Bank of America Merrill Lynch Global Healthcare Conference Company Update. September 17, 2015

Transcription

1 Bank of America Merrill Lynch Global Healthcare Conference 2015 Company Update September 17,

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 - September

3 Multiple Therapeutic Programs with Best-in-Class Potential MOR208: Aimed at Shortcomings of Current Lymphoma and Leukemia Treatments Promising single agent results in NHL and CLL Comprehensive set of combo trials commencing in 2015 & 2016 Pivotal trial aimed to start in 2017 Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody in multiple myeloma MOR209: Bi-specific antibody in Phase 1 for mcrpc; MOR106 & MOR107 in pre-clinic Continued investment in technology leadership drives pipeline growth Partnered Pipeline Providing Strong Foundation and Multiple Near-Term Catalysts Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J/Janssen) expected in 2016 Over 20 clinical studies likely to be completed before the end of 2016 Experienced Team Driving the Next Stage of Growth Cross-functional team with long track record of leadership Deep expertise in biopharmaceutical discovery, development & manufacturing Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics MorphoSys - September

4 The MOR Portfolio Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3 Unpartnered MOR208 NHL CLL CD19 ALL MOR202 Multiple myeloma CD38 MOR107 Fibrosis AT2-R Immuno-oncology programs (Immatics) Cancer Various 7 Programs Various Various Co-development & co-promotion MOR209/ES414 (Emergent) MOR106 (Galapagos) Immuno-oncology programs (Merck Serono) Prostate cancer Inflammation Cancer PSMA / CD3 Undisclosed Undisclosed MorphoSys - September

5 MOR208: Addressing Shortcomings in Treating B-Cell Malignancies DRUG Fc-enhanced, humanized IgG1 antibody Fc modification leads to dramatically enhanced B cell depletion via ADCC, phagocytosis, direct cytotoxicity Convenient dosing schedule, straightforward manufacturing Fast Track Designation in DLBCL; FDA & EMA Orphan Drug Status in DLBCL & CLL TARGET CD19 CD19 has a strong rationale in B cell malignancies Constant expression levels of CD19 across all B cell cancers in contrast to CD20 Patients show down-regulation of CD20 after anti-cd20 treatment; CD19 downregulation is not described Novel TKIs efficacious but characterized by challenging side effects; patients relapsing on TKIs have very unfavorable prognosis MorphoSys - September

6 MOR208 Could Be Superior to Other CD19 & CD20 MAbs in Relapsed/Refractory CLL Response Rates Based on IWCLL2008 Criteria anti-cd19 MAbs anti-cd20 MAbs SD, PD & Non-evaluable ORR mpfs (mo.) 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 - September

7 MOR208: Multiple Studies to Start in 2015/2016 STATUS Phase 2 trial with LEN in 2 nd line R/R DLBCL to start in Q Phase 2 trial with IDE in CLL in BTKi-failures to start in Q Phase 3 combo trial with BEN in 2 nd line R/R DLBCL aimed to start in 2017 Update on NHL monotherapy planned at ASH 2015 NHL DLBCL * Phase 2: MOR208 mono (N=92) Phase 2: MOR208 (12mg/kg) plus lenalidomide (N=80) Safety evaluation leading into anticipated pivotal study (12 mg/kg MOR208 plus bendamustine), N~320 CLL Phase 2: MOR208 (12mg/kg) plus idelalisib, BTKi-failures, N=120 Ph. 2 (ongoing OSU IIT): R/R & naive CLL & Richter s Transformation, MOR208 (9mg/kg) plus LEN, N=50 ALL Phase 2 (St. Jude s IIT): Pedriatic ALL, MOR208 (12mg/kg) plus NK cells, N=13 Phase 3 Phase 2 IIT MorphoSys - September 2015 *no outlook given beyond

8 MOR202: A Novel Antibody for Multiple Myeloma DRUG High affinity HuCAL IgG1 antibody Potent ADCC and ADCP, full killing activity on MM cells and low killing activity on healthy/effector cells, and low/no CDC Strong synergy with IMiDs and proteasome inhibitors in pre-clinical models Best-in-class infusion tolerability as consistent 2-hour infusion MorphoSys regained all rights from Celgene TARGET CD38 Antibody binds to a unique epitope on CD38 CD38 has a compelling scientific rationale based on the highest expression levels of any antibody target in MM Clinical PoC for anti-cd38 antibodies established OPPORTUNITY Multiple myeloma (MM) treatment a large commercial opportunity leading already generate > US $ 5.0 billion in worldwide sales CD38 market peak sales are expected in US$ billions worldwide First clinical data hint at a balanced and potentially best-in-class safety/efficacy profile MorphoSys - September

9 MOR202: Clinical Development Plan STATUS Phase 1/2a clinical trial in MM ongoing Cohorts ongoing: MOR202 16mg/kg weekly + Dex MOR202 + LEN + Dex MOR202 + POM + Dex Encouraging early signs of activity already at low doses Higher level of activity expected at further doses giving full target saturation * MM Phase 1/2a MOR202 mono, dose escalation, plus confirmation cohorts (N~62) Phase 1/2a MOR202 (8 and 16mg/kg) plus lenalidomide or pomalidomide and confirmation cohorts (N~24) Phase 3: MOR202 combination therapy Phase 2 Phase 3 *no outlook given beyond 2018 MorphoSys - September

10 MOR209/ES414: A Bi-specific Immunotherapeutic Against Prostate Cancer DRUG Bi-specific ADAPTIR antibody Directs T cells to kill PSMA+ tumor cells in vitro and in vivo Reduced cytokine release on T cell activation in preclinical models compared to other formats Prolonged serum half-life in mouse and NHP compared to antibody fragments TARGET PSMA expressed in normal and hyperplastic prostate tissue, expression levels increase with prostate cancer progression CD3 on cytotoxic T-cells PSMA/CD3 OPPORTUNITY Prostate cancer is the most common and second most lethal cancer in men Current treatments provide only a months increase in OS for metastatic CRPC patients Global market for mcrpc therapeutics expected to exceed US$ 5.1 billion in 2022 MorphoSys - September

11 MOR209/ES414: New Treatment Option in mcrpc STATUS Preclinical studies successfully concluded, promising results presented in 2013 Pharmacologically active and well tolerated Shows activity at very low doses Phase 1 in mcrpc in the U.S. and Australia ongoing Stage 1: identify MTD of MOR209/ES414 administered iv Stage 2: evaluate clinical activity in patients that have or have not received prior chemotherapy NEXT First clinical data expected in * mcrpc MOR209/ES414: Phase 1/2 dose escalation (N~50) MOR209/ES414: Phase 1/2 dose extension (N~80) Phase 2 Phase 3 Phase 3 preparations *no outlook given beyond 2018 MorphoSys - September

12 Leveraging Technology Leadership Antibodies Peptides GPCR target Immuno-oncology Slonomics 2010 LanthioPharma Heptares 2013 MerckSerono Enables very efficient antibody optimization Ylanthia Largest Fab antibody library Based on the expertise gained in building and using HuCAL in drug discovery and development Stabilized peptide technology complements existing antibody drug discovery platform Delivers challenging GPCRs in stabilized form as drug targets G7 Therapeutics Delivers tailormade GPCRs as drug targets Antibodies against immune checkpoints Immatics Antibody-based therapies targeting tumor-associated peptides MorphoSys Group Technologies Collaborations MorphoSys - September

13 Programs Being Developed by Partners (I) Program Partner Target Indication Phase 1 Phase 2 Phase 3 Bimagrumab Novartis ActRIIB sibm (52 weeks) (BYM338) sibm (long-term study) Cachexia (COPD) Cachexia (cancer) 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 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 Wet AMD Geographic atrophy Multifocal Choroiditis and Panuveitis Dry AMD Paroxysmal nocturnal hemoglobinuria Outlicensed Contract Discovery MorphoSys - September

14 Programs Being Developed by Partners (II) Program Partner Target Indication Phase 1 Phase 2 Phase 3 LJM716 Novartis HER3 ESCC (combo with BYL719) HER2+ cancer (combo with BYL719 & trastuzumab) HER2+ cancer, combo with trastuzumab HER2+ cancer Advanced solid tumors 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 Mesothelin Solid tumors 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, combination with PD-1 inhibitor MK-3475 Advanced solid tumors, combo with mogamulizumab 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 Outlicensed Contract Discovery MorphoSys - September

15 Bimagrumab (BYM338): A Novartis Musculoskeletal Program DRUG Lead indication: sporadic inclusion body myositis (sibm) FDA breakthrough therapy designation Orphan drug designation Supportive initial data in sibm CLINICAL DATA Potential novel treatment of sibm Phase 2 results in sibm [*] : Muscle mass increased substantially from baseline, approx. 5% more than placebo Muscle gain was functional as supported by parallel increases in strength and 6- minute walking distance Data courtesy by Novartis NEXT Pivotal study in sibm with 240 patients ongoing, completion scheduled in Q Data expected in H Listed by Novartis as planned filing 2016 Phase 2 read-outs in hip fracture surgery, sarcopenia expected in 2016 [*] A Amato et al; Neurology; Nov 7, 2014, online [1] Statistically significant difference MorphoSys - September

16 Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program DRUG 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 CLINICAL DATA Guselkumab has potential to provide unique value to patients: Highest levels of durable skin clearance with less intensive dosing regimens vs. anti- IL-17 class Potential for similar safety profile vs. longterm blockade of IL with STELARA Potential for long-term, drug-free efficacy NEXT Phase 3 data in 2016 Anticipated Filing in 2016 MorphoSys - September

17 Financial Guidance 2015 in million 2014A H 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 - September

18 PHASE 1 PHASE 2 PHASE 3 Clinical Trials Scheduled for Completion Bimagrumab sibm Guselkumab Psoriasis (VOYAGE 1) Guselkumab Psoriasis (VOYAGE 2) Guselkumab Psoriasis (NAVIGATE) Bimagrumab Sarcopenia LFG316 PNH CNTO6785 Rheumatoid arthritis MOR208 NHL (mono - update) LFG316 Dry AMD LJM716 ESCC, combo w/byl719 CNTO6785 COPD MOR208 - IST CLL (combo with len) LFG316 MCP Tarextumab Pancreatic cancer BAY Solid tumors BI Various solid cancer LJM716 Advanced solid tumors LJM716 HER2+ cancer (combo) MOR202 Multiple myeloma 2015 Tarextumab Solid tumors Vantictumab NSCLC Vantictumab Pancreatic cancer BI Advanced solid tumors BI NSCLC BI Solid tumors (Japan) LJM716 HER2+ cancer (combo) Potential data events based on clinical trial design & MorphoSys estimates MOR209 Prostate cancer MorphoSys - September Vantictumab Breast cancer Vantictumab Solid tumors Partnered Programs MOR Programs

19 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.