Bio-Techne Conference Call Summary Company Overview - **Company**: Bio-Techne (NasdaqGS: TECH) - **Date**: November 10, 2025 - **Key Speakers**: Kim Kelderman, Jim Hippel, Dave Clair Key Points Financial Performance - **Organic Growth**: The company reported a negative 1% organic growth in the top line, primarily due to a $7 million impact from larger orders in GMP proteins not repeating year over year [3][10] - **EBITDA Margins**: The EBITDA margin stood at 29.9%, indicating strong operational performance despite headwinds [6] Market Dynamics - **Pharmaceutical Market**: Continued to show double-digit growth, with positive trends in funding and deal activity [4] - **Academic Market**: Flat performance, but core business showed strength [4] - **Regional Performance**: - **Europe**: Mid-single digit growth as expected [4] - **U.S.**: Negative low single digits, but showing improvement [4] - **China**: Two consecutive quarters of growth, indicating a positive trend [4] Business Segments - **Core Business**: Flat performance, recovering from previous quarters [5] - **Growth Verticals**: - **Gene Therapy**: Added numerous customers in cell therapy [5] - **Protein Analytics**: Mid-single digit growth [5] - **Molecular Diagnostics**: Mid-single digit growth, with a significant 34% growth in the same quarter last year [5] GMP Proteins - **Customer Concentration**: Two major customers accounted for a significant portion of GMP protein revenue, with a $12 million headwind expected in the next quarter [16] - **Market Conditions**: The biotech market showed improvement, moving from negative 30% to negative 19% [11] Product Innovations - **New Product Introductions**: Strong pipeline of new products across various lines, including ELA and Western Blot instruments, expected to drive future growth [32][33] - **Organoid Market**: The organoid business is projected to grow significantly, with a current estimated revenue of $50 million and a CAGR of 20% [51][52] Future Outlook - **Growth Projections**: The company anticipates low single-digit growth for the year, with expectations for improvement in the second half due to easing headwinds and market stabilization [55][59] - **China Market**: Optimism about sustained growth in China, with a focus on gradual recovery [60][61] Margin Expansion Opportunities - **Divestitures**: The divestiture of Exosome and exiting low-margin businesses like fetal bovine serum are expected to enhance margins [62] - **Operational Efficiency**: Ongoing efforts to optimize manufacturing and improve collaboration across business units are anticipated to drive margin improvements [63][64] Conclusion - Bio-Techne is navigating a challenging market environment with a focus on innovation, customer acquisition, and operational efficiency. The company is optimistic about future growth, particularly in the organoid and cell therapy markets, while managing the impacts of customer concentration and market fluctuations.

Core Insights - ProKidney Corp. presented full results from the Phase 2 REGEN-007 trial, demonstrating the potential of rilparencel to preserve kidney function in patients with advanced chronic kidney disease (CKD) and diabetes [1][2][3] Phase 2 REGEN-007 Overview - The REGEN-007 trial was a multi-center, open-label, randomized study involving two treatment groups, focusing on different dosing regimens of rilparencel [4] - Group 1 followed the dosing schedule of the ongoing Phase 3 PROACT 1 study, while Group 2 tested an exploratory regimen based on disease progression triggers [4] - A total of 87 rilparencel injections were administered to 49 participants, with follow-ups extending up to 18 months post-injection [4] Efficacy and Safety Findings - Rilparencel treatment resulted in a statistically significant 4.6 mL/min/1.73m² (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 [6][7] - Among Group 1 patients, 63% met key Phase 3 PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² (85%) improvement observed in this subgroup [7] - Group 2 showed a 1.7 mL/min/1.73m² (50%) improvement in eGFR slope, although this was not statistically significant [8] - No serious adverse events related to rilparencel were reported, and the safety profile was consistent with previous studies [6][14] Phase 3 PROACT 1 Program Update - The Phase 3 PROACT 1 trial aims to further assess rilparencel's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes [9] - The FDA confirmed that eGFR slope is an acceptable surrogate endpoint for the study, supporting both accelerated and confirmatory approval pathways for rilparencel [9] - More than half of the required 360 patients for the accelerated approval analysis had been enrolled as of August 2025, with topline results expected in Q2 2027 [9] About Chronic Kidney Disease - CKD is a progressive condition affecting approximately 37 million adults in the U.S., with diabetes being the leading cause [11] - ProKidney is targeting patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S. [11] - There is a significant unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in advanced CKD patients [11] About ProKidney Corp. - ProKidney is a pioneer in cell therapy for CKD, with rilparencel being a first-in-class autologous cellular therapy currently in Phase 3 trials [12] - The company was founded in 2015 and has a decade of research backing its innovative treatment approach [12]

Core Insights - NewcelX Ltd. has announced the appointment of Professor Tamir Ben-Hur to its Scientific Advisory Board, enhancing its expertise in neuroimmunology and regenerative medicine [1][2][3] - The company aims to combine cell therapy with central nervous system drug innovation to advance treatments for neurodegenerative diseases such as ALS and Type 1 Diabetes [3][4] Company Overview - NewcelX Ltd. is a biotechnology company focused on developing transformative cell-based and small-molecule therapies for neurodegenerative and metabolic diseases [4] - The company is headquartered in Zurich, Switzerland, with research and development operations in Ness Ziona, Israel [4] Strategic Developments - The merger between Kadimastem Ltd. and NLS Pharmaceutics Ltd. is expected to strengthen NewcelX's scientific foundation and enhance its capabilities in delivering breakthrough therapies [3] - Professor Ben-Hur's involvement is seen as a strong endorsement of the company's mission and scientific approach [3]

Core Insights - Gilead Sciences, Inc. (GILD) reported a 3% year-over-year growth in total revenues for Q3 2025, driven by higher royalty, contract, and other revenues, alongside strong product sales from its HIV franchise and liver disease drug Livdelzi [1][10] Revenue Breakdown - Total revenues include product sales and royalty, contract, and other revenues [1] - Excluding Veklury, product sales increased by 4% to $7.1 billion [2] HIV Franchise Performance - Gilead's HIV franchise remains strong, with flagship therapies Biktarvy and Descovy contributing significantly to revenue growth [3] - Biktarvy sales rose 6% year-over-year to $3.7 billion, capturing over 52% of the U.S. treatment market [4] - Descovy sales increased by 20% year-over-year to $701 million, with approximately 75% of sales for HIV prevention [6] - Newly approved Yeztugo generated $39 million in sales, achieving a 75% coverage goal ahead of schedule [7] - Gilead anticipates approximately 5% HIV revenue growth in 2025, despite challenges from Medicare Part D redesign [7] Liver Disease Portfolio - Sales from the liver disease portfolio increased by 12% to $819 million, primarily due to demand for Livdelzi [9] - Livdelzi surpassed $100 million in quarterly sales for the first time and is now the first-line treatment for second-line PBC in the U.S. [10][11] Cell Therapy Franchise - Sales from the Cell Therapy franchise decreased by 11% to $432 million, missing consensus estimates [12] - Yescarta sales fell by 10% to $349 million, while Tecartus sales decreased by 15% to $83 million due to lower demand [12] Overall Performance and Market Position - Despite declines in Veklury and Cell Therapy sales, the strong performance of the HIV franchise and Livdelzi supports future growth [10][14] - Gilead's shares have surged 32.2% year-to-date, outperforming the industry growth of 12.1% [14]

Core Insights - Gilead Sciences Inc reported adjusted earnings of $2.47 per share, surpassing the consensus estimate of $2.13 [1] - The company achieved revenues of $7.77 billion, exceeding the consensus of $7.45 billion, despite a 2% decline in product sales to $7.3 billion [2] Financial Performance - HIV product sales increased by 4% to $5.3 billion, while liver disease portfolio sales rose by 12% to $819 million [3] - Biktarvy sales grew by 6% to $3.7 billion, and Descovy revenues surged by 20% to $701 million [3] Guidance and Outlook - Gilead raised its fiscal 2025 adjusted earnings guidance from $7.95-$8.25 per share to $8.05-$8.25, compared to the consensus of $8.03 [4] - The sales guidance was also increased from $28.3 billion-$28.7 billion to $28.4 billion-$28.7 billion, exceeding the consensus of $28.84 billion [4] Analyst Ratings - Needham reiterated its Buy rating for Gilead with a price forecast of $133, highlighting upcoming catalysts related to HIV treatment and cell therapy [5] - Cantor Fitzgerald maintained an Overweight rating with a price forecast of $135, while RBC Capital raised its price forecast from $100 to $105 [6] Market Performance - Gilead Sciences shares were up 0.29% at $118.78 at the time of publication [6]

Financial Data and Key Metrics Changes - Total company sales for Q3 2025 were approximately $12.2 billion, reflecting strong demand across the business, with a year-over-year increase of 17% [17][6] - Gross margin was approximately 73%, primarily due to product mix, while operating expenses decreased by approximately $100 million to roughly $4.2 billion compared to the same period last year [22][23] - Overall diluted earnings per share was $1.63, including net charges of approximately $530 million, or $0.20 per share, attributed to acquired in-process R&D and licensing income [22][24] Business Line Data and Key Metrics Changes - The oncology portfolio saw OPDIVO global sales of approximately $2.5 billion, up 6%, driven by demand in various indications [17][18] - REBLOZYL global sales were $615 million, reflecting a 38% increase in the U.S. and a 31% increase outside the U.S. [19] - CAMZYOS global sales increased 88% to $296 million, while Eliquis global sales reached $3.7 billion, growing 23% [20][21] Market Data and Key Metrics Changes - Global sales of the growth portfolio increased 17%, driven by multiple brands including the IO portfolio, REBLOZYL, CAMZYOS, and BREYANZI [6][17] - Sales of COBENFY were $43 million in the quarter, with a year-to-date total of $105 million, indicating steady growth [21][22] Company Strategy and Development Direction - The company is focused on long-term sustainable growth, with plans to introduce 10 new medicines to the market by the end of the decade [14] - Recent acquisitions, such as Orbital Therapeutics, aim to strengthen the cell therapy franchise and enhance the company's capabilities in RNA technology [10][11] - The company is integrating digital technology and AI to drive efficiencies and enhance organizational agility [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth portfolio's performance and the ability to navigate through the upcoming challenges, emphasizing financial discipline and strategic investments [66][67] - The company anticipates a data-rich period ahead, with multiple pivotal readouts expected in the next 12-24 months [13][14] Other Important Information - The company is maintaining its full-year revenue guidance, increasing it by $750 million at the midpoint to a range of $47.5 billion-$48 billion [24] - The effective tax rate for the quarter was 22.3%, reflecting the earnings mix [22] Q&A Session Summary Question: Updates on ADEPT program and confidence in studies - Management reiterated confidence in the ADEPT program, with results expected by the end of the year, and emphasized the importance of execution across the company [31][32] Question: Commercialization of COBENFY and prescriber engagement - The company is pleased with COBENFY's progress, noting positive physician feedback and a significant number of new trialists being added weekly [40][41] Question: Competitive landscape for PD-1/VEGF bispecifics - Management expressed confidence in the partnership with BioNTech and the potential of pomitomig to become a new standard of care [49][51] Question: Barriers to adoption for COBENFY - Management acknowledged the entrenched market dynamics and emphasized ongoing efforts to educate prescribers and increase adoption [56][58] Question: Cost management and strategic productivity initiatives - The company is on track for $1 billion in cost savings this year and has clear visibility on achieving $2 billion by 2027 [66][67]

Financial Data and Key Metrics Changes - Total company sales for Q3 2025 were approximately $12.2 billion, reflecting strong demand across the business, with a 17% year-over-year increase in the growth portfolio [15][4] - Gross margin was approximately 73%, primarily due to product mix, and operating expenses decreased by approximately $100 million to roughly $4.2 billion compared to the same period last year [19][20] - The company generated cash flow from operations of about $6.3 billion in Q3, with nearly $17 billion in cash, cash equivalents, and marketable securities as of September 30 [20][21] Business Line Data and Key Metrics Changes - The oncology portfolio saw Opdivo global sales of approximately $2.5 billion, up 6%, driven by demand in various indications [15][16] - Reblozyl global sales were $615 million, reflecting a 38% increase in the U.S. and a 31% increase outside the U.S. [17] - Breyanzi sales grew 58% globally to $359 million, with U.S. sales up 45% [17] - Camzyos global sales increased 88% to $296 million, while Eliquis global sales were $3.7 billion, growing 23% [18] Market Data and Key Metrics Changes - The U.S. market saw strong growth in multiple brands, with Opdivo and Qvantig both contributing positively to sales [15][16] - Outside the U.S., sales growth was driven by demand in newly launched markets, particularly for Reblozyl and Breyanzi [17] Company Strategy and Development Direction - The company is focused on long-term sustainable growth, with a strategy to enhance and sustain growth through a robust pipeline and business development activities [4][12] - Recent acquisitions, such as Orbital Therapeutics, aim to strengthen the cell therapy franchise and expand the company's capabilities in RNA technology [9][10] - The company anticipates introducing 10 new medicines to the market by the end of the decade, alongside 30 significant life cycle management opportunities [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate through the current operating environment, emphasizing strong execution and financial discipline [14][22] - The company is optimistic about the potential of its pipeline, particularly in addressing unmet medical needs in various therapeutic areas [8][12] Other Important Information - The company is maintaining its full-year revenue guidance, increasing it by $750 million to a range of $47.5 billion to $48 billion, while expecting a decline in the legacy portfolio [22][23] - The effective tax rate for the quarter was 22.3%, and diluted earnings per share were reported at $1.63 [19][20] Q&A Session Summary Question: Updates on clinical site reviews and ADEPT program confidence - Management reiterated confidence in the Cabenfi development program, with ongoing studies and positive external data supporting their outlook [36][37] Question: Commercial characterization of Cabenfi's reimbursement speed - The company is pleased with Cabenfi's progress, noting strong physician feedback and access, while acknowledging the need for continued education and expansion of prescribing [51][52] Question: Competitive landscape for PD-1/VEGF bispecifics - Management expressed confidence in the partnership with BioNTech and the potential of pomitomig to become a new standard of care, with ongoing trials across multiple indications [66][67] Question: Barriers to adoption for Cabenfi - Feedback from physicians has been positive, with ongoing efforts to educate on switching from D2 blockers to Cabenfi, and the company is tracking ahead of recently launched D2s in schizophrenia [72][75] Question: Cost management and strategic productivity initiatives - The company is on track for $1 billion in cost savings this year, with a clear line of sight to $2 billion by 2027, while balancing investments in growth and maintaining financial discipline [86][87]

Core Insights - Kyverna Therapeutics announced positive interim data from the Phase 2 portion of the KYSA-6 clinical trial for KYV-101 in generalized myasthenia gravis (gMG), achieving 100% clinically meaningful responses in primary endpoints [1][2][5] - The results indicate that KYV-101 can provide rapid and durable symptom improvement with a single dose, potentially leading to drug-free, disease-free remission [2][5][10] Efficacy - 100% of patients (6 out of 6) achieved clinically meaningful reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, with mean reductions of -8.0 points and -7.7 points at 24 weeks, respectively [6][12] - Deep responses were observed as early as two weeks post-treatment, indicating rapid efficacy [6][12] Safety - KYV-101 was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) reported [12] - One patient experienced a serious adverse event of Grade 4 neutropenia, which improved with standard supportive care [12] Clinical Trial Design - The Phase 2 portion of the KYSA-6 trial is a single-arm, open-label, multicenter study focusing on the efficacy and safety of KYV-101 in gMG [3][8] - The trial was amended to a registrational Phase 2/3 study following discussions with the FDA [8] Future Plans - The company plans to initiate enrollment for the Phase 3 portion of the trial by the end of the year and will share updated data from the Phase 2 portion next year [5][12] - Kyverna aims to establish a first-in-class neuroimmunology franchise and expand growth opportunities across multiple autoimmune indications [2][13]

Core Insights - FibroBiologics, Inc. is a clinical-stage biotechnology company focused on developing therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials [1][3] - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [3] Company Presentation - The CEO, Pete O'Heeron, will present at the Bio-Europe 2025 conference from November 3-5, 2025, in Vienna, Austria [1] - FibroBiologics is scheduled to deliver a company presentation on November 4 at 4:15 p.m. CET and will be available for one-on-one investor meetings during the event [2] Company Overview - FibroBiologics is based in Houston and represents the next generation of medical advancement in cell therapy and tissue regeneration [3] - The company is actively developing a pipeline of treatments aimed at chronic diseases, leveraging its extensive patent portfolio [3]

Core Viewpoint - Biotechnology firm Galapagos will cease its cell therapy business after unsuccessful attempts to sell it, resulting in the loss of 365 jobs across Europe, China, and the U.S. [1] Company Summary - Galapagos is winding down its cell therapy operations due to failed sale efforts [1] - The decision will impact 365 employees in multiple regions, including Europe, China, and the U.S. [1] Industry Summary - The biotechnology sector is facing challenges, as evidenced by Galapagos' decision to exit a segment of its business [1]