Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management &...

18
Piper Jaffray 22nd Annual Health Care Conference New York – November 30, 2010

Transcript of Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management &...

Page 1: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

Piper Jaffray p y22nd Annual Health Care Conference

New York – November 30, 2010

Page 2: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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.

Page 3: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 4: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 5: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 6: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 6

n.d. – not disclosed

MorphoSys AG – R&D Day – November 2010

Page 7: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 8: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 9: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 10: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 11: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 12: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 13: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 14: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 15: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 15

Page 16: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 17: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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

Page 18: Pippyer Jaffray 22nd Annual Health Care Conference...17% 5% Novartis AstraZeneca Management & Supervisory Board In million EUR 9M 2010 9M 2009 Revenues 62.8 57.6 Cost of Goods Sold

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