Financial Data and Key Metrics Changes - The company reported revenue of $9 billion, reflecting an 8.7% increase year-over-year and a 6% organic growth, which is a 50 basis point acceleration from the previous quarter [18][19] - Adjusted gross margin was 64.9%, ahead of expectations, with a 30 basis point benefit from pricing [19][20] - Adjusted operating profit was $2.2 billion, resulting in an adjusted operating margin of 24.1%, also ahead of expectations [21] Business Line Data and Key Metrics Changes - The cardiovascular portfolio delivered 11% year-over-year revenue growth, with 13% growth in the U.S., marking the strongest growth in the last 10 years, excluding COVID comparisons [12] - Cardiac rhythm management (CRM) contributed 15% of total revenue and grew 5%, driven by double-digit growth in Micra and over 70% growth in Aurora EV-ICD [12][13] - The neuroscience portfolio grew 3%, with expectations for the pipeline to impact growth in the fourth quarter [14][15] Market Data and Key Metrics Changes - U.S. growth was 6% year-over-year, the strongest performance since fiscal year 2019, excluding COVID comparisons [19] - In China, low single-digit growth was reported while navigating volume-based procurement challenges [19] - Western Europe experienced high single-digit growth, contributing to balanced geographical performance [19] Company Strategy and Development Direction - The company is focused on expanding its innovation pipeline, particularly in high-growth areas such as hypertension treatment with Symplicity and urinary incontinence with Altaviva [2][3] - The launch of the Hugo robotic system is seen as a significant growth driver, with initial installations and positive feedback from early cases [5][6] - The company is committed to M&A strategies, focusing on tuck-in deals that align with existing business segments [59][60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining revenue and earnings growth, highlighting strong contributors like CAS and CRM [10][24] - The company anticipates continued growth from new product launches and market expansions, particularly in the U.S. [10][39] - There is an expectation for high single-digit EPS growth in fiscal year 2027, despite some headwinds from tariffs and M&A activities [24][68] Other Important Information - The planned separation of the MiniMed diabetes business is on track, with expectations for completion by the end of calendar year 2026 [18] - The company is investing in R&D and marketing to support growth areas, particularly in renal denervation and Altaviva [66] Q&A Session Summary Question: Comments on accelerating revenue growth next year and high single-digit earnings growth - Management indicated that growth will continue, driven by strong performance in CAS and other growth drivers like Symplicity and Altaviva [30][39] Question: Monitoring progress for RDN and Altaviva - Management mentioned strong leading indicators, including training of over 500 physicians and opening of new accounts for RDN [43] Question: Thoughts on capital allocation and M&A strategy - The company is focused on tuck-in M&A opportunities that align with existing business segments, prioritizing high-growth areas [59][60] Question: Impact of Hugo on surgical business growth - Management expressed excitement about the Hugo system's potential, noting positive feedback from initial cases and strong leading indicators [87]

Core Insights - Scienture Holdings, Inc. is focused on enhancing patient care through the development and commercialization of novel pharmaceutical products, specifically highlighting the upcoming launch of REZENOPY and the growth of ARBLI [1][4][17] Group 1: Product Developments - ARBLI, the first FDA-approved ready-to-use oral liquid formulation of losartan, addresses a significant market need in the U.S. losartan market, which has an annual size of approximately $241 million and 72 million prescriptions [2][8] - The company plans to launch REZENOPY, an opioid overdose emergency treatment, in Q2 2026, targeting a market with annual sales of $143 million and 9.2 million prescriptions [4][14] Group 2: Market Access and Growth Initiatives - Scienture has implemented various initiatives to expand access to ARBLI, including securing GPO agreements and expanding formulary inclusion, which will increase patient and provider access [4][5] - The company has established partnerships with BlinkRx to enhance patient access and adherence through a digital pharmacy platform [5] Group 3: Financial Performance and Outlook - Scienture reported a significant improvement in its balance sheet, with a cash position of approximately $7.0 million as of December 31, 2025, and a reduction in outstanding debt [7] - The company anticipates continued growth in ARBLI prescription volumes and improved commercial efficiency, expecting Q1 2026 to reflect the momentum built in prescriber adoption and patient demand [6][7]

Core Insights - Mineralys Therapeutics, Inc. is focused on developing treatments for hypertension and related comorbidities, with a significant emphasis on its drug candidate lorundrostat, which has shown promising results in clinical trials [1][8] Recent Clinical Highlights and Upcoming Milestones - The company has completed four successful clinical trials for lorundrostat, demonstrating its efficacy and safety profile, particularly in patients with uncontrolled hypertension (uHTN) and resistant hypertension (rHTN) [5] - The Phase 2 Explore-OSA trial is set to report topline results in Q1 2026, evaluating lorundrostat's effects on obstructive sleep apnea (OSA) and blood pressure [7] - An NDA for lorundrostat was submitted to the FDA in late 2025, following three positive clinical trials that highlighted its safety and 24-hour blood pressure control [7] - The ongoing Transform-HTN open-label extension trial allows participants to continue receiving lorundrostat, providing additional long-term safety and efficacy data [7] About Lorundrostat - Lorundrostat is a proprietary, orally administered aldosterone synthase inhibitor designed to treat uHTN, rHTN, chronic kidney disease (CKD), and OSA, with a 374-fold selectivity for aldosterone-synthase inhibition over cortisol-synthase [4][8] - The drug has demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants, with a half-life of 10-12 hours [4] Company Overview - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, focusing on innovative treatments for hypertension and related conditions [8]

Core Insights - Scienture Holdings, Inc. reported significant revenue growth to $590,050 and a substantial increase in gross profit to $574,621 for Q3 2025 compared to Q3 2024 [2][5][19] - The company launched Arbli, the first FDA-approved ready-to-use liquid formulation of losartan for hypertension, which has been added to key national payor formularies, expanding access to over 100 million covered lives [2][3] - Scienture is preparing to launch REZENOPY, an opioid overdose emergency treatment, in Q1 2026, leveraging a strong commercial infrastructure [2] Financial Performance - Net revenue increased from approximately $65,000 in Q3 2024 to $590,050 in Q3 2025, representing a growth of over 800% [5][19] - Gross profit rose from approximately $4,000 in Q3 2024 to $574,621 in Q3 2025, indicating a significant improvement in profitability [5][19] - The company strengthened its balance sheet by reducing outstanding debt and enhancing its cash position to over $8 million as of November 13, 2025 [2] Product Development - Arbli is a proprietary formulation of losartan, approved for treating hypertension in patients over six years old, and offers a convenient liquid alternative without the need for compounding [3][4] - The product has a shelf life of 24 months at room temperature and is designed to provide consistent quality and dosing accuracy [4] - Scienture's development pipeline remains strong, with ongoing evaluations for additional products to enhance its commercial portfolio [2] Market Position - The launch of Arbli has allowed Scienture to penetrate approximately 20% of the U.S. institutional market through agreements with over 2,500 healthcare institutions [2] - The company aims to create long-term value through sustained adoption of its products across various channels, including retail and long-term care [2]

Core Insights - Mineralys Therapeutics is preparing for the submission of a New Drug Application (NDA) for lorundrostat, anticipated by late 2025 or early 2026, following positive pre-NDA feedback from the FDA [2][3] - The company has completed enrollment in the Explore-OSA trial, with topline results expected in Q1 2026, which will evaluate lorundrostat's efficacy in patients with obstructive sleep apnea and hypertension [1][2] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and investments totaling $593.6 million, a significant increase from $198.2 million at the end of 2024, indicating a strengthened balance sheet [4][25] - Research and Development (R&D) expenses for Q3 2025 were $31.5 million, down from $54.0 million in Q3 2024, primarily due to the conclusion of the lorundrostat pivotal program [5] - General and Administrative (G&A) expenses rose to $9.7 million in Q3 2025 from $6.1 million in Q3 2024, driven by increased compensation and professional fees [6] - The net loss for Q3 2025 was $36.9 million, a decrease from $56.3 million in Q3 2024, reflecting improved expense management [8][23] Clinical Development - Lorundrostat is being developed as a treatment for uncontrolled and resistant hypertension, chronic kidney disease, and obstructive sleep apnea, with a focus on normalizing aldosterone production [2][17] - The company has completed four successful clinical trials for lorundrostat, demonstrating its efficacy and safety profile [18] Market Context - Hypertension affects a significant portion of the population, with less than 50% of patients achieving their blood pressure goals with current medications, highlighting the need for new treatments like lorundrostat [10][11] - Chronic Kidney Disease (CKD) affects over 10% of the global population, and its relationship with hypertension presents a substantial market opportunity for effective therapies [12][13]

Core Insights - Mineralys Therapeutics presented clinical data for lorundrostat at ASN Kidney Week 2025, highlighting its potential in treating hypertension and chronic kidney disease (CKD) [1][2] - The Explore-CKD trial demonstrated significant reductions in blood pressure and albuminuria, supporting the drug's efficacy [2][4] - The Launch-HTN trial was recognized in the "Best of JAMA and NEJM" session, showcasing lorundrostat's robust performance in managing resistant hypertension [2][4] Clinical Trial Results - The Explore-CKD trial (NCT06150924) showed a 9.3 mmHg reduction in automated office systolic blood pressure (AOSBP) and a 25.6% reduction in urinary albumin-to-creatinine ratio (UACR) after four weeks of treatment with lorundrostat [2][7] - The Launch-HTN trial reported a 16.9 mmHg absolute reduction in systolic blood pressure at week 6 and a 19 mmHg reduction at week 12, with significant placebo-adjusted results [4][10] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile, with serious adverse events occurring in only 3% of participants during treatment, compared to none in the placebo group [3][5] - Discontinuations due to treatment-emergent adverse events were low, indicating good tolerability among participants [3] Broader Implications - The results from both trials suggest that lorundrostat could address the growing burden of cardio-renal-metabolic diseases, particularly in high-risk populations [2][5] - The ongoing Transform-HTN study aims to evaluate the long-term safety and efficacy of lorundrostat, further supporting its clinical potential [5][6] Company Overview - Mineralys Therapeutics is focused on developing therapies targeting hypertension and related comorbidities, with lorundrostat as its lead candidate [1][16] - The company aims to file a New Drug Application (NDA) with the FDA by late 2025 or early 2026, based on the promising results from its clinical trials [2][15]

Core Insights - New analysis confirms that aprocitentan significantly reduces blood pressure and albuminuria in patients with true resistant hypertension and high cardiovascular risk, including those with chronic kidney disease [1][3] Company Overview - Idorsia Ltd is set to present new findings from the Phase 3 PRECISION study of aprocitentan at the American Society of Nephrology Kidney Week 2025 in Houston, TX, from November 5 to 9, 2025 [2] - Aprocitentan is a once-daily, orally active dual endothelin receptor antagonist, approved as TRYVIO in the US for systemic hypertension treatment in combination with other antihypertensives since October 2024 [5] - The drug is also approved as JERAYGO for resistant hypertension treatment in the European Union, UK, and Switzerland, with a marketing authorization application under review in Canada [5] Clinical Findings - A poster presentation titled "Is Aprocitentan's Effect on Albuminuria Merely Due to Lowered BP? Subgroup Analysis of the PRECISION Trial" will take place on November 6, highlighting significant reductions in systolic blood pressure and Urine Albumin-to-Creatinine Ratio (UACR) compared to placebo across all subgroups [3] - The analysis indicates that the reductions in UACR are not solely due to lowered blood pressure, suggesting additional renal-protective mechanisms of aprocitentan, such as decreased glomerular permeability and functional tubular changes [3] Upcoming Events - Idorsia will also participate in the American Heart Association Scientific Sessions 2025 in New Orleans, LA, from November 7 to 10, with a symposium discussing the next era in hypertension treatment [4]

Core Insights - Scienture Holdings, Inc. has successfully added Arbli (losartan potassium) Oral Suspension to key national payors' formularies, expanding access to over 100 million covered lives in the U.S. [1][2][3] Product Overview - Arbli is the first FDA-approved ready-to-use oral suspension formulation of losartan potassium, providing a safe and convenient alternative to solid dosage forms [2][4]. - The U.S. losartan market is valued at approximately $256 million annually, with over 71 million prescriptions written each year, indicating a significant commercial opportunity for Scienture [2][4]. - Arbli is designed for patients over six years old and is indicated for the treatment of hypertension, reducing the risk of stroke, and treating diabetic nephropathy in certain patients with type 2 diabetes [4][7]. Market Impact - The inclusion of Arbli in major national formularies reflects the confidence health plans have in Scienture's products and enhances patient access to affordable treatment options [3][4]. - The product's unique formulation does not require compounding, has a reduced dosing volume, and offers a long shelf life at room temperature, addressing common issues associated with traditional losartan prescriptions [4][5]. Company Strategy - Scienture's leadership emphasizes the commitment to sustainable growth and improving public health outcomes through expanded access to its product portfolio [3][4]. - The company aims to make its specialty products available to millions more patients across the country, indicating a broader strategy for market penetration [3].

Core Viewpoint - Mineralys Therapeutics, Inc. is set to report its third-quarter financial results on November 10, 2025, focusing on its development of medicines targeting hypertension and related comorbidities [1] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, specializing in treatments for hypertension and related conditions such as chronic kidney disease (CKD) and obstructive sleep apnea (OSA) [3] - The company's lead product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor [3] - Mineralys was founded by Catalys Pacific and aims to address diseases driven by dysregulated aldosterone [3] Upcoming Financial Results - The financial results for the third quarter ended September 30, 2025, will be announced after market close on November 10, 2025 [1] - A conference call will be held on the same day at 4:30 p.m. ET, with details provided for both domestic and international participants [2]

Core Insights - Scienture Holdings, Inc. has launched commercial sales of Arbli, the first FDA-approved ready-to-use oral suspension of losartan potassium, marking a significant milestone in the company's growth [1][4][5] - The U.S. losartan market is valued at approximately $256 million annually, with over 71 million prescriptions written each year, presenting a substantial commercial opportunity for Scienture and its partners [2][3] - Arbli is designed to provide a safe, consistent, and convenient therapeutic option for patients who require a liquid formulation, addressing unmet market needs [5][6] Company Overview - Scienture Holdings, Inc. focuses on developing, commercializing, and distributing novel specialty pharmaceutical products that enhance value for patients, physicians, and caregivers [1][11] - The company has a highly experienced team dedicated to bringing unique specialty products to market, with a commitment to addressing unmet market needs [11] Product Details - Arbli is a proprietary formulation of losartan, an angiotensin receptor blocker (ARB) for hypertension, approved for patients over six years old [5][6] - It is the only liquid formulation of losartan that does not require compounding, offering reduced dosing volume and a shelf life of 24 months at room temperature [5][6] - The product is indicated for treating hypertension, reducing stroke risk in patients with hypertension and left ventricular hypertrophy, and treating diabetic nephropathy in certain type 2 diabetes patients [7][13] Market Strategy - Scienture is executing a multi-channel promotional campaign targeting healthcare professionals and has established agreements with pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) to enhance market access [3][4] - The agreements expand Arbli's market access to over 2,500 healthcare institutions, potentially penetrating an estimated 20% of the U.S. institutional market [3][4]