Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management &...
Transcript of Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management &...
Piper Jaffray p y22nd Annual Health Care Conference
New York – November 30, 2010
Safe Harbour
This presentation includes forward-looking statements.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 thecompetitive 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 Glancep y
CAn independent antibody companyM i i d/G i i UK USCompany Martinsried/Germany, sites in UK, USFrankfurt Stock Exchange – TecDAX
TechnologyLeading, proprietary HuCAL platformStrong & undisputed patent estate
SegmentsTherapeutic antibodiesAbD Serotec: Research/diagnostic antibodies
BusinessStrong alliances with pharma companiesOver 70 drug programs based on HuCAL
FinancialsSustained profitability10-year $1bn strategic alliance with Novartis
© MorphoSys AG© MorphoSys AG
10 year, $1bn strategic alliance with Novartis
MorphoSys AG – Company Update – November 2010 Page 3
Recent Developmentsp
June MorphoSys and Xencor Sign License & Collaboration Agreement for Clinical Antibody ProgramAgreement for Clinical Antibody Program
J lMorphoSys Receives Research Grant to Advance A ti CD38 C P MOR202 d E lJuly Anti-CD38 Cancer Program MOR202 and Explore Relevant Biomarkers
July & August MorphoSys Announces Two Clinical Milestones from Strategic Alliance with Novartis
September MorphoSys Initiates Program Against Drug-Resistant MRSA Infections
OctoberMorphoSys Acquires the Private German Company Sloning, a Biotechnology Company Developing New Methods of Synthetic Biology
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 4
Methods of Synthetic Biology
Strategy & Deal Termsgy
Proprietary Development
Building a sustainable pipeline of antibody drugs
MorphoSys selects targets, develops antibodies through Phase 2Focus on oncology and inflammationOut-licensing at PoC very lucrative− Total milestones in excess of $100 million− Royalties in mid- to high-teens possible
Partnered DiscoveryPartner provides target molecule & indication expertiseMorphoSys delivers optimized antibody drug candidatesMorphoSys delivers optimized antibody drug candidatesPartner responsible for further development and marketingR&D funding, license fees & milestones €9 - €12 million per programRoyalties in mid-single digits
© MorphoSys AG© MorphoSys AG
Royalties in mid single digits
Page 5MorphoSys AG – Company Update – November/December 2010
Broadest Antibody Pipeline in the Industry:y p y76 Programs Ongoing
Name Partner/MOR Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 MarketMOR103 MOR GM-CSF RABHQ880 N ti DKK 1 CBHQ880 Novartis DKK-1 Cancer
CNTO888 Centocor MCP-1 Immunology/Cancer
n.d. Novartis n.d. n.d.Gantenerumab Roche Amyloid-β ADCNTO1959 Centocor n.d. PsoriasisBAY79-4620 Bayer Schering CA IX (MN) CancerCNTO3157 Centocor n d AsthmaCNTO3157 Centocor n.d. Asthman.d. Novartis n.d. Musculoskeletaln.d. Novartis n.d. OphthalmologyMOR208 MOR CD19 CLL(XmAb5574) MOR CD19 CLL
MOR202 MOR CD38 Multiple Myeloma24 Partnered Programs Partners Various Various*
32 P t d
* Includes cancer, inflammatory, autoimmune,
32 Partnered Programs Partners Various Various*
2 Programs MOR n.d. Inflammation3 Programs MOR n.d. Cancer
,infectious, musculoskeletal & central nervous system diseases
n d not disclosed
© MorphoSys AG© MorphoSys AG
2 Programs MOR/NOV n.d. Inflammation
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n.d. – not disclosed
MorphoSys AG – R&D Day – November 2010
MOR103In Development for Rheumatoid Arthritis
TargetGM-CSF, which plays a central role in activating granulocytes and macrophages, essential in the inflammatory cascade
DrugA high affinity, fully human, HuCAL antibody
Clinical Trial Design and Development TimelineEuropean Phase 1b/2a study in 135 RA patients, randomized, double-blind, placebo-controlled, multiple ascending dosep , p gPrimary outcome measures: Adverse event rate and safety profile Secondary outcome measures: DAS28, ACR score set measures and EULAR28 response criteria, cytokines, synovitis, bone edema, pharmaco-kinetics, immunogenicity and patient reported outcomes up to 16 weeks
2008 2009 2010 2011 2012
Phase 1Phase 1
Phase 1b/2a
Follow up & Data Analysis
© MorphoSys AG© MorphoSys AG
Final Phase 1b/2a Data
MorphoSys AG – Company Update – November 2010 Page 7
MOR208In Development for B-Cell Malignancies
TargetCD19, a pan B-cell marker
DrugHumanized, affinity optimized anti-CD19 antibody, comprising a proprietary modification that enhances effector cell recruitmentIn-licensed from XencorEnhanced affinity for Fc receptor leads to rapid and sustained B-cell depletion
Clinical Trial DesignMulti-centre, open-label, multi-dose, single-arm phase 1, dose-escalation study in USAyPatients with chronic lymphocytic leukaemia, who have not responded to or have become refractory to previous therapiesObjectives: Investigate maximum tolerated dose, safety and tolerability, pharmacokinetics and immunogenicitySecondary Objective: Assess preliminary anti-tumor activityXencor funds phase 1 trial from US$ 13 million up-front payment
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 8
MOR202In Development for Multiple Myeloma
TargetCD38, a key target present on the vast majority of multiple myeloma cells
DrugA high affinity, fully human HuCAL antibody
Clinical Trial Design and Development TimelineClinical Trial Design and Development TimelineFile CTA in Q4 2010Very promising pre-clinical efficacy dataMOR202 cross reacts with CD38 from a relevant toxicology species which facilitates generation of aMOR202 cross-reacts with CD38 from a relevant toxicology species, which facilitates generation of a comprehensive safety package, and will lead to shorter clinical development timelinesPharmacokinetics in all species tested showed half-life suitable for clinical development
2009 2010 2011
Manufacturing
Toxicity Studyy y
CTA Preparation
CTA Filing
S f Ph 1/2
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 9
Start of Ph 1/2a
Partnered ProgramsgPhase 2 Clinical Development
Partner &Program
Phase Disease StatusProgram
NovartisPh 1/2 Osteolytic bone
di
HuCAL antibody targeting DKK-1Clinical trials in multiple myeloma patients
BHQ880Ph 1/2 disease Clinical trials in multiple myeloma patients
Early data point to stimulation of bone formation
Centocor OrthoBiotechCNTO888
Ph 2 Oncology & immunology
HuCAL antibody targeting MCP-1MCP-1 regulates prostate cancer growth and metastasis
CNTO8882 oncology trials and 1 immunology trial ongoing
HuCAL IgG1 antibody targeting amyloid-βRocheGantenerumab
Ph 2 Alzheimer‘s disease
HuCAL IgG1 antibody targeting amyloid βAmyloid-β implicated as causal factor in ADPhase 2 study in patients with prodromal AD to start soon
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 10
start soon
Partnered ProgramsgPhase 1 Clinical Development
Partner Status
NovartisJune 2009: Start of Phase 1Clinical proof of concept achieved
Centocor Ortho Biotech June 2009: Start of Phase 1 in inflammation
Bayer HealthcareOctober 2009: Start of Phase 1 trial in oncologyBAY79-4620, targeting CA IX is an antibody-drug conjugate
Centocor Ortho Biotech June 2010: Start of Phase 1 in inflammation/auto-immune disease
Novartis July 2010: Start of Phase 1 in musculoskeletal diseases
Novartis August 2010: Start of Phase 1 in ophthalmological diseases
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 11
g p g
Great Progress of Clinical Pipeline g p
Number of Partnered and Proprietary Programs in Clinical Trials at Year-end*
20Phase 1 Phase 2
6E10
15
9E145
10
1 2 4 4 49E1
0
5
Clinical Antibody Pipeline is a Key Value Driver
2005 2006 2007 2008 2009 2010E 2011E
© MorphoSys AG© MorphoSys AGMorphoSys AG – R&D Day – November 2010 Page 12
Clinical Antibody Pipeline is a Key Value Driver* assuming no attrition
AbD SerotecPromising Market Opportunities
Optimized antibodies based on HuCAL technology
Diagnostic Antibodies$ 7bn market – strong growthStrong demand for optimized antibodies forStrong demand for optimized antibodies for existing assaysNeed to develop new tools for diagnostic applications
Research Antibodies
applications
Research Antibodies$ 2bn marketSolid and profitable business based on 15,000 productsS f l l t t bli h d
© MorphoSys AG© MorphoSys AG
Successful supply agreements established
Page 13MorphoSys AG – Company Update – November 2010
Guidance 2010
In million EUR 2010E* 2009A
Total Group Revenues 89 – 90 81.0
AbD Serotec ~21 19 4AbD Serotec ~21 19.4
Group Operating Profit 7 – 9 11.4
AbD Serotec Operating Profit Margin 5% – 8% 5%
2010* Estimated numbers
2010Increase of total proprietary R&D investment to € 27 – 29 million (2009: € 19.3 million)
2011 – 2012Aiming for 10% - 20% annual revenue growthMaintain profitability while strengthening pipeline
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 14
Maintain profitability while strengthening pipeline
Shareholder Structure and Key Financialsy
Key Financials Shareholder Structure (Dec. 2009)
7%5%17%
NovartisAstraZeneca
Management & Supervisory Board
In million EUR 9M 2010 9M 2009Revenues 62.8 57.6Cost of Goods Sold 5.5 5.15%
2%
10%
17%R&D Expenses 32.5 27.5
S,G&A Expenses 16.8 15.7
T l O i E 4 8 48 37%
7%30%
Total Operating Expenses 54.8 48.3Operating Profit 8.0 9.3Net Profit 7.2 7.7
4%4%7%
EPS (diluted) in EUR 0.32 0.34
USA GermanyUK FranceSwitzerland Other countries
Cash, Cash Equivalents and Available-for-sale Financial Assets as of September 30, 2010:
€ 132 1 illi
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010
Retail Unidentified € 132.1 million
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Anticipated News-flowp
Proprietary product portfolioCommence MOR208 Phase 1 CLL trial in US (Q4E)( )
File clinical trial application for MOR202 (Q4E)
New projects, including co-developments
Partners’ pipeline1 – 3 additional, new INDs
At least one additional phase 2
Clinical data
Technology: Update regarding latest technology developmentPotential strategic transactions
Strengthen technology platform
Broaden offering in the diagnostic space (AbD Serotec)
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 16
Future Value Creation
Proprietary HuCAL-based
First HuCAL-based drugs
p ydrugs on the market
Out-licensing of
on the market
gown compounds
First clinical proof of concept
Investments in proprietary compounds
proof of concept
St t i lliStrategic alliance with Novartis
T d
© MorphoSys AG© MorphoSys AGMorphoSys AG – Company Update – November 2010 Page 17
Today
Thank You
www.morphosys.com
Dr. Claudia Gutjahr-LöserHead of Corporate Communications & IR
Phone +49 (0)89 / 899 27-122
Dr. Simon MoroneyChief Executive Officer
Phone +49 (0)89 / 899 27-311 ( )Fax +49 (0)89 / 899 27-5122Email [email protected]
( )Fax +49 (0)89 / 899 27-5311
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT® and AutoCAL® are registered trademarks of MorphoSys AG