Company Update
August 27, 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.
Highlights
Strong Financial Position
Recurring cash-flows
Sale of AbD, GSK & Celgene deals strengthen balance sheet
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
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) GSK GM-CSF
Rheumatoid Arthritis Multiple Sclerosis Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
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
38 Programs Various Partners 3 Proprietary Pr. - Various Indications 74 Partnered Programs
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
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
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
0 10 20 30 40 50 60 70 0 1 2 3 4 MOR103 1 mg/kg mavrilimumab Humira Orencia Actemra
MOR103
Compelling Clinical Data
Time (weeks) % of p at ient s
ACR20*
Very fast onset of therapeutic effect
DAS28
Durable response Week M e an ch ang e fr om b as e li ne Clean safety profile
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
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
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) GSK GM-CSF
Rheumatoid Arthritis Multiple Sclerosis Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
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
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
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
% Amy lo id c ha nge fro m ba se li ne
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) GSK GM-CSF
Rheumatoid Arthritis Multiple Sclerosis Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
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
38 Programs Various Partners 3 Proprietary Pr. - Various Indications 74 Partnered Programs
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”
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) GSK GM-CSF
Rheumatoid Arthritis Multiple Sclerosis Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
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
38 Programs Various Partners 3 Proprietary Pr. - Various Indications 74 Partnered Programs
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”
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
Shareholdings
52% 6% 20% 18,5% Institutional Investors - 52% Novartis - 6% Treasury Stock - 1.5%Management & Supervisory Boards - 2% Retail Investors - 20%
Unidentified Investors - 18.5%
2% 1.5%
Geographic Split of Institutional Holdings
USA: 58% Scandinavia: 12% United Kingdom: 10% Switzerland: 7% Benelux: 6% Germany: 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)
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
Assignable Loans as of June 30, 2013 166.3**
* Updated following MOR202 regulatory clearance (August 10, 2013) ** Cash position does not include any payments from GSK or Celgene
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 extensionMOR202
Partnership with Celgene
MM Phase 1/2a study continues First clinical data expected
MOR208
CLL (extension arm)
Gantenerumab AD/Japan
Clinical Trials Scheduled for Completion
Potential data events based on clinical trial design & MorphoSys estimates Bimagrumab Sarcopenia BHQ880 Smoldering MM MOR208 B-ALL Bimagrumab Cachexia (cancer) LFG316 MCP LFG316 AMD Guselkumab RA (vs. Stelara) LFG316 AMD Guselkumab Psoriasis Bimagrumab Cachexia (COPD) LJM716 Combo OMP-59R5 Solid Tumors BI-1 undisclosed BI-1 undisclosed Guselkumab Psoriasis (Japan) BAY94-9343 (ADC) Solid Tumors Gantenerumab Liquid vs. Lyophilized OMP-18R5 Solid Tumors MOR103 Multiple sclerosis 2013 NOV-3 undisclosed NOV-3 undisclosed 2014 Phase 3 Phase 2 Phase 1 Partnered Proprietary Phase 2 Phase 1 Guselkumab Devices/Formulation BHQ880 MM/Renal Insufficiency Bimagrumab Ventilated Patients NOV-3 Undisclosed LJM716 Single Guselkumab Palmoplantar Postulosis CNTO3157 Asthma
HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla® , Ylanthia® and 100 billion high potentials® are registered trademarks of MorphoSys AG.
® .
Dr. Simon Moroney
Chief Executive Officer
Phone +49 (0)89 / 899 27-311 Fax +49 (0)89 / 899 27-5311 Email investors@morphosys.com