What changed in this filing

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Item 1. Business

2023-02-28 compared with 2022-02-28 · 358 added, 359 removed, 701 unchanged (51% of the section changed)

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from SkyePharma Holdings, Inc.

(now a subsidiary of Vectura Group plc), or Skyepharma (referred to herein as the “Skyepharma Acquisition”).

In April 2019, we acquired MyoScience, a privately held medical technology company (referred to herein as the “MyoScience Acquisition”) and in November 2021, we acquired Flexion Therapeutics, Inc., a publicly traded biopharmaceutical company (referred to herein as the “Flexion Acquisition”).

(now a subsidiary of Vectura Group plc), or Skyepharma (the “Skyepharma Acquisition”).

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”).

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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and in April 2019, we changed our name to Pacira BioSciences, Inc.

Our principal executive offices are located in Tampa, Florida.

Our principal executive offices and corporate headquarters are located in Tampa, Florida.

Trademarks and Service Marks

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We are the industry leader in our commitment to non-opioid pain management and providing a non-opioid option to as many patients as possible to redefine the role of opioids as a rescue therapy only.

We are also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity.

We are advancing a pipeline of unique, safe, best-in-class products across a variety of therapeutic areas that include acute postsurgical pain;

acute and chronic osteoarthritis, or OA, pain of the knee;

low back and other areas;

spasticity and stellate ganglion block of the sympathetic nerves.

acute and chronic osteoarthritis, or OA, pain, spasticity and stellate ganglion block.

We have three commercialized non-opioid treatments:

EXPAREL ® (bupivacaine liposome injectable suspension), a long-acting, local analgesic currently approved for postsurgical pain management;

ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, corticosteroid injection indicated for the management of OA knee pain;

ZILRETTA ® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, or IA (meaning in the joint), corticosteroid injection indicated for the management of OA knee pain;

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.

Flexion Acquisition

On November 19, 2021, we completed the Flexion Acquisition pursuant to an Agreement and Plan of Merger (the “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 Therapeutics, Inc., a Delaware corporation (“Flexion”).

Following the completion of a successful tender offer for the shares of Flexion’s common stock, and pursuant to the terms of the Merger Agreement and in accordance with Section 251(h) of the General Corporation Law of the State of Delaware, Purchaser merged with and into Flexion with Flexion surviving as a wholly owned subsidiary of Pacira.

We changed the name of Flexion to Pacira Therapeutics, Inc.

after completing the merger.

As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, intra-articular, or IA (meaning in the joint), injection indicated for the management of OA knee pain.

ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.

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.

The total consideration for the Acquisition was approximately $578.8 million consisting of (i) $448.5 million of cash paid to Flexion shareholders and to settle restricted stock units and certain stock options;

(ii) an $85.1 million cash payment of Flexion debt not to be 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

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Flexion Acquisition.

The consideration is subject to adjustments based on the estimated fair value of the potential milestone payments.

We funded the cash portion of the purchase price with cash on hand.

For more information, see Note 5, Acquisitions , to our consolidated financial statements included herein.

To achieve our goal of global leadership in non-opioid pain management and regenerative health solutions, we are advancing a three-pronged strategy:

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EXPAREL is also approved for infiltration in pediatric patients aged six years and older in the U.S.

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.

Anesthesia-driven postsurgical management with long-acting field and nerve blocks utilizing EXPAREL are enabling the migration of complex, painful surgeries to outpatient sites of care.

Anesthesia-driven postsurgical pain management with long-acting field and nerve blocks utilizing EXPAREL are enabling the migration of complex, painful surgeries to outpatient sites of care.

ZILRETTA is the first and only extended-release, intra-articular therapy that can provide major relief for OA knee pain for three months and has the potential to become an alternative to hyaluronic acid, or HA, and platelet rich plasma, or PRP, injections or other early intervention treatments.

With the iovera° system, healthcare providers can replace narcotics and radiofrequency ablation with an innovative drug-free nerve block.

With the iovera° system,

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healthcare providers can replace narcotics and radiofrequency ablation with an innovative drug-free nerve block.

We believe the iovera° system is also highly complementary to ZILRETTA.

In addition to our current commercial opportunities, we are advancing label expansion activities.

For EXPAREL, we are advancing two Phase 3 studies in lower extremity nerve block procedures, as well as a development program for pediatric patients under six years of age.

For ZILRETTA, we plan to initiate a Phase 3 study in shoulder OA and we are defining label expansion studies to include safety superiority in patients with Type 2 diabetes and repeat dosing for OA knee pain.

For EXPAREL, we recently submitted an sNDA seeking expansion of our label to include sciatic nerve blocks in the popliteal fossa, as well as femoral nerve blocks in the adductor canal, with an anticipated FDA action date under the Prescription Drug User Fee Act, or PDUFA, in the second half of 2023.

We are also advancing a clinical development program for EXPAREL in patients under six years of age.

For ZILRETTA, we plan to initiate a Phase 3 study in shoulder OA and a Phase 4 study in Type 2 diabetes.

For iovera°, we are developing new iovera° Smart Tips for chronic lower back pain and spine procedures.

We are also advancing plans to develop iovera° as a treatment for spasticity.

We also plan to initiate a registration study of iovera° as a treatment for spasticity.

• Advancing our clinical-stage pipeline within multiple areas of unmet need.

We are advancing our pipeline of clinical-stage assets that utilize our proprietary multivesicular liposome (pMVL) technology.

We have completed a Phase 1 study of PCRX-201, a novel, IA gene therapy product candidate that produces the anti-inflammatory protein interleukin-1 receptor antagonist (IL-1Ra) treating OA pain in the knee.

Based upon compelling initial Phase 1 efficacy and safety data for PCRX-201, we are working with investigators and plan to request an FDA meeting to discuss the regulatory pathway forward for OA of the knee, as well as a Regenerative Medicine Advanced Therapy, or RMAT, designation.

We are also advancing our pipeline of clinical-stage assets that utilize our proprietary multivesicular liposome (pMVL) technology.

The pMVL carrier matrix consists of microscopic, spherical, lipid-based particles composed of a honeycomb of numerous, non-concentric, internal aqueous chambers containing the encapsulated active agent.

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Following injection, the pMVL particles release the active agent over an extended period as the lipid membranes erode or reorganize.

We are preparing to launch a Phase 2 study of Dexamethosone-pMVL for low back pain (“PCRX-401”), a Phase 2 study of high-dose bupivacaine-pMVL for five or more days of pain relief (“PCRX-501”), and a Phase 2 study of low-dose bupivacaine-pMVL for epidural analgesia.

We are preparing to launch a Phase 1 study of Dexamethosone-pMVL for low back pain (“PCRX-401”), a Phase 1 study of high-dose bupivacaine-pMVL for five or more days of pain relief (“PCRX-501”), and a Phase 1 study of EXPAREL for intrathecal analgesia.

• Accessing complementary innovative assets using a combination of strategic investment, in-licensing, or acquisition.

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has reached epidemic proportions, with the U.S.

Centers for Disease Control and Prevention, or CDC, reporting that overdose deaths rose by 29 percent to an unprecedented amount of more than 100,000 in the U.S.

in the 12-months ending April 2021.

This represents a worsening of the drug overdose epidemic in the U.S.

and is the largest number of drug overdoses for a 12-month period ever recorded.

The recent increase in drug overdose mortality began in 2019 and continued into 2020, prior to the declaration of the COVID-19 National Emergency in the U.S.

The increases in drug overdose deaths appear to have accelerated during the COVID-19 pandemic.

Synthetic opioids are the primary driver of the increases in overdose deaths, with deaths from synthetic opioids and psychostimulants also increasing in the 12-months ending April 2021.

Centers for Disease Control and Prevention, or CDC, reporting that over 107,000 Americans died from a drug overdose in the 12-month period ending March 2022—a 44 percent jump from the statistics reported two years earlier.

Opioids were involved in more than two-thirds of all drug overdose deaths reported, with synthetic opioids being the primary driver of the increase in fatalities.

In 2018, new research showed that patients received nearly 100 to 200 opioid pills to help manage pain from four common procedures ranging from rotator cuff repair and hip replacement to knee replacement and sleeve gastrectomy.

Further, one-quarter of orthopedic surgery patients were prescribed a daily dose of opioids equal to 90 milligrams of morphine or more, which are doses so potent that the CDC says they put patients at high risk for overdose.

A 2017 report shows that across the

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seven orthopedic and soft tissue surgical procedures examined, patients were prescribed an average of 82 opioid pills each to help manage postsurgical pain.

A 2017 report shows that across the seven orthopedic and soft tissue surgical procedures examined, patients were prescribed an average of 82 opioid pills each to help manage postsurgical pain.

The research also indicates that close to nine percent of surgical patients became newly persistent users in 2017, continuing to take these opioids at least three to six months after their procedure.

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An Analysis of the Impact of Opioid Overprescribing in America , based on an analysis of 2016 adjudicated medical and pharmacy claims data conducted by QuintilesIMS.

LPGA Sponsorship

In February 2023, we announced a multi-year sponsorship with the Ladies Professional Golf Association, or LPGA, to make iovera° the official non-opioid pain management partner of the LPGA.

The sponsorship will aim to draw attention to the role non-opioid pain management options can play in curbing the U.S.

opioid epidemic.

We will host initiatives at various LPGA tournaments to drive awareness and education on the availability of non-opioid interventions as well as encourage fans to wear purple each September, which is recognized as Opioid Awareness Month.

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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:

* Pediatric FDA action date of March 22, 2021 was for infiltration in patients aged 6 to 17 years old.

Study designs have not been finalized for pediatric populations in infiltration or nerve block in patients aged 0 to less than 6 years old.

- TAP block is a transversus abdominis plane field block

- NOCITA ® is a registered trademark of Aratana Therapeutics, Inc., a wholly owned subsidiary of Elanco Animal Health, Inc.

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Our Commercial Products

EXPAREL (bupivacaine liposome injectable suspension)

EXPAREL was approved by the FDA in October 2011 and was commercially launched in April 2012.

EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S.

in April 2012.

In the U.S., EXPAREL is currently indicated in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

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.

We launched EXPAREL in the United Kingdom, or U.K., and select European Union, or E.U., countries in November 2021.

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(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.

(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.

Our net product sales of EXPAREL in 2022 were $536.9 million.

For the years ended December 31, 2022, 2021 and 2020, net product sales of EXPAREL accounted for 81%, 94% and 96% of our total revenues, respectively.

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)

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shortly thereafter.

We market ZILRETTA through our ZILRETTA and iovera° sales force of approximately 50 Treatment Solutions Mangers who are providing clinicians with two unique OA treatment options to individualize patient care.

ZILRETTA is the first and only extended-release, intra-articular therapy for patients confronting OA knee pain.

ZILRETTA employs a proprietary microsphere technology combining triamcinolone acetonide, or TA, a commonly administered, immediate-release corticosteroid, with a poly lactic-co-glycolic acid, or PLGA, matrix to provide extended pain relief.

PLGA is a proven extended-release delivery vehicle that is metabolized to carbon dioxide and water as it releases drug in the IA space and is used in other approved drug products and surgical devices.

The ZILRETTA microspheres slowly and continuously release triamcinolone acetonide into the knee to provide significant pain relief for 12 weeks, with some people experiencing pain relief through 16 weeks.

ZILRETTA is the first and only extended-release, intra-articular therapy 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.

We added ZILRETTA to our commercial offering with the completion of the Flexion Acquisition in November 2021.

ZILRETTA net product sales were $105.5 million for the year ended December 31, 2022 .

The vast majority of the 2021 ZILRETTA sales occurred prior to the completion of the Flexion Acquisition and prior to our ownership of Flexion.

We recognized ZILRETTA net product sales of $12.7 million during the post-closing period of November 19, 2021 to December 31, 2021.

In 2021, we recognized ZILRETTA net product sales of $12.7 million during the post-closing period of the Flexion Acquisition of November 19, 2021 to December 31, 2021.

The iovera° system

The iovera° system is an FDA-approved, non-opioid handheld cryoanalgesia device used to produce precise, controlled doses of cold temperature only to targeted nerves.

It has been FDA 510(k) cleared for use in pain applications since March 2014.

We believe 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.

For the year ended December 31, 2021, our net product sales of iovera° were $16.2 million.

The iovera° system is an FDA-approved, non-opioid handheld cryoanalgesia device used to produce precise, controlled doses of cold temperature to targeted nerves.

It has been FDA 510(k) cleared in the U.S., has a CE mark in the E.U.

and is cleared for marketing in Canada for the blocking of pain.

The iovera° system is highly complementary to EXPAREL and ZILRETTA as a non-opioid therapy that alleviates pain using a non-pharmacological nerve block to disrupt pain signals being transmitted to the brain from the site of injury or surgery.

It is also indicated for the relief of pain and symptoms associated with arthritis of the knee for up to 90 days.

For the years ended December 31, 2022, 2021 and 2020, our net product sales of iovera° were $15.3 million, $16.2 million and $8.8 million, respectively.

EXPAREL Clinical Benefits

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• leverages existing interscalene brachial plexus nerve block, field block and infiltration administration techniques;

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• allowed 13% of patients who received EXPAREL to remain opioid-free for 48 hours after surgery (p<0.01) compared to one opioid-free patient in the placebo arm.

In our Phase 3 trial as a femoral nerve block in the adductor canal in patients undergoing total knee arthroplasty, or TKA, EXPAREL:

• achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p<0.01);

• achieved its secondary endpoint with a statistically significant reduction in postsurgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl.

In our Phase 3 trial as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, EXPAREL:

• achieved the primary endpoint by significantly reducing cumulative pain scores from zero to 96 hours after surgery compared with bupivacaine HCl (p<0.00001);

• achieved its secondary endpoints with statistically significant reductions in postsurgical opioid consumption through 96 hours (p<0.00001) and the percentage of opioid-free subjects (p<0.001) compared with bupivacaine HCl.

EXPAREL can improve patient satisfaction and outcomes.

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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 orthopedic procedures to the 23-hour stay environment.

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EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures.

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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.

Managing postsurgical pain in these adult degenerative patients

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can be challenging due to their established opioid tolerance, but with 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.

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.

EXPAREL administered as a brachial plexus nerve block is a key and growing part of our business.

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A variety of truncal blocks have emerged for use in abdominal and colorectal procedures.

Transversus abdominis plane, or TAP, and erector spine plane blocks represent a significant market where EXPAREL is providing long-acting pain control in the abdominal region and supporting the migration of these procedures to the 23-hour setting.

Transversus abdominis plane, or TAP, and erector spinae plane blocks represent a significant market where EXPAREL is providing long-acting pain control for abdominal and spinal surgeries and supporting the migration of these procedures to the 23-hour setting.

We expect the expanding use of EXPAREL field blocks as the foundation of enhanced recovery protocols across various abdominal and colorectal procedures to continue to be a significant growth driver.

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There is a significant and growing demand among women for managing pain with non-opioid options.

Opioid addiction in women is growing at an alarming rate and studies have shown that women are 40% more likely than men to become newly persistent users of opioids following surgery.

Women’s Health continues to be an important source of growth as anesthesia-driven EXPAREL-based TAP and pectoralis blocks take hold as institutional protocol for C-section, abdominoplasty, gynecologic oncology, mastectomy and breast reconstruction procedures.

Opioid addiction in women is growing at an alarming rate and studies have shown that women are 40 percent more likely than men to become newly persistent users of opioids following surgery.

Women’s Health continues to be an important source of growth as anesthesia-driven EXPAREL-based TAP and pectoralis blocks take hold as institutional protocol for Cesarean section, abdominoplasty, gynecologic oncology, mastectomy and breast reconstruction procedures.

Cardiothoracic

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As a result, opioids are widely used, but are often inadequate.

Poorly controlled postoperative pain leads to the development of chronic persistent pain in as many as 40% of these patients and persistent opioid use after surgery is seen in over 10% of such patients.

Regional anesthesia approaches have been evolving, with EXPAREL replacing thoracic epidurals as an alternative method of producing long-lasting analgesia.

Poorly controlled postoperative pain leads to the development of chronic persistent pain in as many as 40 percent of these patients and persistent opioid use after surgery is seen in over 10 percent of such patients.

Regional anesthesia approaches have been evolving, with EXPAREL replacing thoracic epidurals as an alternative method of producing long-lasting postsurgical analgesia.

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In March 2021, the FDA approved our sNDA to expand the EXPAREL label to include use in patients six years of age and older for single-dose infiltration to produce postsurgical local analgesia.

EXPAREL is the first and only FDA-approved long-acting local analgesic for the pediatric population as young as age six.

In November 2022, both the EMA’s Committee for Medicinal Products for Human Use, or CHMP, and the Medicines and Healthcare Products Regulatory Agency, or MHRA, approved marketing authorization for an expanded indication of EXPAREL to include use in children aged six years and older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

Opioids, short-acting local anesthetics and catheter-based devices have been the historical mainstay in pediatric postsurgical pain management despite safety implications and limited studies in children.

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A large retrospective review of the Medicaid database found that of 2.8 million patients who underwent surgical tooth extraction, 1.2 million—or roughly 42 percent—filled a prescription for opioids within seven days after surgery, with a median of 120 morphine milligram equivalents dispensed per patient.

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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.

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.

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.

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Aetna now includes the cost of EXPAREL as a covered expense for impacted third molar extractions performed by surgeons who have completed training on use of the product.

In September 2022, we announced a joint initiative with Sevāredent Sourcing Solutions, or Sevāredent, a Group Purchasing Organization (GPO) that creates a competitive advantage for like-minded dental organizations through vendor partnerships that drive supply chain value and efficiencies, to provide expanded access to EXPAREL for patients undergoing oral and maxillofacial (OMFS) procedures ranging from third molar and full mouth extractions to dentures and implants.

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.

ZILRETTA Clinical Benefits

ZILRETTA combines a commonly administered steroid, TA, with PLGA, delivering a 32 milligram dose of TA to provide extended therapeutic concentrations in the joint and persistent analgesic effect.

ZILRETTA combines a commonly administered steroid, TA, with a proprietary, extended-release microsphere technology to administer extended therapeutic concentrations in the joint and persistent analgesic effect.

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Based on the strength of its pivotal and other clinical trials, we believe that ZILRETTA represents an important treatment option for the millions of patients in the U.S.

in need of safe and effective extended relief from OA knee pain.

The pivotal Phase 3 trial, on which the approval of ZILRETTA was based, showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16.

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.

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• Patients who were administered iovera° were far less likely to take opioids six weeks after surgery.

The number of patients taking opioids six weeks after TKA in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14% vs.

44%, p<0.01).

The number of patients taking opioids six weeks after TKA in the control group was three times the number of patients taking opioids in the cryoanalgesia group (14 percent vs.

44 percent, p<0.01).

• 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).

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• iovera° is repeatable;

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• The iovera° technology does not risk damage to the surrounding tissue;

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With OA, the cartilage within a joint begins to break down and the underlying bone begins to change.

These changes usually develop slowly and get worse over time.

These changes usually develop slowly and worsen over time.

OA can cause pain, stiffness and swelling.

In some cases it also causes reduced function and disability;

some people are no longer able to do daily tasks or work.

In some cases it also causes reduced function and disability—some people are no longer able to do daily tasks or work.

According to the CDC, OA affects over 32.5 million adults in the U.S.

The lifetime risk of developing symptomatic knee OA is 45 percent.

The lifetime risk of developing symptomatic knee OA is 45 percent according to the Arthritis Foundation.

The prevalence of symptomatic knee OA increases with each decade of life, with the annual incidence of knee OA being highest between age 55 and 64 years old.

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With the addition of ZILRETTA to our product offering, we can now offer clinicians the flexibility to individualize OA knee pain treatment with either ZILRETTA or a drug-free nerve block with iovera° based on patient factors and preference, physician training, site of care and reimbursement considerations.

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Label and Global Expansion Activities

• Pediatrics.

We are working with the FDA to finalize a regulatory pathway to expand the EXPAREL label for patients under six years of age, as well as the administration of EXPAREL as a nerve block in the pediatric setting.

We are working with both the FDA and the European Medicines Agency, or EMA, to harmonize our pediatric clinical studies as much as possible between the two regions.

• Lower extremity nerve block.

We are advancing two Phase 3 studies of EXPAREL as a nerve block in lower extremity surgeries.

One is a popliteal sciatic nerve block for bunionectomy and the second is an adductor canal block for TKA.

We believe positive results from these studies will form the basis for an sNDA submission seeking label expansion to include lower extremity nerve blocks.

We believe the addition of this indication is significant as anesthesia-driven regional approaches using nerve and field blocks continue to expand as institutional protocols.

In September 2022, we announced positive topline results from two Phase 3 registration studies of EXPAREL as a single-dose nerve block for postsurgical regional analgesia in lower extremity surgeries.

The first study, which evaluated EXPAREL as a femoral nerve block in the adductor canal in patients undergoing TKA achieved the primary endpoint, demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.01).

EXPAREL also achieved a statistically significant reduction in postsurgical opioid consumption through 96 hours (p<0.01) compared with bupivacaine HCl, a key secondary endpoint.

The second study, which evaluated EXPAREL as a sciatic nerve block in the popliteal fossa in patients undergoing bunionectomy, achieved the primary endpoint by demonstrating a statistically significant reduction in cumulative pain scores from 0 to 96 hours compared with bupivacaine HCl (p<0.00001).

EXPAREL also achieved statistically significant reductions in postsurgical opioid consumption (p<0.00001) and percentage of opioid-free subjects (p<0.001) through 96 hours compared with bupivacaine HCl, which were key secondary endpoints.

EXPAREL was well tolerated with a safety profile consistent with bupivacaine HCl.

With these positive results, we submitted an sNDA to the FDA in January 2023 seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal and sciatic nerve block in the popliteal fossa, with an anticipated FDA action date under PDUFA in the second half of 2023.

• Pediatrics.

We expect to initiate a Phase 1 pharmacokinetic study after which we would initiate a registration study to support expansion of the EXPAREL single-dose infiltration label to include patients under six years of age.

If successful, we expect this study will support expansion of the EXPAREL labels in the U.S.

We are also discussing our regulatory strategy for EXPAREL administered as a nerve block in the pediatric setting.

• Stellate ganglion block.

We believe a long-acting stellate ganglion block with EXPAREL has the potential to be an effective approach for managing ventricular tachycardia (commonly referred to as “electrical storm”), a life-threatening clinical condition characterized by the recurrence of hemodynamically unstable ventricular tachycardia and/or ventricular fibrillation.

We are planning pilot studies that will separately evaluate long-acting stellate ganglion blocks with EXPAREL and iovera° for managing electrical storm.

Planning is underway for a multicenter registration study of EXPAREL as a stellate ganglion block for treating refractory cardiac ventricular dysrhythmias and for use to prevent postoperative atrial fibrillation after open heart surgery.

We are working with a steering committee of Key Opinion Leaders, or KOLs, in regional anesthesia and stellate ganglion blocks to help finalize study design.

After we meet with the FDA to align on our regulatory strategy for expanding the EXPAREL label to include stellate ganglion block, we expect to proceed with a registration trial.

We believe a stellate ganglion block utilizing EXPAREL will last for several days and address a significant unmet need in patients with ventricular and atrial dysrhythmias.

• Global expansion.

We have prioritized the European and Latin American markets for global expansion.

In Europe, we were granted marketing authorization by the EC in November 2020 for EXPAREL as a brachial plexus block or femoral nerve block for treatment of post-operating pain in adults and as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults.

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 in November 2022, we received approval to include children aged 6 years or older as a field block for treatment of somatic post-operative pain from small- to medium-sized surgical wounds.

We launched EXPAREL in the U.K.

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Eurofarma has the exclusive right to market and distribute EXPAREL in 19 countries in Latin America, including Argentina, Brazil, Colombia and Mexico.

In addition, Eurofarma will be responsible for regulatory filings for EXPAREL in these countries.

In addition, Eurofarma will be responsible for regulatory filings for EXPAREL in these countries, and recently submitted an application seeking approval in Brazil.

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.

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We believe ZILRETTA’s extended-release profile may also provide effective treatment for OA pain of the shoulder, and we intend to initiate a Phase 3 trial investigating ZILRETTA in shoulder OA in 2023.

In addition, we are planning a comparative safety study of ZILRETTA in patients with Type 2 diabetes and are evaluating a repeat dosing study.

The iovera° System

We recently launched a next-generation iovera° handheld device, which we believe is more efficient, easier to use and more durable.

In addition, we are planning a Phase 4 study in patients with Type 2 diabetes.

The shoulder study and the diabetes study will both compare ZILRETTA to immediate release TA.

In 2022, we launched a next-generation iovera° handheld device, which we believe is more efficient, easier to use and more durable.

We are also developing new iovera° Smart Tips for certain procedures and are developing a specific tip for a medial branch block for treating chronic low-back pain, as well as spine procedures.

We are also seeking a label expansion for the treatment of spasticity, which we believe is a significant long-term opportunity for iovera°.

Additionally, we expect to begin selling iovera° in the E.U.

through a contracted sales force in the first quarter of 2022.

We are also seeking a label expansion for the

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treatment of spasticity, which we believe is a significant long-term opportunity for iovera°.

Additionally, we began selling iovera° in the E.U.

through a contracted sales force in 2022.

Clinical Development Programs

PCRX-201 and PCRX-301 (Formerly FX-201 and FX-301)

PCRX-201 and PCRX-301 were added to our portfolio as part of the Flexion Acquisition.

PCRX-201 is a gene therapy product candidate designed to provide “on demand” production of an anti-inflammatory protein, interleukin-1 receptor antagonist (IL-1Ra) whenever inflammation is detected in the joint.

PCRX-301, is a locally administered Na V 1.7 inhibitor, known as funapide, formulated for extended release in a thermosensitive hydrogel.

The initial development of PCRX-301 was intended to support administration as a peripheral analgesic lower extremity nerve block for management of post-operative pain.

PCRX-201 was added to our portfolio as part of the Flexion Acquisition.

PCRX-201 is a novel, IA gene therapy product candidate that produces the anti-inflammatory protein, IL-1Ra, for treating OA pain in the knee.

pMVL-Based Clinical Programs

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(i) PCRX-401, a dexamethasone-pMVL for low back pain;

(ii) PCRX-501, a high-dose bupivacaine-pMVL for extended pain relief and (iii) a low-dose bupivacaine-pMVL for intrathecal analgesia.

We are planning to initiate a Phase 2 study for low-dose bupivacaine-pMVL for intrathecal analgesia in late 2022.

(ii) PCRX-501, a high potency bupivacaine-pMVL for longer-lasting pain relief (20.0 mg/mL) and (iii) EXPAREL for intrathecal analgesia (13.3 mg/mL).

We are planning to initiate the second half of our Phase 1 study of EXPAREL for intrathecal analgesia in the first half of 2023.

PCRX-301 is a locally administered Na V 1.7 inhibitor, known as funapide, formulated for extended release in a thermosensitive hydrogel.

The initial development of PCRX-301 was intended to support administration as a peripheral analgesic lower extremity nerve block for management of post-operative pain.

In September 2022, based on the results of a completed phase 1 study, we decided to discontinue further development of PCRX-301 due to a lack of clinical efficacy when compared to placebo and issues with the hydrogel formulation.

External Innovation

In parallel to our internal clinical programs, our business development team continues to pursue innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.

In parallel to our internal clinical programs, our business development team is pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera° and are of great interest to the surgical and anesthesia audiences we are already calling on today.

We are using a combination of strategic investments, in-licensing and acquisition transactions to buildout a pipeline of innovation to improve patients’ journeys along the neural pain pathway.

Select strategic investments we have made to support promising early stage platforms are summarized below.

The strategic investments we have made to support promising early stage platforms are summarized below:

Company Development Stage Description of Platform Technology Potential Therapeutic Areas

Coda Therapeutics, Inc.

Preclinical Chemogenetic platform to reverse the aberrant neuronal activity underlying neurological disorders using optimized adeno-associated virus (AAV) vectors

Neuropathic pain

Genascence Corporation Phase 1 Adeno-Associated Vector (AAV)-based gene therapy targeting Interleukin 1 Receptor Antagonist (IL-1Ra)

GeneQuine Biotherapeutics GmbH Preclinical Next-generation gene transfer vehicles that enter joint cells to confer multi-year gene expression

OA and other musculoskeletal disorders

Spine BioPharma, LLC Phase 3-ready Remedisc 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1)

Degenerative disc disease

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CarthroniX, Inc.

Phase 1-Ready CX-011, a small molecule modulator of gp130 formulated as an intra-articular injection designed to slow joint degeneration by mediating IL-6 cytokines Knee OA

Genascence Corporation Phase 1b-Ready Adeno-associated virus (AAV) based gene therapy engineered to deliver Interleukin-1 Receptor Antagonist (IL-1Ra) to target cells in joint(s)

GQ Bio Therapeutics GmbH Preclinical Helper-dependent adenovirus (HDAd) based gene therapy engineered to deliver DNA to target cells in joint(s) and intervertebral disc(s)

Knee OA and degenerative disc disease (DDD)

Spine BioPharma, LLC Phase 3 SB-01, a 7-amino acid chain peptide that binds to and induces down regulation of transforming growth factor, beta 1 (TGFβ1)

Degenerative disc disease (DDD)

Sales and Marketing

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Our primary target audiences are healthcare practitioners who influence pain management decisions including anesthesiologists, surgeons, pharmacists and physician extenders (including physician assistants, nurse practitioners and registered nurses).

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Our field team, consisting of sales representatives, account managers, scientific and medical affairs personnel and reimbursement and market access professionals, executes on a full range of activities to broaden the use of our non-opioid products for pain management, including:

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• working in tandem with hospital staff, such as anesthesiologists, surgeons, heads of quality, pharmacists, executives and registered nurses, to provide access and resources for drug utilization or medication use evaluations and health outcomes studies, which provide retrospective and prospective analyses for our hospital customers using their own hospital data to demonstrate the true cost of opioid-based postsurgical pain control;

• working with Key Opinion Leaders (KOLs) and advisory boards to address topics of best practice techniques as well as guidelines and protocols for the use of our products, meeting the educational and training needs of our physician, surgeon, anesthesiologist, pharmacist and registered nurse customers

• working with KOLs and advisory boards to address topics of best practice techniques as well as guidelines and protocols for the use of our products, meeting the educational and training needs of our physician, surgeon, anesthesiologist, pharmacist and registered nurse customers;

• undertaking education initiatives such as center of excellence programs;

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• facilitating reimbursement and the shift of procedures to hospital outpatient and ambulatory surgical center, or ASC, sites of care.

Pacira Innovation and Training Center of Tampa

In October 2020, we opened the Pacira Innovation and Training center of Tampa (the “PITT”).

Pacira Training Facilities

We maintain and operate two training facilities—one in Tampa, Florida and one in Houston, Texas.

These sites were constructed with a singular goal in mind:

to advance education on best practice techniques to effectively manage acute pain while reducing or eliminating the need for opioids.

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.

Tampa, Florida

In October 2020, we opened the Pacira Innovation and Training, or PIT, Center of Tampa.

We designed this facility to help advance clinician understanding of the latest local, regional and field block approaches for managing pain.

The PITT provides an unparalleled training environment for healthcare providers working to reduce or eliminate patient exposure to opioids.

The PITT supports a full range of educational events to advance clinician understanding of the latest local, regional, and field block approaches for managing pain and reducing or eliminating exposure to opioids.

Our corporate headquarters are also located at the PITT.

The PITT consists of approximately 13,000 square-feet of fully adaptable space and is equipped with state-of-the-art technology and audio/visual capabilities and features several distinct training spaces including a simulation lab equipped with seven ultrasound scanning stations;

The PIT of Tampa provides an unparalleled training environment for healthcare providers working to reduce or eliminate patient exposure to opioids.

The PIT of Tampa supports a full range of educational events to advance clinician understanding of the latest local, regional, and field block approaches for managing pain and reducing or eliminating exposure to opioids.

Our principal executive offices and corporate headquarters are also located at the PIT of Tampa.

The PIT of Tampa consists of approximately 13,000 square-feet of fully adaptable space and is equipped with state-of-the-art technology and audio/visual capabilities and features several distinct training spaces including a simulation lab equipped with seven ultrasound scanning stations;

a lecture hall featuring a 4½-foot tall by 24-foot wide liquid crystal display video wall to support live, virtual and even global presentations;

and a green-screen broadcast studio designed to livestream content with single or multiple hosts.

In addition to our EXPAREL programs, we are hosting ongoing workshops to train new users on best practice techniques for iovera° administration at the PITT.

In addition to our EXPAREL programs, we are hosting ongoing workshops to train new users on best practice techniques for iovera° administration at the PIT of Tampa.

Led by healthcare professionals, these labs include didactic lectures and hands-on trainings including live model nerve scanning and identification using ultrasound and peripheral nerve stimulation.

The PITT also serves as a venue for national anesthesia provider organizations to host their own workshops and training sessions.

We have started the process for opening a second innovation and training center that will be located in Houston, Texas.

At no fee to the organization, the PIT of Tampa also serves as a venue for national anesthesia provider organizations to host their own workshops and training sessions to educate healthcare providers.

Houston, Texas

In January 2023, we opened our second training facility, the Houston Pacira Innovation and Training Center, in Houston, Texas.

This 19,000 square-foot state-of-the-art facility features a 125-seat adaptive lecture hall featuring the same liquid crystal

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display video wall that the PIT of Tampa has, a broadcast studio and both wet and dry lab space for cadaver and other interactive workshops.

A simulation lab is equipped with eight advanced ultrasound machines equipped with artificial intelligence and 3-D training software in addition to professional medical lighting and in-ceiling cameras.

The PIT of Houston is core to developing both our physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management.

With this new training facility, we have doubled our capacity and ability to host programs for EXPAREL, ZILRETTA and iovera°.

DePuy Synthes Sales Inc.

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The collaboration began in January 2017 and concluded in January 2021.

During that time

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DePuy Synthes field representatives collaborated with the Pacira field teams to support EXPAREL use and education in orthopedic surgical settings.

During that time DePuy Synthes field representatives collaborated with the Pacira field teams to support EXPAREL use and education in orthopedic surgical settings.

In addition to partnering with DePuy Synthes in support of orthopedic surgical procedures, Pacira field representatives remained the overall EXPAREL account managers and commercial leads for soft tissue surgeons, anesthesiologists and ASCs.

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Other Agreements

Flexion Acquisition

On November 19, 2021, we completed the Flexion Acquisition pursuant to an Agreement and Plan of Merger (the “Flexion Merger Agreement”), dated as of October 11, 2021, by and among us, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of Pacira (“Purchaser”), and Flexion.

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.

We changed the name of Flexion to Pacira Therapeutics, Inc.

after completing the merger.

As part of the Flexion Acquisition, we acquired ZILRETTA, the first and only extended-release, IA (meaning in the joint) injection indicated for the management of OA knee pain.

ZILRETTA is a non-opioid therapy that employs a proprietary microsphere technology to provide pain relief.

Initially, the total consideration for the Acquisition was approximately $578.8 million consisting of (i) $448.5 million of cash paid to Flexion shareholders and to settle restricted stock units and certain stock options;

(ii) an $85.1 million cash payment of Flexion debt not assumed by us and (iii) $45.2 million of estimated fair value of contingent consideration related to contingent value rights that were issued to Flexion shareholders and certain equity award holders in conjunction with the Flexion Acquisition.

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, 2022, these contingent value rights could aggregate up to a total of $372.3 million if certain regulatory and commercial milestones are met.

For more information, see Note 5, Flexion Acquisition and Note 12, Financial Instruments , to our consolidated financial statements included herein.

MyoScience Acquisition

In April 2019, we completed the MyoScience Acquisition.

The consideration included an initial cash payment of $120.0 million, reduced by $1.0 million for post-closing purchase price adjustments and indemnification obligations incurred to date, plus contingent milestone payments up to an aggregate of $100.0 million of which $43.0 million is available at December 31, 2021.

Upon the completion of the MyoScience Acquisition, we renamed MyoScience Pacira CryoTech, Inc.

For more information on the MyoScience Acquisition, refer to Note 5, Acquisitions , to our consolidated financial statements included herein.

SkyePharma Holdings, Inc.

(Now a Subsidiary of Vectura Group plc)

In connection with the stock purchase agreement related to the Skyepharma Acquisition, we agreed to certain earn-out and milestone payments.

Milestones were based on net sales of DepoBupivacaine products collected, including EXPAREL, and certain other yet-to-be-developed products.

The milestones were as follows:

• $10.0 million upon the first commercial sale in the U.S.

(met April 2012);

• $4.0 million upon the first commercial sale in the U.K., France, Germany, Italy or Spain (met November 2021);

• $8.0 million when annual net sales collected reach $100.0 million (met September 2014);

• $8.0 million when annual net sales collected reach $250.0 million (met June 2016);

• $32.0 million when annual net sales collected reach $500.0 million (met December 2021).

In the fourth quarter of 2021, we met both remaining milestones:

$4.0 million upon the first commercial sale in the U.K., France, Germany, Italy or Spain which was paid in the fourth quarter of 2021;

and $32.0 million when annual net sales collected reached $500.0 million, which was paid in the first quarter of 2022.

See Note 9, Goodwill and Intangible Assets , to our consolidated financial statements included herein for further information related to the Skyepharma Acquisition.

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 of which $43.0 million is available at December 31, 2022.

The expiration date for the achievement of the milestones is December 31, 2023.

We changed the name of MyoScience to Pacira CryoTech, Inc.

after completing the merger.

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.

Research Development Foundation

Pursuant to an agreement with the Research Development Foundation, or RDF, we were required to pay RDF a low single-digit royalty on the collection of revenues from certain products for as long as certain patents assigned to us under the agreement remain valid.

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agreement remain valid.

RDF has the right to terminate the agreement for an uncured material breach by us, in connection with our bankruptcy or insolvency or if we directly or indirectly oppose or dispute the validity of the assigned patent rights.

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Thereafter, RDF asserted that the issuance of that patent extends our royalty obligations under the agreement until 2041.

We disagreed and explained that the royalty period under the agreement was set to end on December 24, 2021 with the expiration of our U.S.

Because of the disagreement over the interpretation of the agreement, in December 2021, we filed a declaratory judgment lawsuit in the U.S.

We disagreed and explained that the royalty period under the agreement ended on December 24, 2021 with the expiration of our U.S.

Because of the disagreement over the interpretation of this agreement, in December 2021, we filed a declaratory judgment lawsuit in the U.S.

District Court for the District of Nevada (21-cv-02241).

The lawsuit seeks a declaration from the court that we owe no royalties to RDF with respect to our EXPAREL product after December 24, 2021.

During the pendency of the lawsuit, we will continue to pay royalties to RDF under protest.

We are unable to predict the outcome of this action at this time.

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During the pendency of the lawsuit, we will continue to pay royalties to RDF under protest, however, we are unable to predict the outcome of this action at this time.

Aratana Therapeutics, Inc.

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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.

Eurofarma recently submitted an application seeking approval in Brazil.

In addition, Eurofarma is responsible for regulatory filings for EXPAREL in these countries.

We will receive royalties based on Eurofarma’s future commercialization of the product and are also eligible to receive milestone payments that are triggered by the achievement of certain regulatory and commercial events.

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.

Verve Medical Products, Inc.

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We began selling iovera° in Canada in the fourth quarter of 2021.

Hong Kong Pharma Tainuo Ltd.

In March 2020, Flexion entered into an exclusive license agreement with Hong Kong Pharma Tainuo Ltd., or HK Tainuo, and Jiangsu Tainuo Pharmaceutical Co.

Ltd., or Jiangsu Tainuo, a subsidiary of China Shijiazhuang Pharmaceutical Co, Ltd., for the development and commercialization (other than manufacturing) of ZILRETTA in Greater China (consisting of mainland China, Hong Kong, Macau and Taiwan).

Under the terms of the agreement, HK Tainuo made upfront payments to Flexion in 2020.

We are eligible to receive up to $32.5 million in aggregate development, regulatory and commercial sales milestone payments.

All payments received from HK Tainuo are subject to applicable Hong Kong withholding taxes.

HK Tainuo is responsible for the clinical development, product registration and commercialization of ZILRETTA in Greater China and Jiangsu Tainuo serves as the guarantor of HK Tainuo’s obligations and responsibilities under the agreement.

We are solely responsible for the manufacture and supply of ZILRETTA to HK Tainuo for all clinical and commercial activities.

The terms related to product manufacturing and supply, including pricing and minimum purchase requirements agreed to in the license

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agreement, will be covered by a separate supply agreement.

All amounts owed to us are nonrefundable and non-creditable once paid.

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Significant Customers

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We refer to these three buildings as the Science Center Campus, and together they consist of approximately 195,000 square feet.

Our manufacturing facilities are inspected regularly and approved by the FDA, EMA, Medicines and Healthcare Products Regulatory Agency, or MHRA, and the Environmental Protection Agency (EPA).

Our iovera° facility in Fremont, California, consists of approximately 20,000 square feet of mixed-use manufacturing, research and development and office space.

Our manufacturing facilities are inspected regularly and approved by the FDA, EMA, MHRA and the Environmental Protection Agency (EPA).

We purchase raw materials and components from third-party suppliers to manufacture EXPAREL, ZILRETTA and iovera°.

In most instances, alternative sources of supply are available, although switching to an alternative source would, in some instances, take time and could lead to delays in manufacturing our product candidates.

While we have not experienced shortages of our raw materials in the past, such suppliers may not sell these raw materials to us at the times that we need them or on commercially reasonable terms and we do not have direct control over the availability of these raw materials from our suppliers.

Suppliers may not sell these raw materials to us at the times that we need them or on commercially reasonable terms and we do not have direct control over the availability of these raw materials from our suppliers.

In order to manage the risk related to raw material shortages, we strive to keep adequate supplies of key raw materials on hand and qualify additional sources of supply as appropriate.

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.

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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.

This building houses our Science Center related research and development activities and general and administrative functions, as it includes both laboratories and the building infrastructure necessary to support the formulation, analytical testing, clinical and process development activities for manufacturing additional commercial product indications and new pipeline products.

We manufacture all of the iovera° handpieces at this facility.

This building also houses our Science Center related research and development activities and general and administrative functions, as it includes both laboratories and the building infrastructure necessary to support the formulation, analytical testing, clinical and process development activities for manufacturing additional commercial product indications and new pipeline products.

Our pilot plant suite for early stage clinical product production is located in this building and there is additional space for future expansion opportunities.

We also have an approximately 21,000 square foot warehouse that serves as the main CGMP warehouse for our San Diego operations, primarily being used for the storage of production materials.

We also have an approximately 21,000 square foot warehouse that serves as the main CGMP warehouse for our Science Center Campus operations, primarily being used for the storage of production materials.

It contains ambient as well as cold temperature CGMP warehouse storage and also features a quality control clean room for sampling incoming materials.

Our Fremont, California facility has been leased since 2015.

It is dedicated to the iovera° product line and consists of approximately 20,000 square feet of space for manufacturing, quality control, research and development and the warehousing of raw materials and finished goods.

We have expanded our iovera° manufacturing capacity through a third party, Providien Device Assembly, LLC, or Providien, as explained below.

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Distribution of our pMVL products, including EXPAREL, requires cold-chain distribution, whereby a product must be maintained between specified temperatures.

We have validated processes for continuous monitoring of temperature from manufacturing through delivery to the end-user.

We have validated processes for continuous monitoring of temperature from manufacturing through delivery to the end-users.

Co-Production Facilities

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In April 2014, we and Thermo Fisher entered into a Strategic Co-Production Agreement, Technical Transfer and Service Agreement and Manufacturing and Supply Agreement (the “EXPAREL Manufacturing and Supply Agreement”) to collaborate in the manufacture of EXPAREL.

Thermo Fisher undertook certain technical transfer activities and construction services needed to prepare Thermo Fisher’s Swindon, England facility for the manufacture of EXPAREL in two dedicated manufacturing suites.

Thermo Fisher undertook certain technical transfer activities and construction services

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needed to prepare Thermo Fisher’s Swindon, England facility for the manufacture of EXPAREL in two dedicated suites.

We provided Thermo Fisher with the equipment necessary to manufacture EXPAREL and pay fees to Thermo Fisher based on Thermo Fisher’s achievement of certain technical transfer and construction milestones.

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In February 2019, we announced that commercial production of EXPAREL was underway at the first Thermo Fisher suite.

We developed a second dedicated suite that is expected to enable another doubling of EXPAREL manufacturing capacity.

We are now using a second, larger-scale dedicated suite that has more than doubled our EXPAREL manufacturing capacity at the Thermo Fisher site.

We began commercial production of EXPAREL out of that second suite in August 2021.

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We make monthly payments to Thermo Fisher for such activities and reimburse Thermo Fisher for certain material, equipment and miscellaneous expenses and additional services.

The initial term of the ZILRETTA Manufacturing Agreement that we assumed as part of the Flexion Acquisition expires in October 2027.

The initial term of the ZILRETTA Manufacturing and Supply Agreement that we assumed as part of the Flexion Acquisition expires in October 2027.

We pay a monthly base fee to Thermo Fisher for the operation of the manufacturing suites and a per product fee for each vial of ZILRETTA based upon a forecast of commercial demand.

We also reimburse Thermo Fisher for purchases of materials and equipment made on our behalf, certain nominal expenses and additional services.

The ZILRETTA Manufacturing Agreement will remain in full effect unless and until it expires or is terminated.

Upon termination of the ZILRETTA Manufacturing Agreement (other than termination by us in the event that Thermo Fisher does not meet the construction and manufacturing milestones or for a breach by Thermo Fisher), we will be obligated to pay for the costs incurred by Thermo Fisher associated with the removal of our manufacturing equipment and for Thermo Fisher’s termination costs up to a specified capped amount.

Providien Device Assembly

In January 2020, we and Providien entered into a Manufacturing and Supply Agreement (the “Providien Agreement”) to collaborate in the manufacture of iovera° Smart Tips at Providien’s Tijuana, Mexico facility.

The initial term of the Providien Agreement is five years.

We will pay fees based on the amount of iovera° Smart Tips delivered by Providien.

The Providien Agreement may be terminated by either party upon one years’ written notice without cause.

We may terminate the Providien Agreement upon thirty days’ written notice in the event that iovera° is withdrawn from the market or no longer sold by us.

Either party may terminate the Providien Agreement in the event of the breach or bankruptcy of the other party.

The ZILRETTA Manufacturing and Supply Agreement will remain in full effect unless and until it expires or is terminated.

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.

Either party may terminate the ZILRETTA Manufacturing and Supply Agreement in the event of the breach or bankruptcy of the other party.

Upon termination of the ZILRETTA Manufacturing Agreement (other than termination by us in the event that Thermo Fisher does not meet the manufacturing milestones or for a breach by Thermo Fisher), we will be obligated to pay for the costs incurred by Thermo Fisher associated with the removal of our manufacturing equipment and for Thermo Fisher’s termination costs up to a specified capped amount.

Carlisle Companies, Inc.

In January 2020, we and Carlisle Companies, Inc., or Carlisle, (formerly Providien Device Assembly, LLC) 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.

The initial term of the Carlisle Agreement is five years.

Under the Carlisle Agreement, we pay fees based on the amount of iovera° Smart Tips delivered by Carlisle.

Since April 2022, all iovera° Smart Tips are now produced by Carlisle.

The Carlisle Agreement may be terminated by either party upon one years’ written notice without cause.

We may terminate the Carlisle Agreement upon thirty days’ written notice in the event that iovera° is withdrawn from the market or no longer sold by us.

Either party may terminate the Carlisle Agreement in the event of the breach or bankruptcy of the other party.

Intellectual Property and Exclusivity

We seek to protect our products, our product candidates and our technologies through a combination of patents, trade secrets, proprietary know-how, regulatory exclusivity and contractual restrictions on disclosure.

We note that the patents and

We note that the patents and applications described below are only examples intended to highlight the variety of coverage provided by our existing and constantly developing portfolio.

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applications described below are only examples intended to highlight the variety of coverage provided by our existing and constantly developing portfolio.

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Patents and Patent Applications

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Patents have been issued in numerous countries, with an emphasis on the North American, European and Japanese markets.

These patents generally have a term of 20 years from the date of the non-provisional filing unless referring to an earlier filed application.

These utility patents generally have a term of 20 years from the date of the non-provisional filing unless claiming priority to an earlier filed non-provisional application.

Some of our expired U.S.

patents had a term of 17 years from the grant date.

Our issued patents expire at various dates in the future, as discussed below, with the last currently issued patent for the pMVL drug delivery technology expiring in 2041, the last currently issued patent for ZILRETTA expiring in 2031 and the last currently issued patent for the iovera° technology expiring in 2040.

Our issued patents expire at various dates in the future, as discussed below, with the last currently issued patent for the pMVL drug delivery technology expiring in 2041, the last currently issued patent for ZILRETTA expiring in 2031 and the last currently issued utility patent for the iovera° technology expiring in 2040.

Patents and Patent Applications for our pMVL and pMVL Products

A patent relating to product-by-process and process in connection with the production of multivesicular liposomes was issued on March 7, 2017.

This patent is listed in the Orange Book for EXPAREL and includes a patent term adjustment that equates to an expiration date of December 24, 2021.

Several Track One patent applications directed to various aspects of an improved EXPAREL manufacturing process were filed in January 2021 and, if granted, would provide patent protection through 2041.

Additionally, we have filed several patent applications directed to other important aspects of the EXPAREL technology which, if granted, would provide additional patent protection through 2040 and beyond.

In June 2021, the United States Patent and Trademark Office, or USPTO, issued U.S.

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11,185,506 and 11,179,336, claiming the improved EXPAREL manufacturing process and EXPAREL composition, respectively.

All three patents will have an expiration date of January 22, 2041.

patents relating to product and product-by-process in connection with the improved manufacturing process for EXPAREL were issued between March and September 2022, providing additional patent protection through 2041.

In March 2022, the USPTO issued U.S.

11,278,494, claiming EXPAREL composition.

In April 2022, the USPTO issued U.S.

11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by the improved manufacturing process and EXPAREL composition, respectively.

In June 2022, the USPTO issued U.S.

11,357,727, claiming composition of EXPAREL prepared by the improved manufacturing process.

In August 2022, the USPTO issued U.S.

11,426,348, claiming EXPAREL batch compositions.

In September 2022, the USPTO issued U.S.

11,452,691, claiming EXPAREL batch compositions.

All eight of the patents issued in 2021 and 2022 will 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, 11426,348 and 11,452,691 are currently listed in the FDA’s “ Approved Drug Products with Therapeutic Equivalence Evaluations ” (the “Orange Book”).

Additionally, we recently received four Notices of Allowance from the USPTO for four EXPAREL patents that have been examined and will issue.

Two patents claim chemical composition of EXPAREL and two claim product-by-process.

After issuance, we will submit these patents for listing in the Orange Book.

After listing, the Orange Book would have a total of six EXPAREL patents each with an expiration date of January 22, 2041.

Issued patents for EXPAREL in the U.S.

relating to methods for modifying the rate of drug release of the product candidate and the composition of the product candidate expired in January 2017 and September 2018, respectively.

In the U.S., a patent relating to the composition of the product was issued in September 2014 and expired in September 2018.

A patent relating to the method of treatment using EXPAREL was issued in December 2015 and expired in September 2018.

In Europe, granted patent(s) related to the composition of EXPAREL expired in September 2018.

A patent relating to methods of modifying the rate of drug release of the product candidate expired in January 2018.

In addition, a patent relating to the process for making the product candidate expired in November 2018.

In April 2010, a provisional patent was filed relating to an alternative process to manufacture EXPAREL and other pMVL-based products.

Additionally, we recently received a Notice of Allowance from the USPTO for one EXPAREL patent that has been examined and will issue in due course in 2023.

After issuance, we will submit this patent for listing in the Orange Book.

After listing, the Orange Book would have a total of nine EXPAREL patents each with an expiration date of January 22, 2041.

We also own a family of U.S.

and foreign patents on an alternative process to manufacture EXPAREL and other pMVL-based products.

The process offers many advantages, including larger scale production and lower manufacturing costs.

In April 2011, we filed an international patent application providing the basis for several national phase patent applications, for example in Europe, China, Japan, Israel and India which, if granted, could potentially prevent others from using this process until at least 2031.

In the U.S., we also filed a series of patent applications directed to the alternative manufacturing process.

Eight of the patent applications were issued as patents as of December 2020.

There are eight issued U.S.

Patents that claim the process and apparatus will expire at the latest in November 2033.

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As of December 31, 2022, we have four granted patents in China, one granted patent in Europe, one granted patent in Japan and one granted patent in Israel, protecting various aspects of the alternative process, including the methods of using the apparatus and the apparatus itself.

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In February 2022, we filed a provisional application relating to the use of EXPAREL as stellate ganglion blocks for managing cardiac arrhythmia, including electrical storm.

In October 2022, we filed a U.S.

and a Patent Cooperation Treaty, or PCT, application relating to compositions of matter, processes of making and method of treatment in connection with dexamethasone sodium phosphate-pMVL product.

In addition, we also filed a U.S.

and a PCT application were filed relating to compositions of matter, processes of making and method of treatment in connection with a high-potency bupivacaine-pMVL product.

Patents and Patent Applications for ZILRETTA

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The USPTO has also issued two patents directed at the methods of manufacturing and using ZILRETTA with patent terms into 2031.

Considerable expertise and effort were required to carry out the large body of original work underlying the formulation of ZILRETTA, including experimenting with, and observing the effects of over 50 steroid and PLGA formulations.

We believe our extensive know-how and trade secrets relating to the manufacturing process for ZILRETTA, including those that relate to precise pharmaceutical release profiles, represent a meaningful entry barrier.

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We own three U.S.

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patents directed at compositions of matter similar to ZILRETTA, as well as methods of making and using the same, with patent terms into 2031.

In 2021, we had one patent granted in Hong Kong, further expanding our global intellectual property portfolio, which includes patents in the U.S., Australia, Canada, China, E.U., Indonesia, India, Japan, Malaysia, Mexico, New Zealand, the Philippines, the Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan and Ukraine.

In 2022, we had one patent granted in Pakistan, further expanding our global intellectual property portfolio, which includes patents in the U.S., Australia, Canada, China, Europe, Hong Kong, Indonesia, India, Israel, Japan, Malaysia, Mexico, New Zealand, Pakistan, the Philippines, the Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan and Ukraine.

These foreign patents cover the composition of matter, methods of manufacturing, and methods of using ZILRETTA and are similar in scope to the protection in the U.S.

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These patents are scheduled to expire in 2025.

PCRX-201 (Formerly FX-201)

In December 2017, Flexion acquired the global rights to PCRX-201 from GeneQuine, including a direct exclusive license of certain foundational patents, patent applications, and other proprietary rights owned by the Baylor College of Medicine, or Baylor, that are related to PCRX-201 for human applications.

These patents generally cover the composition of matter and method of use of PCRX-201 in the treatment of OA.

In 2019, the USPTO issued patent number 10,301,647, which covers the composition of matter and method of use of PCRX-201 in the treatment of OA with a term through January 2033.

In addition, the Baylor patents related to PCRX-201 are issued in Europe, with an expiry date in 2032, and in Australia, Japan, China, India and Eurasia with expiry dates in 2033.

We are continuing to prosecute one U.S.

Baylor patent application related to PCRX-201.

Further, we have a pending Patent Cooperation Treaty, or PCT, application covering composition of matter and effective dosages of PCRX-201 in the treatment of OA in humans, which, if granted, is expected to provide protection until 2040.

We also have a U.S.

provisional application covering composition of matter and method of use of PCRX-201 for the treatment of degenerative disc disease (DDD), which, if granted, is expected to provide protection until 2042.

PCRX-301 (Formerly FX-301)

In September 2019, Flexion acquired the global rights to develop and commercialize funapide from Xenon Pharmaceuticals, Inc., or Xenon, which we have formulated for extended release with our proprietary thermosensitive hydrogel as PCRX-301.

As part of the transaction with Xenon, we acquired foundational patents and patent applications covering the composition of matter, methods of use, and methods of manufacture related to funapide.

We own patents directed to funapide granted in the U.S.

as well as Australia, Canada, China, Europe, Hong Kong, Mexico and New Zealand with expiry dates in 2030.

In addition, we have a PCT patent application covering composition of matter, method of use, and method of manufacture for PCRX-301, which, if granted, is expected to provide protection until 2040.

We also have a U.S.

provisional application covering a composition of matter, method of use, and method of manufacture for PCRX-301 with different amounts of polar organic solvent and solubility enhancer, which if converted and granted, is expected to provide protection until 2042.

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Patents and Patent Applications for iovera°

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For example, patents covering the probe filtration system are set to expire in 2033 and patents on the Smart Tip technology are set to expire between 2034 and 2037.

Other patents and applications cover methods of using needles with blunt tips and aspects of cryogenic devices coupled with a neurostimulator for locating nerves.

We also have three design patent families that cover the current handheld cryogenic device, its charging station dock and combinations thereof.

To obtain coverage of our developing next-generation technology, we filed eight new non-provisional and PCT applications in 2020, which if granted, could potentially prevent others from using this next-generation technology until at least 2040.

In addition, we filed four new design patent families in 2021 in the U.S.

and foreign jurisdictions covering ornamental aspects of our next-generation cryogenic device.

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.

There are eight new 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.

In addition, we also filed several provisional applications in 2022 covering the use of iovera° as stellate ganglion blocks for managing cardiac arrhythmia, including electrical storm.

In December 2017, Flexion acquired the global rights to PCRX-201 from GQ Bio Therapeutics GmbH (formerly named GeneQuine BioTherapeutics GmbH), including a direct exclusive license of certain foundational patents, patent applications, and other proprietary rights owned by the Baylor College of Medicine, or Baylor, that are related to PCRX-201 for human applications.

These patents generally cover the composition of matter and method of use of PCRX-201 in the treatment of OA.

In 2019, the USPTO issued U.S.

10,301,647, which covers the composition of matter and method of use of PCRX-201 in the treatment of OA with a term through January 2033.

In addition, the Baylor patents related to PCRX-201 are issued in Europe, with an expiry date in 2032, and in Australia, Canada, China, India, Japan and Eurasia with expiry dates in 2033.

We are continuing to prosecute one U.S.

Baylor patent application related to PCRX-201.

Further, we have entered the national phase in Brazil, China, Europe, 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.

We also have a U.S.

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.

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Additional Intellectual Property

We have a provisional application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.

We have a PCT application covering composition of matter, method of use, and method of manufacture for formulations of an anesthetic drug of amino amide group (lidocaine, bupivacaine and ropivacaine) formulated in a triblock copolymer component (one or more PLGA-polyethylene glycol-PLGA triblock copolymers), which if converted and granted, is expected to provide protection until 2042.

Trade Secrets and Proprietary Information

Trade secrets play an important role in protecting our pMVL-based products and pipeline, ZILRETTA and iovera° and provide protection beyond patents and regulatory exclusivity.

Trade secrets play an important role in protecting our pMVL-based products (including EXPAREL) and pipeline, ZILRETTA and iovera° and provide protection beyond patents and regulatory exclusivity.

The scale-up and commercial manufacture of pMVL-based and iovera° products involve processes, custom equipment and in-process and release analytical techniques that we believe are unique to us.

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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 manufacturing techniques that are able to provide the precision and tight tolerances required for a self-contained handheld cryogenic device.

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.

Additionally, the iovera° device includes proprietary software for device operations during cryotherapy treatments.

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Further, we require confidentiality agreements from third parties that receive our confidential data or materials.

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The pharmaceutical industry is intensely competitive and subject to rapid and significant technological change.

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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.

Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, 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.

Currently EXPAREL also competes with elastomeric pumps/catheter devices intended to provide bupivacaine over several days and with off-label combinations of other approved analgesics, called “cocktails”, that are physician-combined in an attempt to extend the duration of pain control.

Additional products may be developed for the treatment of acute pain, including new injectable NSAIDs, novel opioids, new formulations of currently available

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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.

Immediate-release steroids and HA injections are currently the two marketed classes of IA products that compete directly with ZILRETTA.

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As a result, it is critical that we continue to innovate and to increase marketing efforts in our primary markets.

We expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety,

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convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers.

We expect any products that we develop and commercialize to compete on the basis of, among other things, efficacy, safety, convenience of administration and delivery, price and the availability of reimbursement from government and other third-party payers.

Besides pharmaceutical products for pain management, iovera° competes with medical devices that ablate or degenerate peripheral nerves to treat indications such as joint pain, neuralgia and OA pain.

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Outside the U.S., prescription drug and medical device products are regulated by comparable agencies (including the EMA and MHRA in the E.U.

as well as authorities in Canada and Latin America), laws and regulations.

and U.K., respectively, as well as authorities in Canada and Latin America), laws and regulations.

Failure to comply with applicable regulatory requirements may result in, among other things, refusal to approve pending applications, withdrawal of an approval, warning letters, clinical holds, civil or criminal penalties, recall or seizure of products, injunction, debarment, partial or total suspension of production or withdrawal of the product from the market.

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This process generally involves:

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• completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations;

• submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.;

• submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.;

• approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated;

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Further, an IRB covering each site proposing to conduct the clinical trial must review and approve the plan for any clinical trial along with informed consent information for subjects before the clinical trial commences at that center.

The IRB also must monitor the clinical trial

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until it is completed.

The IRB also must monitor the clinical trial until it is completed.

The FDA, the IRB or the sponsor may suspend a clinical trial at any time, on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.

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When Phase 2 evaluations suggest the effectiveness of a dose range of the product and acceptability of such product’s safety profile, sponsors undertake Phase 3 clinical trials in larger patient populations to obtain additional information needed to evaluate the overall benefit and risk balance of the drug and to provide an adequate basis to develop labeling.

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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.

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For example, EXPAREL is approved in femoral nerve block for treatment of post-operative pain in adults in Europe, but the FDA has not approved this indication in the U.S.

However, based on positive results from our Phase 3 clinical trials of EXPAREL as a femoral nerve block in lower extremity surgeries, we submitted an sNDA to the FDA in January 2023 seeking expansion of the EXPAREL label to include femoral nerve block in the adductor canal and sciatic nerve block in the popliteal fossa, with an anticipated FDA action date under PDUFA in the second half of 2023.

Medical Devices

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There are also certain requirements of state, local and foreign governments that must be complied with in the manufacture and marketing of our products.

A new indication for 510(k) clearance may or may not require a clinical trial—for instance, expanding the use of iovera° to treat spasticity will, and we expect to commence a clinical trial in 2022.

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A new indication for 510(k) clearance may or may not require a clinical trial.

Expanding the iovera° label to include the treatment of spasticity requires a clinical trial, which we expect to begin in 2023.

Review and Approval Process

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In addition, 505(b)(2) applications must contain a patent certification for each patent listed in the FDA’s Orange Book that covers the drug referenced in the application and upon which the third-party studies were conducted.

For some drugs, the FDA may require Risk Evaluation and Mitigation Strategies, or REMS, which could include medication guides, physician communication plans or restrictions on distribution and use, such as limitations on who may prescribe the drug or where it may be dispensed or administered.

For some drugs, regulatory agencies may require Risk Evaluation and Mitigation Strategies, or REMS, which could include medication guides, physician communication plans or restrictions on distribution and use, such as limitations on who may prescribe the drug or where it may be dispensed or administered.

Currently, the FDA does not require a REMS for EXPAREL but the EMA and MHRA do.

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The recommendations of an advisory committee do not bind the FDA, but the FDA generally follows such recommendations.

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Under PDUFA, NDA applicants must pay significant NDA user fees upon submission.

In addition, manufacturers of approved prescription drug products must pay annual program fees.

In addition, manufacturers of approved prescription drug products must pay annual program fees, as we do for EXPAREL and ZILRETTA.

Before approving an NDA, the FDA will inspect the facility or facilities where the product is manufactured.

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The first pathway, a pre-market notification (the 510(k) process), requires demonstration that the new device is substantially equivalent to an already legally marketed medical device.

The second pathway, a PMA, requires an independent demonstration that a medical

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device is safe and effective for its intended use.

The second pathway, a PMA, requires an independent demonstration that a medical device is safe and effective for its intended use.

In general, PMAs require a much longer time horizon and can be much more expensive than obtaining clearance through the 510(k) process.

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facial wrinkle reduction).

The MyoScience business focus shifted to pain management in 2014, and since then there have been a number of advancements that led to three additional 510(k) submissions and clearances to support iovera° and the subsequent growth of the iovera° product line.

MyoScience’s focus shifted to pain management in 2014, and since then there have been a number of advancements that led to three additional 510(k) submissions and clearances to support iovera° and the subsequent growth of the iovera° product line.

After a device receives 510(k) clearance or a PMA approval, it may be changed or modified.

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Section 505(b)(2) was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984 (also known as the Hatch-Waxman Act), and permits the submission of an NDA where at least some of the information required for approval comes from preclinical and/or clinical trials not conducted by or for the applicant.

The FDA interprets Section 505(b)(2) of the FDCA to permit the applicant to rely upon the FDA’s previous findings of safety and effectiveness for an approved product.

The FDA interprets Section 505(b)(2) of the FDCA to

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permit the applicant to rely upon the FDA’s previous findings of safety and effectiveness for an approved product.

The FDA may also require companies to perform additional clinical trials or measurements to support any change from the previously approved product.

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Similar reporting and pharmacovigilance obligations exist with regulatory agencies outside the U.S.

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If new safety issues are identified following approval, the FDA can require the NDA sponsor to revise the approved labeling to reflect the new safety information;

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• fines, warning letters or holds on post-approval clinical trials;

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• refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

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• QSRs, which require manufacturers, including third‑party manufacturers, to follow stringent design, testing, documentation and other quality assurance procedures during product design and throughout the manufacturing process;

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• Labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off‑label uses;

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In addition to regulations in the U.S., we are subject to a variety of foreign regulations governing clinical trials and the commercial sales and distribution of our products.

Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries.

Whether or not we obtain FDA approval for a product, we must obtain approval by the comparable regulatory authorities of foreign countries before we can commence clinical trials or marketing of

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the product in those countries.

The approval process and requirements vary from country to country, and the time may be longer or shorter than that necessary for FDA approval.

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The marketing application is similar to the NDA in the U.S.

and is evaluated by the Committee for Medicinal Products for Human Use, or CHMP, the expert scientific committee of the EMA.

and is evaluated by the CHMP, the expert scientific committee of the EMA.

If the CHMP determines that the marketing application fulfills the requirements for quality, safety and efficacy, it will submit a favorable opinion to the EC.

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Also, third-party payers have attempted to control costs by limiting coverage and the amount of reimbursement for particular procedures, medical devices or drug treatments.

Congress and state legislatures from time to time propose and adopt

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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.

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.

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.

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.

The Affordable Care Act also established a new Medicare Part D coverage gap discount program, in which drug manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand name drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

The Affordable Care Act also established a new Medicare Part D coverage gap discount program, in which drug manufacturers must agree to offer 50 percent point-of-sale discounts off negotiated prices of applicable brand name drugs to eligible beneficiaries during their coverage gap period as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

Substantial new provisions affecting compliance have also been enacted, which may require us to modify our business practices with healthcare practitioners.

One such governmental program that was expanded as part of the Affordable Care Act is the 340B Drug Pricing Program, which requires pharmaceutical manufacturers that participate in Medicaid to enter into a pharmaceutical pricing agreement, or PPA, with the Secretary of Health and Human Services, and requires the manufacturer to extend discounts to entities covered under the 340B Drug Pricing Program.

The 340B Drug Pricing Program aims to cover entities that have scarce financial resources to be able to reach the U.S.’s most financially vulnerable patient populations.

There have been proposed in Congress a number of legislative initiatives regarding healthcare, including possible repeal of the Affordable Care Act.

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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.

In December 2022, as part of the Consolidated Appropriations Act of 2023, President Biden signed into law the Non-Opioids Prevent Addition in the Nation, or NOPAIN, Act, a federal mandate that requires Medicare to reimburse for non-opioid

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products, such as EXPAREL, used during all surgeries conducted in the ASC or hospital outpatient department (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;

and (ii) all devices used to deliver a therapy or reduce postoperative pain or produce postsurgical or regional analgesia.

Any drug or device that qualifies for reimbursement under the NOPAIN Act must have demonstrated the ability to reduce or avoid intraoperative opioid use or the quantity of opioids prescribed in a clinical trial or through data published in a peer-reviewed journal.

The Centers for Medicare and Medicaid Services (CMS) requires time to implement the NOPAIN Act, which is currently expected to take effect beginning in January 2025.

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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There can be no assurance that our products will be considered medically reasonable and necessary for a specific indication, that our products will be considered cost-effective by third-party payers or that an adequate level of reimbursement will be available so that the third-party payers’ reimbursement policies will not adversely affect our ability to sell our products profitably.

Marketing/Data Exclusivity

Marketing and Data Exclusivity

Market exclusivity provisions under the FDCA can delay the submission or approval of certain applications of other companies seeking to reference another company’s NDA.

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In Europe, manufacturers qualify for 8 years of data exclusivity upon marketing authorization approval and an additional two years of market exclusivity, for a total of 10 years of regulatory exclusivity.

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Manufacturing Requirements

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We and any third-party manufacturers we engage or with which we partner are also subject to periodic inspections of facilities by the FDA and other authorities, including procedures and operations used in the testing and manufacture of our products to assess our compliance with applicable regulations.

Failure to comply with these and other statutory and regulatory requirements subjects a manufacturer to possible legal or regulatory action, including warning letters, the seizure or recall of products, injunctions, consent decrees placing significant restrictions on or suspending manufacturing operations and civil and criminal penalties.

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significant restrictions on or suspending manufacturing operations and civil and criminal penalties.

Adverse experiences with the product or product complaints must be reported and could result in the imposition of market restrictions through labeling changes or in product removal.

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Outside the U.S., other countries have implemented requirements for disclosure of financial interactions with healthcare providers and additional countries may consider or implement such laws.

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Regenerative Medicine Advanced Therapies

As part of the 21 st Century Cures Act, Congress amended the FDCA to create the regenerative medicine advanced therapies, or RMAT, designation.

As part of the 21 st Century Cures Act, Congress amended the FDCA to create the RMAT designation.

The RMAT designation is intended to facilitate efficient development and expedite review of regenerative medicine advanced therapies, which are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition.

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A sponsor may request that the FDA designate a regenerative medicine advanced therapy concurrently with or at any time after submission of an IND.

For example, we intend to seek an RMAT designation from the FDA for PCRX-201.

The FDA has 60 calendar days to determine whether the criteria are met, including whether there is preliminary clinical evidence indicating the potential to address unmet medical needs for a serious or life-threatening disease or condition.

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Healthcare Privacy and Security Laws

We may be subject to, or our marketing activities may be limited by, the Health Insurance Portability and Accountability Act, or HIPAA and its implementing regulations, which established uniform standards for certain “covered entities” (healthcare providers, health plans and healthcare clearinghouses) governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health information.

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providers, health plans and healthcare clearinghouses) governing the conduct of certain electronic healthcare transactions and protecting the security and privacy of protected health information.

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.

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While we believe we are in compliance with applicable environmental regulations, the failure to fully comply with any such regulations could result in the imposition of penalties, fines and/or sanctions which could have a material adverse effect on our business.

It is possible, however, that environmental issues may arise in the future which we cannot now predict.

It is also possible that environmental issues may arise in the future which we cannot now predict.

We are working towards improving our sustainable footprint through key practices like waste reduction, water recycling, and using energy efficient equipment where possible.

We have a focus on raising awareness and educating associates on reducing our internal use of consumables and natural resources.

We have a focus on raising awareness and educating our employees on reducing our internal use of consumables and natural resources.

In addition, we have a broad range of recycling and waste management initiatives at our manufacturing facilities and corporate offices.

For example, at our internal manufacturing facilities we have addressed our use and recycling of paper products, aluminum cans, glass, electronics and plastic, as well as disposal of non-recyclables and effective water management.

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For example, at our internal manufacturing facilities we have addressed our use and recycling of paper products, aluminum cans, glass, electronics and plastic, as well as responsible disposal of non-recyclables and effective water management.

Cybersecurity

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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.

In 2021, we provided support for charitable medical missions in Honduras and Ghana by donating EXPAREL to help support surgeries for patients in need and have also supported the Louisiana State University Opioid Minimization Initiative as well as made a commitment to donate EXPAREL to not-for-profit children’s hospitals each year over the next three years.

In 2021 and 2022, we provided support for charitable medical missions in Honduras, Ghana, Zambia, Guatemala, Ecuador, Mexico and India by donating EXPAREL to help support surgeries for patients in need and have also supported the Louisiana State University Opioid Minimization Initiative as well as made a commitment to donate EXPAREL to not-for-profit children’s hospitals each year over the next three years.

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Human Capital

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The cornerstone of our business success

Corporate Sustainability Report

In January 2023, we published our inaugural Corporate Sustainability Report, or CSR, available on our corporate website.

The CSR report contains information about our people, our culture, patient and product safety, our commitment to our communities and opioid-sparing initiatives and our corporate governance and ethics.

The foregoing reference to our CSR report is not intended to, nor shall it be deemed to, incorporate information in the CSR report or any other information contained on our corporate website into this Annual Report by reference.

Total Rewards

In order to attract and retain talent, we maintain broad-based benefits that are provided to all employees, including our 401(k) retirement plan with an employer matching contribution, 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.

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.

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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We encourage our employees to give back in their communities and offer one paid day off per year to volunteer.

We regularly benchmark our

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rewards programs, adjusting as needed, to ensure our total rewards are competitive.

We regularly benchmark our rewards programs, adjusting as needed, to ensure our total rewards are competitive.

We are committed to paying all our employees a fair and living wage.

Talent Management

We have a desire to cultivate and develop our future leaders.

We regularly assess and identify our emerging talent and support their development with programs including leadership development, executive coaching and mentoring.

We invest significantly in our future leaders by cultivating their growth and development.

We regularly assess and identify our emerging talent and support their development with formal programs including classroom training, executive coaching, mentoring programs and “360-degree feedback” surveys geared towards our high-potential leaders.

Many of our leaders participating in these programs advance to higher level positions within the organization.

We are committed to soliciting employee feedback throughout their tenure with the organization, to shape organizational culture and to inform our people strategy.

We conduct new hire surveys to solicit feedback on employees’ initial experiences with us to help ensure a successful onboarding and accelerate their assimilation into the organization and ability to contribute to our mission.

We track turnover and employee engagement among other metrics, and conduct stay and exit interviews to ensure our talent strategy serves our goal of attracting, developing and retaining top talent to serve as our future leaders and stewards of our vision.

We offer targeted selection training for interviewers to ensure a consistent methodology applied in identifying and hiring the best candidates for open positions.

We offer a number of critical skills programs including management skills training for people managers, as well as project management and communications training.

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.

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.

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Employee Wellbeing, Health and Safety

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We hold one another accountable to promote trust and transparency in support of our communities and collective purpose.

In support of this diversity, equity and inclusion vision, we have developed a strategy and multi-year roadmap, prioritizing education and training, and have also developed a global labor and human rights policy.

Our executive team and senior leaders have received training on Unconscious Bias and Inclusive Leadership.

In support of our diversity, equity and inclusion vision, we have developed a strategy and multi-year roadmap, prioritizing education and training, and developed a global labor and human rights policy.

Our executive team and senior leaders have received Unconscious Bias and Inclusive Leadership training.

We list our job postings on state job banks and distribute them to community engaged veteran, minority, women and diversity organizations.

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leadership development, diversity recruiting, culture and communications.

COVID-19 Pandemic

The health and safety of our employees has always been important to us, which is why we took responsible action in response to the COVID-19 pandemic.

We covered the cost of COVID-19 testing and treatment for our employees and covered family members under our benefit plans and extended our paid sick leave for COVID-related absences.

We amended our 401(k)

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savings plan to enhance loan eligibility and repayment terms and to permit certain distributions.

We implemented additional safety protocols and guidelines at our manufacturing sites and required our non-manufacturing personnel to work from home, including our field sales force and clinical education teams which continue to support our customers remotely.

With the reopening of many states, the ability of our sales representatives to renew their in-person engagement efforts, in conjunction with these remote efforts, has occurred across all sites of care, with more focus on physician offices and ASCs.

Our offices have since re-opened with strict safety, social distancing and hygiene guidelines implemented, and we continue to support remote working as appropriate.

As of December 31, 2021, we had 697 employees, all of which are full-time.

30 of these employees are Flexion employees who remain with us on a transitional basis of up to eight months.

As of December 31, 2022, we had 715 employees, of which 713 are full-time and two are part-time.

All of our employees are based in the U.S.

except for nine located in England and one located in the Netherlands.

except for 13 employees based in England.

None of our employees are represented by a labor union, and we consider our current employee relations to be good.

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We file reports and other information with the United States Securities and Exchange Commission, or SEC, as required by the Exchange Act, which are accessible on the SEC’s website at www.sec.gov.

We also make available free of charge through our website our Annual Report, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and any amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act.

We make these reports available through our website as soon as reasonably practicable after we electronically file such reports with, or furnish such reports to, the SEC.

We also make available free of charge through our corporate website our Annual Report, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and any amendments to those reports filed or furnished pursuant to Sections 13(a) and 15(d) of the Exchange Act.

We 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.

In addition, we regularly use our corporate website to post information regarding our business, product development programs and 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.

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 website.

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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.

What changed 10-K

Item 1. Business