deutsches eigenkapitalforum 2012 - morphosys...26 sites in holland, germany, poland, bulgaria &...

Company Update Deutsches Eigenkapitalforum 2012

November 13, 2012

© MorphoSys - Deutsches Eigenkapitalforum - November 13, 2012

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

Components of the Business


Technology-driven Alliances

Proven HuCAL platform

Ylanthia launched

Innovative Product Pipeline

MOR103 shows excellent

safety and efficacy in RA

Partner Phase 2 read-outs

coming

21 clinical programs

AbD Serotec

Emerging diagnostics

business

Research antibody

catalog

Financially Strong

Sustainably cash-flow

positive

Strong balance sheet

3

Pipeline Gathering Momentum


MOR103

Excellent clinical proof-of-concept and safety data generated in rheumatoid

arthritis Phase 1b/2a trial

MOR208

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

Gantenerumab

Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche

Solanezumab results provide support for Roche trial design

Selected by Dominantly-Inherited Alzheimer Network (DIAN) for world-wide trial in

early-onset AD

CNTO1959

Janssen commences Phase 2 RA comparison study with Stelara®

BYM338

Novartis completes Phase 2 study in sporadic inclusion body myositis

OMP-59R5

Oncomed commences Phase 1b/2 trial in first-line advanced pancreatic cancer

4

Innovative Product Pipeline

© MorphoSys - Deutsches Eigenkapitalforum - November 13, 2012 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 - Musculoskeletal

NOV – 3 Novartis - not discl.

NOV – 4 Novartis - Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL

MOR202 - CD38 MM

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

NOV – 5 Novartis - Inflammation

NOV – 6 Novartis - Cancer

OMP-18R5 OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

21 Programs Various Partners - Various Indications

34 Programs Various Partners - Various Indications

76 Therapeutic Antibody Programs

21 Programs in Clinical Development


70 Partnered Programs

6 Proprietary Programs

6

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 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

MOR103 1.0mg

MOR103 1.5mg

MOR103 Shows Impressive Efficacy & Fast

Onset of Action


ACR20 Response at week 4 (FAS population)

% o

f pati

ents

FAS: Full Analysis Set, N= 96

p<0.0001

ACR20 ranks amongst highest observed

for a biologic in RA after 4 weeks

Very fast onset of therapeutic effect

within 2 weeks

Robust and durable responses 10

weeks beyond treatment

Imaging confirms anti-inflammatory

activity

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

MOR103 1.5 mg/kg

mavrilimumab

adalimumab

abatacept

tocilizumab in TNF-IR

Time (weeks)

% o

f pati

ents

ACR20 Response over 4 weeks*

Level of efficacy and speed of onset exceed those seen for mavrilimumab,

adalimumab (Humira), abatacept (Orencia) and tocilizumab (Actemra)

* Data from separate clinical studies

10

MOR103

Safe & Well-tolerated at All Doses


Serious Adverse Events (SAEs)

No treatment-related SAEs in the active treatment groups

Related adverse events (AEs)

More frequent in placebo group (25.9%) than in active treatment group (14.5%)

Most common AEs (≥6%) were nasopharyngitis, RA flare, fatigue and hypertension

Majority of AEs were of mild intensity

One patient on placebo discontinued treatment due to an AE

11

MOR103

Looking Ahead


Rheumatoid arthritis

Expect even higher efficacy on

longer treatment

development in moderate to severe patients

Potential for dosing monthly or even less frequently

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

Sub-cutaneous formulation

Phase 1 study in healthy volunteers confirms feasibility of subcutaneous administration

Partnering

Discussions ongoing

12

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

Relapsing patients have limited treatment options

Phase 2 data for blinatumomab validate CD19 as

target for B-cell malignancies

MOR208

Humanized, high affinity anti-CD19 antibody

Exclusive license from Xencor

Antibody comprises a proprietary Xencor modification

of the Fc part of the antibody leading to rapid and

sustained B-cell depletion

13

MOR208 Has Compelling Prospects


MOR208 Has An Attractive Competitive Profile

Expect convenient dosing schedule

Straightforward manufacturing

Potential for good safety profile

Significantly increased ADCC compared to unmodified antibody

Clinical Development

Preclinical data show synergistic effects on target cell killing in

combination therapies with existing drugs

Phase 1, in relapsed or refractory CLL/SLL patients, to be

presented at ASH 2012:

Favorable safety profile

3/27 partial responses and 22/27 patients with stable disease

Results from trial extension expected in Q1 2013

Phase 2: Trials in B cell malignancies starting Q4 2012

14

MOR202

A Novel Antibody for Multiple Myeloma



Revenues with approved drugs in MM exceed $2bn, but

median survival is only 3-5 years

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 to be presented at ASH


Phase 1, in relapsed or refractory MM patients ongoing

Phase 2a, monotherapy extension

Phase 1b, MOR202 + Velcade

Phase 1b, MOR202 + Revlimid

Up to 82 patients, at sites in Germany and Austria

15

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 is the Most Advanced Antibody

in Prodromal AD Patients


Gantenerumab

High affinity HuCAL antibody targeting amyloid-β

Binds & breaks down amyloid-β fibrils and plaques


Phase 1, in patients completed

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

Initial data expected in 2015: favorable

outcome could support a marketing application

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

MorphoSys 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

AbD Serotec


AbD Serotec Segment Complements

Therapeutic Business


Catalogue of 15,000+ products

Stable and recurring cash flows

Customers comprise universities,

government bodies, life science

companies

Website, eCommerce

Custom antibody generation

Using proprietary technologies to deliver

superior Dx antibodies

Future upside via royalties

Working with over 20 Dx companies

HuCAL – Diagnostic Applications Research Activities

22

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

24

Shareholdings


Shares issued: 23,308,622 (September 30, 2012)

Treasury stock: 255,415 (September 30, 2012)

25

Forthcoming Pipeline Developments


Proprietary Portfolio

MOR103 phase 1b/2a data at ACR 2012 (November)

MOR208 phase 1 data at ASH 2012 (December)

MOR208 data from extended dose group (Q1 2013)

MOR202 interim data from phase 1 open label study

Partnered Pipeline

Several Phase 2 studies to complete shortly

BHQ880 (Novartis, oncology to be presented at ASH)

CNTO888 (Janssen Biotech, IPF)

BYM338 (Novartis, musculoskeletal diseases)

NOV-3 (n.d.)

NOV-4 (ophthalmology)

Roche hints at interim analysis of gantenerumab Phase 3 study

during 2013

* MorphoSys estimates based on publicly-available information

26

Thank You

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.

www.morphosys.com

Jens Holstein Chief Financial Officer

Phone +49 (0)89 / 899 27-439 Fax +49 (0)89 / 899 27-5439

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]

deutsches eigenkapitalforum 2012 - morphosys...26 sites in holland, germany, poland, bulgaria &...

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