Insmed 2026 Conference Summary Company Overview - **Company**: Insmed (NasdaqGS: INSM) - **Focus**: Development of treatments for serious, life-threatening conditions, particularly in respiratory diseases - **Commercial Products**: - **ARIKAYCE**: Approved for nontuberculous mycobacteria in refractory settings, with potential label expansion expected in March-April 2026 - **BRINSUPRI**: Launched in August 2025 for bronchiectasis, showing strong market demand [2][3][21] Key Points on ARIKAYCE - **ENCORE Study**: A pivotal study designed to assess the efficacy of ARIKAYCE, focusing on patient-reported outcomes (PRO) and culture conversion rates - **ARISE Study**: A smaller, earlier study that indicated a 4.5-point change in respiratory symptom scores and an 80% culture conversion rate in the treatment arm [5][6][7][9] - **ENCORE Design**: A 12-month study with 425 patients, aiming for a 4-point change in PRO, with a 90% power to detect this change [9][10] - **Patient Population**: Approximately 12,000-17,000 diagnosed patients in the U.S. and 15,000-18,000 in Japan, with a total of about 100,000 in the U.S. and 125,000 in Japan for nontuberculous mycobacteria [11][12] Potential Outcomes from ENCORE - **Success Scenario**: Filing for market approval by the end of 2026, with potential market availability in 2027 - **Mixed Results**: Discussions with the FDA regarding the product's continued availability, given its established patient success [15][19][20] Key Points on BRINSUPRI - **Market Potential**: First and only approved treatment for bronchiectasis, with an estimated 500,000 diagnosed patients in the U.S. - Initial focus on patients with two or more exacerbations, estimated at 250,000 patients [26][27][30] - **Launch Strategy**: A secondary focus on underdiagnosed patients with COPD or asthma, potentially expanding the patient base significantly [30][31] - **Revenue Goals**: Aiming for at least $1 billion in revenue for the year, with peak sales potential estimated at $5 billion [39][40] Other Development Programs - **TPIP**: A new prostacyclin therapy showing promising results in phase 2 studies, with plans for four global phase 3 programs [42][46][47] - **INS1033**: A next-generation DPP1 therapy targeting rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), expected to enter IND by the end of the year [56][57] - **INS1148**: A monoclonal antibody for ILD and asthma, in-licensed with a promising safety profile and efficacy in previous studies [58][59] Conclusion - Insmed is positioned for significant growth with its current product offerings and pipeline, focusing on expanding treatment options for serious respiratory conditions and leveraging its established market presence to capture additional patient populations. The upcoming data readouts and ongoing studies will be critical in shaping the company's future trajectory and market strategy.

Summary of Insmed Conference Call Company Overview - **Company**: Insmed (NasdaqGS:INSM) - **Focus**: Development of treatments for serious, life-threatening conditions, particularly in respiratory diseases - **Commercial Products**: - **ARIKAYCE**: Approved for nontuberculous mycobacteria (NTM) in refractory settings, with a potential label expansion readout expected in March-April 2026 - **BRINSUPRI**: Launched in August 2025 for bronchiectasis, showing strong demand and initial success [2][3][20] Key Points on ARIKAYCE - **ENCORE Study**: A 12-month study designed to assess the primary endpoint of patient-reported outcomes (PRO) and culture conversion rates - **ARISE Study**: A smaller, shorter study that provided preliminary data, showing a 4.5-point change in respiratory symptom scores and an 80% culture conversion rate in the drug arm at the 6-month endpoint [5][6][8][9] - **Patient Population**: Approximately 12,000-17,000 diagnosed patients in the U.S. and 15,000-18,000 in Japan under the current label, with total NTM cases estimated at 100,000 in the U.S. and 125,000 in Japan [11] - **Potential Outcomes**: - Clear win scenario: Filing for market approval by the end of 2026 - Mixed results: Discussion with FDA regarding the product's continued availability due to its established patient impact [14][18][19] Key Points on BRINSUPRI - **Market Potential**: First and only treatment for bronchiectasis, with an estimated 500,000 diagnosed patients in the U.S. - **Initial Focus**: Targeting patients with two or more exacerbations in the past 12 months, estimated at 250,000 patients, with potential for an additional 250,000 patients who may be under-diagnosed [25][26][28] - **Launch Strategy**: A secondary focus on under-diagnosed patients with COPD or asthma, with a potential overlap of 30%-50% of moderate to severe COPD patients also having bronchiectasis [29][30] - **Revenue Goals**: Aiming for at least $1 billion in revenue for the year, with peak sales potential estimated at $5 billion [39] Other Important Developments - **TPIP**: A new prostacyclin therapy showing promising results in phase 2 studies, with a potential peak sales estimate of $2 billion. Four global phase 3 programs are planned to commence [44][46][47] - **INS1033**: A next-generation DPP1 therapy targeting rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), expected to progress through IND by the end of the year [53][54] - **INS1148**: A monoclonal antibody recently acquired for ILD and asthma, showing promise in previous studies and expected to enter clinical trials soon [55][56] Conclusion Insmed is positioned for significant growth with its innovative therapies targeting serious respiratory conditions. The upcoming data readouts and market strategies for ARIKAYCE and BRINSUPRI are critical for the company's future success, alongside the development of new therapies like TPIP and INS1033.

Summary of Insmed Fireside Chat at TD Cowen Healthcare Conference Company Overview - **Company**: Insmed - **Key Product**: BRINSUPRI, a treatment for bronchiectasis Key Industry Insights - **Market Dynamics**: The bronchiectasis market is currently underserved, with Insmed targeting 250,000 patients diagnosed with two or more exacerbations, which could lead to peak sales exceeding $5 billion [27][28][65] - **Patient Experience**: Positive patient experiences with BRINSUPRI are crucial for driving repeat prescriptions from physicians. Anecdotal evidence suggests significant improvements in patients' quality of life [25][26][40] Financial Performance - **Q4 Revenue**: Insmed reported Q4 revenue of $144 million, significantly exceeding both buy-side and sell-side consensus estimates [6][7] - **Future Projections**: Initial revenue guidance for the upcoming quarters has been revised upwards, with estimates now exceeding $1 billion, driven by strong physician engagement and patient feedback [34][37][40] Launch Strategy - **Physician Engagement**: Insmed has engaged over 4,000 physicians, with a focus on expanding the breadth and depth of prescribing behavior. Half of these physicians have only written one prescription, indicating potential for growth as they receive positive feedback from patients [7][8][40][42] - **Market Access**: Insmed is working with insurance companies to streamline access for patients, particularly those with two or more exacerbations. The company has offered modest discounts to facilitate policy shaping [50][61] Competitive Landscape - **ARIKAYCE**: Insmed has been selling ARIKAYCE for eight years, which has a challenging administration process. In contrast, BRINSUPRI is a once-daily pill with a favorable safety profile, making it easier to prescribe [23][24] - **TPIP Development**: Insmed is developing TPIP, a once-daily inhaled treatment for pulmonary arterial hypertension (PAH). The competitive landscape is evolving, but Insmed believes TPIP's profile remains strong against emerging products [66][67] Regulatory and Market Challenges - **MFN Policy**: Insmed is monitoring the Most Favored Nation (MFN) policy, which could impact pricing strategies in the U.S. market. The company is cautious but optimistic about navigating these regulatory challenges [46][48] - **Insurance Coverage**: The company is addressing payer access and reimbursement hurdles, with a focus on simplifying the attestation process for patients with two or more exacerbations [50][51] Research and Development - **ENCORE Study**: The upcoming ENCORE study for ARIKAYCE could significantly increase the addressable market, potentially doubling the current target population [82][86] - **Patient Outcomes**: Insmed is focused on demonstrating durable culture conversion in patients, which is critical for gaining physician trust and expanding usage [97][98] Conclusion - Insmed is positioned for growth with BRINSUPRI, leveraging positive patient experiences and strong physician engagement. The company is navigating market access challenges while preparing for significant upcoming studies that could expand its market presence.

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI set at a minimum of $1 billion for 2026, reflecting confidence in market access and early launch performance [9][10] - The company anticipates total revenue in 2026 to be more than double that of 2025, driven by both BRINSUPRI and ARIKAYCE [10][37] - As of the end of 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company well for future investments [40][41] Business Line Data and Key Metrics Changes - BRINSUPRI achieved $144.6 million in net revenue in its first full quarter, exceeding expectations and indicating a strong launch trajectory [12] - ARIKAYCE experienced significant growth, particularly in Japan with a 40% increase compared to 2024, contributing over a quarter of its global revenues [31] - The cost of product revenues for Q4 2025 was $44.2 million, or 16.8% of revenues, reflecting improved gross margin due to BRINSUPRI's contributions [45] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant potential for expansion as more patients are identified [13][18] - The company is actively working to identify additional patients with undiagnosed bronchiectasis among the 32 million diagnosed with COPD or asthma in the U.S. [17][20] Company Strategy and Development Direction - Insmed aims to expand its leadership in bronchiectasis and NTM, with plans to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE [7][8] - The company is pursuing additional DPP1 inhibitors for respiratory diseases, indicating a strategy to broaden its therapeutic offerings [48] - Insmed is focused on educating physicians about bronchiectasis to enhance patient identification and treatment [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for strategic opportunities [11][43] - The positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive increased prescribing behavior in the coming quarters [23][81] - Management highlighted the importance of market access dynamics, noting that over 90% of targeted patient lives have access to BRINSUPRI reimbursement [25][28] Other Important Information - The company received orphan drug designation for TPIP for the treatment of pulmonary arterial hypertension, which could enhance its market position [32] - Insmed is evaluating several business development opportunities to expand its pipeline and support future growth [11][76] Q&A Session Summary Question: Expansion of BRINSUPRI's Total Addressable Market - Management acknowledged the potential for expanding BRINSUPRI's market by identifying patients with COPD or asthma who may have undiagnosed bronchiectasis [47] Question: Guidance for BRINSUPRI and Patient Behavior - Management provided insights into patient compliance and prescription dynamics, indicating strong metrics that support their revenue guidance [51][52] Question: Trends in Prescription and Business Development - Management confirmed strong initial performance and expressed confidence in the ongoing launch, while also discussing potential business development opportunities [54][57] Question: Depth of Prescribing and Education Efforts - Management noted that many physicians are initially prescribing BRINSUPRI to one patient, with expectations that positive experiences will lead to increased prescribing [78][81] Question: Ex-U.S. Contribution to Revenue Guidance - Management indicated that contributions from ex-U.S. markets for BRINSUPRI in 2026 will be minimal, with a focus on U.S. sales [71][72]

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI of at least $1 billion in 2026, reflecting confidence in market access and early launch performance [7][8][28] - The company anticipates total revenue in 2026 to be more than double that of 2025, indicating significant growth potential [8][28] - Cash position at the end of 2025 was approximately $1.4 billion, with a cash burn in Q4 including $70 million of one-time items [31][32] Business Line Data and Key Metrics Changes - BRINSUPRI launched with $144.6 million in net revenue in its first full quarter, exceeding expectations [9] - ARIKAYCE showed strong growth, particularly in Japan with a 40% increase compared to 2024, contributing over a quarter of its global revenues [23] - The company is pursuing four Phase III clinical programs for TPIP, which received orphan drug designation for pulmonary arterial hypertension [24][25] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant room for expansion as only 11,550 new patients started treatment in 2025 [10][11] - The company is focusing on identifying undiagnosed bronchiectasis patients among the 32 million diagnosed with COPD or asthma, which could significantly increase the patient base for BRINSUPRI [14][15][16] Company Strategy and Development Direction - Insmed aims to expand its leadership in bronchiectasis and NTM, with plans to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE [6][7] - The company is also exploring additional DPP-1 inhibitors for respiratory diseases and other indications, indicating a broader strategy for pipeline expansion [38] - Insmed is actively working on outreach and education initiatives to identify potential patients who could benefit from BRINSUPRI [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for business development opportunities [8][33] - Positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive additional prescribing behavior [19][70] - The market access landscape for BRINSUPRI is progressing well, with over 90% of targeted patient lives having access to reimbursement [20][21] Other Important Information - The gross-to-net guidance for BRINSUPRI in 2026 is expected to be in the mid-20s to low 30s percentage range, reflecting good visibility into payer contracting [30][31] - The company is evaluating several business development opportunities to expand its pipeline and support future growth [8][33] Q&A Session Summary Question: Plans to develop other DPP-1 inhibitors within respiratory disease - Insmed intends to bring other DPP-1 inhibitors forward, including INS1033 for rheumatoid arthritis and inflammatory bowel disease, and is also advancing other DPP-1s for respiratory conditions [38] Question: Guidance for BRINSUPRI and patient behavior dynamics - Management is seeing positive metrics across various patient behavior indicators, which supports their confidence in achieving at least $1 billion in revenue for BRINSUPRI [41][42] Question: Trends in scrip data and interest in business development - The launch is performing strongly, and while management does not track Symphony data, they are confident in the trajectory based on internal metrics [45][46] Question: Depth of prescribing and physician behavior - Many physicians are initially prescribing BRINSUPRI to one or two patients, and positive experiences are expected to lead to increased prescribing [68][70] Question: Ex-U.S. contribution to BRINSUPRI guidance - Ex-U.S. contributions for BRINSUPRI in 2026 are expected to be very small, with the majority of revenue coming from the U.S. market [61] Question: Additional capital for business development - Insmed sees a clear path to cash flow positivity based on existing programs, with business development being a separate consideration for potential capital sourcing [63][65]

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI of at least $1 billion in 2026, reflecting confidence in market access and early launch performance [5][6][25] - The company anticipates total revenue in 2026 to be more than double that of 2025, indicating a significant growth trajectory [6][25] - As of the end of 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company well for future investments [29][31] Business Line Data and Key Metrics Changes - BRINSUPRI launched in the U.S. with net revenue of $144.6 million in its first full quarter, exceeding expectations [7][20] - ARIKAYCE showed strong growth, particularly in Japan with a 40% increase compared to 2024, contributing significantly to global revenues [21][25] - The company is pursuing additional DPP1 inhibitors for respiratory diseases, indicating a strategy to expand its product portfolio [35] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant potential for expansion as more patients are identified [8][10] - The company is actively working to identify additional patients with undiagnosed bronchiectasis among those with COPD and asthma, which could significantly increase the patient base for BRINSUPRI [12][13] Company Strategy and Development Direction - Insmed aims to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE, focusing on expanding its clinical pipeline in respiratory, inflammation, immunology, and neurology [4][5] - The company is committed to pursuing first or best-in-class therapies within its target therapeutic areas, indicating a proactive approach to pipeline development [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for strategic opportunities [6][31] - The positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive further prescribing behavior, enhancing the launch's momentum [17][66] Other Important Information - The gross-to-net guidance for BRINSUPRI in 2026 is expected to be in the mid-20s to low 30s percentage range, reflecting favorable payer contracting dynamics [27][28] - The company is evaluating several business development opportunities to support pipeline expansion and value creation [6][31] Q&A Session Summary Question: Plans to develop other DPP1 inhibitors - Insmed intends to bring other DPP1s forward, including INS1033 for rheumatoid arthritis and inflammatory bowel disease, and is also advancing DPP1s for respiratory conditions [35] Question: Guidance for BRINSUPRI and patient behavior - Management is seeing metrics at or above targets, contributing to confidence in achieving at least $1 billion in revenue for BRINSUPRI [39] Question: Trends in scrip data and interest in business development - Management noted strong initial performance and is open to pursuing first or best-in-class compounds for business development [42][45] Question: Depth of prescribing and physician behavior - Physicians are initially prescribing BRINSUPRI to one or two patients, with expectations that positive experiences will lead to increased prescribing [66] Question: Ex-U.S. contribution to BRINSUPRI guidance - Ex-U.S. contributions for BRINSUPRI in 2026 are expected to be very small, with a focus on U.S. market dynamics [58]

Core Insights - Insmed reported total revenues of $606.4 million for the full year 2025, with significant contributions from its products BRINSUPRI and ARIKAYCE [1][2] - The company anticipates full-year 2026 revenues for BRINSUPRI to be at least $1 billion and for ARIKAYCE to be between $450 million and $470 million [1][2] - Insmed's net loss for the fourth quarter of 2025 was $328.5 million, compared to a net loss of $235.5 million in the same quarter of 2024 [2][3] Financial Performance - Total revenues for the fourth quarter of 2025 were $263.8 million, a 153% increase compared to $104.4 million in the fourth quarter of 2024 [2] - ARIKAYCE revenues for the fourth quarter of 2025 were $119.2 million, reflecting a 14% growth year-over-year, while full-year revenues reached $433.8 million, a 19% increase from 2024 [2] - BRINSUPRI generated $144.6 million in the fourth quarter and $172.7 million for the full year 2025, marking its successful U.S. commercial launch [1][2] Research and Development Updates - Insmed is advancing its clinical programs, including the Phase 3 ENCORE trial for ARIKAYCE and additional Phase 3 studies for TPIP in patients with pulmonary conditions [1][2] - The company plans to submit a supplementary new drug application for ARIKAYCE in the second half of 2026, pending positive topline data from the ENCORE trial [1][2] - Insmed is also developing INS1148 and INS1201, targeting various respiratory and genetic diseases, with IND filings expected in 2026 [1][2] Cash Position and Future Guidance - As of December 31, 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company for continued investment in its pipeline [1][2] - The company expects to maintain a focus on commercialization and expansion of its product offerings, particularly BRINSUPRI and ARIKAYCE, throughout 2026 [1][2] - Insmed anticipates that pre-clinical research programs will comprise less than 20% of overall expenditures, indicating a strategic focus on advancing clinical development [2]

February 2026 Investor Presentation We're in. For patients. 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 ...

Financial Performance & Guidance - BRINSUPRI achieved preliminary unaudited U S net revenues of approximately $144 6 million in Q4 2025 and $172 7 million for the full year 2025[23] - ARIKAYCE generated worldwide revenue of approximately $433 8 million in FY 2025, representing a 19 3% increase year-over-year[27] - The company anticipates ARIKAYCE revenue to be between $450 million and $470 million for the full year 2026[28] Clinical Development Programs - The company expects topline data readout from the Phase 3 ENCORE trial for ARIKAYCE in March/April 2026, potentially leading to label expansion[30, 31] - Phase 3 trials for TPIP in PAH, PPF, and IPF are expected to initiate in early and the second half of 2026 respectively[13, 38] - Topline data readout from the Phase 2 CEDAR trial for brensocatib in Hidradenitis Suppurativa is expected in Q2 2026[46, 50] Pipeline Expansion - The company plans to file Investigational New Drug (IND) applications for RA and IBD in the second half of 2026[13, 50] - IND filing for Stargardt is anticipated in 2026[13, 59] - Phase 2 programs in ILD and moderate to severe asthma are planned for INS1148[13, 40] Commercial Expansion - BRINSUPRI is expected to launch in the EU and UK, pending regulatory approval[13, 44] - BRINSUPRI is also anticipated to launch in Japan, pending regulatory approval[13, 44] Cash Position - The company reported a cash position of $1 7 billion as of September 30, 2025[62]

Summary of Key Points from the Conference Call Industry Overview - **Industry**: US Biopharmaceuticals - **Performance**: Biopharma ended 2025 positively with NBI up 32% and DRG up 21%, outperforming SPX at 17% [1] - **Outlook for 2026**: Optimism exists despite macro concerns like inflation and tariffs, with easing drug pricing worries, increased M&A activity, new product cycles, and modest expectations positioning the sector favorably [1] Core Insights and Arguments - **Valuation**: Biotech/Pharma P/E multiples are around 19x, which is lower compared to Financials at 18x and Utilities at 20x, indicating potential undervaluation [1] - **Catalysts**: Companies like Insmed (+152%), BridgeBio (+179%), and Travere (+119%) have shown strong performance driven by value-driving catalysts [1] Company-Specific Highlights Insmed - **Performance**: Insmed was a top performer in 2025, driven by Brinsupri's launch and TPIP's phase 2 results [2] - **2026 Outlook**: Continued upside is expected as Brinsupri's uptake alleviates skepticism over the $5B NCFB opportunity [2] BridgeBio - **Focus for 2026**: The debate will center around Attruby, with positive channel checks suggesting potential for accelerated sales [2] - **Key Data**: Anticipation for PROPEL3 readout in January, which could significantly impact the stock [10] Travere - **Performance**: Outperformance in 2025 attributed to commercial success in IgAN [3] - **Approval Outlook**: Filspari's potential approval for FSGS is a major debate, with FDA signals indicating a favorable outlook [9] Cytokinetics - **Market Entry**: Myqorzo's approval for oHCM is expected to face challenges in market execution against established competitors [15][40] - **Upcoming Data**: ACACIA readout in 2Q26 is crucial for assessing the drug's competitive position [19] Tyra - **Expansion**: Tyra is expanding dabogratinib's development into LG-UTUC, which could offer greater regulatory flexibility and market opportunity [43] - **Market Potential**: Management believes an oral option could be a game changer in a relatively underserved market [43] Acumen - **Pipeline Development**: Acumen's EBD program is expected to provide optionality, with initial non-clinical data anticipated early in 2026 [13] - **Key Event**: ALTITUDE-AD is a defining event for Acumen, with expectations for significant data to outperform competitors [33] Additional Important Insights - **M&A Activity**: The biopharma sector is seeing increased M&A activity as companies prepare for patent expirations [1] - **Regulatory Environment**: The FDA's involvement in various drug approvals and feedback mechanisms is crucial for shaping market expectations [9][10] - **Investor Sentiment**: There remains a cautious sentiment among investors, particularly regarding the approval of new drugs and their market uptake [9][19] This summary encapsulates the key points from the conference call, highlighting the overall industry outlook, company-specific developments, and critical upcoming events that could influence market dynamics in the biopharmaceutical sector.