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MorphoSys AG — Investor Presentation 2010
Sep 28, 2010
291_ip_2010-09-28_da29f753-7a82-4b08-983f-7179d20d1be2.pdf
Investor Presentation
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Rodman & RenshawAnnual Global Investment Conference
September 13, 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 p 72 Programs Ongoing
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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 – September 2010 Page 6
MOR103 – Ph 1b/2a (MSC-1001) in Rheumatoid Arthritis
Target: GM-CSF
- GM-CSF plays a central role in activating granulocytes and macrophages, which are essential in the inflammatory cascade
- Primary indication: rheumatoid arthritis (RA)
Clinical Trial Design and Development Timeline
- Study in 135 RA patients, randomized, double-blind, placebo-controlled, multiple ascending dose (approved in Germany, Bulgaria, the Netherlands)
- 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 kinetics,
| 2 0 0 8 |
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| F i l P h 1 b / 2 D t n a a s e a a a |
MOR208 – Anti-CD19 Opportunity in B-Cell Malignancies
Target: CD19
- Humanized, affinity optimized anti-CD19 antibody, in-licensed from Xencor, comprising a proprietary modification that enhances effector cell recruitment
- First indication: CLL
- Enhanced affinity for Fc receptor leads to rapid and sustained B-cell depletion
Clinical Trial Design and Development Timeline
- Design: multicentre, open-label, multi-dose, single-arm phase 1, doseescalation study in USA
- Population: Patients with CLL, who have not responded to or have become refractory to previous therapies
- Objectives: Investigate maximum tolerated dose, safety and tolerability, pharmacokinetics and immunogenicity
- Secondary Objective: Assess preliminary anti-tumor activity
- Xencor funds phase 1 trial from US\$ 13 million up-front payment
MOR202 – Anti-CD38 Opportunity in Multiple Myeloma
Target: CD38
- CD38 is a key target to address multiple myeloma therapy due to high expression on multiple myeloma cells
- Primary indication: Multiple Myeloma
Clinical Trial Design and Development Timeline
- File CTA in Q4 2010
- Clinical trial material available for Phase I/II; Produced in PER.C6® cell line (Crucell/DSM)
- Research grant of approx. €1m to explore relevant biomarkers
- MOR202 shows cross-reactivity to relevant toxicology species -> This facilitates generation of a comprehensive safety package, and hence a shorter clinical development life cycle
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Partnered Discover y Novartis – BHQ880
HuCAL IgG1 antibody targeting DKK-1
- Over-ex pression of DKK-1 b y y m yeloma cells may 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 show that BHQ880 promotes bone formation and thereby inhibits tumorinduced osteolytic disease
- A phase 1/2 combination study with Zometa/ Reclast in relap yy sed or refractor y m yeloma patients started in February 2009
- Early clinical results from Novartis at ASH meeting, December 2009
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, chronic treatment led to a significant reduction in amyloid load
- Peripheral A β-levels were not increased after administration to transgenic mice suggesting that clearance of p p eri pheral Aβ was not affected
Development
- Two Phase 1 studies completed (single dose arm and multiple ascending dose arm)
- Mild-to-moderate Alzheimer's patients
- Randomized, double double-blind
- Antibody behaved as expected
- Internal "go" decision by Roche in Q2 2010
- Expect FPI in H1 2011
Partnered Discovery Additional Programs in Clinical Development
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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
AbD SerotecPromising Market Opportunities
| 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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| A b D S O i P f i M i t t t e r o e c p e r a n g r o a r g n |
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| * Es t im te d b 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
Shareholder Structure
Key Financials
| 4 3 5 |
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| 3 9 7 |
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| 3 | 3 |
| 8 | 3 |
| 2 | 1 |
| 0 | 8 |
| 5 | 0 |
| 1 | 1 |
| 0 | 0 |
| 9 | 0 |
| 3 3 5 2 |
3 3 1 1 3 3 |
| 8 | 6 |
| 3 | 6 |
| 5 | 5 |
| 9 | 0 |
Cash, Cash Equivalents and Available-for-sale Financial Assets as of June 30, 2010:
€ 152 1 illi 152.1 million
Anticipated News-flow
Proprietary product portfolio
- Commence MOR208 Phase 1 CLL trial in US ( ) Q3E
- File clinical trial application for MOR202 (Q4E)
- New projects, including co-developments
Partners' pipeline
- 1 – 3 additional, new INDs
- At least one additional phase 2
- Clinical data
Technology: Update regarding latest technology development
- Potential strategic transactions
- Strengthen technology platform
- Broaden offering in the diagnostic space (AbD Serotec)
Future Value Creation
Thank You.
www.morphosys.com
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]