Core Insights - The biotech industry has shown strong performance in 2025 despite macroeconomic uncertainties, driven by new drug approvals and pipeline progress [1][2] - Mergers and acquisitions (M&A) have surged in 2025, with large companies expanding their portfolios through strategic collaborations and acquisitions [2][9] - Smaller biotech firms leveraging breakthrough technologies are gaining attention, contributing to overall sector momentum [2] Industry Overview - The Zacks Biomedical and Genetics industry includes biopharmaceutical and biotechnology companies that develop innovative drugs using advanced technologies [4] - The industry has outperformed both the Zacks Medical sector and the S&P 500, with a 22.1% gain over the last six months compared to 12.5% and 16.5% respectively [18] - The current valuation of the industry, based on the trailing 12-month price-to-sales ratio, is 2.47X, lower than the S&P 500's 5.96X and the Zacks Medical sector's 2.66X [19] Trends and Challenges - Key trends shaping the industry include a focus on innovation, the use of AI in drug discovery, and the rise of precision medicine [6][12] - Successful commercialization remains a challenge for smaller biotechs, often leading to collaborations with larger firms for shared sales or royalties [7] - Pipeline setbacks and potential tariffs pose risks, as developing drugs is costly and time-consuming, with many therapies taking years to gain approval [13][14] Notable Companies - Amicus Therapeutics has seen strong performance with its lead drug Galafold, which is approved for Fabry disease, and has settled patent litigation to fend off generic competition [21][22] - ANI Pharmaceuticals has a diversified focus on rare diseases and generics, with a notable 70% year-over-year sales increase for its ACTH-based injection [23][24] - Arcutis Biotherapeutics is focused on treating inflammatory skin diseases, with its lead product Zoryve performing well and expanding its label [25][26] - Tango Therapeutics is developing precision medicine for oncology, with promising data from its ongoing studies [27][28] - Pacira BioSciences is expanding its lead drug Exparel's label and has seen a 36.4% gain in shares over the past year [29][30]

The volatile biotech industry has put up a strong performance in 2025 despite the uncertain macroeconomic environment. While the tariff saga hit the pharma/biotech industry earlier in the year, the sector held up well, driven by solid momentum from new drug approvals and encouraging pipeline progress. Given the continuous need for innovative medical treatments (regardless of the state of the economy), the dynamic biotech industry will continue to capture investors’ interest going forward.2025 saw a surge in ...

Summary of Pacira BioSciences Conference Call Company Overview - **Company**: Pacira BioSciences (NasdaqGS:PCRX) - **Focus**: Musculoskeletal pain management - **Products**: - Exparel: Flagship nerve block product - Zilretta: Long-acting steroid for osteoarthritis - Iovera: Medical device using cryoneurolysis for pain relief - **Future Goals**: 5x30 initiative aiming for significant growth and development by 2030 [1][2] Financial Performance - **Revenue Projection**: Expected to be around $750 million for the year, with Exparel contributing over $500 million [4] - **EBITDA**: Anticipated to be around $200 million [4] - **Growth Drivers**: Exparel is the main growth driver, with ongoing investments in commercial medical market access [3][5] Exparel Growth Dynamics - **Reimbursement Catalyst**: Introduction of "no pain" reimbursement for Medicare patients, allowing separate reimbursement for Exparel [6] - **Volume Growth**: Year-over-year volume increases of 3%, 6%, and 9% in the first three quarters, respectively [7] - **Adoption Challenges**: Larger institutions are slower to adopt due to organizational complexities [12][13] Market Access and Sales Strategy - **GPO Contracts**: Over 80% of business contracted under Group Purchasing Organizations (GPOs) [10] - **Sales Force Structure**: Dedicated sales forces for Exparel, Zilretta, and Iovera to enhance focus and efficiency [17][18] - **Education Efforts**: Increased focus on educating payers and healthcare professionals about the benefits of Exparel [16] Pipeline and Future Products - **PCRX-201**: A gene therapy targeting osteoarthritis of the knee, with a completed Phase I program and a recently enrolled Phase 2A program [29][30] - **Market Potential**: Positioned as a gene therapy for the masses, with a focus on local administration and improved safety profiles [29][31] - **Phase 2 Program**: Aiming for transformative pain relief extending beyond the current standard of care [32] Manufacturing and Margins - **Manufacturing Improvements**: Transition to a 200-liter process has improved production reliability and reduced waste, leading to enhanced gross margins [26][27] - **Margin Guidance**: Expected to achieve at least a five-point margin improvement over five years [27] International Expansion - **Global Market Opportunities**: Plans to explore markets outside the U.S. without the need for additional clinical studies [24] Conclusion - **Outlook**: Anticipated continued growth driven by Exparel, Zilretta, and Iovera, alongside new product developments and strategic partnerships [21][23]

Core Viewpoint - DOMA Perpetual Capital Management LLC, a significant stockholder of Pacira BioSciences, Inc., is urging the Board to hire bankers and initiate a full sale process for the company due to perceived management underperformance and financial mismanagement [1][2][4]. Financial Performance and Management Concerns - Pacira's management has been criticized for excessive spending, with stock-based compensation projected to be approximately 6% of the company's market capitalization for 2025, exceeding the firm's entire operating income [2][6]. - Year-to-date sales of Zilretta have declined by 2% year over year through Q3, indicating poor business performance [3]. - Revenue growth has been modest at 3% year over year, while expenditures have surged, with R&D costs increasing by 36% and SG&A by 25% year over year [6]. Valuation and Sale Potential - A potential sale could yield a valuation of around $2.7 billion, translating to approximately $66 per share, which is three times the current stock price and represents a reasonable acquisition valuation [4][5]. - The cash flows from Pacira's assets, particularly Exparel, could exceed $10 billion through patent expiration, suggesting significant value under a larger owner [4]. Strategic Recommendations - The company should immediately pursue a sale process, with a target completion date before the end of Q1 2026 [7]. - Cost-cutting strategies must be implemented to enhance shareholder returns, and all new development programs should be put on hold until a sale is explored [12]. - Free cash flow should be prioritized for share buybacks, with a recommendation for a new $300 million buyback program following the completion of the current one [12]. Shareholder Relations and Governance - The Board's actions have been perceived as neglecting shareholder interests, with ongoing dilution of shareholder value through unapproved share issuances [10][11]. - DOMA has been in communication with the Board for over a year, advocating for a shareholder-friendly capital allocation framework, which has only recently begun to materialize [9].

Financial Data and Key Metrics Changes - Year-over-year revenues increased by 6%, driven by strong performance from Exparel and iovera [4] - Third-quarter Exparel sales rose to $139.9 million from $132.0 million in 2024, with a volume growth of 9% [21] - Non-GAAP gross margin improved to 82% from 78% year-over-year, benefiting from manufacturing efficiencies [22] - Adjusted EBITDA for the third quarter was $49.4 million [22] Business Line Data and Key Metrics Changes - Exparel demand saw a year-over-year volume increase of approximately 9%, marking the highest quarterly growth in over three years [4] - ZILRETTA sales increased to $29.0 million from $28.4 million in 2024 [21] - Iovera sales grew to $6.5 million from $5.7 million in 2024 [21] Market Data and Key Metrics Changes - Approximately 60 million commercial lives now have access to Exparel through separate reimbursement mechanisms, with a total covered population nearing 90 million across commercial and government payers [15] - Strong adoption of Exparel in ambulatory surgery centers, with volumes up more than 25% year-over-year [19] Company Strategy and Development Direction - The company is focused on its 5x30 growth strategy, which aims for a five-year double-digit compound annual growth rate (CAGR) for revenue [14] - The in-licensing of AMT 143 aligns with the company's strategy to expand its clinical pipeline and enhance its product offerings [5] - The company is prioritizing complementary mid to late-stage opportunities in its pipeline, particularly in musculoskeletal pain [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Exparel, anticipating that volume growth will converge with revenue growth over time [21] - The company expects to see significant earnings driven by improving sales and enhanced gross margins [25] - Management remains optimistic about the potential of PCRX 201 to revolutionize osteoarthritis treatment [8] Other Important Information - The company executed an additional $50 million in share repurchases during the third quarter [23] - The company has a strong balance sheet with cash and investments of approximately $246 million [23] Q&A Session Summary Question: Impact of GPO on volume growth and selling days - Management noted strong uptake from the GPO signed in June, which contributed to volume growth [30] - There was no significant impact from the number of selling days in the quarter [33] Question: Rationale behind AMT 143 program and trial design - The company sees a market need for a product with longer durability and ease of use, complementary to Exparel [35] - IP protection for AMT 143 extends to 2042, with plans to expand upon that [38] Question: Awareness of Exparel in larger hospitals and market growth for elective procedures - Growth has been faster in smaller hospitals and ASCs, with larger institutions taking more time due to more decision-makers [43] - Modest improvements in elective procedures were noted in the third quarter, with expectations for more in the fourth quarter [49] Question: Early indicators for ZORVOLTA and gross margin expectations - The dedicated ZORVOLTA sales force is expected to drive momentum in the fourth quarter and significant progress in 2026 [52] - Gross margins are expected to improve next year, with a long-term goal of a 5% improvement over 2024 levels [56]

Core Viewpoint - A lawsuit is pending against Pacira BioSciences, Inc. for alleged violations of securities laws related to misleading statements about patent protections for its product 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 Pacira BioSciences, Inc. shares prior to August 2023 and continue to hold them are encouraged to contact the Shareholders Foundation for options related to the lawsuit [1][3].

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].

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].

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]

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]