Core Viewpoint - Pacira BioSciences, Inc. reported strong financial results for Q1 2025, highlighting its commitment to non-opioid pain therapies and the successful execution of its 5x30 strategy, which aims to enhance its market position and drive growth through innovation and strategic acquisitions [4][6][11]. Financial Highlights - Total revenues for Q1 2025 were $168.9 million, a slight increase from $167.1 million in Q1 2024 [6][11]. - Net product sales included $136.5 million for EXPAREL, $23.3 million for ZILRETTA, and $5.1 million for iovera°, with EXPAREL showing a growth from $132.4 million in the same quarter last year [6][11]. - Net income was reported at $4.8 million, or $0.10 per share, compared to $9.0 million, or $0.19 per share in Q1 2024 [6][11]. - Adjusted EBITDA for the quarter was $44.1 million, slightly down from $44.6 million in Q1 2024 [6][11]. Recent Business Developments - The company successfully settled U.S. patent litigation for EXPAREL, securing exclusivity until 2039, which is expected to enhance market share and cash flow [7][11]. - The first patient was dosed in a Phase 2 study for PCRX-201, targeting osteoarthritis of the knee, with topline results expected by the end of 2026 [7][11]. - A favorable court ruling eliminated the royalty obligation on EXPAREL sales to RDF, allowing the company to cease future payments and seek repayment for previously paid royalties [7][11]. - The corporate headquarters was relocated to Brisbane, California, aligning with the company's growth strategy [7][11]. Strategic Initiatives - The company reiterated its full-year 2025 financial guidance, projecting total revenues between $725 million and $765 million, with a non-GAAP gross margin of 76% to 78% [21][11]. - Pacira acquired GQ Bio Therapeutics GmbH to enhance its 5x30 growth strategy, bringing in a novel local delivery platform for genetic medicines [11][37]. - The company is focused on expanding the market for EXPAREL and other products through strategic initiatives and clinical trials [11][40].

Core Insights - Pacira BioSciences, Inc. is presenting new data on its gene therapy candidate PCRX-201 at the 2025 EULAR Annual Congress, highlighting its commitment to innovative, non-opioid pain therapies [1] Group 1: Clinical Data and Study Results - The Phase 1 study of PCRX-201 demonstrated that a single intra-articular injection was safe and provided sustained clinical benefits for patients with moderate-to-severe knee osteoarthritis over three years [2] - In a previous Phase 1 study, PCRX-201 showed sustained improvements in knee pain, stiffness, and function for two years post-administration, with a well-tolerated safety profile [3] - PCRX-201 has received RMAT designation from the FDA and ATMP designation from the EMA, marking it as the first gene therapy to achieve these clinical results in knee osteoarthritis [3] Group 2: Ongoing Research and Development - Following promising Phase 1 results, dosing is currently underway in a Phase 2 study (ASCEND study) for the treatment of knee osteoarthritis [4] - The company is advancing the development of PCRX-201 as a novel, locally administered gene therapy aimed at treating prevalent diseases like osteoarthritis [5] Group 3: Company Overview - Pacira BioSciences focuses on delivering innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera® [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, while ZILRETTA is an extended-release injection for osteoarthritis knee pain [5]

Core Insights - The Medical sector is experiencing a robust first-quarter earnings season, with several drugmakers reporting results, and large caps like J&J, Merck, and Amgen exceeding earnings and sales estimates [1][2] - Overall, first-quarter earnings for the Medical sector are projected to rise by 40%, with revenues expected to increase by 8.3% [3] Earnings Performance - As of April 30, 45% of Medical sector companies, representing approximately 57.9% of the sector's market capitalization, have reported earnings, with 66.7% beating both earnings and revenue estimates [2] - Year-over-year earnings growth for the sector is reported at 60.5%, while revenues have increased by 7.8% [2] Company Highlights - **Novo Nordisk**: Expected to report earnings of 92 cents per share and revenues of $11.33 billion, with strong sales anticipated from diabetes and obesity care products [6][7] - **Pacira BioSciences**: Projected earnings of 57 cents per share and revenues of $174.96 million, driven by sales of its pain-management product Exparel [8][9] - **Ultragenyx Pharmaceuticals**: Expected to report a loss of $1.54 per share and revenues of $141.99 million, with growth driven by its lead drug Crysvita [10][11] - **Acadia Pharmaceuticals**: Anticipated earnings of 6 cents per share and revenues of $241.74 million, primarily from sales of Nuplazid for Parkinson's disease psychosis [12][13] - **Denali Therapeutics**: Expected loss of 71 cents per share and revenues of $8.3 million, with updates on pipeline programs anticipated during the earnings report [17][18] Earnings Surprise Potential - The Earnings ESP methodology indicates that stocks with a positive Earnings ESP and a Zacks Rank of 1, 2, or 3 have a high chance of delivering earnings surprises, with a success rate of up to 70% [4][5]

Core Insights - Pacira BioSciences is set to present findings from its Phase 1 study of PCRX-201, a gene therapy for knee osteoarthritis, at the ASGCT Annual Meeting on May 15, focusing on the impact of neutralizing antibodies on therapy efficacy and safety [1][2] - The company has reported promising Phase 1 results showing sustained improvements in knee pain and function over two years, leading to regulatory designations from the FDA and EMA [4][5] Company Overview - Pacira BioSciences specializes in innovative, non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera, alongside the development of PCRX-201 [6] - PCRX-201 utilizes a proprietary high-capacity adenovirus vector platform and targets chronic inflammatory processes in knee osteoarthritis, a condition affecting over 14 million individuals in the U.S. [3][4] Upcoming Events - The presentation titled "Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy" will be delivered by Dr. MiJeong Kim on May 15 [2] - A symposium on "High-Capacity Adenoviral Vectors: Advancing Gene Therapy Beyond AAV to Deliver Cost-Effective Therapies for Common Diseases" is scheduled for May 16 [3]

Core Insights - PharmaCorp RX Inc. has successfully completed the acquisition of a pre-1954 charter company in Ontario, allowing it to operate pharmacies in the region [1][2] - The acquisition is significant as it enables PharmaCorp to bypass ownership restrictions under the Drug and Pharmacies Regulations Act (Ontario), which limits non-pharmacist owned corporations from operating pharmacies [2] - PharmaCorp currently operates three PharmaChoice bannered pharmacies and plans to continue acquiring more pharmacies under the PharmaChoice Canada brand [3] Company Overview - PharmaCorp operates under the TSX Venture Exchange with the symbol PCRX and is focused on expanding its pharmacy operations in Canada [3] - The company aims to acquire both PharmaChoice Canada branded pharmacies and independently owned non-PharmaChoice Canada bannered pharmacies, integrating them into its operations [3]

Core Viewpoint - Pacira BioSciences, Inc. is set to report its first quarter financial results on May 8, 2025, and will host a live conference call following the release [1] Company Overview - Pacira specializes in innovative, non-opioid pain therapies aimed at transforming patient lives [3] - The company has three commercial-stage non-opioid treatments: - EXPAREL, a long-acting local analgesic for various postsurgical pain management applications [3] - ZILRETTA, an extended-release injection for osteoarthritis knee pain management [3] - ioveraº, a handheld device providing immediate, long-acting, drug-free pain control [3] - Pacira is also developing PCRX-201, a novel gene therapy targeting prevalent diseases like osteoarthritis [3]

Core Insights - Pacira BioSciences, Inc. announced new data on its gene therapy candidate PCRX-201, showing sustained improvements in knee pain, stiffness, and function for up to two years after a single local administration in patients with varying severity of osteoarthritis [2][3][9] Study Findings - The study presented at the 2025 OARSI World Congress demonstrated that PCRX-201 provided clinically meaningful improvements across all structural severity subgroups, including advanced disease [1][2] - The open-label, phase 1 trial involved 72 patients aged 30 to 80, stratified by the severity of knee osteoarthritis, graded on the Kellgren-Lawrence scale [4] - Improvements in pain, stiffness, and function were assessed using the WOMAC and KOOS scores, showing significant reductions across all cohorts and severity levels [6][7] Treatment Efficacy - Patients receiving corticosteroid pretreatment experienced greater benefits, with pain reductions of 48%-65% and stiffness reductions of 53%-72%, compared to 41%-58% and 33%-53% in the non-pretreated cohort [7] - The greatest improvement was observed in patients with K/L grade 2 osteoarthritis [7] Safety Profile - No serious treatment-emergent adverse events were reported, with treatment-related joint effusions being the most common adverse event, occurring in 36% of the corticosteroid-pretreated group and 61% of the non-pretreated group [8] Regulatory Designations - PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA in March 2024, facilitating efficient drug development and potential accelerated approval [9][10] - The therapy also received Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency in May 2023 [10][13] Future Developments - Following promising Phase 1 results, a Phase 2 study (ASCEND study) is underway for PCRX-201, focusing on the treatment of knee osteoarthritis [11][13] - The company aims to advance its position as an innovative biopharmaceutical entity through this development [9]

Summary of Pacira BioSciences Inc (PCRX) Update / Briefing April 27, 2025 Company Overview - **Company**: Pacira BioSciences Inc (PCRX) - **Focus**: Development of innovative therapies for pain management and degenerative diseases, specifically targeting osteoarthritis Key Points - **Commitment to Change**: The company emphasizes its dedication to creating lasting improvements for patients suffering from pain and degenerative diseases like osteoarthritis [1] - **Clinical Development Plan**: Introduction of PCRX201, an innovative gene therapy aimed at addressing both the underlying causes and symptoms of knee osteoarthritis [1] Additional Important Content - **Target Patient Population**: The focus on osteoarthritis indicates a strategic alignment with a significant patient demographic that experiences chronic pain [1]

PCRX-201 Overview - PCRX-201 is an innovative, locally-administered gene therapy targeting the underlying cause of osteoarthritis (OA)[1, 10] - It offers unprecedented pain relief and durability for at least 2 years from a single injection across all levels of disease severity[11] - Phase 1 trial data showed a 48-65% reduction from baseline pain through 104 weeks[13] - In the Phase 1 trial, over 70% of patients experienced a greater than 50% improvement in pain and stiffness vs baseline at week 16 and 78[15] Clinical Development Plan - The company plans a clinical development pathway including Phase 2 Part A, Phase 2 Part B, Phase 2 Bilateral Dosing, Phase 3 Single Injection, and Phase 3 Extension with repeat dosing, targeting a BLA submission by 2032[17, 19] Phase 2 Study Design - The Phase 2 study is a two-part, randomized, double-blind, active-controlled study to assess the safety and tolerability of PCRX-201 in subjects with painful knee OA[20, 22] - Part A will use existing inventory from the Phase 1 trial, while Part B will use a new manufacturing process intended for commercial scale-up[28] - Both parts will pretreat all subjects with a 40 mg intra-articular (IA) dose of methylprednisolone acetate[28, 40, 43] - Part A plans for a maximum of 45 subjects (15 per group), and Part B plans for 90 subjects (30 per group)[32, 39, 42]

Core Insights - Pacira BioSciences, Inc. is presenting new 104-week data for its gene therapy candidate PCRX-201 at the OARSI World Congress, highlighting its commitment to innovative, non-opioid pain therapies [1][4]. Group 1: Product Information - PCRX-201 (enekinragene inzadenovec) is based on a proprietary high-capacity adenovirus vector platform and targets chronic inflammatory processes in knee osteoarthritis, affecting over 14 million individuals in the U.S. [3] - The therapy has shown sustained improvements in knee pain, stiffness, and function for up to two years post-administration, with a favorable safety profile [4]. - PCRX-201 has received RMAT designation from the FDA and ATMP designation from the EMA, marking it as the first gene therapy to achieve such regulatory recognition in knee osteoarthritis [4]. Group 2: Clinical Development - Following promising Phase 1 results, a Phase 2 study (ASCEND study) is currently underway for PCRX-201 to further evaluate its efficacy in treating knee osteoarthritis [5]. Group 3: Company Overview - Pacira specializes in non-opioid pain therapies and has three commercial-stage products: EXPAREL®, ZILRETTA®, and iovera® [6]. - The company is advancing the development of PCRX-201 as a novel treatment option for prevalent diseases like osteoarthritis [6].