Commerzbank Sector Conference Week. Company Update August 27, 2013

Transcription

1 Commerzbank Sector Conference Week Company Update August 27, 2013

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 Highlights Two Major Alliances for Proprietary Antibodies Alliance with Celgene for co-development & co-promotion of MOR202 Successful out-licensing of MOR103 to GSK Pipeline Progress 21 programs in clinical development Strong Financial Position Recurring cash-flows Sale of AbD, GSK & Celgene deals strengthen balance sheet 3

4 Innovative Product Pipeline 4

5 The MorphoSys Pipeline 21 Clinical Programs, 81 Total Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Gantenerumab Roche Amyloid-ß Alzheimer s Disease MOR103 (2 programs) Guselkumab (CNTO1959) (2 programs) GSK Janssen/J&J GM-CSF IL23p19 BHQ880 Novartis DKK-1 Cancer Rheumatoid Arthritis Multiple Sclerosis Psoriasis Rheumatoid Arthritis Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal NOV 3 Novartis - not discl. LFG316 Novartis C5 Ophthalmology OMP-59R5 OncoMed/GSK Notch 2 Cancer MOR208 - CD19 CLL, NHL, ALL MOR202 Celgene/MOR CD38 Multiple Myeloma BAY Bayer Healthcare Mesothelin (ADC) Cancer BI 1 BI - not discl. CNTO3157 Janssen/J&J - Asthma CNTO 5 Janssen/J&J - Inflammation VAY736 Novartis BAFF-R Inflammation LJM716 Novartis HER3 Cancer Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer PFE 1 Pfizer - Cancer NOV - 7 Novartis - Ophthalmology 22 Programs Various Partners - Various Indications 38 Programs Various Partners 3 Proprietary Pr. - Various Indications 74 Partnered Programs 7 MOR Programs 5

6 MOR202 A Novel Antibody for Multiple Myeloma Large Market and Unmet Need Revenues with approved drugs in MM exceed $2bn Responders eventually relapse or become refractory to existing therapies MOR202 High affinity HuCAL antibody targeting CD38 Competitive Profile Preclinical data show strong synergy in combinations of MOR202 with Velcade or Revlimid Clinical Development Phase 1/2a clinical trial in relapsed or refractory MM patients currently ongoing Strategic Alliance with Celgene Joint development of MOR202 globally and co-promotion in Europe 6

7 Alliance with Celgene for MOR202 Scope Global co-development and European co-promotion agreement Up-front MOR receives EUR 70.8 million Equity Celgene pays EUR 46.2 million for 3.4% stake in MOR at EUR per share 53% premium to pre-announcement price Milestones Up to EUR 511 million in development, regulatory and sales milestones Commercialization Co-promotion in Europe with 50:50 profit share Exclusive Celgene in rest-of-world, tiered double digit royalties to MOR 7

8 MOR103 Global License Agreement with GSK MOR103 Ultra-high affinity HuCAL IgG1 targeting GM-CSF Potential for superior efficacy and better safety than current treatments Phase 1b/2a trial in RA successfully completed Phase 1b in MS ongoing GSK assumes global responsibility for clinical development and commercialization of MOR103 in all indications MorphoSys receives EUR 22.5 million upfront payment Up to EUR 423 million in success-based payments Tiered, double-digit royalties on net sales 8

9 % of patients Mean change from baseline MOR103 Compelling Clinical Data ACR20* DAS MOR103 1 mg/kg mavrilimumab Humira Orencia Actemra Time (weeks) Week Very fast onset of therapeutic effect Durable response Clean safety profile * Data from separate clinical studies 9

10 MOR208 (XmAb5574) A Novel Anti-Cancer Antibody Large Market and Unmet Need Large unmet medical need in NHL, CLL & ALL Revenues with approved drugs for B cell malignancies exceed $5bn MOR208 Anti-CD19 antibody in-licensed from Xencor CD19 expressed earlier than CD20 potential greater efficacy vs. anti-cd20s Proprietary modification in Fc region increased ADCC rapid & sustained B-cell depletion Minor modification means convenient dosing schedule, straightforward manufacturing Blinatumomab data validate CD19 as target for B-cell malignancies 10

11 MOR208 Phase 1/2a Trial in CLL/SLL Trial Design Phase 1, multi-center, US study in heavily pre-treated, relapsed or refractory CLL/SLL patients Dosage 0.3 mg/kg - 12 mg/kg; days 1&4, weeks 2-8 Results Acceptable safety profile Responses observed in 67% of patients by physical exam 4/27 (15%) partial responses and 20/27 (74%) patients with stable disease (IWCLL 2008 criteria including CT) Full results from trial extension expected in Q Phase 2 Phase 2 trials in ALL and NHL ongoing Combination therapy study in CLL being considered 11

13 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 13

14 % Amyloid change from baseline Gantenerumab: The Most Advanced Antibody in Development for Alzheimer s Disease Gantenerumab High affinity HuCAL antibody targeting amyloid-β Binds & breaks down amyloid-β fibrils and plaques Clinical Development Phase 1: gantenerumab reduces brain amyloid 3x faster than other amyloid-targeting substances Pivotal Phase 3 study ongoing 770 prodromal patients, 2 doses (105mg & 225mg s.c.), placebo-controlled 104 weeks on drug, with an option for an additional 2 years of treatment Primary Endpoint: Change in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Sub-study: Change in brain amyloid over time assessed by PET Interim safety analysis in 2013 Data expected 2016 Data from Phase 1 Effect of gantenerumab on amyloid load as indexed by PET SUVR at end of treatment Data: Courtesy of Roche 14

16 Bimagrumab (BYM338) A Novartis Musculoskeletal Program Bimagrumab is a HuCAL antibody against ActRIIB Novartis received FDA breakthrough therapy designation for sporadic inclusion body myositis (sibm) Phase 2 study showed that bimagrumab substantially benefited patients with sibm Results will be presented at the American Neurological Association meeting on Oct. 14, 2013 In Phase 2 development for Sporadic inclusion body myositis Cancer-related cachexia COPD-related cachexia Sarcopenia Mechanically ventilated patients Recently Highlighted by Novartis Imagine the equivalent of 8 or 10 weeks of exercise in one injection Listed as a planned filing 2016 Source: 16

18 Guselkumab A Janssen Anti-Inflammatory Program Guselkumab is a HuCAL antibody against IL-23 Phase 2 development for psoriasis Phase 2 study vs. Stelara in rheumatoid arthritis Specific for IL23 Guselkumab binds the p19 sub-unit of IL-23, while Stelara binds the p40 sub-unit of IL-23 and IL-12 Highlighted at Janssen s Last Analyst Day Listed under planned filings Sources: Jetten AM, Nucl Recept Signal,

19 Technology 19

20 Next Generation Drug Discovery Technologies Ylanthia Totally new antibody platform Higher quality antibodies, greater diversity faster access to superior drug leads US patent granted January 2013 Antibodies Against GPCRs MorphoSys secures access to stabilized GPCRs produced by Heptares MorphoSys will make and offer antibodies against GPCRs Most important target class; challenging for antibodies Lantipeptides MorphoSys collaborates with Lanthio Pharma to develop lantipeptide libraries for drug discovery Preferred rights to exclusive license MorphoSys has minority equity position UK-based GPCR drug discovery & development company with proprietary StaR technology for generating stabilized receptors Dutch start-up focused on lantipeptides: cyclic peptides showing high target selectivity and improved drug-like properties 20

21 Strong Financials 21

22 Shareholdings Shareholdings by Investor Type Institutional Investors - 52% Novartis - 6% Treasury Stock - 1.5% Management & Supervisory Boards - 2% Retail Investors - 20% Unidentified Investors % Geographic Split of Institutional Holdings USA: 58% Scandinavia: 12% United Kingdom: 10% Switzerland: 7% Benelux: 6% Germany: 5% 18,5% 20% 52% 2% 1.5% 6% MorphoSys AG (FSE: MOR, Prime Standard, TecDAX; OTC: MPSYY) Shares issued: 23,400,632 (June 30, 2013) / Treasury stock: 339,890 (June 30, 2013) 22

23 Key Financials in EUR million H Guidance 2013* Group Revenues EBIT to 6 Cash & Marketable Securities and Interest-bearing Assignable Loans as of June 30, ** * Updated following MOR202 regulatory clearance (August 10, 2013) ** Cash position does not include any payments from GSK or Celgene 23

24 Progress in Proprietary Portfolio 2013 MOR103 Partnership for further development Multiple sclerosis Phase 1b study continues MOR208 ALL Phase 2 study to commence NHL Phase 2 study to commence Clinical data from Phase 1b extension MOR202 Partnership with Celgene MM Phase 1/2a study continues First clinical data expected

25 Clinical Trials Scheduled for Completion Partnered Phase 3 Phase 2 Phase 1 LFG316 AMD Bimagrumab Sarcopenia Bimagrumab Ventilated Patients Guselkumab RA (vs. Stelara) Guselkumab Palmoplantar Postulosis Proprietary Phase 2 Phase 1 BHQ880 Smoldering MM LFG316 MCP Guselkumab Psoriasis LFG316 NOV-3 AMD undisclosed NOV-3 Undisclosed Bimagrumab Cachexia (COPD) BHQ880 MM/Renal Insufficiency NOV-3 undisclosed MOR103 Multiple sclerosis MOR208 B-ALL Bimagrumab Cachexia (cancer) MOR208 CLL (extension arm) BI-1 undisclosed BI-1 undisclosed BAY (ADC) Solid Tumors Gantenerumab Liquid vs. Lyophilized Guselkumab Devices/Formulation Gantenerumab AD/Japan CNTO3157 Asthma Guselkumab Psoriasis (Japan) OMP-59R5 Solid Tumors OMP-18R5 Solid Tumors LJM716 Single LJM716 Combo 2013 Potential data events based on clinical trial design & MorphoSys estimates

26 Thank You Dr. Simon Moroney Chief Executive Officer 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.