1. No category

J.P. Morgan 33rd Annual Healthcare Conference
Company Update
January 14, 2015
© MorphoSys - January 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 - January 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 - January 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 - January 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)
 Clinical readouts for another 8 partnered programs expected
 Up to 10 new INDs
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 - January 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 - January 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 - January 2015
Indication
Phase 1
Moderate to severe psoriasis
Psoriasis (VOYAGE 1)
Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
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 evidenced by
parallel increases in strength and 6-minute
walking distance
NEXT
sIBM patient who has typical prominent
weakness and atrophy of quadriceps and
finger flexors[2]
 Pivotal study in sIBM ongoing, completion
scheduled for Q4 2015
 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 - January 2015
8
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 efficacy than comparator Humira
NEXT
Clinical response to a single dose of
10 mg of guselkumab administered
at baseline[1]
 Three Phase 3 trials scheduled for completion in 2016
 “Planned filings 2013–2017” (J&J analyst day 2013)
[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 - January 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 - January 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
RA
Phase 2b study in RA
Multiple sclerosis
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
Data from phase 2 (mono)
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 - January 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) at recommended dose despite short treatment
 CLL: Median PFS at 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
 Start of combination trials
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 - January 2015
12
MOR208 is Superior to Other
CD19 & CD20 Antibodies in R/R CLL
Single-agent Antibodies in R/R CLL (IWCLL2008)
CD19 Antibodies
CD20 Antibodies
SD, PD and
non-evaluable/info
not available if SD
or PD
ORR
38%
MOR208
12mg/kg
(n=16)
24%
30%
MEDI-551
phase I/II
12mg/kg
(n=26)
Obinutuzumab
phase II
(n=20)
© MorphoSys - January 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
MOR202 Shows High ADCC and ADCP
Activity as Single Agent
 Ability to kill MM cells in vitro and in
multiple in vivo models (ADCC & ADCP)
 2 hour infusion time
DATA
 Strong synergy with IMiDs lenalidomide &
pomalidomide in pre-clinical models via
CD38 up-regulation on MM cells and effector
cell activation
NEXT
 Additional cohorts at weekly dosing
schedule, with & without dexamethasone
 Clinical data to be presented in 2015
 Combination cohorts with lenalidomide &
pomalidomide to start in H1 2015
© MorphoSys - January 2015
14
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
 Co-development with Emergent BioSolutions
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 - January 2015
15
Key Financials
in EUR million
Guidance 2014
Q3 2014
Group Revenues
58 to 63
46.9
EBIT
-5 to -8
-3.7
Cash, cash equivalents & marketable securities
as well as other financial assets as of June 30, 2014
364.3
 2015 financial guidance will be issued on February 26, 2015
 Cash position at YE 2014 approximately EUR 353 million
Stock Information
 Frankfurt Stock Exchange, Prime Standard, TecDAX
 Ticker:
 Bloomberg: MOR:GR
 Reuters: MORG.DE
 Thomson ONE: MOR-XE
 Shares issued: 26,456,834 (Dec 31, 2014)
© MorphoSys - January 2015
16
PHASE 1
PHASE 2
PHASE 3
Clinical Trials Scheduled for Completion
Guselkumab
Psoriasis (VOYAGE 1)
Guselkumab
Psoriasis (NAVIGATE)
Bimagrumab
sIBM
Guselkumab
Psoriasis (VOYAGE 2)
CNTO6785
Rheumatoid Arthritis
Bimagrumab
Hip Fracture Surgery
CNTO6785
COPD
Bimagrumab
Sarcopenia
MOR208
ALL (mono)
LFG316
MCP
Tarextumab
Pancreatic cancer
LJM716
ESCC, combo w/BYL719
VAY736
RRMS
MOR208
NHL (mono - update)
MOR208 - IST
CLL (combo with Len)
BAY94-9343
Solid tumors
MOR202
Multiple Myeloma
BI-836845
Advanced solid tumors
Tarextumab
Solid tumors
BI-836845
NSCLC
BI-836845
Various solid tumors
Vantictumab
Breast cancer
BI-836845
Solid tumors (Japan)
LJM716
Advanced solid tumors
Vantictumab
NSCLC
Vantictumab
Solid tumors
LJM716
HER2+ cancer (combo)
Vantictumab
Pancreatic cancer
LJM716
HER2+ cancer (combo)
2015
Potential data events based on clinical trial design & MorphoSys estimates
© MorphoSys - January 2015
2016
Partnered Programs
MOR Programs
17
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.