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MorphoSys AG — Investor Presentation 2008
Apr 3, 2008
291_ip_2008-04-03_fdeb9055-c163-409d-93d9-f9043e7410fa.pdf
Investor Presentation
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Company Update
London – April 2008
Safe Harbour
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 at a Glance
| C o m p a n y |
A i d d i b d t t " n n e p e n e n a n o c o m p a n y y |
|---|---|
| L i d t s e |
f S F k t t k E h T D A X " r a n u r o c x c a n g e e c , |
| O i i t r g a n a o n z |
Q / H i M t i i d M i h " n a r n s r e u n c |
| T h i & h i b d t t t " e r a p e u c r e s e a r c a n o y s e g m e n s |
|
| T h l e c n o o g y |
L d i i H C A L l f t t " e a n g p r o p r e a r y u p a o r m , |
| P i l i p e n e |
B d i l i b i l t t h h t h i i t h " r o a p p e n e u r o u g p a r n e r s p s w t 2 0 h o p p a r m a |
| F i i l n a n c a s |
f P i t b l t b l h t " r o a e s r o n g a a n c e s e e , |
Very Favorable Risk/Return Profile
HuCAL stands for Human Combinatorial Antibody Library
- Antibodies are fully human
- Modular gene construction enables systematic optimization of antibody lead candidates for each therapeutic application
- Proprietary phage-based CysDisplay screening system
- Proprietary AutoCAL system for high throughput
HuCAL GOLD & HuCAL PLATINUM
HuCAL GOLD
- Introduced 2000
- Library size over 12 billion
- Fab format
- Diversification of all six CDRs
- Frameworks & CDRs reflect human repertoire
- Unique modular structure
- Underpinned by strong patent portfolio
HuCAL PLATINUM Next generation Currently under construction Same modular concept Complete new sequence
- alignment using latest human genome IgG data
- Shorter selection timelines via earlier access to IgGs
- Part of proprietary technology suite including CysDisplay, RapMAT, others
Robust Intellectual Property Protected by Core Patent Families
HuCAL Library Design and Use (~2016 expiry)
- 5 US Patents
- 1 EU Patent (several EU states); allowance received for Divisional
- 2 AU Patents
- Pending applications: CA EU JP US
- TRInucleotide Mutagenesis (JHU excl. license) (~2012 expiry)
- 1 US Patent; EP upheld in amended form; pending in JP, CA
Disulfide Display (CysDisplay) (~2020 expiry)
- 1 US Patent
- Favorable prosecution for EU application
- Pending applications: AU CA EU IL JP NO US
- Technology Development (HuCAL PlatinumTM)
- Several applications in priority year or international phase (PCT)
- Co-exclusive access to various Dyax biologics patent families
Business Segments
Therapeutic Antibody Partnerships
| T h l e c n o o g y |
G O L D & P L A T I N U M H C A L l i b i & l d t ƒ u r a r e s r e a e n e w h l i t e c n o o g e s |
||
|---|---|---|---|
| L d e a |
"f f " E l i t t d l, i t- i t- d ƒ c s e a r g e m o e r s c o m e- r s s e r e x u v v f O L b t t N V t t ƒ a r g e n u m e r o p r o g r a m s a r s o n a r g e s |
||
| P l i i l r e c n c a D l t e v e o p m e n |
P l i i l d l t f l t d t ƒ r e c n c a e e o p m e n o s e e c e p r o g r a m s a v O f O M R d d b N V n e u y , |
||
| C l i i l n c a D l t e e o p m e n v |
M O R h i d l l i i d b f t t t ƒ a s o p o n s o c o- e v e o p a m e n u m e r o p r o g r a m s |
||
| M k i t a r e n g |
M O R h t i t d t i l t h i t ƒ a s o p o n s o c o- e a o s e p r o g r a m s c o d l i t i k t e e o p s n c e r a n m a r e s v |
||
| P i r m a r y r e s p o |
i b i l i t n s y |
O t i p o n s |
N i f M h S t t e w o p p o r u n y o r o r p o y s |
| R t e v e n u e o S M h o r p o y s |
\$ 1 b i l l i i i " o n c o m p r s n g , \$ 6 0 0 i d f d i ( b l ) t t ƒ m c o m m e u n n g s e e e o w \$ 4 0 0 i i l ( b b i l i i h d ) t t t t ƒ m n m e s o n e s p r o a y -w e g e a s s e s s m e n D i l d l i t t ƒ o e s n o n c u e r o y a e s |
|---|---|
| C i d t t o m m e F d i u n n g |
\$ A 6 0 0 1 0 " p p r o x m o v e r y e a r s \$ A h l f ( 3 0 0 ) i t h l l i f l i t l i t i f f p p r o a m n e c n o o g c e n s e e e s p s n e r n a a o n e e o r ƒ x. y u z C H A L, i i t i t d b l d i i t t u c o m p r s n g c o n n g e n o u e g s u c c e s s p a y m e n \$ f ( ) f f S A h l 3 0 0 i h d i t t M h p p r o a m n r e s e a r c n n g o r e a m a o r p o s ƒ x. u y |
| T e r m |
1 0 i t h N t i h i t i t " e a r s o a r s a n g o p o n s o y w v v : , 1 2 E t d t x e n o y e a r s ƒ f f T i t t 7 i t i t h l l t t e r m n a e a e r e a r s c e r a n e c n o o g g o a s a r e n o m e ƒ y y |
| M i l & t e s o n e s i R l t o a e s y |
O l l " n a p r o g r a m s |
| C o d l t e v e o p m e n |
S h d & f i ( l i d i l ) d l d t t " a r e c o s s p r o s s n g s c a e o n c o e v e o p e p r o g r a m s - |
Active Collaborations: Timelines
Partnerships: Typical Terms per Program
Product Pipeline
| N a m e |
P t a r n e r |
I d i i t n c a o n |
D i s c o e r v y |
P l i i r e- c n c |
P h 1 a s e |
P h 2 a s e |
P h 3 a s e |
|---|---|---|---|---|---|---|---|
| 1 D 0 9 C 3 |
G P C B i h t o e c |
C a n c e r |
|||||
| R 1 4 0 5 |
R h o c e |
A l h i 's z e m e r D i s e a s e |
|||||
| N t d i l. o s c |
C t e n o c o r |
C a n c e r |
|||||
| B H Q 8 8 0 |
N t i o a r s v |
C a n c e r |
|||||
| M O R 1 0 3 |
- | R h i d t e u m a o A t h i t i r r s |
|||||
| M O R 2 0 2 |
- | C a n c e r |
|||||
| 2 3 P t d a r n e r e P r o g r a m s |
V i a r o u s |
* V i a r o u s |
|||||
| 2 3 P t d a r n e r e P r o g r a m s |
V i a r o s u |
* V i a r o s u |
* Includes cancer, inflammatory, autoimmune, infectious, musculoskeletal & central nervous system diseases
Lead Proprietary Program: MOR103
MOR103: Fully human antibody vs. GM-CSF for the treatment of inflammatory diseases
Initial Indication Focus: Rheumatoid Arthritis
- RA patients adequately treated: Under 25% Non-responders to anti-TNFs: 30%
- Non-responders after 2 years on anti-TNF: 50%
- Long-term safety issues with anti-TNFs
Drug Candidate
- HuCAL IgG1 antibody with pM affinity for GM-CSF
- Very high affinity: potential CoGS advantage
- Drug product produced in PerC6 (Crucell/DSM)
Strong IP Position
- Exclusive license to US patent application covering GM-CSF as target
- Patent applications on the MOR103 antibody family
GM-CSF as a Target for Rheumatoid Arthritis
Target
- GM-CSF: Cytokine that stimulates growth, differentiation and activation of macrophages and granulocytes
- Due to its diverse functions in the immune system, GM-CSF is a target for anti-inflammatory therapies
Validation
- GM-CSF induces proliferation and activation of macrophages, increasing production of pro-inflammatory cytokines, chemokines and proteases
- Anti-GM-CSF mAb is an effective treatment in an RA disease model in mice
- Therapeutic GM-CSF led to flares of RA in patients
- Number of macrophages correlates directly with level of joint destruction in human RA patients
MOR103: Development
Pre-Clinical Development
- Positive efficacy in two different in vivo RA models
- No adverse clinical signs in toxicity study
Clinical Development
- Phase I to be conducted in Holland
- Approx. 50 healthy volunteers / 5 cohorts of 10
- Randomized, double-blind, placebo-controlled, singleascending dose trial
- Safety, tolerability & pharmacokinetics
- CTA approved in 6 weeks by Dutch authorities
MOR202: A HuCAL Antibody for Multiple Myeloma (MM)
Medical Need
- MM accounts for 10-15% of hematological & 1% of all cancers
- Few available treatment options, no curative therapies
- New agents, Velcade and Revlimid, have efficacy (nonresponders) and safety issues
Drug Candidate
- HuCAL antibodies vs. CD 38, a 45kDa glycoprotein
- Over-expressed on MM (95%) and some leukemia cell-lines
- Compelling efficacy data in vitro and in vivo (SCID mouse)
- Mechanism is ADCC plus effector cell independent
Development
Lead selection completed
Timeline Proprietary Drug Pipeline
Roche's Alzheimer Program R1450
Mechanism
- Plaques of amyloid-β peptide are believed to be a cause of Alzheimer's disease
- HuCAL antibody aimed at binding and dissolving amyloid-β plaques in the human brain
Development
- Phase 1 studies ongoing in Denmark, Netherlands, Sweden and the UK
- −Single dose and dose escalation
- Randomized, double-blind in patients
- −Both studies with up to 100 patients
- − First results expected in 2008 (MorphoSys estimate)
GPC Biotech's Cancer Program 1D09C3
Mechanism
- HuCAL-derived anti-MHC II antibody triggers programmed cell death in activated B-cells and certain tumor cell lines
- Bivalent interaction of MHC II molecules on the cell surface required
Development
- European phase 1 study at 3 sites
- Initial, promising phase 1 data published in Dec-2006
- Initial clinical testing with 1D09C3 has not raised any unexpected or unacceptable safety concerns and the maximum tolerated dose has not yet been reached.
- GPC is currently seeking a partner for this program
Source: Nagy ZA (2003) J Mol Med 81:757-765, Truman JP (1994) Int. Immunol., 6:887-896
Other Partnered Programs in the Clinic
Novartis - BHQ880
- HuCAL antibody vs. undisclosed cancer target
- 3 years from start of project to IND
Centocor
- HuCAL antibody vs. undisclosed cancer target
- IND filing in June 2007
Business Segments
AbD Serotec: The Business
Research Antibody Market: US\$ 1bn
AbD Serotec: Gaining Scale
Case Study: An AbD Synergy
Oct. 8, 2007: MorphoSys Enters Therapeutic Research Collaboration on Novel Target Molecule with Genesis Research
March 2006
Genesis Research becomes an AbD client, sourcing custom HuCAL antibodies against FGFR-5
October 2007
- Genesis gets:
- Preliminary therapeutic license
- Cooperation from MorphoSys in filing IP around FGFR-5
- MorphoSys gets:
- Access to all scientific data generated by Genesis Research
- Option to co-develop
Profit & Loss Statement (Group)
| I E U R i l l i n m o n s |
2 0 0 7 |
2 0 0 6 |
|---|---|---|
| R e v e n u e s |
6 2. 0 |
5 3. 0 |
| C f G d S l d t o s o o o s o |
9 7. |
8 0 |
| R & D E p e n s e s x |
2 2 2 |
1 7. 5 |
| S G & A E x p e n s e s , |
2 4 8 |
2 1. 4 |
| i T l O E t t o a p e r a n g x p e n s e s |
5 4. 9 |
4 6. 9 |
| P f i f O i t t r o r o m p e r a o n s |
7. 0 * |
6. 2 * |
| N O i I / ( E ) t o n- p e r a n g n c o m e x p e n s e s |
2 2 |
( 0 9 ) |
| f i f P B T t r o e o r e a x e s |
9. 2 |
5. 3 |
| I T B f i t n c o m e a x e n e |
2 3 |
0 7 |
| f i N P t t e r o |
1 1. 5 |
6. 0 |
| E i S h ( d i l t d ) i E U R a r n n g s p e r a r e u e n |
1. 5 9 |
0 9 3 |
* Differences due to rounding
Condensed Balance Sheets (Group)
| I E U R i l l i n m o n s |
/ / 1 2 3 1 2 0 0 7 |
/ / 1 2 3 1 2 0 0 6 |
|---|---|---|
| A t s s e s |
||
| C C & h, h E i l t M k t b l a s a s q a e n s a r e a e u v S i t i e c u r e s |
1 0 6 9 |
6 6 0 |
| O t h C t A t e r u r r e n s s e s |
1 6 0 |
1 0 1 |
| T t l N C t A t o a o n- r r e n s s e s u |
6 1. 8 |
5 1. 7 |
| T l A t t o a s s e s |
1 8 4. 7 |
1 2 7. 8 |
| i i i i L b l t a e s |
||
| C T t l t L i b i l i t i o a u r r e n a e s |
2 9 4 |
1 8 3 |
| C T t l N t L i b i l i t i o a o n- u r r e n a e s |
9 8 |
9 5 |
| T l S h h l d ' E i t t o a a r e o e r s q u y |
1 4 5 5 |
1 0 0 1 |
| T l L i b i l i i t t o a a e s |
1 8 4. 7 |
1 2 8 * 7. |
* Differences due to rounding
Guidance 2008
| I E U R i l l i n m o n s |
E * 2 0 0 8 |
A 2 0 0 7 |
|---|---|---|
| T l G R t o a r o u p e v e n u e s |
7 3 7 7 – |
6 2 |
| A b D |
2 1 ~ |
1 9 6 |
| G O i P f i t t r o p p e r a n g r o u |
9 1 1 – |
0 7. |
| O f A b D t i P i t M i p e r a n g r o a r g n |
1 0 % 5 – |
- |
- Revenues in the Therapeutic Antibodies segment include success-based payments of EUR 10 million
- Spend on proprietary product & technology development of EUR 13 million, the second successive 100% annual increase
* Estimated numbers
Shareholder Structure
| S h I d M h 3 1, 2 0 0 7 t a r e s s s u e a a r c |
7, 4 1 3, 7 0 3 |
|---|---|
| N t i " o v a r s |
% 7 ~ |
| A Z t " s r a e n e c a |
% 5 ~ |
| F f l t " r e e o a |
8 8 % ~ |
Page 31 | Company Update | April 2008 © MorphoSys AG
Forthcoming Events
Visible news-flow from proprietary antibody pipeline
| S O t t M R 1 0 3 P h I t i l a r a s e r a ƒ |
|
|---|---|
| P b l i h l i i l l t ƒ u s p r e -c n c a r e s u s |
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| f O M t M R 2 0 2 l i i l t i l a n a c r e c n c a m a e r a ƒ u u |
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| C d l d l t ƒ o e v e o p m e n e a s - |
|
| P i d i b d i l i t t " r o g r e s s n p a r n e r e a n o y p p e n e |
|
| 1- 2 I N D t ƒ p a r n e r s |
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| C l i i l d f i P h I t n c a a a r o m o n g o n g a s e p r o g r a m s ƒ |
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| P i " t a r n e r n g |
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| E i f h i h h i i i t t t t t e n s o n o p a r n e r s p s r o g p r e -e s n g o p o n s ƒ x u x |
5 |
| A b D " |
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| N B h l i k d l ƒ e w u r n a m e e a - |
|
| I d i t i t b n c r e a s e a g n o s c c u s o m e r a s e ƒ |
5 |
| M b l f i i l i t ƒ e a s u r a e n a n c a m p r o v e m e n |
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 Corp. Comm. & IR
Phone +49 (0)89 / 899 27-122 Fax +49 (0)89 / 899 27-5122 Email [email protected]
HuCAL®, HuCAL GOLD®, CysDisplay®, RapMAT® and AutoCAL® are registered trademarks, HuCAL PLATINUMTM is a trademark of MorphoSys AG.