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March 2015
Company Update
© MorphoSys - March 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 - March 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, 22 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 - March 2015
3
The MorphoSys Pipeline
22 Clinical Programs, 94 Total
Most advanced development stage
Program
Partner
Target
Bimagrumab (BYM338)
Guselkumab (CNTO1959)
Gantenerumab
MOR103
MOR208
BHQ880
CNTO3157
CNTO6785
LFG316
LJM716
NOV–3
Tarextumab (OMP-59R5)
VAY736
MOR202
BAY94-9343
BI–836845
NOV–7
NOV–8
NOV-9
NOV-10
PF-05082566
Vantictumab (OMP-18R5)
MOR209/ES414
MOR106
25 programs
Immuno-oncology program
4 MOR programs
40 programs
Novartis
Janssen
Roche
GSK
Novartis
Janssen
Janssen
Novartis
Novartis
Novartis
OncoMed
Novartis
Celgene
Bayer
BI
Novartis
Novartis
Novartis
Novartis
Pfizer
OncoMed
Emergent
Galapagos
Various
Merck Serono
Various
ActRIIB
sIBM (musculoskeletal)
IL23p19
Psoriasis
Amyloid-ß
Alzheimer’s disease
GM-CSF
Rheumatoid arthritis
CD19
ALL, CLL, NHL
DKK-1
Multiple myeloma
Inflammation
Inflammation
C5
Eye diseases
HER3
Cancer
not discl.
Notch 2
Solid tumors
BAFF-R
Inflammation
CD38
Multiple myeloma
Mesothelin (ADC) Solid tumors
IGF-1
Solid tumors
Eye diseases
Inflammation
Diabetic eye diseases
Cancer
4-1BB
Solid tumors
Fzd 7
Solid tumors
PSMA/CD3
Prostate cancer
Inflammation
Various
Cancer
Various
Various
© MorphoSys - March 2015
Disease Area
Discovery
Preclinic
Phase 1 Phase 2 Phase 3
84 Partnered Programs
10 MOR Programs
4
What to Expect in 2015/2016
 Readouts from 2 pivotal studies (bimagrumab & guselkumab)
 Up to 10 new INDs
 Clinical readouts for additional 8 partnered programs expected
MOR208
 Updated phase 2 mono-therapy data
 Start of combination trials
MOR202
 Clinical data from phase 1/2a trial
 Start of combination cohorts
MOR209
 Start of phase 1 trial
 Potential in-licensing of additional compound(s)
 Deals for access to targets and/or technologies
© MorphoSys - March 2015
5
Partnered Clinical Pipeline (I)
Program
Bimagrumab
(BYM338)
Partner
Novartis
Target
ActRIIB
BHQ880
Novartis
DKK-1
LFG316
Novartis
C5
NOV-3
VAY736
Novartis
Novartis
n.d.
BAFF-R
LJM716
Novartis
HER3
NOV-7
NOV-8
NOV-9
NOV-10
Novartis
Novartis
Novartis
Novartis
n.d.
n.d.
n.d.
n.d.
© MorphoSys - March 2015
Indication
Phase 1
sIBM (52 weeks)
sIBM (long-term study)
Cachexia (COPD)
Cachexia (cancer)
Hip fracture surgery
Sarcopenia
MM (renal insufficiency)
Smoldering MM
Wet AMD
Geographic atrophy
MCP
n.d.
Pemphigus vulgaris
Primary Sjögren's syndrome
RRMS
ESCC (combo with BYL719)
HER2+ cancer (combo with
BYL719 & trastuzumab)
HER2+ cancer, combination with
trastuzumab
HER2+ cancer
Advanced solid tumors
Eye disease
Inflammation
Diabetic eye disease
Cancer
Phase 2
Phase 3
6
Partnered Clinical Pipeline (II)
Program
Guselkumab
(CNTO1959)
Partner
Janssen/J&J
Target
IL23p19
Gantenerumab
Roche
Amyloid-ß
CNTO3157
Janssen/J&J
n.d.
CNTO6785
Janssen/J&J
n.d.
Tarextumab
(OMP-59R5)
Oncomed/GSK
Notch 2
Vantictumab
(OMP-18R5)
Oncomed/Bayer
Fzd 7
BAY94-9343
BI-836845
Bayer
BI
Mesothelin
IGF-1
PF-05082566
Pfizer
4-1BB
© MorphoSys - March 2015
Indication
Phase 1
Psoriasis (VOYAGE 1)
Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
Pustular/Erythrodermic Psoriasis
Moderate to severe psoriasis
Rheumatoid arthritis
Palmoplantar pustulosis
Active psoriatic arthritis
Mild Alzheimer‘s disease
Genetically predisposed
Asthma
Safety/Pharmacokinetic
COPD
Rheumatoid arthritis
Pancreatic cancer (ALPINE)
Small cell lung cancer (Pinnacle)
Solid tumors
Solid tumors
Breast cancer
Pancreatic cancer
NSCLC
Solid tumors
Solid tumors, Japanese patients
EGFR mutant NSCLC
Breast cancer
CRPC + enzalutamide
Various solid cancer
Advanced solid tumors
Solid Tumors, NHL (+rituximab)
Solid tumors, combination with
PD-1 inhibitor MK-3475
Phase 2
Phase 3
7
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
walking distance
NEXT
 Pivotal study in sIBM ongoing, completion
scheduled in Q4 2015
sIBM patient who has typical prominent
weakness and atrophy of quadriceps and
finger flexors[2]
 Listed by Novartis as “planned filing 2016”
[1] A Amato et al; Neurology; Nov 7, 2014, online
[2] WK Engel and V Askanas; Neurology 2006; 20-29
© MorphoSys - March 2015
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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
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
disease at week 16 (primary endpoint)
 Significantly higher levels of efficacy at all doses
compared to placebo group
NEXT
Clinical response to a single dose of
10 mg of guselkumab administered
at baseline[1]
 Three Phase 3 trials are scheduled for completion in ‘16
 “Planned filings 2013–2017” (J&J analyst day ‘13)
[1] H Sofen et al; J Allergy Clin Immunol 2014;
133: 1032-40
Results from phase 2b study: 293 patients with mild-to-moderate plaque psoriasis
@week 16
PGA 0 or 1
PASI 75
PASI 90
© MorphoSys - March 2015
Placebo
7%
5%
2%
5 mg
50 mg
200 mg
at week 0, 4, then every 12
34%
79%
44%
81%
34%
45%
weeks
83%
81%
57%
15 mg
100 mg
every 8 weeks
61%
86%
76%
79%
34%
62%
Humira
58%
70%
44%
9
Gantenerumab
A Roche Alzheimer’s Disease Program
 HuCAL antibody against amyloid-ß, binds Nterminus and middle of peptide
 Binds/disrupts amyloid plaque and oligomers;
binds peptide only weakly
CLINICAL  In phase 1, gantenerumab clears brain amyloid
DATA
very efficiently in mild-to-moderate AD patients
 Phase 3 SCarlet RoAD trial in prodromal patients
discontinued based on pre-planned futility
analysis
 Phase 3 Marguerite RoAD trial with 1,000
patients with mild AD ongoing
 DIAN network trial in genetically pre-disposed
patients ongoing
NEXT
% Amyloid change
from baseline
DRUG
Data from Phase 1
Effect of gantenerumab on amyloid load
as indexed by PET SUVR at end of
treatment
 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 - March 2015
10
The MorphoSys Proprietary Portfolio
Program
Indication
Discovery Preclinic
Phase 1 Phase 2 Phase 3 Next Event
Fully partnered (tiered, double-digit royalties)
MOR103
Inflammation
Phase 2b study in RA
Co-development & co-promotion
MOR202
Multiple myeloma
Start of combo cohorts
Data from phase 1/2a
MOR209/ES414
Prostate cancer
Start of phase 1
ALL
Phase 2 (IST, cell therapy)
NHL
Phase 2 mono-therapy
data update
Start of combo trials
CLL (IST)
Data from combo trial
Unpartnered
MOR208
Early-stage programs
MOR106
Inflammation
Immuno-oncology
program
Cancer
4 Programs
Various
© MorphoSys - March 2015
Start of phase 1 in 2016
11
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 CLL/SLL and DLBCL
CLINICAL  Phase 2 data for mono-therapy:
DATA
 CLL: ORR of 38% (IWCLL 2008) within the recommended dose despite short treatment
(Median PFS in CLL within recommended dose: 37 weeks; 60 weeks in expansion
cohort)
 DLBCL: ORR of up to 36% within evaluable patients
 FL: ORR of up to 28% within evaluable patients
NEXT
 Updated phase 2 mono-therapy data (NHL)
 Initiate two combination trials in DLBCL in H2 2015 (lenalidomide or bendamustine)
 Initiate pediatric phase 2 trial (IST): MOR208 + NK cell transfer from parental donor
Efficacy outcome, n (%)
ORR (all pts in cohort)
ORR (evaluable patients†)
DLBCL
(n=35)
9 (26%)
9 (36%)
FL
(n=31)
7 (23%)
7 (28%)
iNHL
(n=11)
4 (36%)
4 (40%)
MCL
(n=12)
0
0
Overall
(n=89)
20 (22%)
20 (28%)
† patients that have completed two cycles of treatment and subsequently received disease response assessment
© MorphoSys - March 2015
12
MOR208 is Superior to Other CD19 & CD20
Mabs in R/R CLL
Single-agent antibodies in R/R CLL*
α-CD19 mabs
α-CD20 mabs
SD, PD and
Non-evaluable/info
not available if SD
or PD
ORR
*IWCLL2008 criteria
38%
MOR208
12mg/kg
(n=16)
24%
30%
MEDI-551
phase I/II
12mg/kg
(n=26)
Obinutuzumab
phase II
(n=20)
© MorphoSys - March 2015
23%
Ofatumumab
phase III
(n=196)
13%
Rituximab
(n=110)
MEDI-551 data source: Poster
ASCO 2013, 12mg/kg dosing group
Obinutuzumab data source:
GAUGUIN study, Cartron et al,
Blood 2014
Ofatumumab data source: control
arm in ibrutinib vs. O phase III
trial (RESONATE, ASCO 2014)
Rituximab data source: Late
breaking abstract #6, ASH 2013
Criteria: Hallek et al 2008
(including CT)
13
MOR202
A Novel Antibody for Multiple Myeloma
DRUG
 High affinity HuCAL antibody targeting CD38
 Binds to a unique epitope with low
nanomolar affinity
 Ability to kill MM cells in vitro and across
multiple pre-clinical in vivo models (ADCC &
ADCP)
 2 hour infusion time
DATA
 Strong synergy with IMiDs (lenalidomide and
pomalidomide) in pre-clinical models (CD38
up-regulation on MM cells and effector cell
activation)
NEXT
 Additional cohorts with weekly dosing
schedule, with and without dexamethasone
ongoing
 Clinical data to be presented in 2015
 Combination cohorts with pomalidomide and
lenalidomide to start in H1 2015
© MorphoSys - March 2015
MOR202 Shows High ADCC and ADCP
Activity as Single Agent
14
MOR202 Phase 1/2a Study Design
H1 2015
H2 2015
MOR202* mono / + dexamethasone (dex)
Dose escalation, weekly dosing, up to 16mg/kg
MOR202* + lenalidomide + dex – dose escalation + confirmation
MOR202* + pomalidomide + dex – dose escalation + confirmation
* MOR202 is given by IV infusion over approximately 2h
© MorphoSys - March 2015
15
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 repeatdose studies
NEXT
 IND filed; phase 1 clinical trial to be initiated
in mCRPC in the U.S. and Australia
© MorphoSys - March 2015
16
Technology Development and Target Sourcing
Acquisition of the Lanthipeptide Library Technology
 Feasibility study completed
 Technology being applied in selected discovery projects
 Positive example for Innovation Capital initiative
Investments in Ylanthia Platform & Beyond
 All in-house programs now based on Ylanthia
 Best technology for our future antibody generation requirements
 Access to antibodies against new target classes, e.g. GPCRs
 Investments in bi-specific antibody technology
Relationship with Moulder Center of Temple University
 Collaboration for target identification and validation
 MorphoSys has options on therapeutic antibody candidates
emerging from the collaboration
© MorphoSys - March 2015
17
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: 26,456,834 (Dec 31, 2014)
Institutional Investors - 73%
Retail Investors - 16%
Novartis - 5%
Celgene - 3%
Treasury Stock - 1%
Management & Supervisory Board - 2%
© MorphoSys - March 2015
18
Financial Guidance 2015
2014A
Guidance 2015
Group Revenues
64.0
58 to 63
Proprietary R&D Expenses
(incl. Technology Development)
36.4
48 to 58
EBIT
-5.9
-20 to -30
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial assets
352.8
in € million
© MorphoSys - March 2015
19
PHASE 2
PHASE 3
Clinical Trials Scheduled for Completion
Guselkumab
Psoriasis (VOYAGE 1)
Bimagrumab
sIBM
Guselkumab
Psoriasis (VOYAGE 2)
CNTO6785
Rheumatoid arthritis
Bimagrumab
Hip fracture surgery
CNTO6785
COPD
MOR208
ALL (mono)
Bimagrumab
Sarcopenia
LFG316
MCP
MOR208
NHL (mono - update)
LJM716
ESCC, combo w/BYL719
LFG316
Geographic Atrophy
MOR208 - IST
CLL (combo with len)
VAY736
RRMS
PHASE 1
BAY94-9343
Solid tumors
Tarextumab
Pancreatic cancer
BI-836845
Advanced solid tumors
BI-836845
Various solid tumors
Tarextumab
Solid tumors
BI-836845
NSCLC
LJM716
Advanced solid tumors
Vantictumab
Breast cancer
BI-836845
Solid tumors (Japan)
LJM716
HER2+ cancer (combo)
Vantictumab
NSCLC
Vantictumab
Solid tumors
MOR202
Multiple Myeloma
Vantictumab
Pancreatic cancer
LJM716
HER2+ cancer (combo)
2015
Potential data events based on clinical trial design & MorphoSys estimates
© MorphoSys - March 2015
Guselkumab
Psoriasis (NAVIGATE)
2016
Partnered Programs
MOR Programs
20
APPENDIX
© MorphoSys - March 2015
21
Pipeline Programs: Business Structure
Partner Programs
MOR Programs
 Partner provides target
 MorphoSys selects program at
 MorphoSys technology used to develop
optimized antibody lead candidate
 target stage (discovery) or
 later (in-licensing)
 Partner responsible for development and
commercialization
 MorphoSys is fully responsible for pre-clinical
and clinical development
 MorphoSys receives milestone & royalties
 Various partnering strategies
Partner
Discovery
© MorphoSys - March 2015
Partnering
Market
Discovery
Market
22
MOR208 Phase 1 Study in R/R CLL
High Single Agent Overall Response Rate
Best Response, n (%)
0.3 - 9 mg/kg
(N=11)
12 mg/kg
(N=16)
Total
(N=27)
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%)
Response by IWCLL 2008 criteria (CT scan)
Complete Response
 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%)
0
0
0
Progressive Disease
MOR208 shows encouraging single-agent efficacy!
Woyach et al. Blood 2014
© MorphoSys - March 2015
23
MOR208 Phase 2 in R/R NHL
Efficacy Results by Subtype
Efficacy outcome, n (%)
DLBCL
(n=35)
FL
(n=31)
iNHL
(n=11)
MCL
(n=12)
Overall
(n=89)
Complete Response
2 (6%)
1 (3%)
1 (9%)
0
4 (4%)
Partial Response
7 (20%)
6 (19%)
3 (27%)
0
16 (18%)
Stable Disease
5 (14%)
14 (45%)
3 (27%)
6 (50%)
28 (31%)
Progressive Disease
11 (31%)
4 (13%)
3 (27%)
5 (42%)
23 (26%)
Not evaluable
10 (29%)
6 (19%)
1 (9%)
1 (8%)
18 (20%)
ORR (all pts in cohort)
9 (26%)
7 (23%)
4 (36%)
0
20 (22%)
ORR (evaluable patients†)
9 (36%)
7 (28%)
4 (40%)
0
20 (28%)
† patients that have completed two cycles of treatment and subsequently received disease response assessment
MOR208 is efficacious as single agent in NHL
Blum et al. #3089, ASH 2014
© MorphoSys - March 2015
24
Novartis Alliance: Landmark Deal
Novartis pays…
Approx. €20m p.a. technology license
including HuCAL internalization fees
Approx. €20m p.a. in research funding
Over €250m milestones (probability adjusted)
Royalties on all resulting drugs
Novartis gets…
Preferred access to HuCAL for use in over
100 discovery programs
Timeline
Excluded
May 2004: Initial deal, including equity stake
Most infectious disease targets
November 2007: Major expansion
November 2017: End, subject to 2-year extension option
© MorphoSys - March 2015
25
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 - March 2015
26
Forthcoming Events & Conferences
April 16, 2015
May 5, 2015
May 12-14, 2015
8th Kempen Lifesciences Conference
New York, USA
Q1 2015 Results
May 19-20, 2015
Bank of America Merrill Lynch 2015
Health Care Conference
Las Vegas, USA
BioEquity,
Vienna, Austria
© MorphoSys - March 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.