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PACIRA ALERT: Bragar Eagel & Squire, P.C. is Investigating Pacira BioSciences, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-06-18 01:00
Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Pacira BioSciences, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors following a significant patent ruling that negatively impacted the company's stock value [1][2]. Summary by Relevant Sections Company Overview - Pacira BioSciences, Inc. is primarily known for its product Exparel, which constitutes approximately 80% of its revenue [2]. Legal Issues - A class action complaint was filed against Pacira on June 16, 2025, concerning a Class Period from August 2, 2023, to August 8, 2024, focusing on potential breaches of fiduciary duties by the company's board [1]. - On August 9, 2024, Pacira announced that its U.S. Patent No. 11,033,495 was deemed invalid by the court, which raises concerns about the validity of its other patents and could lead to increased competition from generic products [2]. Stock Performance - Following the announcement regarding the patent ruling, Pacira's stock price plummeted from $22.36 per share on August 8, 2024, to a low of $11.70 per share on August 9, 2024, marking a decline of over 47% in just one day [3].
Pacira BioSciences Unveils Three-Year Clinical Data Following a Single Local Administration of Investigational Gene Therapy, PCRX-201, in Patients with Moderate-to-Severe Osteoarthritis of the Knee
Globenewswire· 2025-06-11 12:00
Core Insights - Pacira BioSciences, Inc. announced long-term follow-up data from its Phase 1 clinical trial of PCRX-201, a gene therapy for knee osteoarthritis, showing sustained clinical efficacy for up to three years [1][3][12] - The therapy demonstrated significant improvements in pain, stiffness, and function, with a single injection being well tolerated [1][7] Study Details - The Phase 1 trial involved 72 patients aged 30 to 80, with assessments conducted over 156 weeks using WOMAC and KOOS scores [4][6] - Participants were divided into two cohorts: one receiving varying doses of PCRX-201 and the other receiving a corticosteroid pretreatment [4] Key Findings - No serious treatment-related adverse events were reported, with treatment-related joint effusions occurring in 36% of the corticosteroid-pretreated group and 61% in the non-pretreated group [6][7] - Significant reductions in pain and stiffness were observed, with 51-53% reduction in WOMAC-A pain scores and 38-76% reduction in WOMAC-B stiffness scores [7] - Improvements in KOOS daily living function scores ranged from 26 to 28 points [7] Regulatory Designations - PCRX-201 received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency [8][9][12] - These designations facilitate efficient drug development and potential accelerated approval processes [9] Future Developments - Following promising Phase 1 results, a Phase 2 study (ASCEND study) is currently underway for PCRX-201 [10] - The therapy targets chronic inflammation at the cellular level, aiming to modify the disease rather than just alleviate symptoms [3][11]
Pacira BioSciences Inc (PCRX) 2025 Conference Transcript
2025-06-04 13:47
Summary of Pacira BioSciences Inc (PCRX) Conference Call Company Overview - Pacira BioSciences is a leader in non-opioid pain management therapies, with market-leading products including EXPAREL for post-operative pain, ZILRETTA (the only long-acting FDA-approved steroid lasting up to three months), and ioverao (a cryoneurolysis device) [3][4] Core Points and Arguments - **EXPAREL Settlement**: A recent positive settlement regarding EXPAREL provides total exclusivity until February 2030, followed by a volume-limited market share for generics until February 2039. This settlement removes stock overhang and ensures substantial cash flows for reinvestment [10][11] - **Market Growth Potential**: The company believes there is significant room for growth in the market for EXPAREL, as it remains underpenetrated with a total addressable market (TAM) still in the high single digits [15] - **No Pain Act**: The No Pain Act, effective January 1, 2025, allows for additional reimbursement for innovative products like EXPAREL, which could positively impact the company’s revenue. Approximately 6 million out of 18 million procedures annually are covered under CMS [21][22][26] - **Commercial Payer Adoption**: There is an encouraging trend of commercial payers beginning to adopt policies similar to CMS, which is expected to enhance market penetration over time [26][30] - **Gross Margin Expansion**: The company aims to expand gross margins by five percentage points by 2030, aided by the cessation of low single-digit royalties on EXPAREL and increased manufacturing efficiency [36][37][41] Other Important Content - **Five by 30 Strategy**: The company has outlined a strategic plan to treat over 3 million patients, achieve double-digit growth, expand gross margins, develop five novel programs, and establish partnerships by 2030 [41][45] - **PCRX-201 Development**: The company is optimistic about PCRX-201, a gene therapy for osteoarthritis, citing compelling data and a favorable local delivery method. A Phase 2 study is underway, with results expected by the end of next year [60][62][64] - **Partnership Opportunities**: The company is exploring partnerships to expand its market reach, particularly outside the U.S., and to enhance its product offerings through synergistic sales strategies [46][50][54] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic direction, market opportunities, and product developments.
PharmaCorp Rx Inc. Reports First Quarter 2025 Results and Announces Non-Binding Letters of Intent to Acquire Four Pharmacies
Globenewswire· 2025-05-29 18:02
Core Insights - PharmaCorp Rx Inc. reported a net income of $254,000 for Q1 2025, marking its first quarter of positive net income [2][3] - The company has entered into non-binding letters of intent to acquire four community pharmacies for approximately $12.5 million, aligning with its acquisition-driven growth strategy [5][6] Financial Performance - Same-store sales increased by 4.0% year-over-year compared to Q1 2024, indicating organic growth across the pharmacy network [3] - Total prescription volumes rose by 3.2% year-over-year, reflecting sustained patient engagement [4] Acquisition Strategy - The proposed acquisitions are expected to be accretive to earnings and will be funded through a combination of cash and common shares [5][6] - The completion of these acquisitions is subject to the execution of definitive agreements and customary conditions, with anticipated closings between June 30 and August 31, 2025 [7] Operational Outlook - The company remains committed to expanding its national footprint through strategic acquisitions and operational excellence [9] - Management expresses confidence that the momentum from Q1 results will continue to build in future quarters [3][9]
Pacira BioSciences Inc (PCRX) 2025 Conference Transcript
2025-05-21 13:30
Summary of Pacira BioSciences Inc (PCRX) 2025 Conference Company Overview - **Company**: Pacira BioSciences Inc (PCRX) - **Focus**: Non-opioid innovative pain management therapies, primarily through products like EXPAREL, ZILRETTA, and ioverao [4][16] Core Points and Arguments - **Sales Performance**: The company generated over $700 million in sales in 2025, indicating a strong cash flow [4] - **Pipeline Development**: The lead product in the pipeline is PCRX201, aimed at transforming treatment for osteoarthritis of the knee and potentially other joints [5] - **5x30 Strategy**: The company aims to achieve five key objectives by 2030: 1. Help over 3 million patients (currently around 2.4 million) [10] 2. Achieve double-digit growth, moving from historical low single digits [11] 3. Expand margins by at least five percentage points [11] 4. Develop five novel projects by 2030, with PCRX201 as the lead [12] 5. Establish five partnerships for commercialization and development [13] Recent Developments - **Litigation Settlement**: A significant settlement regarding Paragraph IV litigation around EXPAREL provides visibility until 2039, alleviating previous stock overhang concerns [7][18] - **Market Dynamics**: EXPAREL's average daily sales grew by 7% in the first quarter, contrasting with previous low single-digit growth [24] - **Sales Force Reorganization**: Transitioned to three separate sales forces for each product to enhance focus and execution [25] Commercial Strategy - **No Pain Initiative**: The company is seeing early adoption in smaller community settings and ambulatory surgical centers, with expectations for broader uptake in larger health systems [29] - **Reimbursement Dynamics**: Encouraging signs of commercial payer adoption are emerging, with a focus on aligning with CMS reimbursement strategies [32] Pipeline Insights - **PCRX201**: The product shows promising data with 72 patients in Phase 1, demonstrating significant pain relief and durability [36][39] - **Gene Therapy Approach**: The company is exploring gene therapy with a focus on local administration, which may broaden the applicability of gene therapies beyond rare diseases [45] Additional Considerations - **Intellectual Property**: The company holds 19 Orange Book listed patents, enhancing its competitive position [19] - **Future Projects**: There are ongoing discussions about additional projects stemming from the newly acquired GQ Bio platform, emphasizing locally administered therapies [47] Conclusion - Pacira BioSciences is positioned for growth with a robust pipeline and strategic initiatives aimed at expanding its market presence and improving patient outcomes through innovative pain management solutions [48]
Pacira BioSciences Presents New Data on the Effects of Clinical Immunogenicity on Locally Administered PCRX-201 in Patients with Moderate to Severe Osteoarthritis of the Knee
Globenewswire· 2025-05-15 12:00
Core Insights - Preliminary data indicates that pre-existing and treatment-induced anti-Ad5 neutralizing antibodies do not affect the safety and effectiveness of PCRX-201 for knee osteoarthritis [1][2][4] - The findings will be presented at the ASGCT Annual Meeting, highlighting the potential of PCRX-201 as a durable treatment option for knee osteoarthritis [1][2] Company Overview - Pacira BioSciences, Inc. is focused on innovative, non-opioid pain therapies, with PCRX-201 being a key candidate for treating knee osteoarthritis [1][11] - The company has received RMAT designation from the FDA for PCRX-201, which facilitates efficient drug development and potential accelerated approval [6][7][10] Study Details - An open-label, phase 1 trial involved 72 participants aged 30 to 80, assessing the impact of anti-Ad5 neutralizing antibodies on PCRX-201 [3] - The study measured NAb titers and IL-1Ra levels over 52 weeks, with results showing no adverse effects on efficacy or safety across different dosing levels [4][5] Treatment Efficacy - All doses of PCRX-201 led to improvements in knee pain, stiffness, and function, as measured by WOMAC-A and WOMAC-B indices [4] - Corticosteroid pretreatment was found to reduce treatment-induced NAb titers and related knee swelling [5] Future Developments - A Phase 2 study (ASCEND study) is currently underway for PCRX-201, building on the promising Phase 1 results [8] - The innovative design of PCRX-201 utilizes a high-capacity adenovirus vector platform to enhance treatment efficacy for chronic inflammation in knee osteoarthritis [2][9]
Pacira BioSciences to Participate in Fireside Chat at Two Upcoming Healthcare Conferences
Globenewswire· 2025-05-14 12:00
Core Insights - Pacira BioSciences, Inc. is committed to delivering innovative, non-opioid pain therapies to transform patients' lives [2] - The company will participate in two upcoming healthcare conferences, providing opportunities for analysts to engage with its leadership [1][3] Company Overview - Pacira has three commercial-stage non-opioid treatments: - EXPAREL, a long-acting local analgesic approved for various postsurgical pain management applications [2] - ZILRETTA, an extended-release injection for osteoarthritis knee pain management [2] - ioveraº, a handheld device for drug-free pain control using cold temperature [2] - The company is also developing PCRX-201, a novel gene therapy aimed at treating prevalent diseases like osteoarthritis [2]
Lawsuit for Investors in shares of Pacira BioSciences, Inc. (NASDAQ: PCRX) announced by the Shareholders Foundation
Prnewswire· 2025-05-13 14:35
Core Viewpoint - A lawsuit is pending against Pacira BioSciences, Inc. for alleged violations of securities laws related to misleading statements about patent protections for Exparel, which is critical for the company's revenue growth [2]. Group 1: Lawsuit Details - An investor filed a lawsuit on January 13, 2025, claiming that Pacira made false statements regarding the patent protections for Exparel, which accounts for approximately 80% of the company's revenue [2]. - The lawsuit alleges that Pacira misrepresented the strength of the '495 patent, which was invalidated in a separate case, leading to concerns that generic competition could arise during the patent's life [2]. Group 2: Investor Information - Shareholders who purchased shares of Pacira BioSciences, Inc. prior to August 2023 and continue to hold them are encouraged to contact the Shareholders Foundation for options regarding the lawsuit [1][3].
Pacira(PCRX) - 2025 Q1 - Earnings Call Presentation
2025-05-09 17:31
Business Growth and Strategy - Pacira is transitioning into an innovative biopharmaceutical organization, aiming to lead in musculoskeletal pain and related areas[6] - The company is focused on accelerating growth in its base business and advancing its pipeline value through strategic partnerships and clinical development[5, 8] - Pacira plans to opportunistically return capital to shareholders, supported by a newly authorized share repurchase program of $300 million[39] EXPAREL - A patent litigation settlement secures EXPAREL's exclusivity until 2039, setting the stage for long-term growth[9, 10, 11] - In 1Q25, EXPAREL average daily sales (ADS) increased by approximately 7% year-over-year[15] - A favorable court ruling eliminates RDF royalty obligation, benefiting EXPAREL gross margins by a low-single-digit percentage[9] Pipeline Development - The acquisition of GQ Bio added a novel platform, preclinical portfolio, and R&D talent[9] - Patient dosing is underway in the Phase 2 ASCEND study of PCRX-201 for knee osteoarthritis (OA)[9] - Phase 3 shoulder OA study progressing for ZILRETTA with topline results expected in 2026[16] Financial Performance and Guidance - Total revenue for 1Q25 was $169 million[40] - Non-GAAP gross margins for 1Q25 reached 81%[40] - Adjusted EBITDA for 1Q25 was $44 million[40] - The company reiterated its 2025 financial guidance, projecting total revenue between $725 million and $765 million and non-GAAP gross margins between 76% and 78%[40]
Pacira BioSciences Q1 Earnings Beat, Revenues Miss Estimates
ZACKS· 2025-05-09 16:15
Core Viewpoint - Pacira BioSciences reported first-quarter 2025 adjusted earnings of 62 cents per share, exceeding the Zacks Consensus Estimate of 57 cents, while total revenues of $168.9 million fell short of the expected $175 million [1][2] Financial Performance - Adjusted earnings for Q1 2025 were 62 cents per share, consistent with the same quarter last year [1] - Total revenues reached $168.9 million, a 1% increase year over year, but missed the Zacks Consensus Estimate [1] - Exparel's net product sales were $136.5 million, up 3% from the previous year, but below the consensus estimate of $140.2 million [2][4] - Zilretta's net product sales were $23.3 million, down 10% year over year, missing both the consensus and model estimates [4] - Iovera's net product sales were $5.1 million, a 2% increase year over year, but below the consensus estimate of $5.5 million [5] Expenses - Research and development (R&D) expenses (excluding stock-based compensation) increased by 41% to $23.1 million due to higher product development and clinical study costs [6] - Selling, general and administrative (SG&A) expenses (excluding stock-based compensation) rose 19% to $76.2 million, driven by increased investments in commercial and marketing activities [7] Guidance and Projections - For 2025, Pacira BioSciences expects total revenues between $725 million and $765 million, with an adjusted gross margin projected between 76% and 78% [8] - Adjusted R&D expenses are anticipated to be between $90 million and $105 million, while adjusted SG&A expenses are expected to range from $290 million to $320 million [10] Recent Developments - The company announced the dosing of the first patient in a mid-stage study for pipeline candidate PCRX-201, aimed at treating osteoarthritis of the knee [11] - A settlement agreement with Fresenius and others regarding Exparel patents protects sales from generic competition until at least 2030 [12] - A U.S. District Court ruling eliminated the obligation to pay a low single-digit royalty on Exparel sales, expected to enhance profitability and revenue growth [13]