: Additionally, our 401(k) retirement plan fiduciary also serves as a financial advisors to all employees in the plan to help them with their personal financial planning needs.
−Removed: 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.
−Removed: We also offer our employees and their covered family members in-network coverage of each of EXPAREL, ZILRETTA and iovera° through our medical care plans.
−Removed: We have a formal Environmental Health and Safety (EHS) Program.
+Added: Additionally, our 401(k) retirement plan fiduciary is available to serve as a financial advisor to all employees with one-on-one personal financial planning.
+Added: 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.
+Added: We also offer our employees and their covered family members in-network coverage of each of EXPAREL, ZILRETTA and iovera° through our employer-sponsored health benefit plans.
+Added: Pacira BioSciences, Inc.
+Added: | 2024 Annual Report on Form 10-K | Page 33
+Added: We have a formal Environmental Health and Safety Program.
It is our policy that everyone is entitled to a safe and healthful place to work.
12 unchanged sentences
leadership development, diversity recruiting, culture and communications.
−Removed: As of December 31, 2023, we had 712 employees, of which 711 are full-time and one is part-time.
+Added: 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.
−Removed: except for 11 employees based in England.
+Added: 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.
4 unchanged sentences
We make these reports available through our corporate website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the SEC.
−Removed: In addition, we
−Removed: Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 34
−Removed: Table of Content s
−Removed: 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.
−Removed: 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.
+Added: 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.
+Added: 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.
Pacira BioSciences, Inc.
−Removed: | 2023 Form 10-K | Page 35
−Removed: Table of Content s
+Added: | 2024 Annual Report on Form 10-K | Page 34
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.