About Pacira BioSciences

Pacira BioSciences, Inc. engages in the development, manufacture, marketing, distribution and sale of non-opioid pain management and regenerative health solutions. The company is the industry leader in its 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. The company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain and spasticity. The company is 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, spasticity and stellate ganglion block. The company has three commercialized non-opioid treatments: EXPAREL (bupivacaine liposome injectable suspension), a long-acting, local analgesic approved for postsurgical pain management; 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. Product Portfolio and Product Candidate Pipeline Commercial Products EXPAREL (bupivacaine liposome injectable suspension) EXPAREL was approved by the FDA in October 2011 and was commercially launched in the U.S. in April 2012. In the United States (U.S.), EXPAREL is 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. In November 2020, the European Commission, or EC, granted marketing authorization for EXPAREL as a brachial plexus block or femoral nerve block for the treatment of post-operative pain in adults, and as a field block for the treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults and children aged six years and older. The company launched EXPAREL in the United Kingdom (U.K.), and select European Union (E.U.), countries in November 2021. Since its initial approval in 2011, more than 12 million patients have been treated with EXPAREL. EXPAREL consists of bupivacaine, an amide-type local anesthetic, encapsulated in the company’s proprietary multivesicular liposome (pMVL) drug delivery technology, which delivers bupivacaine over time for extended analgesia. EXPAREL addresses a significant medical need for a safe and effective long-acting non-opioid postsurgical analgesic and plays a significant role in opioid minimization strategies. EXPAREL is designed for recovery with minimal opioid use by delivering targeted local analgesia at the surgical site; reliably releasing bupivacaine over time for prolonged analgesia; eliminating the need for catheters and pumps that may hinder recovery and providing long-lasting pain control while reducing the need for opioids. ZILRETTA (triamcinolone acetonide extended-release injectable suspension) ZILRETTA was approved by the FDA in October 2017 and launched in the U.S. shortly thereafter. 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. The company added ZILRETTA to its commercial offering with the completion of the Flexion Acquisition in November 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 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. Key EXPAREL Markets 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. Orthopedics EXPAREL is used across multiple orthopedic procedures, including joint reconstruction, shoulder, spine, extremity procedures, and hip fractures. EXPAREL-based regional analgesia as part of multimodal pain management protocols in enhanced ERAS pathways is supporting this surgical migration. EXPAREL administered as a brachial plexus nerve block is a key and growing part of the company’s business. An EXPAREL brachial plexus block provides pain coverage for the upper quadrant for use in rotator cuff, shoulder arthroplasty, elbow, wrist, and hand procedures. Additionally, EXPAREL reimbursement is consistently improving as payers and self-insured employers continue to drive the shift from inpatient to outpatient care for a variety of surgeries. Abdominal and Colorectal 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. Women’s Health 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 Cardiothoracic surgery is considered one of the most painful types of surgical procedures for both open and minimally invasive procedures. 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 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. Pediatrics In March 2021, the FDA approved the company’s supplemental New Drug Application (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 the 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. EXPAREL is redefining the paradigm of care for postsurgical pain management in children as the market’s only clinically proven safe alternative for long-acting, non-opioid postsurgical pain control in children aged 6 and over. There are approximately one million pediatric procedures per year in the U.S. The company is working with prominent thought leaders who are providing a rapid transfer of best-practice for establishing EXPAREL-based protocols as the new standard of care. Third Molar (Wisdom Tooth) Procedures In September 2017, the company announced a collaboration with Aetna, one of the nation’s leading diversified health care benefits companies, with the support of the American Association of Oral and Maxillofacial Surgeons (AAOMS). This national program aims to reduce the number of opioid tablets dispensed to patients undergoing impacted third molar extractions by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control. In September 2022, the company announced a joint initiative with Sevaredent Sourcing Solutions, or Sevaredent, 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. The Osteoarthritis Market With the addition of ZILRETTA to the company’s product offering, it can 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. Label and Global Expansion Activities EXPAREL Lower Extremity Nerve Block: In September 2022, the company 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. With these positive results, the company 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 the Prescription Drug User Fee Act (PDUFA) in the second half of 2023. Pediatrics: The company is discussing its regulatory strategy for EXPAREL administered as a nerve block in the pediatric setting. Stellate Ganglion Block: 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. The company is working with a steering committee of Key Opinion Leaders, or KOLs, in regional anesthesia and stellate ganglion blocks to help finalize study design. After the company meets with the U.S. Food and Drug Administration (FDA) to align on its regulatory strategy for expanding the EXPAREL label to include stellate ganglion block, it expects to proceed with a registration trial. Global Expansion: The company has prioritized the European and Latin American markets for global expansion. In Europe, EXPAREL is approved as a brachial plexus block or femoral nerve block for the treatment of post-operative pain in adults and as a field block for the treatment of somatic post-operative pain from small- to medium-sized surgical wounds in adults, and in November 2022, the company received approval to include children aged 6 years or older as a field block for the treatment of somatic post-operative pain from small- to medium-sized surgical wounds. The company launched EXPAREL in the U.K. and targeted E.U. countries in the fourth quarter of 2021. In Latin America, the company has a distribution agreement with Eurofarma Laboratories S.A., or Eurofarma, for the development and commercialization of EXPAREL. 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, and recently submitted an application seeking approval in Brazil. ZILRETTA ZILRETTA’s extended-release profile may also provide effective treatment for OA pain of the shoulder, and the company intends to initiate a Phase 3 trial investigating ZILRETTA in shoulder OA in 2023. In addition, the company is 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. iovera° In 2022, the company launched a next-generation iovera° handheld device, which is more efficient, easier to use and more durable. The company is 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. The company is also seeking a label expansion for the treatment of spasticity, which is a significant long-term opportunity for iovera°. Additionally, the company began selling iovera° in the E.U. through a contracted sales force in 2022. Clinical Development Programs PCRX-201 PCRX-201 was added to the company’s 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. Based upon compelling initial Phase 1 efficacy and safety data for PCRX-201, the company is working with investigators and plan to request an FDA meeting to discuss the regulatory pathway forward for OA of the knee, as well as an RMAT designation. pMVL-Based Clinical Programs Given the proven safety, flexibility and customizability of the company’s pMVL drug delivery technology platform for acute, sub-acute and chronic pain applications, it has several pMVL-based products in clinical development. Following data readouts from preclinical and feasibility studies for these candidates, the company has prioritized three programs for clinical development, such as PCRX-401, a dexamethasone-pMVL for low back pain; PCRX-501, a high potency bupivacaine-pMVL for longer-lasting pain relief (20.0 mg/mL) and EXPAREL for intrathecal analgesia (13.3 mg/mL). The company is planning to initiate the second half of its Phase 1 study of EXPAREL for intrathecal analgesia in the first half of 2023. PCRX-301 PCRX-301 is a locally administered NaV1.7 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, the company 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 the company’s internal clinical programs, its business development team is pursuing innovative acquisition targets that are complementary to EXPAREL, ZILRETTA and iovera°. The comapny is 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. The company has made strategic investments in CarthroniX, Inc.; Genascence Corporation; GQ Bio Therapeutics GmbH; and Spine BioPharma, LLC to support early stage platforms. Sales and Marketing The company has built its sales and marketing organization to commercialize its products. The company’s 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). The company’s 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 its non-opioid products for pain management, including: Providing publications and abstracts showing clinical efficacy and safety, health outcomes and review articles; 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 its 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 its products, meeting the educational and training needs of its physician, surgeon, anesthesiologist, pharmacist and registered nurse customers; Undertaking education initiatives, such as center of excellence programs; preceptorship programs; opioid-sparing and ERAS pain protocols and predictive models for enhanced patient care; interactive discussion forums; patient education platforms leveraging public relations, advocacy partnerships and public affairs efforts where appropriate; web-based training and virtual launch programs; Collaborating with healthcare providers towards improving the knowledge and management of pain in surgical and OA patients with a focus on opioid risk and non-opioid alternatives and engaging its field-based medical teams in system-wide partnerships to address the national opioid epidemic, with a goal of studying alternative postsurgical pain management options that focus on optimization and opioid alternative strategies; and Facilitating reimbursement and the shift of procedures to hospital outpatient and ambulatory surgical center, or ASC, sites of care. DePuy Synthes Sales Inc. In July 2020, the company announced the conclusion of a co-promotion agreement with DePuy Synthes Sales, Inc., or DePuy Synthes, part of the Johnson & Johnson family of companies to market and promote the use of EXPAREL for orthopedic procedures in the U.S. market. The collaboration began in January 2017 and concluded in January 2021. 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 ambulatory surgical centers (ASCs). Other Agreements Flexion Acquisition In November 2021, the company 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 it, Oyster Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of the company (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 the company. The company changed the name of Flexion to Pacira Therapeutics, Inc. after completing the merger. As part of the Flexion Acquisition, the company 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. The addition of ZILRETTA to the company’s innovative non-opioid product portfolio directly aligns with its mission to provide an opioid alternative to as many patients as possible and address medical needs along the neural pain pathway. MyoScience Acquisition In April 2019, the company completed the MyoScience Acquisition. The expiration date for the achievement of the milestones is December 31, 2023. The company changed the name of MyoScience to Pacira CryoTech, Inc. after completing the merger. Aratana Therapeutics, Inc. In December 2012, the company entered into an Exclusive License, Development and Commercialization Agreement and related Supply Agreement with Aratana Therapeutics, Inc., a wholly owned subsidiary of Elanco Animal Health, Inc., or Aratana. Under the agreements, the company granted Aratana an exclusive royalty-bearing license, including the limited right to grant sublicenses, for the development and commercialization of its bupivacaine liposome injectable suspension product for use in animals. In August 2016, the FDA’s Center for Veterinary Medicine, or CVM, approved NOCITA (bupivacaine liposome injectable suspension), as a local post-operative analgesia for cranial cruciate ligament surgery in dogs (NOCITA is a registered trademark of Aratana). In August 2018, the CVM expanded the NOCITA label to include its use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy in cats. In June 2019, the CVM approved a 10mL vial size for NOCITA. Aratana began purchasing the company’s bupivacaine liposome injectable suspension product in 2016. Unless terminated earlier pursuant to its terms, the license agreement is effective until July 2033, after which Aratana has the option to extend the agreement for an additional five-year term, subject to certain requirements. Eurofarma Laboratories S.A. In June 2021, the company entered into a distribution agreement with Eurofarma for the development and commercialization of EXPAREL in Latin America. 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. Verve Medical Products, Inc. In July 2021, the company entered into a licensing agreement with Verve Medical Products, Inc. for the distribution of iovera° in Canada. The company began selling iovera° in Canada in the fourth quarter of 2021. Significant Customers The company had three wholesalers each comprising 10 percent or more of its total revenue for the year ended December 31, 2022: Cardinal Health, Inc.; McKesson Drug Company; and AmerisourceBergen Health Corporation, which accounted for 31%, 23% and 22% of its total revenues, respectively. Co-Production Facilities Thermo Fisher Scientific Pharma Services In April 2014, the company 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 suites. In February 2019, the company announced that commercial production of EXPAREL was underway at the first Thermo Fisher suite. The company is using a second, larger-scale dedicated suite that has more than doubled its EXPAREL manufacturing capacity at the Thermo Fisher site. The company began commercial production of EXPAREL out of that second suite in August 2021. Carlisle Companies, Inc. In January 2020, the company and Carlisle Companies, Inc., or Carlisle, entered into a Manufacturing and Supply Agreement (the Carlisle Agreement) to collaborate in the manufacture of iovera° Smart Tips at Carlisle’s Tijuana, Mexico facility. The initial term of the Carlisle Agreement is five years. Since April 2022, all iovera° Smart Tips are produced by Carlisle. Intellectual Property and Exclusivity Patents and Patent Applications As of December 31, 2022, there are over 13 families of patents and patent applications relating to various aspects of the pMVL drug delivery technology and 29 families of patents and patent applications relating to various aspects of the technology used by iovera°. There is one family of patents and patent applications relating to various aspects of the technology used by ZILRETTA. Patents have been issued in numerous countries, with an emphasis on the North American, European and Japanese markets. 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 the company’s expired U.S. patents had a term of 17 years from the grant date. The company’s issued patents expire at various dates in the future, with the last issued patent for the pMVL drug delivery technology expiring in 2041, the last issued patent for ZILRETTA expiring in 2031 and the last issued utility patent for the iovera° technology expiring in 2040. Patents and Patent Applications for pMVL and pMVL Products In June 2021, the United States Patent and Trademark Office, or USPTO, issued U.S. Patent No. 11,033,495 related to EXPAREL. The patent, ‘Manufacturing of Bupivacaine Multivesicular Liposomes,’ claims composition of EXPAREL prepared by the improved manufacturing process. In November 2021, the USPTO issued U.S. Patent Nos. 11,185,506 and 11,179,336, claiming the improved EXPAREL manufacturing process and EXPAREL composition, respectively. Six U.S. 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. Patent No. 11,278,494, claiming EXPAREL composition. In April 2022, the USPTO issued U.S. Patent Nos. 11,304,904 and 11,311,486, claiming composition of EXPAREL prepared by the improved manufacturing process and EXPAREL composition, respectively. In June 2022, the USPTO issued U.S. Patent No. 11,357,727, claiming composition of EXPAREL prepared by the improved manufacturing process. In August 2022, the USPTO issued U.S. Patent No. 11,426,348, claiming EXPAREL batch compositions. In September 2022, the USPTO issued U.S. Patent No. 11,452,691, claiming EXPAREL batch compositions. All eight of the patents issued in 2021 and 2022 will have an expiration date of January 22, 2041. U.S. Patent Nos. 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 listed in the FDA’s ‘Approved Drug Products with Therapeutic Equivalence Evaluations’ (the Orange Book). Additionally, the company 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, the company 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. The company also owns a family of U.S. and foreign patents on an alternative process to manufacture EXPAREL and other pMVL-based products. There are eight issued U.S. patents. Patents that claim the process and apparatus will expire at the latest in November 2033. One of the patents claims a product made by the process and expires in April 2031. As of December 31, 2022, the company had 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. In February 2022, the company filed a provisional application relating to the use of EXPAREL as stellate ganglion blocks for managing cardiac arrhythmia, including electrical storm. In October 2022, the company 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, the company 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 A composition of matter patent has been issued by the USPTO for ZILRETTA, with a patent term into 2031. The USPTO has also issued two patents directed at the methods of manufacturing and using ZILRETTA with patent terms into 2031. Considerable expertise and effort were required to carry out the large body of original work underlying the formulation of ZILRETTA, including experimenting with, and observing the effects of over 50 steroid and poly lactic-co-glycolic acid, or PLGA, formulations. The company’s 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. The company owns three U.S. ZILRETTA patents, as well as counterpart foreign patents and patent applications covering composition of matter, methods of manufacture, and methods of use. The company’s U.S. ZILRETTA patents have expiration dates in 2031. The ZILRETTA composition of matter invention is the result of several unique discoveries relating to a narrow drug load specification, a certain release profile of polymers, specific polymer weights and ratios, and clinical efficacy observed within a dose-range. The U.S. patents directed to ZILRETTA’s composition of matter and methods of use are listed in the FDA Orange Book. The company also has two U.S. 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 2022, the company had one patent granted in Pakistan, further expanding its 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 the matter, methods of manufacturing, and methods of using ZILRETTA and are similar in scope to the protection in the U.S. The company has also in-licensed intellectual property, owned by the Southwest Research Institute, or SwRI, which gives us exclusive rights to SwRI patents covering its proprietary microsphere manufacturing technology used in the production of ZILRETTA. These patents are scheduled to expire in 2025. Patents and Patent Applications for iovera° Issued patents in the U.S. afford the company a range of coverage of various aspects of the iovera° technology. For example, several of the company’s earliest filed patents cover the structural aspects of a handheld cryogenic device with single needle and needle arrays, tissue-penetrating needle probes that may be detachable, fused silica tubing fluid delivery paths, methods of applying cryotherapy using the cryogenic device and methods for using replaceable needle probes. These patents are set to expire between 2025 and 2032. An important patent family specifically directed to systems and methods of treating pain offers both broad and variable coverage of cryogenic device features and methods of using the same for pain management, including single-use needle probes, particular needle sizes and shapes. Patents in this family are set to expire between 2025 and 2028. Another important patent family has broad disclosure and coverage of a variety of indications for treatment by cryogenic devices, including joint function and stiffness, OA, occipital neuralgia, spasticity, neuroma and other nerve entrapment indications and is set to expire between 2033 and 2037. Additionally, there are several patents and pending patent applications directed to other important aspects of the iovera° technology. 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 and are set to expire between 2035 and 2038. There are eight new utility and design patent families covering 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 commercial next-generation cryogenic device until at least 2040 for utility patents and 2046 for design patents. PCRX-201 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. patent No. 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. The company is continuing to prosecute one U.S. Baylor patent application related to PCRX-201. Further, it has 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. The company also has 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. Additional Intellectual Property The company has 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 the company’s 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 are unique to the company. The expertise and knowledge required to understand the critical aspects of the company’s pMVL manufacturing steps requires knowledge of both traditional and non-traditional emulsion processing and traditional pharmaceutical production, overlaid with all of the challenges presented by aseptic manufacturing. ZILRETTA is also manufactured using custom equipment and proprietary processes with respect to certain of the formulation and manufacturing techniques related to the TA-formulated PLGA microspheres in ZILRETTA, including those that relate to its precise pharmaceutical release profile. The iovera° system relies on custom manufacturing techniques that are able to provide the precision and tight tolerances required for a self-contained handheld cryogenic device. Additionally, the iovera° device includes proprietary software for device operations during cryotherapy treatments. Trademarks and Service Marks Pacira, EXPAREL, ZILRETTA, iovera, the Pacira logo and other trademarks or service marks of the company. Strategy The key elements of the company’s strategy include expanding the use of its opioid-free commercial assets; advancing its clinical-stage pipeline within multiple areas of unmet need; and accessing complementary innovative assets using a combination of strategic investment, in-licensing, or acquisition. Government Regulations To obtain 510(k) clearance, the company must file with the U.S. Food and Drug Administration (FDA) a pre-market notification demonstrating that its proposed device is substantially equivalent to a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for the submission of a pre-market approval (PMA). The company is subject to unannounced inspections by the FDA to determine its compliance with Quality System Regulations (QSRs) and other rules and regulations. The company must comply with the FDA’s Current Good Manufacturing Practices (CGMP) requirements and comparable regulations in other countries. History The company was founded in 2006. It was incorporated in Delaware under the name Blue Acquisition Corp. in 2006 and changed its name to Pacira, Inc. in 2007. In 2010, the company changed its name to Pacira Pharmaceuticals, Inc. and to Pacira BioSciences, Inc. in 2019.

Country
Industry:
Pharmaceutical preparations
Founded:
2006
IPO Date:
02/03/2011
ISIN Number:
I_US6951271005
Address:
5401 West Kennedy Boulevard, Suite 890, Tampa, Florida, 33609, United States
Phone Number
813 553 6680

Key Executives

CEO:
Lee, Frank
CFO
Reinhart, Charles
COO:
Gaugler, Daryl