Charles River Laboratories (NYSE:CRL) Q4 2025 Earnings call February 18, 2026 08:30 AM ET Company ParticipantsBirgit Girshick - EVP and COOCasey Woodring - VP, Equity ResearchDave Windley - Managing DirectorElizabeth Anderson - Senior Managing DirectorEric Coldwell - Managing DirectorJames Foster - Chair, President and CEOLuke Sergott - Director - Healthcare Equity ResearchMichael Knell - VP and Chief Financial OfficerMichael Ryskin - Managing DirectorTodd Spencer - VP of Investor RelationsConference Call P ...

Market Overview - The government shutdown began on October 1, 2025, after Congress failed to reach a consensus, yet the stock market remains optimistic with a positive start for October [1] - The S&P 500 index increased by 0.34%, reaching a 52-week high, while the Dow Jones Industrial Average rose by 0.1%, the Nasdaq Composite by 0.42%, and the Russell 2000 by 0.4% [7] Treasury Yield and Economic Impact - The 10-year Treasury yield experienced a slight dip of 0.033% following the government shutdown, with potential long-term impacts on the market if the shutdown persists [2] - Jobs data from the Department of Labor is delayed due to the shutdown, which could affect market sentiment [2] Company Performances - Nike's stock rose by 6.4% after its Q1 2026 earnings report exceeded expectations, closing at $74.20, although it is down 2.37% year-to-date [4][10] - Eli Lilly's stock increased by 8.2% due to optimism surrounding a deal with Pfizer for cheaper medicines [4] - Reddit's stock declined by 11.9% amid competition from ChatGPT [4] Notable Stock Movements - The top five S&P 500 stocks with significant gains include AES Corp (+16.8%), Biogen Inc (+10.1%), Thermo Fisher (+9.4%), Super Micro Computer (+9.3%), and Charles River Laboratories (+8.9%) [8] - Other notable stocks include Corteva Inc (-9.1%), News Corp Class B (-6%), and Pfizer (-6.8%) [12]

Financial Data and Key Metrics Changes - The company reported revenue of $1,030 million in Q2 2025, a 0.6% increase year over year, with nearly half of the revenue outperformance driven by foreign exchange [9][10] - Organic revenue declined by 0.5%, primarily due to a low single-digit decline in the DSA segment, partially offset by low single-digit increases in RMS and manufacturing segments [10][12] - The operating margin improved to 22.1%, an increase of 80 basis points year over year, reflecting cost savings from restructuring and better sales volume [10][11] Business Line Data and Key Metrics Changes - DSA segment revenue was $618 million, a 2.4% decrease year over year on an organic basis, driven by lower revenue for discovery services [13] - RMS revenue increased by 2.3% on an organic basis to $213.3 million, primarily driven by the timing of NHP shipments and higher revenue for research model services [21][22] - Manufacturing segment revenue was $200.8 million, a 2.9% increase on an organic basis, driven by growth in microbial solutions [25][26] Market Data and Key Metrics Changes - Revenue for small and mid-sized biotech clients improved slightly for the third consecutive quarter, while revenue for global biopharmaceutical clients remained below last year's level but improved sequentially [10][21] - The demand environment for global biopharmaceutical clients appears to be stabilizing, with proposal activity increasing both year over year and sequentially [15][50] - The academic and government client segments saw revenue increases despite potential NIH budget cuts, with only a minor impact observed [22] Company Strategy and Development Direction - The company is focused on expanding its NAMS portfolio and enhancing scientific capabilities to support biopharmaceutical companies in transitioning to alternative technologies [19][20] - A strategic review is underway to evaluate avenues for value creation, including portfolio and capital allocation strategies [28][29] - The company aims to generate over $175 million in cost savings this year, contributing to improved financial performance [11][44] Management's Comments on Operating Environment and Future Outlook - Management noted that the global biopharmaceutical demand trends appear to have bottomed and are beginning to slowly move upward [7] - The company raised its revenue and non-GAAP earnings per share guidance due to outperformance in Q2, reflecting a more favorable demand environment [12][33] - There is recognition of ongoing uncertainty in the healthcare landscape, but management remains optimistic about stabilization in demand [8][9] Other Important Information - The company experienced a slight decline in DSA backlog to $1.93 billion, with gross and net bookings improving at mid-single-digit rates year over year [14] - The non-GAAP tax rate increased to 22.7%, primarily due to stock-based compensation, but was more favorable than expected [40][41] - Free cash flow for Q2 was strong at $169.3 million, driven by higher earnings and improved working capital [42][43] Q&A Session Summary Question: Current demand environment and pharma's perspective - Management indicated that the demand situation is stabilizing for pharma, with some demand trends having bottomed [48] - Revenue and proposals are up, but cancellations have also increased, particularly for longer-term post-IND work [49][50] Question: Clarification on revenue guidance and book-to-bill ratio - Management stated that the current book-to-bill ratio is expected to remain in the range of 0.8 to 0.93, which does not require improvement to meet guidance [55] Question: CDMO performance and revenue impact - The CDMO revenue headwind is expected to be around $20 million due to the wind-down of a client relationship, with higher margins noted in the first half [62][63] Question: Backlog conversion and revenue support - Management believes the backlog is stable and robust, allowing for continued drawing from it to replace studies that slip or cancel [72][74] Question: Hiring confidence and future growth - Management expressed confidence in hiring to meet current demand, with improvements in the overall demand curve expected to support future growth [78][79] Question: Pricing stability and margin implications - Pricing in DSA remains stable, with mix favorability contributing positively to margins [82][84] Question: Cancellations in longer-term work - Cancellations are not expected to significantly impact margins, as the margin profile for different types of work is often comparable [86]

Summary of Key Points from the Conference Call Industry Overview - The conference call discusses the **global and Chinese laboratory animal market**, highlighting a pre-pandemic growth rate of **5%-7%** globally, with China reaching **15%-20%**. Post-pandemic, China's growth has slowed to **5%-7%** primarily due to price increases, not volume changes. The domestic market size is approximately **40 billion RMB**, with ancillary services generating around **20 billion RMB** in revenue [1][2]. Core Insights and Arguments - **Price Increases**: The rise in laboratory animal prices is attributed to multiple factors, including increasing labor, feed, energy costs, and testing fees [4]. - **Market Dynamics**: If internal demand from pharmaceutical companies is included, the overall market space would significantly expand, although specific data is currently unavailable [5]. - **Outsourcing Trends**: Pharmaceutical companies are reducing outsourcing to cut costs but are increasingly adopting one-stop services to enhance R&D efficiency. Many firms are opting for phased outsourcing, keeping early research in-house while outsourcing evaluation stages to ensure objectivity [6]. - **Market Leaders**: In the U.S., key players include **Jackson Laboratory**, **Charles River Laboratories**, and **Taconic Biosciences**, each with distinct market strategies and growth trajectories [7][8]. - **Regulatory Impact**: New U.S. policies from **FDA** and **NIH** limiting animal use may lead to a contraction in the U.S. market, shifting focus towards cell or organoid projects [10]. Additional Important Content - **European Market**: The European laboratory animal industry is fragmented, with strict animal welfare regulations leading to a shift towards cell-based alternatives [9]. - **Gene Editing Technologies**: The conference highlights the dominance of **CRISPR/Cas9** technology in gene editing, with companies like **百奥** and **博** leading in humanized antibody mouse technology [3][14]. - **Market Trends**: Demand for laboratory animals is increasing from pharmaceutical companies, with a **10%** year-on-year sales growth noted, particularly for specific strains like **C57** and **SD rats** [21]. - **CRO Challenges**: The decline in orders from Contract Research Organizations (CROs) is linked to U.S. government restrictions on using Chinese CROs, leading to a shift in orders to South Korea and Japan [22]. - **Future Directions**: The laboratory animal industry is expected to consolidate, with smaller companies potentially being acquired by larger firms, emphasizing the importance of scale in reducing costs [28][29]. - **Emerging Research Areas**: While tumor immunology has been a focus, research into metabolic diseases is gaining traction, indicating a shift in research priorities [30]. Conclusion The laboratory animal market is experiencing significant changes driven by regulatory shifts, cost pressures, and evolving research needs. The consolidation trend suggests that larger firms will dominate, while emerging areas of research may redefine market dynamics in the coming years.

Core Viewpoint - FibroBiologics, Inc. is advancing its clinical programs, particularly focusing on the upcoming Phase 1/2 clinical trial for its fibroblast-based spheroids product candidate, CYWC628, aimed at treating diabetic foot ulcers, with plans to initiate in Q2 2025 [1][5]. Financial Highlights - As of December 31, 2024, the company reported cash and cash equivalents of approximately $14.0 million [1][10]. - For the year ended December 31, 2024, research and development expenses were approximately $4.5 million, an increase from approximately $2.4 million in 2023, primarily due to increased drug product expenses and hiring additional personnel [10]. - General and administrative expenses rose to approximately $9.2 million for the year ended December 31, 2024, compared to approximately $6.5 million in 2023, mainly due to costs associated with operating as a public company [10]. - The net loss for the year ended December 31, 2024, was approximately $11.2 million, a decrease from a net loss of approximately $16.5 million in 2023, attributed to changes in the fair value of the warrant liability [10]. Corporate Developments - The company established a master services agreement with Charles River Laboratories for the development and manufacture of its therapeutic master cell bank and CYWC628 [4]. - FibroBiologics engaged Southern Star Research for clinical research organization services in Australia for the planned Phase 1/2 clinical trial [4]. - The company expanded its patent portfolio, including a patent from the European Patent Office for cancer treatment methods using modified fibroblasts [4]. Upcoming Milestones - The initiation of the Phase 1/2 clinical trial in Australia for CYWC628 is planned for the second quarter of 2025, with completion expected by the end of 2025 [9]. - The company aims to complete pre-clinical IND-enabling studies for the treatment of psoriasis with CYPS317 by the end of 2025 [9]. Research and Development Focus - FibroBiologics is also pursuing early-stage research in human longevity, focusing on the recovery of thymic functionality using transplanted artificial thymic organoids [4]. - The discovery phase project CYPS317 has been moved to the product candidate pipeline for psoriasis treatment [4]. Strategic Financing - The company entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN LTD., allowing it to sell up to $25.0 million in common stock over two years, with an initial advance of $10.0 million received in December 2024 [4].

Core Insights - The global biologics contract manufacturing market is projected to grow from USD 22.2 billion in the current year to USD 58 billion by 2035, with a CAGR of 9.12% during the forecast period [3] - Increasing reliance on contract manufacturers for end-to-end solutions is driving the growth of the biologics contract manufacturing market [8] Market Segmentation - The market is segmented by type of service, with the majority captured by Active Pharmaceutical Ingredients (APIs) due to significant capital investments required for their production [9] - Cell therapies are identified as the fastest-growing segment within the biologics contract manufacturing market [10] - The mammalian expression system is expected to dominate the market due to its high protein yield and improved product consistency [11] - Commercial scale manufacturing is projected to be the primary driver of the market, although preclinical/clinical scale is expected to grow at a higher CAGR [12] - Large and very large companies hold the maximum market share, but small companies are anticipated to experience substantial growth [13] - North America currently accounts for the largest share of the market, with Asia-Pacific expected to grow at a higher CAGR in the coming years [14] Industry Trends - Over 305 contract manufacturing organizations (CMOs) are engaged in biologics production, with over 90% providing finished dosage form (FDF) manufacturing services [15] - The biopharmaceutical contract manufacturing industry has seen a shift towards developing regions in Asia-Pacific for manufacturing facilities [17] - More than 695 deals have been made by biologics CMOs in the past five years, primarily for vaccines, antibodies, and cell therapies [17] - Significant investments amounting to USD 7.5 billion have been made by investors in the biologics contract manufacturing sector over the past eight years [17] - The existing installed capacity is sufficient to meet current demand, but incremental capacity investments are anticipated to meet long-term demand [17]

Core Insights - FibroBiologics has completed its proprietary master cell bank for the CYWC628 drug product, which will support upcoming clinical trials for diabetic foot ulcers [1][3][4] - The master cell bank was manufactured in compliance with FDA Good Manufacturing Practices (cGMP) and has passed all required safety testing [1][3] - The CYWC628 therapy targets diabetic foot ulcers, a condition affecting millions globally, and aims to provide effective long-term treatment solutions [3][4] Company Overview - FibroBiologics is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, holding over 160 patents [2][8] - The company is exploring treatments for various conditions, including wound healing, multiple sclerosis, degenerative disc disease, psoriasis, human longevity, and cancer [2][8] Collaboration and Manufacturing - Charles River Laboratories will manufacture the CYWC628 cell banks and drug product at its state-of-the-art cGMP facilities, facilitating the upcoming phase I/II clinical trial [3][4] - The partnership between FibroBiologics and Charles River aims to expedite the development of advanced therapies and ensure readiness for scaling the CYWC628 product [4]