Bio-Techne FY Conference Summary Company Overview - **Company**: Bio-Techne (NasdaqGS: TECH) - **Industry**: Life Science Tools Key Points Company Positioning and Growth Strategy - Bio-Techne is a leader in reagents for life science research, focusing on proteins, antibodies, and assays for diagnostics and therapeutics [4][6] - The company has invested heavily in automation of protein analytics, spatial biology, and cell therapy, which now account for approximately 45% of revenue, up from 30% pre-COVID [6][7] - 90% of Bio-Techne's business is recurring, primarily from consumables, which supports sustainable growth [7] Recent Financial Performance - The company reported a 3% growth in the most recent quarter, with notable performance in China (10% growth) and continued double-digit growth in large pharma [9][10] - Challenges included delays in shipping high-priced instruments due to geopolitical issues [9] Academic Market Exposure - Academic sales account for about 20% of total revenue, with U.S. academia contributing approximately 11-12% [13][14] - Despite funding constraints, consumables have remained flat, indicating resilience in the product portfolio [14][15] Market Dynamics in China - Positive sentiment in China suggests a gradual ramp-up in growth, with expectations of returning to double-digit growth in the long term [18][19] Biopharma Market Insights - Biopharma constitutes roughly 50% of revenue, with large pharma showing strong recovery and growth, while biotech funding has decreased significantly [20][21] - The uncertainty in biotech funding may impact future spending, but recent improvements in funding could signal a recovery [22] Cell Therapy Business - Bio-Techne is well-positioned in the cell therapy market, focusing on GMP proteins, with a significant increase in revenue from this segment [23][24] - The company has built a strong reputation for quality and has a competitive edge in the regen med space, which has greater market potential than CAR-T therapies [25][26] Core Reagents and Instrumentation - The core reagents business remains stable, with healthy competition in the antibody market [30][31] - The ProteinSimple platform has shown resilience, with growth driven by increased usage of consumables despite a downturn in new instrument placements [34][36] Spatial Biology and Competitive Position - Bio-Techne leads in spatial biology with RNAscope reagents and the new COMET instrument, which automates RNA and protein detection [39][41] - The company is positioned to capitalize on the growing demand for translational research tools [40] Strategic Divestiture - The recent divestiture of the Exosome Diagnostics business was driven by a misalignment with Bio-Techne's core capabilities and a lack of a clear path to profitability [43][45] Revenue Outlook and Market Conditions - The company anticipates low single-digit growth, managing costs and investments amid market uncertainties [47][50] - Optimism remains regarding recovery in key markets, with expectations that administrative-induced noise will settle down [51][53] Conclusion Bio-Techne is strategically positioned for growth in the life science tools industry, with a strong focus on automation, spatial biology, and cell therapy. Despite current market challenges, the company maintains a positive outlook for future performance driven by its recurring revenue model and innovative product offerings.

Financial Data and Key Metrics Changes - The company has revised its revenue guidance for FY 2025 to a range of $250 to $300 million, reflecting a reset based on learnings from the market [4][6] - There was a quarter-over-quarter growth of 24% in Q2, indicating a ramp-up in performance [6] Business Line Data and Key Metrics Changes - The company is focusing on improving patient access to its product, Amtagvi, by adding authorized treatment centers and large community centers [6][7] - The average time for financial clearance has improved significantly to around three weeks, with efforts to streamline the patient journey from ordering to infusion [9][10] Market Data and Key Metrics Changes - The company is targeting a global addressable patient population of approximately 30,000 patients per year for Amtagvi [23] - The company has identified a significant opportunity in large community practices that have grown in recent years, which were previously not targeted [16][18] Company Strategy and Development Direction - The company is committed to financial discipline and has undertaken a restructuring to right-size the organization, aiming for profitability as soon as possible [5][32] - The company is exploring a virtual control arm for its European Medicines Agency application to expedite the approval process [25][27] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, citing the effectiveness of the product and ongoing improvements in manufacturing and reimbursement processes [4][5] - The company is focused on capturing earlier-stage patients to improve treatment outcomes, supported by real-world evidence showing better results than clinical trials [12][15] Other Important Information - The company has a pipeline that includes trials for non-small cell lung cancer and endometrial cancer, with expectations for data releases later this year [38][51] - The company is also working on improving gross margins through operational efficiencies and cost control measures [32][35] Q&A Session Summary Question: What are the key initiatives to achieve the revised revenue guidance? - The company is ramping up external-facing initiatives and adding treatment centers to improve patient access [6][7] Question: What improvements have been made in the patient journey? - Financial clearance times have improved, and the company is working to streamline scheduling and infusion processes [9][10] Question: What is the potential for Amtagvi in the U.S. market? - The company believes Amtagvi has the potential to reach $1 billion in sales, contingent on effective patient access and education initiatives [23] Question: What is the status of the European Medicines Agency application? - The company withdrew its application to gather necessary data for a virtual control arm and plans to resubmit [25][27] Question: What are the expectations for gross margin improvements? - The company anticipates significant savings from restructuring and operational efficiencies, aiming for improved gross margins [32][35] Question: What is the competitive landscape for non-small cell lung cancer? - The company sees limited competition in the second-line treatment space, with current options primarily being chemotherapy [43][44] Question: What are the expectations for the endometrial cancer trial? - The company is optimistic about the trial's potential, with plans to release first-in-human data by the end of the year [51][54]

Financial Data and Key Metrics Changes - The company reported a strong second quarter with increased guidance for both top-line and bottom-line growth, driven by strong performance across all business units [3] - The HIV prevention business saw significant growth, with Descovy sales up 37% quarter over quarter [7] Business Line Data and Key Metrics Changes - The launch of YES2Go for HIV prevention has been described as the strongest execution seen in a launch, with 73% unaided awareness and 95% aided awareness [6][7] - The company is on track to achieve 75% coverage in the U.S. by the end of the year, with significant early wins with commercial and Medicaid payers [11][12] Market Data and Key Metrics Changes - The HIV prevention market is currently underpenetrated, with only 50,000 to 400,000 patients on the drug, compared to a potential 1.2 to 3 million [25] - The company anticipates significant market growth as awareness and access to HIV prevention therapies increase [29] Company Strategy and Development Direction - The company is focused on expanding its HIV prevention market, targeting individuals already on HIV prevention therapies and those at risk of HIV [27][30] - The company is also investing in its oncology pipeline, with multiple launches expected, including a CAR T therapy for multiple myeloma [56][65] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing growth of the HIV treatment business despite headwinds from Part D reforms, expecting a 3% growth rate [34][38] - The company is preparing for potential macroeconomic headwinds but believes its strong clinical profile will help mitigate risks [51][52] Other Important Information - The company has made substantial investments in internal research and development, enhancing the quality and breadth of its portfolio [72] - The approval of a reimbursement code (J code) for YES2Go was granted earlier than expected, which is crucial for the launch [13] Q&A Session Summary Question: How is the launch of YES2Go performing? - The launch has been strong, with high awareness and a solid execution plan in place [5][6] Question: What challenges are anticipated with the new injectable model? - The company acknowledges logistical challenges but is confident in its execution strategy and coverage goals [9][10] Question: How does the company view the competitive landscape for HIV treatments? - Management believes Biktarvy remains the gold standard and expects to maintain market share despite upcoming generic competition [40][41] Question: What is the outlook for the oncology pipeline? - The company is optimistic about the potential of its CAR T therapy and other oncology products, viewing them as significant growth opportunities [56][65] Question: How is the company preparing for potential Medicaid funding cuts? - The company is actively engaging with policymakers and believes it can manage any changes due to its strong clinical data [51][52]

Financial Data and Key Metrics Changes - The company reported a 17% organic growth excluding COVID for Q2, indicating a strong recovery [5][6] - For the first half of the year, the company achieved mid-teens top-line growth and a 20% increase in orders, leading to an upward revision of full-year guidance by 50 basis points despite a 100 basis point headwind from a specific gene therapy program [7][10] - EBITDA margin is around 19% this year, with a target of 30% in the coming years, expecting 1-2 points of margin improvement annually [67][68] Business Line Data and Key Metrics Changes - The monoclonal antibody business is performing well, contributing to overall growth [7] - New modalities accounted for about 17% of total sales in the first half, with gene therapy making up approximately 50% of that segment [14] - Instrument revenues increased by high teens, with orders up over 20%, indicating a recovery in hardware sales [18][20] - Chromatography sales and orders grew over 30%, attributed to a focus on big pharma and the successful switch to OPUS columns [52][53] Market Data and Key Metrics Changes - The biopharma segment saw revenue and orders increase over 20%, driven by a successful key account management strategy [26][28] - The company anticipates that the Chinese biopharma market will grow faster than other markets, particularly by 2026, due to increased investment and innovation [34][36] - Local competition in China has intensified, with several established companies in filtration and chromatography [37] Company Strategy and Development Direction - The company aims to double its business in the midterm, focusing on organic growth with limited acquisitions [77][78] - A specific strategy for the Chinese market is being developed, emphasizing collaboration with local companies [36][39] - The company is committed to innovation, with several new products and technologies expected to drive growth in the coming years [62][63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about entering a growth cycle for hardware, driven by limited capacity and increasing demand, particularly in Asia [25][24] - The company is not overly concerned about the impact of tariffs, expecting minimal effects on top-line revenue [65][66] - Management believes that pricing pressures from pharma reforms may create opportunities for the company to gain market share [72][74] Other Important Information - The company has $700 million in cash available for potential acquisitions, with a focus on technologies that complement existing workflows [78] - The company is actively looking for opportunities in the current market conditions, which may present assets at more affordable prices [77] Q&A Session Summary Question: Can you elaborate on the growth in the biopharma segment? - The biopharma revenue and orders increased over 20%, supported by a key account management strategy that has led to deeper relationships with major pharma companies [26][28] Question: What is the outlook for the Chinese market? - The Chinese biopharma market is expected to grow rapidly, with a need for a tailored strategy that considers local competition and collaboration [34][36] Question: How is the company addressing potential competition in filtration? - The company maintains a strong position in the ATF market, with most pharma companies now using ATF technology, and is confident in its competitive edge [40][41] Question: What is the impact of tariffs on the business? - The impact of tariffs is minimal, with only a couple of million dollars affecting top-line revenue, and the company has adjusted its pricing strategy accordingly [65][66] Question: What is the company's approach to M&A? - The company is actively looking for acquisition opportunities but emphasizes organic growth as the primary focus, with a significant cash reserve available for strategic purchases [77][78]

Financial Data and Key Metrics Changes - The company reported a 3% organic growth in Q4, aligning with expectations of low single digits growth [3][4] - Strong performance was noted in the large pharma end markets with double-digit growth, while biotech showed low single-digit growth [3][4] - The company expects a low single-digit growth environment for the upcoming fiscal year, influenced by market conditions and previous performance comparisons [49][52] Business Line Data and Key Metrics Changes - The cell therapy product line experienced a 20% growth in Q4 and 30% growth for the entire year, indicating strong momentum [10][11] - GMP proteins, part of the cell therapy business, grew 20% in Q4 and 30% for the full year, although growth is described as lumpy due to large orders for clinical trials [21][23] - Core reagents business saw low single-digit growth in the quarter, with over 50% of revenue still coming from this segment [29][30] Market Data and Key Metrics Changes - The academic market contributed 21% of the company's revenue globally, with U.S. institutions showing low single-digit exposure to NIH funding [17][18] - The company noted a positive trend in European academic funding, which is expected to increase due to new Horizon funding initiatives [20] - The Chinese market showed double-digit growth in Q4, attributed to pull-ins from customers avoiding tariffs, although the underlying growth is believed to be more stable and flattish [5][6] Company Strategy and Development Direction - The company is focusing on expanding its presence in cell therapy and biopharma markets, leveraging its strong product lines and regulatory certifications [10][11] - There is an emphasis on innovation in core reagents, with new AI-designed proteins being introduced to enhance efficiency and effectiveness [30][32] - The company is committed to improving its margin profile, targeting a long-term goal of over 35% operating profit margin [57][62] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the stabilization of the Chinese market and the potential for growth in biotech activities [7][8] - There are concerns about the impact of tariffs and funding uncertainties in the biotech sector, which could affect growth rates [12][50] - The company plans to invest in areas with strong growth potential, such as organoids and protein sciences, to drive future performance [58][60] Other Important Information - The company divested from ExosomeDx due to a lack of synergy with its core products, which is expected to positively impact the bottom line by 200 basis points [44][48] - The company is actively assessing its portfolio for further strategic adjustments beyond the recent divestiture [44][46] Q&A Session Summary Question: What drove the growth in the biopharma segment? - The cell therapy product line saw significant growth, with a 20% increase in Q4 and a 30% increase for the year, driven by strong demand and a promising pipeline [10][11] Question: How is the academic market performing? - The academic market has been volatile, with U.S. institutions showing low single-digit growth, while European markets are expected to see increased funding [17][20] Question: What are the expectations for the Chinese market? - The Chinese market showed double-digit growth in Q4, primarily due to pull-ins related to tariffs, but the underlying growth is expected to stabilize [5][6] Question: How does the company plan to achieve margin expansion? - The company expects to achieve a 200 basis point increase in margins through strategic investments and operational efficiencies, targeting a long-term margin of over 35% [57][62]

Core Insights - The article highlights nine research papers published in the prestigious journal Cell, with six authored by Chinese scholars, covering various advancements in molecular biology and plant science [3]. Group 1: RNA Editing and Gene Regulation - A study from Yale University transformed IscB and Cas9 into RNA-guided RNA editors, demonstrating potential applications in variable splicing interference and RNA base editing, with performance surpassing Cas13 and enhanced safety [5][7]. - The research on modified adenosines from Tohoku University revealed a detoxification mechanism involving adenosine kinase and ADAL, linking modified RNA metabolism to human diseases [14][17]. Group 2: Plant Science and Immunity - A unified cell atlas of vascular plants was created by researchers from the Chinese Academy of Sciences, identifying foundational genes and facilitating gene discovery, thus providing a new paradigm for plant developmental biology [9][12]. - A study on systemin antagonists in tomatoes uncovered a molecular mechanism regulating the plant immune system, which could inform the design of disease-resistant crops [19][22]. Group 3: CAR-T Cell Therapy - Researchers from Peking University developed a novel allogeneic CAR-T cell therapy by targeting the SPPL3 gene, which enhances the therapy's safety and efficacy, potentially revolutionizing CAR-T treatments [24][27]. Group 4: Neuroscience and Synaptic Plasticity - A study from Southern University of Science and Technology explored the material properties of postsynaptic density condensates, revealing how Shank3 oligomerization affects synaptic plasticity and could relate to autism spectrum disorders [29][32].

Group 1 - The National Healthcare Security Administration has announced the preliminary review list for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Catalog, highlighting CAR-T therapies as a focal point [1] - Among the seven CAR-T products that have been launched, five are applying for the commercial insurance innovative drug catalog, while three are simultaneously pushing for inclusion in the basic medical insurance [1] - The commercial insurance innovative drug catalog covers a wide range of rare disease medications, cell and gene therapies, and advanced tumor immunotherapies, indicating a shift in the competitive landscape of the industry [1] Group 2 - The commercial insurance innovative drug catalog aims to include drugs that are not yet eligible for the medical insurance catalog but possess high innovation and clinical value [1] - This initiative is seen as a crucial step in building a multi-tiered medical security system, allowing more high-value innovative drugs to enter the payment system earlier, alleviating short-term pressure on medical insurance funds [1] - Companies involved in cell therapy concepts listed on the A-share market include Chengda Pharmaceutical and Guanhao Biological [1]

Financial Data and Key Metrics Changes - Research and development expenses increased to approximately $1,400,000 for Q2 2025 from approximately $800,000 in Q2 2024, and increased to approximately $2,900,000 for the six months ended June 2025 from $2,800,000 in the same period of 2024 [16] - Selling, general and administrative expenses decreased to approximately $700,000 in Q2 2025 from approximately $900,000 in Q2 2024, while remaining consistent at approximately $1,900,000 for the six months ended June 2025 compared to the same period in 2024 [16] - Net loss was approximately $2,000,000 for Q2 2025 compared to approximately $1,600,000 for Q2 2024, and approximately $4,800,000 for the six months ended June 2025 compared to approximately $3,900,000 for the same period in 2024 [17] - Cash and cash equivalents totaled $980,000 at the end of the quarter, with a current cash balance of approximately $1,100,000 after selling $769,000 in common stock [18] Business Line Data and Key Metrics Changes - The CardioAmp heart failure trial showed a lower incidence of all-cause death and non-fatal MACE in the treatment group compared to the control group, with a p-value of 0.17, and a statistically significant composite endpoint in patients with elevated NT proBNP with a p-value of 0.02 [6][9] - The CARDI Amp cell therapy in chronic myocardial ischemia (BCDO2) is expected to deliver final top-line data in Q4 2025 [14] - The Helix Biotherapeutic delivery system is anticipated to be submitted for FDA approval in Q3 2025 [15] Market Data and Key Metrics Changes - Japan's PMDA has shown interest in heart failure therapy, with the company expecting to align on pathways for therapy availability [7] - The company is preparing for a meeting with the FDA regarding the approvability of the CardiAmp system based on clinical data [9] Company Strategy and Development Direction - The company aims to partner its Helix delivery system for the cardiac electrophysiology market and is focused on creating value through partnerships across its four platforms: CardiAmp, CardiAllo, Helix, and MorphDNA [11][12] - The company is actively pursuing distribution partnerships in Japan and the U.S. for its therapies, emphasizing the cultural alignment of its autologous cell therapy with Japanese preferences [23][40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the upcoming regulatory meetings with PMDA and FDA, highlighting the potential for approval based on compelling clinical data [35] - The company is focused on maintaining a low burn rate while advancing multiple trials and regulatory submissions, with an annual burn rate of approximately $6,000,000 [76] Other Important Information - The company is preparing a peer-reviewed manuscript based on the data presented at the American College of Cardiology, which will be accessible to the public [70] - The company is working on a financing event that aims to be beneficial for current shareholders, with a focus on minimizing dilution [73] Q&A Session Summary Question: Expectations regarding PMDA reviewing Cardium for heart failure as a medical device - Management indicated that the approval process is viewed as a lower hurdle for medical device approval, with a focus on the clinical consultation process [20][21] Question: Timing for the Cardium CMI program data - Management confirmed that the rolling cohort data related to primary endpoint results is expected in Q4 [26] Question: Timing of regulatory meetings and potential outcomes - If meetings go well, the approval process could take up to a year, with parallel efforts on reimbursement and distribution partnerships [32][34] Question: Status of FDA meeting type and HF2 trial screening - Management is contemplating the type of FDA meeting and confirmed that the HF2 trial is actively enrolling patients with a focus on compliance and stability [45][50] Question: Expectations following data readout for BCDA - Management stated that outcomes depend on PMDA and FDA responses, with potential for non-dilutive capital to accelerate the BCDA program [60] Question: Release of new data observations to the public - Management confirmed that a peer-reviewed manuscript will be prepared to share data observations, while also working on regulatory submissions [70] Question: Details on the upcoming financing event - Management emphasized the importance of a financing event that minimizes dilution and supports ongoing trials and partnerships [73][75]

Financial Data and Key Metrics Changes - CarVicti net trade sales reached approximately $439 million, representing a 136% increase year over year and a 19% increase from the first quarter [7][17] - Total revenues were RMB 255 million, driven by collaboration revenue growth of 136% year over year [30] - The company reported a net loss of RMB 10 million but achieved RMB 10 million in adjusted net income after excluding non-core items [30] - Operating loss improved from RMB 41 million in the same period last year to RMB 22 million [30] - Gross margin on net product sales was 57% [30] Business Line Data and Key Metrics Changes - CarVicti's U.S. net trade sales were $358 million, growing 114% year over year and 13% quarter over quarter [18] - Outside the U.S., sales were $81 million, which is four times the amount from the same period a year ago, representing a 59% increase quarter over quarter [19] Market Data and Key Metrics Changes - Over 60% of CarVicti utilization is now in earlier line settings [8] - The company has treated over 7,500 patients with CarVicti, marking it as the strongest CAR T launch to date [7][16] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CarVicti by 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8][30] - The company is focused on solidifying its leadership in cell therapy and expanding into new indications such as solid tumor programs [14][15] - A new research facility is being built in Philadelphia to focus on in vivo delivery, enhancing innovation capabilities [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA's decision to remove risk evaluation and mitigation strategies for approved CAR T therapies, which is expected to improve patient experience and access [8] - The company anticipates continued strong performance for CarVicti, driven by recent long-term survival data presented at ASCO [21][28] Other Important Information - The company has a cash position of approximately $1 billion, allowing for continued investment in core differentiators in cell therapy [16][32] - Manufacturing success rate remains at 97%, which is believed to be the highest in the CAR T industry [20] Q&A Session Summary Question: Update on interim readouts from CARDISUDE V and VI - Management is monitoring events closely and is in discussions with the FDA about using MRD as a dual primary endpoint [37][38] Question: Community oncology efforts and Virginia Oncology Associates - Virginia Oncology Associates is a key milestone for community adoption, having previously administered CAR T therapies and is part of the McKesson network [39] Question: Revenue contribution from community expansion efforts - Approximately 70% of patients come from the community setting, with over half of patients administered in outpatient settings [42][43] Question: Breakdown of treated patients in early line settings - Nearly 60% of orders are from the second through fourth line population, which is expected to grow significantly [48] Question: Impact of recent efficacy data from a competitor - Management emphasized that CarVicti is best in class with demonstrated overall survival benefits, differentiating it from competitors [63] Question: Future demand and supply dynamics - The company plans to drive both supply and demand simultaneously, with increasing contributions expected from Europe [83][85] Question: Novartis commercial supply ramp-up - Novartis is expected to reach full capacity by the end of the year, contributing to growth [107] Question: Impact of recent tariff changes - The company believes any potential exposure to tariffs will not be material based on current evaluations [103]

新一期《自然》杂志刊登了一项里程碑式研究：美国斯坦福大学医学院团队利用非基因匹配的健康前体 细胞，替换掉罹患桑德霍夫病小鼠超过半数的病变小胶质细胞，使实验鼠寿命从135天延长至250天，运 动功能与探索行为几乎恢复至正常水平。这也是首次为泰萨克斯病和桑德霍夫病等目前无药可治的致命 性脑病提供了"即用型"细胞疗法蓝图。 该成果同时解决了三大难题：无需全身毒性预处理、无需基因编辑即可补充缺失酶、避免排异反应。方 案所用放射剂量、微胶质清除剂及免疫抑制剂均已用于其他疾病，具备快速进入临床的潜力。同时，该 疗法不依赖患者自身细胞，未来有望像输血一样成为"货架产品"，大幅降低成本与等待时间。 团队指出，阿尔茨海默病、帕金森病等常见神经退行性疾病同样伴随小胶质功能障碍，这或许是溶酶体 病的"慢速版本"。如果后续人体试验成功，受益者远不止罕见病患儿，而是数百万神经退行性疾病患 者。下一步，团队计划在更接近人类的大型动物模型中验证这种疗法的安全性，并与美国食品和药物管 理局讨论设计早期临床试验。 （文章来源：科技日报） 泰萨克斯病和桑德霍夫病同属溶酶体贮积症。患儿因缺乏关键酶，神经"清道夫"小胶质细胞及邻近神经 元内代谢垃圾 ...