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]

Third-Quarter 2025 Earnings Presentation October 30, 2025 1 Forward Looking Statements The forward-looking statements in this presentation are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any fo ...

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]

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. [32] - The company remains on track to achieve its 2025 full-year ARIKAYCE net revenue guidance of $400 to $425 million [33] - As of the end of the quarter, Insmed had approximately $1.9 billion in cash, cash equivalents, and marketable securities, indicating a strong financial position [33][34] Business Line Data and Key Metrics Changes - ARIKAYCE continues to show consistent year-over-year growth in its seventh year of launch, with significant contributions from the U.S., Europe, and Japan [6][32] - Brensocatib is anticipated to launch in the U.S. soon, with launches in Europe, the UK, and Japan expected in 2026 [9] - TPIP has produced positive results in two Phase 2 studies, with plans to enter Phase 3 for PH ILD in 2025 and for PAH in early 2026 [10] Market Data and Key Metrics Changes - In Japan, ARIKAYCE saw a 45% growth this quarter due to new targeting strategies [32] - Europe experienced a 48% growth driven primarily by strong demand in Germany, Switzerland, and Austria [33] - The U.S. sales team is conducting disease state education on bronchiectasis, which is expected to enhance market penetration [7] Company Strategy and Development Direction - Insmed aims to address over two million patients with serious diseases across multiple products and indications in the coming years [6] - The company is focused on advancing first and best-in-class therapies for patients facing serious diseases, with a strong emphasis on commercial readiness and patient access [15][30] - Insmed's culture supports collaboration and innovation across its research sites, which is expected to accelerate the development process [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming twelve months, anticipating a steady cadence of meaningful events that could significantly expand the company's impact on patients [5] - The company is prepared for the launch of brensocatib, with extensive preparations in place to ensure a successful rollout [22] - Management remains cautiously optimistic about the potential for brensocatib and TPIP, highlighting the importance of patient experience in driving future performance [69] Other Important Information - Insmed has been certified as a great place to work for the fifth consecutive year, reflecting employee satisfaction and commitment [30] - The company has over 30 preclinical programs in active development across its early-stage portfolio [11] Q&A Session Summary Question: What are the practical steps being taken to capture patients for brensocatib? - The company has initiated a disease state awareness campaign and has built relationships with physicians to identify suitable patients for treatment [40][44] Question: What is the feedback from payers regarding the approach to patients? - Payer feedback has been positive, with alignment on the criteria for patient eligibility, focusing on those with a bronchiectasis diagnosis and two or more exacerbations [54][56] Question: How does the company view the potential for TPIP in relation to competitor trials? - The company is optimistic about TPIP's potential and is prepared to advance it into Phase 3 studies quickly if competitor trials show positive results [62][64] Question: Can you elaborate on the interim futility analysis for HS? - The analysis will look for a signal of efficacy rather than a p-value, and an expert panel will determine whether to continue the trial based on the first 100 patients [90][92]