Insmed (NasdaqGS:INSM) FY Conference December 02, 2025 11:15 AM ET Company ParticipantsSara Bonstein - CFOGavin Clark-Gartner - Managing DirectorGavin Clark-GartnerAll right. Let's go ahead and get started. 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, another exciting 2026. After that, we'll get into it.Sara BonsteinGreat. Great. Thank you so much, Gavin, for having us. Th ...

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 - 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]

Core Insights - Insmed Incorporated (NASDAQ: INSM) is recognized as one of the best performing healthcare stocks, focusing on rare diseases with significant unmet medical needs [1] - The recent FDA approval of Brinsupri for non-CF bronchiectasis has significantly boosted investor interest and stock performance, with shares rising nearly 9% [2] - Analysts have raised price targets for INSM, with estimates ranging from $135 to $240, reflecting the potential for Brinsupri to generate $7 billion in revenue by 2033 [2] Financial Performance - For Q2 2025, Insmed reported revenues of $107.4 million for ARIKAYCE, representing a 19% year-over-year increase, with a gross margin of 75.7% [3] - Despite the revenue growth, the company reported a net loss of $321.7 million [3] - Insmed completed a public offering, raising approximately $823 million to support pipeline development and commercialization efforts [3] Pipeline Developments - Insmed's pipeline includes several promising late-stage assets, with Brensocatib receiving FDA approval on August 12, 2025 [4] - The Treprostinil Palmitil Inhalation Powder (TPIP) program is advancing towards Phase 3 studies for pulmonary hypertension, expected to commence in late 2025 to early 2026 [4] - These developments position Insmed for continued growth and expansion in the rare disease market [4]

Financial Data and Key Metrics Changes - The company reported approximately $1.9 billion in cash as of the last report, which will support its business operations [8] - The peak sales opportunity for Brensocatib is estimated at $5 billion in CFBE, with potential for additional indications [6][39] Business Line Data and Key Metrics Changes - ARIKAYCE has shown double-digit growth year over year and is expected to expand its label, with data readouts anticipated in the first half of next year [5][64] - Brensocatib has received FDA approval and is positioned as a first-in-class treatment for bronchiectasis, with significant market potential [5][6] - Treprostinil Palmitil Inhalation Powder (TPIP) is projected to have a peak sales opportunity of $2 billion, excluding potential indications for IPF [11][12] Market Data and Key Metrics Changes - The company has established strong relationships with pulmonologists and ID docs, which has led to increased enrollment in clinical trials [19] - There are approximately 500,000 diagnosed patients in the U.S. with NCFB, with about half experiencing two or more exacerbations in the prior 12 months [35] Company Strategy and Development Direction - The company is focused on expanding its product pipeline with three key programs in clinical/commercial stages and aims to leverage its cash reserves for growth [4][8] - The strategy includes early investment in medical affairs and market access to ensure a seamless launch for Brensocatib [23][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for significant growth, citing the unique opportunities presented by their product pipeline [4][5] - The company anticipates starting phase III programs for TPIP by the end of the year and is preparing for regulatory interactions [16][17] Other Important Information - The company is exploring additional indications such as chronic rhinosinusitis without nasal polyps and hidradenitis suppurativa, with significant patient populations and unmet needs [44][50] - The company has developed over 800 follow-on molecules related to the TP1 mechanism, with plans to advance candidates into IND status [58] Q&A Session Summary Question: What is the current state of the TPIP program? - Management expressed excitement about TPIP, indicating a potential peak sales opportunity of $2 billion, with plans to move quickly into phase III trials [11][12] Question: What steps have been taken to ensure a successful launch of Brensocatib? - The company invested early in medical affairs and expanded its field force to ensure disease state awareness and market access [23][25] Question: How does the company plan to address potential enrollment challenges in clinical trials? - Management noted that strong relationships with the medical community have led to increased enrollment, and they are committed to addressing any feasibility concerns [19] Question: What is the expected timeline for revenue from Brensocatib? - The first full quarter of revenue is expected in Q4, following the product's launch on August 12 [29][30] Question: Can you provide insights on the potential market for chronic rhinosinusitis without nasal polyps? - The company is conducting a phase II trial with a significant patient population, aiming for a placebo-adjusted change of one point or greater [44][49] Question: What are the next steps for the hidradenitis suppurativa trial? - An interim analysis is planned at week 16, with results expected in the first quarter of next year [50][51]

Financial Data and Key Metrics Changes - The company reported approximately $1.9 billion in cash as of the last report, which will help fund its business operations [8] - The peak sales opportunity for Brensocatib is estimated at $5 billion in CFBE, with potential for additional indications [6][54] Business Line Data and Key Metrics Changes - ARIKAYCE has shown double-digit growth year over year and is expected to have label expansion data read out in the first half of next year [5] - Brensocatib has received FDA approval and is positioned as a first-in-class drug for non-CF bronchiectasis patients, with significant market potential [5][6] - Treprostinil Palmitil Inhalation Powder (TPIP) is projected to have a peak sales opportunity of $2 billion, with ongoing phase III programs planned [11][12] Market Data and Key Metrics Changes - The company has established strong relationships with pulmonologists and infectious disease doctors, which is crucial for patient enrollment in clinical trials [19] - There are approximately 500,000 diagnosed patients in the U.S. with non-CF bronchiectasis, with about half experiencing two or more exacerbations in the prior 12 months [34] Company Strategy and Development Direction - The company is focused on expanding its product pipeline with three key programs in clinical/commercial stages and aims to leverage its cash reserves for growth [4][8] - The strategy includes early investment in medical affairs and market access to ensure a seamless launch for Brensocatib [23][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for significant growth, citing the unique opportunities presented by their product pipeline and the unmet needs in the market [4][5] - The company is optimistic about the upcoming data readouts and the potential for additional indications to drive future revenue [6][54] Other Important Information - The company plans to start phase III programs for TPIP by the end of the year and has an FDA meeting scheduled for PAH in October [16] - The company is also exploring follow-on molecules for TP1 inhibition, with potential market opportunities expected to be discussed in 2026 [56] Q&A Session Summary Question: What is the current state of the TPIP program? - The company believes TPIP could be a drug of choice for PAH and PAH-ILD, with a peak sales opportunity of $2 billion, excluding IPF [11][12] Question: What steps have been taken to ensure a successful launch of Brensocatib? - The company invested early in medical affairs and expanded its field force to ensure disease state awareness and market access [23][24] Question: How does the company plan to address potential enrollment challenges in clinical trials? - The company has established strong relationships with medical professionals and has seen an uptick in enrollment following the release of blinded data [19] Question: What is the expected timeline for data readouts and future guidance? - The company anticipates sharing data for CRS without nasal polyps by the end of the year and will provide updates on other programs as they progress [47][49] Question: What is the peak sales potential for the new indications being pursued? - The company has indicated that the peak sales potential for CRS without nasal polyps could be significant, potentially matching or exceeding that of bronchiectasis [54]

Core Insights - The report highlights the approval of semaglutide (Wegovy) for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) by the FDA, which is expected to enhance the market penetration of related products and diagnostic tools [7][10][15] - The report suggests that companies like Furuya Co., Ltd. will benefit from the growth opportunities in the MASH indication market due to the increasing prescription rates of semaglutide and the rising demand for diagnostic instruments [15][5] Industry Performance Review - As of August 15, 2025, the pharmaceutical and biotechnology sector's TTM-PE stands at 51.31 times, which is 110% higher than its historical low of 24.38 times [16] - The healthcare sector has shown a relative premium of 281% compared to the CSI 300 index, which is significantly above the average premium rate of 241% over the past decade [16] - The pharmaceutical and biotechnology sector experienced a 3.08% increase in the week from August 11 to August 15, 2025, ranking 10th among 27 sub-industries [20][24] Company Dynamics - Furuya Co., Ltd. is noted for its FibroScan series of liver fibrosis diagnostic instruments, which are the first globally to utilize transient elastography technology for non-invasive liver stiffness measurement [15] - The report emphasizes the strategic collaborations between Furuya and leading pharmaceutical companies to promote the clinical application and commercialization of new drugs [15] - The report identifies several companies that could be key players in the MASH treatment landscape, including innovative drug and device companies such as Furuya, Anglikon, and others [15]

Investment Rating - The report does not explicitly state an investment rating for the industry, but it indicates a positive trend in the pharmaceutical and biotechnology sector with a weekly increase of 3.08% [3][8]. Core Insights - The pharmaceutical and biotechnology sector outperformed the Wind All A index and the CSI 300 index during the week of August 11 to August 15, with notable gains in medical research outsourcing (7.77%), hospitals (5.59%), and medical consumables (4.47%) [3][8]. - The upcoming launch of the commercial insurance innovative drug directory is expected to activate the domestic high-end payment market for innovative drugs, with 121 drug names passing preliminary review [3][8]. - The World Conference on Lung Cancer (WCLC) will take place from September 6 to 9, showcasing significant research advancements in lung cancer, with domestic research playing an increasingly important role [3][8]. Market Weekly Review - The pharmaceutical and biotechnology sector rose by 3.08%, outperforming the Wind All A index (2.95%) and the CSI 300 index (2.37%) [3][8]. - Medical research outsourcing, hospitals, and medical consumables led the sector's gains, while offline pharmacies, blood products, and medical circulation experienced declines [3][8]. - Notable individual stock performances included Sino Medical (69.1%), Innovation Medical (51.5%), and Guangsheng Tang (40.7%) for gains, while *ST Suwu (-16.8%), ST Sansheng (-15.2%), and Nanhua Biological (-14.2%) faced significant losses [3][11]. Industry News and Key Company Announcements - The National Medical Insurance Administration announced the preliminary review of the 2025 National Basic Medical Insurance drug directory and the commercial insurance innovative drug directory [3][13]. - Novo Nordisk received accelerated FDA approval for its therapy Wegovy for treating non-alcoholic steatohepatitis (NASH) [3][13]. - Yunnan Baiyao approved a full acquisition of An Guo Shi Ju Yao Tang Pharmaceutical Co., Ltd. for 660 million RMB to enhance its traditional Chinese medicine business [3][15]. - Insmed's DPP1 inhibitor Brensocatib received FDA approval for treating non-cystic fibrosis bronchiectasis [3][14].

Core Viewpoint - The third-party medical imaging service sector in China has significant growth potential, driven by AI technology that enhances data utilization and operational efficiency [14][20][22]. Market Overview - The medical imaging service market in China has grown from 147.4 billion yuan in 2018 to 270.9 billion yuan in 2023, with a CAGR of 12.9%. It is projected to reach 661.5 billion yuan by 2030, with a CAGR of 13.6% [16][18]. - The penetration rate of third-party imaging centers in China is currently around 1%, compared to over 40% in the US, indicating substantial room for growth [28][22]. Industry Dynamics - The value chain of the medical imaging industry in China consists of three segments: upstream (equipment providers), midstream (hospitals and third-party centers), and downstream (patients and healthcare consumers) [19][15]. - Public hospitals dominate the imaging service market, but there are challenges such as resource shortages and uneven distribution of advanced imaging equipment [20][22]. AI Integration - AI is transforming the medical imaging sector by optimizing imaging equipment, assisting in diagnostics, and enhancing data quality control processes. AI's role has evolved from a supportive tool to a core driver of business growth [29][27]. - The integration of AI in third-party imaging centers allows for the production of standardized imaging data, which can be leveraged for algorithm development and additional revenue streams [29][28]. Investment Opportunities - The third-party imaging center market has seen rapid growth, with a CAGR of 29.0% from 8 billion yuan in 2018 to 29 billion yuan in 2023, and is expected to reach 68 billion yuan by 2026 [28]. - Companies like Radnet in the US are leveraging AI to enhance their imaging capabilities and drive revenue growth, serving as a model for potential developments in the Chinese market [32]. Future Outlook - The medical imaging service market is expected to continue expanding due to increasing demand from an aging population and improvements in service penetration rates [16][20]. - The combination of AI technology and third-party imaging services is anticipated to create a more efficient and profitable sector, with significant implications for investment strategies in the healthcare industry [29][14].