Insmed Incorporated · NASDAQ:INSM
Insmed — Q1 2025 Earnings Presentation
23 slides from Insmed's earnings presentation, May 8, 2025
Slide 1: First-Quarter 2025 Earnings Presentation
First-Quarter 2025 Earnings Presentation May 8, 2025 1
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. “Forward-looking statements,” any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory as that te
Slide 3: Speakers and Agenda
Speakers Agenda Slides 1 Opening Remarks 5-6 Will Lewis 2 Brensocatib Updates 8-9 3 Chair & CEO TPIP Updates 11 4 ARIKAYCE® Updates 13 Sara Bonstein Chief Financial Officer 5 Financial Results 16-20 3
Slide 4: Opening Remarks
Opening Remarks Will Lewis | Chair & CEO 4
Slide 5: First-Quarter 2025 Highlights
First-Quarter 2025 Highlights • Double-digit ARIKAYCE growth • All mid- to late-stage clinical programs on or ahead of schedule • FDA review of brensocatib undisrupted • PDUFA target action date of Aug. 12th for potential U.S. approval of brensocatib* * Pending regulatory approval for bronchiectasis
Slide 6: Achieved Clinical Success In At Least One Indication
Achieved Clinical Success In At Least One Indication 1 Brensocatib • Bronchiectasis: Ph3 ASPEN • CRSsNP: Ph2 BiRCh • HS: Ph2 CEDAR Three Mid- to Late-Stage 2 TPIP Programs • PH-ILD: Phase 2 • PAH: Phase 2 3 ARIKAYCE® • Refractory MAC: Ph3 CONVERT • All MAC LD: Ph3 ARISE • All MAC LD: Ph3 ENCORE Bron
Slide 7: Brensocatib Updates
Brensocatib Updates Will Lewis | Chair & CEO 7
Slide 8: Brensocatib FDA Review Remains On Track
Brensocatib FDA Review Remains On Track Bronchiectasis Bronchiectasis Patients • Phase 3 ASPEN results published in NEJM Are Motivated to Act1 ~1 Million • Focused on a frictionless launch • Regulatory submissions accepted in Europe & UK Unique visits to U.S. disease state website* CRSsNP HS • Phase
Slide 9: Leading the Way in Neutrophil-Mediated Disease Management
Leading the Way in Neutrophil-Mediated Next Gen DPP1 Disease Management Next-Generation DPP1s Rheumatoid Other COPD Arthritis Indications Anticipate first indication to enter clinic as early as 2026 DPP1: dipeptidyl peptidase 1 enzyme that plays a crucial role in the activation of neutrophil serine
Slide 10: TPIP Updates
TPIP Updates Will Lewis | Chair & CEO TPIP: Treprostinil Palmitil Inhalation Powder 10
Slide 11: Phase 2b PAH Trial Topline Readout Expected in June 2025
Phase 2b PAH Trial Topline Readout Expected in June 2025 Placebo-Adjusted PAH Reduction from • Key Trial Details • PVR measured at trough1 Baseline PVR2 • Max tolerated dose of 640 μg ≥20% • ~95% of completed patients enrolled in OLE permitting a “clear win”* ~25% dose up to 1,280 μg PH-ILD “best-in
Slide 12: ARIKAYCE Updates
ARIKAYCE Updates ® Will Lewis | Chair & CEO 12
Slide 13: Phase ENCORE Trial Progressing On Schedule
Phase 3 ENCORE Trial Progressing On Schedule Refractory MAC LD All MAC LD +22.9% • ENCORE Primary Endpoint • United States: PRO (Month 13) • Japan: Durable culture conversion Worldwide Sales* $92.8M (Month 15) $75.5M • Expect topline readout in 1H:26 after Month 15 results are available 1Q:24 1Q:25
Slide 14: Let's Recap
Let’s Recap 1 Each clinical program showing meaningful progress 2 Regulatory filings and launch preparations for brensocatib advancing on or ahead of schedule 3 Strong commercial execution keeps us on track to achieve 2025 ARIKAYCE guidance Committed to delivering on behalf of patients and stakehold
Slide 15: Financial Results
Financial Results Sara Bonstein | Chief Financial Officer 15
Slide 16: Strong Fundamentals Minimize Tariff Exposure
Strong Fundamentals Minimize Tariff Exposure Intellectual Property Manufacturing Intend to expand U.S. U.S. IP is domiciled in the manufacturing footprint; U.S.; expected to limit tariff project underway to establish exposure to actual cost base brensocatib secondary source of the product manufactur
Slide 17: ARIKAYCE Growing Double-Digits in 7th Year Post Launch
ARIKAYCE Growing Double-Digits in 7th Year Post Launch Three Months Ended March 31, 20251 • 6th consecutive quarter of double- Japan digit growth in each region United $22.1M, +48.3% States Worldwide • Strength ex-U.S. driven by $64.3M, +14.1% $92.8M increased new patient starts GTN: ~20%2 +22.9% •
Slide 18: Well-Capitalized As We Approach Upcoming Catalysts
Well-Capitalized As We Approach Upcoming Catalysts March 31, 2025† • Sequential increase in burn driven by annual employee incentive compensation1 ~$1.2B • Following brensocatib launch*, expect sales growth to accelerate faster than spend In Cash, Cash Equivalents, • The strength of our business aff
Slide 19: Called Remaining Convertible Debt
Called Remaining Convertible Debt* Remaining Principal1,2 Underlying Shares3 ~$570M ~17.8M (if all notes are converted) Expect conversion to lower ongoing interest expense and reduce outstanding debt 2 Original principal amount of approximately $575M excludes the approximately $6M of previously * CU
Slide 20: Investing to Advance Our Commercial & Clinical Programs
Investing to Advance Our Commercial & Clinical Programs Three Months Ended* March 31, March 31, (in $ millions, except for percentages) 2025 2024 Product Revenues $92.8 $75.5 • Cost of product revenues as a % of Cost of Product Revenues** (21.3) (17.5) revenues was in-line with historical As a % of
Slide 21: Closing Remarks
Closing Remarks 1 In a unique position of strength financially & operationally 2 Brensocatib launch* expected to accelerate already strong revenue growth 3 Strong cash position to support upcoming commercial and clinical catalysts * Pending regulatory approval for bronchiectasis indication | Bronchi
Slide 22: Q&A Session
Q&A Session Will Lewis Sara Bonstein Martina Flammer Chair & CEO Chief Financial Officer Chief Medical Officer 22
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