Company UpdateNovember 24, 2015
Deutsches Eigenkapitalforum 2015
Safe Harbor
© MorphoSys AG, Company Update - November 2015
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 AG, Company Update - November 2015 3
The MorphoSys Pipeline
25 Clinical Product Candidates, 104 Total
Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3
Bimagrumab (BYM338) Novartis ActRIIB sIBM (musculoskeletal)
Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis
Gantenerumab Roche Amyloid-ß Alzheimer’s disease
MOR208 - CD19 ALL, CLL, NHL
MOR103/GSK3196165 GSK GM-CSF Inflammation
MOR202 - CD38 Multiple myeloma
BHQ880 Novartis DKK-1 Multiple myeloma
CNTO3157 Janssen - Inflammation
CNTO6785 Janssen - Inflammation
LFG316 Novartis C5 Eye diseases
LJM716 Novartis HER3 Cancer
BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome
Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors
VAY736 Novartis BAFF-R Inflammation
MOR209/ES414 Emergent PSMA/CD3 Prostate cancer
Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors
BAY1093884 Bayer TFPI Hemophilia
BI–836845 BI IGF-1 Solid tumors
NOV–7 Novartis - Eye diseases
NOV–8 Novartis - Inflammation
NOV-9 Novartis - Diabetic eye diseases
NOV-10 Novartis - Cancer
NOV-11 Novartis - Blood disorders
PF-05082566 Pfizer 4-1BB Solid tumors
Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors
MOR106 Galapagos - Inflammation
MOR107 (LP2) - AT2-R Fibrosis
Immuno-oncology program Merck Serono - Cancer
Immuno-oncology program Immatics - Cancer
6 MOR programs - - Various
90 Partnered Programs
13 MOR Programs
1 Outlicensed Program
Most advanced development stage
In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery
The MOR Portfolio
© MorphoSys AG, Company Update - November 2015
Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3
Unpartnered
MOR208 NHL
CD19CLL
ALL
MOR202 Multiple myeloma CD38
MOR107 Fibrosis AT2-R
Immuno-oncology program(Immatics)
Cancer Various
6 Programs Various Various
Co-development & co-promotion
MOR209/ES414 (Emergent)
Prostate cancer PSMA / CD3
MOR106(Galapagos)
Inflammation Undisclosed
Immuno-oncology program(Merck Serono)
Cancer Undisclosed
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FTD, orphan status US & EU
Orphan status US & EU
MOR208
First- & Best-in Class Potential
© MorphoSys AG, Company Update - November 2015 5
Fc-enhanced, humanized IgG1 antibody targeting CD19
CD19 is target of choice for B-cell malignancies
CD20 down-regulated after anti-CD20 treatment
CD19 down-regulation not described
Fc modification leads to dramatically enhanced B cell
depletion
antibody dependent cellular cytotoxicity (ADCC)
phagocytosis
direct cytotoxicity
Convenient dosing schedule, straightforward manufacturing
Strong pre-clinical support for combo therapy
Major medical need in DLBCL and CLL
DLBCL: Ca. 40% treated with chemo-immune
therapy/ASCT eventually relapse, becoming
refractory to current agents*
CLL: Patients who are discontinued after BTKi
treatment relapse very quickly and have a
very poor prognosis
MOR208
Comprehensive Clinical Development Plan
6© MorphoSys AG, Company Update - November 2015
Indication 2015 2016 2017 2018
NHL
DLBCL
CLL
ALL
Phase 2
Phase 2/3
IIT: Investigator-initiated trial
MOR208 (12mg/kg) + lenalidomide; 2nd line R/R; N=80
Safety evaluation leading into anticipated pivotal study
MOR208 (12 mg/kg) + bendamustine; 2nd line R/R; N~320
MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120
MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation; N=50 (Ohio State Univ. IIT)
MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude’s IIT)
MOR208 (12 mg/kg); N=92
MOR202
A Novel Antibody for Multiple Myeloma
© MorphoSys AG, Company Update - November 2015 7
HuCAL IgG1 antibody binding unique epitope
on CD38
One of only three CD38 antibodies in clinic
Potent ADCC and ADCP
Full killing of MM cells
Low killing of healthy/effector cells
Strongly synergistic with IMiDs and proteasome
inhibitors in pre-clinical models
Best-in-class infusion tolerability as consistent
2-hour infusion
Multiple myeloma (MM) treatment: a large
commercial opportunity
Leading therapies already generate over
$5.0bn in worldwide sales
Estimated to reach $10.2bn by 2020
MOR202
Clinical Development Plan
8© MorphoSys AG, Company Update - November 2015
Indication 2015 2016 2017 2018
Multiple
myeloma
Phase 2
Phase 2/3
MOR202 combo study to be based on Phase 2
MOR202 monotherapy, dose escalation &
confirmation cohorts; N~62*
MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24**
MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24*
* Patients who have failed at least 2 prior therapies
** Patients who have failed at least 1 prior therapy
Indication 2015 2016 2017 2018
mCRPC*
Phase 3 preparations
MOR209/ES414
A Novel Bi-specific Antibody for Prostate Cancer
© MorphoSys AG, Company Update - November 2015 9
Bi-specific ADAPTIR antibody targeting
PSMA on prostate cancer cells, levels increase with progression
CD3 on cytotoxic T cells
Compelling pre-clinical data
Encouraging activity in vitro and in vivo
Less cytokine release on T cell activation in pre-clinical models
compared to other formats
Prolonged half-life in mouse and NHP compared to other
formats
* Metastatic castration-resistant prostate cancer
Phase 1/2a
Phase 3
MOR209/ES414: Phase 1/2 dose extension (N~80)
MOR209/ES414: Phase 1/2 dose escalation (N~50)
Clinical Programs Pursued by Partners (I)
© MorphoSys AG, Company Update - November 2015 10
Program Partner Target Indication Phase 1 Phase 2 Phase 3
Bimagrumab Novartis ActRIIB sIBM (52 weeks)
(BYM338) sIBM (extension)
sIBM (long-term study)
Hip fracture surgery
Sarcopenia
Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1)
(CNTO1959) Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
Pustular/Erythrodermic Psoriasis
Moderate to severe psoriasis
Active psoriatic arthritis
Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease
Prodromal Alzheimer‘s disease
Genetically predisposed
BHQ880 Novartis DKK-1 MM (renal insufficiency)
Smoldering MM
BPS804 Mereo/Novartis Sclerostin Osteoporosis
Hypophosphatasia (HPP)
Osteogenesis Imperfecta
CNTO3157 Janssen/J&J n.d. Asthma
Safety/Pharmacokinetic
CNTO6785 Janssen/J&J n.d. COPD
Rheumatoid arthritis
LFG316 Novartis C5 Age-related AMD
Geographic atrophy
Panuveitis
Paroxysmal nocturnal hemoglobinuria
LJM716 Novartis HER3 ESCC (combo with BYL719)
HER2+ cancer (combo BYL719 & trastuzumab)
HER2+ cancer, combo with trastuzumab
Partnered discovery programs
Clinical Programs Pursued by Partners (II)
© MorphoSys AG, Company Update - November 2015 11
Program Partner Target Indication Phase 1 Phase 2 Phase 3
MOR103/GSK3196165 GlaxoSmithKline GM-CSF Rheumatoid Arthritis
Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)
(OMP-59R5) Small cell lung cancer (Pinnacle)
Solid tumors
BAY1093884 Bayer TFPI Bleeding disorders
BAY94-9343 Bayer Mesothelin Solid tumors
Anetumab Ravtansine Advanced malignancies (Japan)
BI-836845 BI IGF-1 Solid tumors, Japanese patients
EGFR mutant NSCLC
Breast cancer
CRPC + enzalutamide
Various solid cancer
Advanced solid tumors
NOV-7 Novartis n.d. Eye disease
NOV-8 Novartis n.d. Inflammation
NOV-9 Novartis n.d. Diabetic eye disease
NOV-10 Novartis n.d. Cancer
NOV-11 Novartis n.d. Blood disorders
PF-05082566 Pfizer 4-1BB Solid tumors, NHL (+rituximab)Solid tumors, combo with PD-1i MK-3475
Advanced solid tumors, with mogamulizumab
Advanced malignancies, with avelumab
VAY736 Novartis BAFF-R Pemphigus vulgaris
Primary Sjögren‘s syndrome
Primary Sjögren‘s syndrome
Vantictumab Oncomed/Bayer Fzd 7 Solid tumors
(OMP-18R5) Breast cancer
Pancreatic cancer
NSCL
Out-licensed programPartnered discovery programs
MOR103/GSK3196165
Anti-inflammatory Program Licensed to GSK
© MorphoSys AG, Company Update - November 2015 12
MOR103/GSK3196165
HuCAL antibody specific for GM-CSF
GM-CSF is important in every step of macrophage
production and infiltration in the tissues
Indications
Lead indication: Rheumatoid arthritis (RA)
Potential for disease modification & analgesic activity in
hand osteoarthritis (HOA)
Current Status
BAROQUE (RA phase 2b) ongoing
Initial clinical read-out 2016
Phase 2 in hand osteoarthritis to start in 2016
GM-CSF plays a key role in
activation of macrophages at the
site of injury or inflammation
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
© MorphoSys AG, Company Update - November 2015 13
Bimagrumab
HuCAL antibody specific for ActRIIB, antagonizes
myostatin binding
Lead indication: sporadic inclusion body myositis (sIBM)
FDA breakthrough therapy designation
Orphan drug designation
Current Status
Pivotal study in sIBM with 240 patients ongoing,
completion scheduled for Q4 2015
Phase 3 data expected in H1 2016
Listed by Novartis as “planned filing 2016”
Phase 2 read-outs in sarcopenia expected in 2016
M. Schuelke at al, N Engl J Med 2004;350:2682-8
Guselkumab (CNTO1959)
A Janssen Anti-Inflammatory Program
© MorphoSys AG, Company Update - November 2015 14
Guselkumab
A HuCAL antibody specific for IL-23, does not bind IL-12
IL-23 blockade inhibits production of multiple cytokines
beyond IL-17A and preserves Th1 & Treg regulatory pathways
Being developed in psoriasis and psoriatic arthritis
Current Status
Five Phase 3 clinical trials ongoing
First Phase 3 data expected in 2016
Anticipated filing in 2016
Source: Jetten AM, Nucl Recept Signal, 2009
Clinical Trials Scheduled for Completion
© MorphoSys AG, Company Update - November 2015 15
PH
ASE
2PH
ASE 3
PH
ASE 1
Potential data events based on clinical trial design & MorphoSys estimates Partnered Discovery Programs
MOR Programs
LJM716
ESCC, combo w/BYL719
LFG316
PanuveitisMOR208
NHL (mono - update)
Guselkumab
Psoriasis (VOYAGE 2)
Guselkumab
Psoriasis (VOYAGE 1)
Bimagrumab
sIBM
Guselkumab
Psoriasis (NAVIGATE)
MOR202
Multiple myeloma
MOR208 - IST
CLL (combo with len)
LFG316
PNH
LJM716
HER2+ cancer (combo)
LJM716
Advanced solid tumors
CNTO6785
Rheumatoid arthritis
CNTO6785
COPD
Tarextumab
Pancreatic cancer
Tarextumab
Solid tumors
Vantictumab
Solid tumorsVantictumab
Pancreatic cancer
Vantictumab
NSCLC
Vantictumab
Breast cancer
BAY94-9343
Solid tumors
BI-836845
Solid tumors (Japan)
BI-836845
NSCLC
BI-836845
Various solid cancer
BI-836845
Advanced solid tumors
MOR209
Prostate cancer
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√
√
Bimagrumab
Sarcopenia
2015 2016
LFG316
Age-related AMD
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Financial Guidance 2015
© MorphoSys AG, Company Update - November 2015
in € million 2014A 9M 2015 Guidance 2015
Group Revenues 64.0 93.9 101 to 106
Proprietary R&D Expenses
(incl. Technology Development)36.4 39.9 56 to 63
EBIT -5.9 34.7 9 to 16
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial
assets
352.8 317.7
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What to Expect?
© MorphoSys AG, Company Update - November 2015 17
MOR208
Updated data from phase 2 mono-therapy trial at ASH 2015
DLBCL: Phase 2 lenalidomide combo trial to start in Q4 2015
Phase 3 bendamustine combo trial expected to start in 2017
CLL: Phase 2 idelalisib combo trial to start in Q1 2016
ALL: Phase 2 pediatric IIT with NK cell transfusion to start in H1 2016
MOR202 Updated data from phase 1/2a trial at ASH 2015
MOR209 First phase 1 data expected in 2016
BimagrumabData from pivotal trial in sporadic inclusion body myositis expected early 2016
Filing expected in 2016
GuselkumabData from 3 pivotal trials in psoriasis expected 2016
Filing expected in 2016
PipelineMOR106 & MOR107 to start clinical development in 2016
Potential in-licensing of additional compounds
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