Company Update...BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI – 1 BI - not discl....
Transcript of Company Update...BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer BI – 1 BI - not discl....
Company Update June 6, 2013
Jefferies 2013 Global Healthcare Conference
© MorphoSys - June 2013
Safe Harbour
© MorphoSys - June 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.
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MorphoSys: The Investment Case
© MorphoSys - June 2013
Technology-driven Alliances
Proven HuCAL platform
Major alliance with
Novartis
Ongoing investment in
new technologies
Broad Product Pipeline
21 clinical programs, multiple read-outs pending
Successful out-licensing of MOR103 to GSK
Promising proprietary programs MOR202 & MOR208
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Financially Strong
Secure cash-flows
Strong balance sheet
Innovative Product Pipeline
© MorphoSys - June 2013 4
80 Therapeutic Antibody Programs
21 Clinical Programs
© MorphoSys - June 2013
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
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 - 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
21 Programs Various Partners - Various Indications
38 Programs Various Partners
3 Proprietary Pr. - Various Indications
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MOR103
Global License Agreement with GSK
© MorphoSys - June 2013
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
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0
10
20
30
40
50
60
70
0 1 2 3 4
MOR103 1 mg/kgmavrilimumabHumiraOrenciaActemra
MOR103
Compelling Clinical Data
© MorphoSys - May 2013
Time (weeks)
% o
f pati
ents
ACR20*
Very fast onset of therapeutic effect
Clean safety profile
* Data from separate clinical studies
DAS28
Durable response
Week
Mean c
hange f
rom
base
line
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MOR208 (XmAb5574)
A Novel Anti-Cancer Antibody
© MorphoSys - June 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 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
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MOR208
Phase 1/2a Trial in CLL/SLL
© MorphoSys - June 2013
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 mid-year 2013
Phase 2
Phase 2 trials in ALL and NHL ongoing
Combination therapy study in CLL being considered
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MOR202
A Novel Antibody for Multiple Myeloma
© MorphoSys - June 2013
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
New pre-clinical data presented at ASH
Clinical Development
Phase 1/2a clinical trial in relapsed or refractory MM patients
currently ongoing
82 patients, at sites in Germany and Austria
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80 Therapeutic Antibody Programs
21 Clinical Programs
© MorphoSys - June 2013
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
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 - 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
21 Programs Various Partners - Various Indications
38 Programs Various Partners
3 Proprietary Pr. - Various Indications
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Gantenerumab: A HuCAL Antibody Being
Developed by Roche for Alzheimer’s Disease
© MorphoSys - June 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
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Gantenerumab: The Most Advanced Antibody in
Development for Alzheimer’s Disease
© MorphoSys - June 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
Potentially pivotal Phase 3 study ongoing
770 prodromal patients, 2 doses, placebo-
controlled
104 weeks on drug
CDR-SOB, ADAS-COG, change in brain amyloid
Roche will conduct an 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
% A
mylo
id c
hange
from
base
line
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80 Therapeutic Antibody Programs
21 Clinical Programs
© MorphoSys - June 2013
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
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 - 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
21 Programs Various Partners - Various Indications
38 Programs Various Partners
3 Proprietary Pr. - Various Indications
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Guselkumab
A Janssen Anti-Inflammatory Program
© MorphoSys - June 2013 15
Guselkumab is a HuCAL antibody against IL-23
In Phase 2 development for psoriasis
In a Phase 2 study vs. Stelara in rheumatoid arthritis
Specific for IL23
Guselkumab binds the p19 sub-unit of IL23, while
Stelara binds the p40 sub-unit of IL23 and IL12
Highlighted at Janssen’s Last Analyst Day
Listed as a “planned filing 2013 – 2017”
Sources: Jetten AM, Nucl Recept Signal, 2009
80 Therapeutic Antibody Programs
21 Clinical Programs
© MorphoSys - June 2013
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
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 - 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
21 Programs Various Partners - Various Indications
38 Programs Various Partners
3 Proprietary Pr. - Various Indications
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BYM338
A Novartis Musculoskeletal Program
© MorphoSys - June 2013 17
BYM338 is a HuCAL antibody against ActRIIB
In Phase 2 development for
Sporadic inclusion body myositis
Cancer-related cachexia
COPD-related cachexia
Sarcopenia
Recently Highlighted by Novartis
Promising Phase 1 data shown at analyst day
“Imagine the equivalent of 8 or 10 weeks of exercise
in one injection”
Listed as a “planned filing 2016”
Source: www.actionduchenne.org
Technology-driven Alliances
© MorphoSys - June 2013 18
New Technology
1. Slonomics & Ylanthia
© MorphoSys - June 2013
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
US patent granted January 2013
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New technologies now part of expanded Novartis strategic alliance
Through 2017: EUR 20m annual license fees; EUR 20m FTE funding;
milestones; royalties
MOR free to partner platform broadly
New Technology
2. Antibodies Targeting GPCRs
© MorphoSys - June 2013 20
G-Protein Coupled Receptors comprise the most important
drug target class
Over 25% of approved drugs hit GPCRs
Only one marketed antibody targets a GPCR
No reliable method of making antibodies against GPCRs
Collaboration with Heptares
MorphoSys secures access to stabilized GPCRs produced by
Heptares
MorphoSys will make and offer antibodies against GPCRs
Heptares option on antibody program
UK-based GPCR drug
discovery and
development company
Proprietary StaR®
technology platform
generates stabilized
receptors
Opens way to reliable
anti-GPCR antibody
generation
New Technology
3. Lantipeptides
© MorphoSys - June 2013 21
Lantipeptides
Cyclic peptides made in bacteria
Rigidity improves binding characteristics, proteolytic
stability
Collaboration with Lanthio Pharma
MorphoSys will develop lantipeptide libraries for drug
discovery; preferred rights to exclusive licence
Complements antibody capability
MorphoSys has minority equity position in Lanthio Pharma
Groningen, Holland-
based start-up
Focused on
lantipeptides
Lantipeptides are
constrained peptides
showing high target
selectivity and
improved drug-like
properties
Strong Financials
© MorphoSys - June 2013 22
Shareholdings
© MorphoSys - June 2013 23
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
Shares issued: 23,358,228 (March 31, 2013) / Treasury stock: 339,890 (May 31, 2013)
Shareholdings by Investor Type
Key Financials
© MorphoSys - June 2013
in EUR million Q1 2013 Guidance 2013*
Group Revenues 16.9 68 – 72
Total Operating Expenses 14.6 70 - 74
thereof Investment in Proprietary R&D 7.0 32 to 37
EBIT 1.9 -2 to +2
Cash & Marketable Securities and Interest-bearing
Assignable Loans as of March 31, 2013 177.4
* Updated after global licensing agreement with GSK for MOR103 (June 3, 2013)
Sale of AbD Serotec to BioRad completed January 10, 2013, for approx. EUR 53 million
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Expected Progress in Proprietary Portfolio 2013
© MorphoSys - June 2013 25
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
MM Phase 1/2a study continues
First clinical data expected
Partnership
Clinical data
Clinical data
2013
Clinical Trials Scheduled for Completion
© MorphoSys - Juni 2013
BYM338
COPD
BYM338
Krebs
BYM338
Sarkopenia
BHQ880
Smoldering MM
MOR208, B-ALL
Phase 2
LFG316
MCP
LFG316
AMD
NOV-3
Phase 2
CNTO1959
RA versus Stelara
LFG316
AMD
LFG316
AMD
CNTO1959
Psoriasis
LJM716
Combo
LJM716
Single
OMP-59R5
Solid Tumors
BI-1
Phase 1
BI-1
Phase 1
CNTO1959
Psoriasis / Japan
BAY94-9343
Solid Tumors
Gantenerumab
Liquid vs. Lyophilized
Gantenerumab
Japanese AD Patients
OMP-18R5
Solid Tumors
NOV-3
Phase 2
NOV-3
Phase 2
MOR208, CLL
Phase 1/2a Extension
Gantenerumab
Phase 2/3 interim
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MOR103, MS
Phase 1b
Phase 3
Phase 2
Phase 1
2013 2014 H2 2012 Potential data events based on clinical trial design & MorphoSys estimates
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. Simon Moroney
Chief Executive Officer
Phone +49 (0)89 / 899 27-311
Fax +49 (0)89 / 899 27-5311
Email [email protected]
Thank You
www.morphosys.com