Stryker (NYSE:SYK) 2025 Investor Day November 13, 2025 02:30 PM ET Speaker7Good afternoon. That got you excited, right? Good afternoon. Hey, we're excited to have you here. Welcome to Stryker's 2025 Investor Day. Welcome to those on the webcast as well. I think what you'll find here is we have an absolutely action-packed agenda. We've got a number of speakers from across the business to hit for a variety of topics that we'll share with you here today. A couple of logistics items in here will be roughly two ...

Summary of RAPT Therapeutics Conference Call Company Overview - **Company**: RAPT Therapeutics (NasdaqGM:RAPT) - **Key Product**: Ozureprubart (RPT-904), a half-life extended anti-IgE therapy targeting food allergies and chronic spontaneous urticaria (CSU) [3][4] Core Insights and Arguments - **Product Differentiation**: - Ozureprubart is designed to improve upon Xolair, a 20-year-old drug, by offering a longer half-life (60 days vs. 24 days for Xolair) and reduced dosing frequency (4-6 injections per year vs. 13-26 for Xolair) [5][6] - It aims to address limitations of Xolair, including frequent dosing and restrictions based on patient weight and IgE levels [4][6][23] - **Clinical Study Results**: - A recent Phase 2 study in China showed that Ozureprubart administered every 8 or 12 weeks performed numerically better than Xolair in terms of UAS7 scores, with durability lasting up to 16 weeks [7][9] - The drug was well tolerated, with safety profiles comparable to Xolair [9] - **Regulatory Strategy**: - Plans for two Phase 3 pivotal studies with 300-350 patients each, focusing on UAS7 at week 12 as the primary endpoint for approval [10][12] - Collaboration with Shanghai Jeyou Pharmaceutical for additional studies in China, which will contribute to the overall safety database for FDA submissions [12][18] - **Market Potential**: - Current market checks indicate that Xolair is predominantly used in adolescents and young adults, with a significant unmet need for patients requiring less frequent dosing [21][22] - Approximately 25-30% of food allergy patients are ineligible for Xolair due to high IgE levels, presenting a significant opportunity for Ozureprubart [23][24] Additional Important Points - **Study Design**: The ongoing Prestige study will include a placebo-controlled design with a 2:2:1 allocation for Q8, Q12, and placebo groups, aiming for a 90% confidence level in detecting omalizumab-like activity [25][29] - **Food Allergy Treatment**: Ozureprubart aims to treat multiple allergens, unlike oral immunotherapy, which is limited to single allergens and has tolerability issues [23][24] - **Future Studies**: Plans to explore the efficacy of Ozureprubart across various allergens, with a focus on achieving a label that is independent of IgE and weight [23][24][33] Conclusion RAPT Therapeutics is positioning Ozureprubart as a significant advancement in the treatment of food allergies and CSU, with a focus on improved dosing convenience and broader patient eligibility. The company is actively pursuing clinical studies to support its regulatory strategy and market entry, while addressing the limitations of existing therapies like Xolair.

Summary of Mineralys Therapeutics Conference Call Company Overview - **Company**: Mineralys Therapeutics (NasdaqGS: MLYS) - **Focus**: Development of aldosterone synthase inhibitors (ASI) targeting cardiorenal metabolic disorders, primarily hypertension [1][2] Industry Context - **Market Opportunity**: Approximately 20 million patients in the U.S. suffer from resistant and uncontrolled hypertension, with 10 million specifically identified as resistant hypertension patients [4][5] - **Competitive Landscape**: The ASI class is emerging as a new treatment option for hypertension, with recent data from competitors like AstraZeneca's Baxdrostat [2][3] Key Clinical Data - **Clinical Trials**: Successful outcomes from pivotal studies LAUNCH HTN and ADVANCE HTN, with significant blood pressure reductions observed [1][2] - **Efficacy**: Lorundrostat demonstrated a 15-19 mmHg reduction in blood pressure compared to the typical 5 mmHg improvement seen with existing treatments [5][6] - **Patient Demographics**: Strong representation of Black or African American patients in trials, addressing a high-risk population for hypertension [9][10] Drug Profile - **Selectivity**: Lorundrostat shows a selectivity ratio of 374:1 for aldosterone over cortisol, compared to Baxdrostat's 101:1, indicating a better safety profile [11][12] - **Half-Life**: Lorundrostat has a half-life of 10-12 hours, aligning with the diurnal pattern of aldosterone secretion, which may enhance safety [12][13] - **Safety Signals**: Lower incidence of hyperkalemia compared to Baxdrostat, with 8% incidence above 5.5 mEq/L for lorundrostat versus 11% for Baxdrostat [15][16] Market Strategy - **Target Population**: Initial focus on resistant hypertension, with plans to expand into uncontrolled hypertension as prescriber comfort increases [27][30] - **Commercialization Approach**: Open to partnerships but emphasizes the importance of selecting the right partner to maximize the drug's potential [45][46] - **Market Size**: Targeting a broad market of 120 million people with hypertension, with a focus on the top 60,000 prescribers [46][47] Future Developments - **NDA Filing**: Anticipated NDA filing by the end of 2025, with ongoing collection of safety and efficacy data beyond the initial 12-week trials [37][38] - **Additional Studies**: Ongoing studies in chronic kidney disease (CKD) and obstructive sleep apnea (OSA) to explore additional benefits and potential label expansions [42][43] Conclusion - **Investment Potential**: Mineralys Therapeutics is positioned with a best-in-class molecule in a growing market, with strong clinical data supporting its efficacy and safety, making it a compelling investment opportunity in the pharmaceutical sector [19][50]

Dianthus Therapeutics Conference Call Summary Company Overview - **Company**: Dianthus Therapeutics (NasdaqCM:DNTH) - **Focus**: Biotech company specializing in autoimmune diseases with two main programs, including Claseprubart, a potent active C1s inhibitor [2][3] Key Points and Arguments Lead Program: Claseprubart - **Mechanism**: Claseprubart is an active C1s inhibitor with a half-life of 60 days, aimed at delivering best-in-class efficacy for conditions like Myasthenia Gravis (MG) [3][4] - **Efficacy**: Phase two data for MG showed a significant 3-point difference on the MG-ADL scale compared to placebo, indicating superior efficacy over existing therapies [12] - **Safety Profile**: Improved safety profile compared to current complement therapies, with no box warning or REMS program required [3][4][20] - **Dosing Strategy**: Plans to test both bi-weekly and monthly dosing in phase three trials, with expectations of maintaining efficacy at lower dosing frequencies [4][17] Upcoming Trials and Data - **CIDP and MMN**: Ongoing development in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Multifocal Motor Neuropathy (MMN), with interim analysis for CIDP expected in Q2 2026 [5][29] - **Funding**: Company has raised approximately $525 million, providing a runway into 2028 [5] Competitive Landscape - **Market Position**: Currently, only C5 inhibitors are approved for MG, with Claseprubart positioned to offer a safer and potentially more effective alternative [9][10] - **Comparison with Competitors**: Other therapies like Enjaymo (C1s inhibitor) and Regeneron's simdisiran (C5 inhibitor) are mentioned, highlighting the unique advantages of Claseprubart [10][16] New Pipeline Addition - **Bifunctional Fusion Protein**: Recently in-licensed a bifunctional fusion protein targeting both innate and adaptive immune systems, expected to enter clinical trials soon [5][41] - **Indications**: Targeting diseases where both immune systems are involved, with potential for superior efficacy [6][45] Safety and Regulatory Considerations - **Safety Monitoring**: No significant safety concerns reported in phase two trials, with no cases of autoimmune activation or serious infections [20][21] - **Regulatory Strategy**: Plans to align with FDA guidelines to streamline safety monitoring processes in future trials [20] Market Potential - **MMN Market**: Although smaller, MMN presents an opportunity for Dianthus to leverage existing infrastructure and expertise from MG and CIDP programs [39] - **Future Growth**: Anticipation of increased diagnosis and treatment options in MMN, similar to trends observed in MG and CIDP [39] Additional Important Insights - **Investor Sentiment**: Positive reception from physicians regarding MG data has accelerated recruitment for CIDP trials [34][36] - **Trial Design**: Emphasis on open-label responder portions in trials to enhance patient experience and recruitment [28][29] This summary encapsulates the key points discussed during the conference call, highlighting Dianthus Therapeutics' strategic direction, competitive advantages, and future growth potential in the biotech sector focused on autoimmune diseases.

Summary of Maze Therapeutics Conference Call Company Overview - **Company**: Maze Therapeutics (NasdaqGM:MAZE) - **Focus**: Development of small molecule precision medicines, primarily targeting kidney diseases, particularly APOL1-mediated kidney disease [4][11] Key Highlights from the American Society of Nephrology (ASN) Conference - **Abstracts**: Maze Therapeutics had seven abstracts accepted at ASN, showcasing significant research contributions [4] - **Genotyping Study**: - Previous literature indicated that approximately 13% of the general population has pathogenic variants causing APOL1 kidney disease - Maze's study found about 18% prevalence in enriched kidney disease patients, indicating a higher incidence due to the specific population studied [5][6] - Approximately 1 million individuals in the U.S. have these variants, with at least 250,000 potentially benefiting from therapy [5] - Breakdown: 40% of affected individuals have diabetes, while 60% do not [6] - **Disease Progression**: - The progression of APOL1-mediated kidney disease occurs at similar rates in patients with and without diabetes [6][7] - A protective variant, N264K, was identified, showing protective effects regardless of diabetes status [7][19] Mechanistic Insights - **Pathogenic Mechanism**: APOL1 variants lead to nephrotoxicity through aberrant pore channel function in podocytes [9][10] - **Therapeutic Approach**: Maze's dual mechanism APOL1 inhibitor aims to block the pore and disrupt its assembly, showing significant potency advantages in preclinical models [11][12] Clinical Development Plans - **Maze 829 Program**: - Aiming for clinical proof of concept (POC) in broad APOL1-mediated kidney disease by Q1 2026, targeting a minimum 30% reduction in proteinuria [12][13] - The 30% threshold is based on historical data correlating with clinical significance and regulatory guidelines [21][23] - **Patient Cohorts**: Expecting data from both diabetes and non-diabetes cohorts, with a focus on demonstrating POC in a broader patient population [14][15] Market Potential - **Patient Population**: The broader AMKD landscape includes approximately 250,000 patients, significantly larger than the FSGS population [31][32] - **Comparative Advantage**: Maze aims to differentiate its therapy from existing treatments like inaxaplin by demonstrating superior efficacy and safety profiles [34][44] Additional Insights on SLC6A19 (782) Program - **PKU Treatment**: The therapy targets severe classical PKU, aiming to reduce plasma phenylalanine levels significantly, with a goal of improving patient outcomes [39][40] - **CKD Insights**: The program has shown promise in improving kidney health, with genetic associations and in vivo proof of concept supporting its efficacy [41][42] Conclusion - Maze Therapeutics is positioned to potentially lead in the treatment of APOL1-mediated kidney disease with its innovative therapeutic approaches and significant market opportunity, while also exploring promising avenues in PKU and CKD treatments [44][46]

Summary of Vera Therapeutics Conference Call Company Overview - **Company**: Vera Therapeutics (NasdaqGM:VERA) - **Event**: Conference Call at TD Cowen I&I Summit on November 13, 2025 Key Industry Insights - **Focus**: IgA nephropathy treatment and clinical trial results - **Recent Achievements**: Presentation at ASN and publication in the New England Journal of Medicine [1][2] Core Findings from Clinical Trials - **Phase 2b Results**: - Two-thirds reduction in autoantigen over two years [3] - 75% of patients showed resolution of hematuria [3] - Over 50% reduction in proteinuria, a key FDA measure for accelerated approval [4] - Annual rate of loss of GFR was -0.6 mL/min, comparable to healthy population [4] - **Phase 3 Results**: - 46% reduction in proteinuria for atacicept-treated patients vs. 7% for placebo [4] - Placebo-adjusted reduction in proteinuria was 42%, exceeding the FDA's 30% threshold [5] - Consistent efficacy across various patient subgroups, including age, sex, and race [5][12] - **Safety Profile**: - Favorable safety data comparable to placebo, with no evidence of opportunistic infections [9][30] - Mild injection site reactions were self-limited [10] Regulatory and Market Position - **BLA Submission**: Submitted to FDA, with anticipation of bringing the new medicine to market next year [2][12] - **Market Strategy**: Confidence in leading position due to comprehensive data set and positive patient experience [14][21] Competitive Landscape - **Comparison with Competitors**: - Discussion on differential efficacy between atacicept and competitor Sibeprenlimab, particularly regarding proteinuria reduction [11][20] - Emphasis on the strength of atacicept's data set in the context of other B-cell modulating drugs [23] Future Directions - **Pioneer Basket Study**: Phase 2 program focusing on IgA nephropathy and other autoimmune kidney diseases, with data expected in 2026 [31][32] - **Long-term Goals**: Aim to stabilize GFR and reduce the need for dialysis or transplant in patients [19][26] Additional Considerations - **Hematuria as a Marker**: Early reduction in hematuria indicates anti-inflammatory benefits and potential long-term kidney function preservation [18][19] - **Hypogammaglobulinemia Concerns**: No significant findings in atacicept program, contrasting with other drugs in the class [28][30] This summary encapsulates the critical insights and data shared during the conference call, highlighting Vera Therapeutics' advancements in treating IgA nephropathy and its strategic positioning in the market.

Summary of OrthoPediatrics Conference Call Company Overview - **Company**: OrthoPediatrics (NasdaqGM: KIDS) - **Focus**: Pediatric orthopedics, specifically in trauma deformity and OPSB (Orthotic and Prosthetic Services Business) - **Sales Contribution**: Trauma Deformity and OPSB account for approximately 75% of company sales [1][1] Key Financial Performance - **Q3 Performance**: Trauma Deformity sales increased by 17%, and OPSB sales rose over 20% [1][1] - **Sales Guidance**: The company lowered its full-year sales guidance due to temporary issues, not related to competition or market opportunity [20][20] - **Growth Rate**: The company aims for a baseline growth rate of 12%, with potential for higher growth in certain quarters [29][29] Product Innovation and Strategy - **New Product Launches**: Recent launches include PD HIP products aimed at addressing developmental dysplasia of the hip (DDH) [8][8] - **R&D Pipeline**: Plans to launch four new products next year, with an increasing number in subsequent years [9][9] - **Market Expansion**: The company is expanding its clinic presence, having already surpassed its goal of four new markets for 2025, reaching seven [13][13] Market Dynamics - **Total Addressable Market (TAM)**: The company identifies 80 target markets in the US, with plans to penetrate 27 of those [19][19] - **Competitive Landscape**: Disruption in larger orthopedic companies may provide opportunities for OrthoPediatrics to gain market share and attract talent [46][46] Challenges and Risks - **Sales Miss**: The company experienced a sales miss due to unpredictable capital sales, particularly with a navigation platform for pediatric spine surgery [21][21][22][22] - **Latin America Operations**: The company has pulled set sales from Brazil out of guidance due to complex market dynamics and cash flow concerns [42][42] Future Outlook - **Profitability Goals**: The company maintains confidence in achieving its 25% margin and profitability targets despite recent disruptions [63][63] - **Long-term Vision**: OrthoPediatrics aims to evolve into a broader pediatric healthcare company, exploring opportunities in other subspecialties beyond orthopedics [66][66][68][68] Additional Insights - **Procedure Trends**: Stable pediatric procedure volumes are expected to continue into Q4 and beyond [44][44] - **Innovation Cycle**: The company is in the early stages of a significant R&D cycle, with multiple product launches anticipated in the coming years [60][60] This summary encapsulates the key points discussed during the OrthoPediatrics conference call, highlighting the company's performance, strategic initiatives, market dynamics, and future outlook.

Rapport Therapeutics Conference Call Summary Company Overview - Rapport Therapeutics is focused on precision neuroscience, leveraging receptor-associated proteins to enhance treatment efficacy and tolerability for patients [2][3] Key Programs - The lead program, RAP-219, is a TARP gamma-8 AMPA modulator, showing promising results in epilepsy and ongoing programs in bipolar mania [2][3] - RAP-219 has demonstrated a 78% median reduction in clinical seizure frequency and a 24% seizure freedom rate in a proof of concept study [11][12] FDA Engagement and Study Plans - The company plans to meet with the FDA by the end of 2025 for an end of phase two meeting, aiming to start phase three studies by Q3 2026 [4][5] - Two parallel registrational studies are planned, following a standard protocol for focal epilepsy [4][5] Safety and Efficacy Insights - The biological thesis focuses on modulating the AMPA receptor through TARP gamma-8, which is expressed in key brain structures related to focal seizures [6][8] - The tolerability profile from phase two data showed a 10% discontinuation rate, indicating best-in-class tolerability for anti-seizure medications [9] - Concerns regarding adverse events (AEs) related to psychiatric disorders were addressed, with no significant findings in their trials [10] Patient Population and Efficacy Expectations - The proof of concept study involved a highly refractory patient population, with 70% on three or four anti-seizure medications [16] - The efficacy results are expected to translate well into the broader phase three patient population, despite potential variability [18][13] Bipolar Mania and Other Indications - The company is exploring RAP-219 for bipolar mania, supported by the drug's mechanism targeting excitatory processes in the limbic structure [24][26] - Enrollment for the bipolar trial is progressing well, with data expected in 2027 [26] Market Opportunity - The potential market opportunity for RAP-219 in epilepsy is estimated to be multi-billion dollars, with expected utilization similar to existing treatments like Keppra [29] Upcoming Milestones - Key updates expected include the end of phase two meeting with the FDA, additional data analyses at AES in December 2025, and the initiation of phase three studies in 2026 [30][31] - The company has sufficient cash reserves, approximately $500 million, to fund operations through 2029 [32]

Summary of Abeona Therapeutics Conference Call Company Overview - **Company**: Abeona Therapeutics (NasdaqCM:ABEO) - **Industry**: Biotechnology, specifically focused on cell and gene therapy - **Product**: ZivaSkin, approved for treating recessive dystrophic epidermolysis bullosa (RDEB) [2][80] Key Points and Arguments Product Launch and Demand - ZivaSkin was approved in Q2 2025, and the company is making significant progress towards its U.S. launch [2][80] - Patient demand is strong, with favorable coverage from payers and interest from Centers of Excellence (QTCs) [2][80] - The company has received 12 ZivaSkin Product Order Forms (ZPOFs) from identified patients, indicating a good conversion rate [28][29] Manufacturing and Sterility Testing - A temporary pause was placed on patient biopsy collection to optimize a sterility test after a false positive was detected during the first manufacturing run [3][4] - The FDA required a more robust sterility testing process, which has now been validated, reducing the risk of false positives from 35% to less than 1% [19][20] - The shelf life of the manufactured product is 84 hours, necessitating careful scheduling of surgeries [13][20] Patient Treatment and Logistics - The company is working to schedule surgeries within a tight timeframe, with a focus on maximizing patient logistics [23][24] - The average time from patient identification to treatment is expected to decrease from 3-4 months to 2-3 months as payer policies improve [31][32] Expansion of Treatment Centers - Abeona aims to activate 5-7 QTCs by 2026, with ongoing discussions with hospitals interested in becoming treatment centers [46][47] - The company is strategically considering geographic locations to ensure broad access for patients [47] Reimbursement and Coverage - A permanent J Code has been received, which is expected to streamline the reimbursement process for hospitals [58][60] - The payer mix shows that 60% of patients are commercially insured, with baseline coverage established for all 50 states [59][60] Future Growth and Capacity - The company plans to increase manufacturing capacity from 6 to 10 slots per month by mid-2026, with potential for further expansion [72][73] - The total addressable market (TAM) is estimated at 750 patients, with an expectation that each patient may require an average of two treatments [75][76] Pipeline and Financial Outlook - Abeona has a gene therapy platform with ongoing preclinical assets, including ABO 503, which has been selected for a rare disease pilot program by the FDA [78][79] - The company reported $207.5 million in cash, providing a two-year operating runway, with expectations to become profit-generating in the first half of 2026 [80] Additional Important Information - The company is focused on building relationships with Centers of Excellence to enhance patient access and treatment options [54][55] - There is a positive outlook on the competitive landscape, as ZivaSkin is an approved product, which may favor its utilization over investigational products [54][56]

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Core Areas**: Biopharma business and drug development focusing on rosnilimab, ANB033, and a royalty business from GSK's Jemperli [2][3] Key Points on Drug Development - **Rosnilimab**: - A PD-1 pathogenic T-cell depleter aimed at treating arthritis, with plans to advance into phase three trials [2] - Recent trial in ulcerative colitis (UC) did not meet criteria for progression; the drug was found ineffective for UC despite being safe [4][5] - High bar for remission was not met, leading to a focus on rheumatoid arthritis (RA) instead [7][11] - Data from a 424-patient trial in RA showed 85% of patients maintained low disease activity or remission after 14 weeks off the drug [12] - Market opportunity in RA is significant, with a second-line plus market valued at $10 billion in the U.S. alone [15] - **ANB033**: - Currently enrolling patients in initial celiac disease trials, with data expected by the end of Q4 next year [2][14] - The company is exploring additional indications for this drug, including eosinophilic esophagitis (EOE) [30] Royalty Business - **Jemperli Royalties**: - Expected to generate significant revenue, with GSK guiding for over $2.7 billion in sales, translating to approximately $390 million in royalty value for AnaptysBio [33] - The royalty business is being separated to highlight its value, which is expected to exceed the current market cap of AnaptysBio [32][36] - The separation aims to provide clarity and attract investors focused on growth opportunities [36] Market Dynamics and Competitive Landscape - **Market Opportunity**: - There are 500,000 patients cycling off TNF therapies, with 150,000 having no other treatment options, indicating a substantial unmet need [15] - The competitive landscape includes other companies like Teva and Novartis, which are also pursuing treatments for celiac disease and other indications [28][29] - **Safety and Efficacy Concerns**: - Comparisons were made with Lilly's PD-1 agonist, which faced efficacy issues, suggesting that AnaptysBio's drug has a better safety profile [18][19] - The company emphasizes that the class of drugs does not have inherent safety issues, but rather operational challenges in other trials [20] Future Plans and Financial Position - **Separation Timeline**: - The split into two companies is expected by the end of next year, with flexibility on timing based on regulatory processes [39][40] - AnaptysBio is well-funded with $300 million in cash, which will support ongoing and future trials [42] - **Strategic Focus**: - The company is committed to advancing rosnilimab in RA while also exploring other indications for ANB033 [14][45] - The royalty business will operate with a low cost of capital, focusing on returning value to shareholders [33][41] Conclusion - AnaptysBio is strategically positioning itself for growth through the advancement of its drug candidates and the separation of its royalty business, which is expected to provide significant revenue potential. The focus remains on addressing unmet medical needs in autoimmune diseases while ensuring a strong financial foundation for future developments.