Insmed Incorporated · NASDAQ:INSM
Insmed — J.P. Morgan Healthcare Conference 2011
26 slides from Insmed's conference presentation, January 2011
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 combination, the results of clinical trials trials, the d
Slide 2: Important Information
Important Information Insmed intends to file a proxy statement and other relevant materials with the Securities and Exchange Commission (the “SEC”) to obtain shareholder approval of the conversion of the Series B Conditional Convertible Preferred Stock issued in the business combination with Transav
Slide 3: Developing Innovative Inhaled Treatments for Serious Lung Infections
Developing Innovative Inhaled Treatments for Serious Lung Infections January 2011 2 CONFIDENTIAL
Slide 4: Transaction Overview
Transaction Overview Stock Ticker Nasdaq CM: INSM Close/ Closing: December 1, 2010 Announce Date Announce: December 2, 2010 Stock for stock merger Transaction Issued 25,938,818 25 938 818 Common shares and 91,745,892 91 745 892 Contingently Description Convertible Preferred shares to Trans
Slide 5: 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
Slide 6: Insmed: Value Proposition
Insmed: Value Proposition Arikace™ (liposomal amikacin for inhalation), is Phase 3-ready for cystic Attractive fibrosis (CF) Pseudomonas and non-TB mycobacteria (NTM) lung infections Late-Stage Amikacin is an FDA-approved antibiotic, long recognized as one of the most Opportunity effective treat
Slide 7: Arikace: Amikacin Summary
Arikace™: Amikacin Summary Amikacin is an FDA-approved antibiotic with proven efficacy in the treatment of gram-negative infections OH Member of the aminoglycoside class of antibiotics HO O + NH H3N g Recognized as one of the most 3 + potent and effective treatments O HO HO for gram-negative inf
Slide 8: 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 (Bi Layer Interior) Enginee
Slide 9: 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 l lung deposition d iti Small, portable, silent and cordless devi
Slide 10: 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 Sales Potential ($ in Millions) Product Discovery Preclinical Phase 1 Phase 2 Phase 3 Approval Cystic Fibrosis (CF) $500 - $1
Slide 11: 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 Years) and adults in the U.S. (70,000 worldwide) 40
Slide 12: 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 13: Aztreonam vs. Tobi CF Phase 3 Trial Results
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 14: 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 FEV1 (ml
Slide 15: Open Label Extension: Duration of Response
Arikace—Cystic Fibrosis Open Label Extension (TR-05): 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 Arikace 560 mg Once Daily for 28 Days and Off-Treatment for 56 Days 19% Cy
Slide 16: Arikace—Cystic Fibrosis Phase III Program Highlights
Arikace—Cystic Fibrosis Phase III Program Highlights Insmed has reached agreement with FDA and EMEA on NDA/MAA path for CF Patients with Pseudomonas lung infections One E.U. Phase 3 ((Arikace vs Tobi® Study, y N = 300)) – Primary End-Point: Relative Change in FEV-1 at week 24 • Key Secondary End-P
Slide 17: 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 g with Non-TB Mycobacteria y Di Diagnosis i off NTM pulmonary l Pul
Slide 18: Arikace—Non-TB Mycobacteria Summary of Opportunity
Arikace—Non-TB Mycobacteria Summary of Opportunity Opportunity for accelerated path to market for chronic treatment of Non-TB Mycobacteria High g unmet need Current treatment often includes chronic use of poorly formulated, compounded solutions of amikacin Arikace opportunity: provide superior
Slide 19: 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 20: Arikace Future Development Plan
Arikace Future Development Plan Insmed currently anticipates an aggressive development plan for Arikace in CF and NTM 2011 2012 2013 Task 1H 2H 1H 2H 1H 2H Initiate Phase 3 Trials Complete Enrollment in Phase 3 Cystic Fibrrosis onas Trials Pseudomo Data Available from Phase 3 Trials File NDA and MAA
Slide 21: Arikace Phase III Program Highlights: Study Costs
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 Study Description # of Patients ($Millions)* Cystic Fibrosis ¾Arikace vs. Tobi® Study – EU 300 $20 - $25 ¾Arikace vs. vs Place
Slide 22: 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 Two U.S. patents already issued for Arikace − Composition-of-matter patent issued in U.S. with protection to October 2026 − Patent
Slide 23: IPLEX (mecasermin rinfabate injection)
IPLEX™ (mecasermin rinfabate [rDNA origin] injection) IPLEX™ is a combination of two proteins: p Human insulin-like growth factor I (IGF-I) – IGF-I is a polypeptide hormone, similar in molecular structure to insulin and has both growth promoting as well as anabolic and other metabolic effects. It
Slide 24: IPLEX - Current Status
IPLEX™ - Current Status Insmed currently maintains a propriety protein platform, based on the FDA- approved IPLEX™ Company currently holds 28 United States patents relating to the composition, production, antibodies and methods of use for IPLEX and rhIGFBP-3 Ongoing IPLEX™ Activities are Cash Ne
Slide 25: Transaction Overview
Transaction Overview Stock Ticker Nasdaq CM: INSM Close/ Closing: December 1, 2010 Announce Date Announce: December 2, 2010 Stock for stock merger Transaction Issued 25,938,818 25 938 818 Common shares and 91,745,892 91 745 892 Contingently Description Convertible Preferred shares to Trans
Slide 26: 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 $1billion Limited commercial infrastructure required Strong management team with relevant experi