company update...committed to bringing to market differentiated antibody and peptide therapeutics...
TRANSCRIPT
Company Update
September 9, 2015
2015 Wells Fargo Securities
Healthcare Conference
1
Safe Harbor
© MorphoSys - September 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.
2
Partnered Pipeline Providing Strong Foundation and Multiple Near-Term Catalysts
Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J/Janssen) expected in 2016
Over 20 clinical studies likely to be completed before the end of 2016
Multiple Therapeutic Programs with
Best-in-Class Potential
MOR208: Aimed at Shortcomings of Current Lymphoma and Leukemia Treatments
Promising single agent results in NHL and CLL
Comprehensive set of combo trials commencing in 2015 & 2016
Pivotal trial aimed to start in 2017
3
Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics
Broad Pipeline of Differentiated Proprietary Therapeutics
MOR202: Unique CD38 antibody in multiple myeloma
MOR209: Bi-specific antibody in Phase 1 for mCRPC; MOR106 & MOR107 in pre-clinic
Continued investment in technology leadership drives pipeline growth
© MorphoSys - September 2015
Experienced Team Driving the Next Stage of Growth
Cross-functional team with long track record of leadership
Deep expertise in biopharmaceutical discovery, development & manufacturing
The MOR Portfolio
© MorphoSys - September 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
7 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
Immuno-oncology alliance(Immatics)
Cancer Various
4
MOR208: Addressing Shortcomings in Treating
B-Cell Malignancies
© MorphoSys - September 2015 5
DRUG Fc-enhanced, humanized IgG1 antibody
Fc modification leads to dramatically enhanced B cell depletion via ADCC,
phagocytosis, direct cytotoxicity
Convenient dosing schedule, straightforward manufacturing
Fast Track Designation in DLBCL; FDA & EMA Orphan Drug Status in DLBCL & CLL
TARGET
CD19
CD19 has a strong rationale in B cell malignancies
Constant expression levels of CD19 across all B cell cancers in contrast to CD20
Patients show down-regulation of CD20 after anti-CD20 treatment; CD19 down-
regulation is not described
Novel TKIs efficacious but characterized by challenging side effects; patients
relapsing on TKIs have very unfavorable prognosis
SD, PD &
Non-evaluable
MOR208 Could Be Superior to Other CD19 &
CD20 MAbs in Relapsed/Refractory CLL
© MorphoSys - September 2015 6
anti-CD19 MAbs anti-CD20 MAbs
38%24% 30%
23%13%
MOR20812mg/kg(n=16)
MEDI-551phase 1/212mg/kg(n=26)
Obinutuzumabphase 2(n=20)
Ofatumumabphase 3(n=196)
Rituximab(n=110)
Response Rates Based on IWCLL2008 Criteria
ORR
MEDI-551 data source: Poster
ASCO 2013, 12mg/kg dosing group
Obinutuzumab data source:
GAUGUIN study, Cartron et al,
Blood 2014
Ofatumumab data source: control
arm in ibrutinib vs. O phase 3
trial (RESONATE, ASCO 2014)
Rituximab data source: Late
breaking abstract #6, ASH 2013
Criteria: Hallek et al 2008
(including CT)
[NR – not reported]
mPFS
(mo.)14 NR 10.7 8 5.5
MOR208: Multiple Studies to Start in 2015/2016
7© MorphoSys - September 2015
2015 2016 2017 2018*
NHL
DLBCL
CLL
ALL
Phase 2: MOR208 (12mg/kg) plus lenalidomide (N=80)
Phase 2: MOR208 mono
(N=92)
Safety evaluation leading into anticipated pivotal study
(12 mg/kg MOR208 plus bendamustine), N~320
Ph. 2 (ongoing OSU IIT): R/R & naive CLL & Richter’s Transformation, MOR208 (9mg/kg) plus LEN, N=50
Phase 2: MOR208 (12mg/kg) plus idelalisib, BTKi-failures, N=120
Phase 2 (St. Jude’s IIT): Pedriatic ALL, MOR208 (12mg/kg) plus NK cells, N=13
*no outlook given beyond 2018
STATUS Phase 2 trial with LEN in 2nd line R/R DLBCL to start in Q4 2015
Phase 2 trial with IDE in CLL in BTKi-failures to start in Q1 2016
Phase 3 combo trial with BEN in 2nd line R/R DLBCL aimed to start in 2017
Update on NHL monotherapy planned at ASH 2015
Phase 3Phase 2
IIT
MOR202: A Novel Antibody for Multiple
Myeloma
© MorphoSys - September 2015 8
OPPORTUNITY Multiple myeloma (MM) treatment – a large commercial opportunity
leading already generate > US $ 5.0 billion in worldwide sales
CD38 market peak sales are expected in US$ billions worldwide
First clinical data hint at a balanced and potentially best-in-class
safety/efficacy profile
DRUG High affinity HuCAL IgG1 antibody
Potent ADCC and ADCP, full killing activity on MM cells and low killing activity on
healthy/effector cells, and low/no CDC
Strong synergy with IMiDs and proteasome inhibitors in pre-clinical models
Best-in-class infusion tolerability as consistent 2-hour infusion
MorphoSys regained all rights from Celgene
TARGET
CD38
Antibody binds to a unique epitope on CD38
CD38 has a compelling scientific rationale based on the highest expression levels
of any antibody target in MM
Clinical PoC for anti-CD38 antibodies established
2015 2016 2017 2018*
MM
MOR202: Clinical Development Plan
© MorphoSys - September 2015 9
STATUS Phase 1/2a clinical trial in MM ongoing
Cohorts ongoing:
MOR202 16mg/kg weekly + Dex
MOR202 + LEN + Dex
MOR202 + POM + Dex
Encouraging early signs of activity already at low doses
Higher level of activity expected at further doses giving full target saturation
Phase 1/2a MOR202 (8 and 16mg/kg) plus lenalidomide or pomalidomide and
confirmation cohorts (N~24)
Phase 1/2a MOR202 mono, dose escalation,
plus confirmation cohorts (N~62)
Phase 3: MOR202 combination therapy
Phase 3Phase 2
*no outlook given beyond 2018
TARGET
PSMA/CD3
PSMA expressed in normal and hyperplastic prostate tissue, expression levels
increase with prostate cancer progression
CD3 on cytotoxic T-cells
OPPORTUNITY Prostate cancer is the most common and second most lethal cancer in men
Current treatments provide only a 2-4.5 months increase in OS for metastatic
CRPC patients
Global market for mCRPC therapeutics expected to exceed US$ 5.1 billion in 2022
MOR209/ES414: A Bi-specific
Immunotherapeutic Against Prostate Cancer
© MorphoSys - September 2015 10
DRUG Bi-specific ADAPTIR antibody
Directs T cells to kill PSMA+ tumor cells in vitro and in vivo
Reduced cytokine release on T cell activation in preclinical
models compared to other formats
Prolonged serum half-life in mouse and NHP compared to
antibody fragments
2015 2016 2017 2018*
mCRP
MOR209/ES414: New Treatment Option in
mCRPC
© MorphoSys - September 2015 11
STATUS Preclinical studies successfully concluded, promising results presented in 2013
Pharmacologically active and well tolerated
Shows activity at very low doses
Phase 1 in mCRPC in the U.S. and Australia ongoing
Stage 1: identify MTD of MOR209/ES414 administered iv
Stage 2: evaluate clinical activity in patients that have or have not received prior
chemotherapy
NEXT First clinical data expected in 2016
MOR209/ES414: Phase 1/2 dose escalation (N~50)
MOR209/ES414: Phase 1/2 dose extension (N~80)
Phase 3 preparationsPhase 3Phase 2
*no outlook given beyond 2018
Leveraging Technology Leadership
© MorphoSys - September 2015 12
Antibodies Peptides GPCR target Immuno-oncology
Slonomics – 2010
Enables very
efficient antibody
optimization
Ylanthia - 2011
Largest Fab
antibody library
Based on the
expertise gained in
building and using
HuCAL in drug
discovery and
development
LanthioPharma - 2015
Stabilized peptide
technology
complements
existing antibody
drug discovery
platform
Heptares – 2013
Delivers challenging
GPCRs in stabilized
form as drug
targets
G7 Therapeutics -
2015
Delivers tailor-
made GPCRs as
drug targets
MerckSerono - 2014
Antibodies against
immune
checkpoints
Immatics - 2015
Antibody-based
therapies targeting
tumor-associated
peptides
MorphoSys Group Technologies Collaborations
Programs Being Developed by Partners (I)
© MorphoSys - September 2015 13
Program Partner Target Indication Phase 1 Phase 2 Phase 3
Bimagrumab Novartis ActRIIB sIBM (52 weeks)
(BYM338) sIBM (long-term study)
Cachexia (COPD)
Cachexia (cancer)
Hip fracture surgery
Sarcopenia
BHQ880 Novartis DKK-1 MM (renal insufficiency)
Smoldering MM
BPS804 Mereo/Novartis Sclerostin Osteoporosis
Hypophosphatasia (HPP)
Osteogenesis Imperfecta
LFG316 Novartis C5 Wet AMD
Geographic atrophy
Multifocal Choroiditis and Panuveitis
Dry AMD
Paroxysmal nocturnal hemoglobinuria
VAY736 Novartis BAFF-R Pemphigus vulgaris
Primary Sjögren's syndrome
Primary Sjögren's syndrome
LJM716 Novartis HER3 ESCC (combo with BYL719)
HER2+ cancer (combo with BYL719 &
trastuzumab)
HER2+ cancer, combination with
trastuzumab
HER2+ 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 disordersContract DiscoveryOutlicensed
Programs Being Developed by Partners (II)
© MorphoSys - September 2015 14
Program Partner Target Indication Phase 1 Phase 2 Phase 3
MOR103 GlaxoSmithKline GM-CSF Rheumatoid Arthritis
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
Genetically predisposed
CNTO3157 Janssen/J&J n.d. Asthma
Safety/Pharmacokinetic
CNTO6785 Janssen/J&J n.d. COPD
Rheumatoid arthritis
Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)
(OMP-59R5) Small cell lung cancer (Pinnacle)
Solid tumors
Vantictumab Oncomed/Bayer Fzd 7 Solid tumors
(OMP-18R5) Breast cancer
Pancreatic cancer
NSCLC
BAY94-9343 Bayer Mesothelin Solid tumors
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
PF-05082566 Pfizer 4-1BB Solid tumors, NHL (+rituximab)
Solid tumors, combination with PD-1
inhibitor MK-3475
Advanced solid tumors, combo with
mogamulizumabContract DiscoveryOutlicensed
Bimagrumab (BYM338): A Novartis
Musculoskeletal Program
© MorphoSys - September 2015 15
[*] A Amato et al; Neurology; Nov 7, 2014, online
[1] Statistically significant difference
DRUG Lead indication: sporadic inclusion body
myositis (sIBM)
FDA breakthrough therapy designation
Orphan drug designation
CLINICAL
DATA
Potential novel treatment of sIBM
Phase 2 results in sIBM[*]:
Muscle mass increased substantially from
baseline, approx. 5% more than placebo
Muscle gain was functional as supported
by parallel increases in strength and 6-
minute walking distance
NEXT Pivotal study in sIBM with 240 patients
ongoing, completion scheduled in Q4 2015
Data expected in H1 2016
Listed by Novartis as “planned filing 2016”
Phase 2 read-outs in hip fracture surgery,
sarcopenia expected in 2016
Supportive initial data in sIBM
Data courtesy by Novartis
CLINICAL
DATA
Potential to provide unique value to patients:
Highest levels of durable skin clearance with
less intensive regimens vs. anti-IL-17 class
Potential for similar safety profile vs. long-
term blockade of IL-12 + 23 with STELARA®
Potential for long-term, drug-free efficacy
Guselkumab (CNTO1959): A Janssen
Anti-Inflammatory Program
© MorphoSys - September 2015 16
DRUG 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
NEXT Phase 3 data in 2016
Anticipated regulatory filing in 2016
Financial Guidance 2015
© MorphoSys - September 2015
in € million 2014A H1 2015 Guidance 2015
Group Revenues 64.0 82.6 101 to 106
Proprietary R&D Expenses
(incl. Technology Development)36.4 25.3 56 to 63
EBIT -5.9 46.1 9 to 16
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial
assets
352.8 324.9
17
Clinical Trials Scheduled for Completion
© MorphoSys - September 2015 18
PH
ASE
2PH
ASE 3
PH
ASE 1
20162015
Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs
MOR Programs
LJM716
ESCC, combo w/BYL719
LFG316
Dry AMD
MOR208
NHL (mono - update)
Guselkumab
Psoriasis (VOYAGE 2)
Guselkumab
Psoriasis (VOYAGE 1)
Bimagrumab
sIBM
Guselkumab
Psoriasis (NAVIGATE)
MOR202
Multiple myeloma
MOR208
ALL (mono)
MOR208 - IST
CLL (combo with len)
LFG316
PNH
LJM716
HER2+ cancer (combo)
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
LFG316
MCP
MOR209
Prostate cancer√
√
√
√
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