company update - morphosys · ... november 2013 this presentation includes forward-looking...
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Safe Harbour
© MorphoSys - November 2013
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
Investment Proposition
© MorphoSys - November 2013
Financially robust
Recurring cash-flows
Strong balance sheet
Very promising clinical assets with significant ownership
MOR202: Celgene alliance for co-development/European co-promotion
MOR103: Successful out-licensing to GSK
MOR208: In Phase 2 for B-cell malignancies
Deep partnered pipeline with several potential blockbusters
21 programs in clinical development
Gantenerumab, bimagrumab, guselkumab…
3
HuCAL: The Most Successful Antibody Library
Technology in the Industry
© MorphoSys - November 2013
HuCAL: Most successful antibody library with output of >20 clinical programs
Transforming R&D productivity with success rates from target to IND of 40%
Successfully partnered with many of the leading pharmaceutical companies
Pharma partner
Target
HuCAL antibody drug
candidate
R&D funding
Technology licence fees
Milestones and royalties
5
New Technologies
Enabling the Creation of Differentiated Drugs
© MorphoSys - November 2013 6
Ylanthia
Totally new antibody platform
Higher quality antibodies, greater
diversity faster access to superior
drug leads
US patent granted January 2013
Differentiated Drug Candidates
Lantipeptides
Alliance with Lanthio Pharma to
develop lantipeptide libraries for drug
discovery
Preferred rights to exclusive license
MorphoSys has minority equity position
New Target Classes
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
The MorphoSys Pipeline
21 Clinical Programs, 82 Total
© MorphoSys - November 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103 GSK GM-CSF Rheumatoid Arthritis
MOR208 - CD19 CLL, NHL, ALL
BHQ880 Novartis DKK-1 Cancer
CNTO3157 Janssen/J&J - Asthma
CNTO6785 Janssen/J&J - Rheumatoid Arthritis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
LFG316 Novartis C5 Eye Disease
NOV – 3 Novartis - not discl.
OMP-59R5 OncoMed/GSK Notch 2 Cancer
VAY736 Novartis BAFF-R Inflammation
MOR103 GSK GM-CSF Multiple Sclerosis
MOR202 Celgene/MOR CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
LJM716 Novartis HER3 Cancer
NOV - 7 Novartis - Eye Disease
PFE – 1 Pfizer - Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
22 Programs Various Partners - Various Indications
39 Programs Various Partners
3 Proprietary Pr. - Various Indications
75 Partnered Programs
7 MOR Programs
8
MOR103
Global License Agreement with GSK
© MorphoSys - November 2013
MOR103
Human antibody to treat inflammatory conditions, e.g.
rheumatoid arthritis (RA), multiple sclerosis (MS)
Revenues with approved drugs in RA exceed $20bn
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
9
MOR202
Co-development Agreement with Celgene
© MorphoSys - November 2013 10
MOR202
Human antibody to treat multiple myeloma (MM)
Revenues with approved drugs in MM exceed $2bn
Phase 1/2a clinical trial in relapsed or refractory MM patients
currently ongoing
MorphoSys and Celgene sign global co-development and
European co-promotion agreement (Costs: 1/3 MOR, 2/3 Celgene)
MorphoSys receives…
EUR 70.8 million upfront payment
Celgene pays EUR 46.2 million for 3.4% stake in MOR at EUR
57.90 per share (53% premium to pre-announcement price)
Up to EUR 511 million in success-based payments
Co-promotion in Europe with 50:50 profit share; tiered double
digit royalties in rest-of-world
MOR208 (XmAb5574)
A Novel Anti-Cancer Antibody
© MorphoSys - November 2013
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 rapid &
sustained B-cell depletion
Minor modification means convenient dosing schedule,
straightforward manufacturing
Clinical Development
Phase 1 study successfully completed
Phase 2 trials in ALL and NHL ongoing
Combination therapy study in CLL being considered
11
The MorphoSys Pipeline
21 Clinical Programs, 82 Total
© MorphoSys - November 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103 GSK GM-CSF Rheumatoid Arthritis
MOR208 - CD19 CLL, NHL, ALL
BHQ880 Novartis DKK-1 Cancer
CNTO3157 Janssen/J&J - Asthma
CNTO6785 Janssen/J&J - Rheumatoid Arthritis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
LFG316 Novartis C5 Eye Disease
NOV – 3 Novartis - not discl.
OMP-59R5 OncoMed/GSK Notch 2 Cancer
VAY736 Novartis BAFF-R Inflammation
MOR103 GSK GM-CSF Multiple Sclerosis
MOR202 Celgene/MOR CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
LJM716 Novartis HER3 Cancer
NOV - 7 Novartis - Eye Disease
PFE – 1 Pfizer - Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
22 Programs Various Partners - Various Indications
39 Programs Various Partners
3 Proprietary Pr. - Various Indications
75 Partnered Programs
7 MOR Programs
12
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
© MorphoSys - November 2013
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
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
13
The MorphoSys Pipeline
21 Clinical Programs, 82 Total
© MorphoSys - November 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103 GSK GM-CSF Rheumatoid Arthritis
MOR208 - CD19 CLL, NHL, ALL
BHQ880 Novartis DKK-1 Cancer
CNTO3157 Janssen/J&J - Asthma
CNTO6785 Janssen/J&J - Rheumatoid Arthritis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
LFG316 Novartis C5 Eye Disease
NOV – 3 Novartis - not discl.
OMP-59R5 OncoMed/GSK Notch 2 Cancer
VAY736 Novartis BAFF-R Inflammation
MOR103 GSK GM-CSF Multiple Sclerosis
MOR202 Celgene/MOR CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
LJM716 Novartis HER3 Cancer
NOV - 7 Novartis - Eye Disease
PFE – 1 Pfizer - Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
22 Programs Various Partners - Various Indications
39 Programs Various Partners
3 Proprietary Pr. - Various Indications
75 Partnered Programs
7 MOR Programs
14
Gantenerumab: A HuCAL Antibody Being
Developed by Roche for Alzheimer’s Disease
© MorphoSys - November 2013
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
15
Gantenerumab: The Most Advanced Antibody in
Development for Alzheimer’s Disease
© MorphoSys - November 2013
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
Phase 3 study (Roche)
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)
Data expected 2016
Phase 3 study (Dominantly Inherited Alzheimer
Network)
Genetically pre-disposed subjects
Data from Phase 1
Effect of gantenerumab on
amyloid load as indexed by PET
SUVR at end of treatment
% A
mylo
id c
hange
from
base
line
Data: Courtesy of Roche
16
The MorphoSys Pipeline
21 Clinical Programs, 82 Total
© MorphoSys - November 2013
Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal
Gantenerumab Roche Amyloid-ß Alzheimer’s Disease
MOR103 GSK GM-CSF Rheumatoid Arthritis
MOR208 - CD19 CLL, NHL, ALL
BHQ880 Novartis DKK-1 Cancer
CNTO3157 Janssen/J&J - Asthma
CNTO6785 Janssen/J&J - Rheumatoid Arthritis
Guselkumab (CNTO1959)
(2 programs) Janssen/J&J IL23p19
Psoriasis
Rheumatoid Arthritis
LFG316 Novartis C5 Eye Disease
NOV – 3 Novartis - not discl.
OMP-59R5 OncoMed/GSK Notch 2 Cancer
VAY736 Novartis BAFF-R Inflammation
MOR103 GSK GM-CSF Multiple Sclerosis
MOR202 Celgene/MOR CD38 Multiple Myeloma
BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer
BI – 1 BI - not discl.
LJM716 Novartis HER3 Cancer
NOV - 7 Novartis - Eye Disease
PFE – 1 Pfizer - Cancer
Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer
22 Programs Various Partners - Various Indications
39 Programs Various Partners
3 Proprietary Pr. - Various Indications
75 Partnered Programs
7 MOR Programs
17
Guselkumab
A Janssen Anti-Inflammatory Program
© MorphoSys - November 2013 18
Guselkumab is a HuCAL antibody against IL-23
Phase 2 development for psoriasis
Phase 2 study vs. Stelara in rheumatoid arthritis
Specific for IL-23
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”
Shareholdings
© MorphoSys - November 2013
87%
6% 3%
Institutional & Retail Investors - 87%
Novartis - 6%
Celgene - 3%
Treasury Stock - 2%
Management & Supervisory Boards - 2%
Capital Increases Q3 2013
August 2013
Investor: Celgene
Number of new shares: 797,150
Price: €57.90 per share
September 2013:
Investor: Institutional Investors (US/EU)
Number of new shares: 1,514,066
Price: €55.76 per share (at market)
MorphoSys AG (FSE: MOR, Prime Standard, TecDAX; OTC: MPSYY)
Shares issued: 26,119,309 (October 31, 2013)
Shareholdings by Investor Type
20
Key Financials
© MorphoSys - November 2013
in EUR million 9-Month 2013 Guidance 2013*
Group Revenues 63.6 74 – 78
EBIT 14.6 7 to 10
Cash, cash equivalents & marketable securities
as well as other financial assets
as of September 30, 2013
401.9
* Updated on October 24, 2013
21
Outstanding Recent Progress
© MorphoSys - November 2013 22
MOR202
Co-development partnership with Celgene
MOR103
Partnership with GSK
MOR208
Promising Phase 1 data in CLL
Phase 2 studies in ALL and NHL started
Bimagrumab
Breakthrough therapy designation
Pivotal study started in Q3 2013
NOV-7
Seventh program enters clinic from Novartis alliance
2013
MOR208
CLL (extension arm)
Gantenerumab
AD/Japan
Clinical Trials Scheduled for Completion
© MorphoSys - November 2013
Potential data events based on clinical trial design & MorphoSys estimates
Bimagrumab
Sarcopenia
BHQ880
Smoldering MM
MOR208
B-ALL
Bimagrumab
Cachexia (cancer)
LFG316
AMD
Guselkumab
RA (vs. Stelara)
LFG316
Wet 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 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
23
MOR202
Multiple myeloma
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.
Dr. Claudia Gutjahr-Löser
Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-122
Fax +49 (0)89 / 899 27-5122
Email [email protected]
Thank You
www.morphosys.com