April 2015
Company Update
© MorphoSys - April 2015 1 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 2015 2 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 2015 3 The MorphoSys Pipeline 23 Clinical Programs, 94 Total Most advanced development stage 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 BAY94-9343 Bayer Mesothelin (ADC) Solid tumors BI–836845 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-05082566 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 84 Partnered Programs 40 programs Various - Various 10 MOR Programs
© MorphoSys - April 2015 4 The MorphoSys Proprietary Portfolio
Program Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Next Event Unpartnered
MOR208 ALL Phase 2 IST + NK cells Phase 2 mono-therapy NHL data update Start of combo trials Data from IST combo trial CLL Start of new combo trials Start of combo cohorts MOR202 Multiple myeloma Phase 1/2a data Co-development & co-promotion with Emergent BioSolutions
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 2015 5 MOR208 A Novel Antibody to Treat B cell Malignancies
DRUG 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
CLINICAL 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
NEXT NHL Updated phase 2 mono-therapy data at ASCO DLBCL: Initiate two combo trials, + lenalidomide & + bendamustine, H2 2015 CLL: Initiate combo trials, Q4 2015/Q1 2016 ALL: Initiate pediatric phase 2 IST, + NK cell transfer from parental donor (with St. Jude Children's Research Hospital, USA)
© MorphoSys - April 2015 6 MOR208 Demonstrates Efficacy in DLBCL, FL and iNHL
Efficacy outcome, n (%) DLBCL FL iNHL MCL Overall (n=35) (n=31) (n=11) (n=12) (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%)
* Patients who have completed two cycles of treatment and subsequently received disease response assessment 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) Maintenance Cycle 1 Cycle 2 > SD Cycle 3 > PR (bi-weekly or monthly) Blum et al. #3089, ASH 2014 © MorphoSys - April 2015 7 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
38% 30% 24% 23% MEDI-551 data source: Poster 13% ASCO 2013, 12mg/kg dosing group Obinutuzumab data source: MOR208 MEDI-551 Obinutuzumab Ofatumumab Rituximab GAUGUIN study, Cartron et al, 12mg/kg phase 1/2 phase 2 phase 3 (n=110) Blood 2014 Ofatumumab data source: control (n=16) 12mg/kg (n=20) (n=196) arm in ibrutinib vs. O phase 3 (n=26) trial (RESONATE, ASCO 2014) Rituximab data source: Late breaking abstract #6, ASH 2013 mPFS 15 nr 10.7 8 5.5 Criteria: Hallek et al 2008 (mo.) (including CT)
© MorphoSys - April 2015 8 MOR202 A Novel Antibody for Multiple Myeloma
DRUG High affinity HuCAL antibody targeting CD38 MOR202 Shows High ADCC and ADCP Activity as Single Agent 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
DATA Strong synergy with IMiDs (lenalidomide and pomalidomide) and proteasome inhibitors (bortezomib) in pre-clinical models
NEXT 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
© MorphoSys - April 2015 9 MOR209/ES414 - A Bi-specific Immunotherapeutic Against Prostate Cancer
DRUG 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
DATA 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
NEXT 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 2015 10 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 2015 11 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 BAY94-9343 Bayer Mesothelin Solid tumors BI-836845 BI IGF-1 Solid tumors, Japanese patients EGFR mutant NSCLC Breast cancer CRPC + enzalutamide Various solid cancer Advanced solid tumors PF-05082566 Pfizer 4-1BB Solid Tumors, NHL (+rituximab) Solid tumors, combination with PD-1 inhibitor MK-3475
© MorphoSys - April 2015 12 Bimagrumab (BYM338) A Novartis Musculoskeletal Program
DRUG HuCAL antibody against ActRIIB FDA breakthrough therapy designation for sporadic inclusion body myositis (sIBM) Orphan drug designation in sIBM
CLINICAL Potential novel treatment of sIBM DATA 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 sIBM patient who has typical prominent walking distance weakness and atrophy of quadriceps and finger flexors[2] NEXT Pivotal study in sIBM with 240 patients ongoing, completion scheduled in Q4 2015 Listed by Novartis as “planned filing 2016” Phase 2 read-outs in hip fracture surgery, sarcopenia expected in 2016
[1] A Amato et al; Neurology; Nov 7, 2014, online [2] WK Engel and V Askanas; Neurology 2006; 20-29
© MorphoSys - April 2015 13 Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program
DRUG 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
CLINICAL Phase 2b results in psoriasis at week 16 DATA Up to 86% of patients achieved a Physician's Global Assessment (PGA) score of cleared or minimal Clinical response to a single dose of disease at week 16 (primary endpoint) 10 mg of guselkumab administered Significantly higher levels of efficacy at all doses at baseline[1] compared to placebo group
NEXT Three Phase 3 trials scheduled for completion in 2016 [1] H Sofen et al; J Allergy Clin Immunol 2014; “Planned filings 2013–2017” (J&J analyst day 2013) 133: 1032-40
Results from phase 2b study: 293 patients with mild-to-moderate plaque psoriasis @week 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 2015 14 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 In phase 1, gantenerumab clears brain amyloid from baseline from
DATA very efficiently in mild-to-moderate AD patients change Amyloid % Phase 3 SCarlet RoAD trial in prodromal patients discontinued based on pre-planned futility analysis Data from Phase 1 Phase 3 Marguerite RoAD trial with 1,000 Effect of gantenerumab on amyloid load as indexed by PET SUVR at end of patients with mild AD ongoing treatment DIAN network trial in genetically pre-disposed patients ongoing
NEXT Data from the SCarlet RoAD study will be shared by Roche with the medical community after full review and analysis
Data: Courtesy of Roche
© MorphoSys - April 2015 15 Shareholdings
Shareholdings by Investor Type (Dec. 2014) Stock Information Prime Standard, TecDAX FSE: MOR (ISIN: DE0006632003) 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 2015 16 Financial Guidance 2015
in € million 2014A Guidance 2015
Group Revenues 64.0 101 to 106 Proprietary R&D Expenses 36.4 56 to 63 (incl. Technology Development) EBIT -5.9 9 to 16 Cash, cash equivalents & marketable securities 352.8 as well as other short-term and long-term financial assets
© MorphoSys - April 2015 17 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 H2 2015
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 2015 18 Clinical Clinical TrialsScheduled Completion for © MorphoSys © PHASE 1 PHASE 2 PHASE 3 Potential data events based clinical on trial design MorphoSys & estimates Various BI Solid BAY94 Geographic LFG316 MCP LFG316 COPD CNTO6785 Rheumatoidarthritis CNTO6785 sIBM Bimagrumab Multiple MOR202 HER2+ cancer LJM716 Advancedtumors solid LJM716 - 836845 tumors - 9343 solid m - April2015 yeloma atrophy tumors (combo) 2015 Pancreatic Vantictumab NSCLC Vantictumab Breast Vantictumab Solid tumors Tarextumab NHL (mono NHL MOR208 (mono) ALL MOR208 CLL ( CLL MOR208 combo cancer - IST cancer - with update) len ) Psoriasis(VOYAGE Guselkumab Psoriasis(VOYAGE1) Guselkumab HER2+ ( cancer LJM716 Solid Vantictumab Solid BI NSCLC BI Sarcopenia Bimagrumab Hip Bimagrumab Advanced BI RRMS VAY736 ESCC, LJM716 - - - 836845 836845 836845 f racture tumors tumors combo solid s (Japan) urgery w/BYL719 combo) tumors 2) 2016 Psoriasis Guselkumab Prostate MOR209 Pancreaticcancer Tarextumab MOR MOR Programs Partnered Programs (NAVIGATE) cancer 19 APPENDIX
© MorphoSys - April 2015 20 Pipeline Programs: Business Structure
Partner Programs MOR Programs
Partner provides target MorphoSys selects program at MorphoSys technology used to develop target stage (discovery) or optimized antibody lead candidate later (in-licensing) Partner responsible for development and MorphoSys is fully responsible for pre-clinical commercialization and clinical development MorphoSys receives milestone & royalties Various partnering strategies
Partner Partnering
Discovery Market Discovery Market
© MorphoSys - April 2015 21 MOR208 Phase 1 Study in R/R CLL High Single Agent Overall Response Rate
Best Response, n (%) 0.3 - 9 mg/kg 12 mg/kg Total (N=11) (N=16) (N=27) Response by IWCLL 2008 criteria (CT scan)
Complete Response 0 0 0 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 0 0 0 Partial Response 6 (55%) 12 (75%) 18 (67%) Stable Disease 5 (45%) 4 (25%) 9 (33%) Progressive Disease 0 0 0
MOR208 shows encouraging single-agent efficacy!
Woyach et al. Blood 2014 © MorphoSys - April 2015 22 Novartis Alliance: Landmark Deal
Novartis pays… Approx. €20m p.a. technology license including HuCAL internalization fees Approx. €20m p.a. in research funding Novartis gets… Over €250m milestones (probability adjusted) Preferred access to HuCAL for use in over Royalties on all resulting drugs 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 2015 23 Covering Analysts
Institution Contact
Baader Helvea Dr. Olav Zilian
Bank of America Merrill Lynch Ms. Sarah Potter
Close Brother Seydler Mr. Igor Kim
Commerzbank Mr. Daniel Wendorff
Deutsche Bank Mr. Gunnar Romer
Edison Dr. Mick Cooper
Goldman Sachs Mr. Steve Chesney
Independent Research GmbH Mr. Christoph Schöndube
J.P. Morgan Cazenove Ms. Diana Na
Kempen & Co. Mr. Sachin Soni / Mr. Mark Pospisilik
Landesbank Baden-Württemberg Mr. Timo Kürschner
© MorphoSys - April 2015 24 Forthcoming Events & Conferences
April 16, 2015 8th Kempen Life Sciences Conference New York, USA May 5, 2015
May 12-14, 2015 Q1 2015 Results May 19-20, 2015 Bank of America Merrill Lynch 2015 Health Care Conference Las Vegas, USA
BioEquity, Vienna, Austria
© MorphoSys - April 2015 25 © MorphoSys - April 2015 26 © MorphoSys - April 2015 27 Thank You
www.morphosys.com
Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / 899 27-122 Fax +49 (0)89 / 899 27-5122 Email [email protected]
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.