Insmed Incorporated · NASDAQ:INSM
Insmed — JPMorgan Healthcare Conference 2025
30 slides from Insmed's conference presentation, Jan 10, 2025
Slide 1: JPMorgan Healthcare Conference Presentation
January 13, 2025 JPMorgan Healthcare Conference Presentation
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a
Slide 3: 2025: Building on Our Momentum
2025: Building on Our Momentum * If approved † Preliminary unaudited cash, cash equivalents, and marketable securities position as of December 31, 2024 Continued double-digit growth in ARIKAYCE for refractory MAC Execution of the largest commercial launch* in our history Late-stage clinical data rea
Slide 4: Portfolio of First-in-Class and Potentially Best-in-Class Assets
Portfolio of First-in-Class and Potentially Best-in-Class* Assets Across Each Stage of Development Preclinical Phase 1 Phase 2 Phase 3 Approved ARIKAYCE® Refractory NTM MAC Lung Disease Brensocatib Bronchiectasis CRSsNP HS TPIP PH-ILD PAH Pre-Clinical Research INS1202: ALS INS1203: Stargardt Disease
Slide 5: Total Addressable Patients Has Potential to Grow 80x Through 2030
* If pipeline of assets are approved Bronchiectasis: non-cystic fibrosis bronchiectasis; MAC / MAC LD: Mycobacterium avium complex lung disease; CRSsNP: chronic rhinosinusitis without nasal polyps; PH-ILD: pulmonary hypertension due to interstitial lung disease; PAH: pulmonary arterial hypertension;
Slide 6: Potential Value Creation Will Be Shaped by Two Distinct Drivers
Potential Value Creation Will Be Shaped by Two Distinct Drivers * Pending regulatory approval for bronchiectasis indication; assumes priority review ** 2025 ARIKAYCE revenue guidance as of January 2025; Growth vs. 2024 preliminary unaudited revenue results † Europe/EU5 comprised of France, Germany,
Slide 7: ARIKAYCE Refractory Mycobacterium avium complex lung disease
ARIKAYCE Refractory Mycobacterium avium complex lung disease A rare and chronic disease that can cause irreversible lung damage and is the most common form of NTM respiratory pathogen Mycobacterium avium complex lung disease Image source: Hendrix C, McCrary M, Hou R, Abate G. Diagnosis and Managemen
Slide 8: ARIKAYCE Expected to Deliver Double-Digit Revenue Growth in 2025
ARIKAYCE Expected to Deliver Double-Digit Revenue Growth in 20251 * Preliminary unaudited revenue results for 12-months ended December 31, 2024 1 Growth vs. 2024 preliminary unaudited revenue results EU5 comprised of France, Germany, Italy, Spain, and the United Kingdom Double-digit growth entering
Slide 9: ARIKAYCE has the Potential to be a Best in MAC LD Treatment Regimen
ARIKAYCE has the Potential to be a Best in MAC LD Treatment Regimen MAC / MAC LD: Mycobacterium avium complex lung disease; TAM: Total Addressable Market †EU5 comprised of France, Germany, Italy, Spain, and the United Kingdom Note: Numbered footnote references related to patient prevalence can be fo
Slide 10: Brensocatib
Brensocatib Image sources: 1) Fraser CS, José RJ. Insights into Personalised Medicine in Bronchiectasis. Journal of Personalized Medicine. 2023; 13(1):133. https://doi.org/10.3390/jpm13010133. | 2) Rethinkbronchiectasis.com | 3) Yang Y, Zhang N, Crombruggen KV, Lan F, Hu G, Hong S, Bachert C. Differ
Slide 11: Brensocatib in Bronchiectasis Opportunity Could Reach >1M Patients at Launch
Brensocatib in Bronchiectasis Opportunity Could Reach >1M Patients at Launch* * Pending regulatory approval for bronchiectasis indication † Includes misdiagnosed, miscoded, undiagnosedNote: COPD and asthma may be comorbid with bronchiectasis and not all patients with bronchiectasis have comorbid ast
Slide 12: U.S. Bronchiectasis Market Primed for a Strong Brensocatib Launch
U.S. Bronchiectasis Market Primed for a Strong Brensocatib Launch* * Pending regulatory approval for bronchiectasis indication ** Since website launch in November 2023 through December 2024 † From February-October 2024; Commercial lives include Veterans Affairs, Tricare, and Dept. of Defense ‡ Highl
Slide 13: CRSsNP Represents Another Potential Large Patient Opportunity
Chronic Rhinosinusitis without Nasal Polyps Represents Another Potential Large Patient Opportunity Included in Phase 2 BiRCh Trial Annual New Surgical Patients (Incidence)5 0.5M 3.1M 2.6M Steroid Non-responders (Prevalence)5 40K 200K 160K 6M 29M 24M CRSsNP CRSsNP (Prevalence)4 US TAM EU5† TAM Japan
Slide 14: Potential Expansion into Hidradenitis Suppurativa
Potential Expansion into Hidradenitis Suppurativa Could Be a New Treatment Option for >600K Patients Hurley Stage 2 & 36 Global Diagnosed Prevalence6 30K 275K 300K HS 1.2M – 2.6M US TAM EU5† TAM Japan TAM HS: hidradenitis suppurativa; TAM: Total Addressable Market † EU5 comprised of France, Germany,
Slide 15: TPIP: PH-ILD and PAH
TPIP Pulmonary Hypertension due to Interstitial Lung Disease A rapidly progressing disease associated with poor survival and decreased quality of life Pulmonary Arterial Hypertension A devastating and debilitating disease that pervades all aspects of a patient’s daily life Image source: Valentini A,
Slide 16: TPIP has the Potential for Clear Differentiation in PH-ILD and PAH
TPIP has the Potential for Clear Differentiation in PH-ILD and PAH * No head-to-head or convenience studies have been conducted or planned** Safety analysis based on topline safety and tolerability data from the Phase 2 PH-ILD study of TPIP disclosed on May 6, 2024 †Based on most recent publicly ava
Slide 17: TPIP: Topline Results Moved Forward to Mid-2025 for Phase 2 PAH Trial
TPIP: Topline Results Moved Forward to Mid-2025 for Phase 2 PAH Trial 102 Participants Enrolled 2:1 Randomization Primary Endpoint: Change from baseline in pulmonary vascular resistance (PVR) at 16 weeks
Slide 18: PH-ILD and PAH Represent Substantial Commercial Opportunities
PH-ILD and PAH Represent Substantial Commercial Opportunities TPIP: A Potential Best-in-Class* Prostanoid ‡ Wholesale acquisition cost (WAC) as of March 12, 2024 TAM: Total Addressable Market; †EU5 comprised of France, Germany, Italy, Spain and the United Kingdom Note: Numbered footnote references r
Slide 19: Early-Stage Research Engine Has Produced First Product Candidate
Early-Stage Research Engine Has Produced First Product Candidate Gene Therapy IND for Duchenne Muscular Dystrophy Cleared in December 20241 Our Approach High Potential Impact Multiple preclinical programs Low Upfront Costs to acquire the technologies Low Ongoing Expense <20% of expenditures Expect ~
Slide 20: Our Culture is Our Greatest Strength
Our Culture is Our Greatest Strength In a recent survey* >90% of Employees who responded said they felt: * The 2024 annual Insmed Pulse Survey included 89.4% participation across the organization Proud to work at Insmed Inspired by what we do Confident in Insmed’s future Driven to do their best work
Slide 21: Multiple Catalysts Fuel Our Next Era
Multiple Catalysts Fuel Our Next Era * If approved under priority review TPIP PAH Topline Data Mid-25 U.S. Launch of Brensocatib in Bronchiectasis* 3Q:25 Brensocatib CRSsNP Topline Data YE:25 Initial Clinical Data from DMD Gene Therapy Late- ’25/’26 › › Supported by our unique culture & strong balan
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Slide 23: Epidemiological Footnotes (1 of 3)
Epidemiological Footnotes (1 of 3) 1. Internal analysis of published NTM epidemiology, including internal market research and US patient level claims data analysis: Jennifer Adjemian, Kenneth N Olivier, Amy E Seitz, Steven M Holland, D Rebecca Prevots: Prevalence of nontuberculous mycobacterial lung
Slide 24: Epidemiological Footnotes (2 of 3)
Epidemiological Footnotes (2 of 3) 4. Internal analysis and estimations based on published epidemiology studies: National Health Interview Survey (NHIS) Data (2021) Alshabanat A, Zafari Z, Albanyan O, Dairi M, FitzGerald JM (2015) Asthma and COPD Overlap Syndrome (ACOS): A Systematic Review and Meta
Slide 25: Epidemiological Footnotes (3 of 3)
Epidemiological Footnotes (3 of 3) 7. Internal assessment of published epidemiology and US patient level claims data analysis, including: Kirson, N. Y., Birnbaum, H. G., Ivanova, J. I., Waldman, T., Joish, V., & Williamson, T. (2011). Prevalence of pulmonary arterial hypertension and chronic thrombo
Slide 26: Appendix: Late-Stage Trial Designs
Appendix Late-Stage Trial Designs
Slide 27: ARIKAYCE Phase 3 Clinical Program to Potentially Expand MAC Indication
ARIKAYCE Phase 3 Clinical Program to Potentially Expand MAC Indication Trial summary Key Endpoints Screening Double-Blind Registration PMR Trial ARIKAYCE + AZI* + ETH* Placebo + AZI* + ETH* Key Endpoints Month 13 Culture Negativity Endpoint Month 15 R Months 1-6 ARIKAYCE + AZI* + ETH* Off Treatment
Slide 28: Brensocatib Phase 2b in CRSsNP: BiRCh
Brensocatib Phase 2b in CRSsNP: BiRCh Brensocatib 40 mg QD Placebo QD Screening BASELINE EOT (primary analysis) Up to 5 weeks Brensocatib 10 mg QD 4 weeks Treatment period 24 weeks EOS R Off-treatment follow-up N=~270 total Key eligibility criteria: Male or female ≥18 years old and ≤75 years old At
Slide 29: Brensocatib Phase 2b in HS: CEDAR
Primary Endpoint (Week 16) Percent change in total abscess and inflammatory nodule (AN) count Secondary Endpoints (Week 16) Percentage achieving HiSCR50 Percentage achieving HiSCR75 Change from baseline in draining tunnel count Percentage remaining free from HS flare Change from baseline in Internat
Slide 30: TPIP Phase 2b in PAH
TPIP Phase 2b in PAH 4 weeks TPIP 80-640 µg inhalation capsules QD Placebo inhalation capsules QD Screening Treatment period 16 weeks Baseline EOT (primary analysis) EOS 4 weeks Follow-up Approximately 100 participants randomized in the study 2:1 active : placebo Steady-state period 3-week titration