Momenta Pharmaceuticals — Investor Presentation (January 2018)
24 slides from Momenta Pharmaceuticals's investor presentation, Jan 8, 2018
Slide 1: Forward-Looking Statements
Forward-Looking Statements 2 This presentation contains forward-looking statements about our financial outlook, business plans and objectives and other future events and developments. These forward-looking statements include, but are not limited to statements about our pipeline; the use, efficacy, a
Slide 2: Momenta Today
Momenta Today Analytic Data-Driven Approach Proven expertise in high-resolution analytics, biological characterization and process engineering First to achieve FDA approval of complex generic versions of LOVENOX® and COPAXONE® 20mg Provides advantage in biosimilar and novel drug development Diverse
Slide 3: Momenta 2017: A Year of Progress and Challenges
Novel Drugs M281 (anti-FcRn) successful Phase 1 M230 (rFc multimer) CTA filed by CSL M254 (hsIVIg) IND enabling toxicology initiated Biosimilars M710 (b-EYLEA® candidate) IND filing complete M923 (b-HUMIRA® candidate) BLA ready for filing Research Platform Emerging pipeline of novel drugs for rare a
Slide 4: Proactively Addressing Momenta's Strategic Challenges
Proactively Addressing Momenta’s Strategic Challenges 5 Potential Management Actions Establish new partnerships across the portfolio Implement additional cost reduction strategies Slow pace of future biosimilar program development Potential sale of certain assets Strategic Review Objective to maximi
Slide 5: Glatopa (glatiramer acetate injection)
Glatopa® (glatiramer acetate injection)
Slide 6: Glatopa 40 mg Regulatory Status
Glatopa® 40 mg Regulatory Status Sandoz’s Glatopa 40 mg ANDA remains under review pending resolution of outstanding compliance issues No outstanding questions from the Office of Generic Drugs In the 4th quarter, FDA re-inspected Pfizer’s McPherson facility Form 483 observations were made Pfizer has
Slide 7: Glatopa 20 mg and 40 mg Market Update
Glatopa® 20 and 40 mg Market Update Aggressive competition has reduced the potential of the 20 mg glatiramer acetate market Sandoz has maintained Glatopa 20 mg market share based on strong supply reliability, customer relationships and patient support with GlatopaCare® However, the price point has d
Slide 8: Glatopa 20 mg and 40 mg Market Update
Glatopa® 20 and 40 mg Market Update ° Aggressive competition has reduced the potential of the 20 mg glatiramer acetate market - Sandoz has maintained Glatopa 20 mg market share based on strong supply reliability, customer relationships and patient support with GlatopaCare® - However, the price point
Slide 9: Technology Platform Has Generated a Robust Pipeline of Biosimilar Candidates
Biosimilars Preclinical/Process Development Clinical BLA Filed Marketed M923 Adalimumab (HUMIRA®) M834 Abatacept (ORENCIA®) M710 Aflibercept (EYLEA®) M740 (undisclosed) M615 (undisclosed) M730 (undisclosed) M706 (undisclosed) Momenta’s Technology Platform has Generated a Robust Pipeline of Biosimila
Slide 10: M710: Biosimilar EYLEA (aflibercept) Candidate in Collaboration with Mylan
M710: Biosimilar EYLEA® (aflibercept) Candidate in Collaboration with Mylan EYLEA is the market leading VEGF inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic R
Slide 11: M834: Biosimilar ORENCIA (abatacept) Candidate in Collaboration with Mylan
M834: Biosimilar ORENCIA® (abatacept) Candidate in Collaboration with Mylan 13 ORENCIA is a complex fusion protein M834 did not meet its primary pharmacokinetic (PK) endpoints in the Phase 1 study Momenta is using its deep analytic capabilities to perform a comprehensive investigation into potential
Slide 12: Novel Drugs for Autoimmune Indications
Novel Drugs for Autoimmune Indications
Slide 13: Technology Platform Has Generated a Promising Pipeline of Novel Drug Candidates
Momenta’s Technology Platform has Generated a Promising Pipeline of Novel Drug Candidates 15 Novel Drugs for Autoimmune Indications Preclinical Clinical NDA Filed Marketed M281 (Anti-FcRn Antibody) M230 (Recombinant Fc multimer) M254 (Hyper-sialylated IVIg) Fc Biology Candidates* Sialylation Technol
Slide 14: FcRn is a Key Target for Rare Immune-mediated Disorders
Adapted from NEJM 1999;340-227-8 Endothelial Cell Degradation of IgG Neutralization of FcRn Competitive Binding of FcRn Inactivated FcRn Normal IgG Anti-FcRn Antibody pH 7.4 pH 6.0 Pathogenic IgG pH 6.0 Neonatal Fc Receptor (FcRn) is a Key Target for the Management of Rare Immune-mediated Disorders
Slide 15: M281 (anti-FcRn): Purposefully Engineered to Neutralize FcRn
M281 (anti-FcRn): Purposefully Engineered and Optimized to Neutralize FcRn 17 Engineered Effectorless Design High Affinity Binding to FcRn pH Resistant Binding Epitope Specific to IgG Binding Site Fab Fully Human IgG1 Monoclonal Antibody Fab Fab Fc
Slide 16: M281 Provides Full Range of IgG Suppression with Safety and Consistency in Phase 1
M281 Provides Full Range of IgG Suppression with Safety and Consistency in Phase 1 Healthy Volunteer Study 18 IgG in SAD Cohorts Days Serum IgG as Percent of Baseline MAD 30 mg/kg Weekly x 4 Days Serum IgG as Percent of Baseline Well tolerated with no serious adverse events in either the single asce
Slide 17: M230 Recombinant Fc Multimer in Collaboration with CSL
Potential first-in-class recombinant Fc multimer designed with enhanced avidity and affinity for Fc receptors M230 shows higher potency and efficacy at a lower dose than IVIg in preclinical chronic ITP model CSL has filed a CTA and plans to initiate a Phase 1 trial in healthy volunteers in Q1 2018 C
Slide 18: M254: Hyper-sialylated IVIg Targeted to Enter the Clinic in 2H 2018
Potency Up to 10x increase in potency allows for greater immune modulation Convenience Enables subcutaneous administration and reduces burden to patients and health systems due to shorter infusion times Safety profile Decreased dose reduces treatment-associated AE’s and allow for steroid-sparing in
Slide 19: M254: Hyper-sialylated IVIg Targeted to Enter the Clinic in 2H 2018
M254: Hyper-sialylated IVIg (hsIVIg) Targeted to Enter the Clinic in 2H 2018 M254 has the potential to provide enhanced: Potency Convenience Safety profile Up to 10x increase in Enables subcutaneous Decreased dose reduces potency allows for administration and reduces treatment-associated AE’s greate
Slide 20: Focus on Financial Discipline to Extend Cash Runway
Focus on Financial Discipline to Extend Cash Runway Projecting 2+ years of cash runway Healthy cash balance of $423 MM at end of Q3 2017 Continued Glatopa® 20 mg and potential 40 mg revenues Potential collaboration development milestones Implemented measures to conserve capital Delayed M923 (b-HUMIR
Slide 21: Momenta's 2018 Program Goals and Milestones
Momenta’s 2018 Program Goals and Milestones Novel Drugs Complex Generics Biosimilars M281 (anti-FcRn) M230 (rFc multimer) M254 (hsIVIg) Collaboration Partner Initiation of a Phase 2 proof-of-concept study in 2H 2018 CSL to initiate a Phase 1 study in Q1 2018 Initiation of a Phase 1 study in 2H 2018
Slide 22: Momenta 2018: A Year of Evolution
Momenta 2018: A Year of Evolution 24 Expected launch of Glatopa® 40 mg Clarify revenue potential for Glatopa franchise Advance development pipeline Complete strategic review to align spend and maximize value Maturing Pipeline Strategic Review Create Long-Term Shareholder Value
Slide 23: Momenta Pharmaceuticals, Inc.
Momenta Pharmaceuticals, Inc.
Slide 24: Momenta Pharmaceuticals, Inc.
Momenta Pharmaceuticals, Inc.
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