April Company Update

Transcription

1 April 2015 Company Update MorphoSys - April

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 - April

3 Investment Case MorphoSys is committed to developing a valuable pipeline of truly differentiated therapeutic antibodies built using proprietary technologies Broadest antibody pipeline in the industry, based on HuCAL & Ylanthia 94 programs, 23 antibodies in clinical trials Growing portfolio with currently 10 proprietary programs Favorable economics Strong balance sheet and recurring cash-flows Sustains investment in R&D MorphoSys - April

4 The MorphoSys Pipeline 23 Clinical Programs, 94 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 MOR103 GSK GM-CSF Rheumatoid arthritis MOR208 - CD19 ALL, CLL, NHL BHQ880 Novartis DKK-1 Multiple myeloma CNTO3157 Janssen - Inflammation CNTO6785 Janssen - Inflammation LFG316 Novartis C5 Eye diseases LJM716 Novartis HER3 Cancer NOV 3 Novartis - not discl. Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors VAY736 Novartis BAFF-R Inflammation MOR202 - CD38 Multiple myeloma MOR209/ES414 Emergent PSMA/CD3 Prostate cancer BAY Bayer Mesothelin (ADC) Solid tumors 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 PF Pfizer 4-1BB Solid tumors Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors MOR106 Galapagos - Inflammation 25 programs Various - Various Immuno-oncology program Merck Serono - Cancer 4 MOR programs - - Various 40 programs Various - Various Most advanced development stage 84 Partnered Programs 10 MOR Programs MorphoSys - April

5 The MorphoSys Proprietary Portfolio Program Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Next Event Unpartnered MOR208 ALL Phase 2 IST + NK cells NHL CLL MOR202 Multiple myeloma Co-development & co-promotion with Emergent BioSolutions Phase 2 mono-therapy data update Start of combo trials Data from IST combo trial Start of new combo trials Start of combo cohorts Phase 1/2a data MOR209/ES414 Prostate cancer Phase 1 data Licensed to GSK (tiered, double-digit royalties) MOR103 Inflammation Phase 2b study in RA Early-stage programs MOR106 Inflammation Start of phase 1 in 2016 Immuno-oncology program Cancer 4 Programs Various MorphoSys - April

6 MOR208 A Novel Antibody to Treat B cell Malignancies DRUG CLINICAL NEXT Fc-enhanced, humanized antibody targeting CD19 Fc modification leads to dramatically enhanced B cell depletion Convenient dosing schedule, straightforward manufacturing Fast Track Designation in DLBCL; FDA & EMA Orphan Drug Status in DLBDL and CLL/SLL Phase 2 clinical development in NHL, CLL/SLL and ALL NHL Focus on 4 sub-types DLBCL, FL, MCL and other inhl Encouraging single agent activity CLL/SLL Encouraging single agent activity ALL Signs of activity, but ORR not sufficient to justify continuation with mono-therapy: Phase 2 mono-therapy trial in ALL discontinued NHL Updated phase 2 mono-therapy data at ASCO DLBCL: Initiate two combo trials, + lenalidomide & + bendamustine, H CLL: Initiate combo trials, Q4 2015/Q ALL: Initiate pediatric phase 2 IST, + NK cell transfer from parental donor (with St. Jude Children's Research Hospital, USA) MorphoSys - April

7 MOR208 Demonstrates Efficacy in DLBCL, FL and inhl Efficacy outcome, n (%) DLBCL (n=35) FL (n=31) inhl (n=11) * Patients who have completed two cycles of treatment and subsequently received disease response assessment MCL (n=12) Overall (n=89) Complete Response 2 (6%) 1 (3%) 1 (9%) 0 4 (4%) Partial Response 7 (20%) 6 (19%) 3 (27%) 0 16 (18%) Stable Disease 5 (14%) 14 (45%) 3 (27%) 6 (50%) 28 (31%) Progressive Disease 11 (31%) 4 (13%) 3 (27%) 5 (42%) 23 (26%) Not evaluable 10 (29%) 6 (19%) 1 (9%) 1 (8%) 18 (20%) ORR (all pts in cohort) 9 (26%) 7 (23%) 4 (36%) 0 20 (22%) ORR (evaluable patients * ) 9 (36%) 7 (28%) 4 (40%) 0 20 (28%) International, multi-center, open-label phase 2 study 12 mg/kg MOR208 weekly Two-stage design (total of 120 patients) Stage 1: 10 patients per subgroup Stage 2: 20 patients per subgroup (with at least 2 PR in stage 1) Cycle 1 Cycle 2 > SD Cycle 3 Blum et al. #3089, ASH 2014 Maintenance (bi-weekly or monthly) MorphoSys - April > PR

8 MOR208 is Superior to Other CD19 & CD20 MAbs in Relapsed/Refractory CLL Response Rates Based on IWCLL2008 Criteria α-cd19 MAbs α-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) 15 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) MorphoSys - April

9 MOR202 A Novel Antibody for Multiple Myeloma DRUG DATA NEXT High affinity HuCAL antibody targeting CD38 Binds to a unique epitope Ability to kill MM cells in vitro and across multiple in vivo models (ADCC & ADCP) 2 hour infusion time MorphoSys regained all rights from Celgene Strong synergy with IMiDs (lenalidomide and pomalidomide) and proteasome inhibitors (bortezomib) in pre-clinical models First clinical data to be presented at ASCO 2015 (mono-therapy) Additional cohorts with weekly dosing schedule, with and without dexamethasone ongoing Combination cohorts with pomalidomide and lenalidomide to start in H1 2015; Celgene will supply both IMiDs on preferred terms MOR202 Shows High ADCC and ADCP Activity as Single Agent MorphoSys - April

10 MOR209/ES414 - A Bi-specific Immunotherapeutic Against Prostate Cancer DRUG DATA NEXT Bi-specific anti-psma/anti-cd3 immunotherapeutic: targeting PSMA on prostate cancer cells targeting CD3 on cytotoxic T cells Redirects T cells to kill tumor cells expressing PSMA in vitro and in vivo Reduced cytokine release upon T cell activation compared to other formats Prolonged serum half-life in mouse and NHP compared to antibody fragments Well-tolerated in NHP single-dose and repeat-dose studies Phase 1 in mcrpc in the U.S. and Australia initiated Stage 1: identify MTD of MOR209/ES414 administered iv Stage 2: evaluate clinical activity in patients that have or have not received prior chemotherapy MorphoSys - April

11 Partnered Clinical Pipeline (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 BHQ880 Novartis DKK-1 MM (renal insufficiency) Smoldering MM LFG316 Novartis C5 Wet AMD Geographic atrophy MCP NOV-3 Novartis n.d. n.d. VAY736 Novartis BAFF-R Pemphigus vulgaris Primary Sjögren's syndrome RRMS LJM716 Novartis HER3 ESCC (combo with BYL719) HER2+ cancer (combo with BYL719 & trastuzumab) HER2+ cancer, combination with trastuzumab HER2+ 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 MorphoSys - April

12 Partnered Clinical Pipeline (II) Program Partner Target Indication Phase 1 Phase 2 Phase 3 Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1) (CNTO1959) Psoriasis (VOYAGE 2) Psoriasis (NAVIGATE) Pustular/Erythrodermic Psoriasis Moderate to severe psoriasis Rheumatoid arthritis Palmoplantar pustulosis Active psoriatic arthritis Gantenerumab Roche Amyloid-ß Mild Alzheimer s disease Genetically predisposed CNTO3157 Janssen/J&J n.d. Asthma Safety/Pharmacokinetic CNTO6785 Janssen/J&J n.d. COPD Rheumatoid arthritis Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE) (OMP-59R5) Small cell lung cancer (Pinnacle) Solid tumors Vantictumab Oncomed/Bayer Fzd 7 Solid tumors (OMP-18R5) Breast cancer Pancreatic cancer NSCLC BAY Bayer Mesothelin Solid tumors BI BI IGF-1 Solid tumors, Japanese patients EGFR mutant NSCLC Breast cancer CRPC + enzalutamide Various solid cancer Advanced solid tumors PF Pfizer 4-1BB Solid Tumors, NHL (+rituximab) Solid tumors, combination with PD-1 inhibitor MK-3475 MorphoSys - April

13 Bimagrumab (BYM338) A Novartis Musculoskeletal Program DRUG CLINICAL DATA NEXT HuCAL antibody against ActRIIB FDA breakthrough therapy designation for sporadic inclusion body myositis (sibm) Orphan drug designation in sibm Potential novel treatment of sibm Phase 2 results in sibm [1] : 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 Pivotal study in sibm with 240 patients ongoing, completion scheduled in Q Listed by Novartis as planned filing 2016 Phase 2 read-outs in hip fracture surgery, sarcopenia expected in 2016 sibm patient who has typical prominent weakness and atrophy of quadriceps and finger flexors [2] [1] A Amato et al; Neurology; Nov 7, 2014, online [2] WK Engel and V Askanas; Neurology 2006; MorphoSys - April

14 Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program DRUG CLINICAL DATA HuCAL antibody specific for IL-23, doesn t bind IL-12 Specificity may provide better risk/benefit profile Dosing schedule sc q8w or even less frequently Being developed in psoriasis and psoriatic arthritis Phase 2b results in psoriasis at week 16 Up to 86% of patients achieved a Physician's Global Assessment (PGA) score of cleared or minimal disease at week 16 (primary endpoint) Significantly higher levels of efficacy at all doses compared to placebo group Clinical response to a single dose of 10 mg of guselkumab administered at baseline [1] NEXT Three Phase 3 trials scheduled for completion in 2016 Planned filings (J&J analyst day 2013) [1] H Sofen et al; J Allergy Clin Immunol 2014; 133: Results from phase 2b study: 293 patients with mild-to-moderate plaque 16 Placebo 5 mg 50 mg 200 mg 15 mg 100 mg Humira at week 0, 4, then every 12 weeks every 8 weeks PGA 0 or 1 7% 34% 79% 83% 61% 86% 58% PASI 75 5% 44% 81% 81% 76% 79% 70% PASI 90 2% 34% 45% 57% 34% 62% 44% MorphoSys - April

15 % Amyloid change from baseline Gantenerumab A Roche Alzheimer s Disease Program DRUG HuCAL antibody against amyloid-ß, binds N- terminus and middle of peptide Binds/disrupts amyloid plaque and oligomers; binds peptide only weakly CLINICAL DATA NEXT In phase 1, gantenerumab clears brain amyloid very efficiently in mild-to-moderate AD patients Phase 3 SCarlet RoAD trial in prodromal patients discontinued based on pre-planned futility analysis Phase 3 Marguerite RoAD trial with 1,000 patients with mild AD ongoing DIAN network trial in genetically pre-disposed patients ongoing Data from the SCarlet RoAD study will be shared by Roche with the medical community after full review and analysis Data from Phase 1 Effect of gantenerumab on amyloid load as indexed by PET SUVR at end of treatment Data: Courtesy of Roche MorphoSys - April

16 Shareholdings Shareholdings by Investor Type (Dec. 2014) Stock Information Prime Standard, TecDAX FSE: MOR (ISIN: DE ) OTC: MPSYY Ticker: Bloomberg: MOR:GR Reuters: MORG.DE Thomson ONE: MOR-XE Shares issued: 26,462,834 (March 31, 2015) Institutional Investors - 74% Retail Investors - 16% Novartis - 4% Celgene - 3% Treasury Stock - 1% Management & Supervisory Board - 2% MorphoSys - April

17 Financial Guidance 2015 in million 2014A 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 - April

18 What to Expect in 2015/2016 Readouts from 2 pivotal studies (bimagrumab & guselkumab) Clinical readouts for additional 8 partnered programs expected Up to 10 new INDs MOR208 Updated phase 2 mono-therapy data at ASCO 2015 Start of combination trials in H MOR202 Clinical data from phase 1/2a trial at ASCO 2015 Start of combination cohorts (lenalidomide and pomalidomide) mid 2015 MOR209 Start of phase 1 trial Potential in-licensing of additional compound(s) Deals for access to targets and/or technologies MorphoSys - April

19 PHASE 1 PHASE 2 PHASE 3 Clinical Trials Scheduled for Completion Guselkumab Psoriasis (VOYAGE 1) Bimagrumab sibm Guselkumab Psoriasis (VOYAGE 2) Guselkumab Psoriasis (NAVIGATE) CNTO6785 Rheumatoid arthritis Bimagrumab Hip fracture surgery CNTO6785 COPD MOR208 ALL (mono) Bimagrumab Sarcopenia LFG316 MCP MOR208 NHL (mono - update) LJM716 ESCC, combo w/byl719 LFG316 Geographic atrophy MOR208 - IST CLL (combo with len) VAY736 RRMS Tarextumab Pancreatic cancer BAY Solid tumors BI Various solid tumors LJM716 Advanced solid tumors LJM716 HER2+ cancer (combo) MOR202 Multiple myeloma MorphoSys - April Tarextumab Solid tumors Vantictumab Breast cancer Vantictumab NSCLC Vantictumab Pancreatic cancer BI Advanced solid tumors BI NSCLC BI Solid tumors (Japan) Vantictumab Solid tumors LJM716 HER2+ cancer (combo) Potential data events based on clinical trial design & MorphoSys estimates 2016 MOR209 Prostate cancer Partnered Programs MOR Programs 19

20 APPENDIX MorphoSys - April

21 Pipeline Programs: Business Structure Partner Programs Partner provides target MorphoSys technology used to develop optimized antibody lead candidate Partner responsible for development and commercialization MorphoSys receives milestone & royalties MOR Programs MorphoSys selects program at target stage (discovery) or later (in-licensing) MorphoSys is fully responsible for pre-clinical and clinical development Various partnering strategies Partner Partnering Discovery Market Discovery Market MorphoSys - April

22 MOR208 Phase 1 Study in R/R CLL High Single Agent Overall Response Rate Best Response, n (%) mg/kg (N=11) 12 mg/kg (N=16) Total (N=27) Response by IWCLL 2008 criteria (CT scan) Complete Response Partial Response 2 (18%) 6 (38%) 8 (30%) Stable Disease 7 (64%) 10 (62%) 17 (63%) Progressive Disease 2 (18%) 0 2 (7%) ORR in 12mg/kg (recommended phase 2 dose): 38% (IWCLL2008) Responses by NCI96 criteria (physical exam) Complete Response Partial Response 6 (55%) 12 (75%) 18 (67%) Stable Disease 5 (45%) 4 (25%) 9 (33%) Progressive Disease MOR208 shows encouraging single-agent efficacy! Woyach et al. Blood 2014 MorphoSys - April

23 Novartis Alliance: Landmark Deal Novartis pays Approx. 20m p.a. technology license including HuCAL internalization fees Approx. 20m p.a. in research funding Over 250m milestones (probability adjusted) Royalties on all resulting drugs Novartis gets Preferred access to HuCAL for use in over 100 discovery programs Timeline Excluded May 2004: Initial deal, including equity stake Most infectious disease targets November 2007: Major expansion November 2017: End, subject to 2-year extension option MorphoSys - April

24 Covering Analysts Institution Baader Helvea Bank of America Merrill Lynch Close Brother Seydler Commerzbank Deutsche Bank Edison Goldman Sachs Independent Research GmbH J.P. Morgan Cazenove Kempen & Co. Landesbank Baden-Württemberg Contact Dr. Olav Zilian Ms. Sarah Potter Mr. Igor Kim Mr. Daniel Wendorff Mr. Gunnar Romer Dr. Mick Cooper Mr. Steve Chesney Mr. Christoph Schöndube Ms. Diana Na Mr. Sachin Soni / Mr. Mark Pospisilik Mr. Timo Kürschner MorphoSys - April

25 Forthcoming Events & Conferences April 16, 2015 May 5, 2015 May 12-14, 2015 May 19-20, th Kempen Life Sciences Conference New York, USA Q Results Bank of America Merrill Lynch 2015 Health Care Conference Las Vegas, USA BioEquity, Vienna, Austria MorphoSys - April

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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.