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MorphoSys AG — Investor Presentation 2008
Feb 13, 2008
291_ip_2008-02-13_d6c42ba8-9069-4750-bfe9-a2b21129de2b.pdf
Investor Presentation
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Company Update
New York, February 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.
| C o m p a n y |
A i d d t t i b d ƒ n n e p e n e n a n o y c o m p a n y |
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| L i t d s e |
f S F k t t k E h T D A X ƒ r a n u r o c x c a n g e e c , |
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| O i t i r g a n z a o n |
Q / H i M t i i d M i h ƒ n a r n s r e u n c T h i & h i b d t t t ƒ e r a p e c r e s e a r c a n o s e g m e n s u y |
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| T h l e c n o o g y |
L d i i H C A L l f t t ƒ e a n g p r o p r e a r y u p a o r m , |
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B d i l i b i l t t h h t h i ƒ r o a p p e n e u r o u g p a r n e r s p s i t h t 2 0 h w o p p a r m a |
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| F i i l n a n c a s |
P f i b l b l h t t t ƒ r o a e s r o n g a a n c e s e e , |
Technology
Pipeline
Financial
- Antibodies comprise most successful class of biopharmaceuticals
- 50 HuCAL therapeutic programs ongoing
- Multiple partners and indications
Very Favorable Risk/Return Profile
\$150m cash
upside
Landmark Strategic Alliance With Novartis
Novartis Deal: Financial Details
| 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 t t d f d i ( b l ) 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 |
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\$ 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 h l l i f l i l i i f f t t t ƒ p p r o x a m n e c n o o g y c e n s e e e s p u s n e r n a z a o n e e o r C H A L i i t i t d b l d i i t t c o m p r s n g c o n n g e n o e g s c c e s s p a m e n u u u y , \$ A h l f ( 3 0 0 ) i h f d i f t t M h S 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 |
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| M i l & t e s o n e s R l i t o y a e s |
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 - |
HuCAL: Leading Antibody Technology
- 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 and HuCAL PLATINUM
HuCAL GOLD
- Current version, introduced 2000
- Library contains over 12 billion distinct human antibodies
- Fab format
- Diversification of all six CDRs
- Design of all frameworks & CDRs reflects natural composition of human antibodies
- Unique modular structure allows quick change of format and optimization of selected antibodies
HuCAL PLATINUM
- Next generation, currently under construction
- Based on same modular HuCAL concept
- Complete new sequence alignment using the latest human genome data for immunoglobulins
- Shorter selection timelines via earlier access to fully human IgGs
- Part of antibody technology suite including CysDisplay, RapMAT and others
Company Update | February 2008 © MorphoSys AG Page 9
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 Antibodies Research Antibodies
- Broad partnered pipeline
- Proprietary, un-partnered programs offer even greater upside
- New Novartis alliance secures partnered pipeline, finances own product development
Built by merging:
- Top 20 supplier of research antibodies
- Platform to increase uptake of HuCAL in research community
| N a m e |
P t a r n e r |
I d i t i n c a o n |
D i s c o v e r y |
P l i i r e -c n c |
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A l h i 's z e m e r D i s e a s e |
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| 2 0 P t d a r n e r e P r o g r a m s |
V i a r o s u |
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| 2 4 P d t 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 |
* 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
| R A i d l d t t t t t ƒ p a e n s a e q u a e y r e a e : |
U d 2 5 % n e r |
|---|---|
| N d i- T N F t t o n -r e s p o n e r s o a n s : ƒ |
3 0 % |
| f N d t 2 t i- T N F o n -r e s p o n e r s a e r e a r s o n a n ƒ y : |
% 5 0 |
Long-term safety issues with anti-TNFs
Drug Candidate
- HuCAL IgG1 antibody with pM affinity for GM-CSF
- Very high affinity and expression: potential CoGS advantage
- MOR103 blocks binding of GM-CSF to its receptor
- Drug product produced in PerC6 (Crucell/DSM)
Strong IP Position
- Exclusive license to US patent application covering GM-CSF as a target
- Patent applications on the MOR103 antibody family
GM-CSF as a Target for Rheumatoid Arthritis
Target:
- GM-CSF: cytokine stimulating growth, differentiation and activation of macrophages and granulocytes
- Due to its diverse functions in the immune system, GM-CSF can be considered a target for anti-inflammatory therapies
Validation:
- GM-CSF induces proliferation and activation of macrophages, increasing production of proinflammatory cytokines, chemokines and proteases
- Anti-GM-CSF mAb is an effective treatment in an established 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
- CTA filed December 2007 for Phase I trial in Holland
- Anticipated start: March 2008
Study Design:
- Approx. 50 healthy volunteers
- Randomized, double-blind, placebo-controlled, singleascending dose trial
- Primary Endpoint:
- Safety and tolerability of MOR103
- Pharmacokinetics
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
Currently defining therapeutic window, effective dose level, stability, tox species
Fully independent of Novartis collaboration
MOR202 is Superior to Velcade in a Multiple Myeloma SCID Mouse Model
MOR202 (5 mg/kg) Velcade (0.5 mg/kg) Control antibody
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
- 1D09C3 well tolerated
- Dose escalating study completed
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
- HuCAL antibody vs. undisclosed cancer target
- 3 years from start of project to IND
Undisclosed Partner
- HuCAL antibody vs. undisclosed cancer target
- IND filing in June 2007
Therapeutic Antibody Partnerships
Active Collaborations: Timelines
Partnerships: Typical Terms per Program
Business Segments
Therapeutic Antibodies Research Antibodies Broad partnered pipeline Proprietary, un-partnered programs offer even greater upside New Novartis alliance secures partnered pipeline, finances own product development Built by merging: Top 20 supplier of research antibodies Platform to increase uptake of HuCAL in research community
AbD Serotec: The Business
AbD Serotec: Gaining Scale
Profit & Loss Statement (Group) 9-Months 2007
Condensed Balance Sheets (Group) 9-Months 2007
* Differences due to rounding
Shareholder Structure
| S h I d t D b 3 1 2 0 0 7 a r e s s s e a e c e m e r u , |
3 8 6 3 7 7 5 , , |
|---|---|
| N t i " o a r s v |
7 % ~ |
| A Z t " s r a e n e c a |
5 % ~ |
| F f l t " r e e o a |
8 8 % ~ |
| F k f S k t t r a n u r o c E h x c a n g e |
|---|
| S I I N D E 0 0 0 6 6 3 2 0 0 3 : |
| S E C d M O R o e : |
| B l b M O R G R o o m e r g : |
Forthcoming Events
Update on proprietary development
- MOR103
- CTA approval
- Start Phase 1
- Release pre-clinical data
- MOR202
- Announce development plans
Progress in partnered antibody pipeline
- New INDs
- Data from ongoing phase 1 programs
Feb 28: 2007 results and guidance for 2008
Novartis Deal is Transforming
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]