Company Update August 27, 2013
Total Page:16
File Type:pdf, Size:1020Kb
Commerzbank – Sector Conference Week Company Update August 27, 2013 © MorphoSys - August 2013 Safe Harbour This presentation includes forward-looking statements. Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing. These and other risks and uncertainties are detailed in the Company’s Annual Report. © MorphoSys - August 2013 2 Highlights Two Major Alliances for Proprietary Antibodies Alliance with Celgene for co-development & co-promotion of MOR202 Successful out-licensing of MOR103 to GSK Pipeline Progress 21 programs in clinical development Strong Financial Position Recurring cash-flows Sale of AbD, GSK & Celgene deals strengthen balance sheet © MorphoSys - August 2013 3 Innovative Product Pipeline © MorphoSys - August 2013 4 The MorphoSys Pipeline 21 Clinical Programs, 81 Total Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer’s Disease MOR103 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal NOV – 3 Novartis - not discl. LFG316 Novartis C5 Ophthalmology OMP-59R5 OncoMed/GSK Notch 2 Cancer MOR208 - CD19 CLL, NHL, ALL MOR202 Celgene/MOR CD38 Multiple Myeloma BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI – 1 BI - not discl. CNTO3157 Janssen/J&J - Asthma CNTO – 5 Janssen/J&J - Inflammation VAY736 Novartis BAFF-R Inflammation LJM716 Novartis HER3 Cancer Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer PFE – 1 Pfizer - Cancer NOV - 7 Novartis - Ophthalmology 22 Programs Various Partners - Various Indications Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs © MorphoSys - August 2013 5 MOR202 A Novel Antibody for Multiple Myeloma Large Market and Unmet Need Revenues with approved drugs in MM exceed $2bn Responders eventually relapse or become refractory to existing therapies MOR202 High affinity HuCAL antibody targeting CD38 Competitive Profile Preclinical data show strong synergy in combinations of MOR202 with Velcade or Revlimid Clinical Development Phase 1/2a clinical trial in relapsed or refractory MM patients currently ongoing Strategic Alliance with Celgene Joint development of MOR202 globally and co-promotion in Europe © MorphoSys - August 2013 6 Alliance with Celgene for MOR202 Scope Global co-development and European co-promotion agreement Up-front MOR receives EUR 70.8 million Equity Celgene pays EUR 46.2 million for 3.4% stake in MOR at EUR 57.90 per share 53% premium to pre-announcement price Milestones Up to EUR 511 million in development, regulatory and sales milestones Commercialization Co-promotion in Europe with 50:50 profit share Exclusive Celgene in rest-of-world, tiered double digit royalties to MOR © MorphoSys - August 2013 7 MOR103 Global License Agreement with GSK MOR103 Ultra-high affinity HuCAL IgG1 targeting GM-CSF Potential for superior efficacy and better safety than current treatments Phase 1b/2a trial in RA successfully completed Phase 1b in MS ongoing GSK assumes global responsibility for clinical development and commercialization of MOR103 in all indications MorphoSys receives… EUR 22.5 million upfront payment Up to EUR 423 million in success-based payments Tiered, double-digit royalties on net sales © MorphoSys - August 2013 8 MOR103 Compelling Clinical Data ACR20* DAS28 70 MOR103 1 mg/kg mavrilimumab Humira 60 Orencia Actemra 50 40 30 % of patients 20 10 Mean from change baseline 0 Week 0 1 2 3 4 Time (weeks) Very fast onset of therapeutic effect Durable response Clean safety profile * Data from separate clinical studies © MorphoSys - August 2013 9 MOR208 (XmAb5574) A Novel Anti-Cancer Antibody Large Market and Unmet Need Large unmet medical need in NHL, CLL & ALL Revenues with approved drugs for B cell malignancies exceed $5bn MOR208 Anti-CD19 antibody in-licensed from Xencor CD19 expressed earlier than CD20 potential greater efficacy vs. anti-CD20s Proprietary modification in Fc region increased ADCC rapid & sustained B-cell depletion Minor modification means convenient dosing schedule, straightforward manufacturing Blinatumomab data validate CD19 as target for B-cell malignancies © MorphoSys - August 2013 10 MOR208 Phase 1/2a Trial in CLL/SLL Trial Design Phase 1, multi-center, US study in heavily pre-treated, relapsed or refractory CLL/SLL patients Dosage 0.3 mg/kg - 12 mg/kg; days 1&4, weeks 2-8 Results Acceptable safety profile Responses observed in 67% of patients by physical exam 4/27 (15%) partial responses and 20/27 (74%) patients with stable disease (IWCLL 2008 criteria including CT) Full results from trial extension expected in Q3 2013 Phase 2 Phase 2 trials in ALL and NHL ongoing Combination therapy study in CLL being considered © MorphoSys - August 2013 11 The MorphoSys Pipeline 21 Clinical Programs, 81 Total Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer’s Disease MOR103 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal NOV – 3 Novartis - not discl. LFG316 Novartis C5 Ophthalmology OMP-59R5 OncoMed/GSK Notch 2 Cancer MOR208 - CD19 CLL, NHL, ALL MOR202 Celgene/MOR CD38 Multiple Myeloma BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI – 1 BI - not discl. CNTO3157 Janssen/J&J - Asthma CNTO – 5 Janssen/J&J - Inflammation VAY736 Novartis BAFF-R Inflammation LJM716 Novartis HER3 Cancer Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer PFE – 1 Pfizer - Cancer NOV - 7 Novartis - Ophthalmology 22 Programs Various Partners - Various Indications Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs © MorphoSys - August 2013 12 Gantenerumab: A HuCAL Antibody Being Developed by Roche for Alzheimer’s Disease Large Market and Unmet Need Alzheimer’s disease is estimated to affect 25 million people worldwide Increasing with aging population Once symptoms for AD dementia have appeared, it may be too late to treat Picture: Courtesy of Roche © MorphoSys - August 2013 13 Gantenerumab: The Most Advanced Antibody in Development for Alzheimer’s Disease Gantenerumab High affinity HuCAL antibody targeting amyloid-β Binds & breaks down amyloid-β fibrils and plaques Clinical Development Phase 1: gantenerumab reduces brain amyloid 3x faster than other amyloid-targeting substances Pivotal Phase 3 study ongoing 770 prodromal patients, 2 doses (105mg & from baseline 225mg s.c.), placebo-controlled Amyloid change % 104 weeks on drug, with an option for an additional 2 years of treatment Primary Endpoint: Change in the Clinical Data from Phase 1 Dementia Rating Scale Sum of Boxes (CDR-SOB) Effect of gantenerumab on amyloid load as indexed by PET Sub-study: Change in brain amyloid over time SUVR at end of treatment assessed by PET Interim safety analysis in 2013 Data expected 2016 Data: Courtesy of Roche © MorphoSys - August 2013 14 The MorphoSys Pipeline 21 Clinical Programs, 81 Total Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer’s Disease MOR103 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal NOV – 3 Novartis - not discl. LFG316 Novartis C5 Ophthalmology OMP-59R5 OncoMed/GSK Notch 2 Cancer MOR208 - CD19 CLL, NHL, ALL MOR202 Celgene/MOR CD38 Multiple Myeloma BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI – 1 BI - not discl. CNTO3157 Janssen/J&J - Asthma CNTO – 5 Janssen/J&J - Inflammation VAY736 Novartis BAFF-R Inflammation LJM716 Novartis HER3 Cancer Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer PFE – 1 Pfizer - Cancer NOV - 7 Novartis - Ophthalmology 22 Programs Various Partners - Various Indications Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs © MorphoSys - August 2013 15 Bimagrumab (BYM338) A Novartis Musculoskeletal Program Bimagrumab is a HuCAL antibody against ActRIIB Novartis received FDA breakthrough therapy designation for sporadic inclusion body myositis (sIBM) Phase 2 study showed that bimagrumab substantially benefited patients with sIBM Results will be presented at the American Neurological Association meeting on Oct. 14, 2013 In Phase 2 development for Sporadic inclusion body myositis Cancer-related cachexia COPD-related cachexia Sarcopenia Mechanically ventilated patients Recently Highlighted by Novartis “Imagine the equivalent of 8 or 10 weeks of exercise in one injection” Listed as a “planned filing 2016” Source: www.actionduchenne.org © MorphoSys - August 2013 16 The MorphoSys Pipeline 21 Clinical Programs, 81 Total Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer’s Disease MOR103 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J