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About Pacira BioSciences Inc.
Pacira BioSciences Inc. (NASDAQ: PCRX) is a leading biopharmaceutical company specializing in the development and commercialization of innovative, non-opioid pain management therapies. Headquartered in Parsippany, New Jersey, Pacira is committed to transforming patient care by providing healthcare practitioners with cutting-edge solutions to address acute and chronic pain without the risks associated with opioid use. The company's portfolio reflects its dedication to advancing non-opioid alternatives, leveraging proprietary drug delivery technologies and strategic innovation to meet the evolving needs of patients and clinicians.
Core Products and Technologies
Pacira's product lineup includes three commercialized, non-opioid treatments that exemplify its expertise in pain management:
- EXPAREL®: A long-acting local anesthetic formulated with bupivacaine and delivered via multivesicular liposome technology. EXPAREL is indicated for postsurgical pain management through infiltration and regional nerve blocks, offering prolonged pain relief and reducing opioid consumption in the peri- and postoperative settings.
- ZILRETTA®: An extended-release corticosteroid injection designed for the management of osteoarthritis knee pain. Utilizing proprietary microsphere technology, ZILRETTA provides sustained pain relief for up to 12 weeks, addressing the limitations of traditional corticosteroid therapies.
- iovera°®: A handheld cryoneurolysis device that uses controlled doses of cold temperature to temporarily block pain signals by targeting peripheral nerves. This drug-free solution is FDA-cleared for treating conditions such as osteoarthritis-related knee pain and chronic back pain, offering immediate and long-lasting relief.
Proprietary Platforms
Pacira's innovation is underpinned by its proprietary DepoFoam® and multivesicular liposome technologies, which enable the controlled release of drugs over extended periods without altering their molecular structure. These platforms enhance the efficacy and safety profiles of its products, positioning Pacira as a pioneer in advanced drug delivery systems.
Strategic Expansion into Gene Therapy
In its pursuit of addressing unmet medical needs, Pacira has expanded into the field of gene therapy through the acquisition of GQ Bio Therapeutics. This integration brings the high-capacity adenovirus (HCAd) gene therapy vector platform, which supports the development of innovative treatments for musculoskeletal conditions like osteoarthritis. The lead candidate, PCRX-201, is a locally administered gene therapy designed to reduce inflammation and chronic pain by boosting interleukin-1 receptor antagonist (IL-1Ra) production. This move underscores Pacira's commitment to leveraging cutting-edge science to redefine pain management.
Market Context and Competitive Position
Operating at the intersection of biopharmaceutical innovation and the growing demand for opioid-sparing therapies, Pacira is uniquely positioned to address the challenges of the opioid crisis. Its solutions align with healthcare policies such as the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which promotes reimbursement for non-opioid pain management options. By focusing on clinically validated, non-opioid alternatives, Pacira stands out in a competitive landscape dominated by traditional pain management approaches.
Commitment to Innovation and Patient-Centric Care
Pacira's mission extends beyond product development; it seeks to redefine the role of opioids in pain management by offering sustainable, effective, and safe alternatives. The company's dedication to advancing healthcare is evident in its robust pipeline, strategic acquisitions, and focus on addressing the root causes of chronic pain. Through its innovative therapies, Pacira continues to set new benchmarks for pain management, improving outcomes for millions of patients worldwide.
Pacira BioSciences (PCRX) reported strong second quarter 2021 financial results with total revenues of $135.6 million, up from $75.5 million year-over-year. EXPAREL net sales reached $130.1 million, significantly higher than $73.0 million in Q2 2020. The company achieved a GAAP net income of $19.1 million (or $0.43 per share), a recovery from a loss in the same quarter last year. Adjusted EBITDA soared to $50.3 million. Pacira also announced FDA approval for an enhanced EXPAREL manufacturing process and a distribution agreement with Eurofarma for Latin America, indicating positive growth prospects.
Pacira BioSciences has received FDA approval for an enhanced manufacturing process for its product EXPAREL (bupivacaine liposome injectable suspension), allowing it to double production capacity at a new 200-liter facility in Swindon, England. This move is anticipated to enhance gross margins and extend market exclusivity to January 2041 with the issuance of a new patent. The company aims to commence commercial sales of EXPAREL produced in this facility by the end of the year.
Pacira BioSciences (Nasdaq: PCRX) reported significant findings on the iovera° system from a study focused on total knee arthroplasty (TKA). The addition of preoperative iovera° treatment to a multimodal pain management protocol led to a remarkable 51% reduction in daily opioid consumption and notably decreased pain levels and hospital stay lengths. Analysis of 267 patients showed less than 17% had a hospital stay of two or more days compared to 99% in the control group. These outcomes highlight iovera°'s efficacy in enhancing post-surgical recovery.
Pacira BioSciences, Inc. (NASDAQ:PCRX) will announce its second quarter financial results on August 3, 2021, before U.S. market opening. Following the earnings release, a live conference call will occur at 8:30 a.m. ET. Participants can join the call by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international), using passcode 9991311. A replay will be available for one week post-call. Pacira is known for its commitment to non-opioid pain management, with flagship product EXPAREL® launched in 2012, and acquisition of iovera°® system in 2019.
Pacira BioSciences (Nasdaq: PCRX) announced preliminary unaudited net revenue of $135.6 million for Q2 2021, primarily driven by EXPAREL sales of $130.1 million. Average daily sales of EXPAREL surged to 178% of last year for Q2 and to 120% for June. Despite ongoing challenges due to the COVID-19 pandemic impacting elective surgeries, the company remains optimistic about future growth as conditions normalize. The report also highlights increased interest in iovera° and the company's commitment to non-opioid pain management solutions.
Pacira BioSciences, Inc. (Nasdaq: PCRX) has entered a distribution agreement with Eurofarma Laboratories S.A. for the commercialization of EXPAREL® in 19 Latin American countries, including Brazil and Mexico. This partnership aims to enhance Pacira's presence in a rapidly growing market, allowing Eurofarma to leverage its extensive experience in introducing innovative products. Pacira will earn royalties and milestone payments based on Eurofarma's success in this region, reinforcing its commitment to providing non-opioid pain management solutions.
Pacira BioSciences (Nasdaq: PCRX) reported preliminary unaudited net product sales of EXPAREL and iovera° totaling $41.2 million and $1.0 million, respectively, for May 2021. Sales for EXPAREL showed strong growth, with average daily sales at 162% of May 2020 and 105% of April 2021. This growth is attributed to increased demand in outpatient and non-elective procedures, despite ongoing impacts from the COVID-19 pandemic. The company continues to report monthly sales data to provide clarity on market conditions.
Pacira BioSciences announced topline results from its Phase 3 STRIDE study for EXPAREL, which failed to meet the primary endpoint of pain reduction from 0 to 96 hours compared to bupivacaine HCl. However, significant reductions in pain and opioid consumption were observed from 24 to 96 hours (p<0.01) and cumulative pain scores from 12 to 96 hours (p<0.02). Safety results showed no serious adverse events. The company plans to further analyze the data and discuss next steps with the FDA, emphasizing EXPAREL's potential in opioid-sparing pain management.
PACIRA BIOSCIENCES, INC. (NASDAQ: PCRX) will present at the 2021 Jefferies Virtual Healthcare Conference on June 1, 2021, at 9:30 AM ET. The event can be accessed via the company's website, with a replay available for two weeks after the presentation. Pacira is a leader in non-opioid pain management, known for its long-acting local analgesic EXPAREL®, launched in April 2012. The company aims to reduce opioid reliance and enhance patient care through innovative solutions, including the iovera°® cryoanalgesia device acquired in 2019.
Pacira BioSciences has received a Notice of Allowance from the USPTO for a patent regarding its EXPAREL manufacturing process, extending protection until January 22, 2041. This patent is a key component of the company's strategy to maintain market exclusivity for EXPAREL, a non-opioid pain management solution. The company has invested over $100 million in developing a more efficient manufacturing method. Additionally, Pacira is awaiting FDA approval for its new manufacturing process, with a PDUFA date set for August 6, 2021.
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