Jefferies Autumn 2015 Global Healthcare Conference. Company Update November 18, 2015

Transcription

1 Jefferies Autumn 2015 Global Healthcare Conference Company Update November 18, 2015

2 Safe Harbor 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 AG, Company Update - November

3 Broad Therapeutic Pipeline with Multiple Near-Term Catalysts MOR208 Next generation Fc-enhanced antibody addressing unmet needs in B-cell malignancies Pivotal trial in DLBCL expected to start in 2017 Differentiated Proprietary Programs & Technologies Anti-CD38 antibody MOR202 for multiple myeloma in Phase 1/2 MOR209 in Phase 1, MOR106 & MOR107 in pre-clinic Continued investment in technology leadership drives pipeline expansion Pipeline Provides Strong Foundation for Growth Over 100 compounds in development, over 20 clinical studies to be completed by end 2016 Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J) expected in 2016 MorphoSys AG, Company Update - November

4 The MorphoSys Pipeline 25 Clinical Product Candidates, 104 Total Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3 Bimagrumab (BYM338) Novartis ActRIIB sibm (musculoskeletal) Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer s disease MOR208 - CD19 ALL, CLL, NHL MOR103/GSK GSK GM-CSF Inflammation MOR202 - CD38 Multiple myeloma BHQ880 Novartis DKK-1 Multiple myeloma CNTO3157 Janssen - Inflammation CNTO6785 Janssen - Inflammation LFG316 Novartis C5 Eye diseases LJM716 Novartis HER3 Cancer BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors VAY736 Novartis BAFF-R Inflammation MOR209/ES414 Emergent PSMA/CD3 Prostate cancer Anetumab Ravtansine (BAY ) Bayer Mesothelin (ADC) Solid tumors BAY Bayer TFPI Hemophilia BI BI IGF-1 Solid tumors NOV 7 Novartis - Eye diseases NOV 8 Novartis - Inflammation NOV-9 Novartis - Diabetic eye diseases NOV-10 Novartis - Cancer NOV-11 Novartis - Blood disorders PF Pfizer 4-1BB Solid tumors Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors MOR106 Galapagos - Inflammation MOR107 (LP2) - AT2-R Fibrosis Immuno-oncology program Merck Serono - Cancer Immuno-oncology program Immatics - Cancer 6 MOR programs - - Various In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery Most advanced development stage 90 Partnered Programs 13 MOR Programs 1 Outlicensed Program MorphoSys AG, Company Update - November

5 The MOR Portfolio Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3 Unpartnered MOR208 NHL FTD, orphan status US & EU CLL ALL CD19 Orphan status US & EU MOR202 Multiple myeloma CD38 MOR107 Fibrosis AT2-R Immuno-oncology program (Immatics) Cancer Various 6 Programs Various Various Co-development & co-promotion MOR209/ES414 (Emergent) MOR106 (Galapagos) Immuno-oncology program (Merck Serono) Prostate cancer Inflammation Cancer PSMA / CD3 Undisclosed Undisclosed MorphoSys AG, Company Update - November

6 MOR208 First- & Best-in Class Potential Fc-enhanced, humanized IgG1 antibody targeting CD19 CD19 is target of choice for B-cell malignancies CD20 down-regulated after anti-cd20 treatment CD19 down-regulation not described Fc modification leads to dramatically enhanced B cell depletion antibody dependent cellular cytotoxicity (ADCC) phagocytosis direct cytotoxicity Convenient dosing schedule, straightforward manufacturing Strong pre-clinical support for combo therapy MorphoSys AG, Company Update - November

7 MOR208 Superior to Other CD19 & CD20 MAbs in R/R CLL Response Rates Based on IWCLL2008 Criteria anti-cd19 MAbs anti-cd20 MAbs SD, PD & non-evaluable ORR mpfs (months) 38% MOR208 12mg/kg (n=16) 24% MEDI-551 phase 1/2 12mg/kg (n=26) 30% Obinutuzumab phase 2 (n=20) 23% Ofatumumab phase 3 (n=196) 13% Rituximab (n=110) 14 NR MEDI-551 data source: Poster ASCO 2013, 12mg/kg dosing group Obinutuzumab data source: GAUGUIN study, Cartron et al, Blood 2014 Ofatumumab data source: control arm in ibrutinib vs. O phase 3 trial (RESONATE, ASCO 2014) Rituximab data source: Late breaking abstract #6, ASH 2013 Criteria: Hallek et al 2008 (including CT) [NR not reported] MorphoSys AG, Company Update - November

8 MOR208 Strong Single Agent Efficacy in R/R NHL Best overall response* n (%) DLBCL n=35 FL n=34 Other inhl n=11 MCL n=12 Total n=92 Complete response 2 (6%) 3 (9%) 2 (18%) 0 6 (7%) Partial response 7 (20%) 6 (18%) 1 (9%) 0 15 (16%) Stable disease 5 (14%) 17 (50%) 4 (36%) 6 (50%) 32 (35%) Progressive disease 11 (31%) 4 (12%) 3 (27%) 5 (42%) 23 (25%) Not evaluable 10 (29%) 4 (12%) 1 (9%) 1 (8%) 16 (17%) ORR (CR + PR) 9 (26%) 9 (26%) 3 (27%) 0 21 (23%) ORR (Evaluable pts) 9 (36%) 9 (30%) 3 (30%) 0 21 (31%) *Investigator assessed inhl cohort not expanded due to heterogeneity Post-baseline response assessment not performed/data unavailable CR, complete response; ORR, objective response rate Jurczak et al, #1528, ASH 2015 MorphoSys AG, Company Update - November

9 MOR208 Comprehensive Clinical Development Plan Indication NHL MOR208 (12 mg/kg); N=92 DLBCL MOR208 (12mg/kg) + lenalidomide; 2 nd line R/R; N=80 Safety evaluation leading into anticipated pivotal study MOR208 (12 mg/kg) + bendamustine; 2 nd line R/R; N~320 CLL MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120 MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter s Transformation; N=50 (Ohio State Univ. IIT) ALL MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude s IIT) Phase 2 Phase 2/3 IIT: Investigator-initiated trial MorphoSys AG, Company Update - November

10 MOR208 Significant Unmet Medical Need MOR208 addresses shortcomings in current B cell cancer treatment options CD20 down-regulation Patients unable to manage side effects of TKIs TKI relapses: very unfavourable prognosis, median survival 3-4 months in CLL Major medical need in DLBCL and CLL DLBCL: Ca. 40% treated with chemoimmunotherapy/asct eventually relapse, becoming refractory to current agents * CLL: Patients who are discontinued after BTKi treatment relapse very quickly and have a very poor prognosis Incidence / Deaths (USA, 2015) 0 DLBCL New Cases CLL Deaths * Mounier et al. Best Pract Res Clin Haematol MorphoSys AG, Company Update - November

11 MOR202 A Novel Antibody for Multiple Myeloma HuCAL IgG1 antibody binding unique epitope on CD38 One of only three CD38 antibodies in clinic Potent ADCC and ADCP Full killing of MM cells Low killing of healthy/effector cells Strongly synergistic with IMiDs and proteasome inhibitors in pre-clinical models Best-in-class infusion tolerability as consistent 2-hour infusion MorphoSys AG, Company Update - November

12 MOR202 Encouraging Activity in Ongoing Phase 1/2a Study Data from patients in cohorts 4 mg/kg weekly MOR202 + Dex who received > 1 treatment cycle S: serum; U: urine. 30% ORR seen so far (study not completed yet) Raab et al., IMW 2015 MorphoSys AG, Company Update - November

13 MOR202 Clinical Development Plan Indication MOR202 monotherapy, dose escalation & confirmation cohorts; N~62* Multiple myeloma MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24** MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24* MOR202 combo study to be based on Phase 2 Phase 2 Phase 2/3 * Patients who have failed at least 2 prior therapies ** Patients who have failed at least 1 prior therapy MorphoSys AG, Company Update - November

14 MOR202 Increasing Interest in Antibodies in MM Multiple myeloma (MM) treatment: a large commercial opportunity Leading therapies already generate over $5.0bn in worldwide sales Estimated to reach $10.2bn by 2020 Biologics to generate $8bn by 2023 mostly from anti-cd38 Mabs MM is a growing market Increasing adoption of new agents in 1st line setting & maintenance Use of targeted agents in combo regimens CD38 is an Ideal Target for Hematologic Diseases Opportunities beyond MM based on CD38 expression MorphoSys AG, Company Update - November

15 MOR209/ES414 A Novel Bi-specific Antibody for Prostate Cancer Bi-specific ADAPTIR antibody targeting PSMA on prostate cancer cells, levels increase with progression CD3 on cytotoxic T cells Compelling pre-clinical data Encouraging activity in vitro and in vivo Less cytokine release on T cell activation in pre-clinical models compared to other formats Prolonged half-life in mouse and NHP compared to other formats Indication MOR209/ES414: Phase 1/2 dose escalation (N~50) mcrpc* MOR209/ES414: Phase 1/2 dose extension (N~80) Phase 3 preparations Phase 1/2a Phase 3 * Metastatic castration-resistant prostate cancer MorphoSys AG, Company Update - November

16 Clinical Programs Pursued by Partners (I) Program Partner Target Indication Phase 1 Phase 2 Phase 3 Bimagrumab Novartis ActRIIB sibm (52 weeks) (BYM338) sibm (extension) sibm (long-term study) Hip fracture surgery Sarcopenia Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1) (CNTO1959) Psoriasis (VOYAGE 2) Psoriasis (NAVIGATE) Pustular/Erythrodermic Psoriasis Moderate to severe psoriasis Active psoriatic arthritis Gantenerumab Roche Amyloid-ß Mild Alzheimer s disease Prodromal Alzheimer s disease Genetically predisposed BHQ880 Novartis DKK-1 MM (renal insufficiency) Smoldering MM BPS804 Mereo/Novartis Sclerostin Osteoporosis Hypophosphatasia (HPP) Osteogenesis Imperfecta CNTO3157 Janssen/J&J n.d. Asthma Safety/Pharmacokinetic CNTO6785 Janssen/J&J n.d. COPD Rheumatoid arthritis LFG316 Novartis C5 Age-related AMD Geographic atrophy Panuveitis Paroxysmal nocturnal hemoglobinuria LJM716 Novartis HER3 ESCC (combo with BYL719) HER2 + cancer (combo BYL719 & trastuzumab) HER2+ cancer, combo with trastuzumab Partnered discovery programs MorphoSys AG, Company Update - November

17 Clinical Programs Pursued by Partners (II) Program Partner Target Indication Phase 1 Phase 2 Phase 3 MOR103/GSK GlaxoSmithKline GM-CSF Rheumatoid Arthritis Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE) (OMP-59R5) Small cell lung cancer (Pinnacle) Solid tumors BAY Bayer TFPI Bleeding disorders BAY Bayer Mesothelin Solid tumors Anetumab Ravtansine Advanced malignancies (Japan) BI BI IGF-1 Solid tumors, Japanese patients EGFR mutant NSCLC Breast cancer CRPC + enzalutamide Various solid cancer Advanced solid tumors NOV-7 Novartis n.d. Eye disease NOV-8 Novartis n.d. Inflammation NOV-9 Novartis n.d. Diabetic eye disease NOV-10 Novartis n.d. Cancer NOV-11 Novartis n.d. Blood disorders PF Pfizer 4-1BB Solid tumors, NHL (+rituximab) Solid tumors, combo with PD-1i MK-3475 Advanced solid tumors, with mogamulizumab Advanced malignancies, with avelumab VAY736 Novartis BAFF-R Pemphigus vulgaris Primary Sjögren s syndrome Primary Sjögren s syndrome Vantictumab Oncomed/Bayer Fzd 7 Solid tumors (OMP-18R5) Breast cancer Pancreatic cancer NSCL Out-licensed program Partnered discovery programs MorphoSys AG, Company Update - November

18 MOR103/GSK Anti-inflammatory Program Licensed to GSK MOR103/GSK HuCAL antibody specific for GM-CSF GM-CSF is important in every step of macrophage production and infiltration in the tissues Indications Lead indication: Rheumatoid arthritis (RA) Potential for disease modification & analgesic activity in hand osteoarthritis (HOA) Current Status BAROQUE (RA phase 2b) ongoing Initial clinical read-out 2016 Phase 2 in hand osteoarthritis to start in 2016 GM-CSF plays a key role in activation of macrophages at the site of injury or inflammation MorphoSys AG, Company Update - November

19 MOR103/GSK Promising Clinical Data in RA Phase 1b/2a study in RA patients Good magnitude of effect with fast onset of action and long duration post treatment Effect size appears similar to or greater than anti-tnf Targeting the macrophage in early RA Potential for early use to induce remission MorphoSys AG, Company Update - November

20 Bimagrumab (BYM338) A Novartis Musculoskeletal Program Bimagrumab HuCAL antibody specific for ActRIIB, antagonizes myostatin binding Lead indication: sporadic inclusion body myositis (sibm) FDA breakthrough therapy designation Orphan drug designation Current Status Pivotal study in sibm with 240 patients ongoing, completion scheduled for Q Phase 3 data expected in H Listed by Novartis as planned filing 2016 Phase 2 read-outs in sarcopenia expected in 2016 M. Schuelke at al, N Engl J Med 2004;350: MorphoSys AG, Company Update - November

21 Bimagrumab (BYM338) Promising Phase 2 Data in sibm* Bimagrumab, single dose, 30 mg/kg Muscle mass increased approx. 5% more than placebo Muscle gain was functional Increases in strength parallel to physical performance and in 6-minute walking distance Data courtesy of Novartis [*] A Amato et al; Neurology; Nov 7, 2014, online [1] Statistically significant difference MorphoSys AG, Company Update - November

22 Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program Guselkumab A HuCAL antibody specific for IL-23, does not bind IL-12 IL-23 blockade inhibits production of multiple cytokines beyond IL-17A and preserves Th1 & Treg regulatory pathways Being developed in psoriasis and psoriatic arthritis Current Status Five Phase 3 clinical trials ongoing First Phase 3 data expected in 2016 Anticipated filing in 2016 Source: Jetten AM, Nucl Recept Signal, 2009 MorphoSys AG, Company Update - November

23 Guselkumab (CNTO1959) Clinical Data Highest levels of durable skin clearance with less intensive dosing regimens vs. anti-il-17 class Potential for similar safety profile vs. long-term blockade of IL with STELARA Potential for long-term, drug-free efficacy Data courtesy of Janssen MorphoSys AG, Company Update - November

24 Clinical Trials Scheduled for Completion PHASE 1 PHASE 2 PHASE 3 Bimagrumab sibm CNTO6785 Rheumatoid arthritis CNTO6785 COPD LFG316 Age-related AMD MOR202 Multiple myeloma MOR208 NHL (mono - update) MOR208 - IST CLL (combo with len) Guselkumab Psoriasis (VOYAGE 1) Guselkumab Psoriasis (VOYAGE 2) Bimagrumab Sarcopenia LFG316 Panuveitis LFG316 PNH Guselkumab Psoriasis (NAVIGATE) LJM716 ESCC, combo w/byl719 Tarextumab Pancreatic cancer BI Advanced solid tumors BAY Solid tumors Tarextumab Solid tumors BI NSCLC MOR209 Prostate cancer LJM716 Advanced solid tumors Vantictumab NSCLC BI Solid tumors (Japan) Vantictumab Breast cancer LJM716 HER2+ cancer (combo) Vantictumab Pancreatic cancer BI Various solid cancer Vantictumab Solid tumors Potential data events based on clinical trial design & MorphoSys estimates Partnered Discovery Programs MOR Programs MorphoSys AG, Company Update - November

25 Powerful Technology Base Ensures Pipeline Sustainability Innovative Targets GPCRs, ion channels Proprietary Platforms Antibody library Immune checkpoints Differentiated drug candidates Protein optimization MHC-presented, tumour-associated peptides Lantipeptides MorphoSys AG, Company Update - November

26 Financial Guidance 2015 in million 2014A 9M 2015 Guidance 2015 Group Revenues to 106 Proprietary R&D Expenses (incl. Technology Development) to 63 EBIT to 16 Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets MorphoSys AG, Company Update - November

27 What to Expect? MOR208 Updated data from phase 2 mono-therapy trial at ASH 2015 DLBCL: Phase 2 lenalidomide combo trial to start in Q Phase 3 bendamustine combo trial expected to start in 2017 CLL: Phase 2 idelalisib combo trial to start in Q ALL: Phase 2 pediatric IIT with NK cell transfusion to start in H MOR202 Updated data from phase 1/2a trial at ASH 2015 MOR209 First phase 1 data expected in 2016 Bimagrumab Guselkumab Pipeline Data from pivotal trial in sporadic inclusion body myositis expected early 2016 Filing expected in 2016 Data from 3 pivotal trials in psoriasis expected 2016 Filing expected in 2016 MOR106 & MOR107 to start clinical development in 2016 Potential in-licensing of additional compounds MorphoSys AG, Company Update - November

28 Thank You Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com HuCAL, HuCAL GOLD, HuCAL PLATINUM, CysDisplay, RapMAT, aryla, Ylanthia and 100 billion high potentials are registered trademarks of MorphoSys AG. Slonomics is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.