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Company Update November 2012 © MorphoSys - November 2012

121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

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Page 1: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Company Update

November 2012

© MorphoSys - November 2012

Page 2: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Safe Harbour

© MorphoSys - November 2012

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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Page 3: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Components of the Business

© MorphoSys - November 2012

Technology-driven Alliances

Proven HuCAL platform

Ylanthia launched

Collaboration with Lanthio Pharma

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

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Page 4: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Pipeline Gathering Momentum

© MorphoSys - November 2012

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

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Page 5: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Innovative Product Pipeline

© MorphoSys - November 2012 5

Page 6: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3Gantenerumab Roche Amyloid-ß Alzheimer’s DiseaseMOR103 (2 programs) - GM-CSF Rheumatoid Arthritis

Multiple sclerosisCNTO888 Janssen/J&J MCP-1 (CCL-2) IPFCNTO1959(2 programs) Janssen/J&J IL23p19 Psoriasis

RABHQ880 Novartis DKK-1 CancerBYM338 Novartis - MusculoskeletalNOV – 3 Novartis - not discl.NOV – 4 Novartis - OphthalmologyOMP-59R5 OncoMed/GSK Notch 2 CancerMOR208 - CD19 CLLMOR202 - CD38 MMBAY94-9343 Bayer Healthcare Mesothelin (ADC) CancerBI – 1 BI - not discl.CNTO3157 Janssen/J&J - AsthmaCNTO – 5 Janssen/J&J - InflammationNOV – 5 Novartis - InflammationNOV – 6 Novartis - CancerOMP-18R5 OncoMed/Bayer Fzd 7 CancerPFE – 1 Pfizer - Cancer

21 Programs Various Partners - Various Indications

34 Programs Various Partners - Various Indications

76 Therapeutic Antibody Programs21 Programs in Clinical Development

© MorphoSys - November 2012

70 Partnered Programs6 Proprietary Programs

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Page 7: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR103A Novel Anti-Inflammatory Antibody

© MorphoSys - November 2012

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

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Page 8: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR103Phase 1b/2a Trial in Rheumatoid Arthritis

© MorphoSys - November 2012

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

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Page 9: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

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

© MorphoSys - November 2012

ACR20 Response at week 4 (FAS population)

% o

f pa

tien

ts

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

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Page 10: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

ACR20 Scores Compare Favorably to Other Biological DMARDs

© MorphoSys - November 2012

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 pa

tien

ts

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

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Page 11: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR103Safe & Well-tolerated at All Doses

© MorphoSys - November 2012

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

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Page 12: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR103Looking Ahead

© MorphoSys - November 2012

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

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Page 13: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR208 (XmAb5574)A Novel Anti-Cancer Antibody

© MorphoSys - November 2012

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

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Page 14: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR208 Has Compelling Prospects

© MorphoSys - November 2012

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

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Page 15: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

MOR202A Novel Antibody for Multiple Myeloma

© MorphoSys - November 2012

Large Market and Unmet Need

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

Clinical Development

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

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Page 16: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Gantenerumab: A HuCAL Antibody Being Developed by Roche for Alzheimer’s Disease

© MorphoSys - November 2012

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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Page 17: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Gantenerumab is the Most Advanced Antibody in Prodromal AD Patients

© MorphoSys - November 2012

Gantenerumab

High affinity HuCAL antibody targeting amyloid-β

Binds & breaks down amyloid-β fibrils and plaques

Clinical Development

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 1Effect of gantenerumab on

amyloid load as indexed by PET SUVR at end of treatment

% Am

yloi

d ch

ange

from

bas

elin

e

17

Page 18: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Technology-driven Alliances

© MorphoSys - November 2012 18

Page 19: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Proprietary Technology Platform Underpins Lucrative Alliances

© MorphoSys - November 2012

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 fundingTechnology licence feesMilestones and royalties

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Page 20: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Commercial Launch of Ylanthia

© MorphoSys - November 2012

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

Page 21: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Technology Alliance on New Class of Therapeutic Peptides

© MorphoSys - November 2012 21

MorphoSys and Lanthio Pharma Sign Technology Alliance on New Class of Therapeutic Peptides Lanthio Pharma is focused on discovering and developing

lantipeptides (constrained peptides) Lantipeptides comprise a novel class of therapeutics

with high target selectivity and improved drug-like properties

The companies will jointly apply their respective technologies to establish high quality and diverse lantipeptide-based libraries

Peptides: Where‘s the Niche? Constrained peptides can be positioned between small

molecules and biological drugs

First transaction combining collaborative aspects and a corporate VC-like investment

Lanthio Pharma Groningen,

Holland Founded:

2010

Series A financing: BioGeneration

Ventures INKEF Capital MorphoSys Hanzepoort

Page 22: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

AbD Serotec

© MorphoSys - November 2012 22

Page 23: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

AbD Serotec Segment Complements Therapeutic Business

© MorphoSys - November 2012

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 ApplicationsResearch Activities

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Page 24: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Strong Financials

© MorphoSys - November 2012 24

Page 25: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Key Financials

© MorphoSys - November 2012

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

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Page 26: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Shareholdings

© MorphoSys - November 2012

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

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

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Page 27: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Forthcoming Pipeline Developments

© MorphoSys - November 2012

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

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Page 28: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

Appendix

© MorphoSys - November 2012

Page 29: 121129 MOR Company Update web...Advanced to Phase 3 development for Alzheimer’s Disease by Hoffmann La Roche Solanezumab results provide support for Roche trial design Selected by

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-LöserHead of Corporate Communications & IR

Phone +49 (0)89 / 899 27-122Fax +49 (0)89 / 899 27-5122Email [email protected]

Thank You

www.morphosys.com