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Pacira(PCRX) - 2025 Q1 - Quarterly Report
2025-05-08 20:07
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35060 PACIRA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 51-0619477 (State or Other Juris ...
Pacira(PCRX) - 2025 Q1 - Quarterly Results
2025-05-08 20:06
Pacira BioSciences Reports First Quarter 2025 Financial Results FOR IMMEDIATE RELEASE NEWS RELEASE -- Conference call today at 4:30 p.m. ET -- BRISBANE, CA, May 8, 2025 - Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today reported financial results for the first quarter of 2025. First Quarter 2025 Financial Highlights See "Non-GAAP Financial Information" below. "We entered 2025 sharply focu ...
Pacira BioSciences Reports First Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-05-08 20:00
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].
Pacira BioSciences to Present New Data on Clinical Immunogenicity of Intra-Articular PCRX-201 and Its Implications for Dosing Strategy in Knee Osteoarthritis
GlobeNewswire News Room· 2025-05-02 12:00
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]
Pharmacorp Completes Acquisition of Pre-1954 Charter Company in Ontario
Globenewswire· 2025-05-01 12:32
SASKATOON, Saskatchewan, May 01, 2025 (GLOBE NEWSWIRE) -- PHARMACORP RX INC. (“PharmaCorp” or the “Corporation”) (TSXV: PCRX) is pleased to announce that, further to its news release dated April 3, 2025, it has completed the acquisition of all issued and outstanding shares of a pre-1954 charter company (the “Charter Company”) in Ontario, Canada (the “Acquisition”). The Acquisition of the Charter Company is an arm’s length transaction and no finder’s fees were paid in respect of the Acquisition. The Acquisit ...
Pacira to Report First Quarter 2025 Financial Results on Thursday May 8, 2025
Globenewswire· 2025-04-29 12:00
BRISBANE, Calif., April 29, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced that it will report its first quarter financial results after the close of the U.S. markets on Thursday May 8, 2025. Following the release, the company will host a live conference call and webcast at 4:30 p.m. ET. For listeners who wish to participate in the question and answer ...
Pacira BioSciences Announces Two-Year Efficacy Data Following a Single Local Administration of PCRX-201 in Patients with Mild to Severe Osteoarthritis of the Knee
Globenewswire· 2025-04-28 12:00
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]
Pacira BioSciences Inc (PCRX) Update / Briefing Transcript
2025-04-28 00:55
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]
Pacira BioSciences Inc (PCRX) Earnings Call Presentation
2025-04-25 23:53
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]
Pacira BioSciences to Present 104-Week Efficacy Data Following a Single Local Administration of PCRX-201 for Patients with Mild to Severe Osteoarthritis of the Knee
Newsfilter· 2025-04-22 20:01
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].