Commerzbank – Sector Conference Week
Company Update August 27, 2013
© MorphoSys - August 2013 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.
© MorphoSys - August 2013 2 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
© MorphoSys - August 2013 3 Innovative Product Pipeline
© MorphoSys - August 2013 4 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 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer 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 BAY94-9343 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
Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs
© MorphoSys - August 2013 5 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
© MorphoSys - August 2013 6 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 57.90 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
© MorphoSys - August 2013 7 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
© MorphoSys - August 2013 8 MOR103 Compelling Clinical Data
ACR20* DAS28
70 MOR103 1 mg/kg mavrilimumab Humira 60 Orencia
Actemra 50
40
30 % % patients of
20
10 Mean from change baseline
0 Week 0 1 2 3 4 Time (weeks)
Very fast onset of therapeutic effect Durable response
Clean safety profile
* Data from separate clinical studies
© MorphoSys - August 2013 9 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
© MorphoSys - August 2013 10 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 Q3 2013 Phase 2 Phase 2 trials in ALL and NHL ongoing Combination therapy study in CLL being considered
© MorphoSys - August 2013 11 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 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer 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 BAY94-9343 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
Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs
© MorphoSys - August 2013 12 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
© MorphoSys - August 2013 13 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 & frombaseline
225mg s.c.), placebo-controlled change Amyloid % 104 weeks on drug, with an option for an additional 2 years of treatment Primary Endpoint: Change in the Clinical Data from Phase 1 Dementia Rating Scale Sum of Boxes (CDR-SOB) Effect of gantenerumab on amyloid load as indexed by PET Sub-study: Change in brain amyloid over time SUVR at end of treatment assessed by PET Interim safety analysis in 2013 Data expected 2016 Data: Courtesy of Roche
© MorphoSys - August 2013 14 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 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer 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 BAY94-9343 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
Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs
© MorphoSys - August 2013 15 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: www.actionduchenne.org
© MorphoSys - August 2013 16 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 Rheumatoid Arthritis GSK GM-CSF (2 programs) Multiple Sclerosis Guselkumab (CNTO1959) Psoriasis Janssen/J&J IL23p19 (2 programs) Rheumatoid Arthritis BHQ880 Novartis DKK-1 Cancer 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 BAY94-9343 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
Various Partners 74 Partnered Programs 38 Programs - Various Indications 3 Proprietary Pr. 7 MOR Programs
© MorphoSys - August 2013 17 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 2013 – 2017”
Sources: Jetten AM, Nucl Recept Signal, 2009
© MorphoSys - August 2013 18 Technology
© MorphoSys - August 2013 19 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 UK-based GPCR drug discovery & MorphoSys will make and offer antibodies against GPCRs development company with proprietary StaR® technology for Most important target class; challenging for antibodies generating stabilized receptors
Lantipeptides MorphoSys collaborates with Lanthio Pharma to develop lantipeptide libraries for drug discovery Dutch start-up focused on lantipeptides: cyclic peptides Preferred rights to exclusive license showing high target selectivity MorphoSys has minority equity position and improved drug-like properties
© MorphoSys - August 2013 20 Strong Financials
© MorphoSys - August 2013 21 Shareholdings
Shareholdings by Investor Type Geographic Split of Institutional Holdings Institutional Investors - 52% USA: 58% Novartis - 6% Scandinavia: 12% Treasury Stock - 1.5% United Kingdom: 10% Management & Supervisory Boards - 2% Switzerland: 7% Retail Investors - 20% Benelux: 6% Unidentified Investors - 18.5% Germany: 5%
18,5%
52% 20%
6% 2% 1.5%
MorphoSys AG (FSE: MOR, Prime Standard, TecDAX; OTC: MPSYY) Shares issued: 23,400,632 (June 30, 2013) / Treasury stock: 339,890 (June 30, 2013)
© MorphoSys - August 2013 22 Key Financials
in EUR million H1 2013 Guidance 2013*
Group Revenues 48.2 74 – 78
EBIT 17.3 2 to 6
Cash & Marketable Securities and Interest-bearing 166.3** Assignable Loans as of June 30, 2013
* Updated following MOR202 regulatory clearance (August 10, 2013) ** Cash position does not include any payments from GSK or Celgene
© MorphoSys - August 2013 23 Progress in Proprietary Portfolio 2013
MOR103 Partnership for further development Multiple sclerosis Phase 1b study continues 2013 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
© MorphoSys - August 2013 24 Clinical Trials Scheduled for Completion
Partnered LFG316 Bimagrumab Phase 3 AMD Ventilated Patients Phase 2 Bimagrumab Guselkumab Guselkumab Phase 1 Sarcopenia RA (vs. Stelara) Palmoplantar Postulosis BHQ880 Guselkumab NOV-3 Proprietary Smoldering MM Psoriasis Undisclosed Phase 2 LFG316 LFG316 NOV-3 Bimagrumab Phase 1 MCP AMD undisclosed Cachexia (COPD)
BHQ880 NOV-3 MOR103 MOR208 MM/Renal Insufficiency undisclosed Multiple sclerosis B-ALL
Bimagrumab MOR208 BI-1 BI-1 BAY94-9343 (ADC) Cachexia (cancer) CLL (extension arm) undisclosed undisclosed Solid Tumors Gantenerumab Guselkumab Gantenerumab CNTO3157 Liquid vs. Lyophilized Devices/Formulation AD/Japan Asthma
Guselkumab OMP-59R5 OMP-18R5 LJM716 LJM716 Psoriasis (Japan) Solid Tumors Solid Tumors Single Combo 2013 2014 Potential data events based on clinical trial design & MorphoSys estimates
© MorphoSys - August 2013 25 Thank You
www.morphosys.com
Dr. Simon Moroney Chief Executive Officer Phone +49 (0)89 / 899 27-311 Fax +49 (0)89 / 899 27-5311 Email [email protected]
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.