Accessible version US Biopharmaceuticals 2026 Year Ahead: What to expect from our coverage universe in 2026 Price Objective Change Biopharma favorable despite lingering uncertainties Despite its challenges, Biopharma ended 2025 on a high note (NBI +32%, DRG +21% vs. SPX +17%)—with, in our view, reasons for optimism heading into 2026. Admittedly, the macro concerns weighing on 1H25 sentiment (inflation, tariffs) remain overhangs. That said, 1) sector-specific worries, mostly around drug pricing, eased; 2) lo ...

Summary of Insmed Conference Call Company Overview - **Company**: Insmed - **Key Products**: ARIKAYCE, Brensocatib, TPIP - **Focus Areas**: Rare diseases, particularly in pulmonary and chronic conditions Key Industry Insights - **FDA Approvals**: Insmed received FDA approval for Brensocatib for bronchiectasis, marking a significant milestone in the company's history [3][5] - **Market Potential**: Brensocatib is projected to achieve peak sales of over $5 billion in the bronchiectasis indication alone [5][24] - **Patient Population**: There are approximately 500,000 diagnosed bronchiectasis patients in the U.S., with a significant overlap with COPD patients, potentially increasing the addressable market [22][24] Core Product Updates Brensocatib - **Launch Performance**: Initial revenue of $28 million in a partial quarter, with caution advised due to potential inventory build [14] - **Prescribing Trends**: Positive early signs with broad prescribing beyond centers of excellence, indicating strong community physician engagement [15] - **Market Access**: Ongoing discussions with plans to finalize criteria by early next year, which will impact uptake [17] ARIKAYCE - **Expansion Opportunity**: Expected to expand from a patient population of 30,000 to 250,000 if the ENCORE trial is successful [42] - **Revenue Guidance**: Projected revenue between $420 million and $440 million, with Japan contributing significantly to revenue [43] TPIP - **Clinical Trials**: Four phase three trials planned for PAH, PH-ILD, IPF, and PPF, with promising early data showing a 35.5% reduction in pulmonary vascular resistance [36][41] - **Market Potential**: Estimated peak sales for TPIP in PAH alone could reach $7 billion [41] Research and Development Focus - **Pipeline**: Insmed has around 30 programs in preclinical development, including gene therapies for DMD, ALS, and Stargardt disease [9][44] - **Innovative Technologies**: Development of deimmunized therapeutic technology and synthetic rescue for CNS disorders [10][44] Upcoming Milestones - **CRS Trials**: Data readout for CRS without nasal polyps expected by early January, with a significant patient population of over 30 million in the U.S. [25][35] - **DPP-1 Applications**: Potential applications in multiple diseases, including rheumatoid arthritis and asthma, if the CRS trials are successful [34] Financial Position - **Capitalization**: Insmed is well-capitalized to pursue its development programs, with revenue generation from Brensocatib expected to exceed development costs [12][13] Conclusion - Insmed is positioned for significant growth with multiple product launches and a robust pipeline. The company is focused on executing its strategy effectively to capitalize on the opportunities presented by its innovative therapies in rare diseases.

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]

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]

Market Overview - The second quarter saw significant volatility for small and mid-cap (SMID) stocks, with the Russell 2500 Index returning 8.6%, while the Russell 2000 Index matched this but lagged behind the Russell 1000 Index's return of 11.1% [2] - The Russell 2500 Growth Index outperformed the Value Index, returning 11.3%, indicating a preference for growth stocks during this period [2] Economic and Market Sentiment - Recent months have been characterized by reversals in trade policy and legislative priorities, with the market adapting to trade threats and pricing in more favorable outcomes [3] - Macroeconomic indicators such as unemployment, inflation, and spending trends remain stable, suggesting manageable operating conditions for businesses and consumers [4] Sector Performance - The ClearBridge SMID Growth Strategy outperformed its benchmark due to strong contributions from the health care and consumer staples sectors [5] - In health care, companies like Insmed saw stock price increases due to positive clinical results and improved earnings estimates [5] - Insulet, a medical device company, also performed well, driven by strong earnings and product launches [6] - Consumer staples companies like e.l.f. Beauty and Casey's General Stores benefited from strategic acquisitions and reinvestments, respectively [7] Detractors and Challenges - The information technology sector was a significant detractor, with companies like Wix.com and Globant facing challenges due to uneven demand [8] - The exit from Ashland was due to persistent headwinds and management turnover, impacting long-term confidence [11] Portfolio Positioning and Transactions - New positions were initiated in Ryan Specialty Holdings and Duolingo, both showing strong growth potential in their respective markets [9][10] - The portfolio also saw exits from several positions, including Ashland and Tradeweb Markets, reflecting a strategic shift in response to market conditions [11][19] Outlook - Despite recent market performance, there remains uncertainty regarding macroeconomic policies and geopolitical factors, with a focus on companies with unique growth drivers [12] - The potential for faster earnings growth in SMID stocks is highlighted, suggesting a favorable outlook for this segment [12]

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]

Core Viewpoint - William Blair initiated coverage on Insmed Incorporated, emphasizing the potential for significant valuation increase due to the clinical and commercial execution of its drugs, particularly Brinsupri [1] Group 1: Product Approval and Market Potential - The FDA approved Insmed's Brinsupri as an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children aged 12 and older [2] - Brinsupri is the first and only FDA-approved treatment for non-cystic fibrosis bronchiectasis, a chronic lung condition that leads to persistent mucus production and difficulty breathing [3] Group 2: Clinical Trial Results - The Phase 2b study of treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension met its primary endpoint, showing a placebo-adjusted reduction in pulmonary vascular resistance of 35% [4] Group 3: Financial Projections and Valuation - Insmed's peak sales potential could approach $15 billion by 2035, supported by upcoming trial readouts for Brinsupri, Arikayce, and TPIP [4] - The strong initial launch of Brinsupri is expected to command a valuation of roughly five times the five-year sales forecasts, with an estimated revenue of $7.7 billion by 2031 [6] - Insmed's stock is currently up 1.84% at $129.55, reflecting investor confidence in its market opportunities [6] Group 4: Strategic Outlook - William Blair sees Insmed evolving into a leading large-cap biotech, with strong value in its sizable market opportunities and de-risked clinical programs [5]

Financial Data and Key Metrics Changes - Insmed reported strong commercial performance with double-digit year-over-year revenue growth globally, driven by the highest quarterly revenue ever achieved in the U.S. [33] - The cash balance at the end of the quarter was approximately $1.9 billion, reflecting a recent equity offering that generated about $823 million in net proceeds [34][35] - The underlying cash burn for the quarter remained consistent with previous levels, despite increased investments in launch preparations [35] Business Line Data and Key Metrics Changes - ARIKAYCE demonstrated consistent year-over-year growth in its seventh year of launch, with U.S. sales team conducting disease state education on bronchiectasis [7][8] - Brensocatib is expected to launch in the U.S. soon, with anticipated launches in Europe, the UK, and Japan in 2026 [9][10] - TPIP produced positive results in two Phase 2 studies, with plans to enter Phase 3 for PH ILD in 2025 and PAH in early 2026 [10] Market Data and Key Metrics Changes - In Japan, ARIKAYCE saw a 45% growth due to new targeting strategies, while Europe experienced a 48% growth driven by demand in Germany, Switzerland, and Austria [33][34] - The U.S. market for bronchiectasis is estimated at around 500,000 patients, with approximately half having had two or more exacerbations in the last twelve months [44][85] Company Strategy and Development Direction - Insmed aims to expand its impact on patients through a steady cadence of meaningful commercial and clinical events over the next twelve months [6][31] - The company is focused on bringing first and best-in-class therapies to patients facing serious diseases, with a strong emphasis on patient access and support [16][20] - Insmed's early-stage portfolio includes over 30 preclinical programs, with a goal of producing one to two new INDs per year [11][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of brensocatib, highlighting extensive preparations and positive feedback from payers [21][56] - The company anticipates up to 10 additional commercial, clinical, development, and regulatory milestones over the next twelve months [38] - Insmed's culture of collaboration and support is seen as a key factor in its ability to execute on future opportunities [31] Other Important Information - Insmed was recently certified as a great place to work for the fifth consecutive year, reflecting employee satisfaction and commitment [31] - The company is preparing for a potential Phase 3 start in early 2026 for PAH, following a meeting with regulators [30] Q&A Session Summary Question: What are the practical steps being taken to capture patients for brensocatib? - Management highlighted the importance of disease state awareness campaigns and building relationships with physicians to identify suitable patients [41][44] Question: Can you elaborate on the payer feedback regarding brensocatib? - Positive alignment with payers was noted, focusing on making the prior authorization process as smooth as possible for physicians [54][56] Question: What is the expected timeline for the interim futility analysis in hidradenitis suppurativa? - The analysis will be based on the first 100 patients, looking for a signal of efficacy rather than a p-value [91] Question: How confident is the company in achieving a successful launch for brensocatib? - Management expressed cautious optimism, emphasizing extensive preparations and the importance of patient experience in driving success [67][70]