Core Insights - Bio-Techne Corporation's Simple Western™ Technology was instrumental in the FDA approval of ZEVASKYN™, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) developed by Abeona Therapeutics [1][5] - ZEVASKYN addresses a significant unmet medical need for RDEB patients, who previously had no durable therapies available [3][8] Company Overview - Bio-Techne Corporation is a global life sciences company that generated approximately $1.2 billion in net sales in fiscal 2024 and employs around 3,100 people worldwide [6] - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, with ZEVASKYN being its flagship product [8] Technology and Methodology - Simple Western was chosen by Abeona for its speed, reproducibility, sensitivity at picogram levels, and minimal sample volume requirements, effectively detecting both trimeric and monomeric forms of Collagen VII [2][4] - The platform provided GMP-compliant data to ensure consistency across ZEVASKYN product lots, overcoming challenges in analytical standardization and complex assay development [4] Clinical Significance - RDEB is a rare genetic skin disorder caused by mutations in the COL7A1 gene, leading to severe symptoms and increased risk of life-threatening complications [3] - The approval of ZEVASKYN marks a significant milestone in the field of cell-based gene therapy, providing a new treatment option for RDEB patients [5]

Company Overview - Bio-Techne Corp. (TECH) has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards alongside its analytical solutions, including the Maurice system, to support global monoclonal antibody and gene therapy development [1][8] - The company has a market capitalization of $8.13 billion and an earnings yield of 3.6%, which is significantly better than the industry's -28.4% yield [4] Recent Developments - The partnership with USP is seen as a significant milestone in advancing Bio-Techne's efforts to provide innovative tools and solutions to the scientific community [2] - Bio-Techne's tools enable efficient and integrated analysis of complex biologics from development to product release, addressing analytical challenges in mAb and gene therapy development [8][6] Market Context - The global monoclonal antibody therapeutics market was valued at $222.6 billion in 2023 and is expected to grow at a compound annual growth rate of 14.5% through 2029, driven by advancements in biotechnology and genetic engineering [10] - The need for consistent mAb quality is increasing as patent protections expire and biosimilar versions become available, necessitating thorough testing of critical quality attributes throughout the development and manufacturing processes [5] Stock Performance - Following the announcement of the partnership, Bio-Techne shares dipped 0.1%, closing at $51.84, but the collaboration is expected to positively influence market sentiment towards TECH stock [3] - Over the past three months, TECH shares have declined 11.6%, while the industry has seen a smaller decline of 2.7% [12]

Core Insights - Bio-Techne Corporation has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, enhancing support for mAb and gene therapy development globally [1] - The need for consistent mAb quality is increasingly critical as patent protections expire and biosimilars emerge, necessitating rigorous testing of quality attributes during development and manufacturing [2] - Gene therapy, utilizing recombinant AAV, is rapidly growing but faces challenges such as low yields and high costs; USP reference standards provide benchmarks for analytical testing to ensure product quality [3] - USP mAbs and AAV reference standards can be used with Bio-Techne's analytical instruments, facilitating reliable characterization of complex biologics throughout the development process [4] - The collaboration between Bio-Techne and USP aims to address quality challenges in biotherapeutics, ensuring safety and efficacy for patient care [5] Company Overview - Bio-Techne Corporation is a global life sciences company that provides innovative tools and bioactive reagents for research and clinical diagnostics, generating approximately $1.2 billion in net sales in fiscal 2024 [6]

Summary of Bio Techne Conference Call Company Overview - **Company**: Bio Techne - **Analyst**: Matt Sykes, Goldman Sachs - **CFO**: Jim Hipple - **Head of IR**: David Claire Key Highlights from Fiscal Q3 Results - **Overall Growth**: Achieved 6% organic growth in Q3 despite macroeconomic headwinds [5][6] - **Protein Sciences Segment**: Notable 7% growth, driven by widespread demand across core reagents and instrument platforms [5][6] - **Large Pharma Market**: Contributed significantly to growth, accounting for 30% of total revenue, with double-digit growth observed [6][7] U.S. Academic Market Insights - **Revenue Contribution**: U.S. academic customers represent approximately 12% of total revenue [12] - **Market Volatility**: Academic market has been volatile due to budget cuts and NIH funding fluctuations, but core reagents remain stable [10][11] - **International Exposure**: Academic markets outside the U.S., particularly in Europe, have shown robust growth, helping to stabilize overall academic revenue [14] Tariff Exposure and Mitigation - **Manufacturing Resilience**: Most products manufactured in the U.S., with core reagents exempt from tariffs, minimizing exposure [16][17] - **Mitigation Strategies**: Ability to ramp up production in non-China facilities to avoid tariff impacts [18] China Market Performance - **Revenue Impact**: China accounts for about 8% of total revenue, with recent quarters showing negative mid-single-digit growth [20][21] - **Customer Sentiment**: A slight shift towards optimism among customers in China, indicating potential for future growth [22][23] Biopharma Market Dynamics - **Market Segmentation**: Distinction between large pharma and biotech, with large pharma showing more stability and less volatility [26][27] - **R&D Budgets**: Anticipated increases in R&D budgets for large pharma in 2025, despite recent caution due to external factors [28][30] Instrumentation and Consumables - **Growth in Instrumentation**: Achieved upper single-digit growth in instrumentation, driven by strong consumable pull-through [43][44] - **Competitive Advantage**: Unique product offerings with minimal direct competition in key instrument platforms [45][46] GMP Reagents and Cell & Gene Therapy - **Revenue Dynamics**: Growth in GMP reagents is lumpy due to reliance on clinical trial purchases, but reflects progress in customer development [50][52] - **Wilson Wolf Acquisition**: Bio Techne owns 20% of Wilson Wolf, with plans to acquire the remaining 80% based on performance metrics, enhancing growth potential in cell therapy [62][65] Spatial Biology and Diagnostics - **Market Position**: Bio Techne is a leading player in spatial biology, with a focus on translational applications and a profitable business model [67][68] - **COMET Platform**: New automated solution for spatial biology, capable of multi-omic detection, enhancing reagent pull-through [69][70] Financial Outlook - **Q4 Expectations**: Anticipating low single-digit growth due to continued market challenges, particularly in large pharma [73][75] - **Margin Projections**: Expected decline in operating margins due to tariff impacts, but viewed as a temporary issue [76][77] Capital Allocation Strategy - **Share Repurchase Plan**: Announced a $500 million share repurchase plan, indicating confidence in company valuation and a tactical approach to capital allocation [78][81] - **M&A Strategy**: Continued focus on M&A as a key growth strategy, particularly targeting private companies [80][82]

Summary of Biotechni Conference Call Industry Overview - The life science tools industry is experiencing significant volatility due to macroeconomic factors and uncertainties, particularly in the U.S. and China [1][3] - The company has observed a recovery in the life science tools space, particularly in the pharmaceutical sector, which has shown double-digit growth across various geographies [3][4] Company Performance - The company reported double-digit growth in the pharmaceutical segment, which is widespread across its portfolio [4] - Academic revenue, which constitutes about 12% of total revenue, has been stable despite discussions of NIH budget cuts [5][6] - The worst-case scenario of a 40% cut in NIH funding would only result in a negative 1% impact on the company's projected growth rate over five years [6][7] Market Dynamics - Smaller biotech firms have been conservative in spending due to external market uncertainties, impacting their growth [9][10] - The pharmaceutical sector has seen a slight deceleration in growth rates from double digits to mid-single digits due to tariff discussions and pricing uncertainties [11][12] Academic Market Insights - Academic sales have remained stable despite concerns over funding cuts, attributed to the psychological impact on purchasing behavior [15][17] - Daily sales in the academic sector have shown stability over the past three months, indicating a return to normalcy [17] Instrumentation and Product Lines - The instrumentation segment, which accounts for about 20% of revenue, has seen growth driven by the biologics platform and specific products like the Maurice instrument [18][19] - The company is well-positioned in the bioprocessing market, with opportunities in biosimilars and other emerging markets [19][20] Tariff Impact and Mitigation Strategies - The company has low exposure to tariffs, with most of its reagents exempt from tariff increases [22][23] - Manufacturing strategies include moving production to Canada and stocking inventories in Europe and Asia to mitigate future tariff impacts [25][26] China Market Dynamics - China represents 88% of the company's revenues, and there are signs of a subtle shift towards optimism in customer demand [27][28] - The company is targeting the replacement of older instruments with newer technology, which is expected to drive growth [30][31] - Despite competition, the company maintains a strong position based on quality and consistency, which are prioritized by customers [34] Long-term Growth Outlook - The company remains bullish on long-term growth in China, driven by an aging population and ongoing scientific innovation [35][36] - The life science tools market is expected to grow significantly, with the company well-positioned to capitalize on these trends [37] Liquid Biopsy Segment - The liquid biopsy business is focused on scaling sustainably, with growth rates exceeding 20% [39] - The company is integrating exosome technology into its kit business, targeting multiple tests for disease monitoring [40][41] Spatial Market Position - The company is differentiating itself in the mid-plex spatial market by offering integrated solutions that combine molecular and antibody reagents [46][48] - The competitive landscape includes key players like Akoya and Molteni, but the company has a high win rate against these competitors [53] Margin Performance - The company achieved nearly 200 basis points of margin improvement year-over-year, although a contraction of approximately 150 basis points is expected in the near term due to tariffs and lower growth rates [54][55] - The long-term target is to achieve operating margins above 35%, supported by organic growth and effective cost management [55]

Summary of Biotechnology Management Presentation Company Overview - **Company Name**: Bio Techne - **Headquarters**: Minneapolis - **Employees**: Approximately 3,100 across 34 global locations - **Industry**: Biotechnology, focusing on protein-based reagents and products Core Business Segments - **Segments**: - Protein Sciences - Diagnostics and Spatial Biology - **Revenue Breakdown (2024)**: - Total Revenue: $1.2 billion - 80% from consumables - 9% from instrumentation - 9% from services related to instrumentation - 2% from royalties - **Revenue Composition**: - 72% from Protein Sciences - 28% from Diagnostics and Spatial Biology, which has grown from 26% the previous year [8][9][10] Growth Factors and Market Trends - **Key Growth Areas**: - Discovery of novel biological insights - Development and manufacturing of advanced therapeutics - Enablement of precision diagnostics - **Market Trends**: - Multiomic insight generation - AI-enabled innovation - Novel therapeutic approaches like cell therapy - Precision medicine and healthy aging [16][18][19] Financial Performance - **Recent Growth**: - 1% growth during a challenging period, with a return to 6% organic growth year-to-date for fiscal year 2025 [34] - **Operating Margins**: - Targeting 35-40% EBITDA range, with a historical CAGR of 40% [34][45] - **Market Position**: - Positioned to outgrow the overall market by 500 to 1,000 basis points [44] Innovations and Product Development - **Recent Launches**: - LEO instrument for high-throughput western blotting - Multi-omic solutions for RNA and protein visualization - ESR1 kit for breast cancer management [26][29][31] - **Acquisitions**: - Focus on M&A to enhance product offerings and market position, particularly in high-margin or high-growth companies [36] Sustainability and Corporate Governance - **Sustainability Initiatives**: - Published fourth corporate sustainability report, focusing on reducing waste and improving environmental footprint [42] - **Diversity and Inclusion**: - Commitment to a diverse and inclusive workplace [43] Conclusion - **Strategic Position**: - Bio Techne has built a differentiated proteomic core portfolio over 48 years, addressing a $28 billion market opportunity with a strong innovation pipeline [44] - **Future Aspirations**: - Aim for sustainable financial performance while unlocking scientific possibilities [45]

Core Insights - Bio-Techne's GMP reagents, including proteins and small molecules, are essential for its cell therapy offerings, with acquisitions playing a significant role in expanding its portfolio and entering adjacent markets [1] - The company is pursuing clinical diagnostic opportunities with its Ella platform, despite facing macroeconomic challenges that may impact operations [1][10] Financial Performance - Over the past year, Bio-Techne's shares have declined by 38.1%, underperforming the industry’s 15.3% decline, while the S&P 500 composite grew by 13.1% [2] - The company has a market capitalization of $7.63 billion, with earnings surpassing estimates in three of the last four quarters, averaging a surprise of 6.7% [2] Growth Drivers - The Cell and Gene Therapy segment is a major growth area, with the GMP reagents business experiencing high single-digit revenue growth in Q3 of fiscal 2025 and over 500 customers engaged in cell therapy development [3] - The GMP reagents business grew by just over 13% on a trailing 12-month basis, influenced by large, infrequent orders from late-stage clinical trials [3] - In China, the cell and gene therapy solutions are resilient despite funding challenges, with increasing adoption of organoid solutions expected to drive demand for GMP reagents [4] Strategic Initiatives - Bio-Techne has made several strategic acquisitions, including Lunaphore in fiscal 2024 and a 19.9% investment in Wilson Wolf, with plans to acquire the remaining ownership by the end of 2027 [5] - The launch of ProPak GMP Cytokines optimized for the Wilson WolfG-Rex bioreactor and an investment in Spear Bio for ultra-sensitive immunoassays highlight the company's focus on innovation [6] Market Opportunities - The Ella platform has received ISO 13485 certification and is being positioned for clinical diagnostics, with a partnership with Novomol-Dx to launch the BMP kit in India [7][9] - Ella is gaining traction among cell and gene therapy customers for viral titer and release testing, as well as among CROs for its high sensitivity and reproducibility [9] Challenges - The macroeconomic environment is causing increased raw material and labor costs, with a 2.8% rise in cost of sales and a 35.2% increase in selling, general, and administrative expenses year over year [10] - Funding challenges, particularly in China, are leading to extended sales cycles and production-related hazards, compounded by potential NIH funding cuts [11] Earnings Estimates - The Zacks Consensus Estimate for fiscal 2025 earnings has decreased by a cent to $1.88, while revenue estimates are pegged at $1.22 billion, indicating a 5.2% increase from the previous year [12]

Core Insights - ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation, and CellReady, has awarded three G-Rex Grants totaling $1,025,000 to faculty members at USC and CHLA to support cell and gene therapy initiatives [1][8] Grant Details - Dr. Mohamed Abou-el-Enein received a $300,000 G-Rex Grant to develop a non-viral manufacturing platform for CAR-T cell therapies, building on initial funding from the CIRM [2] - Dr. Saul Priceman was awarded a $275,000 G-Rex Grant to advance a CAR-T cell therapy for metastatic solid cancers into Phase 1/2 clinical trials, addressing manufacturing bottlenecks [4] - Dr. Shahab Asgharzadeh received a $250,000 G-Rex Grant for preclinical development of a CAR-T cell therapy targeting recurrent solid tumors in children and young adults [5] - Dr. Preet Chaudhary was granted $200,000 for the development and IND submission of a novel Synthetic Immune Receptor engineered T cell therapy for solid tumors [6] G-Rex Platform Significance - The G-Rex system is recognized for its efficiency, scalability, and cost-effectiveness in CAR-T manufacturing, enabling high-yield cell expansion and robust scale-up [3] - The G-Rex Grant Program has awarded nearly 200 grants and is extending with millions in additional funding, providing recipients access to a consortium of partners for support in CGT development [8][10] Industry Impact - The G-Rex manufacturing platform is utilized by over 800 organizations and is involved in approximately 50% of CGT clinical trials, contributing to the commercialization of CGT drugs [10] - ScaleReady aims to enhance CGT drug product development and manufacturing, saving time and costs for entities in the CGT field [10]

Summary of Bio-Techne (TECH) 2025 Conference Call Company Overview - **Company**: Bio-Techne (TECH) - **Date**: May 13, 2025 - **Key Speakers**: Kim Kelderman (CEO), Jim Hipple (CFO) Key Highlights Financial Performance - **Fiscal 3Q Results**: Reported a solid 6% growth despite macroeconomic headwinds [3][4] - **Protein Sciences Segment**: Achieved 7% growth, driven by core reagents and instrumentation for protein detection [4] - **Diagnostics and Special Segment**: Growth was muted at 2%, influenced by timing of orders rather than market conditions [5][6] - **EBITDA Margins**: Maintained strong margins at 34.9%, reflecting operational efficiencies [6] Market Exposure and Headwinds - **U.S. Academic Exposure**: 21% of revenues from academic business, with 12% from U.S. academic institutions [7] - **NIH Funding Impact**: Approximately 50% of academic revenue is exposed to NIH funding, which has created uncertainty [8] - **Consumables vs. Equipment**: Consumables (80% of business) remained steady, while equipment sales were more volatile due to budget uncertainties [10] Regulatory and Policy Environment - **Tariff Exposure**: Estimated exposure of $20 million from tariffs, but proactive measures have mitigated this risk [24][25] - **Biopharma Sector**: Comprises 50% of revenues, with large pharma showing double-digit growth while biotech remained flat due to funding challenges [35][38] Strategic Focus - **Cell and Gene Therapy**: Significant focus on GMP reagents, with a strong pipeline of customers in clinical studies [46][48] - **Spatial Business**: Competitive instruments showing double-digit growth, leveraging a large reagent portfolio [52][53] - **M&A Strategy**: Continued focus on acquisitions that align with high-margin reagent sales, with a disciplined approach to valuation [56][57] Future Outlook - **Q4 Expectations**: Anticipated continued uncertainty, with large pharma expected to drive growth while biotech remains challenged [60][61] - **Fiscal Year 2026 Guidance**: Uncertainty prevails, with hopes for stabilization in the coming months to provide clearer guidance [62][63] Additional Insights - **Market Dynamics**: The consolidation in the research reagents market has changed competitive dynamics, but the company remains well-positioned due to its strong portfolio and technical sales force [42][44] - **Regulatory Discussions**: Positive sentiment around cell and gene therapies, with a focus on maintaining high regulatory standards to avoid negative industry impacts [49][50] This summary encapsulates the key points discussed during the Bio-Techne conference call, highlighting the company's performance, market challenges, strategic initiatives, and future outlook.

Core Insights - Bio-Techne Corporation will showcase its latest spatial biology and cell and gene therapy workflow solutions at the ASGCT 2025 meeting in New Orleans from May 13th to 17th [1] - The company will highlight advancements in cell and gene therapy development, including the RNAscope™ protease-free workflow and ProPak™ GMP cytokines [2][4] - Bio-Techne generated approximately $1.2 billion in net sales in fiscal 2024 and employs around 3,100 people globally [5] Product Highlights - The RNAscope™ protease-free workflow allows visualization of biodistribution of AAV vectors, transgene mRNA, and small RNAs [2] - ProPak™ GMP cytokines are designed for closed-system cell therapy manufacturing, featuring dose-optimized, single-use bags [2] - The Simple Western Leo™ System enables simultaneous processing of up to 100 samples in a single 3-hour run [2] Symposium and Presentations - ACD's symposium will feature innovations with RNAscope technology, including NextGen RNAscope™ Multiomics Solutions [3] - A talk on protein quantitation applications to advance gene therapy development will be presented by guest speakers from Sangamo Therapeutics and Nervosave Therapeutics [3][6] - Additional presentations will cover AI-designed AAV capsids and RNA gene writer activity in therapeutic contexts [6]