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Capital Markets Day 2017MorphoSys AG
SEPTEMBER 2017
Dr. Malte Peters
CDO
Today’s Speakers
© MorphoSys AG, Capital Markets Day – September 2017
Dr. Markus Enzelberger
Interim CSO
Dr. Simon Moroney
CEO
Jens Holstein
CFO
2
This presentation includes forward-looking statements.
© MorphoSys AG, Capital Markets Day – September 2017
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.
The compounds discussed in this slide presentation are investigational
products being developed by MorphoSys and its partners and are not currently
approved by the U.S. Food and Drug Administration (FDA), European Medicine
Agency (EMA) or any other regulatory authority (except for
guselkumab/TremfyaTM).
3
Agenda
© MorphoSys AG, Capital Markets Day – September 2017 4
INTRODUCTION1.
PROPRIETARY PORTFOLIO – ADVANCED CANDIDATES2.
PROPRIETARY PORTFOLIO – PROMISING DISCOVERY ASSETS3.
PARTNERED PIPELINE4.
FINANCIALS5.
Q&A6.
© MorphoSys AG, Capital Markets Day – September 2017 5
Dr. Simon Moroney
Introduction
MorphoSys is at an exciting stage of its development
World-class technology platforms paying off in pipeline
Building our proprietary development portfolio & capabilities
Financially strong, able to invest
On track to become a fully-integrated biopharmaceutical company
Today’s Key Messages
© MorphoSys AG, Capital Markets Day – September 2017 6
Our Future
© MorphoSys AG, Capital Markets Day – September 2017 7
A fully-integrated
biopharmaceutical company
Attractive partner for big pharma
and biotech
Innovative science and technology
driving expansion of proprietary
portfolio
Commercializing own products in
selected geographies
Lucrative milestone & royalty
streams from deep partnered
pipeline
PARTNERED DISCOVERY
Maximizing utilization of technology
Lucrative source of revenue from licence fees,
milestones & royalties
PROPRIETARY DEVELOPMENT
Focus on oncology/inflammation
Retained rights translate into greater
revenue potential
StrategyBusiness Model Provides Lucrative Growth Opportunities
© MorphoSys AG, Capital Markets Day – September 2017 8
Value
Time
PARTNERED
DISCOVERY
PROPRIETARY
DEVELOPMENT
Our Clinical Pipeline28 Product Candidates in Clinical Development, First Launched
© MorphoSys AG, Capital Markets Day – September 2017 9
* MOR103/GSK3196165 is out-licensed to GSK
Partnered Discovery ProgramsProprietary Development Programs
PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 LAUNCHED
Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis
Gantenerumab Roche Amyloid-ß Alzheimer’s disease
MOR208 - CD19 DLBCL, CLL/SLL
Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors
BHQ880 Novartis DKK-1 Multiple myeloma
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases
BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome
CNTO3157 Janssen - Inflammation
CNTO6785 Janssen - Inflammation
Elgemtumab (LJM716) Novartis HER3 Cancer
MOR103/GSK3196165* GSK GM-CSF Inflammation
MOR202 - CD38 Multiple myeloma
Tesidolumab (LFG316) Novartis C5 Eye diseases
Utomilumab (PF-05082566) Pfizer CD137 (4-1BB) Cancer
VAY736 Novartis BAFF-R Inflammation
Xentuzumab (BI-836845) BI IGF-1 Solid tumors
BAY1093884 Bayer TFPI Hemophilia
MOR106 Galapagos IL-17C Inflammation
MOR107 (LP2-3) - AT2-R Not disclosed
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
NOV-14 Novartis - Asthma
Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors
13
12
2
Expected Pipeline NewsflowUp to 30 Clinical Data Points Expected to Year-end 2017*
© MorphoSys AG, Capital Markets Day – September 2017 10
PHASE 1 PHASE 2 PHASE 3 LAUNCH
Anetumab RavtansineCancer
BAY-1093884Bleeding disorders
Anetumab RavtansineMesothelioma (MPM)
Elgemtumab (LJM716)Esophageal cancer
(+ BYL716)
GuselkumabPsoriasis (VOYAGE 2)
GuselkumabPsoriasis
Elgemtumab (LJM716)Breast cancer
(+ BYL716/trastuzumab)
Elgemtumab (LJM716)Breast/gastric cancer
GuselkumabActive psoriatic arthritis
(PsA)
MOR103/GSK3196165Osteoarthritis
GuselkumabPsoriasis (NAVIGATE)
GantenerumabAlzheimer’s disease
(sc, impact of speed)
Gantenerumab Alzheimer’s disease (sc)
MOR103/GSK3196165Rheumatiod arthritis
MOR103/GSK3196165Rheumatiod arthritis
(Japan)
GuselkumabModerate to severe plaque
psoriasis (POLARIS)
MOR106Atopic dermatitis
MOR107Not disclosed
(trial ongoing)
MOR103/GSK3196165Rheumatiod arthritis
MOR202Multiple Myeloma
(trial ongoing)
GuselkumabSevere plaque psoriasis
NOV-7Eye diseases
Tesidolumab
(LFG316) Kidney Transplantation
MOR208DLBCL (+ lenalidomide)
(trial ongoing)
MOR208CLL (+ lenalidomide)
(IIT)
Utomilumab
(PF-05082566)Solid tumors (+ MK-3475)
Utomilumab
(PF-05082566)NHL/solid tumors
(+ rituximab)
Tarextumab
(OMP-59R5)Small cell lung cancer
Tesidolumab (LFG316) Geographic atrophy
(+ CLG561)
Utomilumab
(PF-05082566)
Solid tumors
(+ mogamulizumab)
Vantictumab
(OMP-18R5)Pancreatic cancer
Tesidolumab (LFG316) Paroxysmal nocturnal
hemoglobinuria
Tesidolumab (LFG316) Panuveitis
Vantictumab
(OMP-18R5)Lung Cancer (NSCLC)
Vantictumab
(OMP-18R5)Breast cancer
VAY736Rheumatoid arthritis
Xentuzumab
(BI-836845)Prostate cancer
(+ enzalutamide)
Xentuzumab
(BI-836845)Multiple cancer types
(EGFR mutant NSCLC)
Xentuzumab
(BI-836845)Breast cancer
Partnered Discovery Programs
Proprietary Development Programs
* Anticipated data readouts and/or primary completion dates,
according to clinicaltrials.gov and/or MorphoSys‘s own estimates
Positive data readout
Negative data readout
BRING MOR208 TO MARKET AS QUICKLY AS POSSIBLE
Secure approval in DLBCL
Build commercial capabilities
Partner in non-MOR geographies
SECURE FUTURE DEVELOPMENT OF MOR202
Optimize outcome from ongoing partnering activities
ADVANCE NEXT GENERATION OF PRODUCT CANDIDATES
Prioritize investment behind highest-value assets
Focus on most promising target/drug opportunities at intersection of oncology and immunology
Our Priorities
© MorphoSys AG, Capital Markets Day – September 2017 11
© MorphoSys AG, Capital Markets Day – September 2017 12
Dr. Malte Peters
Proprietary Portfolio –
Advanced Candidates
Strategic Priorities for MorphoSys Development Team
© MorphoSys AG, Capital Markets Day – September 2017 13
Secure approval of MOR208 in DLBCL and increase value
by investigating additional indications
Support partnering of MOR202
Build world-class development organization
Prioritize focus on speed to bring pipeline of
innovative drugs to market
Changing Paradigm in Clinical DevelopmentMake Drug Development Faster
© MorphoSys AG, Capital Markets Day – September 2017 14
Phase 1 Phase 2 Phase 3
Proof of concept Pivotal
TRADITIONAL
MODERN
Design phase 1 such that phase 3 is successful
Use translational medicine tools
Pharmacokinetics/pharmacodynamics in place
Include this thinking in early development
discussions
Portfolio of Proprietary Development SegmentFive Clinical Candidates
© MorphoSys AG, Capital Markets Day – September 2017 15
* MOR103/GSK3196165 is out-licensed to GSK
PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 LAUNCHED
MOR208 - CD19 • DLBCL B-MIND
• DLBCL L-MIND
• CLL
MOR103/GSK3196165* GSK GM-CSF Inflammation
MOR202 - CD38Multiple
myeloma
MOR106 Galapagos IL-17C Atopic
Dermatitis
MOR107 - AT2-R Not disclosed
MOR209 (co-development with Aptevo Therapeutics), a bi-specific antibody against PSMA and CD3, was
terminated following a portfolio review.
MOR208: Anti-CD19 studied in Hematological CancersA Next Generation Anti-CD19 Antibody with Enhanced Effector Functions
© MorphoSys AG, Capital Markets Day – September 2017 16
W Jurczak et al.; ASH 2016
BACKGROUND
IgG1k antibody
In-licensed from Xencor
Humanized and affinity optimized with Xencor
technology
Fc-engineered for enhanced ADCC &
phagocytosis
MODE OF ACTION
ADCC, phagocytosis, direct cytotoxicity
STRONG PRECLINICAL PACKAGE
Highly active as single agent in vitro and in
vivo
Strong rationale for multiple combination
therapies
MOR208
Fc-enhancement
ADCC
ADCP
directcytotoxicity
ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity
ADCP: Antibody-Dependent Cell-Mediated Phagocytosis
Development Plan for MOR208 Focuses on DLBCLDLBCL Patients have a Poor Prognosis and are Difficult to Treat
© MorphoSys AG, Capital Markets Day – September 2017 17
1: US, EU14, Israel, Japan, Canada
MOST FREQUENT MALIGNANT LYMPHOMA WORLDWIDE
VERY AGGRESSIVE TUMOR
RELAPSED OR REFRACTORY DLBCL
No standard therapy available
Patients are difficult to treat and prognosis is dismal
POTENTIALLY ELIGIBLE PATIENTS BASED ON INCIDENCE1
2nd line: 33,000 patients
3rd line and higher: 16,000 patients
Patients with R/R DLBCL have a Poor Prognosis
© MorphoSys AG, Capital Markets Day – September 2017 18
PARAMETER WITZIG ET AL
LEN
CZUCZMAN ET
AL LEN
WANG ET AL
RTX + LEN
VACIRCA ET AL
RTX + BEN
CRUMP ET AL
META-ANALYSIS
Evaluable
patient
population
R/R DLBCL
n=108
R/R DLBCL
n=51
R/R DLBCL
n=32
R/R DLBCL
n=59
Refractory
DLBCL
n=635
Objective
response rate
28% 27% 28% 46% 26%
Complete
response rate
7% 10% 22% 15% 8%
Median PFS,
months
2.7 3.1 2.8 3.6 -
Median overall
survival, months
- 7.1 10.2 - 6.6
MOR208Clinical Development Plan for NHL and DLBCL
© MorphoSys AG, Capital Markets Day – September 2017 19
NHL MOR208 monotherapy in
R/R NHL
DLBCL
Lenalidomide + MOR208 in R/R DLBCLL-MIND
Phase 3 pivotal study opened in June 2017
Bendamustine + MOR208 vs. bendamustine + rituximab in
R/R DLBCL
B-MIND
INDICATION 2016 2017 2018
MOR208 Showed Encouraging PFS Results as Single Agent
© MorphoSys AG, Capital Markets Day – September 2017 20
W Jurczak et al., ASH 2016
DLBCL iNHL
Results from NHL Trial
© MorphoSys AG, Capital Markets Day – September 2017 21
Lenalidomide with MOR208: Phase 2 in R/R DLBCL
A Phase 2, single-arm, open-label, multicentre study to evaluate the safety
and efficacy of lenalidomide combined with MOR208 in patients
with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL)
L-MINDStudy Design
© MorphoSys AG, Capital Markets Day – September 2017 22
Response assessment after cycles 2, 4, 6 and 12, thereafter every 3 cycles. ASCT, autologous stem cell transplant; HDCT,
high-dose chemotherapy; R/R DLBCL, relapsed or refractory diffuse large B cell lymphoma; SD, stable disease, IV,
intravenous; PO, per os.
PATIENTS WITH
R/R DLBCL:
have received
1-3 prior
regimens
are not
eligible for
HDCT and
ASCT
MOR208
12mg/kg IV
Days 1,15
MOR208
12mg/kg IV
Days
1,8,15,22
Lenalidomide
25mg PO
Days 1-21
Cycle 1 - 3 Cycle 4 -12
Disease
control
(≥SD)
Additional
antibody
treatment
phase
Survival
follow-up
MOR208
12mg/kg IV
Days 1,15
Objective Response RateMOR208/Lenalidomide is a Novel Combination that Showed ORR of 56% in a
Phase 2 Study in DLBCL
© MorphoSys AG, Capital Markets Day – September 2017 23
CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.
G Salles et al.; ASCO 2017
CR: 32%
(n=11)
PR: 24%
(n=8)
SD: 12% (n=4)
PD/NE: 32%
(n=11)
0
20
40
60
80
100
n=34
ORR: 56%
Best
Overa
ll R
esp
onse
(%
)
Time on Study and Best ResponsePatients Stay on Study for a Long Time
© MorphoSys AG, Capital Markets Day – September 2017 24
CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease
G Salles et al.; ASCO 2017
Median time to response 1.8 months, median time to CR 3.4 months
16 out of 19 responders (10 out of 11 CRs) ongoing
SD
PR
CR
Ongoing patients
n=34
MOR208 SAFETY PROFILE TO DATE IN COMBINATION WITH LENALIDOMIDE
Most frequently observed toxicity was neutropenia (36%)
Addition of MOR208 did not result in increased lenalidomide toxicity
Lenalidomide dose reductions were seen in 27%
MOR208 IN COMBINATION WITH LENALIDOMIDE HAS THE POTENTIAL TO BE A SUITABLE
THERAPY FOR R/R DLBCL PATIENTS, INCLUDING ELDERLY AND FRAIL PATIENTS
MOR208/Lenalidomide Appears to be Well Toleratedin a Phase 2 Study
© MorphoSys AG, Capital Markets Day – September 2017 25
MOR208/LEN is a Novel Drug Combination in DLBCLSignificantly Increased Response Rate Compared to Standard of Care and
New Therapies
© MorphoSys AG, Capital Markets Day – September 2017 26
Caution should be applied in making cross trial comparisons
PARAMETER L-MIND
MOR00208
+ LEN
WITZIG ET AL
LEN ALONE
WANG ET AL
RTX + LEN
VACIRCA ET AL
RTX + BEN
CRUMP ET AL
META-ANALYSIS
NEELAPU
AXI-CEL
Evaluable
patient
population
R/R DLBCL
n=34R/R DLBCL
n=108
R/R DLBCL
n=32
R/R DLBCL
n=59
Refractory
DLBCL
n=635
Refractory
DLBCL
n=77
Objective
response rate
56% 28% 28% 46% 26% 82%/36%
Total/@6 Mo
Complete
response rate
32% 7% 22% 15% 8 49%/31%
Total/@6 Mo
Median PFS,
months
Update will be
provided at ASH2.7 2.8 3.6 - -
Median overall
survival,
months
- - 10.2 - 6.6 -
© MorphoSys AG, Capital Markets Day – September 2017 27
Bendamustine with MOR208: Phase 2/3 in R/R DLBCL
A phase 2/3, randomised, multicentre study of MOR208 with bendamustine
versus rituximab with bendamustine in patients with relapsed or refractory
diffuse large B cell lymphoma (R/R DLBCL) who are not eligible for high-dose
chemotherapy (hdc) and autologous stem-cell transplantation (ASCT)
B-MINDPhase 2/3 Trial of MOR208 in R/R DLBCL
© MorphoSys AG, Capital Markets Day – September 2017 28
Phase 3 part of the trial was opened for recruitment in June 2017
Cycle 1 - 6
RELAPSED/REFRACTORY
DIFFUSE LARGE B CELL
LYMPHOMA
(R/R DLBCL)
Patients after failure of ASCT
or not eligible for HDCT and
ASCT
At least one prior regimen
included an anti-CD20
antibody
1-3 prior regimen
ECOG 0 to 2
N=330
R 1:1
Until PD, max. 24 cycles
MOR208
+ Bendamustine MOR208
Rituximab
+ BendamustineRituximab
MOR208Regulatory Status
© MorphoSys AG, Capital Markets Day – September 2017 29
MOR208 received Orphan Drug Designation for the treatment of DLBCL in the US
(December 2014) and the EU (January 2015)
MOR208 received Fast Track Designation from the FDA for the treatment of R/R DLBCL (October
2014)
June 2017: B-MIND was cleared for start of phase 3 recruitment in the US
Exploring fast to market strategy with FDA for L-MIND
MOR208: Additional Development Opportunities
© MorphoSys AG, Capital Markets Day – September 2017 30
DLBCL
More advanced patient population
Primary refractory DLBCL patients
CLL
Phase 1b COSMOS study ongoing in combination with idelalisib and venetoclax
Follicular lymphoma
Mantle cell lymphoma
Marginal zone lymphoma
Combination therapies with immuno-oncology compounds in hematological cancers
MOR202A Differentiated Anti-CD38 Antibody to Treat Multiple Myeloma
© MorphoSys AG, Capital Markets Day – September 2017 31
KEY FEATURES
Targets a unique epitope on CD38
ADCC & ADCP cell-killing mechanisms
Low NK cell depletion, which may translate into
longer duration of response
CLINICAL
Very low rate of infusion-related reactions
Short infusion time
Enduring & deepening clinical responses:
− Responses ongoing in 65% of patients
− Longest time on study with ongoing
response: >19 months
Potential in other oncology indications and auto-
immune diseases
ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity
ADCP: Antibody-Dependent Cell-Mediated Phagocytosis
ADCC
ADCP
PRIMARY
Assess the safety profile and establish the maximum tolerated dose (MTD) and/or recommended dose
of MOR202 in patients with R/R MM*:
− In combination with dexamethasone (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 R/R MM
Objectives for MOR202
© MorphoSys AG, Capital Markets Day – September 2017 32
*R/R MM, relapsed or refractory multiple myeloma
© MorphoSys AG, Capital Markets Day – September 2017 33
Infusion related reactions (IRRs)
MOR202
+ DexSIRIUS*
MOR202
+ LEN/DexPOLLUX# MOR202
+ POM/DexEQUULEUS$
Number of
patientsn=18 n=106 n=17 n=283 n=13 n=103
Grade G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4
IRRs, n (%) 2 (11) 0 42 (40) 5 (5) 1 (6) 0 112 (42) 15 (5) 0 0 48 (47) 3 (3)
6%
47%
MOR202 q1w + LEN/Dex
POLLUX
11%
45%
MOR202 q1w + Dex
SIRIUS
0%
50%
MOR202 q1w + POM/Dex
EQUULEUS
Lower Incidence of IRRs for MOR202 than for Daratumumab
*Lonial et al., Lancet, 2016 / # Dimopoulos et al., NEJM, 2016 / $ Chari et al., Blood, 2017
No clinical data exist that directly compare these
therapies, please note limitations of cross-trial comparisons
MOR202q1w + POM/DEX COHORTSMOR202q1w + DEX COHORTS MOR202q1w + LEN/DEX COHORTS
Efficacy EvaluationResponse Data are Comparable to Daratumumab
© MorphoSys AG, Capital Markets Day – September 2017 34
CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease;
VGPR, very good partial response; MR, marginal response; modified from Raab et al, ASCO 2017; ITT population shown
VGPR: 11%
PR: 17%
MR: 11%
SD: 50%
PD: 6%
NE: 6%
n=18
ORR:
28%
Best
Overa
ll R
esp
onse
s (%
)
CR: 6%
VGPR: 18%
PR: 47%
SD: 6%
PD: 6%
NE: 18%
n=17
ORR:
71%
CR: 15%
VGPR: 8%
PR: 23%
MR: 23%
PD: 8%
NE: 15%
n=13
SD: 8%
ORR:
46%
100
80
60
40
20
0
MORPHOSYS HAS SUED JANSSEN BIOTECH AND GENMAB FOR PATENT INFRINGEMENT
Suit includes U.S. patents 8,263,746 and 9,200,061
Patents cover
− Antibodies with particular features that bind to CD38, and
− Methods of treating hematologic cancer associated with undesired presences of CD38-positive cells
by administering antibodies that bind to a specific region of CD38
Not in suit - new patent due to issue September 12, 2017
MorphoSys seeks redress for the infringing manufacture, use and sale of daratumumab
CURRENT STATUS OF LITIGATION
Defendants motions to dismiss filed at the outset of the litigation were not granted
Early Markman Ruling regarding “specifically binds within” favours MorphoSys
Second Markman Hearing held on August 28, 2017 – decision pending
Fact discovery in progress, currently due to be completed by Fall 2017
Expert discovery currently due to be completed by Winter 2018
Trial currently scheduled for August 2018
CD38 Patent Litigation
© MorphoSys AG, Capital Markets Day – September 2017 35
MOR106: Anti-IL-17C for Atopic DermatitisThe MorphoSys–Galapagos Collaboration
© MorphoSys AG, Capital Markets Day – September 2017 36
&
MOR106 arises from a strategic discovery and co-development alliance between MorphoSys and
Galapagos
Galapagos provides the disease-related biology including cellular assays and targets discovered
using its target discovery platform
MorphoSys contributes its Ylanthia antibody technology to generate fully human antibodies
directed against the target and contributes full CMC development of this compound
MorphoSys and Galapagos co-develop MOR106 50/50
MOR106 is Effective in Two Animal Models Relevant for Atopic Dermatitis
© MorphoSys AG, Capital Markets Day – September 2017 37
Skin severity score: composite score of erythema, excoriation & scaling
CALCIPOTRIOL INDUCED ATOPIC DERMATITIS
ON MURINE EAR SKIN
FLAKY TAIL MOUSE MODEL
0 1 2 3 4 5 60
3
6
9isotype
3mg/kg MOR106
30mg/kg MOR106
DEX
**
*****
****
*
Weeks
Skin
severi
ty s
co
re
Psoriasis and Atopic DermatitisApproved Antibody Therapies
© MorphoSys AG, Capital Markets Day – September 2017 38
Data based on Artisan Healthcare Analysis, January 2017
Market Forecast
Mod–severe Population
Current Antibody
Therapies
Double from 2014-2024 to $7.3 bn (7MM)
9-17 m
anti-IL-4R
• Dupixent® (dupilumab)
Atopic Dermatitis
Double from 2015-2025 to $16 bn (7MM)
3 m
anti-TNFα
• Cimzia® (certolizumab pegol)
• Enbrel® (etanercept)
• Humira® (adalimumab)
• Remicade® (infliximab)
• Simponi® (golimumab)
anti-IL-17A or anti-IL-17RA
• Cosentyx® (secukinumab)
• Siliq® (brodalumab)
• Taltz® (ixekizumab)
anti-IL-12/23 or anti-IL-23
• Stelara® (ustekinumab)
• TremfyaTM (guselkumab)
Psoriasis
MOR106 Phase 1 Studies in Atopic Dermatitis
© MorphoSys AG, Capital Markets Day – September 2017 39
Primary & secondary objectives: safety/tolerability & pharmacokinetics
Exploratory objectives:
Eczema Area & Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), Investigator Global
Assessment (IGA), serum TARC (CCL17)
Topline results expected shortly
ATOPIC DERMATITIS:
Inflammatory skin disease characterized by red, dry skin causing severe itch
(35M patients in US, Europe and Japan)
Single
ascending
dose
Multiple
ascending
dose
7-week
follow up
10-week
follow up
Healthy males, 7 cohorts, i.v. infusion (n=42)
4 WEEKS
Placebo (n=14)
Patients, 3 cohorts, weekly i.v. infusion (n=18)
Placebo (n=6)
MOR103/GSK3196165A Novel anti-GM-CSF Antibody for Inflammatory Diseases
© MorphoSys AG, Capital Markets Day – September 2017 40
Clinicaltrials.gov
Global agreement with GSK (June 2013) to develop and commercialize MOR103/GSK3196165
GSK with responsibility for all development and commercialization of the compound
MorphoSys:
− Received € 22.5 million upfront payment in 2013
− Is eligible for € 423 million milestones (on achievement of certain developmental, regulatory,
commercial and sales-based milestones)
− Is eligible for tiered, double-digit royalties on net sales
STUDY INDICATION PHASEEST. PRIMARY
COMPLETION DATE
Efficacy & safety in patients with active
moderate to severe rheumatoid arthritis
Rheumatoid
arthritis2 August 2017
Mechanistic study Rheumatoid
arthritis2 October 2017
Pharmacokinetics and safety in Japanese
patients
Rheumatoid
arthritis2 December 2017
Efficacy and safety in inflammatory
hand osteoarthritisOsteoarthritis 2 December 2017
Strategic Priorities for MorphoSys Development Team
© MorphoSys AG, Capital Markets Day – September 2017 41
Secure approval of MOR208 in DLBCL and increase value
by investigating additional indications
Support partnering of MOR202
Build world-class development organization
Prioritize focus on speed to bring pipeline of
innovative drugs to market
© MorphoSys AG, Capital Markets Day – September 2017 42
Dr. Markus Enzelberger
Proprietary Discovery Assets
& Partnered Pipeline
Technology Platform Serves Pipeline GrowthDifferentiated Drugs for Treatments of Patients Suffering from Serious Diseases
© MorphoSys AG, Capital Markets Day – September 2017 43
MORPHOSYS’S TECHNOLOGICAL LEADERSHIP
25 years of antibody discovery expertise
− 6 generations of antibody libraries
− ≥ 100 therapeutic projects
− ≥ 25 collaboration partners
− 28 product candidates in clinical development,
thereof 1 product launched
Latest library Ylanthia
− Largest phage antibody library in the industry
− Built to deliver fully human antibodies with
convincing developability profile
− Covering huge epitope space
− Designed for difficult targets
Broad assay and disease model experience in
multiple indications
Differentiated
drugs for
treatments of
patients
suffering from
serious diseases
Proprietary pipeline
with 13 programs,
thereof 5 in the clinic
Partnered pipeline
with 100 programs,
thereof 23 in the clinic
GOAL:
1 new IND
every 18
months
C5A/C5AR AXIS: EFFECT ON TUMOR MICRO-
ENVIRONMENT
Tumor cells produce C5a
C5a attracts MDSCs through C5aR
Release of immunosuppressive cytokines
Generation of an immunosuppressive TME at site
of primary tumor as well as in metastatic niche
Impairment of T cell functions
Antibodies in Immuno-OncologyProgram Targeting C5aR Aiming to Unleash the Power of Immune Defense
© MorphoSys AG, Capital Markets Day – September 2017 44
EFFECT OF C5AR BLOCKADE
Reversion of immunosuppression
Enabling patient’s immune system to fight
cancer
Enabling other checkpoint inhibitors to deliver
their full potential
TME: Tumor microenvironment
MDSC: Myeloid-derived suppressor cells
SELECTED PATIENT DATA
C5aR in Immuno-OncologyRecently Published Data Implicate a Role for C5a/C5aR in Cancer
© MorphoSys AG, Capital Markets Day – September 2017 45
1 Cho et al., 2014; 2 Vadrevu et al., 2014; 3 Corrales et al., 2012; 4 Xi et al., 2016
Ovarian Cancer
Higher C5aR expression levels (mRNA) in tumor samples correlated with shorter overall survival1
Breast Cancer
Detection of myeloid-derived suppressor cells and complement depositions in tumor draining lymph
nodes of breast cancer patients2
Non-Small Cell Lung Cancer (NSCLC)
Significantly increased C5a plasma levels in NSCLC patients3
Metastatic Renal Cell Carcinoma
High tumoral C5a levels associated with poor overall survival4
SYNERGISTIC EFFECT OF ANTI-C5AR IN
COMBINATION WITH ANTI-PD-1 IN ANIMAL
MODELS
Therapeutic efficacy of a combination of anti-
PD-1 & anti-C5aR was shown in a preclinical
model of colon cancer
MORPHOSYS THERAPEUTIC C5AR PROGRAM
Fully human, highly specific anti-C5aR antibody
in fully silent IgG format
Inhibits migration and activation of immune
cells
Good pharmacokinetics in rodents
C5aR Blockade in Immuno-OncologyOvercoming Resistance Mechanisms by Tumor Microenvironment, Boosting T/NK Cell Response
© MorphoSys AG, Capital Markets Day – September 2017 46
The C5aR lead candidate will enter preclinical and CMC
development this year and is expected to enter the clinic in 2019
Days
Fra
cti
on s
urv
ival
MC38 Syngeneic Colon Cancer
0 10 20 30 40 500.0
0.2
0.4
0.6
0.8
1.0Negative ControlAnti-C5aR surrogateAnti-PD-1Anti-C5aR surrogate
+anti-PD-1
Number of truly specific tumor-associated
targets is very low
Cancer cells present unique, highly specific
peptides of protein (neo)epitopes via the HLA
complex on the cell surface
Opens a truly new target universe to be targeted
by biologics
MorphoSys technology enables generation of
antibodies with high affinity and specificity for
cancer cells, without harming healthy tissue
T Cell-Receptor Mimicking AntibodiesOpening a New Target Universe in Cancer
© MorphoSys AG, Capital Markets Day – September 2017 47
Peptide/HLA
(human leukocyte antigen) complex
T Cell-Receptor Mimicking AntibodiesForging Strategic Alliances
© MorphoSys AG, Capital Markets Day – September 2017 48
MORPHOSYS’S
TECHNOLOGICAL
LEADERSHIP
IMMATICS
XPRESIDENT platform to identify tumor-associated
peptides directly from primary human tumor material
Huge database of peptides presented on healthy tissues
STATUS OF 1ST PROGRAM
Peptide/HLA on various tumor types but not normal tissue
High affinity, high specificity antibodies identified
Lead candidate selection ongoing
Differentiated
drug candidates
against tumor-
specific peptide/
HLA complexes MD ANDERSON CANCER CENTER
ECLIPSE: Evolution of Cancer, Leukemia, and Immunity
Platform to identify target molecules on leukemia cells
Substantial specimen bank from patients & healthy donors
STATUS OF 1ST PROGRAM
Target class: Peptide/HLA complex
Antibody selection initiated
Ylanthia®
MorphoSys’s Technological LeadershipBispecific Platforms for Oncology Applications
© MorphoSys AG, Capital Markets Day – September 2017 49
MorphoSys’s proprietary anti-CD3 binding
moieties
Optimized pharmacokinetics and biophysical
properties
Potentially increased therapeutic window
MorphoSys’s proprietary anti-4-1BB binding
moieties
Optimized pharmacokinetics and biophysical
properties
Selectively stimulating NK & tumor specific
T cells within the tumor environment
Avoiding systemic side effects
Anti-4-1BB Bispecific FormatAnti-CD3 Bispecific Format
Technology Platform Serves Pipeline GrowthWith Differentiated Drugs for Treatments of Patients Suffering from Serious Diseases
© MorphoSys AG, Capital Markets Day – September 2017 50
MORPHOSYS’S TECHNOLOGICAL LEADERSHIP
25 years of antibody discovery expertise
− 6 generation of antibody libraries
− ≥ 100 therapeutic projects
− ≥ 25 collaboration partners
− 28 product candidates in clinical development,
thereof 1 product launched
Latest library Ylanthia
− Largest phage antibody library in the industry
− Built to deliver fully human antibodies with
convincing developability profile
− Covering huge epitope space
− Designed for targeting difficult targets
Broad assay and disease model experience in
multiple indications
Differentiated
Drugs for
Treatments of
Patients
Suffering from
Serious Diseases
Proprietary pipeline
with 13 programs,
thereof 5 in the clinic
Partnered pipeline
with 100 programs,
thereof 23 in the clinic
GOAL:
1 new IND
every 18
month
Late-Stage Partnered ProgramsParticipating in the Most Exciting Pharma Market Opportunities
© MorphoSys AG, Capital Markets Day – September 2017 51
GUSELKUMAB (TREMFYATM)
Psoriasis
Psoriatic Arthritis
Crohn’s Disease
UTOMILUMAB
Immuno-Oncology
GANTENERUMAB
Alzheimer’s Disease
Guselkumab/TremfyaTM
The First HuCAL Antibody on the Market
© MorphoSys AG, Capital Markets Day – September 2017 52
Partnered Discovery project with Janssen targeting IL23p19
FDA approval for psoriasis July 13, 2017
Available to patients in the US since end of July 2017
DIFFERENTIATION POTENTIAL
Superiority vs. Humira® in head to head phase 3 trial (VOYAGE 1)
Superiority in Humira® (VOYAGE 2) and STELARA® (NAVIGATE)
inadequate responders
Convenience: 8-weekly vs. 2-weekly dosing
SAFETY
Consistent profile across all trials
5 year, long term extension ongoing with Janssen
STATUS
Head to head phase 3 trial vs. Cosentyx® ongoing
Start of phase 3 psoriatic arthritis trial anticipated shortly
Phase 3 study planned for Crohn’s disease
UtomilumabUnleashing T Cells and NK Cells to Fight Cancer
© MorphoSys AG, Capital Markets Day – September 2017 53
Source: Pfizer Fact Sheet
Partnered Discovery project with Pfizer against solid tumors
Targets CD137 (4-1BB) expressed by cell types of hemato-
poietic lineage, e.g. T cells, B cells, T regs, NK cells, DCs
FUNCTION
T cells
− Induction of proliferation
− Upregulation of anti-apoptotic pathways
Dendritic cells
− Induction of maturation and upregulation of co-stimulatory
molecules
− Production of pro-inflammatory cytokines
NK cells
− Enhancement of cytotoxicity
STATUS
Multiple clinical trials in different combinations & indications
GantenerumabA HuCAL Antibody Binding Aggregated Forms of Amyloid-beta
© MorphoSys AG, Capital Markets Day – September 2017 54
Partnered Discovery project with Roche
developed against Alzheimer’s disease
HuCAL antibody against amyloid-beta (Ab),
that binds N-terminus and middle of Ab
peptide
Binds/disrupts amyloid plaque and oligomers
In phase 1, gantenerumab clears brain amyloid
very efficiently in mild-to-moderate
Alzheimer’s disease patients
Alzheimer’s DiseaseClearance Mechanisms of Anti-Ab Immunotherapy - Evolving Picture
© MorphoSys AG, Capital Markets Day – September 2017 55
Citron M. 2010, Nat Rev Drug Discov 9: 387-98
GantenerumabGantenerumab in the Competitive Environment
56
1 DeMattos et al, 2001, PNAS 98: 8850-8855; 2 Miles et al., 2013, Scientific Reports 3:1302; 3 Ultsch et al., 2016, Scientific Reports; 4 Adolfsson et al., 2012, Neuroscience
32: 9677-9689; 5 Sevigny et al., 2016, Nature 537: 50-56; 6 Bohrmann et al., 2012, J Alzheimer’s Disease 28: 49-69; 7 Interim analysis presented at CTAD 2016
Aducanumab has shown dose-dependent amyloid plaque reduction and clinical benefit measured by
CDR-SB and MMSE7
In titration arm to 10 mg/kg IV over 12 months, similar clinical decline benefit as in 10 mg/kg flat dose
was achieved while serious adverse events of ARIA-E rate in APOE carriers dropped from 56% to 35% 7
Good rationale for much higher dose (supported by PK studies) and improved dosing scheme
Confidence that higher dose of gantenerumab can be achieved with manageable ARIA-E rate and will
result in clinical benefit for patients
Graduate I/II trials with higher dose will start in 2017
Antibody Company EpitopeRelative Binding Profiles
IsotypeMonomers Oligomers Plaques
Solanezumab1 terminated Eli Lilly 13-28 +++ IgG1
Bapineuzumab2 terminated Pfizer/J&J 1-5 + +++ + IgG1
Crenezumab3,4 Roche/AC Immune 12-23 + +++ + IgG4
Aducanumab5 Biogen/Neurimmune 3-6 ++ +++ IgG1
Gantenerumab6 Roche/MorphoSys 1-10, 19-26 ++ +++ IgG1
ARIA-E: Amyloid-related imaging abnormalities-edema; APOE: Apolipoprotein E epsilon; CDR-SB: Clinical Dementia Rating-Sum of Boxes; MMSE: Minimal Mental
State Examination Score
© MorphoSys AG, Capital Markets Day – September 2017
Partnered Clinical Pipeline23 Product Candidates in Clinical Development, Thereof One Launched
© MorphoSys AG, Capital Markets Day – September 2017 57
PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 LAUNCHED
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
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases
BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome
CNTO3157 Janssen - Inflammation
CNTO6785 Janssen - Inflammation
Elgemtumab (LJM716) Novartis HER3 Cancer
Tesidolumab (LFG316) Novartis C5 Eye diseases
Utomilumab (PF-05082566) Pfizer CD137 (4-1BB) Cancer
VAY736 Novartis BAFF-R Inflammation
Xentuzumab (BI-836845) BI IGF-1 Solid tumors
BAY1093884 Bayer TFPI Hemophilia
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
NOV-14 Novartis - Asthma
Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors
11
10
© MorphoSys AG, Capital Markets Day – September 2017 58
Jens Holstein
Financials
Financials 2017 Guidance Re-confirmed
© MorphoSys AG, Capital Markets Day – September 2017 59
*Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets.
As stated before, this does not include revenues from potential future collaborations and/or licensing partnerships, nor effects from potential in-licensing or
co-development deals for new development candidates. Included is a milestone payment for the TremfyaTM approval. Royalties for TremfyaTM cannot be
accurately projected shortly after the approval, guidance will be reviewed as soon as the revenue uptake allows for reliable projections for FY 2017.
IN € MILLION FY 2016 Q1-Q2 2017 GUIDANCE 2017
49.7 23.6 46 to 51
78.5 37.9 85 to 95
-59.9 -30.3 -75 to -85
359.5 334.8 -
Group Revenues
Proprietary R&D Expenses
(incl. Technology Development)
EBIT
Cash, cash equivalents & marketable
securities as well as other short-term
and long-term financial assets
(end of reporting period)
42.7
48.043.6 42.3 43.6
1.9 3.05.4 4.0 5.67.0
26.9
15.0
59.9
0.6
2012 2013 2014 2015 2016 2017e
51.9 78.0 64.0 106.2 49.7 46-51
Revenue Development by Segment
© MorphoSys AG, Capital Markets Day – September 2017 60
Proprietary Development:
Partnering deals
Partnered Discovery:
Success-based paymentsPartnered Discovery:
Funded research & licensing fees
TOTAL REVENUES
IN € MILLION
Areas of Revenues – Evolving Business Model
Own Revenues and Royalties to Become Drivers of Cash Flow
61© MorphoSys AG, Capital Markets Day – September 2017
up to 2016 Partnering
DealsMilestones R&D Funding
2021 onwardsProduct SalesRoyaltiesMilestones
Partnering
Deals
increasing financial impact p.a.
2017-2020Royalties
Partnering
DealsMilestonesR&D Funding
R&D Funding
Focus on Proprietary Portfolio
© MorphoSys AG, Capital Markets Day – September 2017 62
Number of Programs in
Proprietary Development
from early to late stage
MOR103
Early Stage, Discovery &
Technology Development
Late Stage
79
56
32
22
36
2012 20142013 20162015
5 6 10 14 14
INVESTMENT
IN € MILLION
Supported by Increase in Proprietary R&D
TremfyaTM First HuCAL Antibody on the Market
© MorphoSys AG, Capital Markets Day – September 2017 63
Source: Johnson & Johnson Pharmaceutical Business Review Day; www.fiercepharma.com; clinicaltrials.gov
First Commercialized Product from Partnered Discovery Segment
Janssen/J&J assumes wholesale acquisition cost (WAC) of US$ 58,100 (per patient per year)
Addressable adult patients with moderate-severe plaque psoriasis are 679,000 (US)
We see blockbuster potential for TremfyaTM not only for the US psoriasis market, but also in other
jurisdictions and indications
INDICATION PHASE STATUSEST. PRIMARY
COMPLETION DATE
Psoriasis vs. Cosentyx® 3 recruiting September 2018
Pustular psoriasis 3 active, not recruiting August 2018
Palmoplantar pustulosis 3 recruiting January 2018
Psoriatic arthritis 3 not yet recruiting October 2019
Crohn’s disease 3 planned n/a
Financial OutlookMultiple Generators for Future Growth
© MorphoSys AG, Capital Markets Day – September 2017 64
R&D
Funding
Partnering
Deals
Product
Revenues
Royalties
Milestones
MorphoSys has evolved significantly with late
stage poprietary and partnered assets expected
to generate substantially growing cash flows.
© MorphoSys AG, Capital Markets Day – September 2017 65
Q&A-Session
© MorphoSys AG, Capital Markets Day – September 2017 66
Dr. Simon Moroney
Wrap Up
www.morphosys.com
Thank You
MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been
approved by the FDA or other ex-US regulatory agencies. HuCAL® , HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high
potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.
TremfyaTM and STELARA® are trademarks of Janssen Research & Development, LLC; Humira® is a trademark of Abbvie Inc.; Cosentyx® is a trademark of Novartis AG;
Dupixent® is a trademark of Sanofi Biotechnology; Cimzia® is a trademark of UCB Pharma, S.A.; Enbrel® is a trademark of Immunex Corporation/Wyeth LLC; Remicade®
is a trademark of Janssen Biotech, Inc./Centocor Inc.; Simponi® is a trademark of Johnson & Johnson; Siliq® is a trademark of Amgen Inc.; Taltz ® is a trademark of Eli
Lilly and Company.
Anke Linnartz
Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-404
Fax +49 (0)89 / 899 27-5404
Email [email protected]