November 13, Company Update Deutsches Eigenkapitalforum 2012

Transcription

1 November 13, 2012 Company Update Deutsches Eigenkapitalforum 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. 2

3 Components of the Business Innovative Product Pipeline MOR103 shows excellent safety and efficacy in RA Partner Phase 2 read-outs coming Technology-driven Alliances Proven HuCAL platform Ylanthia launched 21 clinical programs AbD Serotec Financially Strong Emerging diagnostics business Research antibody catalog Sustainably cash-flow positive Strong balance sheet 3

4 Pipeline Gathering Momentum MOR103 MOR208 Excellent clinical proof-of-concept and safety data generated in rheumatoid arthritis Phase 1b/2a trial Positive safety and efficacy data from Phase 1/2a trial in CLL/SLL Gantenerumab CNTO1959 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 Janssen commences Phase 2 RA comparison study with Stelara BYM338 OMP-59R5 Novartis completes Phase 2 study in sporadic inclusion body myositis Oncomed commences Phase 1b/2 trial in first-line advanced pancreatic cancer 4

5 Innovative Product Pipeline 5

6 76 Therapeutic Antibody Programs 21 Programs in Clinical Development Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer s Disease MOR103 (2 programs) - GM-CSF CNTO888 Janssen/J&J MCP-1 (CCL-2) IPF CNTO1959 (2 programs) Janssen/J&J IL23p19 Rheumatoid Arthritis Multiple sclerosis 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 BAY 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 70 Partnered Programs 6 Proprietary Programs 6

7 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

8 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

9 % of patients MOR103 Shows Impressive Efficacy & Fast Onset of Action ACR20 Response at week 4 (FAS population) p< Placebo MOR mg MOR mg MOR mg ACR20 ranks amongst highest observed for a biologic in RA after 4 weeks 50 Very fast onset of therapeutic effect within 2 weeks Robust and durable responses 10 weeks beyond treatment Imaging confirms anti-inflammatory activity Week 4 FAS: Full Analysis Set, N= 96 9

10 % of patients ACR20 Scores Compare Favorably to Other Biological DMARDs ACR20 Response over 4 weeks* Placebo MOR103 1 mg/kg MOR mg/kg mavrilimumab adalimumab abatacept tocilizumab in TNF-IR Time (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

11 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

12 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

13 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

14 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 Q Phase 2: Trials in B cell malignancies starting Q

15 MOR202 A Novel Antibody for Multiple Myeloma 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 15

16 Gantenerumab: A HuCAL Antibody Being Developed by Roche for Alzheimer s Disease 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 16

17 % Amyloid change from baseline 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 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, placebocontrolled 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 17

18 Technology-driven Alliances 18

19 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 Target MorphoSys Pharma partner HuCAL antibody drug candidate R&D funding Technology licence fees Milestones and royalties 19

20 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 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 20

21 AbD Serotec 21

22 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 Working with over 20 Dx companies 22

23 Strong Financials 23

24 Key Financials in million 2011 Guidance 2012* 9M 2012 Group Revenues Total Operating Expenses COGS Funded R&D Proprietary R&D (incl. technology development) Sales, General & Administrative Expenses EBIT (2.3) Cash & Marketable Securities and Interest-bearing Assignable Loans (at end of period) * as of Nov 7,

25 Shareholdings Shares issued: 23,308,622 (September 30, 2012) Treasury stock: 255,415 (September 30, 2012) 25

26 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

27 Thank You Jens Holstein Chief Financial 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, 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.