Insmed Incorporated · NASDAQ:INSM
Insmed — Investor Presentation (August 2011)
21 slides from Insmed's investor presentation, Aug 15, 2011
Slide 1: Developing Innovative Inhaled Treatments for Serious Lung Infections
EXHIBIT 99.1 Developing Innovative Inhaled Treatments for Serious Lung Infections August 2011
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements which are made pursuant to provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that such statements in this presentation, including statements relating to our financial position, results
Slide 3: Experienced, Successful Combined Management Team
Experienced, Successful Combined Management Team The management team has more than 150 years experience in drug development and commercialization 30 Years Experience Don Hayden Chairman 15 Years as a Senior Executive, BMS 5 Years Leading Entrepreneurial Biotech Companies 25 Years Experience Tim Whit
Slide 4: Insmed: Value Proposition
Insmed: Value Proposition Arikace® is a potentially highly differentiated phase 3 product opportunity that offers a compelling business model in two orphan diseases Arikace® (liposomal amikacin for inhalation), is Phase 3-ready for cystic Attractive fibrosis (CF) Pseudomonasand non-TBmycobacteria (N
Slide 5: Arikace — Update on Clinical Hold
Arikace® —Update on Clinical Hold Insmed announced on 8/1/11 that the FDA placed the Phase 3 clinical trials for Arikace in CF and NTM on clinical hold based on the Agency'sinitial review of findings from a rat inhalation carcinogenicity study Insmed believes it has sound scientific rationale for th
Slide 6: Arikace: Amikacin Summary
Arikace™: Amikacin Summary Amikacin is an FDA-approved antibiotic with proven efficacy in the treatment of gram-negative infections, including Pseudomonas and NTM Member of the aminoglycoside class of antibiotics The value of the IV use has been limited by issues of nephro- toxicity and ototoxicity
Slide 7: Arikace: Proprietary Liposomal Formulation
Arikace: Proprietary Liposomal Formulation Arikace delivers the potency of Amikacin at the site of lung infection while minimizing potential systemic toxicity Water Core (where Amikacin resides) Lipid Polar Head Groups (at Both Surfaces) Lipid Hydrophobic Chains (Bi-Layer Interior) Engineered Specif
Slide 8: Arikace: Delivery Using Proprietary eFlow Technology
Arikace: Delivery Using Proprietary eFlow Technology® Arikace is delivered once daily via the state-of-the-art PARI Optimized, Investigational eFlow ® Nebulizer System with Advanced Mesh Technology Fast drug delivery with efficient lung deposition Small, portable, silent and cordlessdevice weighs le
Slide 9: Arikace: Pipeline in a Product
Arikace: “Pipeline in a Product” Arikace offers efficient, rapid sequential entry into growing markets that we believe require limited commercial infrastructure Global Market Potential ($ in Millions) Product Discovery Preclinical Phase 1 Phase 2 Phase 3 Approval Cystic Fibrosis (CF) $500 - $1,000 L
Slide 10: Arikace—Cystic Fibrosis: Epidemiology and Disease Description
Arikace—Cystic Fibrosis Epidemiology and Disease Description Cystic fibrosis is a life-threatening disease with significant unmet needs that is growing in prevalence U.S. CF Patients Median Predicted Survival Age 45 Affects about 30,000 children and adults in the U.S. (70,000 worldwide) 40 Inherited
Slide 11: Arikace—Cystic Fibrosis: Need for New Inhaled Antibiotics
Arikace—Cystic Fibrosis Need for New Inhaled Antibiotics Current inhaled antibiotics produce modest efficacy in a limited patient population providing an opportunity for Arikace to become first-line treatment Current inhaled antibiotics are not indicated for a significant segment of the CF populatio
Slide 12: Aztreonam vs. Tobi (inhaled tobramycin)
Aztreonam vs. Tobi® (inhaled tobramycin) CF Phase 3 Trial Results: Pulmonary Function Lung function returned to baseline or lower during each off treatment period and at the end of 24 weeks, both treatment groups showed a decline in lung function from baseline Lung Function Adjusted Mean Relative Ch
Slide 13: Arikace—Cystic Fibrosis: Phase 2 Pooled Results
Arikace—Cystic Fibrosis Phase 2 Pooled Results (560mg QD): Pulmonary Function Arikace demonstrated statistically significant and clinically meaningful improvement in pulmonary function throughout the 28-day treatment period that was sustained through the off-treatment period 18% % Change in FEV 1 (m
Slide 14: Arikace—Cystic Fibrosis: Open Label Extension
Arikace—Cystic Fibrosis Open Label Extension (TR02-105): Duration of Response An open label extension study TR02-105 demonstrated the sustained efficacy Of Arikace during and between multiple cycles of therapy Patients Receiving 560 mg Arikace® Once Daily for 28 Daysand Off-Treatment for 56 Days Cyc
Slide 15: Arikace—Cystic Fibrosis: Phase III Program
Arikace—Cystic Fibrosis Phase III Program (pending FDA review and lifting of clinical hold) Insmed had reached agreement with FDA and EMA on NDA/MAA path for CF Patients with Pseudomonas lung infections One E.U. Phase 3 (Arikace vs Tobi® Study, N = 300) – Primary End-Point: Relative Change in FEV-1
Slide 16: Arikace—Non-TB Mycobacteria: Epidemiology and Disease Description
Arikace—Non-TB Mycobacteria Epidemiology and Disease Description Non-TB mycobacteria (NTM) is an intracellular pathogen that can cause severe pulmonary disease with limited effective treatment options Total U.S. Patients Diagnosed with Non-TB Mycobacteria Diagnosis of NTM pulmonary Pulmonary Disease
Slide 17: Arikace—Non-TB Mycobacteria: Summary of Opportunity
Arikace—Non-TB Mycobacteria Summary of Opportunity Opportunity for accelerated path to market for chronic treatment of NTM High unmet need Current treatment often includes chronic use of poorly formulated, compounded solutions of amikacin Arikace opportunity: provide superior efficacy in NTM treatme
Slide 18: Arikace—Non-TB Mycobacteria: Phase 3 Program
Arikace—Non-TB Mycobacteria Phase 3 Program (pending FDA review and lifting of clinical hold) High unmet medical need enables a phase 3 program consisting of a single study of approximately 100 patients Trial Design and Patient Population: – Randomized, double-blind, placebo controlled phase 3 study
Slide 19: Current Overview: Capital Structure and Key Financials
Current Overview: Capital Structure and Key Financials Insmed has a strong cash position and no debt 25.8 M fully diluted shares following reverse stock split: Present Capital 24.8 million Common Shares Structure 1.0 million options, restricted stock and warrants Pro Forma Pro forma cash of ~$94 mil
Slide 20: Arikace Intellectual Property and Exclusivity
Arikace Intellectual Property and Exclusivity Insmed has extensive patent coverage and other exclusive agreements protecting composition, use, and delivery of Arikace Composition-of-matter patent issued in U.S. with protection to October 2026 Additional applications under review in the U.S. and E.U.
Slide 21: Insmed: Value Proposition
Insmed: Value Proposition Arikace® is a potentially highly differentiated phase 3 product opportunity that offers a compelling business model in two orphan diseases Arikace® (liposomal amikacin for inhalation), is Phase 3-ready for cystic Attractive fibrosis (CF) Pseudomonasand non-TBmycobacteria (N