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Investor Event ASH 2016*
DECEMBER 5, 2016
* FOR INVESTORS ONLY. DO NOT DISSEMINATE.
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, Investor Event, December 5, 2016 2
Agenda
© MorphoSys AG, Investor Event, December 5, 2016 3
8:00 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSysMorphoSys‘s growing proprietary portfolio of biopharmaceuticals
8:10 Arndt Schottelius, M.D. Ph.D., Chief Development Officer, MorphoSysSingle-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL):Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
8:20 Kerry A Rogers, M.D., Division of Hematology Department of Internal Medicine, The OhioState UniversityUpdated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones
8:35 Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg, GermanyA Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
8:50 Q&A Session
Recent Newsflow
© MorphoSys AG, Investor Event, December 5, 2016 4
November 2016:
Guselkumab in Moderate to Severe Plaque Psoriasis: Biologics License
Application Submitted by Janssen.
November 2016:
Strategic Partnership with LEO Pharma to Develop Antibodies in Dermatology
October 2016:
Start of New Partnered Clinical Program From Novartis
October 2016:
Updated response rates reported in RR multiple myeloma patients in higher
doses of MOR202 in combo with IMiDs in ongoing phase 1/2a trial
FIRST PRODUCT APPLICATION
SUBMITTED BY PARTNER
NEW STRATEGIC PARTNERSHIP
SUCCESSFUL CAPITAL INCREASE
GROWING CLINICAL PIPELINE
CLINICAL DATA UPDATES
November 2016:
Capital Raise of EUR 115m Intended to Support Further Pipeline
Development
PROGRAM PARTNER TARGET DISEASE AREA DISCOVERY PRECLINIC PHASE 1 PHASE 2 PHASE 3
Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis
Gantenerumab Roche Amyloid-ß Alzheimer’s disease
Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors
BHQ880 Novartis DKK-1 Multiple myeloma
BI–836845 BI IGF-1 Solid tumors
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases
BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome
CNTO3157 Janssen - Inflammation
CNTO6785 Janssen - Inflammation
MOR103/GSK3196165 GSK GM-CSF Inflammation
MOR202 - CD38 Multiple myeloma
MOR208 - CD19 ALL, CLL, NHL
Elgemtumab (LJM716) Novartis HER3 Cancer
Tarextumab (OMP-59R5) OncoMed Notch 2 Cancer
Tesidolumab (LFG316) Novartis C5 Eye diseases
Utomilumab (PF-05082566) Pfizer 4-1BB Solid tumors
VAY736 Novartis BAFF-R Inflammation
BAY1093884 Bayer TFPI Hemophilia
MOR209/ES414 Aptevo PSMA/CD3 Prostate cancer
MOR106 Galapagos - Inflammation
NOV–7 Novartis - Eye diseases
NOV–8 Novartis - Inflammation
NOV-9 Novartis - Diabetic eye diseases
NOV-10 Novartis - Cancer
NOV-11 Novartis - Blood disorders
NOV-12 Novartis - Prevention of thrombosis
NOV-13 Novartis - Cancer
Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors
MOR107 (LP2) - AT2-R Fibrosis
Immuno-oncology program Merck - Cancer
Immuno-oncology program Immatics - Cancer
6 MOR programs - - Various
The MorphoSys Pipeline28 Clinical Product Candidates, 110 Total*
© MorphoSys AG, Investor Event, December 5, 2016 5
In addition, 23 partnered programs in preclinic, and 50 partnered programs in discovery
2
15
11
* All product candidates are investigational and have not yet been established as safe and effective by regulatory authorities.
The MOR Portfolio5 Clinical Product Candidates*/**
© MorphoSys AG, Investor Event, December 5, 2016 6
** including MOR103, which is out-licensed to GSK
PROGRAM INDICATION TARGET DISCOVERY PRECLINIC PHASE 1 PHASE 2 PHASE 3
UNPARTNERED
MOR208 DLBCL (B-MIND)
CD19DLBCL (L-MIND)
CLL (planned)
CLL (IIT)
MOR202 Multiple Myeloma CD38
MOR107 Fibrosis AT2-R
Immuno-oncology program CancerMHC-associated
peptides
6 programs Various Various
CO-DEVELOPMENT AND CO-PROMOTION
MOR209/ES414 (Aptevo) Prostate cancer PSMA/CD3
MOR106 (Galapagos) Inflammation IL-17C
Immuno-oncology program
(Merck)Cancer Undisclosed
FTD, orphan status US & EU
Orphan status US & EU
* All product candidates are investigational and have not yet been established as safe and effective by regulatory authorities.
TODAY
A Vision for the Future
© MorphoSys AG, Investor Event, December 5, 2016 7
THE FUTURE
First product application submitted
for partnered antibody
Investing in proprietary pipeline
Strong technology platform
delivering differentiated
drug candidates
Fully-integrated biotech
Commercial footprint in EU
Sustainable income from partner
royalties
Fuels pipeline and R&D engine
Agenda
© MorphoSys AG, Investor Event, December 5, 2016 8
8:00 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSysMorphoSys‘s growing proprietary portfolio of biopharmaceuticals
8:10 Arndt Schottelius, M.D. Ph.D., Chief Development Officer, MorphoSysSingle-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL):Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
8:20 Kerry A Rogers, M.D., Division of Hematology Department of Internal Medicine, The OhioState UniversityUpdated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones
8:35 Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg, GermanyA Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
8:50 Q&A Session
AN INVESTIGATIONAL CD38 ANTIBODY IN CLINICAL STUDIES IN MULTIPLE MYELOMA (MM)
MOR202 - OverviewA Differentiated Antibody Option for Multiple Myeloma
Targeting CD38, a highly expressed and validated target in multiple myeloma
Preclinical models suggest that MOR202 may induce effector mechanisms ADCC and ADCP
KEY FEATURES & POSITIONING
Currently under clinical investigation as a potential option for RRMM
Pre-clinical data suggest preservation of NK cells and maintenance of CD38 expression
Biomarker data suggest expression of CD38 was preserved on bone marrow plasma cells during MOR202 treatment
Current clinical data suggest improved responses associated with longer treatment durations in patients in the higher
dosing cohorts, e.g.
− ORR of currently 100% in 16mg/kg MOR202+Len cohort;
− Responses currently ongoing for 14+ months versus 10+ months reported at ASCO 2016 (June 2016)
7% of patients showing IRRs of grade 1 or 2 in current phase 1/2a study
Analysts forecast central role and growing substantial market for CD38 mAbs in MM treatment in all lines
STATUS / NEXT DATA
Phase 1/2a dose escalation study ongoing, increasing number of patients to be studied in highest dosing cohorts
Updated clinical data at ASH 2016 and ASCO 2017
© MorphoSys AG, Investor Event, December 5, 2016 9
AN INVESTIGATIONAL FC-MODIFIED ANTIBODY TARGETING CD19
MOR208 - OverviewFc-modified Antibody to Treat B Cell Lymphoma
© MorphoSys AG, Investor Event, December 5, 2016 10
CD19 is preserved after treatment with B cell targeted therapies, as results from clinical/preclinical testing suggest
Preclinical models suggest that Fc-modification may enhance B cell depletion by ADCC, ADCP and direct cytotoxicity
KEY FEATURES & POSITIONING
Responses of >26 months in RR NHL patients reported in phase 2a monotherapy trial
No unexpected treatment-related safety signals reported to date in phase 2a monotherapy trial
Investigating the potential in phase 2 combination program in B-cell malignancies
− Further clinical investigation in RR DLBCL patients unsuitable for more aggressive therapies
− High unmet medical need in ibrutinib-refractory or ibrutinib-resistant CLL patients
Straightforward manufacturing
STATUS / NEXT DATA
R/R DLBCL: Two phase 2 combination trials ongoing (L-MIND & B-MIND), B-MIND planned to be transitioned into ph 3
Ibrutinib-refractory CLL: Phase 2 about to start (COSMOS)
CLL: IIT with Ohio State University ongoing, ASH update
Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL): Results from Diffuse
Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
Wojciech Jurczak,* Pier Luigi Zinzani, Gianluca Gaidano, Andre Goy, Mariano Provencio, Zsolt Nagy, Tadeusz Robak, Kami Maddocks, Christian Buske, Sumeet Ambarkhane, Mark Winderlich, Maren
Dirnberger-Hertweck, Jan Endell, Kristie A. Blum
*Jagiellonian University, Kraków, Poland
© MorphoSys AG, Investor Event, December 5, 2016 11
Study Design and Treatment
Non-randomized phase IIa multicenter study with 2-stage design (NCT01685008)
iNHL, indolent non-Hodgkin’s lymphoma; IV, intravenous; PR, partial response; SD, stable disease
© MorphoSys AG, Investor Event, December 5, 2016 12
Phase IIa Study of MOR208 in R-R NHL
• Primary objective
ORR in R-R NHL patients who had received at least one prior therapy containing rituximab
• Secondary objective
Duration of response and PFS
Safety and tolerability
Pharmacokinetics and pharmacodynamics
ORR, objective response rate; PFS, progression-free survival
© MorphoSys AG, Investor Event, December 5, 2016 13
Baseline Characteristics
Characteristic, n (%)DLBCLn=35
iNHL*n=45
MCLn=12
Totaln=92
Age, years Median 71 66 64.5 66.5
Sex Male 24 (69) 21 (47) 11 (92) 56 (61)
Ann Arbor stage I-II 4 (11) 5 (11) 1 (8) 10 (11)
III-IV 30 (86) 40 (89) 11 (92) 81 (88)
Missing 1 (3) 0 0 1 (1)
ECOG PS 0-1 34 (97) 43 (96) 11 (92) 88 (96)
2 1 (3) 2 (4) 1 (8) 4 (4)
Prior lines of therapy 1 12 (34) 16 (36) 3 (25) 31 (34)
2 8 (23) 6 (13) 1 (8) 15 (16)
≥3 15 (43) 23 (51) 8 (67) 46 (50)
Rituximab refractory Yes 24 (69) 22 (49) 6 (50) 52 (57)
Last rituximab dose <6 months 14 (40) 6 (13) 1 (8) 21 (23)
Prior stem cell transplantation Yes 4 (11) 8 (18) 1 (8) 13 (14)
*Includes follicular lymphoma and other indolent NHLsData are n (%) unless otherwise stated. Rituximab refractory was defined as patients who demonstrated less than a partial response or response lasting less than 6 months to a prior rituximab-containing regimen
© MorphoSys AG, Investor Event, December 5, 2016 14
Safety Profile
Grade ≥3 TEAEs,* n (%)DLBCLn=35
iNHL†
n=45MCLn=12
Totaln=92
Any‡ 19 (54) 14 (31) 4 (33) 37 (40)
Hematological¥
Neutropenia 6 (17) 2 (4) 0 8 (9)
Thrombocytopenia 2 (6) 1 (2) 1 (8) 4 (4)
Anemia 3 (9) 0 0 3 (3)
Non-Hematological¥
Dyspnea 2 (6) 1 (2) 1 (8) 4 (4)
Pneumonia 3 (9) 0 0 3 (3)
Fatigue 1 (3) 1 (2) 0 2 (2)
Hypokalemia 1 (3) 1 (2) 0 2 (2)
Infections and Infestations# 5 (14) 1 (2) 0 6 (7)
Infusion-related reactions,* n (%)DLBCLn=35
iNHL†
n=45MCLn=12
Totaln=92
Any 4 (11) 5 (11) 2 (17) 11 (12)
Grade 1/2 4 (11) 4 (9) 2 (17) 10 (11)
Grade 4 0 1 (2) 0 1 (1)
• There were no treatment-related deaths
Data are number of patients (%); *Treatment emergent adverse events (TEAEs) according to MedDRA preferred term (PT); ‡TEAEs including PT disease progression; ¥TEAEs of grade ≥3 reported in two or more patients overall; #TEAEs according to MedDRA system organ class; †includes follicular lymphoma and other iNHLs
© MorphoSys AG, Investor Event, December 5, 2016 15
Best Overall Response Rate
© MorphoSys AG, Investor Event, December 5, 2016 16
Best Tumor Shrinkage
© MorphoSys AG, Investor Event, December 5, 2016 17
Tumor Shrinkage: DLBCL
CR, complete response; PD, progressive disease
© MorphoSys AG, Investor Event, December 5, 2016 18
Tumor Shrinkage: iNHL Subtypes
© MorphoSys AG, Investor Event, December 5, 2016 19
Timing and Duration of Response
• 3 DLBCL patients still in remission, longest DoR >26 months, ongoing
• 6 iNHL patients still in remission, longest DoR >26 months, ongoing
• Median DoR 20.1 months in DLBCL and not reached in iNHL
R
R, rituximab refractory
R
R
RR
R
R
RR
DoR, duration of response
#
#
#
#
#
#
*
#
#
#
#
© MorphoSys AG, Investor Event, December 5, 2016 20
PFS in DLBCL and iNHL Subtypes
© MorphoSys AG, Investor Event, December 5, 2016 21
Subgroup Analysis of Disease Control Rate in DLBCL and iNHL Patients
© MorphoSys AG, Investor Event, December 5, 2016 22
PFS in Rituximab Refractory/Non-Refractory DLBCL and iNHL
© MorphoSys AG, Investor Event, December 5, 2016 23
Subgroup Analysis of Disease Control Rate in DLBCL and iNHL Patients
© MorphoSys AG, Investor Event, December 5, 2016 24
PFS in DLBCL and iNHL Patients with High and Low PeripheralNK Cell Count at Baseline
© MorphoSys AG, Investor Event, December 5, 2016 25
Summary and Conclusions
• ORR: 26% in DLBCL and 29% in iNHL
Target lesion shrinkage also observed in patients with stable disease (5/6 DLBCL and 14/17 iNHL)
• Long-lasting responses in DLBCL and iNHL
12 month PFS rate: 39% in DLBCL and iNHL
Longest responses: >26 months in DLBCL and iNHL
• MOR208 efficacious in patients with rituximab-refractory disease
• MOR208 well tolerated, also in long-term treatment
MOR208 showed encouraging single-agent activity in R-R DLBCL and R-R iNHL
MOR208 is currently being studied for the treatment of R-R DLBCL in:• A phase II trial in combination with lenalidomide (L-MIND)• A phase II/III trial in combination with bendamustine (B-MIND)
© MorphoSys AG, Investor Event, December 5, 2016 26
Agenda
© MorphoSys AG, Investor Event, December 5, 2016 27
8:00 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSysMorphoSys‘s growing proprietary portfolio of biopharmaceuticals
8:10 Arndt Schottelius, M.D. Ph.D., Chief Development Officer, MorphoSysSingle-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL):Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
8:20 Kerry A Rogers, M.D., Division of Hematology Department of Internal Medicine, The OhioState UniversityUpdated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones
8:35 Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg, GermanyA Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
8:50 Q&A Session
© MorphoSys AG, Investor Event, December 5, 2016 28
Woyach et al, ASH2016
Updated Results from a Phase II Study
of the Fc Engineered CD19 Antibody
MOR208 in Combination with
Lenalidomide for Patients with
Chronic Lymphocytic Leukemia (CLL)
and Richter’s Transformation or
Ibrutinib for Patients with Ibrutinib-
Resistant Clones
Kerry A Rogers, MDAssistant Professor
Division of Hematology Department of Internal Medicine,
The Ohio State University
Investigator Sponsored Trial (IST) at the Ohio State
University (OSU)
© MorphoSys AG, Investor Event, December 5, 2016 29
Investigator sponsored trial (IST) - PI Jennifer Woyach, OSU
Single center, open-label, single arm study in CLL patients < 80 years of age
4 cohorts, recruiting 75 patients:
1. Combination with lenalidomide in previously untreated patients, ineligible for approved chemo-
and/or immunotherapy options (planned 20 pts)
2. Combination with lenalidomide in R/R disease (planned 20 pts)
3. Combination with lenalidomide in Richter’s disease (planned 10 pts)
4. Combination with ibrutinib in pts with R/R disease under ibrutinib (planned 25 pts)
Woyach et al, ASH2016
© MorphoSys AG, Investor Event, December 5, 2016 30
Woyach et al, ASH2016
Characteristic Previously
Untreated
Number (%)
Relapsed/
Refractory
Number (%)
Richter’s
Number (%)
Ibrutinib
Progressing
Number (%)
Total Patients 11 11 5 7
Median Age (range) 62 (44-75) 70 (62-75) 60 (55-77) 62 (45-77)
Sex
Male 7 (64) 10 (91) 3 (60) 7 (100)
Female 4 (36) 1 (9) 2 (40) 0
Rai Stage
Low 1 (9) 0 NA 1(14)
Intermediate 4 (36) 4 (36) NA 3 (43)
High 6 (55) 7 (64) NA 3 (43)
Complex Stimulated
Karyotype3 (27) 9 (82) 4 (80) 6(86)
Interphase Cytogenetics
del(13q14.3) 4 (36) 7 (64) 3 (60) 1 (14)
Trisomy 12 5 (45) 1 (9) 1 (20) 2 (29)
del(11q22.3) 1 (9) 2 (18) 2 (40) 1 (14)
del(17p13.1) 1 (14) 2 (18) 4 (80) 5 (71)
Demographics - Baseline Characteristics
Study Design - Cohort 1
© MorphoSys AG, Investor Event, December 5, 2016 31
Woyach et al, ASH2016
CYCLE 1
MOR00208 1 mg/kg IV on Day 1
MOR00208 9 mg/kg IV on Days 2, 8, 15 & 22
+
Lenalidomide 2.5 mg orally on Days 9-28
CYCLE 13+
Optional lenalidomide alone until progression
CYCLES 2-12
MOR00208 9 mg/kg IV on Day 1
+
Lenalidomide 2.5 mg* orally on Days 1-28
* Dose escalation up to 10 mg daily
COHORT 1:
No previous treatment
Refuse or are ineligible for
standard therapy
Safety Profile - Cohort 1Combination of MOR208 and lenalidomide has been well tolerated
© MorphoSys AG, Investor Event, December 5, 2016 32
Woyach et al, ASH2016
Cohort 1 Toxicities Occurring in >2 Patients Number (%)
Toxicity Grade
All 1/2 3 4
Hematologic Toxicities
Neutropenia 4 (36.4) 3 (27.3) 0 1 (9.1)
Lymphopenia 4 (36.4) 4 (36.4) 0 0
Thrombocytopenia 3 (27.3) 3 (27.3) 0 0
Non-Hematologic Toxicities
Hyperglycemia 8 (72.7) 7 (63.6) 1 (9.1) 0
Upper Respiratory Infection 6 (54.5) 6 (54.5) 0 0
Dyspnea 5 (45.5) 4 (36.4) 1 (9.1) 0
Infusion Reaction 5 (45.5) 3 (27.3) 2 (18.2) 0
Constipation 4 (36.4) 4 (36.4) 0 0
Cough 4 (36.4) 4 (36.4) 0 0
Diarrhea 4 (36.4) 4 (36.4) 0 0
Hyperhidrosis 4 (36.4) 4 (36.4) 0 0
Nausea 4 (36.4) 4 (36.4) 0 0
Increased ALT 3 (27.3) 3 (27.3) 0 0
Increased AST 3 (27.3) 3 (27.3) 0 0
Dry Mouth 3 (27.3) 3 (27.3) 0 0
Pain 3 (27.3) 3 (27.3) 0 0
Tinnitus 3 (27.3) 3 (27.3) 0 0
Study Design - Cohort 2
© MorphoSys AG, Investor Event, December 5, 2016 33
Woyach et al, ASH2016
CYCLE 1
MOR00208 1 mg/kg IV on Day 1
MOR00208 9 mg/kg IV on Days 2, 8, 15 & 22
+
Lenalidomide 2.5 mg orally on Days 9-28
CYCLE 13+
Optional lenalidomide alone until progression
CYCLES 2-12
MOR00208 9 mg/kg IV on Day 1
+
Lenalidomide 2.5 mg* orally on Days 1-28
* Dose escalation up to 10 mg daily
COHORT 2:
Relapsed or refractory disease
Safety Profile - Cohort 2Combination of MOR208 and lenalidomide has been well tolerated
© MorphoSys AG, Investor Event, December 5, 2016 34
Woyach et al, ASH2016
Cohort 1 Toxicities Occurring in >2 Patients Number (%)
Toxicity Grade
All 1/2 3 4
Hematologic Toxicities
Neutropenia 8 (72.7) 2 (18.2) 5 (45.5) 1 (9.1)
Thrombocytopenia 9 (81.8) 8 (72.7) 0 1 (9.1)
Anemia 5 (45.5) 4 (36.4) 1 (9.1) 0
Non-Hematologic Toxicities
Hyperglycemia 10 (90.9) 8 (72.7) 2 (18.2) 0
Fatigue 8 (72.7) 7 (63.6) 1 (9.1) 0
Increased Creatinine 7 (63.6) 7 (72.7) 0 0
Bruising 6 (54.5) 6 (54.5) 0 0
Diarrhea 6 (54.5) 6 (54.5) 0 0
Dyspnea 6 (54.5) 6 (54.5) 0 0
Hypertension 6 (54.5) 4 (36.4) 2 (18.2) 0
Skin Disorder 6 (54.5) 6 (54.5) 0 0
Cough 5 (45.5) 5 (45.5) 0 0
Dizziness 4 (36.4) 4 (36.4) 0 0
Edema 4 (36.4) 4 (36.4) 0 0
Hypocalcemia 4 (36.4) 4 (36.4) 0 0
Hypomagnesemia 4 (36.4) 4 (36.4) 0 0
Infusion Reaction 4 (36.4) 4 (36.4) 0 0
Nausea 4 (36.4) 4 (36.4) 0 0
Pustular Rash 4 (36.4) 4 (36.4) 0 0
Abdominal Pain 3 (27.3) 3 (27.3) 0 0
Chills 3 (27.3) 3 (27.3) 0 0
Constipation 3 (27.3) 3 (27.3) 0 0
Flu Like Symptoms 3 (27.3) 3 (27.3) 0 0
Other GI Disorders 3 (27.3) 2 (18.2) 1 (9.1) 0
Hyperhidrosis 3 (27.3) 3 (27.3) 0 0
Hyperkalemia 3 (27.3) 3 (27.3) 0 0
Hypokalemia 3 (27.3) 3 (27.3) 0 0
Pain 3 (27.3) 3 (27.3) 0 0
Maculopapular Rash 3 (27.3) 3 (27.3) 0 0
Upper Respiratory Infection 3 (27.3) 2 (18.2) 1 (9.1) 0
Study Design - Cohort 3
© MorphoSys AG, Investor Event, December 5, 2016 35
Woyach et al, ASH2016
CYCLE 1
MOR00208 1 mg/kg IV on Day 1
MOR00208 12 mg/kg IV on Days 2, 8, 15 & 22
+
Lenalidomide 2.5 mg orally on Days 9-28
CYCLE 4-12
MOR208 12 mg/kg IV on Days 1,15
+
Lenalidomide 2.5 mg* orally on Days 1-28
* Dose escalation up to 25 mg daily
CYCLES 2-3
MOR00208 12 mg/kg IV on Day 1, 8, 15 & 22
+
Lenalidomide 2.5 mg* orally on Days 1-28
* Dose escalation up to 10 mg during C2
COHORT 3:
Richter’s Transformation
Safety Profile - Cohort 3Combination of MOR208 and lenalidomide has been well tolerated
© MorphoSys AG, Investor Event, December 5, 2016 36
Woyach et al, ASH2016
Cohort 3 Toxicities Occurring in >1 Patient Number (%)
Toxicity Grade
All 1/2 3 4
Hematologic Toxicities
Decreased WBC 2 (40) 2 (40) 0 0
Thrombocytopenia 2 (40) 1 (20) 1 (20) 0
Non-Hematologic Toxicities
Hyperglycemia 5 (100) 2 (40) 3 (60) 0
Hyponatremia 3 (60) 2 (40) 1 (20) 0
Bruising 2 (40) 2 (40) 0 0
Cough 2 (40) 2 (40) 0 0
Dry Mouth 2 (40) 2 (40) 0 0
Fatigue 2 (40) 2 (40) 0 0
Hypoalbuminemia 2 (40) 2 (40) 0 0
Hypomagnesemia 2 (40) 2 (40) 0 0
Study Design - Cohort 4
© MorphoSys AG, Investor Event, December 5, 2016 37
Woyach et al, ASH2016
CYCLE 1
MOR00208 1 mg/kg IV on Day 1
MOR00208 12 mg/kg IV on Days 2, 8, 15 & 22
+
Ibrutinib 420 mg daily
CYCLES 4-12
MOR00208 12 mg/kg IV on Days 1,15
+
Ibrutinib 420 mg daily
CYCLES 2-3
MOR00208 12 mg/kg IV on Days 1,8,15,22
+
Ibrutinib 420 mg daily
COHORT 4:
Ibrutinib resistance mutation in
>5% of cells while on ibrutinib
Safety Profile - Cohort 4Combination of MOR208 and ibrutinib has been well tolerated
© MorphoSys AG, Investor Event, December 5, 2016 38
Woyach et al, ASH2016
Cohort 4 Toxicities Occurring in >1 Patient Number (%)
Toxicity Grade
All 1/2 3 4
Hematologic Toxicities
Thrombocytopenia 2 (28.6) 2 (28.6) 0 0
Non-Hematologic Toxicities
Hyperglycemia 6 (85.7) 5 (71.4) 1 (14.3) 0
Hypertension 6 (85.7) 4 (57.1) 2 (28.6) 0
Back Pain 4 (57.1) 4 (57.1) 0 0
Fatigue 4 (57.1) 4 (57.1) 0 0
Pain 4 (57.1) 4 (57.1) 0 0
Increased Creatinine 3 (42.9) 3 (42.9) 0 0
Gastroesophageal Reflux Disease 3 (42.9) 3 (42.9) 0 0
Hyperuricemia 3 (42.9) 2 (28.6) 1 (14.3) 0
Musculoskeletal Disorder 3 (42.9) 3 (42.9) 0 0
Peripheral Sensory Neuropathy 3 (42.9) 3 (42.9) 0 0
Anorexia 2 (28.6) 2 (28.6) 0 0
Constipation 2 (28.6) 2 (28.6) 0 0
Diarrhea 2 (28.6) 2 (28.6) 0 0
Dyspnea 2 (28.6) 2 (28.6) 0 0
Hyponatremia 2 (28.6) 2 (28.6) 0 0
Insomnia 2 (28.6) 2 (28.6) 0 0
Mucositis 2 (28.6) 2 (28.6) 0 0
Nausea 2 (28.6) 2 (28.6) 0 0
Maculopapular Rash 2 (28.6) 2 (28.6) 0 0
Renal and Urinary Disorders 2 (28.6) 2 (28.6) 0 0
© MorphoSys AG, Investor Event, December 5, 2016 39
Woyach et al, ASH2016
Variant allele frequency of BTK C481S in Cohort 4Preliminary evidence of activity against CLL cells with BTK C481S
Secondary objective:
To determine whether MOR00208
can eliminate cellular clones
that are resistant to ibrutinib
Conclusion
© MorphoSys AG, Investor Event, December 5, 2016 40
Woyach et al, ASH2016
The combinations of MOR208 and lenalidomide and MOR208
and ibrutinib have been well tolerated in all patient cohorts
Preliminary efficacy has been seen in all cohorts, but
particularly interesting is activity in ibrutinib-resistant CLL
Agenda
© MorphoSys AG, Investor Reception, 2016-12-05 41
8:00 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSysMorphoSys‘s growing proprietary portfolio of biopharmaceuticals
8:10 Arndt Schottelius, M.D. Ph.D., Chief Development Officer, MorphoSysSingle-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL):Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
8:20 Kerry A Rogers, M.D., Division of Hematology Department of Internal Medicine, The OhioState UniversityUpdated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones
8:35 Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg, GermanyA Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
8:50 Q&A Session
A Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with
Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
Marc S. Raab,* Manik Chatterjee, Hartmut Goldschmidt,Hermine Agis, Igor W. Blau, Hermann Einsele,
Monika Engelhardt, Barbara Ferstl, Martin Gramatzki,Christoph Röllig, Katja Weisel, Tiantom Jarutat,
Dominika Weinelt, Jan Endell, Rainer Boxhammer, Christian Peschel
*Universitätsklinikum Heidelberg, Germany
© MorphoSys AG, Investor Event, December 5, 2016 42
MOR202 Mechanisms of Action
MOR202
• Fully human monoclonal IgG1 antibody directed against CD38
• MOR202 induces potent immune effector mechanisms: ADCC and ADCP
ADCC, antigen-dependent cell-mediated cytotoxicity; ADCP, antigen-dependent cell-mediated phagocytosis
© MorphoSys AG, Investor Event, December 5, 2016 43
Objectives
Primary• Assess the safety profile and establish the maximum tolerated dose (MTD) and/or
recommended dose of MOR202 in patients with RRMM: As monotherapy In combination with Dex In combination with pomalidomide (POM)/Dex In combination with lenalidomide (LEN)/Dex
• Assess immunogenicity of MOR202
Secondary• Assess preliminary efficacy, pharmacokinetics and pharmacodynamics of MOR202
monotherapy and in combination with Dex, POM/Dex and LEN/Dex in patients with RRMM
MTD, maximum tolerated dose; RRMM, relapsed or refractory multiple myeloma
© MorphoSys AG, Investor Event, December 5, 2016 44
MOR202 combinations: cohorts and treatment
As of November 14, 2016, 41 patients were treated in the combination cohorts with Dex only or an IMiD + Dex
• Patients were/will be treated until progressive disease or a maximum of 2 years• 1 treatment cycle is 28 days• During cycle 1, patients in all cohorts received/will receive a MOR202 loading dose on day 4• Low dose Dex was orally administered: 40 mg (≤ 75 years old) or 20 mg (> 75 years old) q1w. An additional dose
was administered in cycle 1 on day 4 concomitant with loading dose
d, day; IMiD, immunomodulatory drug; IV, intravenous; po, orally; q1w, weeklyPreliminary data 14 November 2016
© MorphoSys AG, Investor Event, December 5, 2016 45
ScheduleMOR202 dosePatient number
MOR202+Dex4–16 mg/kg q1w
n=18
MOR202+PomDex8,16 mg/kg q1w
n=9
MOR202+LenDex8,16 mg/kg q1w
n=14
Media age, years 67 64 66Lines of prior therapy, n (Median) 3 3 2Prior ASCT, % 78 56 79Prior therapies, %
Immunomodulatory drugsLenalidomide 94 100 43Thalidomide 39 11 14
Pomalidomide 11 11 0Proteosome Inhibitors
Bortezomib 100 100 86
Carfilzomib 6 11 0
Alkylating agents
Melphalan 100 100 93
Cyclophosphamide 94 67 79
Other agents
Doxorubicin 61 33 50
Panobinostat 0 11 7
Refractory to*, n (%)
Last prior therapy 10 (56) 9 (100) 7 (50)
Any prior therapy 11 (61) 9 (100) 9 (64)
Patient Characteristics of Clinically Relevant Cohorts
* Refractory is defined as resistance to treatment due to PD during treatment or within 2 months of last therapy; ASCT, autologous stem cell transplant
© MorphoSys AG, Investor Event, December 5, 2016 46
Safety: Adverse Events CTC Grade ≥3defined as ≥10% in at least one MOR202 combination treatment cohort
• Only two patients(G4 thrombocytopenia and serious G3 bacterial infection) discontinued in these cohorts due to AEs with a suspected causal relationship to MOR202
• No treatment-related deaths
AEs, n (%)MOR202+Dex
n=18
MOR202+PomDex
n=9
MOR202+LenDex
n=14
Any 15 (83) 8 (89) 12 (86)HematologicalLeukopenia 2 (11) 5 (56) 4 (29)Lymphopenia 7 (39) 2 (22) 7 (50)Neutropenia 4 (22) 6 (67) 5 (36)Thrombocytopenia 3 (17) 3 (33) 1 (7)Anemia 3 (17) 1 (11) 2 (14)CD4 lymphocyte decrease 0 1 (11) 2 (14)CRP increase 0 1 (11) 0Febrile neutropenia 0 1 (11) 0
Non-hematologicalPneumonia 1 (6) 3 (33) 1 (7)Hypokalemia 0 2 (22) 0Hypertension 2 (11) 2 (22) 1 (7)Hyperglycemia 1 (6) 0 2 (14)Diarrhea 0 1 (11) 0Hypophosphatemia 0 1 (11) 0Atrial flutter 0 1 (11) 0Skin infection 0 1 (11) 1 (7)Pneumonia pneumococcal 0 1 (11) 0
AE, adverse event; CRP, C-reactive protein;
© MorphoSys AG, Investor Event, December 5, 2016 47
Efficacy: Best Maximum Change in M-Protein
Data from 35 response-evaluable patients treated with clinically relevant dose regimens who received > 1 treatment cycleS, serum; U, urine
© MorphoSys AG, Investor Event, December 5, 2016 48
Data from response-evaluable patients treated with clinically relevant dose regimens who received > 1 treatment cycle
Efficacy: Time on Study by Best Response
CR, complete response; MR, marginal response; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease; VGPR, very good partial response
MOR202/Dex
© MorphoSys AG, Investor Event, December 5, 2016 49
Efficacy: Time on Study by Best Response
Data from response-evaluable patients treated with clinically relevant dose regimens who received > 1 treatment cycle
MOR202 + IMiD/Dex
© MorphoSys AG, Investor Event, December 5, 2016 50
Efficacy: Progression Free Survival
PFS, progression-free survival
© MorphoSys AG, Investor Event, December 5, 2016 51
Conclusions
• MOR202 in doses up to 16 mg/kg can be safely administered as a 2-hour IV infusion
• MOR202 was well tolerated with a low incidence of IRRs, mainly limited to the first infusion
• MOR202 and Dex led to substantial disease control and long-lasting responses in this heavily pre-treated RRMM population
• MOR202 in combination with IMiDs and Dex showed encouraging signs of synergistic activity including complete remissions and emerging data on prolonged response
© MorphoSys AG, Investor Event, December 5, 2016 52
We deeply thank the patients, families, clinical
researchers, hospitals, and clinics that participate in
clinical trials testing the MOR202 drug candidate.
This study was sponsored by MorphoSys AG.
© MorphoSys AG, Investor Event, December 5, 2016 53
Agenda
© MorphoSys AG, Investor Reception, 2016-12-05 54
8:00 Simon Moroney, D.Phil., Chief Executive Officer, MorphoSysMorphoSys‘s growing proprietary portfolio of biopharmaceuticals
8:10 Arndt Schottelius, M.D. Ph.D., Chief Development Officer, MorphoSysSingle-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin’s Lymphoma (NHL):Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study
8:20 Kerry A Rogers, M.D., Division of Hematology Department of Internal Medicine, The OhioState UniversityUpdated Results from a Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL) and Richter's Transformation or Ibrutinib for Patients with Ibrutinib-Resistant Clones
8:35 Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg, GermanyA Phase I/IIa Study of the CD38 Antibody MOR202 Alone and in Combination with Pomalidomide or Lenalidomide in Patients with Relapsed or Refractory Multiple Myeloma
8:50 Q&A Session
Q & A Session
© MorphoSys AG, Investor Event, December 5, 2016 55
Simon Moroney, D.Phil., MorphoSys AG
Arndt Schottelius, M.D. Ph.D., MorphoSys AG
Kerry A Rogers, M.D., The Ohio State University
Marc-Steffen Raab, M.D., Ph.D., University Hospital of Heidelberg
© MorphoSys AG, Investor Event, December 5, 2016 56
Appendix
PipelineSet to Deliver a Lot of Clinical Data*
© MorphoSys AG, Investor Event, December 5, 2016 57
PHASE 2016 2017
3
Guselkumab – Psoriasis
(VOYAGE 1)
Guselkumab - Pustular / Erythrodermic Psoriasis
Guselkumab – Psoriasis
(VOYAGE 2)
Guselkumab – Psoriasis
(NAVIGATE)
2
Guselkumab – Psoriatic Arthritis Anetumab Ravtansine – Mesothelioma (MPM) MOR103/GSK3196165 – RA
LJM716 – ESCC (+ BYL716) BI-836845 – Metastatic breast cancer MOR103/GSK3196165 – RA
MOR202 – Multiple Myeloma BI-836845 – CRPC (+enzalutamide) MOR103/GSK3196165 – Osteoarthritis
MOR208 – CLL (IIT) Bimagrumab – Hip fracture surgery MOR202 – Multiple Myeloma
MOR208 – NHL Bimagrumab – Sarcopenia (dose ranging) MOR208 – DLBCL (+ lenalidomide)
VAY736 – Pemphigus Vulgaris LFG316 – Panuveitis Tarextumab – Small cell lung canc
LFG316 – GA (+ CLG561) VAY736 – Primary Sjögren‘s Syndrome (PD)
1
Anetumab Ravtansine – Cancer Anetumab Ravtansine – Cancer
(+ pemetrexed/cisplatin)
LJM716 – Breast cancer
(+ BYL716/trastuzumab)
Gantenerumab – Alzheimer’s Anetumab Ravtansine – Ovarian cancer
(+ doxorubicin)
MOR106 – Inflammation
LJM716 – Breast/gastric cancer Anetumab Ravtansine – Hepatic/renal impairment MOR209 – Prostate cancer
BAY-1093884 – Bleeding disorders PF-05082566 – NHL/solid tumors
(+ rituximab)
BI-836845 – EGFR mutant NSCLC PF-05082566 – Solid tumors (+ MK-3475)
LFG316 – Kidney Transplantation Vantictumab – NSCLC & pancreatic cancer
* Anticipated primary completion dates, according to clinicaltrials.gov
Covering Analysts
© MorphoSys AG, Investor Event, December 5, 2016 58
INSTITUTION CONTACT
Baader Helvea Bruno Bulic
Berenberg Klara Fernandes
Bryan Garnier Mickael Chane-Du
Commerzbank Daniel Wendorff
Deutsche Bank Gunnar Romer
Edison Maxim Jacobs
Goldman Sachs Tim Woodward
HSBC Julie Mead
Independent Research GmbH Bernhard Weininger
J.P. Morgan Cazenove James Gordon
Kempen & Co. Anastasia Karpova
Landesbank Baden-Württemberg Timo Kürschner
Oddo Seydler Igor Kim
www.morphosys.com
Thank You
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Anke Linnartz
Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-404
Fax +49 (0)89 / 899 27-5404
Email [email protected]
© MorphoSys AG, Investor Event, December 5, 2016 59