Company Update

Jefferies 2014 Global Healthcare Conference
Company Update
June 4, 2014
© MorphoSys - June 2014
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 - June 2014
2
Introduction to MorphoSys
MorphoSys is committed to developing a valuable pipeline of truly differentiated
therapeutic antibodies built using proprietary technologies.
Exciting proprietary assets MOR103, MOR202 & MOR208
Broad partnered pipeline based on proprietary HuCAL technology
Strong balance sheet and recurring cash-flows support investment in R&D
© MorphoSys - June 2014
3
The MorphoSys Pipeline
20 Clinical Programs, 83 Total
Program
Bimagrumab (BYM338)
Gantenerumab
MOR103
MOR208
BHQ880
CNTO3157
CNTO6785
Guselkumab (CNTO1959)
LFG316
LJM716
NOV – 3
OMP-59R5
VAY736
MOR202
BAY94-9343
BI – 836845
NOV – 7
NOV – 8
PF-05082566
Vantictumab (OMP-18R5)
Partner
Novartis
Roche
GSK
Novartis
Janssen
Janssen
Janssen
Novartis
Novartis
Novartis
OncoMed
Novartis
Celgene
Bayer
BI
Novartis
Novartis
Pfizer
OncoMed
Target
ActRIIB
Amyloid-ß
GM-CSF
CD19
DKK-1
IL23p19
C5
HER3
Notch 2
BAFF-R
CD38
Mesothelin (ADC)
IGF-1
4-1BB
Fzd 7
Disease Area
Musculoskeletal
CNS
Inflammation
Cancer
Cancer
Inflammation
Inflammation
Inflammation
Ophthalmology
Cancer
not discl.
Cancer
Inflammation
Cancer
Cancer
Cancer
Ophthalmology
Inflammation
Cancer
Cancer
24 Programs
Various
-
Various
39 Programs
Various
-
Various
© MorphoSys - June 2014
Most advanced development stage
Discovery Preclinic Phase 1 Phase 2 Phase 3
77 Partnered Programs
6 MOR Programs
4
Pipeline Programs: Business Structure
Partner Programs
MOR Programs
 Partner provides target
 MorphoSys selects program at
 MorphoSys technology used to develop
optimized antibody lead candidate
 target stage (discovery) or
 later (in-licensing)
 Partner responsible for development and
commercialization
 MorphoSys is fully responsible for pre-clinical
and clinical development
 MorphoSys receives milestone & royalties
 Various partnering strategies
Partner
Discovery
© MorphoSys - June 2014
Partnering
Market
Discovery
Market
5
INNOVATIVE
PRODUCT PIPELINE
© MorphoSys - June 2014
6
The MorphoSys Proprietary Portfolio
Program
Partner
Target
Indication
Discovery Preclinic Phase 1
Phase 2
Phase 3
Fully partnered (tiered, double-digit royalties)
MOR103
GSK
GM-CSF
Rheumatoid Arthritis
Multiple Sclerosis
Co-development & Co-promotion
MOR202
Celgene
CD38
Multiple Myeloma
CD19
ALL
Un-partnered
MOR208
NHL
CLL (IST)
3 Programs
© MorphoSys - June 2014
Various
7
Two Programs Partnered in Lucrative Deals
with Celgene and GSK
MOR103
MOR202
 Out-licensed on Phase 1b/2a data in RA
 Global co-development and European
co-promotion agreement
GSK
 Responsible for 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 - June 2014
 Costs: 1/3 MorphoSys, 2/3 Celgene
 Upfront payment of EUR 70.8m
 Equity investment of EUR 46.2m
 Up to EUR 511m in development,
regulatory and sales milestones
 Co-promotion in Europe with 50:50 profit
share
 Exclusive Celgene in rest-of-world, tiered
double digit royalties to MOR
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MOR103
Novel Mode of Action in Rheumatoid Arthritis
Results from Phase 1b/2a Trial in RA
DRUG
- DAS28 Scores over 16 weeks -
 GM-CSF is a key inflammatory mediator in
RA and other inflammatory conditions
DIFFERENTIATION
 Targets monocytes & macrophages
 Ultra-high affinity
 Fast onset of therapeutic effect
Mean change from baseline
 HuCAL IgG1 targeting GM-CSF
STATUS
 Phase 1b/2a trial in RA patients showed
excellent efficacy, durable response & clean
safety profile
 Very fast onset of therapeutic effect
 Phase 1b in MS completed
 Durable response
 Global license agreement with GSK
 Clean safety profile
Week
Administration of MOR103
© MorphoSys - June 2014
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MOR202
A Novel Antibody for Multiple Myeloma
DRUG
 High affinity HuCAL antibody targeting CD38
MOR202 Combination with Lenalidomide
Significantly Prolongs Survival in a
Ramos in Vivo Mouse Model
 Binds to a unique epitope
DIFFERENTIATION
 Induces ADCC and ADCP
 Strong synergy with lenalidomide &
bortezomib in pre-clinical models
 2 hour infusion
STATUS

Phase 1/2a trial in relapsed or refractory MM
patients ongoing

Further clinical studies, including combos,
being planned

Global co-development and European
co-promotion agreement with Celgene
Taken from poster presented at ASH 2012 - Abstract #4018
© MorphoSys - June 2014
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MOR208
A Novel Antibody to Treat B-cell Malignancies
DRUG
 Fc-enhanced, humanized antibody
targeting CD19
Best Responses
(Phase 1 in CLL – [email protected])
0.3
1
3
6
9
12
Total (%)
mg/kg mg/kg mg/kg mg/kg mg/kg mg/kg
 In-licensed from Xencor
Responses by NCI96
criteria (physical exam)
DIFFERENTIATION
Complete Response
Partial Response
Stable Disease
Progressive Disease
Unknown

Fc modification leads to dramatically
enhanced B-cell depletion

Convenient dosing schedule

Straightforward manufacturing
STATUS

Phase 2 ALL: 30 R/R patients

Phase 2 NHL: Up to 30 R/R patients each
in FL, MCL, DLBCL & other indolent NHL

Phase 2 CLL: Lenalidomide combo in
R/R CLL and untreated CLL patients
(IST – Investigator sponsored trial by OSU)
© MorphoSys - June 2014
1
1
2
1
1
1
3
0
12
4
2
1
1
1
1
2
1
1
14
0
18 (66.7)
8 (29.6)
0
1 (3.7)
Response by IWCLL
2008 criteria (CT scan)
Complete Response
Partial Response
Stable Disease
Progressive Disease
Unknown
1
1
0
4 (14.8)
20 (74)
2 (7.4)
1 (3.7)
Preliminary Phase 2a Results (CLL)
Overall
response
Total
Phase 1
4 (15%)
27
Phase 2a
8 (30%)
27
11
Partnered Clinical Pipeline (I)
Program
Bimagrumab
(BYM338)
Partner
Novartis
Target
ActRIIB
BHQ880
Novartis
DKK-1
LFG316
Novartis
C5
NOV-3
VAY736
Novartis
Novartis
n.d.
BAFF-R
LJM716
Novartis
HER3
NOV-7
NOV-8
Novartis
Novartis
n.d
n.d
© MorphoSys - June 2014
Indication
sIBM
Cachexia (Cancer)
Sarcopenia
Mechanically ventilated
Cachexia (COPD)
MM (renal insufficiency)
Smoldering MM
Wet AMD
Geographic Atrophy
MCP
n.d.
Pemphigus Vulgaris
Primary Sjögren's Syndrome
RRMS
ESCC
Head & Neck Squamous Cell
Carcinoma
HER2+ Cancer
HER2+ Cancer combination
with trastuzumab
Solid Tumors
Eye Disease
Inflammation
Phase 1
Phase 2
Phase 3
12
Partnered Clinical Pipeline (II)
Program
Gantenerumab
Guselkumab
(CNTO1959)
CNTO3157
CNTO6785
OMP-59R5
Vantictumab
(OMP-18R5)
BAY94-9343
BI-836845
PFE-05082566
Partner
Roche
Indication
Prodromal AD
Mild AD
Genetically predisposed
Japanese AD patients
Biovailability
Janssen/J&J
IL23p19
Psoriasis
Rheumatoid Arthritis
Palmoplantar Pustulosis
Janssen/J&J
n.d.
Asthma
Safety/Pharmacokinetic
Janssen/J&J
n.d.
COPD
Rheumatoid Arthritis
Oncomed/GSK
Notch 2
Pancreatic Cancer
Small Cell Lung Cancer
Solid Tumors
Oncomed/Bayer Fzd 7
Solid Tumors
Breast Cancer
Pancreatic Cancer
NSCLC
Bayer
Mesothelin Solid Tumors
BI
IGF-1
Cancer
Cancer
Cancer
Pfizer
4-1BB
Solid Tumors, NHL
© MorphoSys - June 2014
Target
Amyloid-ß
Phase 1
Phase 2
Phase 3
13
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
DRUG
 HuCAL antibody against ActRIIB
 FDA breakthrough therapy designation for sporadic
inclusion body myositis (sIBM)
 Orphan drug designation in sIBM
DIFFERENTIATION
 Novel mechanism of action
 Phase 2 study showed that bimagrumab substantially
benefited patients with sIBM
STATUS
 Pivotal study in sIBM ongoing
 Phase 2 studies ongoing in:




Cancer-related cachexia
COPD-related cachexia
Sarcopenia
Mechanically ventilated patients
 Listed by Novartis as “planned filing 2016”
M. Schuelke at al, N Engl J Med 2004;350:2682-8
© MorphoSys - June 2014
14
Gantenerumab
A Roche Alzheimer’s Disease Program
DRUG
 Binds N-terminus and middle of peptide
DIFFERENTIATION
 Binds/disrupts amyloid plaque and oligomers; binds
peptide only weakly
 Gantenerumab reduces brain amyloid 3x faster than
other amyloid-targeting substances in mild-tomoderate AD patients
STATUS
 Phase 3 SCarlet RoAD trial with 770 prodromal
patients (2 doses, 104 weeks on drug)
 Data expected in 2016
% Amyloid change
from baseline
 HuCAL antibody against amyloid-ß
Data from Phase 1
Effect of gantenerumab on
amyloid load as indexed by PET
SUVR at end of treatment
 Phase 3 Marguerite RoAD trial with 1,000 patients
with mild AD
 Estimated study completion date: 03/2019
 Phase 3 DIAN network trial in genetically predisposed patients
© MorphoSys - June 2014
Data: Courtesy of Roche
15
Guselkumab (CNTO1959)
A Janssen Anti-Inflammatory Program
DRUG
 HuCAL antibody against IL-23
DIFFERENTIATION
 Guselkumab binds the p19 sub-unit of IL-23, while
Stelara binds the p40 sub-unit of IL-23 and IL-12
 Higher specificity through selected inhibition of
IL-23 may provide better risk/benefit profile
STATUS
 Phase 2 study in psoriasis successfully completed,
J&J plans to start phase 3
 Two additional Phase 2 studies ongoing:
 Active rheumatoid arthritis
 Palmoplantar pustulosis
 Listed under “planned filings 2013 – 2017”
(J&J analyst day 2013)
Source: Jetten AM, Nucl Recept Signal, 2009
© MorphoSys - June 2014
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Guselkumab Shows Significant Efficacy in Treatment of Moderate to Severe Plaque Psoriasis
Results at week 16 presented at the 2014 AAD (phase 2b X-PLORE study)
 Up to 86% of psoriasis patients achieved a Physician's Global Assessment (PGA) score of cleared or
minimal at week 16 (primary endpoint)
 Significantly higher levels of efficacy at all doses studied compared to placebo group
 Safety
 Two serious infections in patients receiving guselkumab
 One guselkumab-treated patient reported a malignancy
 Three cardiovascular [CV] events in guselkumab-treated patients: one fatal myocardial infarction
[MI], one nonfatal MI, one cerebrovascular accident, all patients had multiple pre-existing CV risk
factors
@Week 16
Placebo
5 mg
50 mg
200 mg
at week 0, 4, then every 12 weeks
15 mg
100 mg
Adalimumab
every 8 weeks
PGA score
(cleared (0) or
minimal (1)
disease)
7%
34%
79%
83%
61%
86%
58%
PASI 75
5%
44%
81%
81%
76%
79%
70%
PASI 90
2%
34%
45%
57%
34%
62%
44%
AEs (SAEs) in %
50 (1)
© MorphoSys - June 2014
50 (2)
56 (2)
17
Highlighted Programs All Have Blockbuster
Potential
Program
Indication
Forecast Peak Sales*
MOR103
Rheumatoid Arthritis
$3.2bn
MOR202
Multiple Myeloma
$2.1bn
MOR208
NHL
CLL
ALL
$790m
$350m
$250m
$1.4bn
Bimagrumab
sIBM
Cancer cachexia
Ventilated patients
COPD Cachexia
Sarcopenia
$400m
$1.3bn
$600m
$1.0bn
$1.6bn
$4.9bn
Gantenerumab
Alzheimer’s Disease
$15bn
Guselkumab
Psoriasis
Rheumatoid Arthritis
$950m
$1.6bn
$2.6bn
* Based on an external study by Defined Health using publicly available information
© MorphoSys - June 2014
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FINANCIALS
© MorphoSys - June 2014
19
Shareholdings
Shareholdings by Investor Type
Stock Information
Institutional Investors - 67%
 Prime Standard, TecDAX
Retail Investors 22%
 FSE: MOR (ISIN: DE0006632003)
Novartis - 5%
 OTC: MPSYY
Celgene - 3%
 Ticker:
Treasury Stock - 1%
Management & Supervisory Boards - 2%
 Bloomberg: MOR:GR
 Reuters: MORG.DE
 Thomson ONE: MOR-XE
 Shares issued: 26,220,882 (March 31, 2013)
 Fully diluted number of shares: 26,987,681
(March 31, 2013)
3%
5%
22%
67%
© MorphoSys - June 2014
20
Key Financials
in EUR million
Guidance 2014
Q1 2014
Group Revenues
58 to 63
15.9
Investment in Proprietary R&D
36 to 41
7.3
-11 to -16
1.4
EBIT
Cash, cash equivalents & marketable securities
as well as other financial assets as of March 31, 2014
© MorphoSys - June 2014
380.4
21
Phase 3
Clinical Trials Scheduled for Completion
Bimagrumab
sIBM
Bimagrumab
Phase 2
Cachexia (Cancer)
Guselkumab
RA (vs. Stelara)
Guselkumab
MOR208
Bimagrumab
B-ALL
Cachexia (COPD)
Bimagrumab
CNTO6785
VAY736
Ventilated patients
RA
Multiple Sclerosis
NOV-3
Guselkumab
CNTO6785
LFG316
undisclosed
Palmoplantar pustulosis
COPD
MCP
MOR202
BAY94-9343 (ADC)
Multiple Myeloma
Solid tumors
Psoriasis

LJM716
OMP59-R5
Bioavailability
Solid tumors/Mono
Solid tumors
CNTO3157
Phase 1
Gantenerumab
MOR103
BI – 836845
OMP-18R5
Asthma
Cancer
Pancreatic cancer
CNTO3157
BI – 836845
OMP-18R5
Safety/PK
Cancer
NSCLC
LJM716
LJM716
BI – 836845
OMP-18R5
Solid tumors/Mono
Solid tumors/Combo
Cancer
Breast cancer
Multiple sclerosis

Gantenerumab
AD/Japan
2014
Potential data events based on clinical trial design & MorphoSys estimates
© MorphoSys - June 2014
2015
Partnered Programs
MOR Programs
22
Thank You
www.morphosys.com
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]
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.