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MorphoSys AG — Investor Presentation 2010
Jun 28, 2010
291_ip_2010-06-28_95142297-446a-4249-9528-4fcb20cfe4ea.pdf
Investor Presentation
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Jefferies 2010Global Life Science Conference
New York – June 9, 2010
This presentation includes forward forward-looking statements. looking
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 conditions, reforms, the availability of financing.
These and other risks and uncertainties are detailed in the Company's Annual Report.
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Current Product Pipeline: 72 Programs Ongoing
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* Includes cancer, inflammatory, autoimmune, infectious, musculoskeletal & central nervous system diseases n.d. – not disclosed
MOR103: Anti-GM-CSFGenuine Blockbuster Potential
- GM-CSF plays a central role in activatingg y ranuloc ytes and macrophages, which are essential in the inflammatory cascade
- GM-CSF clearl y p im plicated in rheumatoid arthritis
- Pathway was overlooked due to misleading historical classification Îlimited competition
- New treatment option with distinct mode of action different from action, currently available treatments
- Huge commercial potential in several inflammatory indications
MOR103: Anti-GM-CSFOpportunity in Inflammation
Significant Potential:
- Primary indication: rheumatoid arthritis
- Market >\$10bn
- Fewer than 25% of RA patients adequately treated; 50% of TNFresponders stop responding within 2 years stop
- Promising preclinical data for second indication
Current Status:
- Phase 1 successfully completed
- Phase 1b/2a trial is ongoing
- Production: PER.C6 ®cell-line (Crucell/DSM)
Intellectual Property:
- Exclusive license to granted US patent covering key uses of antibodies against GM-CSF
- Patent applications covering antibodies & new indications
MOR103 – Ph 1b/2a (MSC-1001) in Rheumatoid Arthritis – Clinical Trial Update
- Trial approved in Germany, Bulgaria, The Netherlands
- Study in 135 RA patients, randomized, double-blind, placebo-controlled, multiple ascending dose
- Geographic mix provides access to full spectrum from biologics-pretreated to biologics-naïve RA patients
- Primary outcome measures: Adverse event rate and safety profile
- Secondary outcome measures: DAS28, ACR score set measures and EULAR28 response criteria, cytokines, synovitis, bone edema, pharmacokinetics, immunogenicity and patient reported outcomes up to 16 weeks
- Stable regimen of concomitant RA therapy (including anti-TNFs)
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Partnered Discover y Novartis – BHQ880
HuCAL IgG1 antibody, targeting DKK-1
- Overex pression of DKK-1 b yy y m yeloma cells ma y upset the normal balance between osteoblasts and osteoclasts
- Antibody vs. DKK-1 ma yp y la y a role in preventing osteolytic bone disease in multiple myeloma patients
Phase 1/2 study is ongoing in the US
- Preclinical studies support the hypothesis that BHQ880 p y romotes bone formation and thereb inhibits tumor-induced osteolytic disease
- A phase 1/2 combination study in combination with Zometa/Reclast in relap y sed or refractor myeloma patients has started in February 2009
- Novartis published some early clinical results from this pro gram at the last ASH meetin g in pg g December 2009 in Orlando
Partnered Discovery Centocor – CNTO888
HuCAL IgG1 antibody targeting MCP-1 (CCL2)
- Monocyte chemoattractant p () y rotein 1 (CCL2) is a recently identified prominent regulator of prostate cancer growth and metastasis (Loberg et al., Cancer Res 2007; 67: (19). October 1, 2007)
- Recent studies hig g pp g p hlight a role for CCL2 in supporting the development of prostate cancer skeletal metastasis
(Li et al., Cancer Res 2009; 69: (4). February 15, 2009, p 1691)
Development
- Currently being developed in two indications
- −Phase 2 in oncology
- Phase 2 in immunology
Recently presented at ASCO meeting 2010
- "Utilizing mechanistic PK/PD modeling to simultaneously examine free Utilizing CCL2, total CCL2, and CNTO 888 serum concentration time data"
- "Pre-final analysis of first-in-human, first-in-class, phase1 clinical trial of CNTO888 a human monoclonal antibody to the CC-chemokine ligand 2 CNTO888, CC chemokine(CCL2) in patients with advanced solid tumors"
Partnered Discover y Roche – Gantenerumab
HuCAL IgG1 antibody targeting amyloidβ
- De p y ol ymerizes agg g re gated Aβ
- Crosses blood-brain barrier in transgenic mouse, decreasing cerebral A β burden
Development
- Two Phase 1 studies completed (single dose arm and multiple ascending dose arm)
- Mild-to-moderate Alzheimer's patients
- Randomized, double-blind
- Antibody behaved as expected
Roche plans to move into phase 2 during 2010
Partnered Discovery Additional Programs in Clinical Development
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| S d d i l d i l d t t t " u y e a s n o s c o s e 0 6 / 2 0 0 9 S f 1 t t h " : a r o p a s e 0 5 / 2 0 1 0 C l i i l f- f- h i d t " : n c a p r o o o c o n c e p a c e v e |
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| S t d d t i l t d i l d " u y e a s n o s c o s e 0 6 / 2 0 0 9 S h 1 i i f l i t t t " a r p a s e n n a m m a o n : |
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MOR202: Anti-CD 38Opportunity in Multiple Myeloma
Significant Potential:
- CD38 is a keyg y y g target to address multiple myeloma therapy due to high expression on multiple myeloma cells
- Multiple myeloma represents a large commercial opportunity among hematologic cancers
- Sales of leading therapies in excess of €2.5 billion worldwide
Current Status:
- MOR202 demonstrates the ability y to kill myeloma cells in vitro and across multip p lereclinical in vivo models
- Non-clinical safety and efficacy data support the initiation of clinical studies
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Clinical Pipeline
Number of Partnered and Proprietary Programs at Year-end
Clinical Antibody Pipeline is a Key Value Driver
Current Pipeline: Projected HuCAL Drugs on the Market
Source: MorphoSys internal statistics & Tufts Centre for the Study of Drug Development
Various formats available, can be combined with toxins, etc. The HuCAL Edge: Xolair HuCAL ÂModularity allows us to "dial-in" drug
- properties
- ÂFully human
Î Fastest growing class of therapeutics in the pharmaceutical industry
Total Sales2008: \$32.3bn
Inflammation
- Â Long half life half-life
- ÂNo off-target toxicity
- Â
- ÂMany indications addressable
- ÂNo credible alternatives available
- ÂComplexity limits entry of generics
Why Antibodies?
Avastin
Rituxan
Erbitux
Humira
Tysabri
Lucentis
Synagis
Others
Xli
Remicade
Herceptin
Prop y gy rietary Technology: HuCAL
- Current PLATINUM version is 3rd generation HuCAL platform
- H CAL has generated more than HuCAL €250 million license and 250 success-based payments plus research funding
- Therapeutic, Diagnostic, & Research Antibody Generation
- HuCAL use in in many labs world-wide, and antibodies have been made against thousands of targets
- Clinic
- 9 HuCAL antibodies have entered clinical trials so far
- Hundreds of volunteers and patients already dosed – clinical validation
- First HuCAL-based program showed clinical proof of concept
- 2010: Up to 6 new INDs expected
- Visibility for 20 clinical candidates within the next 18 months
Î HuCAL is a robust, proven technology for generating drugquality fully human antibodies quality, antibodiesMorphoSys AG – Company Update – June 2010
Strategy & Deal Terms
- Partner provides target molecule & indication expertise
- MorphoSys delivers optimized antibody drug candidates antibody
- Partner responsible for further development and marketing
- R&D funding, license fees & milestones €9 - €12 million per program
- Royalties in mid-single digits mid single digitsMorphoSys AG – Company Update – June 2010 Page 17
AbD Serotec: Promising Market Opportunities
AbD Serotec
| S G h t- T l o r e r m o a s |
L T P t i o n g e r m e r s p e c v e - |
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f C P t t i l H A L " o e n a o r u h l i i d d l l i i i i l t t e c n o o g y n n e e v v e e r r n n g g r u y d i f f i d d i i t t t e r e n a e a g n o s c d t p r o u c s G i i f t " r o n g m p o r a n c e o w d i i i t a g n o s c s n h i l d l t t p a r m a c e c a e e o p m e n u v I I i i l l t t " n c r e a s n g r e g u a o r y f d d t k t e m a n s o r p o s m a r e i t i t i t m o n o r n g p a e n , t t t t i i t t s s e e g g m m e e n n a a o o n n e e c c , S i i t h t h t i " y n e r g e s w e r a p e u c a r e a |
| I i l l i E U R n m o n |
2 0 1 0 E * |
2 0 0 9 A |
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| T l G R t o a r o u p e v e n u e s |
8 9 9 3 – |
8 1 0 |
| S A b D t e r o e c |
2 1 2 2 – |
1 9 4. |
| G O i P f i t t r o u p p e r a n g r o |
5 9 – |
1 1 4 |
| S O f A b D t t i P i t M i e r o e c p e r a n g r o a r g n |
% % 5 8 – |
% 5 |
| * Es im d b t te a nu m e rs |
2010
Increase of total proprietary R&D investment to € 26 – 29 million (2009: € 19.3 million)
2011 – 2012
- Aiming for 10% - 20% annual revenue growth
- Maintain profitability while strengthening pipeline pipeline
Shareholder Structure and Key Financials
Key Financials
| M & t a n a g e m e n |
Q 1 2 0 1 0 |
Q 1 2 0 0 9 |
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|---|---|---|---|
| % 7 S i B d u p e r v s o r y o a r % 5 |
R e v e n u e s |
2 0 6 |
1 9 1 |
| % 2 1 0 % 7 % 7 % |
C t f G d S l d o s o o o s o |
1. 7 |
1. 7 |
| R & D E x p e n s e s |
9 3 |
8 5 |
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| S G & A E x p e n s e s , |
4 9 |
4 8 |
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| i i T T l l O O E E t t o a p e r a n g p e n s e s x |
1 1 5 9 |
1 1 4 4 9 9 |
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| O i P f i t t p e r a n g r o |
4 7 |
4 2 |
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| % 4 4 % 7 % |
f i N P t t e r o |
3 2 |
3 5 |
Cash, Cash Equivalents and Available-for-sale Financial Assets as of March 31, 2010:
€ 147 3 illi 147.3 million
Forthcoming Events
- Additional clinical proof-of-concept: First phase 2 read-out possible
- More clinical starts
- At least one additional phase 2
- 4 – 6 new INDs
- MO 0 e c ca t a app cat o Q 0 0 R202: File clinical trial application in Q4 2010
- Strengthen portfolio: New projects, including co-development
- Technology: Update regarding latest technology developments
- Potential strategic transactions
- In-licensing to strengthen portfolio
- Strengthen technology platform
- B d ff i i th di ti (AbD S t )
Future Value Creation
Thank You.
www.morphosys.com
Dr. Simon Moroney
Chief Executive Officer
Phone +49 (0)89 / 899 27-311 ( ) ( ) Fax +49 (0)89 / 899 27-5311 Email [email protected]
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]