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MorphoSys AG — Investor Presentation 2011
Mar 2, 2011
291_ip_2011-03-02_3093a2fb-dc8c-4cbb-8c51-532308f57884.pdf
Investor Presentation
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Company Update
March 2011
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.
| Company | An independent antibody company Martinsried/Germany, with sites in UK & US Frankfurt Stock Exchange – TecDAX |
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|---|---|---|
| Business | Therapeutic antibodies Research & diagnostic antibodies (AbD Serotec) |
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| Technology | Leading, proprietary HuCAL platform New technology from Sloning acquisition |
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| Pipeline | Over 70 therapeutic antibody programs Strong alliances with pharma companies |
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| Financials | Sustainable profitability funds proprietary R&D 10-year, \$1bn strategic alliance with Novartis Cash balance in excess of \$170m |
PROPRIETARY DEVELOPMENT
- Own programs taken by MorphoSys to clinical proof-of-concept
- Lucrative potential upside
PARTNERED DISCOVERY
- Multiple therapeutic antibody products based on MorphoSys's technology
- Generate strong flow of milestones & royalties
AbD SEROTEC
- Growing roster of diagnostic partnerships 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
Growing Significance of the MorphoSys Pipeline
Clinical Programs Total Programs
MorphoSys Has Built One of the Industry´s Broadest Antibody Pipelines
MOR103 A Novel Anti-Inflammatory Antibody
The Target
- GM-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
Page 7
Page 8
MOR103 Clinical Development
In Rheumatoid Arthritis
- European phase 1b/2a trial ongoing to assess 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:
- Primary objectives: Adverse event rate and safety profile
- Secondary objectives: DAS28, ACR & EULAR28, cytokines, MRI (synovitis & bone edema), PK, immunogenicity & patient-reported outcomes up to 16 weeks
- Final phase 1b/2a RA data expected in H1 2012
In Multiple Sclerosis
Phase 1b safety study in MS patients being prepared
MOR208 A Novel Anti-Cancer Antibody
The Target
CD19, a pan B-cell marker
The Drug
- Humanized, affinity optimized anti-CD19 antibody, comprising a proprietary modification that enhances effector cell recruitment
- Exclusive license from Xencor
Selected Pre-clinical Observations
- Enhanced affinity for Fc receptor leads to rapid and sustained B-cell depletion
- Higher ADCC than both Rituxan & Campath against all lymphoma & leukemia cell lines tested (see selected data in figure)
0.01 0.1 0 10 100 %ADCC 30 20 10 0 Namalwa 60 40 20 0 Wac3CD5 SU-DHL-6 30 mAb (ng/mL) B-NHL Burkitt's Lymphoma CLL
MOR208 Clinical Development
Clinical Trial Design
- Multi-centre, open-label, multi-dose, single-arm phase 1, dose-escalation study in USA
- Patients with chronic lymphocytic leukemia, who have not responded to or have become refractory to previous therapies
- Objectives:
- Primary objectives: Investigate maximum tolerated dose, safety and tolerability, pharmacokinetics and immunogenicity
- Secondary objectives: Assess preliminary anti-tumor activity
- Xencor funds phase 1 trial from \$13 m up-front payment
- Final data expected in 2012
MOR202 A Novel Antibody for Multiple Myeloma
The Target
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 2013
Partnered Programs Phase 2 Clinical Development
| Partner & Program | Disease | Status |
|---|---|---|
| Novartis BHQ880 |
Osteolytic bone disease |
HuCAL antibody targeting DKK-1 Clinical trials in multiple myeloma patients Early data show stimulation of bone formation |
| Novartis n.d. |
n.d. | June 2009: Start of phase 1/2 Clinical proof of concept achieved |
| Centocor Ortho Biotech CNTO888 |
Oncology & immunology |
HuCAL antibody targeting MCP-1 MCP-1 regulates prostate cancer growth and metastasis 2 oncology trials and 1 IPF trial ongoing |
| Roche Gantenerumab |
Alzheimer's disease |
HuCAL antibody targeting amyloid-β Amyloid-β implicated as causal factor in AD Phase 2 study in patients with prodromal AD initiated in Q4 2010 |
Partnered Programs Phase 1 Clinical Development
| Partner & Program |
Disease | Status |
|---|---|---|
| Centocor Ortho Biotech CNTO1959 |
Psoriasis | June 2009: Start of phase 1 Study completed in Q4 2010 |
| Bayer Healthcare BAY79-4620 |
Oncology | October 2009: Start of phase 1 trial Antibody-drug conjugate targeting CA IX |
| 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 |
| Novartis – n.d. |
Inflammation | December 2010: Filing for phase 1 |
| Centocor – n.d. |
Inflammation/ Autoimmune |
December 2010: Filing for phase 1 |
| Boehringer Ingelheim – n.d. |
n.d. | December 2010: Filing for phase 1 |
| Pfizer – n.d. |
Oncology | December 2010: Filing for phase 1 |
| Oncomed – OMP-59R5 |
Oncology | December 2010: Filing for phase 1 |
AbD Serotec Complements Therapeutic Segment of the Business
Antibodies for research and diagnostic markets Cash-generative since 2007 Research Antibodies Catalogue comprising 15,000+ products Custom antibody generation using HuCAL Stable and recurring cash flows Diagnostic Antibodies Using proprietary technologies to deliver superior antibodies for diagnostic uses Future upside via royalties Potential synergies with therapeutic side of business Market \$ 7bn \$2bn
Diagnostic HuCAL Antibody Pipeline Gains Visibility
Technology Offers Exciting Growth Opportunities in Diagnostics
| AbD Serotec is working with over 20 diagnostics companies | ||
|---|---|---|
| Application | Technology Feature |
|---|---|
| Poorly served targets | HuCAL provides antibodies where traditional approaches fail |
| New biomarkers | HuCAL offers best possible selectivity & sensitivity |
| Clinical monitoring |
HuCAL is very well-suited to making anti-idiotypic antibodies |
| Thermal stability |
In vitro method HuCAL offers key advantages compared to in vivo antibody generation |
| Diagnostic standards | HuCAL offers precise and indefinite reproducibility |
MorphoSys Transforms Antibody Technologies in Response to Customer Needs
A Unique Platform for Generating Optimized, Fully Human Antibodies
Patent Protection on Platform Expanded Significantly
Patent lifetime on key platform technologies
* Patent applications filed
FY2010: Operating Result
| in million € | 2010 | 2009 | Change |
|---|---|---|---|
| Revenues | 87.0 | 81.0 | 7% |
| Cost of Goods Sold | 7.3 | 6.7 | 9% |
| Research and Development Expenses | 46.9 | 39.0 | 20% |
| Sales, General & Administrative Expenses | 23.2 | 23.9 | (3%) |
| Total Operating Expenses | 77.4 | 69.6 | 11% |
| Other Operating Income | 0.2 | 0.1 | 100% |
| Profit from Operations* | 9.8 | 11.4 | (14%) |
* Differences due to rounding
| in million € | 2010 | 2009 | |
|---|---|---|---|
| Partnered Discovery | |||
| Segment Revenues | 66.3 | 61.7 | |
| Operating Expenses | 23.6 | 22.1 | |
| Segment Result | 42.7 | 39.6 | |
| Proprietary Development | |||
| Segment Revenues | 1.8 | 1.0 | |
| Operating Expenses | 26.5 | 19.3 | |
| Other Operating Income | 0.2 | 0 | |
| Segment Result | (24.5) | (18.3) | |
| AbD Serotec | |||
| Segment Revenues | 20.2 | 19.3 | |
| Operating Expenses | 18.9 | 18.4 | |
| Other Operating Income | 0.02 | 0.1 | |
| Segment Result* | 1.2 | 1.0 |
* Differences due to rounding
Guidance: +20% Revenue Growth, Continued Investment
| in million € | 2011 | 2010 |
|---|---|---|
| Group Revenues | 105 - 110 |
87.0 |
| Investment in Proprietary R&D | 40 – 45 |
26.5 |
| Group Operating Profit | 10 – 13 |
9.8 |
| in million € | 2011 | 2010 |
| AbD Serotec Segment Revenues | 22 - 23 |
20.2 |
| AbD Serotec Profit Margin | ~ 4% | 6% |
A Rich Potential News-flow in 2011
H1 2011
- Commence Phase 1 study of MOR202 in multiple myeloma
- Release MOR202 pre-clinical data
- New partner INDs
- First diagnostic kit based on a HuCAL antibody comes to market
- Further technology announcements
H2 2011
- Complete enrollment in MOR103 Phase 1b/2a RA study
- Commence Phase 1b MS study of MOR103
- Clinical data from trial of CNTO888 in oncology*
- Clinical data from trial of CNTO1959 in psoriasis*
- Clinical data from trial of CNTO3157 in asthma*
- New partner INDs
- New deal(s) based on Slonomics technology
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 Dr. Claudia Gutjahr-Löser Head of Corporate Comm. & IR
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