Credit Suisse Antibody Day - MorphoSys AG · BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI...
Transcript of Credit Suisse Antibody Day - MorphoSys AG · BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI...
Credit Suisse Antibody Day
New York
May 10, 2013
© MorphoSys - May 2013
Safe Harbour
© MorphoSys - May 2013
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.
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MorphoSys: The Investment Case
© MorphoSys - May 2013
Technology-driven Alliances
Proven HuCAL platform
Major alliance with
Novartis
Ongoing investment in
new technologies
Broad Product Pipeline
21 clinical programs
Promising proprietary programs MOR103, MOR202, MOR208
Multiple clinical read-outs pending
Financially Strong
Secure cash-flows
Strong balance sheet
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Antibody Technology: Our Philosophy
© MorphoSys - May 2013
Optimize antibody properties early
HuCAL
Industry’s most successful antibody library technology
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HuCAL
Industry’s Most Successful Antibody Library
© MorphoSys - May 2013
CDR-H3 CDR-L3 CDR-L2 CDR-L1 CDR-H2 CDR-H1
7 x HuCAL VH 6-7 x HuCAL VL
Human Combinatorial Antibody Library
Proprietary to MorphoSys
Modular construction enables systematic optimization of antibody properties
Pre-built DNA cassettes
Master genes
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New Technology
Slonomics & Ylanthia
© MorphoSys - May 2013
Slonomics
Best technology for protein libraries
secured in Sloning acquisition
Deals have already paid for acquisition
Pfizer, Novozymes, unnamed pharma
Ylanthia
Totally new antibody platform
Higher quality antibodies, greater
diversity faster lead generation
US patent granted January 2013
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80 Therapeutic Antibody Programs
© MorphoSys - May 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103
(2 programs) - GM-CSF
Rheumatoid Arthritis
Multiple Sclerosis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
BHQ880 Novartis DKK-1 Cancer
BYM338 Novartis ActRIIB Musculoskeletal
NOV – 3 Novartis - not discl.
LFG316 Novartis C5 Ophthalmology
OMP-59R5 OncoMed/GSK Notch 2 Cancer
MOR208 - CD19 CLL, NHL, ALL
MOR202 - CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
CNTO3157 Janssen/J&J - Asthma
CNTO – 5 Janssen/J&J - Inflammation
VAY736 Novartis BAFF-R Inflammation
LJM716 Novartis HER3 Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
PFE – 1 Pfizer - Cancer
NOV - 7 Novartis - Ophthalmology
21 Programs Various Partners - Various Indications
35 Programs Various Partners - Various Indications 73 Partnered Programs
7 Proprietary Programs
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80 Therapeutic Antibody Programs
© MorphoSys - May 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103
(2 programs) - GM-CSF
Rheumatoid Arthritis
Multiple Sclerosis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
BHQ880 Novartis DKK-1 Cancer
BYM338 Novartis ActRIIB Musculoskeletal
NOV – 3 Novartis - not discl.
LFG316 Novartis C5 Ophthalmology
OMP-59R5 OncoMed/GSK Notch 2 Cancer
MOR208 - CD19 CLL, NHL, ALL
MOR202 - CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
CNTO3157 Janssen/J&J - Asthma
CNTO – 5 Janssen/J&J - Inflammation
VAY736 Novartis BAFF-R Inflammation
LJM716 Novartis HER3 Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
PFE – 1 Pfizer - Cancer
NOV - 7 Novartis - Ophthalmology
21 Programs Various Partners - Various Indications
35 Programs Various Partners - Various Indications 73 Partnered Programs
7 Proprietary Programs
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MOR103: A Novel Anti-Inflammatory Antibody
© MorphoSys - May 2013
MOR103 is a HuCAL antibody made by MorphoSys
Target
Human GM-CSF
Drug
Ultra-high affinity HuCAL IgG1
Large Market and Unmet Need in Rheumatoid
Arthritis
30-40% of patients do not adequately respond to
anti-TNFs
Half no longer respond within 2 years
Intellectual Property
Exclusive license to US patent covering anti-GM-
CSF antibodies to treat chronic inflammation
US patent on MOR103 composition of matter
Kd
(pM)
Improvement
Parental 2,000 -
CDR L3 opt. 63.5 31
CDR H2
opt.
6.0 333
MOR103 0.4 5,000
The Path to MOR103
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7.4
25.0
68.2
30.4
0
10
20
30
40
50
60
70
80
Dose
Placebo
MOR103 0.3mg/kg
MOR103 1.0mg/kg
MOR103 1.5mg/kg
MOR103 Shows Impressive Efficacy, Fast Onset
of Action & Clean Safety Profile
© MorphoSys - May 2013
Phase 1b/2a: ACR20 Response at Week 4, 96 Patients
% o
f pati
ents
p<0.0001
Efficacy
ACR20 amongst highest observed for a
biologic after 4 weeks
1.0 mg/kg dose cohort shows efficacy
potential
Imaging confirms anti-inflammatory
activity
Safety
Related adverse events more frequent
in placebo group than in active
treatment group
Majority of AEs were of mild intensity
No treatment-related SAEs in the
active treatment groups
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0
10
20
30
40
50
60
70
0 1 2 3 4
MOR103 1 mg/kgmavrilimumabHumiraOrenciaActemra
Efficacy Compares Favorably to Other Biologics
© MorphoSys - May 2013
Time (weeks)
% o
f pati
ents
ACR20*
Very fast onset of therapeutic effect
* Data from separate clinical studies
DAS28
Durable response
Week
Mean c
hange f
rom
base
line
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MOR103
Looking Ahead
© MorphoSys - May 2013
Rheumatoid arthritis
Expect even higher efficacy on
longer treatment
development in moderate to severe patients
Potential for monthly or even less frequent dosing
Subcutaneous formulation
Phase 1 study in healthy volunteers shows good PK and
bioavailability
Multiple sclerosis
Phase 1b study in MS patients ongoing
GM-CSF is only non-redundant inflammatory cytokine in EAE
Partnering
Negotiations ongoing
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80 Therapeutic Antibody Programs
© MorphoSys - May 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103
(2 programs) - GM-CSF
Rheumatoid Arthritis
Multiple Sclerosis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
BHQ880 Novartis DKK-1 Cancer
BYM338 Novartis ActRIIB Musculoskeletal
NOV – 3 Novartis - not discl.
LFG316 Novartis C5 Ophthalmology
OMP-59R5 OncoMed/GSK Notch 2 Cancer
MOR208 - CD19 CLL, NHL, ALL
MOR202 - CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
CNTO3157 Janssen/J&J - Asthma
CNTO – 5 Janssen/J&J - Inflammation
VAY736 Novartis BAFF-R Inflammation
LJM716 Novartis HER3 Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
PFE – 1 Pfizer - Cancer
NOV - 7 Novartis - Ophthalmology
21 Programs Various Partners - Various Indications
35 Programs Various Partners - Various Indications 73 Partnered Programs
7 Proprietary Programs
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Gantenerumab: A HuCAL Antibody being
Developed by Roche for Alzheimer’s Disease
© MorphoSys - May 2013
Gantenerumab is a HuCAL antibody made by MorphoSys
in collaboration with Roche
Target
Amyloid-b
Drug
IgG1 with a unique binding profile
N-terminus and mid-section of amyloid peptide
Binds amyloid plaque and oligomers very well,
amyloid peptide weakly
Mechanism
Clearance of amyloid plaque from the brain
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Gantenerumab is Being Developed in Prodromal
Alzheimer’s Disease
© MorphoSys - May 2013
Large Market and Unmet Need
Alzheimer’s disease is estimated to affect 25 million people worldwide
Increasing with aging population
Once symptoms for AD dementia have appeared, it may be too late to treat
Picture: Courtesy of Roche
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Gantenerumab is the Most Advanced Antibody
in Development for Alzheimer’s Disease
© MorphoSys - May 2013
Clinical Development
Phase 1: gantenerumab reduces brain amyloid 3x
faster than other amyloid-targeting substances
Phase 3 study ongoing
SCarlet RoAD
770 biomarker-positive prodromal patients
2 doses, placebo-controlled
104 weeks on drug
CDR-SOB, ADAS-COG, change in brain amyloid
Interim analysis this year
Dominantly Inherited Alzheimer Network Phase 3
study
Early onset Alzheimer's Disease caused by a
genetic mutation
Data from Phase 1
Effect of gantenerumab on
amyloid load as indexed by PET
SUVR at end of treatment
% A
mylo
id c
hange
from
base
line
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80 Therapeutic Antibody Programs
© MorphoSys - May 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103
(2 programs) - GM-CSF
Rheumatoid Arthritis
Multiple Sclerosis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
BHQ880 Novartis DKK-1 Cancer
BYM338 Novartis ActRIIB Musculoskeletal
NOV – 3 Novartis - not discl.
LFG316 Novartis C5 Ophthalmology
OMP-59R5 OncoMed/GSK Notch 2 Cancer
MOR208 - CD19 CLL, NHL, ALL
MOR202 - CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
CNTO3157 Janssen/J&J - Asthma
CNTO – 5 Janssen/J&J - Inflammation
VAY736 Novartis BAFF-R Inflammation
LJM716 Novartis HER3 Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
PFE – 1 Pfizer - Cancer
NOV - 7 Novartis - Ophthalmology
21 Programs Various Partners - Various Indications
35 Programs Various Partners - Various Indications 73 Partnered Programs
7 Proprietary Programs
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LJM716: A HuCAL Antibody being Developed by
Novartis for Cancer
© MorphoSys - May 2013
LJM716 is a HuCAL antibody made by MorphoSys in
collaboration with Novartis
Target
HER3
Three clinical trials
Phase 1: LJM716 + herceptin in patients with HER2-
overexpressing metastatic breast or gastric cancer
Phase 1: LJM716 in squamous cell carcinoma of head
and neck or HER2-positive breast or gastric cancer
Phase 1b/2: Combination of LJM716 & BYL719 in
patients with previously treated esophageal squamous
cell carcinoma
Baselga & Swain Nature Reviews Cancer (2009) 9(7):463-75
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LJM716: Made for Broad Anti-HER Activity
© MorphoSys - May 2013
HER2-driven signaling
(Ligand-independent)
HER2 HER3
anti-HER3 Herceptin
PI3Ki
EGFR HER3
Erbitux
EGFR-driven signaling
(Ligand-dependent)
Breast & gastric cancers Colorectal, HNSCC & pancreatic
cancers
anti-HER3
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HuCAL Delivered a Unique Set of Antibodies
© MorphoSys - May 2013
pH
er3
pAkt
100 1 0.01
100 1 0.01
IgG Conc (nM)
α-HER3
Control
α-HER3
Control
pH
er3
100 1 0.01
pAkt
IgG Conc (nM)
α-HER3
Control
α-HER3
Control
100 1 0.01
KP
RTK
PP
P
HER2 Ligand-independent
(SKBr3, HER2 amp)
Ligand-dependent (MCF7)
LJM716 is a potent inhibitor of pHER3 & pAKT in vitro
Inhibitory effects translate into neuregulin and HER2-driven xenograft models
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Crystal Structure Explains Mechanism
© MorphoSys - May 2013
D1
D2
D3
D4
LJM716 binds here…
… locking HER3 into an inactive
conformation that can neither:
dimerize with HER2, nor
bind the ligand, neuregulin
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Key Financials
© MorphoSys - May 2013
in € million Q1 2013 Guidance 2013
Group Revenues 16.9 48 – 52*
Total Operating Expenses 14.6 70 - 74
thereof Investment in Proprietary R&D 7.0 32 to 37
EBIT 1.9 -18 to -22*
Cash & Marketable Securities and Interest-bearing
Assignable Loans as of March 31, 2013 177.4
* Does not include out-licensing of MOR103, which could lead to significant
out-performance
Sale of AbD Serotec to BioRad completed January 10, 2013, for approx. € 53 million
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Expected Progress in Proprietary Portfolio 2013
© MorphoSys - May 2013
MOR103
Partnership for further development
Multiple sclerosis Phase 1b study continues
MOR208
ALL Phase 2 study to commence
NHL Phase 2 study to commence
Clinical data from Phase 1b extension
MOR202
MM Phase 1/2a study continues
First clinical data expected
Partnership
Clinical data
Clinical data
2013
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Clinical Trials Scheduled for Completion
© MorphoSys - May 2013
BYM338
COPD
BYM338
Cancer
Potential data events based on clinical trial design & MorphoSys estimates
BYM338
Sarcopenia
BHQ880
Smoldering MM
MOR208, B-ALL
Phase 2
LFG316
MCP
LFG316
AMD
NOV-3
Phase 2
CNTO1959
RA versus Stelara
LFG316
AMD
LFG316
AMD
CNTO1959
Psoriasis
LJM716
Combo
LJM716
Single
OMP-59R5
Solid Tumors
BI-1
Phase 1
BI-1
Phase 1
CNTO1959
Psoriasis / Japan
BAY94-9343
Solid Tumors
Gantenerumab
Liquid vs. Lyophilized
Gantenerumab
Japanese AD Patients
OMP-18R5
Solid Tumors
NOV-3
Phase 2
NOV-3
Phase 2
MOR208, CLL
Phase 1/2a Extension
Gantenerumab
Phase 2/3 interim
MOR103, MS
Phase 1b
Phase 3
Phase 2
Phase 1
Partnered
Proprietary
Phase 2
Phase 1
2013 2014 H2 2012
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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.
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]
Thank You
www.morphosys.com