Technology - MorphoSys

Company
p y Update
p
29th Annual J.P. Morgan Healthcare Conference – January 2011
Safe Harbour
This presentation includes forward-looking
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
conditions, regulatory reforms,
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
p
y at a Glance
Company
„ An independent antibody company
„ Martinsried/Germany,
Martinsried/Germany with sites in UK & US
„ Frankfurt Stock Exchange – TecDAX
Business
„ Th
Therapeutic
ti antibodies
tib di
„ Research & diagnostic antibodies (AbD Serotec)
Technology
„ Leading, proprietary HuCAL platform
„ New technology from Sloning acquisition
Pipeline
„ Over 70 therapeutic antibody programs
„ Strong alliances with pharma companies
Financials
„ Sustainable profitability funds proprietary R&D
„ 10-year, $1bn strategic alliance with Novartis
„ Cash
C hb
balance
l
iin excess off $170
$170m
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 3
Strategy
gy
PROPRIETARY DEVELOPMENT
„ Own programs taken by MorphoSys to clinical proof-of-concept
„ Lucrative potential upside
PARTNERED DISCOVERY
AbD SEROTEC
„ Multiple
p therapeutic
p
antibody
yp
products
based on MorphoSys’s technology
„ Generate strong flow of
y
milestones & royalties
„ Growing
g roster of diagnostic
g
p
partnerships
p
developing novel tests
„ Research antibody catalogue business
INNOVATIVE, PROPRIETARY ANTIBODY TECHNOLOGY
„ Commitment to delivering superior antibodies
„ Next generation MAbs to be more efficacious, able to hit new targets and lower cost
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 4
New Technology
gy Enhances Power of Platform
„ October 2010:
„MorphoSys acquires Sloning BioTechnology for access to Slonomics
Slonomics:
gene
synthesis
„ Enzymatic
y a c ge
e sy
es s
„ Enables generation of protein libraries
ƒ With unprecedented speed
ƒ With complete
l t control
t l over composition
iti
ƒ At low cost
Powerful technology for protein discovery & optimization
Slonomics agreement
with Pfizer p
provides
immediate payback of
Sloning acquisition
and foreshadows
commercial potential
MorphoSys
Antibody
Platform
Slonomics
Corporate
December 2010:
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 5
A Unique
q Platform for Generating
g Optimized,
p
,
Fully Human Antibodies
Lead antibody
Optimized drug
candidate
Optimization using unique,
modular design of HuCAL
HuCAL Platinum
High performance, fully
human antibody library
NEW!
45 billion antibodies
Optimization using new
arYla technology
Superior
optimized drug
did t
candidate
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 6
– Higher
g
Probabilities of Success &
Faster Development
Today
Discovery
y
Preclinic
Phase 1
Phase 2
35%
Phase 3
51%
Market
73%
With arYla
Discovery
Preclinic
50%
Phase 1
Phase 2
89%
Phase 3
51%
Market
73%
Expectations:
Source: MorphoSys experience
„ Shorten time to antibody drug candidate by 30%
Source: MorphoSys projections
„ Increase proportion of programs reaching clinic to 50%
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 7
Broadest Antibody
y Pipeline
p
in the Industry:
y
77 Programs Ongoing
Name
Partner/MOR
Target
MOR103
MOR
GM-CSF
BHQ880
Novartis
DKK-1
CNTO888
Centocor
MCP-1
n.d.
Novartis
n.d.
n.d.
Gantenerumab
Roche
Amyloid-β
AD
MOR208
MOR
CD19
CLL
CNTO1959
Centocor
n.d.
Psoriasis
BAY79-4620
Bayer Schering
CA IX (MN)
Cancer
CNTO3157
Centocor
n.d.
Asthma
n.d.
Novartis
n.d.
Musculoskeletal
n.d.
Novartis
n.d.
Ophthalmology
n.d.
Centocor
n.d.
3 Programs
3 Partners
n.d.
MOR202
MOR
CD38
Multiple Myeloma
20 Programs
Partnered
Various
Various*
Various
32 Programs
Partnered
Various
Various*
5 Programs
MOR
n.d.
Inflammation/
Cancer
2 Programs
MOR/NOV
n.d.
Inflammation
Corporate
Technology
Indication
Discovery
Preclinic
Phase 1
Phase 2
Phase 3
Market
RA
MS
Cancer
C
Cancer
IPF
Inflammation/
Autoimmune
Inflammation/
Cancer
Pipeline
* Includes cancer,
inflammatory,
autoimmune,
infectious,
musculoskeletal &
central nervous
system diseases
n d – not disclosed
n.d.
AbD Serotec
© MorphoSys AG
Page 8
MOR103
A Novel Anti-Inflammatory Antibody
The Target
„ GM
GM-CSF,
CSF which plays a central role in activating granulocytes and
macrophages
„ Extensive evidence implicating GM-CSF in the inflammatory cascade
The Drug
„ A HuCAL IgG1 antibody that neutralizes human GM-CSF
„ High potency due to very high target affinity (KD = 0.4 pM)
„ Subcutaneous PK study in healthy volunteers planned for 2011
Intellectual Property
„ Exclusive license to a US patent covering antibodies against GM-CSF for
the treatment of chronic inflammatory conditions
„ Patent filings on antibody
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 9
MOR103
Clinical Development
In Rheumatoid Arthritis
„ European phase 1b/2a trial ongoing to assess safety
safety, signs of efficacy and
immunogenicity of MOR103 in patients with active RA
„ 135 patients with active RA, randomized, double-blind, placebo controlled
„ Four ascending doses i.v. 0.3, 1.0 and 1.5 mg/kg or placebo with stable
regimen of concomitant RA therapy
„ Objectives:
ƒ Primary objectives: Adverse event rate and safety profile
ƒ Secondary objectives: DAS28, ACR & EULAR28, cytokines, MRI
(synovitis & bone edema), PK, immunogenicity & patient-reported
outcomes up to 16 wks
„ Final phase 1b/2a RA data expected in H1 2012
In Multiple Sclerosis
„ Phase 1b safety study in MS patients being prepared
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 10
MOR208
A Novel Anti-Cancer Antibody
The Target
%ADCC
„ CD19,
CD19 a pan B-cell marker
30
Namalwa
CLL
20
10
The Drug
„ Exclusive
E l i lilicense ffrom Xencor
X
60
Burkitt’s
s Lymphoma
„ Humanized, affinity optimized anti-CD19 antibody, comprising a proprietary
modification that enhances effector cell recruitment
0
Wac3CD5
40
20
0
Selected Pre-clinical Observations
„ Higher ADCC than both Rituxan & Campath against
all lymphoma & leukemia cell lines tested
(see selected data in figure)
MOR208/X Ab5574
MOR208/XmAb5574
Anti-CD19 IgG1 (unmodified)
XmAb (-) control
rituximab (CD20)
alemtuzumab (CD52)
Corporate
Technology
Pipeline
AbD Serotec
30
SU-DHL-6
B-NH
HL
„ Enhanced affinity for Fc receptor leads to rapid and sustained B-cell
depletion
20
10
0
0.01
0.1
0
10
100
mAb (ng/mL)
© MorphoSys AG
Page 11
MOR208
Clinical Development
Clinical Trial Design
„ Multi-centre
Multi-centre, open-label
open-label, multi-dose
multi-dose, single-arm phase 1,
1 dose-escalation
study in USA
„ Patients with chronic lymphocytic leukemia, who have not responded to or
h
have
b
become refractory
f t
tto previous
i
th
therapies
i
„ Objectives:
ƒ Primary objectives: Investigate maximum tolerated dose
dose, safety and
tolerability, pharmacokinetics and immunogenicity
ƒ Secondary objectives: Assess preliminary anti-tumor activity
„ Xencor funds phase 1 trial from $13 m up-front payment
„ Final data expected in 2012
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 12
MOR202
A Novel Antibody for Multiple Myeloma
The Target
„ CD38,
CD38 a key target present on the vast majority of multiple myeloma cells
The Drug
„ A high affinity, fully human HuCAL antibody
Clinical Trial Design and Development Timeline
„ Multicentre, open-label, dose-escalation study (EU)
„ Patients with relapsed/refractory multiple myeloma; failure of at least 2 prior
therapies
„ Objectives: Investigate maximum tolerated dose, safety and tolerability,
pharmacokinetics and immunogenicity; assessment of preliminary activity
„ Final data expected in 2012
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 13
Partnered Programs
g
Phase 2 Clinical Development
Partner & Program
Novartis
Disease
Status
Osteolytic bone
disease
BHQ880
Novartis
„ Clinical trials in multiple myeloma patients
„ Early data show stimulation of bone formation
„ June 2009: Start of phase 1/2
n.d.
nd
n.d.
„ HuCAL antibody targeting DKK-1
„ Clinical proof of concept achieved
„ HuCAL antibody targeting MCP-1
Centocor Ortho Biotech
CNTO888
Oncology &
immunology
MCP 1 regulates prostate cancer growth and
„ MCP-1
metastasis
„ 2 oncology trials and 1 IPF trial ongoing
„ HuCAL
H CAL antibody
tib d ttargeting
ti amyloid-β
l id β
Roche
Gantenerumab
Corporate
Alzheimer‘s
disease
Technology
Pipeline
„ Amyloid-β implicated as causal factor in AD
„ Phase 2 study in patients with prodromal AD initiated
i Q4 2010
in
AbD Serotec
© MorphoSys AG
Page 14
Partnered Programs
g
Phase 1 Clinical Development
Partner & Program
Disease
Centocor Ortho Biotech
CNTO1959
Psoriasis
Bayer Healthcare
BAY79-4620
Oncology
Centocor Ortho Biotech
CNTO3157
Asthma
„ June 2010: Start of phase 1
Novartis
n.d.
Musculoskeletal
diseases
„ July 2010: Start of phase 1
Novartis
n.d.
Ophthalmology
„ August 2010: Start of phase 1
Various
Various
Corporate
Technology
Status
„ June 2009: Start of phase 1
„ Study completed in Q4 2010
„ October 2009: Start of phase 1 trial
„ Antibody-drug conjugate targeting CA IX
„ Four additional INDs/CTAs
„ Announced
Anno nced in December 2010
Pipeline
AbD Serotec
© MorphoSys AG
Page 15
A Rapidly
p y Growing
g Clinical Pipeline
p
Number of Partnered & Proprietary Programs in Clinical Trials at Year-end
20
Phase 1
Phase 2
15
6
10
5
0
1
1
2
2005
2006
4
4
4
4
2007
2008
2009
10
2010
2011E*
Clinical Antibody Pipeline is a Key Value Driver
Corporate
Technology
Pipeline
AbD Serotec
* assuming no attrition
© MorphoSys AG
Page 16
Current Pipeline
p
Projected HuCAL Drugs on the Market
Discovery
Preclinic
Phase 1
Phase 2
Market
65%
40%
70%
50%
Phase 3
Projection from today’s pipeline:
4
Success probability of 11%
39
Success probability of 18%
22
4
Success probability of 25%
10
6
2
Success probability of 33%
Projected number of marketed HuCAL drugs from today’s pipeline:
2
12
Source: MorphoSys internal statistics & Tufts Centre for the Study of Drug Development
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 17
AbD Serotec Complements
p
Therapeutic
p
Segment of the Business
„ Antibodies for research and diagnostic markets
Cash-generative
generative since 2007
„ Cash
Diagnostic Antibodies
„ Using proprietary technologies to deliver superior
antibodies for diagnostic uses
„ Future upside via royalties
„ Potential
P t ti l synergies
i with
ith th
therapeutic
ti side
id off b
business
i
Research Antibodies
„ Catalogue comprising 15,000+ products
„ Custom antibody generation using HuCAL
„ Stable and recurring cash flows
Market
$ 7bn
$2bn
© MorphoSys AG
Page 18
Technology
gy Offers Excitingg Growth Opportunities
pp
in Diagnostics
AbD Serotec is working with over 20 diagnostics companies
Application
Technology Feature
Poorly served targets
ƒ HuCAL provides antibodies where traditional approaches fail
New biomarkers
ƒ HuCAL offers best possible selectivity & sensitivity
C
Clinical
monitoring
ƒ HuCAL
C is very well-suited to making anti-idiotypic antibodies
Thermal stability
ƒ In vitro method HuCAL offers key
y advantages
g compared
p
to in
vivo antibody generation
g
standards
Diagnostic
ƒ HuCAL offers p
precise and indefinite reproducibility
p
y
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 19
Guidance 2010
Guidance 2010E
2009A
Updated in
December
Issued in
February
Total Group Revenues
91 – 94
89 – 93
81.0
Group Operating Profit
13 – 16
5–9
11.4
~21
21 – 22
19.4
5 – 8%
5 – 8%
5%
In million EUR
AbD Serotec
Revenue
Operating Profit Margin
2010
„ Increase of total proprietary R&D investment to € 27 – 29
million (2009: € 19.3 million)
2011 – 2012
„ Aiming for 10% – 20% annual revenue growth
„ Maintain profitability while strengthening pipeline
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 20
Shareholder Structure and Key
y Financials
Shareholder Structure (Dec. 2009)
Novartis
17%
7%
AstraZeneca
Management &
Supervisory Board
5%
2%
10%
No of Shares
No.
7%
22,714,362
30%
7%
7% 4%
4%
In million EUR
9M 2010
9M 2009
Revenues
62.8
57.6
55
5.5
51
5.1
R&D Expenses
32.5
27.5
S,G&A Expenses
16.8
15.7
Total Operating Expenses
54.8
48.3
Operating Profit
8.0
9.3
Net Profit
7.2
7.7
0.32
0.34
C t off Goods
Cost
G d Sold
S ld
EPS (diluted) in EUR
USA
Germany
UK
France
Switzerland
Other countries
Retail
Unidentified
Corporate
MorphoSys (MOR GR) Key Financials
Technology
Pipeline
Cash, Cash Equivalents and Available-for-sale
Financial Assets as of September 30, 2010:
€ 132.1 million
AbD Serotec
© MorphoSys AG
Page 21
A Strategy
gy for Substantial Value Creation
Value
PROPRIETARY DEVELOPMENT
Innovative, Proprietary Antibody Technology & Know-how
Future
Today
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 22
Forthcoming
g Events
MOR103
PROPRIETARY DEVELOPMENT
„ Complete
p
enrollment in p
phase 1b/2a RA study
y
„ Commence phase 1b MS study
MOR202
„ Commence phase 1 study in multiple myeloma
„ Release pre-clinical data
MOR208
„ Progress report on open
open-label
label phase 1 study in CLL
Partnerships
PARTNERED DISCOVERY
„ New INDs
„ Clinical data expected at major conferences (ASCO, ACR, ASH…)
„ New deals
Diagnostics
AbD SEROTEC
„ Additional HuCAL-based diagnostic kits on market
Corporate
Technology
Pipeline
AbD Serotec
© MorphoSys AG
Page 23
Thank You.
www.morphosys.com
Dr. Simon Moroney
Chief Executive Officer
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
) / 899 27-311
Phone +49 ((0)89
Fax +49 (0)89 / 899 27-5311
Phone +49 ((0)89
) / 899 27-122
Fax +49 (0)89 / 899 27-5122
Email [email protected]
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT® and AutoCAL® are registered trademarks of MorphoSys AG, arYla™ is a trademark of
MorphoSys AG