Credit Suisse Antibody Day - MorphoSys

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Credit Suisse Antibody Day New York May 10, 2013 © MorphoSys - May 2013

Transcript of Credit Suisse Antibody Day - MorphoSys

Page 1: Credit Suisse Antibody Day - MorphoSys

Credit Suisse Antibody Day

New York

May 10, 2013

© MorphoSys - May 2013

Page 2: Credit Suisse Antibody Day - MorphoSys

Safe Harbour

© MorphoSys - May 2013

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.

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MorphoSys: The Investment Case

© MorphoSys - May 2013

Technology-driven Alliances

Proven HuCAL platform

Major alliance with

Novartis

Ongoing investment in

new technologies

Broad Product Pipeline

21 clinical programs

Promising proprietary programs MOR103, MOR202, MOR208

Multiple clinical read-outs pending

Financially Strong

Secure cash-flows

Strong balance sheet

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Antibody Technology: Our Philosophy

© MorphoSys - May 2013

Optimize antibody properties early

HuCAL

Industry’s most successful antibody library technology

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HuCAL

Industry’s Most Successful Antibody Library

© MorphoSys - May 2013

CDR-H3 CDR-L3 CDR-L2 CDR-L1 CDR-H2 CDR-H1

7 x HuCAL VH 6-7 x HuCAL VL

Human Combinatorial Antibody Library

Proprietary to MorphoSys

Modular construction enables systematic optimization of antibody properties

Pre-built DNA cassettes

Master genes

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New Technology

Slonomics & Ylanthia

© MorphoSys - May 2013

Slonomics

Best technology for protein libraries

secured in Sloning acquisition

Deals have already paid for acquisition

Pfizer, Novozymes, unnamed pharma

Ylanthia

Totally new antibody platform

Higher quality antibodies, greater

diversity faster lead generation

US patent granted January 2013

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80 Therapeutic Antibody Programs

© MorphoSys - May 2013

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) - GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL, NHL, ALL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

NOV - 7 Novartis - Ophthalmology

21 Programs Various Partners - Various Indications

35 Programs Various Partners - Various Indications 73 Partnered Programs

7 Proprietary Programs

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80 Therapeutic Antibody Programs

© MorphoSys - May 2013

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) - GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL, NHL, ALL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

NOV - 7 Novartis - Ophthalmology

21 Programs Various Partners - Various Indications

35 Programs Various Partners - Various Indications 73 Partnered Programs

7 Proprietary Programs

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MOR103: A Novel Anti-Inflammatory Antibody

© MorphoSys - May 2013

MOR103 is a HuCAL antibody made by MorphoSys

Target

Human GM-CSF

Drug

Ultra-high affinity HuCAL IgG1

Large Market and Unmet Need in Rheumatoid

Arthritis

30-40% of patients do not adequately respond to

anti-TNFs

Half no longer respond within 2 years

Intellectual Property

Exclusive license to US patent covering anti-GM-

CSF antibodies to treat chronic inflammation

US patent on MOR103 composition of matter

Kd

(pM)

Improvement

Parental 2,000 -

CDR L3 opt. 63.5 31

CDR H2

opt.

6.0 333

MOR103 0.4 5,000

The Path to MOR103

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7.4

25.0

68.2

30.4

0

10

20

30

40

50

60

70

80

Dose

Placebo

MOR103 0.3mg/kg

MOR103 1.0mg/kg

MOR103 1.5mg/kg

MOR103 Shows Impressive Efficacy, Fast Onset

of Action & Clean Safety Profile

© MorphoSys - May 2013

Phase 1b/2a: ACR20 Response at Week 4, 96 Patients

% o

f pati

ents

p<0.0001

Efficacy

ACR20 amongst highest observed for a

biologic after 4 weeks

1.0 mg/kg dose cohort shows efficacy

potential

Imaging confirms anti-inflammatory

activity

Safety

Related adverse events more frequent

in placebo group than in active

treatment group

Majority of AEs were of mild intensity

No treatment-related SAEs in the

active treatment groups

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0

10

20

30

40

50

60

70

0 1 2 3 4

MOR103 1 mg/kgmavrilimumabHumiraOrenciaActemra

Efficacy Compares Favorably to Other Biologics

© MorphoSys - May 2013

Time (weeks)

% o

f pati

ents

ACR20*

Very fast onset of therapeutic effect

* Data from separate clinical studies

DAS28

Durable response

Week

Mean c

hange f

rom

base

line

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MOR103

Looking Ahead

© MorphoSys - May 2013

Rheumatoid arthritis

Expect even higher efficacy on

longer treatment

development in moderate to severe patients

Potential for monthly or even less frequent dosing

Subcutaneous formulation

Phase 1 study in healthy volunteers shows good PK and

bioavailability

Multiple sclerosis

Phase 1b study in MS patients ongoing

GM-CSF is only non-redundant inflammatory cytokine in EAE

Partnering

Negotiations ongoing

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80 Therapeutic Antibody Programs

© MorphoSys - May 2013

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) - GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL, NHL, ALL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

NOV - 7 Novartis - Ophthalmology

21 Programs Various Partners - Various Indications

35 Programs Various Partners - Various Indications 73 Partnered Programs

7 Proprietary Programs

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Gantenerumab: A HuCAL Antibody being

Developed by Roche for Alzheimer’s Disease

© MorphoSys - May 2013

Gantenerumab is a HuCAL antibody made by MorphoSys

in collaboration with Roche

Target

Amyloid-b

Drug

IgG1 with a unique binding profile

N-terminus and mid-section of amyloid peptide

Binds amyloid plaque and oligomers very well,

amyloid peptide weakly

Mechanism

Clearance of amyloid plaque from the brain

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Gantenerumab is Being Developed in Prodromal

Alzheimer’s Disease

© MorphoSys - May 2013

Large Market and Unmet Need

Alzheimer’s disease is estimated to affect 25 million people worldwide

Increasing with aging population

Once symptoms for AD dementia have appeared, it may be too late to treat

Picture: Courtesy of Roche

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Gantenerumab is the Most Advanced Antibody

in Development for Alzheimer’s Disease

© MorphoSys - May 2013

Clinical Development

Phase 1: gantenerumab reduces brain amyloid 3x

faster than other amyloid-targeting substances

Phase 3 study ongoing

SCarlet RoAD

770 biomarker-positive prodromal patients

2 doses, placebo-controlled

104 weeks on drug

CDR-SOB, ADAS-COG, change in brain amyloid

Interim analysis this year

Dominantly Inherited Alzheimer Network Phase 3

study

Early onset Alzheimer's Disease caused by a

genetic mutation

Data from Phase 1

Effect of gantenerumab on

amyloid load as indexed by PET

SUVR at end of treatment

% A

mylo

id c

hange

from

base

line

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80 Therapeutic Antibody Programs

© MorphoSys - May 2013

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) - GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL, NHL, ALL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

NOV - 7 Novartis - Ophthalmology

21 Programs Various Partners - Various Indications

35 Programs Various Partners - Various Indications 73 Partnered Programs

7 Proprietary Programs

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LJM716: A HuCAL Antibody being Developed by

Novartis for Cancer

© MorphoSys - May 2013

LJM716 is a HuCAL antibody made by MorphoSys in

collaboration with Novartis

Target

HER3

Three clinical trials

Phase 1: LJM716 + herceptin in patients with HER2-

overexpressing metastatic breast or gastric cancer

Phase 1: LJM716 in squamous cell carcinoma of head

and neck or HER2-positive breast or gastric cancer

Phase 1b/2: Combination of LJM716 & BYL719 in

patients with previously treated esophageal squamous

cell carcinoma

Baselga & Swain Nature Reviews Cancer (2009) 9(7):463-75

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LJM716: Made for Broad Anti-HER Activity

© MorphoSys - May 2013

HER2-driven signaling

(Ligand-independent)

HER2 HER3

anti-HER3 Herceptin

PI3Ki

EGFR HER3

Erbitux

EGFR-driven signaling

(Ligand-dependent)

Breast & gastric cancers Colorectal, HNSCC & pancreatic

cancers

anti-HER3

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HuCAL Delivered a Unique Set of Antibodies

© MorphoSys - May 2013

pH

er3

pAkt

100 1 0.01

100 1 0.01

IgG Conc (nM)

α-HER3

Control

α-HER3

Control

pH

er3

100 1 0.01

pAkt

IgG Conc (nM)

α-HER3

Control

α-HER3

Control

100 1 0.01

KP

RTK

PP

P

HER2 Ligand-independent

(SKBr3, HER2 amp)

Ligand-dependent (MCF7)

LJM716 is a potent inhibitor of pHER3 & pAKT in vitro

Inhibitory effects translate into neuregulin and HER2-driven xenograft models

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Crystal Structure Explains Mechanism

© MorphoSys - May 2013

D1

D2

D3

D4

LJM716 binds here…

… locking HER3 into an inactive

conformation that can neither:

dimerize with HER2, nor

bind the ligand, neuregulin

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Key Financials

© MorphoSys - May 2013

in € million Q1 2013 Guidance 2013

Group Revenues 16.9 48 – 52*

Total Operating Expenses 14.6 70 - 74

thereof Investment in Proprietary R&D 7.0 32 to 37

EBIT 1.9 -18 to -22*

Cash & Marketable Securities and Interest-bearing

Assignable Loans as of March 31, 2013 177.4

* Does not include out-licensing of MOR103, which could lead to significant

out-performance

Sale of AbD Serotec to BioRad completed January 10, 2013, for approx. € 53 million

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Expected Progress in Proprietary Portfolio 2013

© MorphoSys - May 2013

MOR103

Partnership for further development

Multiple sclerosis Phase 1b study continues

MOR208

ALL Phase 2 study to commence

NHL Phase 2 study to commence

Clinical data from Phase 1b extension

MOR202

MM Phase 1/2a study continues

First clinical data expected

Partnership

Clinical data

Clinical data

2013

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Clinical Trials Scheduled for Completion

© MorphoSys - May 2013

BYM338

COPD

BYM338

Cancer

Potential data events based on clinical trial design & MorphoSys estimates

BYM338

Sarcopenia

BHQ880

Smoldering MM

MOR208, B-ALL

Phase 2

LFG316

MCP

LFG316

AMD

NOV-3

Phase 2

CNTO1959

RA versus Stelara

LFG316

AMD

LFG316

AMD

CNTO1959

Psoriasis

LJM716

Combo

LJM716

Single

OMP-59R5

Solid Tumors

BI-1

Phase 1

BI-1

Phase 1

CNTO1959

Psoriasis / Japan

BAY94-9343

Solid Tumors

Gantenerumab

Liquid vs. Lyophilized

Gantenerumab

Japanese AD Patients

OMP-18R5

Solid Tumors

NOV-3

Phase 2

NOV-3

Phase 2

MOR208, CLL

Phase 1/2a Extension

Gantenerumab

Phase 2/3 interim

MOR103, MS

Phase 1b

Phase 3

Phase 2

Phase 1

Partnered

Proprietary

Phase 2

Phase 1

2013 2014 H2 2012

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HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® , Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.

Slonomics® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.

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]

Thank You

www.morphosys.com