31st annual j.p. morgan healthcare conference...bay94-9343 bayer healthcare mesothelin (adc) cancer...

Company Update 31st Annual J.P. Morgan Healthcare Conference

January 10, 2013

© MorphoSys - January 2013

Safe Harbour


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.

2

MorphoSys: The Investment Case


Technology-driven Alliances

Proven HuCAL platform

Commercial launch of

Ylanthia

Collaboration with

Lanthio Pharma

Innovative Product Pipeline

MOR103 shows excellent safety and efficacy in RA

Multiple partner Phase 2 read-outs pending

21 clinical programs

3

Financially Strong

Sustainably cash-flow

positive

Strong balance sheet

Recent Developments


MOR103

Excellent clinical safety and efficacy data from Phase 1b/2a trial in rheumatoid

arthritis – proof-of-concept established

MOR208

Positive safety and efficacy data from Phase 1/2a trial in CLL/SLL

Gantenerumab

In Phase 3 development in prodromal Alzheimer‘s disease (Hoffmann La Roche)

Most advanced antibody in development for Alzheimer‘s disease

AbD Serotec

Being sold to Bio-Rad for total consideration of EUR 53m

Enables greater focus on core therapeutics business

Lanthio Pharma

Equity-based option deal to secure access to new therapeutics platform

4

Innovative Product Pipeline

© MorphoSys - January 2013 5

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

CNTO888 Janssen/J&J MCP-1 (CCL-2) IPF

CNTO1959

(2 programs) Janssen/J&J IL23p19

Psoriasis

RA

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis not discl. not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI not discl. not discl.

CNTO3157 Janssen/J&J not discl. Asthma

CNTO – 5 Janssen/J&J not discl. Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

OMP-18R5 OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer not discl. Cancer

21 Programs Various Partners not discl. Various Indications

34 Programs Various Partners not discl. Various Indications

76 Therapeutic Antibody Programs

21 Programs in Clinical Development


70 Partnered Programs

6 Proprietary Programs

MOR103

A Novel Anti-Inflammatory Antibody


Large Market and Unmet Need in Rheumatoid Arthritis

Approved biologics, mostly anti-TNF therapies, generate $20bn

in annual sales

30-40% of patients do not adequately respond to anti-TNFs

50% of responders stop responding within 2 years

MOR103

Ultra-high affinity HuCAL IgG1 targeting GM-CSF

Potential for superior efficacy and better safety than current

treatments

Intellectual Property

Exclusive license to a US patent covering anti-GM-CSF antibodies

for the treatment of chronic inflammatory conditions

US patent on MOR103 composition of matter

7

MOR103: Phase 1b/2a Proof-of-Concept

Trial in Rheumatoid Arthritis


Trial design

96 patients with active, mild-to-moderate RA (DAS28≤5.1)

Randomized, double-blind, placebo-controlled

Dose regimen: 0.3, 1.0 and 1.5 mg/kg weekly x 4 injected intravenously vs. placebo

26 sites in Holland, Germany, Poland, Bulgaria & Ukraine

Primary outcome measures

Adverse event rate and safety profile

Secondary outcome measures

DAS28, ACR core set measures and EULAR28 response criteria, MRI (synovitis & bone

edema), patient reported outcomes at 4 and 8 weeks

8

7.4

25.0

68.2

30.4

0

10

20

30

40

50

60

70

80

Week 4

Placebo

MOR103 0.3mg/kg

MOR103 1.0mg/kg

MOR103 1.5mg/kg

MOR103 Shows Impressive Efficacy, Fast Onset

of Action & Clean Safety Profile


ACR20 Response at week 4*

% o

f pati

ents

* Full Analysis Set, N= 96

p<0.0001 Efficacy

ACR20 ranks amongst highest observed

for a biologic in RA 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

9

ACR20 Scores Compare Favorably to Other

Biological DMARDs


0

10

20

30

40

50

60

70

0 1 2 3 4

Placebo

MOR103 1 mg/kg

mavrilimumab

adalimumab

abatacept

tocilizumab

Time (weeks)

% o

f pati

ents

ACR20 Response over 4 weeks*

Level of efficacy and speed of onset exceed those seen for mavrilimumab (anti-GM-CSFR), adalimumab (Humira), abatacept (Orencia) and tocilizumab (Actemra)

Very fast onset of therapeutic effect within 2 weeks

Robust and durable responses 10 weeks beyond treatment

* Data from separate clinical studies

10

MOR103

Looking Ahead


Rheumatoid arthritis

Expect even higher efficacy on

longer treatment

development in moderate to severe patients

Potential for monthly or even less frequent dosing

Multiple sclerosis

Phase 1b study in MS patients ongoing

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

Major unmet need in progressive forms of the disease

Subcutaneous formulation

Phase 1 study in healthy volunteers shows good PK and bioavailability

Partnering

Discussions ongoing

11

MOR208 (XmAb5574)

A Novel Anti-Cancer Antibody


Large Market and Unmet Need

High unmet medical need in NHL, CLL & ALL

Revenues with approved drugs for B cell malignancies

exceed $5bn

MOR208

Anti-CD19 antibody in-licensed from Xencor

CD19 expressed earlier than CD20 potential greater

efficacy vs. anti-CD20s

Proprietary modification in Fc region increased

ADCC rapid & sustained B-cell depletion

Minor modification means convenient dosing schedule,

straightforward manufacturing

Blinatumomab data validate CD19 as target for B-cell

malignancies

12

MOR208

Phase 1/2a Trial in CLL/SLL


Trial Design

Phase 1, multi-center, US study in heavily pre-treated, relapsed

or refractory CLL/SLL patients

Dosage 0.3 mg/kg - 12 mg/kg; days 1&4, weeks 2-8

Results

Acceptable safety profile

Responses observed in 67% of patients by physical exam

4/27 (15%) partial responses and 20/27 (74%) patients with

stable disease (IWCLL 2008 criteria including CT)

Full results from trial extension expected in Q1 2013

Phase 2

Trials in ALL and NHL will start enrollment in Q1 2013

Combination therapy study in CLL being considered

13

MOR202

A Novel Antibody for Multiple Myeloma



Revenues with approved drugs in MM exceed $2bn

Responders eventually relapse or become refractory to existing

therapies

MOR202

High affinity HuCAL antibody targeting CD38

Competitive Profile

Preclinical data show strong synergy in combinations of MOR202

with Velcade or Revlimid

New pre-clinical data presented at ASH

Clinical Development

Phase 1/2a clinical trial in relapsed or refractory MM patients

currently ongoing

82 patients, at sites in Germany and Austria

14

MOR202

Potential for Combination Therapies


MOR202 monotherapy increased median

survival by 142% vs. vehicle control

MOR202 / LEN resulted in a strong

synergistic/potentiated increase of

median survival by 225% with 3/8

animals remaining disease free until

study termination

15

0 20 40 60 80 1000

20

40

60

80

100LEN (100 mg/kg)

Vehicle ctrl

MOR202 (1mg/kg)

LEN/MOR202 (100 / 1mg/kg)

Treatment period

Days

Su

rviv

al [%

]

MOR202 / LEN Shows Synergy in Disseminated Lymphoma Model

Gantenerumab: A HuCAL Antibody Being

Developed by Roche for Alzheimer’s Disease



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

16

Gantenerumab: The Most Advanced Antibody in

Development for Alzheimer’s Disease


Gantenerumab

High affinity HuCAL antibody targeting amyloid-β

Binds & breaks down amyloid-β fibrils and plaques

Clinical Development

Phase 1: gantenerumab reduces brain amyloid 3x

faster than other amyloid-targeting substances

Potentially pivotal Phase 3 study ongoing

770 prodromal patients, 2 doses, placebo-

controlled

104 weeks on drug

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

Roche have hinted at conducting an interim

analysis in 2013

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

17

Technology-driven Alliances


Proprietary Technology Platform Underpins

Lucrative Alliances


MorphoSys has successfully partnered its human antibody technology HuCAL with many

of the leading pharmaceutical companies

Lucrative model

Makes MOR cash-flow positive

Funds proprietary R&D

Future upside from milestones & royalties

Pharma partner

Target

HuCAL antibody drug

candidate

R&D funding

Technology licence fees

Milestones and royalties

19

Commercial Launch of Ylanthia


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

Opens new opportunities

20

New technologies now part of expanded Novartis strategic alliance

Novartis committed through 2017 with annual license fees, FTE funding,

milestones, royalties

MOR free to partner platform broadly

Lantipeptides:

A New Molecular Class for Drug Discovery


Equity €

Option on lantipeptide platform

Groningen, Holland-

based start-up focused

on developing

lantipeptides:

constrained peptides

showing high target

selectivity and improved

drug-like properties

MorphoSys will apply its

proprietary technology &

know-how to develop

lantipeptide libraries for

drug discovery

Equity-based option deal illustrates new means for MOR to access innovative technologies

Strong Financials


Key Financials


in € million 2011 Guidance 2012* 9M 2012

Group Revenues 100.8 70 – 75 48.9

Total Operating Expenses 89.1 51.3

COGS 7.0 4.8

Funded R&D 20.7 13.1

Proprietary R&D (incl. technology development) 36.8 20 – 25 17.2

Sales, General & Administrative Expenses 24.6 16.2

EBIT 10.1 1 – 5 (2.3)

Cash & Marketable Securities and Interest-bearing

Assignable Loans (at end of period) 134.4 137.5

* as of Nov 7, 2012

23

Shareholdings


Shares issued: 23,358,228 (December 31, 2012)

Treasury stock: 255,415 (December 31, 2012)

24

Forthcoming Pipeline Progress


H1 2013 H2 2013 2014

MOR103, MS

Phase 1b

BYM338

Phase 2

BYM338

Phase 2

Expected dates for completion of clinical trials (MorphoSys estimates)

BYM338

Phase 2

LFG316

Phase 2

BI-1

Phase 1

BHQ880

Phase 2

BAY79-4620

Phase 1

H2 2012

MOR208, B-ALL

Phase 2

LFG316

Phase 2

LFG316

Phase 2

NOV-3

Phase 2

CNTO1959

Phase 2

LFG316

Phase 2

CNTO1959

Phase 2

LJM716

Phase 1

LJM716

Phase 1

OMP-59R5

Phase 1

BI-1

Phase 1

CNTO1959

Phase 1

BAY94-9343

Phase 1

Gantenerumab

Phase 1

Gantenerumab

Phase 1

OMP-18R5

Phase 1

NOV-3

Phase 2

NOV-3

Phase 2

CNTO888

Phase 2

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.

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

Email [email protected]

31st annual j.p. morgan healthcare conference...bay94-9343 bayer healthcare mesothelin (adc) cancer...

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