Slide 1: Safe Harbor Statement
Safe Harbor Statement Information in this document contains forward-looking statements. Investors are cautioned that such statements, including statements relating to expectations regarding the anticipated benefits of the business combination, the results of clinical trials, the development of the c
Slide 2: Initial Transaction Overview
Initial Transaction Overview Stock Ticker * Nasdaq CM: INSM Close/ * Closing: December 1, 2010 Announce Date * Announce: December 2, 2010 * Stock for stock merger ¢ Issued 25,938,818 Common shares and 91,745,892 Contingently Convertible Preferred shares to Transave shareholders Transaction Descripti
Slide 3: Current Overview: Capital Structure
Current Overview: Capital Structure Proxy Meeting « Approved full conversion of Preferred to Common (March 1, 2011) « Approved 1:10 Reverse Stock Split (Effective mkt. open Mar 3) * 25.7 M fully diluted shares following reverse stock split: ¥ 24.8 million Common Shares vy 0.9 million options, restri
Slide 4: Experienced, Successful Combined Management Team
Experienced, Successful Combined Management Team The management team has more than 150 years experience in drug development and commercialization Don Hayden Tim Whitten Kevin Tully CGA Renu Gupta, MD Nick LaBella Nick Gurreri Chairman President & CEO Chief Financial Officer EVP, Development & Chief
Slide 5: Insmed: Value Proposition
Insmed: Value Proposition Attractive Late-Stage Opportunity Compelling Business Model Significant Near Term News Flow Strong Balance Sheet & Experienced Management + Arikace™ (liposomal amikacin for inhalation), is Phase 3-ready for cystic fibrosis (CF) Pseudomonas and non-TB mycobacteria (NTM) lung
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 +N Mi class of antibiotics 3 on * The value of the IV use has been limited by issues of nephro- ~ : Jw tox
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) gineered Specific
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 cordless device weigh
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 (S$ in Millions) Product Discovery Preclinical Phase 1 Phase 2 Phase 3 Approval Cystic Fibrosis (CF) $500 - $1,000
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 g worldwide) = 40 2 +
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 populat
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: 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, (ml
Slide 14: Arikace—Cystic Fibrosis: Open Label Extension
Arikace—Cystic Fibrosis Open Label Extension (TR-05): Duration of Response An open label extension study TRO2-105 demonstrated the sustained efficacy of Arikace during and between multiple cycles of therapy Patients Receiving Arikace 560 mg Once Daily for 28 Days and Off-Treatment for 56 Days 19% 4C
Slide 15: Arikace—Cystic Fibrosis: Phase 3 Program Highlights
Arikace—Cystic Fibrosis Phase II Program Highlights Insmed has 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 at week 24 Key Secondary End-Point: T
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 * Diagnosis of NTM pulmonary infections are growing rapidly * Current treatment approaches have lim
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 t
Slide 18: Arikace—Non-TB Mycobacteria: Phase 3 Program Highlights
Arikace—Non-TB Mycobacteria Phase 3 Program Highlights (Projected) High unmet medical need enables a phase 3 program consisting of a single study of approximately 100 patients * Phase 3, randomized, placebo comparative study in patients with recalcitrant/persistent NTM lung disease * Primary endpoin
Slide 19: Arikace Future Development Plan
Arikace Future Development Plan Insmed currently anticipates an aggressive development plan for Arikace in CF and NTM NIM 2011 2012 2013 Task Initiate Phase 3 Trials 1H 2H kk 1H 2H 1H 2H Complete Enrollment in Phase 3 Ey Trials * Data Available from Phase 3 Trials Led File NDA and MAA Initiate Phase
Slide 20: Arikace—Cystic Fibrosis: Phase III Program Highlights
Arikace—Cystic Fibrosis Phase III Program Highlights Insmed expects to complete the Arikace Phase 3 Programs for CF and NTM with current pro forma cash resources Study Costs (SMillions)* Study Description # of Patients Cystic Fibrosis > Arikace vs. Tobi® Study - EU 300 $20 - $25 > Arikace vs. Placeb
Slide 21: 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
Slide 22: Key Investment Highlights
Key Investment Highlights + Arikace: A highly differentiated Phase 3 product + Focused development plans in place for two orphan indications (CF and NTM) ¢ Global annual market potential of more than $ ‘billion ¢ Limited commercial infrastructure required ¢ Strong management team with relevant exper
Slide 23: IPLEX™ (mecasermin rinfabate [rDNA origin] injection)
IPLEX™ (mecasermin rinfabate [rDNA origin] injection) IPLEX™ is a combination of two proteins: « Recombinant Human insulin-like growth factor | (rhIGF-l) « IGF-lis a polypeptide hormone, similar in molecular structure to insulin and has both growth promoting as well as anabolic and other metabolic e
Slide 24: IPLEX™ - Current Status
IPLEX™ - Current Status Insmed currently maintains a propriety protein platform, based on the FDA- approved IPLEX™ (combination of rhIGF-I and binding protein, rhIGFBP-3) * Company currently holds multiple United States patents relating to the composition, production, antibodies and methods of use f