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]

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]

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].

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]

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]

Pacira (PCRX) came out with quarterly earnings of $0.62 per share, beating the Zacks Consensus Estimate of $0.57 per share. This compares to earnings of $0.62 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 8.77%. A quarter ago, it was expected that this specialty drugmaker would post earnings of $0.86 per share when it actually produced earnings of $0.91, delivering a surprise of 5.81%.Over the last four quarters, the company ...

Financial Data and Key Metrics Changes - First quarter EXPAREL sales increased to $136.5 million compared to $132.4 million in 2024, driven by volume growth [34] - First quarter non-GAAP gross margin improved to 81% from 72% year-over-year [35] - Adjusted EBITDA for the first quarter was $44.1 million [35] - The company has $494 million in cash and investments, indicating a strong balance sheet [37] Business Line Data and Key Metrics Changes - ZILRETTA sales declined to $23.3 million from $25.8 million in 2024, attributed to the transition to new sales forces [34] - Ioverao sales slightly increased to $5.1 million from $5 million in the first quarter of 2024 [34] - The transition to new sales teams for ZILRETTA and Ioverao is expected to stabilize and improve sales in the upcoming quarters [35] Market Data and Key Metrics Changes - First quarter average daily EXPAREL sales and volumes were up approximately 7% over 2024 after adjusting for two fewer selling days in 2025 [12] - There was a more than 30% increase in both new and reactivated EXPAREL accounts [12] - The company is seeing encouraging early indicators in the adoption of the "no pain" reimbursement pathway for outpatient surgical procedures [11] Company Strategy and Development Direction - The company introduced a "five by 30" strategy aimed at accelerating growth in its commercial business and advancing its innovative pipeline [6] - The settlement of patent litigation for EXPAREL extends exclusivity to 2039, providing a strong foundation for future growth [10] - The company is focusing on becoming a leader in musculoskeletal pain and exploring partnerships for its HCAD platform [32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early signs of growth and the potential for significant cash flow from EXPAREL [10][22] - The company anticipates a more meaningful uptick in sales in the second half of the year as awareness of the "no pain" initiative grows [40] - Management is closely monitoring potential tariff impacts but does not expect material effects on operations [40] Other Important Information - The company announced a $300 million stock repurchase program, reflecting confidence in its growth outlook [21] - The HCAD platform is expected to unlock new gene therapies for common diseases, aligning with the company's strategic objectives [32] Q&A Session Summary Question: What proportion of patients are covered by Medicare and how does "no pain" apply? - The company indicated that over 50% of inpatient procedures are commercially covered, while outpatient settings skew more towards Medicare [49] Question: What needs to be shown for wide adoption of PCRX201? - Management noted that providing a year or more of benefit compared to the current standard of care would be transformative [50] Question: What are the logistical challenges with "no pain" and how is education progressing? - The company is seeing significant growth in adoption in community hospitals and ambulatory surgery centers, with ongoing education efforts for larger institutions [57] Question: How will capital be allocated post-settlement with Fresenius? - The company plans to invest in its base business to capitalize on "no pain," advance its pipeline, and return capital to shareholders through the buyback program [64] Question: Are there any enhancements for EXPAREL to extend its lifecycle? - The company continues to innovate EXPAREL and has recently listed additional patents, but there are no new plans for additional indications [73] Question: What is the outlook on gross margins and pricing? - The elimination of RDF royalties is expected to improve gross margins, and pricing is anticipated to remain stable with GPO contracts coming online [86] Question: What is the current competitive landscape? - Management stated that there is no significant new competition, and there remains ample room for growth in market penetration [91]

Financial Data and Key Metrics Changes - In Q1 2025, EXPAREL sales increased to $136.5 million from $132.4 million in Q1 2024, driven by volume growth, with average daily sales and volumes up approximately 7% after adjusting for two fewer selling days in 2025 [34] - Non-GAAP gross margin improved to 81% in Q1 2025 compared to 72% in the previous year, benefiting from improved costs and efficiencies in manufacturing [35] - Adjusted EBITDA for Q1 2025 was $44.1 million, indicating strong operational performance [38] Business Line Data and Key Metrics Changes - ZILRETTA sales declined to $23.3 million in Q1 2025 from $25.8 million in Q1 2024, attributed to the transition to new sales forces [34] - Ioverao sales slightly increased to $5.1 million in Q1 2025 from $5.0 million in Q1 2024 [34] Market Data and Key Metrics Changes - The "no pain" reimbursement pathway is expected to cover 18 million outpatient surgical procedures, with approximately 6 million being CMS procedures now covered [12] - Early indicators show a more than 30% increase in both new and reactivated EXPAREL accounts, indicating growing market penetration [13] Company Strategy and Development Direction - The company introduced a "five by 30" strategy aimed at accelerating growth in its commercial business and advancing an innovative pipeline, including PCRX201 [6] - The settlement of patent litigation for EXPAREL extends exclusivity to 2039, providing a strong foundation for future growth [7][10] - The company is focusing on becoming a leader in musculoskeletal pain and exploring partnerships for its HCAD platform [32] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early positive trends in EXPAREL sales and the potential for significant cash flow generation [11] - The company anticipates a meaningful uptick in sales in the second half of the year as awareness of the "no pain" initiative grows [41] Other Important Information - A new stock repurchase program of $300 million was authorized, reflecting the company's commitment to shareholder value [22] - The company is closely monitoring potential tariff impacts but does not expect material effects on operations [42] Q&A Session Summary Question: Coverage of "no pain" for Medicare patients - The company indicated that over 50% of inpatient procedures are commercially covered, while outpatient settings skew more towards Medicare [50] Question: Adoption requirements for PCRX201 - Management noted that providing a year or more of benefit compared to the current standard of care would be transformative for adoption [51] Question: Logistical challenges with "no pain" - The company is seeing significant growth in community hospitals and ambulatory surgical centers, with expectations for larger institutions to follow [58] Question: Capital allocation priorities post-settlement - The company plans to invest in its base business to capitalize on "no pain" while also advancing its innovative pipeline and returning capital to shareholders [65] Question: Enhancements for EXPAREL - The company continues to innovate EXPAREL and has recently listed its eighteenth patent, indicating ongoing development [73] Question: Gross margins and RDF royalty elimination - The elimination of RDF royalties is expected to improve margins, but overall margins will also improve with increased product sales [78] Question: Pricing trends and GPO contracts - Pricing was mostly flat, with expectations for mid-single-digit impacts as GPO contracts come online [85] Question: Surgery volumes and competition - The company reported a nominal decline in surgical room hours in Q1, but does not see significant new competition impacting its market position [92]

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 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 ...