SI-BONE (NasdaqGM:SIBN) FY Conference September 09, 2025 07:00 AM ET Company ParticipantsAnshul Maheshwari - CFOLaura Francis - CEOMarissa BychAlrighty, morning. Thank you everybody for day two at the MS Healthcare Conference. I appreciate it. The most exciting bit, disclaimers, focusfamily.com forward slash research disclosures. I'm sure you'll all be going there. What is exciting is having Laura and Anshul here, CEO and CFO at SI-BONE respectively. Doing a beautiful morning for us. Thanks so much for join ...

Summary of HMS Networks Capital Markets Day Company Overview - **Company**: HMS Networks (OM:HMS) - **Event**: 2025 Capital Markets Day - **Date**: September 09, 2025 Key Industry Insights - **Industry Focus**: Industrial communication solutions, factory automation, and process industry - **Market Dynamics**: The industry is experiencing behavioral and technological shifts, with a focus on AI and ARR (Annual Recurring Revenue) models [2][3][6] Core Company Strategies - **Five Pillars**: HMS Networks emphasizes five pillars: access, insights, visualize, connect, and diagnose, which are expected to remain relevant over the next five years [3] - **Market Position**: HMS Networks considers itself a dominant player in a fragmented market, with no single competitor offering the same comprehensive solutions across all segments [5][4] - **M&A Strategy**: The company aims to expand its portfolio through acquisitions, focusing on profitable companies with established management teams and a compatible culture [19][20][27] Financial Performance and Projections - **Market Share**: The company has an 8% market share in the INT segment, with a larger share in embedded business compared to gateways [11] - **Revenue Growth**: The target is to achieve organic growth of around 8% annually, in line with market growth, with a focus on improving gross margins [29][64] - **Investment in R&D**: Significant investments in R&D are planned to support product development and enhance competitive positioning [29][51] Competitive Landscape - **Competitors**: The competitive landscape includes various fragmented technology providers, with specific competitors in niches such as remote access and switches [7][9] - **Emerging Trends**: There is a shift towards customers preferring complete industrial communication solutions rather than building their own [7][75] Technology and Product Development - **AI and Data Utilization**: The integration of AI is expected to enhance product offerings and reduce development costs, although there is caution regarding potential new competition [81][83] - **Wireless Solutions**: The company sees potential in wireless technology, particularly in logistics and remote applications, but acknowledges slow adoption in factory settings [66][68] Geographic Focus - **China Strategy**: HMS Networks is selectively targeting opportunities in China, focusing on less government-controlled sectors and leveraging local supply chains [34][36] Customer Segmentation - **Target Customers**: The company segments its customer base into OEMs (45%), system integrators (30%), and end users (25%), with a focus on expanding relationships with system integrators [22] Conclusion - **Future Outlook**: HMS Networks is positioned for growth through strategic investments, a focus on technology synergies, and a commitment to enhancing its market presence in both existing and new industries [25][36][64]

EMVision Medical Devices (ASX:EMV) Update Summary Company Overview - EMVision Medical Devices is transitioning from an R&D-focused entity to a commercialization-focused company, with over $50 million invested in technology development over the past seven years [1][2] - The company has two main products: the EMU™ device for in-hospital use and the First Responder scanner for ambulance deployment [2] Product Details - **EMU™ Device**: A cart-based system designed for rapid neurodiagnostic capabilities, currently undergoing pivotal study for FDA De Novo clearance [2] - **First Responder Scanner**: An ultra-lightweight helmet designed for road and air ambulance use, facilitating earlier triage and treatment decisions [2] Market Opportunity - The incidence of strokes is increasing, with one in four adults experiencing a stroke in their lifetime, leading to significant health economic impacts estimated at $890 billion in 2021, projected to grow to $1.6 trillion by 2050 [4] - Effective treatments exist but are time-sensitive, with only one in three patients receiving timely interventions [7][8] Clinical Studies and Collaborations - Completed a successful multi-site pre-validation study (EMView) in Australia, leading to confidence in progressing to pivotal studies [2][13] - Collaborations with key industry partners, including the Australian Stroke Alliance and Keysight Technologies, which is also a major shareholder [3][16] Regulatory Strategy - Targeting FDA De Novo submission followed by CE mark submission for European clearance [24] - Engaging in continuous innovation studies to enhance product performance and expand indications, including traumatic brain injury [28] Financial Overview - Revenue model includes capital equipment sales, consumables, and service contracts, with expected pricing for the EMU™ device around $175,000 and the First Responder scanner between $15,000 and $100,000 [22][23] - The company has a strong track record in securing non-dilutive grants, totaling approximately $27 million [42] Market Launch Strategy - Focused on a phased launch in the U.S. stroke belt region, targeting high-volume stroke centers and critical access hospitals [29][30] - Plans to build credibility and trust through direct engagement with the clinical community before scaling operations [31] Reimbursement Strategy - Exploring multiple reimbursement programs to foster adoption, including the New Technology Add-on Payment (NTAP) program [32][33] - Aiming to generate post-approval data to support reimbursement and market adoption [35][36] Future Outlook - Anticipated catalysts include updates on pivotal trials, regional benefits studies, and ongoing collaborations with top-tier institutions [41] - The company is well-positioned to address unmet needs in stroke care with its innovative products and strong clinical evidence [38][39]

Summary of Aurora Cannabis FY Conference Call Company Overview - Aurora Cannabis is a leading global medical cannabis company based in Canada, with significant market positions in Canada, Europe, Australia, and New Zealand [4][5] - The company is the largest Canadian exporter of high-quality medical cannabis, supported by world-class manufacturing facilities in Canada and Germany [4][9] Core Financial Highlights - Fiscal year 2025 was a record-setting year for Aurora, with net revenue rising 27% to $343 million, including a 39% increase in global medical cannabis revenue [8][13] - International revenue now comprises over 50% of total global medical cannabis revenue, up from 41% in fiscal year 2024 [8] - Adjusted gross margin improved to 55% from 49%, benefiting from higher cannabis and plant propagation margins [8] - Record adjusted EBITDA reached almost $50 million, with positive free cash flow of approximately $10 million [8][13] Strategic Focus and Market Position - The company has shifted to a medical cannabis-first approach, focusing on high-margin opportunities outside North America [5][6] - Aurora is well-positioned to capitalize on the expanding global medical cannabis market, which is projected to surpass $5 billion [6][9] - The company maintains a strong operational edge due to early mover advantages and a disciplined focus on profitable business segments [6][7] International Market Performance - International medical cannabis net revenue increased by 89% to $137 million in 2025, driven by leadership positions in Germany, Poland, the UK, Australia, and New Zealand [11] - The Canadian medical market saw a 4% year-over-year growth, resulting in net revenue of $107 million in 2025 [11] - The Canadian consumer business contributed $40 million in revenue, reflecting a 28% annual growth [11] Future Outlook - The first quarter of fiscal year 2026 showed continued momentum, with global medical cannabis net revenue reaching $64.8 million, up 37% year-over-year [12] - Adjusted gross margins for medical cannabis consistently meet or exceed 60%, reaching 69% in Q1 of fiscal year 2026 [12] - The company is positioned for sustainable, profitable growth, particularly in underpenetrated markets like Europe and Australia [13] Additional Insights - Aurora's diversified business model focuses on high-margin segments and investments in science and innovation [10] - The company has established strong third-party partnerships to optimize production planning and meet demand [10] - Aurora's operational efficiencies and lower production costs contribute to its ability to generate top-tier margins [10] Conclusion - Aurora Cannabis is strategically positioned to lead in the global medical cannabis market, with a strong financial performance and a focus on high-margin opportunities [13][14]

Summary of Chimeric Therapeutics Update / Briefing Company Overview - **Company**: Chimeric Therapeutics (ASX:CHM) - **Focus**: Development of CAR-T cell therapies, specifically targeting CDH17 for neuroendocrine tumors and other cancers - **Current Trials**: Four active phase one clinical trials under three different FDA INDs across multiple U.S. centers [1][2] Core Points and Arguments - **Lead Program**: CHM 2101 is the first CDH17 CAR-T in clinical trials under an FDA IND, with significant potential in the CDH17 space [2][10] - **Clinical Trials**: - The IND was cleared in November 2023, and fast track status was granted in April 2025, facilitating real-time interaction with the FDA [10][11] - Currently enrolling patients with colorectal cancer, gastric cancer, and neuroendocrine cancers [11] - Eight patients have been treated so far, with plans to treat a total of 15 in the phase one study [11][12] - **Study Design**: The trial is flexible and adaptive, exploring three dose levels, with safety established at the first dose level of 50 million CAR-T cells [12][14] - **Efficacy Indicators**: Early signs of anti-tumor activity observed, including a 12% tumor shrinkage in one patient at dose level two [17] Leadership and Expertise - **Leadership Team**: Includes experienced professionals with backgrounds in CAR-T therapies from companies like Amgen, Celgene, and Kite Pharma [3][4] - **Clinical Expertise**: Dr. Jennifer Eads, a key figure in the trial, emphasizes the importance of quality of life for patients with neuroendocrine tumors and the strategic approach to treatment [22][25] Clinical Experience and Patient Outcomes - **Patient Profiles**: Focus on patients with stable disease who have progressed on standard somatostatin analog therapy [25] - **Cytokine Release Syndrome (CRS)**: Two patients experienced CRS, which is being monitored closely; it can indicate immune activation [34][36] - **Quality of Life Improvements**: One patient reported significant improvements in quality of life post-treatment, highlighting the potential benefits of CAR-T therapy [29] Market Potential - **Market Size**: The global market for CAR-T therapies was approximately $27 billion last year and is expected to grow significantly, particularly due to rising bowel cancer rates among younger populations [43] - **Commercial Opportunities**: Interest from big pharma companies in CAR-T therapies presents potential partnerships and licensing opportunities [46] Safety and Regulatory Considerations - **Safety Monitoring**: Ongoing assessment of safety and efficacy is critical, with a focus on balancing treatment benefits against potential side effects [49][50] - **Regulatory Pathway**: Fast track designation allows for potential market entry at the end of phase two, reducing the need for extensive phase three trials [45] Conclusion - **Progress and Future Outlook**: Chimeric Therapeutics is optimistic about the ongoing trials and the potential for CHM 2101 to provide significant benefits to patients with neuroendocrine tumors and other cancers, with more data expected in the coming weeks [44][51]

Crescent Biopharma FY Conference Summary Company Overview - **Company**: Crescent Biopharma - **Industry**: Biopharmaceuticals, specifically in the immuno-oncology and antibody-drug conjugate (ADC) sectors - **Recent Development**: Entered public markets through a reverse merger in June 2025 [1][2] Core Points and Arguments - **Market Opportunity**: Crescent Biopharma is positioned in a $100 billion market opportunity within the immuno-oncology space, focusing on bi-specific antibodies and ADCs [5] - **Product Pipeline**: - **CR-001**: A bi-specific antibody expected to begin patient dosing in early 2026, with a strong focus on first-in-class opportunities outside of lung cancer [4][5] - **CR-002**: The first ADC, anticipated to enter clinical trials in mid-2026 [4] - **Clinical Strategy**: The company aims to generate robust clinical data over the next 12 to 18 months, focusing on dose finding, safety, and preliminary anti-tumor activity [24][25] - **Leadership and Experience**: The team includes experienced professionals with a history of successful drug development, including the Chief Medical Officer who has worked on approved PD-1 inhibitors [7][9] Key Data and Insights - **Clinical Data Monitoring**: The company is closely monitoring recent data from competitors, particularly in the PD-1/VEGF space, to inform their strategy [40][41] - **Regulatory Focus**: Emphasis on understanding regulatory requirements from bodies like the FDA and EMA to ensure successful drug approval [61] - **Cash Position**: Crescent Biopharma has $153 million in cash, sufficient to fund operations through 2027 and support their clinical development plans [52] Additional Important Content - **Partnership Strategy**: The company is considering partnerships for CR-001 but aims to generate clinical data first to enhance its value proposition [36] - **ADC Development**: There is significant interest in combining ADCs with PD-1/VEGF bi-specifics, and the company is evaluating potential deals to accelerate this aspect of their pipeline [36][48] - **Long-term Vision**: The leadership envisions building a $30-40 billion company, drawing comparisons to successful peers in the industry [64] Conclusion Crescent Biopharma is strategically positioned in the biopharmaceutical industry with a focus on innovative immuno-oncology therapies. The company is preparing for significant clinical developments and is well-capitalized to execute its plans, aiming for a strong market presence in the coming years.

Summary of Cassava Sciences FY Conference Call Company Overview - **Company**: Cassava Sciences (NasdaqCM:SAVA) - **Industry**: Biotechnology, specifically focused on treatments for Alzheimer's disease and tuberous sclerosis complex (TSC) Key Points and Arguments 1. **Management Changes and Controversy**: The company faced significant controversy and investigations by government agencies, leading to the resignation of the CEO and Senior VP of Neuroscience in 2024. A settlement with the SEC was reached, allowing the company to move forward [4][5][21]. 2. **Focus on Alzheimer's Treatment**: Cassava Sciences is developing a drug, simufilam, aimed at treating Alzheimer's disease by addressing root causes rather than amyloid plaques, which is the focus of most existing drugs [3][4]. 3. **Transition to TSC Research**: Following the failure of phase 3 Alzheimer's trials, the company is pivoting to explore simufilam's potential in treating TSC-related epilepsy, leveraging promising preclinical results [10][18]. 4. **Market Opportunity in TSC**: There are approximately 50,000 TSC patients in the U.S., with 80% to 90% experiencing epilepsy. Current treatments do not provide adequate relief for over 60% of these patients, indicating a significant unmet need [14][15]. 5. **Safety Profile**: The safety profile of simufilam was noted to be remarkable, with no drug-related adverse events reported in over 1,200 patients during Alzheimer's trials [10][21]. 6. **Upcoming Clinical Trials**: A phase 2A proof-of-concept clinical trial for TSC is expected to begin in the first half of 2026, pending IND approval by the end of 2025 [22]. 7. **Financial Position**: As of June, the company had $112 million in cash and no debt. Estimated cash at the end of 2025 is projected to be between $61 million and $65 million, with operational burn rates of $16 to $20 million in the second half of the year [22][23]. Additional Important Information 1. **Research Collaboration**: The company is collaborating with Yale University and the TSC Alliance to further explore the efficacy of simufilam in TSC patients [9][12]. 2. **Expert Team**: The addition of Dr. Angelique Bordey, a leading expert in TSC, to the team is seen as a significant asset for the company's research efforts [12]. 3. **Preclinical Findings**: Preclinical studies in mouse models have shown promising results, including a 60% reduction in seizure frequency in the FCD2 model, indicating potential efficacy in humans [19][20]. 4. **Long-term Vision**: The company aims to address the root causes of diseases rather than just symptoms, which could lead to more effective treatments for patients suffering from TSC and Alzheimer's [18][21].

Summary of Insight Molecular Diagnostics FY Conference Company Overview - **Company**: Insight Molecular Diagnostics - **Industry**: Healthcare, specifically diagnostics Core Points and Arguments 1. **Market Opportunity in Transplant Diagnostics**: The U.S. transplant monitoring market is valued at approximately $2 billion, identified as underpenetrated and inefficient, presenting a significant opportunity for disruption [3][4] 2. **Focus on Point of Care**: The company aims to bring testing closer to patients, enhancing care and capturing market share by simplifying workflows and enabling transplant centers to retain revenue [2][4] 3. **Regulatory and Reimbursement Strategy**: The company has a well-defined path to regulatory approval, with expectations to submit to the FDA by the end of the year, and has established reimbursement rates, notably $2,753 from Multi-X [5][8] 4. **High-Value Recurring Revenue**: The diagnostics space offers high margins, with tests costing tens of dollars to manufacture but charging hundreds, leading to a projected $1 billion global opportunity in regulated transplant testing [6][7] 5. **Partnerships and Collaborations**: The company has partnered with three of the top 10 transplant centers in the U.S. and has a strategic relationship with Bio-Rad Laboratories, which has made multiple equity investments [7][8] 6. **Clinical Validation and Data**: The company has published extensively in transplant diagnostics and has shown improved positive predictive value from 50% to 80%, enhancing the reliability of their tests [10][9] 7. **Registry for Data Collection**: A registry is being established to gather data on advanced monitoring technologies, which will support the case for improved patient outcomes and assist in payer negotiations [10][25] Additional Important Content 1. **Physician Adoption Challenges**: Physicians are cautious about adopting new technologies, requiring head-to-head comparisons with existing tests to ensure equivalency [23][24] 2. **Payer Dynamics**: While CMS recognizes the technology's utility, private payers are more hesitant, necessitating further data collection to demonstrate improved outcomes [25] 3. **Future Investment Plans**: The company plans to focus on incremental investments in transplant diagnostics before potentially expanding into heart and lung diagnostics as cash flow improves [16][20] This summary encapsulates the key insights from the conference, highlighting the strategic direction, market opportunities, and challenges faced by Insight Molecular Diagnostics in the healthcare diagnostics industry.

Summary of Alumis FY Conference Call - September 08, 2025 Company Overview - Alumis is a precision immunology company based in the Bay Area, established four years ago, with a focus on TIK2 inhibitors [3][4] - The lead asset, Envuducitinib (ESK-021), is in Phase 3 for psoriasis and Phase 2 for lupus, with readouts expected in early Q1 2026 and Q3 2026, respectively [3][4][16] Pipeline and Strategic Priorities - The company has four key assets, including a second TIK2 inhibitor that is brain-penetrant and shows a 1:1 ratio between blood and brain [3][4] - A preclinical asset, lenaludomab, is expected to enter the clinic soon, with Phase 1 data anticipated next year [4][5] - The company emphasizes genomic analysis and has identified biomarkers related to TIK2, which may help predict responses in lupus and CNS indications [4][5] TIK2 Inhibition and Clinical Insights - TIK2 is considered a promising target due to its genomic richness and specific mutations that may downregulate its kinase function, potentially leading to safer drugs [7][8] - The protective effect of the P1104A mutation against autoimmune diseases is highlighted, with a 50% average protective rate in lupus and psoriasis [8][9] - The company aims to achieve maximum inhibition of TIK2 without significant side effects, which has been a differentiating factor in their clinical trials [10][24] Competitive Landscape - The oral drug market for psoriasis is growing, with oral drugs currently holding a higher patient share than injectables, despite the latter's higher dollar share [14][15] - Alumis aims to develop a high-efficacy oral drug, with Phase 2 data showing promising results that could change treatment paradigms [15][16] - The company is aware of competitors like Sotyktu and Johnson & Johnson's oral IL-23, and believes that their drug's efficacy and safety profile will differentiate it in the market [27][28] Upcoming Trials and Data Expectations - The Phase 3 trial for psoriasis (Onward) is designed with a placebo-controlled portion and an active control section, with data expected in early Q1 2026 [17][18] - The primary endpoint for the trial is PASI 75, with expectations to exceed 50-60% efficacy at week 16 [20][21] - The company is also preparing for a Phase 2 trial for their CNS-penetrant TIK2 inhibitor, which has been delayed to the first half of 2026 due to resource allocation [56][58] Financial Position and Strategic Partnerships - Alumis ended Q2 2025 with $486 million in cash, projecting a runway into 2027, allowing them to navigate key inflection points [53][55] - The company is considering strategic partnerships for global launches, with a focus on maximizing asset value [37][38] Future Opportunities - High conviction in lupus treatment due to successful trials with interferon inhibition, and ongoing analysis to minimize placebo effects in trials [49][50] - Interest in IBD as a potential indication for TIK2, with ongoing research into the genomic data supporting this [52] - Plans to introduce a new molecule targeting a different mechanism, with Phase 1 expected next year [61][62] Conclusion - Alumis is positioned to make significant advancements in the immunology space with its TIK2 inhibitors, focusing on both efficacy and safety, while navigating a competitive landscape and preparing for upcoming clinical data releases. The strategic financial position allows for flexibility in partnerships and future developments.

Medtronic FY Conference Summary Company Overview - **Company**: Medtronic (NYSE: MDT) - **Event**: FY Conference held on September 08, 2025 Key Points Industry Insights - Medtronic operates in the **medical technology** sector, focusing on various healthcare solutions, including cardiac, diabetes, and surgical products [1][2] Leadership Transition - The CFO, who transitioned from the automotive industry, found Medtronic's culture welcoming and mission-oriented, emphasizing the importance of innovation and efficiency [4][5] Strategic Focus Areas - The CFO is concentrating on: - Short-term performance delivery - Margin expansion strategies - Accelerating growth initiatives [5] Data-Driven Decision Making - The CFO emphasizes a **data-driven approach** to capital allocation, focusing on growth rates, margin opportunities, and return on invested capital [10] Diabetes Business Spin-Off - The operational separation of the diabetes business is progressing well, with plans for an IPO by early 2026. The management team is in place, and the business is expected to operate independently by the end of the calendar year [14][15][16] Cardiac Ablation Solutions (CAS) - CAS is highlighted as a significant growth opportunity, with a market size of **$11 billion**, growing at **20% annually**. The company aims to capture this market by investing in capacity and resources [35][36] Renal Denervation (RDN) - RDN presents a large market opportunity with **18 million potential patients** in the U.S. The product is priced at **$16,000**, making it financially attractive. The company is focused on creating awareness and building referral pathways for this therapy [39][40] Hugo™ Robotic-Assisted Surgery System - Hugo™ is positioned as a key growth area, with **30% of surgeries** in the U.S. currently utilizing robotic assistance. The product is expected to launch in the U.S. by the end of the year, starting with urology [46][48] Margin Expansion and Efficiency - The company is focused on improving gross margins, aiming for an increase of **3.5 to 4 percentage points** over time. Strategies include optimizing the manufacturing footprint and implementing design-to-cost initiatives [52][53] Engagement with Elliott Management - Elliott Management has engaged constructively with Medtronic, suggesting increased MedTech representation on the board and the establishment of committees focused on growth and operations [25][26] Future Outlook - The CFO expresses optimism about Medtronic's growth potential, highlighting the combination of growth opportunities and margin improvements as key drivers for shareholder value [54][55] Additional Insights - The company is committed to maintaining a balance between growth and margin expansion, ensuring that both aspects contribute to high single-digit EPS growth [31][50] - The CFO's previous experience in the automotive industry is seen as beneficial for driving operational efficiency within Medtronic [6][7] This summary encapsulates the critical insights and strategic directions discussed during the Medtronic FY Conference, highlighting the company's focus on growth, innovation, and operational efficiency in the medical technology sector.