Insmed (INSM) FY 2025 Conference September 05, 2025 08:00 AM ET Company ParticipantsTiago Fauth - Director - Equity Research Small/Mid Cap BiotechnologySara Bonstein - CFOTiago FauthAll right. Thanks, everyone, for joining us. I'm Tiago Fauci, biotech analyst here at Wells Fargo. We're joined today by Insmed Incorporated for a fireside chat. We have Sara here. Thanks so much for joining us.Sara BonsteinYeah, thanks for having us. Really appreciate it.Tiago FauthI'd like to just open up with some broad intro ...

Insmed (INSM) FY 2025 Conference September 05, 2025 08:00 AM ET Speaker0All right. Thanks, everyone, for joining us. I'm Tiago Fauci, biotech analyst here at Wells Fargo. We're joined today by Insmed Incorporated for a fireside chat. We have Sara here. Thanks so much for joining us.Speaker1Yeah, thanks for having us. Really appreciate it.Speaker0I'd like to just open up with some broad intro remarks. We have a lot of detailed questions that we usually get from investors that we want to walk through. Overall ...

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].

Core Viewpoint - The valuation logic of Fosun Pharma is undergoing a silent reconstruction following a significant licensing deal for its innovative drug XH-S004, which has led to a notable increase in its stock price and market recognition [1][3]. Group 1: Licensing Deal and Market Reaction - Fosun Pharma announced a global licensing agreement for its oral DPP-1 inhibitor XH-S004 with Expedition Therapeutics, with a potential total transaction value of $645 million (approximately 4.6 billion RMB) [1]. - Following the announcement, Fosun Pharma's H-shares surged by 9.4% and A-shares rose by 5.6%, indicating strong market approval of the deal [1]. - XH-S004 is currently in Phase II clinical trials for non-cystic fibrosis bronchiectasis and Phase Ib trials for chronic obstructive pulmonary disease (COPD) in China [1]. Group 2: Strategic Partnerships and Market Position - Expedition Therapeutics focuses on innovative therapies for autoimmune diseases and has a management team with extensive experience in drug development and commercialization [2]. - The collaboration aims to expand the global reach of XH-S004 for treating non-cystic fibrosis bronchiectasis and COPD patients [2]. - The DPP-1 inhibitor market is becoming increasingly competitive, with major pharmaceutical companies like Merck and GSK investing in this area, highlighting the growing demand for treatments for chronic lung diseases [2]. Group 3: Financial and Market Performance - Fosun Pharma's strategic transformation is reflected in its recent issuance of 1 billion RMB in technology innovation bonds, which received a favorable interest rate of 2.70%, showcasing market confidence in its innovative capabilities [3]. - The stock price of its subsidiary, Fosun Pharma's subsidiary Hanhai, has increased by nearly 235% year-to-date, with a total market capitalization of 43.1 billion HKD [3]. - Hanhai's stock performance is closely linked to its innovative product pipeline, particularly in the lung cancer treatment space, with multiple products gaining recognition at major conferences [3][4]. Group 4: Valuation and Investment Strategy - The innovative pipeline, including HLX43, is expected to drive further stock price increases for Hanhai, although it is not yet included in the Hong Kong Stock Connect, limiting direct investment opportunities for some domestic investors [5]. - Investors are advised to consider holding Fosun Pharma to indirectly benefit from Hanhai's innovation while enjoying the stability and risk mitigation from the parent company's diversified business ecosystem [5]. - As of the latest closing on August 14, Fosun Pharma's H-shares were priced at 19.96 HKD, representing a 34% discount compared to its A-share price of 27.97 RMB, indicating a significant valuation gap [5].

Core Viewpoint - The valuation logic of Fosun Pharma is undergoing a silent reconstruction following a $645 million licensing deal for its innovative drug XH-S004, which has seen a 235% year-to-date increase in its subsidiary, Fosun Hani. [1][3] Group 1: Licensing Deal and Market Reaction - Fosun Pharma announced a global licensing agreement (excluding China and Hong Kong) for its small molecule oral DPP-1 inhibitor XH-S004 with Expedition Therapeutics, with a potential total deal value of $645 million (approximately 4.6 billion RMB) [1] - Following the announcement, Fosun Pharma's H-shares surged by 9.4% and A-shares rose by 5.6%, indicating strong market approval for the deal [1] - XH-S004 is currently in Phase II clinical trials for non-cystic fibrosis bronchiectasis and Phase Ib trials for chronic obstructive pulmonary disease (COPD) in China [1] Group 2: Strategic Partnership and Market Position - Expedition Therapeutics focuses on innovative therapies for autoimmune diseases and has a management team with extensive experience in drug development and commercialization [2] - The partnership aims to expand the global reach of XH-S004 for patients with non-cystic fibrosis bronchiectasis and COPD [2] - The global demand for DPP-1 inhibitors is increasing due to the growing population of chronic lung disease patients, with major pharmaceutical companies like Merck and GSK intensifying their focus on this segment [2] Group 3: Innovation and Financial Performance - Fosun Pharma's licensing deal reflects the market's recognition of its pipeline value and the success of its strategic transformation [3] - The company recently issued 1 billion RMB in technology innovation bonds, marking the first mid-to-long-term technology innovation bond in China's private pharmaceutical sector, showcasing strong capital market support for its innovation efforts [3] - Fosun Hani's stock has increased by nearly 235% year-to-date, with a market capitalization of 43.1 billion HKD, driven by multiple innovative products [3] Group 4: Product Development and Clinical Advancements - HLX43, a PD-L1 ADC, is the first of its kind to enter Phase II clinical trials globally, demonstrating high response rates in specific patient groups [4] - The dual mechanism of HLX43, combining immune checkpoint blockade and cytotoxic payload, addresses treatment challenges for PD-1/L1 resistant patients, making it a notable innovation in lung cancer therapy [4] Group 5: Investment Strategy and Valuation - With the progress of HLX43 and other innovative pipelines, Fosun Hani's stock price is expected to continue rising, although it is not yet included in the Hong Kong Stock Connect, limiting direct investment opportunities for some domestic investors [5] - Investors can benefit from holding Fosun Pharma to indirectly gain from Fosun Hani's innovation value while enjoying the stability and risk mitigation from the parent company's diversified business ecosystem [5] - As of the latest closing on August 14, Fosun Pharma's H-shares were priced at 19.96 HKD, representing a 34% discount compared to its A-share price of 27.97 RMB, highlighting a significant valuation gap [5]

Insmed (INSM) Phase 2b PAH Top Line Results Conference Call Summary Company Overview - **Company**: Insmed (INSM) - **Focus**: Development of TPIP for the treatment of pulmonary arterial hypertension (PAH) Key Industry Insights - **Industry**: Pharmaceutical, specifically focusing on treatments for pulmonary arterial hypertension (PAH) - **Current Treatment Landscape**: TPIP aims to improve upon existing prostanoid therapies, which have limitations in dosing frequency and side effects Core Findings from the Conference Call 1. **Study Success**: The Phase 2b TPIP study in PAH was declared a historic success, with all primary and secondary efficacy endpoints achieving clinically meaningful improvements, with p-values well below 0.05 [4][5][6] 2. **Pulmonary Vascular Resistance (PVR) Reduction**: TPIP demonstrated a placebo-adjusted PVR reduction of 35%, the largest ever recorded in a controlled clinical trial for PAH [5][20] 3. **Six-Minute Walk Distance**: Patients on TPIP showed a placebo-adjusted improvement of 35.5 meters in six-minute walk distance, with a p-value of 0.003, exceeding initial expectations [6][22] 4. **NT proBNP Levels**: TPIP treatment resulted in a 60% reduction in NT proBNP levels compared to placebo, indicating significant cardiac stress reduction [23] 5. **Functional Class Improvement**: 30% of patients in the TPIP group showed an improvement in functional class, compared to 15% in the placebo group [24][25] 6. **Safety Profile**: TPIP had a low treatment discontinuation rate (10%) and a favorable safety profile, with common adverse events being mild [27][28] Additional Important Insights 1. **Patient Population**: The study included a heavily pretreated population, with 66% classified as functional class two and 80% on two background PAH medications, indicating a challenging patient demographic [17][19] 2. **Dosing Strategy**: TPIP was designed for once-daily dosing, which is expected to improve patient adherence compared to existing therapies that require multiple daily doses [12][31] 3. **Future Development Plans**: Insmed plans to initiate Phase 3 trials for both PAH and PH ILD, with an increased maximum dose of TPIP up to 1280 micrograms [32][34] 4. **Market Positioning**: The results position TPIP as a potential cornerstone therapy for PAH, with implications for changing treatment paradigms and possibly displacing existing therapies [38][42] 5. **Regulatory Strategy**: Insmed intends to engage with the FDA to discuss the implications of the Phase 2b results for future regulatory submissions [47][52] Conclusion - The Phase 2b results for TPIP in PAH are promising, indicating significant efficacy and a favorable safety profile. The company is poised to advance to Phase 3 trials, with the potential to redefine treatment standards in the PAH space.

Summary of Insmed (INSM) 2025 Conference Call Company Overview - **Company**: Insmed (INSM) - **Event**: 2025 Conference on May 13, 2025 - **Key Speaker**: Will Lewis, Chair and CEO of Insmed Key Points Discussed 1. Focus on TPIP Phase Two Asset - Investors are particularly interested in the phase two asset TPIP, with data expected in June 2025 [2][24] - A success benchmark for TPIP is set at a 20% reduction in pulmonary vascular resistance (PVR) [3][4] - The six-minute walk test improvement of 15 to 20 meters is also considered a win [5] 2. Differentiation of TPIP - TPIP is designed as a once-a-day medication, contrasting with current inhaled prostanoids that require four times a day administration [6][7] - The formulation aims to provide nighttime coverage, which is a significant improvement for patient compliance [7] 3. Rationale for Study Design - The focus on PVR as a primary endpoint is due to its direct measurement of pulmonary vascular resistance, which is critical for patients with pulmonary arterial hypertension (PAH) [9][10] - The study duration of 16 weeks may not capture the full benefit of the six-minute walk improvement, hence the emphasis on PVR [10] 4. Safety Profile - Safety is crucial, especially for inhaled drugs, with common side effects leading to discontinuation in existing therapies [12] - The design of TPIP aims to reduce cough sensitivity, a common issue with inhaled drugs [13][16] 5. Market Potential and Growth Strategy - Insmed has $1.2 billion in cash and forecasts ARIKAYCE to generate over $400 million in revenue [27] - The potential market for ARIKAYCE could expand significantly with upcoming phase three data [27] - Brensocatib is expected to target multiple indications, including bronchiectasis and hidradenitis suppurativa, with significant market potential [28][52] 6. Regulatory Engagement - The FDA review process for Insmed's products has been smooth, with no significant issues raised [33][34] - The company is on track for timely submissions and approvals, with a focus on market access strategies [39][40] 7. Market Access and Pricing Strategy - The market access strategy is focused on patients with two or more exacerbations and a definitive diagnosis of bronchiectasis [37][40] - Insmed is optimistic about the drug's ability to preserve lung function and improve quality of life, which is appealing to payers [49][50] 8. Future Indications and Research - Insmed is exploring additional indications for brensocatib, including neutrophil-driven diseases like CRS and HS [52][54] - The company is developing new DPP-1 inhibitors for various diseases, indicating a robust pipeline for future growth [54][55] 9. Confidence in Execution - The growth of Insmed's workforce and deliberate hiring practices contribute to the company's confidence in executing its strategic plans [56] Additional Insights - The skepticism from the investment community regarding TPIP's dosing and efficacy is acknowledged, but the company remains optimistic about upcoming data [24][22] - The potential for a truncated phase three trial is discussed, contingent on the strength of the phase two data [30] This summary encapsulates the critical discussions and insights from the Insmed conference call, highlighting the company's strategic focus, product pipeline, and market positioning.