Company Presentation - J.P. Morgan Healthcare ... - MorphoSys
Company Presentation - J.P. Morgan Healthcare ... - MorphoSys
Company Presentation - J.P. Morgan Healthcare ... - MorphoSys
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<strong>Company</strong> p yUpdate p<br />
29th Annual J.P. <strong>Morgan</strong> <strong>Healthcare</strong> Conference – January 2011
Safe Harbour<br />
This presentation includes forward-looking forward looking statements.<br />
Actual results could differ materially from those included in the forward-looking statements<br />
due to various risk factors and uncertainties including changes in business, economic<br />
competitive conditions conditions, regulatory reforms, reforms foreign exchange rate fluctuations and the<br />
availability of financing.<br />
These and other risks and uncertainties are detailed in the <strong>Company</strong>’s Annual Report.
<strong>MorphoSys</strong> p y at a Glance<br />
� An independent antibody company<br />
<strong>Company</strong> �� Martinsried/Germany Martinsried/Germany, with sites in UK & US<br />
Business<br />
Technology<br />
Pipeline<br />
Financials<br />
Corporate<br />
� Frankfurt Stock Exchange – TecDAX<br />
� Th Therapeutic ti antibodies tib di<br />
� Research & diagnostic antibodies (AbD Serotec)<br />
� Leading, proprietary HuCAL platform<br />
� New technology from Sloning acquisition<br />
� Over 70 therapeutic antibody programs<br />
� Strong alliances with pharma companies<br />
� Sustainable profitability funds proprietary R&D<br />
� 10-year, $1bn strategic alliance with Novartis<br />
�� CCash h bbalance l iin excess of f $170 $170m<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 3
Strategy gy<br />
PROPRIETARY DEVELOPMENT<br />
� Own programs taken by <strong>MorphoSys</strong> to clinical proof-of-concept<br />
� Lucrative potential upside<br />
PARTNERED DISCOVERY AbD SEROTEC<br />
� Multiple p therapeutic p antibody y pproducts<br />
based on <strong>MorphoSys</strong>’s technology<br />
� Generate strong flow of<br />
milestones & royalties y<br />
� Growing g roster of diagnostic g ppartnerships p<br />
developing novel tests<br />
� Research antibody catalogue business<br />
INNOVATIVE, PROPRIETARY ANTIBODY TECHNOLOGY<br />
� Commitment to delivering superior antibodies<br />
� Next generation MAbs to be more efficacious, able to hit new targets and lower cost<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG Page 4
New Technology gy Enhances Power of Platform<br />
� October 2010:<br />
�<strong>MorphoSys</strong> �<strong>MorphoSys</strong> acquires Sloning BioTechnology for access to Slonomics<br />
Slonomics:<br />
� Enzymatic y a c ge gene e sy synthesis es s<br />
� Enables generation of protein libraries<br />
� With unprecedented speed<br />
� With complete l t control t l over composition iti<br />
� At low cost<br />
Powerful technology for protein discovery & optimization<br />
Slonomics<br />
Corporate<br />
<strong>MorphoSys</strong><br />
Antibody<br />
Platform<br />
Technology Pipeline AbD Serotec<br />
December 2010:<br />
Slonomics agreement<br />
with Pfizer provides p<br />
immediate payback of<br />
Sloning acquisition<br />
and foreshadows<br />
commercial potential<br />
© <strong>MorphoSys</strong> AG Page 5
A Unique q Platform for Generating gOptimized, p ,<br />
Fully Human Antibodies<br />
HuCAL Platinum<br />
Lead antibody Optimized drug<br />
candidate<br />
Optimization using unique,<br />
modular design of HuCAL<br />
High performance, fully<br />
human antibody library<br />
NEW! Optimization using new<br />
45 billion antibodies arYla technology<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
Superior<br />
optimized drug<br />
candidate did t<br />
© <strong>MorphoSys</strong> AG Page 6
– Higher g Probabilities of Success &<br />
Faster Development<br />
Today<br />
Discoveryy Preclinic Phase 1 Phase 2 Phase 3 Market<br />
With arYla<br />
35% 51% 73%<br />
Discovery Preclinic Phase 1 Phase 2 Phase 3 Market<br />
Expectations:<br />
50% 89% 51% 73%<br />
�� Shorten time to antibody drug candidate by 30%<br />
� Increase proportion of programs reaching clinic to 50%<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
Source: <strong>MorphoSys</strong> experience<br />
Source: <strong>MorphoSys</strong> projections<br />
© <strong>MorphoSys</strong> AG Page 7
Broadest Antibody yPipeline p in the Industry: y<br />
77 Programs Ongoing<br />
Name Partner/MOR Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Market<br />
MOR103 MOR GM-CSF<br />
RA<br />
MS<br />
BHQ880 Novartis DKK-1 Cancer<br />
CNTO888 Centocor MCP-1<br />
CCancer<br />
IPF<br />
n.d. Novartis n.d. n.d.<br />
Gantenerumab Roche Amyloid-β AD<br />
MOR208 MOR CD19 CLL<br />
CNTO1959 Centocor n.d. Psoriasis<br />
BAY79-4620 Bayer Schering CA IX (MN) Cancer<br />
CNTO3157 Centocor n.d. Asthma<br />
n.d. Novartis n.d. Musculoskeletal<br />
n.d. Novartis n.d. Ophthalmology<br />
n.d. Centocor n.d.<br />
Inflammation/<br />
Autoimmune<br />
3 Programs 3 Partners n.d.<br />
Inflammation/<br />
Cancer<br />
MOR202 MOR CD38 Multiple Myeloma<br />
20 Programs Partnered Various Various* Various<br />
32 Programs Partnered Various Various*<br />
5 Programs MOR n.d.<br />
Inflammation/<br />
Cancer<br />
2 Programs MOR/NOV n.d. Inflammation<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
* Includes cancer,<br />
inflammatory,<br />
autoimmune,<br />
infectious,<br />
musculoskeletal &<br />
central nervous<br />
system diseases<br />
nd n.d. – not disclosed<br />
Page 8
MOR103<br />
A Novel Anti-Inflammatory Antibody<br />
The Target<br />
�� GM GM-CSF, CSF which plays a central role in activating granulocytes and<br />
macrophages<br />
� Extensive evidence implicating GM-CSF in the inflammatory cascade<br />
The Drug<br />
� A HuCAL IgG1 antibody that neutralizes human GM-CSF<br />
� High potency due to very high target affinity (KD = 0.4 pM)<br />
�� Subcutaneous PK study in healthy volunteers planned for 2011<br />
Intellectual Property<br />
� Exclusive license to a US patent covering antibodies against GM-CSF for<br />
the treatment of chronic inflammatory conditions<br />
�� Patent filings on antibody<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 9
MOR103<br />
Clinical Development<br />
In Rheumatoid Arthritis<br />
�� European phase 1b/2a trial ongoing to assess safety safety, signs of efficacy and<br />
immunogenicity of MOR103 in patients with active RA<br />
� 135 patients with active RA, randomized, double-blind, placebo controlled<br />
� Four ascending doses i.v. 0.3, 1.0 and 1.5 mg/kg or placebo with stable<br />
regimen of concomitant RA therapy<br />
�� Objectives:<br />
� Primary objectives: Adverse event rate and safety profile<br />
� Secondary objectives: DAS28, ACR & EULAR28, cytokines, MRI<br />
(synovitis & bone edema), PK, immunogenicity & patient-reported<br />
outcomes up to 16 wks<br />
� Final phase 1b/2a RA data expected in H1 2012<br />
In Multiple Sclerosis<br />
� Phase 1b safety study in MS patients being prepared<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 10
MOR208<br />
A Novel Anti-Cancer Antibody<br />
The Target<br />
�� CD19 CD19, a pan B-cell marker<br />
The Drug<br />
� Humanized, affinity optimized anti-CD19 antibody, comprising a proprietary<br />
modification that enhances effector cell recruitment<br />
�� EExclusive l i li license ffrom XXencor<br />
Selected Pre-clinical Observations<br />
� Enhanced affinity for Fc receptor leads to rapid and sustained B-cell<br />
depletion<br />
MOR208/X MOR208/XmAb5574 Ab5574<br />
%ADCC<br />
30 Namalwa<br />
20<br />
10<br />
0<br />
60<br />
40<br />
20<br />
0<br />
30<br />
20<br />
Wac3CD5<br />
SU-DHL-6<br />
� Higher ADCC than both Rituxan & Campath against<br />
10<br />
Anti-CD19 IgG1 (unmodified)<br />
all lymphoma & leukemia cell lines tested<br />
0<br />
XmAb (-) control<br />
(see selected data in figure)<br />
rituximab (CD20)<br />
0.01 0.1 0 10 100<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
alemtuzumab (CD52)<br />
mAb (ng/mL)<br />
CLL<br />
Burkitt’ss<br />
Lymphoma<br />
B-NHHL<br />
© <strong>MorphoSys</strong> AG Page 11
MOR208<br />
Clinical Development<br />
Clinical Trial Design<br />
�� Multi-centre Multi-centre, open-label open-label, multi-dose multi-dose, single-arm phase 1, 1 dose-escalation<br />
study in USA<br />
� Patients with chronic lymphocytic leukemia, who have not responded to or<br />
hhave bbecome refractory f t tto previous i th therapies i<br />
� Objectives:<br />
� Primary objectives: Investigate maximum tolerated dose dose, safety and<br />
tolerability, pharmacokinetics and immunogenicity<br />
� Secondary objectives: Assess preliminary anti-tumor activity<br />
� Xencor funds phase 1 trial from $13 m up-front payment<br />
� Final data expected in 2012<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG Page 12
MOR202<br />
A Novel Antibody for Multiple Myeloma<br />
The Target<br />
�� CD38 CD38, a key target present on the vast majority of multiple myeloma cells<br />
The Drug<br />
� A high affinity, fully human HuCAL antibody<br />
Clinical Trial Design and Development Timeline<br />
� Multicentre, open-label, dose-escalation study (EU)<br />
�� Patients with relapsed/refractory multiple myeloma; failure of at least 2 prior<br />
therapies<br />
� Objectives: Investigate maximum tolerated dose, safety and tolerability,<br />
pharmacokinetics and immunogenicity; assessment of preliminary activity<br />
� Final data expected in 2012<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG Page 13
Partnered Programs g<br />
Phase 2 Clinical Development<br />
Partner & Program Disease Status<br />
Novartis<br />
BHQ880<br />
Osteolytic bone<br />
disease<br />
� HuCAL antibody targeting DKK-1<br />
� Clinical trials in multiple myeloma patients<br />
� Early data show stimulation of bone formation<br />
Novartis<br />
� June 2009: Start of phase 1/2<br />
n.d.<br />
nd n.d. �� Clinical proof of concept achieved<br />
Centocor Ortho Biotech Oncology &<br />
CNTO888<br />
immunology<br />
Roche<br />
Gantenerumab<br />
Corporate<br />
Alzheimer‘s<br />
disease<br />
Technology Pipeline AbD Serotec<br />
� HuCAL antibody targeting MCP-1<br />
� MCP-1 MCP 1 regulates prostate cancer growth and<br />
metastasis<br />
� 2 oncology trials and 1 IPF trial ongoing<br />
�� HHuCAL CALantibody tib d ttargeting ti amyloid-β l id β<br />
� Amyloid-β implicated as causal factor in AD<br />
� Phase 2 study in patients with prodromal AD initiated<br />
iin Q4 2010<br />
© <strong>MorphoSys</strong> AG<br />
Page 14
Partnered Programs g<br />
Phase 1 Clinical Development<br />
Partner & Program Disease Status<br />
Centocor Ortho Biotech<br />
CNTO1959<br />
Bayer <strong>Healthcare</strong><br />
BAY79-4620<br />
Centocor Ortho Biotech<br />
CNTO3157<br />
Psoriasis<br />
Oncology<br />
Novartis<br />
Musculoskeletal<br />
n.d.<br />
diseases<br />
Novartis<br />
n.d.<br />
Various Various<br />
Corporate<br />
� June 2009: Start of phase 1<br />
� Study completed in Q4 2010<br />
� October 2009: Start of phase 1 trial<br />
� Antibody-drug conjugate targeting CA IX<br />
Asthma � June 2010: Start of phase 1<br />
� July 2010: Start of phase 1<br />
Ophthalmology �� August 2010: Start of phase 1<br />
� Four additional INDs/CTAs<br />
Technology Pipeline AbD Serotec<br />
�� Anno Announced nced in December 2010<br />
© <strong>MorphoSys</strong> AG<br />
Page 15
A Rapidly p y Growing gClinical Pipeline p<br />
Number of Partnered & Proprietary Programs in Clinical Trials at Year-end<br />
20<br />
15<br />
10<br />
5<br />
0<br />
Corporate<br />
1<br />
2<br />
Phase 1 Phase 2<br />
1<br />
4<br />
4 4 4<br />
6<br />
10<br />
2005 2006 2007 2008 2009 2010 2011E*<br />
Clinical Antibody Pipeline is aKeyValueDriver<br />
a Key Value Driver<br />
Technology Pipeline AbD Serotec<br />
* assuming no attrition<br />
© <strong>MorphoSys</strong> AG Page 16
Current Pipeline p<br />
Projected HuCAL Drugs on the Market<br />
Discovery Preclinic Phase 1 Phase 2 Phase 3 Market<br />
39<br />
50% 70% 40% 65%<br />
Projection from today’s pipeline:<br />
22<br />
Success probability of 11%<br />
Source: <strong>MorphoSys</strong> internal statistics & Tufts Centre for the Study of Drug Development<br />
Corporate<br />
Success probability of 18%<br />
10 Success probability of 25%<br />
2<br />
6 Success probability of 33% 2<br />
Projected number of marketed HuCAL drugs from today’s pipeline: 12<br />
Technology Pipeline AbD Serotec<br />
4<br />
4<br />
© <strong>MorphoSys</strong> AG Page 17
AbD Serotec Complements p Therapeutic p<br />
Segment of the Business<br />
� Antibodies for research and diagnostic markets<br />
� Cash-generative Cash generative since 2007<br />
Diagnostic Antibodies<br />
�� Using proprietary technologies to deliver superior<br />
antibodies for diagnostic uses<br />
� Future upside via royalties<br />
� PPotential t ti l synergies i with ith th therapeutic ti side id of f bbusiness i<br />
Research Antibodies<br />
� Catalogue comprising 15,000+ products<br />
�� Custom antibody generation using HuCAL<br />
� Stable and recurring cash flows<br />
Market<br />
$ 7bn<br />
$2bn<br />
© <strong>MorphoSys</strong> AG Page 18
Technology gy Offers Exciting g Growth Opportunities pp<br />
in Diagnostics<br />
AbD Serotec is working with over 20 diagnostics companies<br />
Application Technology Feature<br />
Poorly served targets � HuCAL provides antibodies where traditional approaches fail<br />
New biomarkers � HuCAL offers best possible selectivity & sensitivity<br />
CClinical monitoring � HuCAL C is very well-suited to making anti-idiotypic antibodies<br />
Thermal stability<br />
� In vitro method HuCAL offers key y advantages g compared p to in<br />
vivo antibody generation<br />
Diagnostic g standards � HuCAL offers precise p and indefinite reproducibility<br />
p y<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 19
Guidance 2010<br />
In million EUR<br />
Guidance 2010E 2009A<br />
Updated in<br />
Issued in<br />
December February<br />
Total Group Revenues 91 – 94 89 – 93 81.0<br />
Group Operating Profit 13 – 16 5 – 9 11.4<br />
AbD Serotec<br />
Revenue ~21 21 – 22 19.4<br />
Operating Profit Margin 5 – 8% 5 – 8% 5%<br />
2010<br />
� Increase of total proprietary R&D investment to € 27 – 29<br />
million (2009: € 19.3 million)<br />
2011 – 2012<br />
� Aiming for 10% – 20% annual revenue growth<br />
� Maintain profitability while strengthening pipeline<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 20
Shareholder Structure and Key y Financials<br />
Shareholder Structure (Dec. 2009)<br />
30%<br />
Corporate<br />
Novartis<br />
7%<br />
5%<br />
2%<br />
AstraZeneca<br />
<strong>MorphoSys</strong> (MOR GR) Key Financials<br />
In million EUR 9M 2010 9M 2009<br />
Management &<br />
Revenues 62.8 57.6<br />
17% Supervisory Board CCost t of f Goods G d Sold S ld 55 5.5 51 5.1<br />
No No. of Shares<br />
22,714,362<br />
7%<br />
10%<br />
7%<br />
4%<br />
4%<br />
7%<br />
R&D Expenses 32.5 27.5<br />
S,G&A Expenses 16.8 15.7<br />
Total Operating Expenses 54.8 48.3<br />
Operating Profit 8.0 9.3<br />
Net Profit 7.2 7.7<br />
EPS (diluted) in EUR 0.32 0.34<br />
USA<br />
UK<br />
Switzerland<br />
Germany<br />
France<br />
Other countries<br />
Cash, Cash Equivalents and Available-for-sale<br />
Financial Assets as of September 30, 2010:<br />
Retail Unidentified € 132.1 million<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG<br />
Page 21
A Strategy gy for Substantial Value Creation<br />
Value<br />
PROPRIETARY DEVELOPMENT<br />
Innovative, Proprietary Antibody Technology & Know-how<br />
Today Future<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
© <strong>MorphoSys</strong> AG Page 22
Forthcoming g Events<br />
MOR103<br />
� Complete p enrollment in pphase 1b/2a RA study y<br />
� Commence phase 1b MS study<br />
MOR202<br />
�� Commence phase 1 study in multiple myeloma<br />
� Release pre-clinical data<br />
MOR208<br />
�� Progress report on open open-label label phase 1 study in CLL<br />
Partnerships<br />
� New INDs<br />
� Clinical data expected at major conferences (ASCO, ACR, ASH…)<br />
� New deals<br />
Diagnostics<br />
� Additional HuCAL-based diagnostic kits on market<br />
Corporate<br />
Technology Pipeline AbD Serotec<br />
PROPRIETARY DEVELOPMENT<br />
PARTNERED DISCOVERY<br />
AbD SEROTEC<br />
© <strong>MorphoSys</strong> AG Page 23
Thank You.<br />
www.morphosys.com<br />
Dr. Simon Moroney<br />
Chief Executive Officer<br />
Dr. Claudia Gutjahr-Löser<br />
Head of Corporate Communications & IR<br />
Phone +49 (0)89 ( ) / 899 27-311 Phone +49 (0)89 ( ) / 899 27-122<br />
Fax +49 (0)89 / 899 27-5311<br />
Fax +49 (0)89 / 899 27-5122<br />
Email investors@morphosys.com<br />
HuCAL ® , HuCAL GOLD ® , HuCAL PLATINUM ® , CysDisplay ® , RapMAT ® and AutoCAL ® are registered trademarks of <strong>MorphoSys</strong> AG, arYla is a trademark of<br />
<strong>MorphoSys</strong> AG