May 2016
Company Update 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 - May 2016 2 MorphoSys at a Glance
MorphoSys is developing a pipeline of truly differentiated therapeutic antibodies built using proprietary technologies
Munich, Germany-based biopharmaceutical company The industry’s largest antibody therapeutic pipeline assembled using proprietary technologies: 104 active therapeutic programs 26 antibodies in clinical trials Growing portfolio of attractive proprietary assets Strong balance sheet with recurring cash-flows supports growing investment in R&D Successful track-record of partnering world-wide Listed on the German TecDAX
© MorphoSys AG, Company Update - May 2016 3 The MorphoSys Pipeline 26 Clinical Product Candidates, 104 Total Most advanced development stage Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3 Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer’s disease MOR208 - CD19 ALL, CLL, NHL MOR202 - CD38 Multiple myeloma MOR103/GSK3196165 GSK GM-CSF Inflammation Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors BHQ880 Novartis DKK-1 Multiple myeloma BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome CNTO3157 Janssen - Inflammation CNTO6785 Janssen - Inflammation LFG316 Novartis C5 Eye diseases LJM716 Novartis HER3 Cancer Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors VAY736 Novartis BAFF-R Inflammation MOR209/ES414 Emergent PSMA/CD3 Prostate cancer MOR106 Galapagos - Inflammation BAY1093884 Bayer TFPI Hemophilia 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 NOV-11 Novartis - Blood disorders PF-05082566 Pfizer 4-1BB Solid tumors Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors MOR107 (LP2) - AT2-R Fibrosis Immuno-oncology program Merck - Cancer 90 Partnered Discovery Programs Immuno-oncology program Immatics - Cancer 13 MOR Programs 6 MOR programs - - Various 1 Outlicensed Program In addition, 24 partnered programs in pre-clinic, and 45 partnered programs in discovery © MorphoSys AG, Company Update - May 2016 4 The MOR Portfolio 5 Clinical Product Candidates, 14 Total
Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3 Unpartnered MOR208 DLBCL FTD, orphan status US & EU CD19 CLL Orphan status US & EU MOR202 Multiple myeloma CD38 MOR107 Fibrosis AT2-R Immuno-oncology MHC-associated program Cancer peptides 6 Programs Various Various Co-development & co-promotion MOR209/ES414 (Emergent) Prostate cancer PSMA / CD3 MOR106 (Galapagos) Inflammation Undisclosed Immuno-oncology program Cancer Undisclosed (Merck Serono) Outlicensed to GSK
RA MOR103/ GM-CSF GSK3196165 Osteoarthritis of the hand
© MorphoSys AG, Company Update - May 2016 5 MOR208 First- & Best-in Class Potential
CD19 is an ideal target in NHL because CD19 is broadly and homogeneously expressed Across different NHL subtypes incl. DLBCL and CLL CD19 conveys a survival signal for B cells Via B cell receptor signaling CD19 expression seems to be preserved Even after pretreatments targeting B cells
MOR208 is an Fc-enhanced, humanized IgG1 antibody targeting CD19 Fc modification leads to dramatically enhanced B cell depletion by Antibody dependent cellular cytotoxicity (ADCC) Antibody dependent cell phagocytosis (ADCP) ADCC Direct cytotoxicity Straightforward manufacturing Strong pre-clinical support for combo therapy
© MorphoSys AG, Company Update - May 2016 6 MOR208 in R/R CLL Superior to Other CD19 and CD20 MAbs
anti-CD19 MAbs anti-CD20 MAbs
50% ORR [%]* 40% 38% 30% 30% 24% 23% 20% 13% 10%
0% MOR208 MEDI-551 Obinutuzumab Ofatumumab Rituximab 12mg/kg phase 1/2 phase 2 phase 3 (n=110) (n=16) 12mg/kg (n=20) (n=196) (n=26)
PFS 15 14 [months] 10.7 10 Sources: 8 MOR208: Woyach et al., Blood 2014 MEDI-551: Forero-Torres et al. ASH 2013 5.5 Obinutuzumab: Cartron et al., Blood 2014 5 Ofatumumab: Byrd et al., NEJM 2014 Rituximab: Furman et al., NEJM 2014 *IWCLL Criteria: Hallek et al., 2008 NR 0 [NR – not reported]
© MorphoSys AG, Company Update - May 2016 7 MOR208 in R/R NHL Strong Single Agent Efficacy
Response Rate DLBCL iNHL incl. FL in evaluable patients* n=25 n=40 n (%)
Overall Response (ORR) 9 (36%) 12 (30%)
Complete response (CR) 2 (8%) 5 (13%)
Partial response (PR) 7 (28%) 7 (18%)
Stable disease (SD) 5 (20%) 21 (53%)
*Investigator assessed Jurczak et al., Abstract #1528, ASH 2015
© MorphoSys AG, Company Update - May 2016 8 MOR208 in R/R NHL Very Promising Duration of Response
DLBCL Duration of Response: Longest: 20 months+
PR 12 months: 67%
or
CR CR with Duration of response
DLBCL, n=9 Patients Indolent NHL,* n=12 Ongoing response, n=9
Time to response, n=21
0.0 5.0 10.0 15.0 20.0 25.0 Months
* Includes follicular lymphoma and other indolent NHLs DLBCL, diffuse large B-cell lymphoma; NHL, non-Hodgkin’s lymphoma. Jurczak et al., Abstract #1528, ASH 2015
© MorphoSys AG, Company Update - May 2016 9 MOR208 Comprehensive Clinical Development Plan
Indication 2016 2017 2018
NHL MOR208 (12 mg/kg); N=92
DLBCL L-MIND: MOR208 (12mg/kg) + lenalidomide; 2nd line R/R; N=80
B-MIND: Safety evaluation leading into anticipated pivotal study MOR208 (12 mg/kg) + bendamustine vs. rituximab + bendamustine; 2nd line R/R; N~320
CLL COSMOS: MOR208 (12mg/kg) + combo partner; BTKi-failures
MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation N=80 (Ohio State Univ. IIT) MOR208 + ibrutinib in ibrutinib failures }
Phase 2 Phase 2/3 IIT: Investigator-initiated trial
© MorphoSys AG, Company Update - May 2016 10 MOR202 A Novel Antibody for Multiple Myeloma
Fully human monoclonal HuCAL IgG1 antibody Targeting a unique epitope of CD38 Inducing potent immune effector mechanisms ADCC and ADCP
One of only three CD38 antibodies in clinical development
Strongly synergistic with IMiDs and proteasome inhibitors in pre-clinical models
ADCC = Antibody-Dependent Cell-Mediated Cytotoxicity; ADCP = Antibody-Dependent Cell-Mediated Phagocytosis; CDC = Complement-Dependent cytotoxicity
© MorphoSys AG, Company Update - May 2016 11 MOR202 Preliminary Phase 1/2a Data
SD Single agent MOR202: SD PR ORR = 33% PR MOR202 & IMiD combos: MR Clinical benefit rate of 67% PR VGPR MOR202 q1w + Dex cohorts Treated PR 4 mg/kg + Dex SD 8 mg/kg + Dex VGPR
Patients 16 mg/kg + Dex SD SD 8 mg/kg + POM/Dex PD 8 mg/kg + LEN/Dex PD Response recorded SD Ongoing patients
0 10 20 30 40 50 60 Weeks
Data from patients treated with the clinically relevant dose regimens who received > 1 treatment cycle.
Dex, dexamethasone; LEN, Lenalidomide; MR, minor response; POM, Pomalidomide; PD, progressive disease; PR, partial response; q1w, weekly; SD, stable disease; VGPR, very good partial response. Raab et al, #3035, ASH 2015
© MorphoSys AG, Company Update - May 2016 12 MOR202: Excellent Clinical Safety & Convenience
MOR202 shows best-in-class infusion tolerability & infusion duration
MOR202 Daratumumab Isatuximab 6.5 h Infusion time 2 h (1st infusion) 4 - 6 h (3.5 h @ 3rd infusion) Infusion reactions 6% 70-77% 52% (IRRs) with Steroids (Grade 1 only)
MOR202: Raab et al., ASH 2015 Daratumumab: Lokhorst et al., NEJM 2015 Isatuximab: Martin et al., ASH 2015
© MorphoSys AG, Company Update - May 2016 13 MOR202: Pre-clinical Data Suggest Advantage in Durability of Response
MOR202 shows best-in-class difference between MM cell killing and NK cell preservation
CD38-expressing MM cell line CD38-expressing NK cells 50 40 35 40
killing 30 30 25 20 20 15 10
% specific specific % killing 10
5 specific NK cell
0 % 0 MOR202 Daratumumab Isatuximab MOR202 Daratumumab Isatuximab
© MorphoSys AG, Company Update - May 2016 14 Clinical Programs from Partnered Discovery Alliances (I)
Program Partner Target Indication Phase 1 Phase 2 Phase 3 Bimagrumab Novartis ActRIIB sIBM (extension) (BYM338) sIBM (long-term study) Hip fracture surgery Cachexia (COPD) Sarcopenia (dose-ranging) Sarcopenia (withdrawal extension study) Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1) (CNTO1959) Psoriasis (VOYAGE 2) Psoriasis (NAVIGATE) Pustular/Erythrodermic psoriasis Moderate to severe plaque-type psoriasis Palmoplantar pustulosis Active psoriatic arthritis Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease Prodromal Alzheimer‘s disease Genetically predisposed Safety, Tolerability, and Pharmacokinetics Anetumab Ravtansine Bayer Mesothelin Mesothelioma (MPM) (BAY94-9343) Solid tumors, with pemetrexed and cisplatin Advanced malignancies (Japan) Ovarian cancer, with doxorubicin Solid tumors with hepatic/renal impairment 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 © MorphoSys AG, Company Update - May 2016 15 Clinical Programs from Partnered Discovery Alliances (II)
Program Partner Target Indication Phase 1 Phase 2 Phase 3 LFG316 Novartis C5 Age-related geographic atrophy Geographic atrophy (combo with CLG561) Panuveitis Paroxysmal nocturnal hemoglobinuria Transplant Associated Microangiopathy (TAM) LJM716 Novartis HER3 ESCC (combo with BYL719) HER2+ cancer (combo BYL719 & trastuzumab) HER2+ cancer, combo with trastuzumab Tarextumab Oncomed/GSK Notch 2 Small cell lung cancer (Pinnacle) (OMP-59R5) Solid tumors VAY736 Novartis BAFF-R Pemphigus vulgaris Primary Sjögren‘s syndrome Rheumatoid Arthritis BAY1093884 Bayer TFPI Bleeding disorders BI-836845 BI IGF-1 Solid tumors, Japanese patients EGFR mutant NSCLC Metastatic breast cancer CRPC + enzalutamide 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-05082566 Pfizer 4-1BB Advanced malignancies, with avelumab Solid tumors, NHL (+rituximab) Solid tumors, with PD-1i MK-3475 Advanced solid tumors, with mogamulizumab Solid tumors, with PF04518600 (OX-40) Vantictumab Oncomed/Bayer Fzd 7 Solid tumors (OMP-18R5) Metastatc breast cancer Pancreatic cancer (combo) NSCL
© MorphoSys AG, Company Update - May 2016 16 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 Six 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 - May 2016 17 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-12 + 23 with STELARA® Potential for long-term, drug-free efficacy
Data courtesy of Janssen
© MorphoSys AG, Company Update - May 2016 18 Anetumab Ravtansine (BAY94-9343) A Bayer Anti-Cancer Program
Anetumab Ravtansine ADC comprising HuCAL anti-mesothelin G1 antibody conjugated to potent maytansinoid tubulin inhibitor DM4 In development for mesothelioma & other solid cancers Pre-clinic Anetumab ravtansine potently inhibited growth of human mesothelioma models in vivo Phase 1 Anetumab ravtansine 6.5 mg/kg IV Q3W was well tolerated and showed efficacy in patients with previously treated mesothelioma Phase 2 Started Q1, 2016 Second-line, malignant pleural mesothelioma Estimated enrollment 210
Antibody-drug conjugate anti-tumor therapy (A) General mechanism of action Data courtesy of Bayer Healthcare (B) Structure of anetumab ravtansine
© MorphoSys AG, Company Update - May 2016 19 Pipeline Set to Deliver a Lot of Clinical Data
Bimagrumab Guselkumab Bimagrumab sIBM Psoriasis (VOYAGE 2) sIBM (extension) Guselkumab Guselkumab Guselkumab
Psoriasis (VOYAGE 1) Psoriasis (NAVIGATE) Pustular/Erythrodermic Psoriasis PHASE 3 PHASE LFG316 Anetumab Ravtansine PNH Mesothelioma (MPM) LJM716 Bimagrumab MOR103/GSK3196165 + trastuzumab Hip fracture surgery RA LJM716 Bimagrumab MOR202 ESCC + BYL716 Sarcopenia (dose ranging) Multiple Myeloma MOR202 Guselkumab MOR208 Multiple Myeloma Psoriatic Arthritis CLL + combo
PHASE 2 PHASE MOR208 LFG316 MOR208 CLL (IIT) Panuveitis DLBCL + lenalidomide MOR208 LFG316 Tarextumab NHL GA + CLG561 Small cell lung cancer VAY736 LJM716 VAY736 Pemphigus Vulgaris + BYL716 + trastuzumab Primary Sjögren‘s Syndrome (PD)
Anetumab Ravtansine BI-836845 + pemetrexed & cisplatin EGFR mutant NSCLC Anetumab Ravtansine MOR106 Ovarian cancer + doxorubicin Inflammation Anetumab Ravtansine Anetumab Ravtansine MOR209 Advanced malignancies Solid tumors Prostate cancer BI-836845 BAY-1093884 PF-05082566
Advanced solid tumors Bleeding disorders NHL + rituximab PHASE 1 PHASE Gantenerumab BI-836845 PF-05082566 Safety, Tolerability, & PK Metastatic breast cancer Advanced solid tumors + avelumab LJM716 BI-836845 PF-05082566 + trastuzumab CRPC + enzalutamide Solid tumors + MK-3475 2016 2017 Based on published information and MorphoSys estimates Partnered Discovery Programs MOR Programs Outlicensed programs © MorphoSys AG, Company Update - May 2016 20 Powerful Technology Base Ensures Pipeline Sustainability
Innovative Targets Proprietary Platforms
GPCRs, ion channels Antibody library
Immune checkpoints Protein optimization Differentiated drug candidates MHC-presented, tumor- associated peptides
Lantipeptides
Source of novel targets
© MorphoSys AG, Company Update - May 2016 21 Financial Guidance 2016
Guidance in EUR million 2015A Q1 2016 2016 Group Revenues 106.2 12.1 47 to 52 Proprietary R&D Expenses 56.6 14.6 76 to 83 (incl. Technology Development) EBIT 17.2 -9.7 -58 to -68
Cash, cash equivalents & marketable securities 298.4 287.0 as well as other short-term and long-term financial assets
© MorphoSys AG, Company Update - May 2016 22 Coming Up
Bimagrumab sIBM Data from pivotal trial and regulatory filing expected Guselkumab Psoriasis Data from 3 pivotal trials and regulatory filing expected MOR208 Phase 2 lenalidomide combo trial L-MIND starts Phase 2 bendamustine combo trial B-MIND: DLBCL Safety evaluation to start mid 2016 Pivotal study planned for 2017 CLL Phase 2 idelalisib combo trial in planning MOR202 MM Updated data from phase 1/2a trial at ASCO 2016 Continuation of phase 1 trial under amended protocol, clinical data MOR209 Prostate cancer in 2017 MOR106 Inflammation Start of phase 1 with Galapagos in H1 2016 MOR107 Fibrosis Start of phase 1 in Q4 2016 MOR103 Osteoarthritis Start of phase 1b/2a in osteoarthritis of the hand RA Data from the phase 2b in RA in 2017 Pipeline Up to 5 new program starts Around 5 clinical milestones
© MorphoSys AG, Company Update - May 2016 23 APPENDIX
© MorphoSys AG, Company Update - May 2016 24 MOR103/GSK3196165 Anti-inflammatory Program Licensed to GSK
MOR103/GSK3196165 % EULAR good/moderate response HuCAL antibody specific for GM-CSF at 4 weeks: Rapid onset of action GM-CSF is important in every step of macrophage 80 Phase Ib/IIa study, n=96
production and infiltration in the tissues 60 response response Good magnitude of effect with fast onset of action and 40
long duration post treatment 20 % EULAR % Effect size appears similar to or greater than anti-TNF 0 Targeting the macrophage in early RA Placebo 0.3 mg/kg 1.0 mg/kg 1.5 mg/kg Potential for early use to induce remission Week 4 Week 6 Week 8 Indications Lead indication: Rheumatoid arthritis (RA) Behrens, et al. Ann Rheum Dis. 2015;74:1058-64 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
© MorphoSys AG, Company Update - May 2016 25 MOR209/ES414 A Novel Bi-specific Antibody for Prostate Cancer
Co-development Agreement with Emergent BioSolutions Phase 1 clinical trial in mCRPC patients was started in March of 2015
Restructured Agreement with Emergent BioSolutions Adjustment of dosing regimen and administration Reduction of MorphoSys’s cost sharing and reduced milestone payments
Clinical development will continue in 2016 under an adapted clinical development plan.
© MorphoSys AG, Company Update - May 2016 26 Covering Analysts
Institution Contact
Baader Helvea Dr. Bruno Bulic
Commerzbank Mr. Daniel Wendorff
Deutsche Bank Mr. Gunnar Romer
Edison Mr. Maxim Jacobs
Goldman Sachs Mr. Keyur Parekh
Independent Research GmbH Mr. Bernhard Weininger
J.P. Morgan Cazenove Mr. James Gordon
Kempen & Co. Mr. Sachin Soni / Mr. Mark Pospisilik
Landesbank Baden-Württemberg Mr. Timo Kürschner
Oddo Seydler Mr. Igor Kim
© MorphoSys AG, Company Update - May 2016 27 Thank You
www.morphosys.com
Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / 899 27-404 Fax +49 (0)89 / 899 27-5404 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.