Company Update. March 2012
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1 Company Update March 2012
2 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.
3 Business Strategy Proprietary products Lucrative upside Partnerships Strong current cash-flow plus substantial upside through milestones & royalties Technology Powerful proprietary technology platform drives partnered programs and increasingly, proprietary product development Page 3
4 Maturing Pipeline Illustrates Successful Execution of Strategy Programs clinical programs ongoing with seven different partners 4 proprietary, un-partnered programs Disease areas include cancer, inflammation, CNS, ophthalmology, musculoskeletal, and others as of today Total Phase 1 Phase 2 Page 4
5 Strong Track Record of Technological Innovation HuCAL Slonomics aryla Ylanthia 30 commercial partnerships > 450 million revenues to date Most successful antibody library technology Generation of customized protein libraries 4 deals since acquisition Optimization of any therapeutic or diagnostic antibody Next-generation antibody library extends technology leadership Page 5
6 Slonomics: Multiple Opportunities Beyond Antibodies Rx Proteins e.g. Pfizer deal (2010) Second deal (2012) Slonomics Industrial Enzymes e.g. Novozymes deal (2011) Research & Dx e.g. Dana-Farber alliance (2011) 6 Page 6
7 76 Therapeutic Antibody Programs Ongoing, 20 in Clinical Trials Program Partner Indication Discovery Pre-clinic Phase 1 Phase 2 MOR103 (2 programs) - CNTO888 (2 programs) Janssen Biotech/J&J CNTO1959 Janssen Biotech/J&J Psoriasis BHQ880 Novartis Cancer Rheumatoid arthritis, Multiple sclerosis Cancer, Idiopathic pulmonary fibrosis BYM338 Novartis Musculoskeletal NOV 3 Novartis not discl. NOV 4 Novartis Ophthalmology Gantenerumab Roche Alzheimer s Disease MOR208 - Cancer MOR202 - Cancer BAY (ADC) Bayer HealthCare Cancer BI 1 Boehringer Ingelheim not discl. CNTO3157 Janssen Biotech/J&J Asthma CNTO 5 Janssen Biotech/J&J Inflammation NOV 5 Novartis Inflammation OMP-18R5 Oncomed Cancer OMP-59R5 Oncomed Cancer PFE 1 Pfizer Cancer 24 Partnered Programs Various Partners Various Indications 32 Programs, incl. 2 co-dev with Novartis Various Partners Various Indications New New New New New New New 68 Partnered Programs 8 Proprietary Programs New in 2011/2012 Page 7
8 Current Pipeline Projected HuCAL Drugs on the Market Discovery Preclinic Phase 1 Phase 2 Phase 3 Market 50% 70% 40% 65% Projection from today s pipeline: 32 Success probability of 11% 24 Success probability of 18% 11 Success probability of 25% Projected number of marketed HuCAL drugs from today s pipeline: 14 Source: MorphoSys internal statistics & Tufts Centre for the Study of Drug Development 9 Success probability of 33% 3 Page 8
9 MOR103 New Mode of Action in Inflammation The Drug Ultra-high affinity HuCAL IgG1 targeting GM-CSF Market Large commercial potential in inflammatory conditions including RA, MS, & others Revenues with approved biologics in RA in 2010 exceeded USD15bn Phase 2 data for mavrilimumab, vs. GM-CSF receptor, provides clinical validation of the pathway in rheumatoid arthritis Proportion of subjects achieving a change of 1.2 from baseline in DAS28-CRP 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 Development European phase 1b/2a trial in RA fully recruited, data expected Q Ph1b safety study in MS patients initiated in Q4/11 PK study for sc administration initiated in Q1/12 Source: ACR2011 Abstract: Mavrilimumab (an Anti-GM-CSFRα Monoclonal Antibody) in Subjects with Rheumatoid Arthritis: Results of a Phase 2 Randomized, Double-Blind, Placebo- Controlled Study Page 9
10 GM-CSF is a Key Target in the Pathophysiology of Inflammatory Diseases Adapted from: Hamilton JA, (2008) Nat Rev Immunol. 8: Page 10
11 MOR103 European Phase 1b/2a Trial in RA Trial Patients Study Design Primary Endpoint Secondary Endpoints Study Details A Study of the safety and preliminary efficacy of MOR103, a human antibody to granulocyte macrophage colony-stimulating factor (GM-CSF) Patients with active rheumatoid arthritis Randomized, double-blind, placebo-controlled, multi-center dose-escalation study (three groups with 0.3/1.0/1.5 mg/kg) of MOR103 on background of stable regimen of concomitant RA therapy (NSAIDs, steroids, non- biological DMARDs) Adverse event rate and safety profile DAS28, ACR core set measures and EULAR28 response criteria, hematology, blood chemistry, Ig levels, cytokines, synovitis, bone edema 96 patients Sites in Germany, The Netherlands, Bulgaria, Poland, Ukraine Inclusion of MRI to detect an effect on inflammatory changes such as synovitis or bone edema Results in Q Page 11
12 MOR103 European Phase 1b Trial in MS Trial Patients Study Design Primary Endpoint Secondary Endpoints Study Details Phase Ib study to evaluate the safety and pharmacokinetics of MOR103, a human antibody to GM-CSF, in patients with multiple sclerosis (MS) Patients with relapsing-remitting or secondary progressive MS (RRMS or SPMS) A randomized, double-blind, placebo-controlled study (three groups with 0.5/1.0/2.0 mg/kg; 6 doses) to evaluate the safety and pharmacokinetics of MOR103, a human antibody to GM-CSF, in patients with multiple sclerosis Incidence and severity of adverse events Pharmacokinetic profile Potential immunogenicity 30 patients Sites in Germany, Poland, UK Results expected in 2013 Page 12
13 MOR208 (XmAb5574) A Novel High-Potential Anti-Cancer Antibody The Drug Humanized, high affinity anti-cd19 antibody, exclusive license from Xencor Comprises a proprietary Xencor modification leading to rapid and sustained B-cell depletion Market High unmet medical need in NHL, CLL & ALL Competitive Profile Expect convenient dosing schedule Straightforward manufacturing Potential for good safety profile Significantly increased ADCC compared to rituximab in vitro Development Completion of phase 1 in CLL and reporting of interim data H2/12 Initiation of additional trials in B cell malignancies in 2012 Page 13
14 MOR208 (XmAb5574) Phase 1 Trial in the US Trial Safety and tolerability of MOR208 (XmAb5574) in Chronic Lymphocytic Leukemia Patients Patients with relapsed or refractory CLL/SLL Study Design MOR208/XmAb5574 (humanized, Fc-engineered, anti-cd19 IgG1 antibody) Open-label, multi-dose, single-arm, Phase 1, dose-escalation study Primary Endpoint Study Details To determine the dose limiting toxicities (time frame 28 days) 30 patients Identification of the maximum tolerated dose (MTD) and/or recommended dose(s) (RD) for further study Characterization of safety and tolerability, PK, PD and immunogenicity Evaluation of preliminary antitumor activity of XmAb5574 in patients with relapsed or refractory CLL/SLL Study sponsored by Xencor, Inc. Page 14
15 MOR202 / LEN % lysis of vehicle control normalised M protein level MOR202 / BOR % lysis of vehicle control normalised M protein level MOR202 A Novel High-Potential Antibody for Multiple Myeloma The Drug High affinity HuCAL antibody targeting CD38 The Market High unmet medical need in MM, accounting for approximately 1% of all cancers. Median survival is approximately 3-5 years Competitive Profile Use of targeted therapy in combination with standard regimens in myeloma can minimize adverse events while increasing efficacy MOR202 monotherapy shows a dose-dependent reduction of multiple myeloma graft induced bone lysis (pre-clinical studies) MOR202 plus bortezomib or lenalidomide synergistically inhibits bone lysis and substantially reduces M protein levels (pre-clinical studies) Development Study to last until January 2015, interim reporting planned Non-inoculated Non-inoculated Bone lysis Vehicle MOR202 3mg/kg Vehicle 0.6mg/kg BOR MOR202+BOR (3+0.6mg/kg) MOR202 3mg/kg LEN 50mg/kg MOR202+LEN (3+50mg/kg) Vehicle MOR202 3mg/kg Vehicle BOR 0.6mg/kg MOR202+BOR (3+0.6mg/kg) MOR202 3mg/kg M protein LEN 50mg/kg MOR202+LEN (3+50mg/kg) MOR202/BOR and MOR202/LEN combination therapy is superior to the respective mono therapies Page 15
16 MOR202 European Phase 1/2a Trial Trial Patients Study Design Primary Endpoint Secondary Endpoints Study Details A phase I/IIa, open-label, multicentre, dose-escalation study to evaluate the safety and preliminary efficacy of the human anti-cd38 antibody MOR202 as monotherapy and in combination with standard therapy in subjects with relapsed/refractory multiple myeloma Patients relapsed/refractory multiple myeloma; failure of at least 2 prior therapies MOR202 (anti-cd38 HuCAL IgG1 antibody) Phase I dose escalation (iv administration of MOR202 for up to 2 cycles) Phase IIa monotherapy extension (iv administration of MOR202 for up to 4 cycles) Phase Ib MOR202 combined with bortezomib Phase Ib MOR202 combined with lenalidomide Determination of MTD and / or recommended dose (up to 20 weeks) Safety & immunogenicity Pharmacokinetics of MOR202 Overall response rate (standard response criteria, serum M protein levels) Up to 82 patients Study sites in Germany & Austria Page 16
17 AbD Serotec Segment Complements Therapeutic Business Research Activities HuCAL Diagnostic Applications 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 Collaborations with more than 20 diagnostics companies Page 17
18 FY2011: Income Statement in million Change Revenues % Cost of Goods Sold Total Research and Development Expenses Sales, General & Administrative Expenses Total Operating Expenses % Other Operating Income Profit from Operations % Finance Income Other Expenses Profit before Taxes % Income Tax Expenses Net Profit % EPS (diluted) Page 18
19 Balance Sheet and Shareholder Structure Balance Sheet Shareholdings by Investor Type (12/2011) EUR millions Assets Dec. 31, 2011 Dec. 31, 2010 Treasury Stock 0.7% Management & Supervisory Boards 1.9% Cash, Cash Equivalents & Marketable Securities Other Current Assets Total Non-Current Assets Total Assets Liabilities Total Current Liabilities Total Non-Current Liabilities Total Shareholders Equity Unidentified 23% Novartis 6.4% Retail Investors 22% Institutional Investors 46% Total Liabilities Shares issued: 23,112,167 (Dec. 31, 2011) Page 19
20 Guidance 2012 in million Group Revenues Investment into Proprietary R&D Group EBIT in million AbD Serotec Segment Revenues (at constant currency) AbD Serotec EBIT Margin (at constant currency) ~ 6% 8% 5% Page 20
21 Proprietary Clinical Programs to Advance Significantly in 2012 RA MS CLL MM MOR103 MOR103 MOR208 MOR202 SC Enrollment completed in phase 1b/2a trial in rheumatoid arthritis Phase 1b trial in multiple sclerosis initiated in Q Enrollment target nearly hit in phase 1 trial Phase 1/2a trial initiated in Q Data in Q Data in 2013 Data in H Combination arms to start in 2013 Page 21
22 A Wealth of Clinical Data is Imminent NOV 2 (Ophthalmology) CNTO 1 (Inflammation) CNTO888 (Cancer) BYM338 (Musculoskeletal) CNTO3157 (Asthma) MOR208 (CLL) BHQ880 (Cancer) CNTO888 (IPF) OMP18-R5 (Cancer) OMP59-R5 (Cancer) MOR103 (RA) BYM338 (Musculoskeletal) NOV 3 (n.d.) NOV 3 (n.d.) NOV 4 (Ophthalmology) PFE 1 (Cancer) CNTO1959 (Psoriasis) BI 1 (n.d.) BHQ880 (Cancer) NOV 4 (Ophthalmology) NOV 4 (Ophthalmology) NOV 3 (n.d.) H H H H light colors: phase 1 dark colors: phase 2 PoC in 2012 Page 22
23 Appendix
24 Novartis Alliance: Landmark Deal Timeline May 2004: Initial deal, including equity stake November 2007: Major expansion November 2017: End, subject to 2-year extension option Novartis pays Approx. 20m p.a. technology license including HuCAL internalization fees Approx. 20m p.a. in research funding Over 250m milestones (probability adjusted) Royalties on all resulting drugs Novartis gets Preferred access to HuCAL for use in over 100 discovery programs Co-development option Shared costs & profits (20% 50%) on selected co-developed programs Excluded Most infectious disease targets Page 24
25 Partnerships: Typical Terms per Program 9m - 12m Royalties (mid single digits) Biologics License Application + Approval milestones Phase 3 milestone Phase 1 milestone Exclusive license fee; R&D funding MorphoSys costs Discovery Preclinic Phase 1 Phase 2 Phase 3 Market Page 25
26 Partnered Programs Phase 2 Clinical Development Program Partner Disease Target Status CNTO888 CNTO888 CNTO1959 Janssen Biotech Janssen Biotech Janssen Biotech Oncology Idiopathic pulmonary fibrosis CCL2 (MCP-1) CCL2 (MCP-1) Two trials ongoing, one trial completed Novel approach to IPF Psoriasis IL23p19 Phase 2 trial started in December 2011 n.d. Novartis n.d. n.d. Clinical proof of concept achieved n.d. Novartis Ophthalmology n.d. Phase 2 trial started in January 2012 BHQ880 Novartis Osteolytic bone disease DKK-1 Early data show stimulation of bone formation BYM338 Novartis Musculoskeletal n.d. Two phase 2 trials ongoing Gantenerumab Roche Alzheimer s disease Amyloid-b Only anti-aβ antibody being developed in patients with prodromal AD Page 26
27 Partnered Programs Phase 1 Clinical Development Program Partner Disease Phase 1 Start BAY Bayer Oncology September 2011 n.d. Boehringer Ingelheim n.d. December 2010 CNTO3157 Janssen Biotech Asthma June 2010 n.d. Janssen Biotech Inflammation / Autoimmune December 2010 n.d. Novartis Inflammation December 2010 OMP-18R5 Oncomed Oncology April 2011 OMP-59R5 Oncomed Oncology December 2010 n.d. Pfizer Oncology December 2010 Page 27
28 Carlumab (CNTO 888): CCL2 Specific Antibody in Oncology A Study of the Safety and Efficacy of CNTO 888 in Combination With Standard of Care Chemotherapy in Patients With Solid Tumors Status Study Design Study Start Date May 2010 Completion Date n.d. Enrollment 53 Primary Outcome Measures Secondary Outcome Measures Treatment Period Phase 1 (completed) Non-randomized, open-label safety study The primary objective of the study is to evaluate the safety of CNTO 888 when administered to patients with solid tumors in combination with 4 standard of care chemotherapy regimens (docetaxel; gemcitabine; Paclitaxel and carboplatin; or DOXIL / Caelyx doxorubicin HCl liposome injection) Pharmacokinetics [during study as specified in the protocol and at End of Study (1 year)] Pharmacodynamics [during study as specified in the protocol and at End of Study (1 year)] Combination therapy will be continued until disease progression, unacceptable toxicity, the patient refuses further combination therapy, withdraws consent, or is treated for 1 year A Study of the Safety and Efficacy of Single-agent CNTO 888 (an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With Metastatic Prostate Cancer Status Study Design Phase 2 (completed) Study Start Date September 2009 Completion Date July 2011 Enrollment 46 Primary Outcome Measures Secondary Outcome Measures Treatment Period Non-randomized, open-label safety/efficacy study The primary objective of the study is to determine the composite response in patients with metastatic castrate-resistant prostate cancer (CRPC) who receive single-agent 15 mg/kg CNTO 888 every 2 weeks (Time Frame: 3-6 months) Objective response rate determined as complete response and partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines Progression Free Survival Overall Survival 15mg/kg intravenously every 2 weeks until disease progression Page 28
29 Carlumab (CNTO 888): CCL2 Specific Antibody in Idiopathic Pulmonary Fibrosis A Study to Evaluate the Safety and Effectiveness of CNTO 888 Administered Intravenously (IV) in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Status Study Design Phase 2 (active, not recruiting) Study Start Date December 2008 Completion Date June 2012 Enrollment 129 Randomized, double-blinded safety/efficacy study Primary Outcome Measures The primary objective is to determine the efficacy (as measured by pulmonary function) and safety of CNTO 888 in subjects with IPF. Secondary Outcome Measures To assess the effect of CNTO888 on measures of disease progression, patient reported outcomes, functional capacity and health-related quality of life, and to assess the pharmacokinetics/ pharmacodynamics of CNTO888 in subjects with IPF. Treatment Period Patients will receive study agent until Week 48 and will continue to be followed through Week 72 for assessment of safety and any other effects after discontinuation of therapy. Patients will be in the study for about 74 weeks. Group 1: placebo Group 2: 1 g/kg CNTO888 every 4 weeks Group 3: 5mg/kg CNTO888 every 4 weeks Group 4: 15 mg/kg CNTO888 every 4 weeks Page 29
30 CNTO1959: HuCAL Antibody for the Treatment of Patients with Psoriasis A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis (X-PLORE) Status Study Design Phase 2 (recruiting) Study Start Date October 2011 Completion Date February 2014 Enrollment 280 Primary Outcome Measures Secondary Outcome Measures Treatment Randomized, double-blind, placebo-controlled study Physician's Global Assessment (PGA) score of cleared or minimal (Time Frame: Week 16); Overall assessment of induration, scaling, and erythema Psoriasis Area and Severity Index (PASI) 75% or greater improvement from baseline (Time Frame: Week 16) The difference in the PGA score of cleared (0) or minimal (1) response rate between CNTO 1959 treatment groups and adalimumab treatment group (Time Frame: Weeks 16 and 40) The change from baseline in Dermatology Life Quality Index (DLQI) (Time Frame: Week 16) 5 groups: CNTO 1959 (5 mg / 15 mg / 50 mg / 100 mg / 200 mg Drug: Adalimumab Drug: Placebo to CNTO 1959 (100 mg) A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 1959 Following a Single SC Administration in Japanese Participants With Moderate to Severe Plaque Psoriasis Status Study Design Phase 1 (recruiting) Study Start Date August 2011 Completion Date June 2013 Enrollment 32 Primary Outcome Measures Secondary Outcome Measures Treatment Randomized, double-blind, placebo-controlled study The number and type of adverse events Change in clinical laboratory values Electrocardiogram Changes or abnormalities in body systems Axillary temperature Pulse rate Blood pressure (Time Frame: Up to 24 weeks) Blood levels of CNTO 1959 Antibodies to CNTO 1959 Psoriasis Area and Severity Index (PASI) Physician's Global Assessment (PGA) Drug: CNTO 1959 (10mg, 30mg, 100mg, 300mg, subcutaneous use, ascending dosing for 24 weeks Drug: Placebo Page 30
31 BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis A Study to Assess BHQ880 in Combination With Zoledronic Acid in Relapsed or Refractory Myeloma Patients Status Study Design Study Start Date January 2009 Completion Date April 2012 Enrollment 267 Primary Outcome Measures Secondary Outcome Measures Treatment Period Phase 1/2 (active, not recruiting) Randomized, double-blinded safety/efficacy study Time to first SRE and change in bone markers for bone resorption and formation (Time Frame: 9 months minimum treatment with BHQ880 or placebo in combination with zoledronic acid and standard anti-myeloma therapy Characterize acute and chronic safety and tolerability of BHQ880 Characterize single-dose and repeated-dose pharmacokinetic profiles of BHQ880 Assess the potential immunogenicity of BHQ880 Characterize the binding kinetics of DKK1/BHQ880 complex (free&bhq880 bound DKK1) in serum Determine the pharmacodynamic effects of BHQ880 by measuring biochemical markers of bone formation, resorption, and metabolism in serum and urine Using Various Repeated IV Doses of BHQ880 in Combination With Zoledronic Acid Group 1: Various intravenous doses (low) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Goup 2: Various intravenous doses (medium) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Group 3: Various intravenous doses (high) of BHQ880 (up to 20 mg/kg) in combination with zoledronic acid on day 1 of a 28-day cycle. Group 4: Placebo in combination with zoledronic acid on day 1 of a 28-day cycle Page 31
32 BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis Study of BHQ880 in Patients With High Risk Smoldering Multiple Myeloma Status Study Design Phase 2 (recruiting) Study Start Date May 2011 Completion Date March 2013 Enrollment 40 Primary Outcome Measures Secondary Outcome Measures Non-randomized, open-label study Overall response rate (Complete Response + Partial Response + Minimal Response) of patients achieving an objective response (defined according to the IMWG uniform response criteria by the Frequency of response of serum or urine M-protein to BHQ880A (Time frame: at 6 months) Safety and tolerability of BHQ880 in patients with smoldering multiple myeloma by assessing AEs, SAEs, clinical laboratory values (Time frame: From start of study until disease progression ) Characterize the PK profile of BHQ880 as a single agent administered monthly by assessing BHQ880 levels in plasma (Time frame: Throughout the study until disease progression) Evaluate the effect of BHQ880 on bone metabolism by assessing serum and urine bone biomarkers (Time frame: Throughout the study until disease progression) Evaluate the effect of BHQ880 on bone mineral density by DXA scan and QCT (Time frame: 6 months and 12 months) Treatment Period This study will assess the antimyeloma effects of BHQ880A in patients with smoldering multiple myeloma with high risk of progression to active multiple myeloma BHQ880 will be administered every 28 days in previously untreated patients. Single arm Page 32
33 BHQ880: DKK-1 Specific Antibody in Multiple Myeloma Associated Osteolysis Study in Patients With Untreated Multiple Myeloma and Renal Insufficiency Status Study Design Phase 2 (recruiting) Study Start Date May 2011 Completion Date February 2016 Enrollment 144 Primary Outcome Measures Secondary Outcome Measures Treatment Period Randomized, double-blinded study Effect of BHQ880 compared with placebo on time to first Skeletal Related Event (SRE) in patients with untreated multiple myeloma and renal insufficiency in combination with bortezomib and dexamethasone (Time Frame: 18-month median time to first SRE assumed for the placebo arm) Safety and tolerability of BHQ880 in combination with bortezomib and dexamethasone Characterize the PharmacoKinetics (PK) profiles of BHQ880 and bortezomib (Determine the pharmacokinetic parameters for BHQ880 and bortezomib. Evaluate the effect of BHQ880 on bone metabolism 1) Change in bone mineral density, measured by dual-emission X-ray absorptiometry (DXA), 2) Change in bone strength, measured by quantitative computed tomography (qct), Determine the anti-myeloma effect of BHQ880 compared to placebo when used in combination with bortezomib and dexamethasone 1) The overall response rate (partial response plus complete response); 2) Progression-free survival following initiation of BHQ880 The study will evaluate the effects of BHQ880 in patients with previously untreated multiple myeloma and renal insufficiency who are not considered candidates for bisphosphonate therapy. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone, compared to placebo administered with the combination on the time to first Skeletal Related Event (SRE) on study. Page 33
34 BYM338: HuCAL Antibody for the Unintentional Weight Loss in Cancer Patients Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis Status Study Design Phase 2 (recruiting) Study Start Date August 2011 Completion Date December 2011 Enrollment 12 Primary Outcome Measures Secondary Outcome Measures Patients Randomized, double-blind, placebo-controlled study Assessment of the affect of BYM338 on thigh muscle volume by MRI (time frame: 8 weeks) Assessment of the effect of BYM338 on muscle function by 'Timed Get Up and Go' test (Time frame: 8 weeks) Patients with sporadic Inclusion Body Myositis Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas Status Study Design Phase 2 (recruiting) Study Start Date August 2011 Completion Date September 2012 Enrollment 50 Primary Outcome Measures Secondary Outcome Measures Patients Randomized, double-blind, placebo-controlled study Increase in thigh muscle volume as measured by MRI (Time Frame: 8 Weeks) 6 minute walk test (Time frame: 8 weeks) Efficacy in treating unintentional weight loss (Time frame: 8 weeks) Obtain pharmacokinetic data in this population (Time frame: 8 weeks) Efficacy in improving total lean body mass (LBM) and total bone mineral content (Time frame: 8 weeks) Improving physical activity and function (Time frame: 8 weeks) Patients With Stage IV Non-small Cell Lung Cancer or Stage III/IV Adenocarcinoma of the Pancreas Page 34
35 Gantenerumab: Amyloid-ß Specific Antibody in Alzheimer s Disease A Study of Gantenerumab (RG1450) in Patients With Prodromal Alzheimer's Disease Status Study Design Phase 2 (recruiting) Study Start Date November 2010 Completion Date April 2015 Enrollment 360 Primary Outcome Measures Secondary Outcome Measures Treatment Period Clinical Data Randomized, double-blinded safety/efficacy study To evaluate the effect on the change in the Clinical Dementia Rating scale Sum of Boxes (CDR- SOB), a global measure of cognition and functional ability Sub-study: Change in brain amyloid over time assessed with Positron Emission Tomography Effect on cognition assessed with Alzheimer Disease Assessment Scale-Cognition Effect on functioning assessed with Functional Activities Questionnaire Safety (nature and incidence of adverse events) Pharmacokinetics: gantenerumab levels Patients will be randomized to receive subcutaneous injections of either gantenerumab or placebo Patients who consent to be part of the sub-study will undergo positron emission tomography (PET) scanning to assess brain amyloid The anticipated time on study treatment is 104 weeks. Group 1: 225 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks Group 2: 105 mg gantenerumab subcutaneous doses every 4 weeks for 104 weeks Group 3: Placebo In October 2011, Roche published first amyloid imaging data from Gantenerumab The data, published in the Archives of Neurology, demonstrated a dose-dependent reduction of beta amyloid in the brain of patients treated with the monoclonal antibody, while amyloid load increased in patients on placebo Page 35
36 Management Team Dr. Simon E. Moroney, CEO Co-founder, previously at ImmunoGen German Cross of the Order of Merit (2002), Bavarian State Medal for Outstanding Services to the Bavarian Economy (2009) Jens Holstein, CFO Joined MorphoSys in 2011 Formerly at Fresenius: Regional CFO for region EME of Fresenius Kabi AG; several financial and general management positions at Fresenius; and in consulting industry Dr. Arndt Schottelius, CDO Joined MorphoSys in 2008 Formerly Medical Director in Immunology at Genentech Inc.; Berlex Biosciences, USA; Schering, Germany; Charité University Hospital, Berlin Dr. Marlies Sproll, CSO Joined MorphoSys in 2000, promoted to CSO in 2005 Formerly at Boehringer Ingelheim in Vienna; Merck KGaA in Darmstadt Page 36
37 Covering Analysts Institution Close Brother Seydler Commerzbank Deutsche Bank DZ Bank Edison Equinet Institutional Services Helvea Kempen & Co. Landesbank Baden-Württemberg Nomura Code WestLB AG Contact Mr. Igor Kim Mr. Daniel Wendorff Mr. Gunnar Romer Dr. Elmar Kraus Dr. Mick Cooper Edouard Aubéry Dr. Olav Zilian Mr. Sachin Soni / Mr. Mark Pospisilik Mr. Timo Kürschner Dr. Gary Waanders Dr. Cornelia Thomas / Mr. Oliver Kaemmerer Page 37
38 Upcoming Events & Conferences March 22, 2012 May 4, 2012 May 7-9, 2012 Kempen Healthcare/Life Sciences Conference Amsterdam, The Netherlands Q Results Deutsche Bank Health Care Conference Boston, USA May 14-16, 2012 German Swiss & Austrian Conference 2012 Frankfurt, Germany May 15-16, 2012 June 4-7, 2012 BioEquity, Frankfurt, Germany Jefferies 2012 Global Healthcare Conference New York, USA For more information please visit Page 38
39 Page
40 Thank You Dr. Simon Moroney Chief Executive Officer Phone +49 (0)89 / Fax +49 (0)89 / Dr. Claudia Gutjahr-Löser Head of Corporate Communications & IR Phone +49 (0)89 / Fax +49 (0)89 / investors@morphosys.com HuCAL, HuCAL GOLD, HuCAL PLATINUM, Ylanthia, aryla, CysDisplay, RapMAT and AutoCAL are registered trademarks of MorphoSys AG. Slonomics is a registered trademark of Sloning BioTechnology GmbH, a subsidiary of MorphoSys AG.
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