Stanley Druckenmiller is a Wall Street legend whose trades are truly worth tracking due to how consistently he has been winning. He has been piling into Natera (NASDAQ:NTRA), Insmed (NASDAQ:INSM), and Teva Pharmaceuticals (NYSE:TEVA) as of late, and we'll get into why. Druckenmiller first gained fame by managing George Soros's Quantum Fund, where he orchestrated the $10 billion currency bet that "broke the Bank of England†in 1992. Since founding Duquesne Capital Management in 1981, he's delivered annualized ...

PresentationAll right. Let's go ahead and get started. So thanks for joining us, everyone. Next up, we have Insmed's CFO, Sara Bonstein. Sara, over to you for an overview of the company, where things stand today on the back of a huge 2025 and another exciting '26. After that, we'll get into it.Sara BonsteinChief Financial Officer Great. Great. Thank you so much, Gavin, for having us, and thank you to Evercore for hosting this great conference. It's nice to be in some warm weather coming from an area where t ...

Core Insights - Insmed has experienced a landmark year with a first FDA approval for a disease and strong launch data in pulmonary arterial hypertension (PAH) [1] - The next 18 months are expected to be even more eventful with successful trial readouts and new product approvals [2] Company Developments - The ASPEN trial readout was successful, leading to the approval of brensocatib for bronchiectasis treatment [2] - The company is focusing on three key programs: ARIKAYCE, which is approved for refractory MAC lung disease, and is expected to expand its market opportunity significantly from 30,000 patients to over 250,000 with the upcoming ENCORE trial readout [2]

Core Insights - The biotech sector is experiencing significant momentum, with many clinical-stage and commercial biopharma stocks reaching new 52-week highs due to breakthrough trial data, strategic deals, and earnings surprises [1] Company Summaries - **Metsera Inc. (MTSR)**: A clinical-stage biopharmaceutical company focused on developing hormone analog peptides for obesity and related metabolic diseases. Recently, Novo Nordisk made a $9 billion unsolicited acquisition proposal, which Metsera's board considers superior to its existing agreement with Pfizer [2][3]. Metsera announced positive Phase 2b results for its GLP-1 receptor agonist MET-097i, showing up to 14.1% weight loss after 28 weeks, supporting Phase 3 initiation in late 2025 [4]. The stock rose from $32.35 to a 52-week high of $66.10, a gain of 104.3% [5]. - **Indivior Plc (INDV)**: Develops buprenorphine-based therapies for opioid dependence. The company reported Q3 net income of $42 million, up from $22 million a year ago, with adjusted earnings of $93 million, exceeding Wall Street's expectations [6][7]. The stock increased from $20.86 to a 52-week high of $30.55, reflecting a 46.5% gain [7]. - **Insmed Inc. (INSM)**: Focused on therapies for serious and rare diseases, Insmed reported a Q3 net loss of $370 million but saw net product revenue rise to $142.3 million from $93.4 million last year [8][9]. The company raised its full-year 2025 revenue guidance for ARIKAYCE to $420 million - $430 million, indicating 15% - 18% growth year-over-year [10]. The stock surged from $76.54 to a 52-week high of $194.70, marking a 154.4% gain [10]. - **Ventyx Biosciences Inc. (VTYX)**: A clinical-stage biotech company developing therapies for autoimmune and neurodegenerative diseases. Ventyx reported positive Phase 2 results for its NLRP3 inhibitor VTX3232, showing strong safety and tolerability [11][13]. The stock rose from $3.01 to a 52-week high of $8.52, a gain of over 183% [14]. - **Inhibrx Biosciences Inc. (INBX)**: Focuses on oncology and rare diseases, announcing positive topline results from its ChonDRAgon study for ozekibart in chondrosarcoma [15]. The stock increased from $18.35 to a 52-week high of $83.78, representing a gain of 356.6% [16]. - **ABIVAX Société Anonyme (ABVX)**: Developing therapies for chronic inflammatory diseases, ABIVAX presented positive Phase 3 data for obefazimod in ulcerative colitis [17]. The stock rose from $7.83 to an all-time high of $106.73, marking a significant gain of 1263% [18]. - **Arrowhead Pharmaceuticals Inc. (ARWR)**: Developing RNAi-based therapies, Arrowhead finalized a licensing agreement with Novartis for ARO-SNCA, with financial terms including a $200 million upfront payment [19][20][21]. The stock increased from $29.70 to a 52-week high of $43.33, representing a gain of over 45% [21]. - **Kodiak Sciences Inc. (KOD)**: Focused on retinal diseases, Kodiak announced positive Phase 1b data for KSI-101, showing significant vision improvements [22][23][24]. The stock climbed from $8.98 to a 52-week high of $21.17, delivering a 135.7% gain [22]. - **Arcutis Biotherapeutics Inc. (ARQT)**: Focused on dermatological treatments, Arcutis reported Q3 net income of $7.4 million, a turnaround from a net loss last year, with revenue up 122% year-over-year [25][26]. The stock rose from $14.99 to a 52-week high of $27.08, representing a gain of over 80% [27]. - **Maze Therapeutics Inc. (MAZE)**: Developing precision therapies for various diseases, Maze announced positive Phase 1 results for MZE782 and secured $150 million in a private placement [28][29]. The stock rose from $11.21 to a new 52-week high of $34.29, returning a gain of 206% [29]. - **Supernus Pharmaceuticals Inc. (SUPN)**: Focused on CNS disorders, Supernus is expected to report Q3 earnings of $0.82 per share and revenue of $180.22 million [30][31]. The stock increased from $38.21 to a 52-week high of $57.65, representing a gain of over 50% [31].

Financial Data and Key Metrics Changes - In Q3 2025, BRINSUPRI achieved $28 million in net sales, reflecting a strong early launch performance [32] - ARIKAYCE posted its largest quarter of revenue ever, up 22% year-over-year, with U.S. growth of 11% and international growth exceeding 50% [39][40] - The company raised its full-year global ARIKAYCE net revenue guidance to $420 million-$430 million, up from $405 million-$425 million previously [41] Business Line Data and Key Metrics Changes - BRINSUPRI's launch saw approximately 2,550 new patients starting treatment and about 1,700 physicians prescribing it within the first six weeks [32] - ARIKAYCE continues to perform strongly, with double-digit growth across all geographic regions [39] Market Data and Key Metrics Changes - The early days of BRINSUPRI's launch have shown broad prescribing patterns, with physicians testing the medicine on a small number of patients before wider adoption [33] - The U.S. market access for BRINSUPRI has been encouraging, with most prescriptions approved for coverage without formal contracts [36] Company Strategy and Development Direction - The company aims to position BRINSUPRI alongside leading respiratory launches like DUPIXENT and OFEV, targeting significant commercial opportunities [9] - Insmed is focused on executing multiple late-stage and commercial programs, including brensocatib and ARIKAYCE, while expanding its pipeline of earlier-stage programs [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the BRINSUPRI launch, emphasizing the need for more data from the first full quarter to assess long-term trends [51] - The company is well-capitalized with approximately $1.7 billion in cash, allowing it to support the launch of BRINSUPRI and other portfolio programs [41][43] Other Important Information - The company received a positive opinion from Europe's CHMP for brensocatib, anticipating a potential EU launch in early 2026 [12][13] - Insmed was awarded the number one ranking on Science Magazine's Top Employers list for the fifth consecutive year, highlighting its strong company culture [31] Q&A Session Summary Question: Early feedback on physician experience with BRINSUPRI - Management noted positive feedback from physicians, with enthusiasm for the medicine and manageable reimbursement processes during the early launch phase [47][49] Question: Thresholds for payer coverage and prior authorization - The company aims for clear and non-burdensome criteria for approval, focusing on patients with two or more exacerbations and confirmed diagnoses [54][56] Question: Dynamics of patient journey and DTC impact - There is clear enthusiasm from patients, with social media activity reflecting excitement about the new medicine [66] Question: Investment needed for European launch - The strategy involves cautious investment in Europe, ensuring reimbursement aligns before significant additional investments [70] Question: Phase III design considerations for TPIP - Management is confident in overcoming orphan drug exclusivity and plans to leverage insights from previous studies to inform the design of upcoming trials [75][78]

Financial Data and Key Metrics Changes - Insmed reported $28 million in net sales for Brensupri in its first partial quarter of launch, reflecting a strong initial reception [32] - ARIKAYCE achieved its largest quarter of revenue ever, up 22% year-over-year, with growth in all geographic regions [39] - The company raised its full-year global ARIKAYCE net revenue guidance to $420 to $430 million, indicating a 15% to 18% increase over 2024 revenues [41] Business Line Data and Key Metrics Changes - Brensupri's launch has seen approximately 2,550 new patients starting treatment and about 1,700 physicians prescribing it, indicating broad initial adoption [32] - ARIKAYCE continues to perform well, with an 11% growth in the U.S. despite the focus on Brensupri's launch [39] Market Data and Key Metrics Changes - The early days of Brensupri's launch have shown broad patient access, with most prescriptions approved for coverage without formal contracts [36] - International business for ARIKAYCE set a new all-time high, growing more than 50% compared to the same quarter last year [40] Company Strategy and Development Direction - Insmed aims to position Brensupri alongside leading respiratory launches in the industry, targeting significant commercial opportunities [9] - The company plans to expand its pipeline with multiple late-stage and commercial programs, including potential launches in the EU, UK, and Japan for Brensocatib [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the Brensupri launch, emphasizing the need for more data from the first full quarter to assess long-term trends [51] - The company is focused on ensuring a frictionless market access experience for Brensupri, with ongoing discussions with payers to simplify prior authorization processes [56] Other Important Information - Insmed's pipeline is expected to deliver more catalysts over the next 18 months than in the previous period, with several clinical trials and regulatory submissions planned [10][12] - The company has a strong cash position of approximately $1.7 billion, allowing it to support upcoming launches and clinical programs [41][43] Q&A Session Summary Question: Early feedback on physician experience with Brensupri - Management noted positive feedback from physicians, with enthusiasm for the medicine and a generally straightforward reimbursement process [47][49] Question: Thresholds for payer coverage - The company aims for clear and non-burdensome criteria for approval, focusing on patients with confirmed diagnoses and multiple exacerbations [54][56] Question: Frictionless launch experience - Initial experiences have been positive, with manageable documentation requirements for physicians, and the company is working to ease the process further [60][62] Question: Patient journey and awareness - There is clear enthusiasm from patients, with social media activity reflecting excitement about the new treatment, while physician awareness is also high [66] Question: Investments needed for European launch - The strategy involves cautious investment in Europe, ensuring reimbursement processes are favorable before significant additional investments [70]

Financial Data and Key Metrics Changes - Insmed reported $28 million in net sales for Brensupri in its first partial quarter of launch, reflecting strong early reception [32] - ARIKAYCE achieved its largest quarter of revenue ever, up 22% year-over-year, with U.S. growth of 11% despite Brensupri's launch [39] - The company raised its full-year global ARIKAYCE net revenue guidance to $420 to $430 million, up from $405 to $425 million previously [41] Business Line Data and Key Metrics Changes - Brensupri's launch has seen approximately 2,550 new patients starting treatment and about 1,700 physicians prescribing it [32] - ARIKAYCE's international business, including Japan and Europe, grew more than 50% compared to the same quarter last year [39] Market Data and Key Metrics Changes - The early days of Brensupri's launch have resulted in broad prescribing patterns, with physicians initially prescribing to a small number of severe patients [33] - The company has achieved broad patient access from day one, with most prescriptions approved for coverage on both Medicare and commercial sides [35] Company Strategy and Development Direction - Insmed aims to position Brensupri alongside leading respiratory launches in the industry, targeting significant revenue potential [9] - The company plans to expand Brensocatib's reach in the EU, UK, and Japan, with potential launches expected in early 2026 [12][13] - Insmed is focused on executing multiple clinical and commercial opportunities over the next 18 months, including new Phase 3 programs [30] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the Brensupri launch, emphasizing the need for more data from the upcoming full quarter [53] - The sentiment from physicians regarding Brensupri is positive, with enthusiasm noted during recent conferences [49][50] - The company remains well-capitalized with approximately $1.7 billion in cash and equivalents, positioning it strongly for future investments [41] Other Important Information - Insmed's pipeline includes multiple late-stage programs and a growing number of early-stage therapies, with expectations for significant clinical catalysts in the near term [10][12] - The company has been recognized as the number one employer on Science Magazine's Top Employers list for five consecutive years [31] Q&A Session Summary Question: Feedback on physician experience with Brensupri - Management noted positive feedback from physicians, with enthusiasm for the medicine's potential and straightforward reimbursement processes in the early days of launch [49][50] Question: Thresholds for payer coverage - The company aims for a frictionless launch with clear and manageable criteria for approval, focusing on patients with confirmed diagnoses and multiple exacerbations [66][68] Question: Dynamics of patient journey for Brensupri - There is clear enthusiasm from patients, with social media activity reflecting excitement about the new treatment, while physicians are aware of the medicine's arrival [84] Question: Investment needed for European launch - The strategy in Europe involves cautious investment until reimbursement is confirmed, with some preparatory actions already taken [91] Question: Design considerations for Phase 3 trials - The company is ramping up production and believes it can overcome orphan drug exclusivity challenges based on strong efficacy and safety data [102][104]

Commercial Performance - BRINSUPRI received U S approval and was launched, with approximately 2,550 patients starting treatment and about 1,700 physicians writing at least one prescription[8, 55] - BRINSUPRI's initial sales benefited from inventory stocking, accounting for roughly 40% of Q3 sales[58] - Worldwide ARIKAYCE revenue reached $114.3 million, a 22.3% increase compared to the same period last year[60] - U S ARIKAYCE revenue was $74.0 million, a 10.6% increase year-over-year, while international ARIKAYCE revenue was $40.3 million, a 51.8% increase[60] Financial Highlights - The company anticipates ARIKAYCE revenue for the full year 2025 to be between $420 million and $430 million, representing a 15% to 18% increase compared to 2024[64, 65] - As of September 30, 2025, the company held approximately $1.7 billion in cash, cash equivalents, and marketable securities[68] - Total revenues for the three months ended September 30, 2025, were $142.3 million, compared to $93.4 million for the same period in 2024[69] Clinical Development - International filings for brensocatib are progressing on track, with a potential EMA decision in the next several months that could expand the total addressable market by approximately 600,000 patients[13, 16] - Topline readout for the BiRCh trial is expected by early January 2026[17] - Enrollment for the CEDAR trial was completed ahead of schedule, with topline readout now expected in the first half of 2026[21, 23] - The ENCORE study is progressing on schedule toward a readout in the first half of 2026, potentially expanding ARIKAYCE's label to address an additional 100,000+ patients in both the U S and Japan[31, 32]

Group 1 - Insmed Incorporated (NASDAQ:INSM) is recognized as a promising biotech stock, with Public Employees Retirement System of Ohio acquiring 55,425 shares valued at approximately $5,578,000 in the second quarter [1] - The company has experienced significant market value growth of about $27 billion over the past 18 months, focusing on three key franchises: ARIKAYCE, brensocatib, and TPIP [2] - Insmed raised $650 million, enhancing its business mix with multibillion-dollar compounds, indicating a strong potential for long-term growth by addressing unmet medical needs [3] Group 2 - Insmed specializes in therapies for serious and rare diseases, aiming to transform the lives of its patients since its founding in 1988 [4]

Core Insights - Insmed has experienced significant growth, with its market value increasing from approximately $3 billion to $30 billion over the last 18 months, driven by three main product franchises [3] - The three key products are ARIKAYCE for refractory MAC lung disease, Brinsupri (formerly brensocatib) for bronchiectasis, and TPIP for pulmonary hypertension, each targeting multiple indications [3][4] - The company holds a diversified product portfolio with multibillion-dollar potential for each of its three main compounds, positioning it favorably in the biotech industry [4]