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Company Update - MorphoSys

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<strong>Company</strong> <strong>Update</strong><br />

March 2012


Safe Harbour<br />

This presentation includes forward-looking statements.<br />

Actual results could differ materially from those included in the forward-looking statements<br />

due to various risk factors and uncertainties including changes in business, economic<br />

competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the<br />

availability of financing.<br />

These and other risks and uncertainties are detailed in the <strong>Company</strong>’s Annual Report.


Business Strategy<br />

Proprietary products<br />

Lucrative upside<br />

Partnerships<br />

Strong current cash-flow plus substantial<br />

upside through milestones & royalties<br />

Technology Powerful proprietary<br />

technology platform drives<br />

partnered programs…<br />

and increasingly, proprietary<br />

product development<br />

© <strong>MorphoSys</strong> AG<br />

Page 3


Maturing Pipeline Illustrates Successful<br />

Execution of Strategy<br />

Programs<br />

25<br />

20<br />

15<br />

10<br />

5<br />

0<br />

8<br />

4<br />

4<br />

17<br />

11<br />

6<br />

20<br />

20<br />

12 11<br />

2009 2010 2011 as of today<br />

Total Phase 1 Phase 2<br />

8<br />

9<br />

� 20 clinical programs ongoing<br />

� 16 with seven different partners<br />

� 4 proprietary, un-partnered programs<br />

� Disease areas include cancer,<br />

inflammation, CNS, ophthalmology,<br />

musculoskeletal, and others<br />

© <strong>MorphoSys</strong> AG<br />

Page 4


Strong Track Record of Technological<br />

Innovation<br />

2001<br />

HuCAL<br />

30 commercial<br />

partnerships<br />

>€450 million<br />

revenues to date<br />

Most successful<br />

antibody library<br />

technology<br />

2010 2010<br />

Slonomics<br />

Generation of<br />

customized protein<br />

libraries<br />

4 deals since<br />

acquisition<br />

arYla Ylanthia<br />

Optimization of any<br />

therapeutic or<br />

diagnostic antibody<br />

2012<br />

Next-generation<br />

antibody library<br />

extends technology<br />

leadership<br />

© <strong>MorphoSys</strong> AG<br />

Page 5


Slonomics:<br />

Multiple Opportunities Beyond Antibodies<br />

6<br />

Slonomics<br />

Rx<br />

Proteins<br />

Research<br />

&<br />

Dx<br />

Industrial<br />

Enzymes<br />

� e.g. Pfizer deal<br />

(2010)<br />

� Second deal<br />

(2012)<br />

� e.g. Novozymes<br />

deal (2011)<br />

� e.g. Dana-Farber<br />

alliance (2011)<br />

© <strong>MorphoSys</strong> AG<br />

Page 6


76 Therapeutic Antibody Programs Ongoing,<br />

20 in Clinical Trials<br />

Program Partner Indication Discovery Pre-clinic Phase 1 Phase 2<br />

MOR103 (2 programs) -<br />

Rheumatoid arthritis,<br />

Multiple sclerosis<br />

CNTO888 (2 programs) Janssen Biotech/J&J Cancer,<br />

Idiopathic pulmonary fibrosis<br />

CNTO1959 Janssen Biotech/J&J Psoriasis<br />

BHQ880 Novartis Cancer<br />

BYM338 Novartis Musculoskeletal<br />

NOV – 3 Novartis not discl.<br />

NOV – 4 Novartis Ophthalmology<br />

Gantenerumab Roche Alzheimer’s Disease<br />

MOR208 - Cancer<br />

MOR202 - Cancer<br />

BAY94-9343 (ADC) Bayer HealthCare Cancer<br />

BI – 1 Boehringer Ingelheim not discl.<br />

CNTO3157 Janssen Biotech/J&J Asthma<br />

CNTO – 5 Janssen Biotech/J&J Inflammation<br />

NOV – 5 Novartis Inflammation<br />

OMP-18R5 Oncomed Cancer<br />

OMP-59R5 Oncomed Cancer<br />

PFE – 1 Pfizer Cancer<br />

24 Partnered Programs Various Partners Various Indications<br />

32 Programs, incl.<br />

2 co-dev with Novartis<br />

Various Partners Various Indications<br />

New<br />

New<br />

New<br />

New<br />

68 Partnered Programs<br />

8 Proprietary Programs<br />

New in 2011/2012<br />

© <strong>MorphoSys</strong> AG<br />

New<br />

New<br />

New<br />

Page 7


Current Pipeline<br />

Projected HuCAL Drugs on the Market<br />

Discovery Preclinic Phase 1 Phase 2 Phase 3 Market<br />

32<br />

50% 70% 40% 65%<br />

Projection from today’s pipeline:<br />

24<br />

Success probability of 11%<br />

Projected number of marketed HuCAL drugs from today’s pipeline: 14<br />

Source: <strong>MorphoSys</strong> internal statistics & Tufts Centre for the Study of Drug Development<br />

Success probability of 18%<br />

11 Success probability of 25%<br />

9 Success probability of 33% 3<br />

© <strong>MorphoSys</strong> AG<br />

4<br />

4<br />

3<br />

Page 8


MOR103<br />

New Mode of Action in Inflammation<br />

The Drug<br />

� Ultra-high affinity HuCAL IgG1 targeting GM-CSF<br />

Market<br />

� Large commercial potential in inflammatory<br />

conditions including RA, MS, & others<br />

� Revenues with approved biologics in RA in 2010<br />

exceeded USD15bn<br />

Intellectual Property<br />

� Exclusive license to a US patent covering anti-<br />

GM-CSF antibodies for the treatment of chronic<br />

inflammatory conditions<br />

� US patent on MOR103 composition of matter<br />

Development<br />

� European phase 1b/2a trial in RA fully recruited,<br />

data expected Q3 2012<br />

� Ph1b safety study in MS patients initiated in Q4/11<br />

� PK study for sc administration initiated in Q1/12<br />

Phase 2 data for mavrilimumab, vs. GM-CSF<br />

receptor, provides clinical validation of the<br />

pathway in rheumatoid arthritis<br />

Proportion of subjects achieving a change of 1.2 from<br />

baseline in DAS28-CRP<br />

Source: ACR2011 Abstract: Mavrilimumab (an Anti-GM-CSFRα<br />

Monoclonal Antibody) in Subjects with Rheumatoid Arthritis:<br />

Results of a Phase 2 Randomized, Double-Blind, Placebo-<br />

Controlled Study<br />

http://acr.confex.com/acr/2011/webprogram/Paper24567.html<br />

© <strong>MorphoSys</strong> AG<br />

Page 9


GM-CSF is a Key Target in the<br />

Pathophysiology of Inflammatory Diseases<br />

Adapted from:<br />

Hamilton JA, (2008) Nat Rev Immunol. 8:533-44<br />

© <strong>MorphoSys</strong> AG<br />

Page 10


MOR103<br />

European Phase 1b/2a Trial in RA<br />

Trial<br />

A Study of the safety and preliminary efficacy of MOR103, a human antibody to<br />

granulocyte macrophage colony-stimulating factor (GM-CSF)<br />

Patients Patients with active rheumatoid arthritis<br />

Study Design<br />

Randomized, double-blind, placebo-controlled, multi-center dose-escalation<br />

study (three groups with 0.3/1.0/1.5 mg/kg) of MOR103 on background of stable<br />

regimen of concomitant RA therapy (NSAIDs, steroids, non- biological<br />

DMARDs)<br />

Primary Endpoint Adverse event rate and safety profile<br />

Secondary Endpoints<br />

Study Details<br />

DAS28, ACR core set measures and EULAR28 response criteria, hematology,<br />

blood chemistry, Ig levels, cytokines, synovitis, bone edema<br />

� 96 patients<br />

� Sites in Germany, The Netherlands, Bulgaria, Poland, Ukraine<br />

� Inclusion of MRI to detect an effect on inflammatory changes such as<br />

synovitis or bone edema<br />

� Results in Q3 2012<br />

© <strong>MorphoSys</strong> AG<br />

Page 11


MOR103<br />

European Phase 1b Trial in MS<br />

Trial<br />

Patients<br />

Study Design<br />

Phase Ib study to evaluate the safety and pharmacokinetics of MOR103, a<br />

human antibody to GM-CSF, in patients with multiple sclerosis (MS)<br />

Patients with relapsing-remitting or secondary progressive MS (RRMS or<br />

SPMS)<br />

A randomized, double-blind, placebo-controlled study (three groups with<br />

0.5/1.0/2.0 mg/kg; 6 doses) to evaluate the safety and pharmacokinetics of<br />

MOR103, a human antibody to GM-CSF, in patients with multiple sclerosis<br />

Primary Endpoint Incidence and severity of adverse events<br />

Secondary Endpoints<br />

Study Details<br />

� Pharmacokinetic profile<br />

� Potential immunogenicity<br />

� 30 patients<br />

� Sites in Germany, Poland, UK<br />

� Results expected in 2013<br />

© <strong>MorphoSys</strong> AG<br />

Page 12


MOR208 (XmAb5574) – A Novel<br />

High-Potential Anti-Cancer Antibody<br />

The Drug<br />

� Humanized, high affinity anti-CD19 antibody,<br />

exclusive license from Xencor<br />

� Comprises a proprietary Xencor modification<br />

leading to rapid and sustained B-cell depletion<br />

Market<br />

� High unmet medical need in NHL, CLL & ALL<br />

Competitive Profile<br />

� Expect convenient dosing schedule<br />

� Straightforward manufacturing<br />

� Potential for good safety profile<br />

� Significantly increased ADCC compared to<br />

rituximab in vitro<br />

Development<br />

� Completion of phase 1 in CLL and reporting of<br />

interim data H2/12<br />

� Initiation of additional trials in B cell<br />

malignancies in 2012<br />

© <strong>MorphoSys</strong> AG<br />

Page 13


MOR208 (XmAb5574)<br />

Phase 1 Trial in the US<br />

Trial Safety and tolerability of MOR208 (XmAb5574) in Chronic Lymphocytic Leukemia<br />

Patients Patients with relapsed or refractory CLL/SLL<br />

Study Design<br />

� MOR208/XmAb5574 (humanized, Fc-engineered, anti-CD19 IgG1 antibody)<br />

� Open-label, multi-dose, single-arm, Phase 1, dose-escalation study<br />

Primary Endpoint To determine the dose limiting toxicities (time frame 28 days)<br />

Study Details<br />

� 30 patients<br />

� Identification of the maximum tolerated dose (MTD) and/or recommended<br />

dose(s) (RD) for further study<br />

� Characterization of safety and tolerability, PK, PD and immunogenicity<br />

� Evaluation of preliminary antitumor activity of XmAb5574 in patients with<br />

relapsed or refractory CLL/SLL<br />

� Study sponsored by Xencor, Inc.<br />

© <strong>MorphoSys</strong> AG<br />

Page 14


MOR202 – A Novel High-Potential Antibody<br />

for Multiple Myeloma<br />

The Drug<br />

� High affinity HuCAL antibody targeting CD38<br />

The Market<br />

� High unmet medical need in MM, accounting for<br />

approximately 1% of all cancers.<br />

� Median survival is approximately 3-5 years<br />

Competitive Profile<br />

� Use of targeted therapy in combination with standard<br />

regimens in myeloma can minimize adverse events<br />

while increasing efficacy<br />

� MOR202 monotherapy shows a dose-dependent<br />

reduction of multiple myeloma graft induced bone<br />

lysis (pre-clinical studies)<br />

� MOR202 plus bortezomib or lenalidomide<br />

synergistically inhibits bone lysis and substantially<br />

reduces M protein levels<br />

(pre-clinical studies)<br />

Development<br />

� Study to last until January 2015, interim reporting<br />

planned<br />

MOR202 / BOR<br />

MOR202 / LEN<br />

% lysis of vehicle control<br />

% lysis of vehicle control<br />

110<br />

100<br />

90<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Non-inoculated<br />

110<br />

100<br />

90<br />

80<br />

70<br />

60<br />

50<br />

40<br />

30<br />

20<br />

10<br />

0<br />

Non-inoculated<br />

Bone lysis<br />

Vehicle<br />

MOR202 3mg/kg<br />

Vehicle<br />

0.6mg/kg BOR<br />

MOR202+BOR (3+0.6mg/kg)<br />

MOR202 3mg/kg<br />

LEN 50mg/kg<br />

MOR202+LEN (3+50mg/kg)<br />

normalised M protein level<br />

normalised M protein level<br />

1.4<br />

1.2<br />

1.0<br />

0.8<br />

0.6<br />

0.4<br />

0.2<br />

0.0<br />

1.6<br />

1.4<br />

1.2<br />

1.0<br />

0.8<br />

0.6<br />

0.4<br />

0.2<br />

0.0<br />

Vehicle<br />

MOR202 3mg/kg<br />

Vehicle<br />

© <strong>MorphoSys</strong> AG<br />

BOR 0.6mg/kg<br />

MOR202+BOR (3+0.6mg/kg)<br />

MOR202 3mg/kg<br />

M protein<br />

LEN 50mg/kg<br />

MOR202+LEN (3+50mg/kg)<br />

MOR202/BOR and MOR202/LEN combination<br />

therapy is superior to the respective mono therapies<br />

Page 15


MOR202<br />

European Phase 1/2a Trial<br />

Trial<br />

A phase I/IIa, open-label, multicentre, dose-escalation study to evaluate the safety<br />

and preliminary efficacy of the human anti-CD38 antibody MOR202 as monotherapy<br />

and in combination with standard therapy in subjects with relapsed/refractory multiple<br />

myeloma<br />

Patients Patients relapsed/refractory multiple myeloma; failure of at least 2 prior therapies<br />

Study Design<br />

Primary<br />

Endpoint<br />

Secondary<br />

Endpoints<br />

Study Details<br />

• MOR202 (anti-CD38 HuCAL IgG1 antibody)<br />

• Phase I dose escalation (iv administration of MOR202 for up to 2 cycles)<br />

• Phase IIa monotherapy extension (iv administration of MOR202 for up to 4 cycles)<br />

• Phase Ib MOR202 combined with bortezomib<br />

• Phase Ib MOR202 combined with lenalidomide<br />

• Determination of MTD and / or recommended dose (up to 20 weeks)<br />

• Safety & immunogenicity<br />

• Pharmacokinetics of MOR202<br />

• Overall response rate (standard response criteria, serum M protein levels)<br />

• Up to 82 patients<br />

• Study sites in Germany & Austria<br />

© <strong>MorphoSys</strong> AG<br />

Page 16


AbD Serotec Segment Complements<br />

Therapeutic Business<br />

Research Activities<br />

� Catalogue of 15,000+ products<br />

� Stable and recurring cash flows<br />

� Customers comprise universities,<br />

government bodies, life science<br />

companies<br />

� Website, eCommerce<br />

HuCAL – Diagnostic Applications<br />

� Custom antibody generation<br />

� Using proprietary technologies to<br />

deliver superior Dx antibodies<br />

� Future upside via royalties<br />

� Collaborations with more than 20<br />

diagnostics companies<br />

© <strong>MorphoSys</strong> AG<br />

Page 17


FY2011: Income Statement<br />

in € million 2011 2010 Change<br />

Revenues 100.8 87.0 +16%<br />

Cost of Goods Sold 7.0 7.3<br />

Total Research and Development Expenses 57.5 46.9<br />

Sales, General & Administrative Expenses 24.6 23.2<br />

Total Operating Expenses 89.1 77.4 +15%<br />

Other Operating Income 0.5 0.2<br />

Profit from Operations 12.2 9.8 +24%<br />

Finance Income 1.4 4.1<br />

Other Expenses 2.1 0.8<br />

Profit before Taxes 11.4 13.2 -14%<br />

Income Tax Expenses 3.2 4.0<br />

Net Profit 8.2 9.2 -11%<br />

EPS (diluted) 0.36 0.40<br />

© <strong>MorphoSys</strong> AG<br />

Page 18


Balance Sheet and Shareholder Structure<br />

EUR millions<br />

Assets<br />

Cash, Cash Equivalents &<br />

Marketable Securities<br />

Balance Sheet<br />

Dec. 31,<br />

2011<br />

Dec. 31,<br />

2010<br />

134.4 108.4<br />

Other Current Assets 20.3 24.1<br />

Total Non-Current Assets 73.7 77.3<br />

Total Assets 228.4 209.8<br />

Liabilities<br />

Total Current Liabilities 23.8 21.4<br />

Total Non-Current Liabilities 7.5 2.5<br />

Total Shareholders’ Equity 197.1 185.9<br />

Total Liabilities 228.4 209.8<br />

Shareholdings by Investor Type (12/2011)<br />

Treasury Stock<br />

0.7%<br />

Unidentified<br />

23%<br />

Novartis<br />

6.4%<br />

Retail Investors<br />

22%<br />

Management &<br />

Supervisory Boards<br />

1.9%<br />

Institutional<br />

Investors<br />

46%<br />

Shares issued: 23,112,167 (Dec. 31, 2011)<br />

© <strong>MorphoSys</strong> AG<br />

Page 19


Guidance 2012<br />

in € million 2012 2011<br />

Group Revenues 75 – 80 100.8<br />

Investment into Proprietary R&D 20 – 25 36.7<br />

Group EBIT 1 – 5 11.1<br />

in € million 2012 2011<br />

AbD Serotec Segment Revenues<br />

(at constant currency)<br />

AbD Serotec EBIT Margin<br />

(at constant currency)<br />

20 – 22 19.3<br />

~ 6% – 8% 5%<br />

© <strong>MorphoSys</strong> AG<br />

Page 20


Proprietary Clinical Programs to Advance<br />

Significantly in 2012<br />

RA<br />

MOR103<br />

Enrollment completed<br />

in phase 1b/2a trial in<br />

rheumatoid arthritis<br />

Data in Q3 2012<br />

SC<br />

MS<br />

MOR103<br />

Phase 1b trial in<br />

multiple sclerosis<br />

initiated in Q4 2011<br />

Data in 2013<br />

CLL<br />

MOR208<br />

Enrollment target<br />

nearly hit in phase 1<br />

trial<br />

Data in H2 2012<br />

MM<br />

MOR202<br />

Phase 1/2a trial<br />

initiated in Q3 2011<br />

Combination arms to<br />

start in 2013<br />

© <strong>MorphoSys</strong> AG<br />

Page 21


A Wealth of Clinical Data is Imminent<br />

NOV – 2 (Ophthalmology)<br />

CNTO – 1 (Inflammation)<br />

CNTO888 (Cancer)<br />

BYM338 (Musculoskeletal)<br />

CNTO3157 (Asthma)<br />

MOR208 (CLL)<br />

BHQ880 (Cancer)<br />

CNTO888 (IPF)<br />

OMP18-R5 (Cancer)<br />

OMP59-R5 (Cancer)<br />

MOR103 (RA)<br />

BYM338 (Musculoskeletal)<br />

NOV – 3 (n.d.)<br />

NOV – 3 (n.d.)<br />

NOV – 4 (Ophthalmology)<br />

PFE – 1 (Cancer)<br />

CNTO1959 (Psoriasis)<br />

BI – 1 (n.d.)<br />

BHQ880 (Cancer)<br />

NOV – 4 (Ophthalmology)<br />

NOV – 4 (Ophthalmology)<br />

NOV – 3 (n.d.)<br />

H2 2011 H1 2012 H2 2012 H1 2013<br />

light colors: phase 1<br />

dark colors: phase 2<br />

© <strong>MorphoSys</strong> AG<br />

PoC in 2012<br />

Page 22


Appendix


Novartis Alliance: Landmark Deal<br />

Timeline<br />

Novartis pays…<br />

� May 2004: Initial deal, including equity stake<br />

� November 2007: Major expansion<br />

� November 2017: End, subject to 2-year extension option<br />

� Approx. €20m p.a. technology license including HuCAL internalization fees<br />

� Approx. €20m p.a. in research funding<br />

� Over €250m milestones (probability adjusted)<br />

� Royalties on all resulting drugs<br />

Novartis gets… � Preferred access to HuCAL for use in over 100 discovery programs<br />

Co-development<br />

option<br />

� Shared costs & profits (20% – 50%) on selected co-developed programs<br />

Excluded � Most infectious disease targets<br />

© <strong>MorphoSys</strong> AG<br />

Page 24


Partnerships: Typical Terms per Program<br />

€9m - €12m<br />

Phase 1 milestone<br />

Exclusive license fee; R&D funding<br />

<strong>MorphoSys</strong> costs<br />

Royalties<br />

(mid single<br />

digits)<br />

Phase 3 milestone<br />

Discovery Preclinic Phase 1 Phase 2 Phase 3 Market<br />

© <strong>MorphoSys</strong> AG<br />

Biologics<br />

License<br />

Application<br />

+<br />

Approval<br />

milestones<br />

Page 25


Partnered Programs<br />

Phase 2 Clinical Development<br />

Program Partner Disease Target Status<br />

CNTO888<br />

CNTO888<br />

CNTO1959<br />

Janssen<br />

Biotech<br />

Janssen<br />

Biotech<br />

Janssen<br />

Biotech<br />

Oncology<br />

Idiopathic<br />

pulmonary<br />

fibrosis<br />

CCL2<br />

(MCP-1)<br />

CCL2<br />

(MCP-1)<br />

Two trials ongoing, one trial completed<br />

Novel approach to IPF<br />

Psoriasis IL23p19 Phase 2 trial started in December 2011<br />

n.d. Novartis n.d. n.d. Clinical proof of concept achieved<br />

n.d. Novartis Ophthalmology n.d. Phase 2 trial started in January 2012<br />

BHQ880 Novartis<br />

Osteolytic bone<br />

disease<br />

DKK-1<br />

Early data show stimulation of bone<br />

formation<br />

BYM338 Novartis Musculoskeletal n.d. Two phase 2 trials ongoing<br />

Gantenerumab Roche<br />

Alzheimer‘s<br />

disease<br />

Amyloid-b<br />

Only anti-Aβ antibody being developed<br />

in patients with prodromal AD<br />

© <strong>MorphoSys</strong> AG<br />

Page 26


Partnered Programs<br />

Phase 1 Clinical Development<br />

Program Partner Disease Phase 1 Start<br />

BAY94-9343 Bayer Oncology September 2011<br />

n.d. Boehringer Ingelheim n.d. December 2010<br />

CNTO3157 Janssen Biotech Asthma June 2010<br />

n.d. Janssen Biotech Inflammation / Autoimmune December 2010<br />

n.d. Novartis Inflammation December 2010<br />

OMP-18R5 Oncomed Oncology April 2011<br />

OMP-59R5 Oncomed Oncology December 2010<br />

n.d. Pfizer Oncology December 2010<br />

© <strong>MorphoSys</strong> AG<br />

Page 27


Carlumab (CNTO 888): CCL2 Specific<br />

Antibody in Oncology<br />

A Study of the Safety and Efficacy of CNTO 888 in<br />

Combination With Standard of Care Chemotherapy in<br />

Patients With Solid Tumors<br />

Status Phase 1 (completed)<br />

Study Design Non-randomized, open-label safety study<br />

Study Start Date May 2010<br />

Completion Date n.d.<br />

Enrollment 53<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Treatment<br />

Period<br />

The primary objective of the study is to<br />

evaluate the safety of CNTO 888 when<br />

administered to patients with solid tumors in<br />

combination with 4 standard of care<br />

chemotherapy regimens (docetaxel;<br />

gemcitabine; Paclitaxel and carboplatin; or<br />

DOXIL®/ Caelyx® doxorubicin HCl liposome<br />

injection)<br />

� Pharmacokinetics [during study as specified in<br />

the protocol and at End of Study (1 year)]<br />

� Pharmacodynamics [during study as specified<br />

in the protocol and at End of Study (1 year)]<br />

Combination therapy will be continued until<br />

disease progression, unacceptable toxicity, the<br />

patient refuses further combination therapy,<br />

withdraws consent, or is treated for 1 year<br />

A Study of the Safety and Efficacy of Single-agent CNTO 888<br />

(an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With<br />

Metastatic Prostate Cancer<br />

Status Phase 2 (completed)<br />

Study Design Non-randomized, open-label safety/efficacy study<br />

Study Start Date September 2009<br />

Completion Date July 2011<br />

Enrollment 46<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Treatment<br />

Period<br />

The primary objective of the study is to determine<br />

the composite response in patients with<br />

metastatic castrate-resistant prostate cancer<br />

(CRPC) who receive single-agent 15 mg/kg<br />

CNTO 888 every 2 weeks (Time Frame: 3-6<br />

months)<br />

� Objective response rate determined as complete<br />

response and partial response according to<br />

Response Evaluation Criteria in Solid Tumors<br />

(RECIST) guidelines<br />

� Progression Free Survival<br />

� Overall Survival<br />

15mg/kg intravenously every 2 weeks until<br />

disease progression<br />

© <strong>MorphoSys</strong> AG<br />

Page 28


Carlumab (CNTO 888): CCL2 Specific<br />

Antibody in Idiopathic Pulmonary Fibrosis<br />

A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic<br />

Pulmonary Fibrosis (IPF)<br />

Status Phase 2 (active, not recruiting)<br />

Study Design Randomized, double-blinded safety/efficacy study<br />

Study Start Date December 2008<br />

Completion Date June 2012<br />

Enrollment 129<br />

Primary Outcome Measures<br />

Secondary Outcome Measures<br />

Treatment Period<br />

The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of<br />

CNTO 888 in subjects with IPF.<br />

To assess the effect of CNTO888 on measures of disease progression, patient reported outcomes,<br />

functional capacity and health-related quality of life, and to assess the pharmacokinetics/ pharmacodynamics<br />

of CNTO888 in subjects with IPF.<br />

� Patients will receive study agent until Week 48 and will continue to be followed through Week 72 for<br />

assessment of safety and any other effects after discontinuation of therapy.<br />

� Patients will be in the study for about 74 weeks.<br />

� Group 1: placebo<br />

� Group 2: 1 g/kg CNTO888 every 4 weeks<br />

� Group 3: 5mg/kg CNTO888 every 4 weeks<br />

� Group 4: 15 mg/kg CNTO888 every 4 weeks<br />

© <strong>MorphoSys</strong> AG<br />

Page 29


CNTO1959: HuCAL Antibody for the<br />

Treatment of Patients with Psoriasis<br />

A Study to Evaluate CNTO 1959 in the Treatment of Patients<br />

With Moderate to Severe Plaque-type Psoriasis (X-PLORE)<br />

Status Phase 2 (recruiting)<br />

Study Design<br />

Study Start Date October 2011<br />

Completion Date February 2014<br />

Enrollment 280<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Treatment<br />

Randomized, double-blind, placebo-controlled<br />

study<br />

Physician's Global Assessment (PGA) score of<br />

cleared or minimal (Time Frame: Week 16);<br />

Overall assessment of induration, scaling, and<br />

erythema<br />

� Psoriasis Area and Severity Index (PASI) 75%<br />

or greater improvement from baseline<br />

(Time Frame: Week 16)<br />

� The difference in the PGA score of cleared (0)<br />

or minimal (1) response rate between CNTO<br />

1959 treatment groups and adalimumab treatment<br />

group (Time Frame: Weeks 16 and 40)<br />

� The change from baseline in Dermatology Life<br />

Quality Index (DLQI) (Time Frame: Week 16)<br />

� 5 groups: CNTO 1959 (5 mg / 15 mg / 50 mg /<br />

100 mg / 200 mg<br />

� Drug: Adalimumab<br />

� Drug: Placebo to CNTO 1959 (100 mg)<br />

A Study of the Safety, Tolerability, Pharmacokinetics, and<br />

Pharmacodynamics of CNTO 1959 Following a Single SC<br />

Administration in Japanese Participants With Moderate to<br />

Severe Plaque Psoriasis<br />

Status Phase 1 (recruiting)<br />

Study Design<br />

Study Start Date August 2011<br />

Completion Date June 2013<br />

Enrollment 32<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Treatment<br />

Randomized, double-blind, placebo-controlled<br />

study<br />

� The number and type of adverse events<br />

� Change in clinical laboratory values<br />

� Electrocardiogram<br />

� Changes or abnormalities in body systems<br />

� Axillary temperature<br />

� Pulse rate<br />

� Blood pressure (Time Frame: Up to 24 weeks)<br />

� Blood levels of CNTO 1959<br />

� Antibodies to CNTO 1959<br />

� Psoriasis Area and Severity Index (PASI)<br />

Physician's Global Assessment (PGA)<br />

� Drug: CNTO 1959 (10mg, 30mg, 100mg,<br />

300mg, subcutaneous use, ascending dosing<br />

for 24 weeks<br />

� Drug: Placebo<br />

© <strong>MorphoSys</strong> AG<br />

Page 30


BHQ880: DKK-1 Specific Antibody in<br />

Multiple Myeloma Associated Osteolysis<br />

A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients<br />

Status Phase 1/2 (active, not recruiting)<br />

Study Design Randomized, double-blinded safety/efficacy study<br />

Study Start Date January 2009<br />

Completion Date April 2012<br />

Enrollment 267<br />

Primary Outcome Measures<br />

Secondary Outcome Measures<br />

Treatment Period<br />

Time to first SRE and change in bone markers for bone resorption and formation (Time Frame: 9<br />

months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and<br />

standard anti-myeloma therapy<br />

� Characterize acute and chronic safety and tolerability of BHQ880<br />

� Characterize single-dose and repeated-dose pharmacokinetic profiles of BHQ880<br />

� Assess the potential immunogenicity of BHQ880<br />

� Characterize the binding kinetics of DKK1/BHQ880 complex (free&BHQ880 bound DKK1) in serum<br />

� Determine the pharmacodynamic effects of BHQ880 by measuring biochemical markers of bone<br />

formation, resorption, and metabolism in serum and urine<br />

� Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid<br />

� Group 1: Various intravenous doses (low) of BHQ880 (up to 20 mg/kg) in combination with<br />

zoledronic acid on day 1 of a 28-day cycle.<br />

� Goup 2: Various intravenous doses (medium) of BHQ880 (up to 20 mg/kg) in combination with<br />

zoledronic acid on day 1 of a 28-day cycle.<br />

� Group 3: Various intravenous doses (high) of BHQ880 (up to 20 mg/kg) in combination with<br />

zoledronic acid on day 1 of a 28-day cycle.<br />

� Group 4: Placebo in combination with zoledronic acid on day 1 of a 28-day cycle<br />

© <strong>MorphoSys</strong> AG<br />

Page 31


BHQ880: DKK-1 Specific Antibody in<br />

Multiple Myeloma Associated Osteolysis<br />

Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma<br />

Status Phase 2 (recruiting)<br />

Study Design Non-randomized, open-label study<br />

Study Start Date May 2011<br />

Completion Date March 2013<br />

Enrollment 40<br />

Primary Outcome Measures<br />

Secondary Outcome Measures<br />

Treatment Period<br />

Overall response rate (Complete Response + Partial Response + Minimal Response) of patients<br />

achieving an objective response (defined according to the IMWG uniform response criteria by the<br />

Frequency of response of serum or urine M-protein to BHQ880A (Time frame: at 6 months)<br />

� Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs,<br />

SAEs, clinical laboratory values (Time frame: From start of study until disease progression )<br />

� Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing<br />

BHQ880 levels in plasma (Time frame: Throughout the study until disease progression)<br />

� Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone<br />

biomarkers (Time frame: Throughout the study until disease progression)<br />

� Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT (Time frame: 6<br />

months and 12 months)<br />

� This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple<br />

myeloma with high risk of progression to active multiple myeloma<br />

� BHQ880 will be administered every 28 days in previously untreated patients.<br />

� Single arm<br />

© <strong>MorphoSys</strong> AG<br />

Page 32


BHQ880: DKK-1 Specific Antibody in<br />

Multiple Myeloma Associated Osteolysis<br />

Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency<br />

Status Phase 2 (recruiting)<br />

Study Design Randomized, double-blinded study<br />

Study Start Date May 2011<br />

Completion Date February 2016<br />

Enrollment 144<br />

Primary Outcome Measures<br />

Secondary Outcome Measures<br />

Treatment Period<br />

Effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients<br />

with untreated multiple myeloma and renal insufficiency in combination with bortezomib and<br />

dexamethasone (Time Frame: 18-month median time to first SRE assumed for the placebo arm)<br />

� Safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone<br />

� Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib (Determine the<br />

pharmacokinetic parameters for BHQ880 and bortezomib.<br />

� Evaluate the effect of BHQ880 on bone metabolism<br />

1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA),<br />

2) Change in bone strength, measured by quantitative computed tomography (qCT),<br />

� Determine the anti-myeloma effect of BHQ880 compared to placebo when used in combination with<br />

bortezomib and dexamethasone<br />

1) The overall response rate (partial response plus complete response);<br />

2) Progression-free survival following initiation of BHQ880<br />

The study will evaluate the effects of BHQ880 in patients with previously untreated multiple<br />

myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy.<br />

The primary objective of the study will be to evaluate the effect of BHQ880 in combination with<br />

bortezomib and dexamethasone, compared to placebo administered with the combination on the<br />

time to first Skeletal Related Event (SRE) on study.<br />

© <strong>MorphoSys</strong> AG<br />

Page 33


BYM338: HuCAL Antibody for the<br />

Unintentional Weight Loss in Cancer Patients<br />

Efficacy, Safety and Tolerability of BYM338 in Patients With<br />

Sporadic Inclusion Body Myositis<br />

Status Phase 2 (recruiting)<br />

Study Design<br />

Study Start Date August 2011<br />

Completion Date December 2011<br />

Enrollment 12<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Randomized, double-blind, placebo-controlled<br />

study<br />

Assessment of the affect of BYM338 on thigh<br />

muscle volume by MRI (time frame: 8 weeks)<br />

Assessment of the effect of BYM338 on muscle<br />

function by 'Timed Get Up and Go' test<br />

(Time frame: 8 weeks)<br />

Patients Patients with sporadic Inclusion Body Myositis<br />

Clinical Study of BYM338 for the Treatment of Unintentional<br />

Weight Loss in Patients With Cancer of the Lung or the<br />

Pancreas<br />

Status Phase 2 (recruiting)<br />

Study Design<br />

Study Start Date August 2011<br />

Completion Date September 2012<br />

Enrollment 50<br />

Primary<br />

Outcome<br />

Measures<br />

Secondary<br />

Outcome<br />

Measures<br />

Patients<br />

Randomized, double-blind, placebo-controlled<br />

study<br />

Increase in thigh muscle volume as measured by<br />

MRI (Time Frame: 8 Weeks)<br />

� 6 minute walk test (Time frame: 8 weeks)<br />

� Efficacy in treating unintentional weight loss<br />

(Time frame: 8 weeks)<br />

� Obtain pharmacokinetic data in this population<br />

(Time frame: 8 weeks)<br />

� Efficacy in improving total lean body mass<br />

(LBM) and total bone mineral content<br />

(Time frame: 8 weeks)<br />

� Improving physical activity and function<br />

(Time frame: 8 weeks)<br />

Patients With Stage IV Non-small Cell Lung<br />

Cancer or Stage III/IV Adenocarcinoma of the<br />

Pancreas<br />

© <strong>MorphoSys</strong> AG<br />

Page 34


Gantenerumab: Amyloid-ß Specific Antibody<br />

in Alzheimer‘s Disease<br />

A Study of Gantenerumab (RG1450) in Patients With Prodromal Alzheimer's Disease<br />

Status Phase 2 (recruiting)<br />

Study Design Randomized, double-blinded safety/efficacy study<br />

Study Start Date November 2010<br />

Completion Date April 2015<br />

Enrollment 360<br />

Primary Outcome Measures<br />

Secondary Outcome Measures<br />

Treatment Period<br />

Clinical Data<br />

� To evaluate the effect on the change in the Clinical Dementia Rating scale Sum of Boxes (CDR-<br />

SOB), a global measure of cognition and functional ability<br />

� Sub-study: Change in brain amyloid over time assessed with Positron Emission Tomography<br />

� Effect on cognition assessed with Alzheimer Disease Assessment Scale-Cognition<br />

� Effect on functioning assessed with Functional Activities Questionnaire<br />

� Safety (nature and incidence of adverse events)<br />

� Pharmacokinetics: gantenerumab levels<br />

� Patients will be randomized to receive subcutaneous injections of either gantenerumab or placebo<br />

� Patients who consent to be part of the sub-study will undergo positron emission tomography (PET)<br />

scanning to assess brain amyloid<br />

� The anticipated time on study treatment is 104 weeks.<br />

� Group 1: 225 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks<br />

� Group 2: 105 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks<br />

� Group 3: Placebo<br />

� In October 2011, Roche published first amyloid imaging data from Gantenerumab<br />

� The data, published in the Archives of Neurology, demonstrated a dose-dependent reduction of<br />

beta amyloid in the brain of patients treated with the monoclonal antibody, while amyloid load<br />

increased in patients on placebo<br />

© <strong>MorphoSys</strong> AG<br />

Page 35


Management Team<br />

Dr. Simon E. Moroney, CEO<br />

� Co-founder, previously at ImmunoGen<br />

� German Cross of the Order of Merit (2002), Bavarian State Medal for Outstanding<br />

Services to the Bavarian Economy (2009)<br />

Jens Holstein, CFO<br />

� Joined <strong>MorphoSys</strong> in 2011<br />

� Formerly at Fresenius: Regional CFO for region EME of Fresenius Kabi AG; several<br />

financial and general management positions at Fresenius; and in consulting industry<br />

Dr. Arndt Schottelius, CDO<br />

� Joined <strong>MorphoSys</strong> in 2008<br />

� Formerly Medical Director in Immunology at Genentech Inc.; Berlex Biosciences, USA;<br />

Schering, Germany; Charité University Hospital, Berlin<br />

Dr. Marlies Sproll, CSO<br />

� Joined <strong>MorphoSys</strong> in 2000, promoted to CSO in 2005<br />

� Formerly at Boehringer Ingelheim in Vienna; Merck KGaA in Darmstadt<br />

© <strong>MorphoSys</strong> AG<br />

Page 36


Covering Analysts<br />

Institution Contact<br />

Close Brother Seydler Mr. Igor Kim<br />

Commerzbank Mr. Daniel Wendorff<br />

Deutsche Bank Mr. Gunnar Romer<br />

DZ Bank Dr. Elmar Kraus<br />

Edison Dr. Mick Cooper<br />

Equinet Institutional Services Edouard Aubéry<br />

Helvea Dr. Olav Zilian<br />

Kempen & Co. Mr. Sachin Soni / Mr. Mark Pospisilik<br />

Landesbank Baden-Württemberg Mr. Timo Kürschner<br />

Nomura Code Dr. Gary Waanders<br />

WestLB AG Dr. Cornelia Thomas / Mr. Oliver Kaemmerer<br />

© <strong>MorphoSys</strong> AG<br />

Page 37


Upcoming Events & Conferences<br />

� March 22, 2012 Kempen Healthcare/Life Sciences Conference<br />

Amsterdam, The Netherlands<br />

� May 4, 2012 Q1 2012 Results<br />

� May 7-9, 2012 Deutsche Bank Health Care Conference<br />

Boston, USA<br />

� May 14-16, 2012 German Swiss & Austrian Conference 2012<br />

Frankfurt, Germany<br />

� May 15-16, 2012 BioEquity, Frankfurt, Germany<br />

� June 4-7, 2012 Jefferies 2012 Global Healthcare Conference<br />

New York, USA<br />

For more information please visit www.morphosys.com<br />

© <strong>MorphoSys</strong> AG<br />

Page 38


© <strong>MorphoSys</strong> AG Page


Thank You<br />

www.morphosys.com<br />

Dr. Simon Moroney<br />

Chief Executive Officer<br />

Phone +49 (0)89 / 899 27-311<br />

Fax +49 (0)89 / 899 27-5311<br />

HuCAL ® , HuCAL GOLD ® , HuCAL PLATINUM ® , Ylanthia ® , arYla ® , CysDisplay ® , RapMAT ® and AutoCAL ® are registered trademarks of <strong>MorphoSys</strong> AG.<br />

Slonomics ® is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of <strong>MorphoSys</strong> AG.<br />

Dr. Claudia Gutjahr-Löser<br />

Head of Corporate Communications & IR<br />

Phone +49 (0)89 / 899 27-122<br />

Fax +49 (0)89 / 899 27-5122<br />

Email investors@morphosys.com

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