Insmed Incorporated · NASDAQ:INSM
Insmed — Investor Presentation (January 2019)
20 slides from Insmed's investor presentation, Jan 7, 2019
Slide 1: 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 number of risks and uncert
Slide 2: Our Mission
To transform the lives of people battling serious rare diseases Our Mission Not for promotional use
Slide 3: Insmed: A Global Biopharmaceutical Company Focused on Rare Disease
4 Insmed: A Global Biopharmaceutical Company Focused on Rare Disease U.S. Commercial Launch of ARIKAYCE 4Q 2018 Global Expansion to Support Potential Commercial Opportunity in EU and Japan ARIKAYCE Confirmatory Clinical Study and Lifecycle Management Pipeline to Support Long-Term Growth Not for prom
Slide 4: What is MAC Lung Disease?
What is MAC Lung Disease? 5 Mycobacterium avium complex (MAC) lung disease is a rare, progressive, and chronic condition that can cause severe, permanent damage to the lungs. The disease is caused by bacteria in the environment and is more likely to affect those with a history of lung conditions, li
Slide 5: About ARIKAYCE
About ARIKAYCE 6 Not for promotional use
Slide 6: Now Approved
7 Now Approved* Not for promotional use * Approved under the U.S. Food and Drug Administration's Limited Population Antibacterial Drug and Accelerated Approval pathways for Adult Patients with MAC Lung Disease who have Limited or No Alternative Treatment Options.
Slide 7: ARIKAYCE Developed to Address Significant Unmet Need in MAC Lung Disease
8 ARIKAYCE Developed to Address Significant Unmet Need in MAC Lung Disease An inhaled, innovative, once-daily formulation of liposomal amikacin Advanced liposomal technology delivers drug directly to site of infection; prolongs release of amikacin in the lungs while limiting systemic exposure Uptake
Slide 8: ARIKAYCE Limited Population Indication
LIMITED POPULATION: ARIKAYCE is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum o
Slide 9: Commercial Approach: Near-Term Focus on U.S. Launch; Expansion to EU and Japan
Commercial Approach: Near-Term Focus on U.S. Launch; Expansion to EU and Japan 10 *Source: Internal analysis of published NTM epidemiology, primary market research with treating HCPs, and anonymized patient level claims data in US † EU5 comprised of France, Germany, Italy, Spain and the United Kingd
Slide 10: Therapeutic Specialists Deployed and Covering U.S. Market
11 72 Therapeutic Specialists Deployed and Covering U.S. Market Based on Concentration of MAC Treatment Providers Source: Symphony Health, PatientSourceTM November 2013 – October 2016 ~5K physicians manage 70% of diagnosed MAC patients 8 in 10 diagnosed MAC patients managed by Pulmonologist or Infec
Slide 11: Laying the Groundwork for a Successful U.S. Launch
12 Laying the Groundwork for a Successful U.S. Launch Awareness & Education Disease Awareness, HCP engagement, and advocacy group support Patient Identification Ongoing, innovative efforts to identify appropriate patients and enhance disease diagnosis Access Payer engagement to enable efficient pati
Slide 12: U.S. Launch Update
~600 Physicians Prescribed ARIKAYCE 82% of Tier 1 and 65% of Tier 2 Targets Reached U.S. Launch Update As of 12/31/18 13 Not for promotional use Strong Initial Uptake $9.8M in Preliminary, Unaudited 4Q18 Total Net Product Sales $9.2M in U.S. net sales $0.6M in ex-U.S. net sales from French ATU progr
Slide 13: Established Supply Chain
Redundant drug supply chain Commercial-scale manufacturing capacity on-line and expansion under way 14 Established Supply Chain 50L 200L * 450L *Patheon long term project initiated 4Q 2017 but not yet completed * Not for promotional use
Slide 14: Estimated 2018 U.S. Market Opportunity in NTM Refractory MAC
15 Estimated 2018 U.S. Market Opportunity in NTM Refractory MAC 10K-15K NTM Caused By MAC 60K-85K Diagnosed NTM 75K-105K Launch Population Life Cycle Management and Label Expansion Potential Potential progression toward use as front-line or maintenance therapy Life Cycle Management* Launch focus Tre
Slide 15: ARIKAYCE: Multiple Layers of Market Exclusivity
16 ARIKAYCE: Multiple Layers of Market Exclusivity 2033 2027 2030 2028 2029 2026 2031 2032 2034 2035 U.S. patent portfolio Regulatory exclusivity periods (U.S./EU) Japanese patent portfolio Coverage into 2035 US: 12-year exclusivity (orphan and QIDP designations) EU: 10-year exclusivity (orphan desi
Slide 16: Pipeline to Support Long-Term Growth
Pipeline to Support Long-Term Growth 17 PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED ARIKAYCE® (Amikacin Liposome Inhalation Suspension) Refractory NTM: M. avium complex (MAC) ARIKAYCE® (Amikacin Liposome Inhalation Suspension) Lifecycle Management Front line, maintenance, other non-MAC NTM species,
Slide 17: Additional Financial Highlights
18 Additional Financial Highlights As of September 30, 2018 Cash and cash equivalents $567.6 million Common shares outstanding 77.1 million Not for promotional use
Slide 18: Insmed: 2019 Strategic Priorities
19 Insmed: 2019 Strategic Priorities Complete enrollment in WILLOW, our six-month Phase 2 trial of INS1007 in non-CF bronchiectasis, in mid-2019 Continue to execute successful U.S. launch of ARIKAYCE ARIKAYCE life cycle management through a clinical study in a front-line setting of patients with MAC
Slide 19: Thank You
20 Thank You Not for promotional use
Slide 20: Thank You
Thank You insmed