Insmed Incorporated · NASDAQ:INSM
Insmed — Investor Presentation (November 2011)
17 slides from Insmed's investor presentation, Nov 16, 2011
Slide 1: Developing Innovative Inhaled Treatments for Serious Lung Infections
Developing Innovative Inhaled Treatments for Serious Lung Infections November 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: Insmed: Value Proposition
Insmed: Value Proposition Arikace® is a potentially highly differentiated product opportunity that offers a compelling business model in two orphan diseases Arikace® (liposomal amikacin for inhalation), is Phase 3-ready for cystic fibrosis (CF) Pseudomonasand Phase2-ready for non-TBmycobacteria Attr
Slide 4: Arikace — Update on Clinical Hold
Arikace® —Update on Clinical Hold Insmed announced in October 2011 that the FDA is continuing the clinical hold placed in August 2011 on the Phase 3 clinical trials for Arikace in CF and NTM. The Agency stated that based on the information provided to date it has insufficient information to assess t
Slide 5: 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 6: 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 7: 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 less
Slide 8: 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 9: 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 10: 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 11: Phase 2 Pooled Results (560mg QD): Pulmonary Function
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 % Change in FEV(ml) 1 vs
Slide 12: Open Label Extension (TR02-105): Duration of Response
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 Receiving560 mg Arikace® Once Daily for 28 Daysand Off-Treatment for 56 Days 20 C
Slide 13: Phase III Program (pending FDA review and lifting of clinical hold)
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 14: 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 15: Arikace — Non-TB Mycobacteria: Phase 2 Program
Arikace—Non-TB Mycobacteria Phase 2 Program (pending FDA review and lifting of clinical hold) High unmet medical need enables a phase 2 program consisting of a single study of approximately 100 patients Trial Design and Patient Population: – Randomized, double-blind, placebo controlled phase 2 study
Slide 16: 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 ~$85 mil
Slide 17: Insmed: Value Proposition
Insmed: Value Proposition Arikace® is a potentially highly differentiated product opportunity that offers a compelling business model in two orphan diseases Arikace® (liposomal amikacin for inhalation), is Phase 3-ready for cystic fibrosis (CF) Pseudomonasand Phase2-ready for non-TBmycobacteria Attr