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Company Update June 3, 2015
© MorphoSys - June 2015
Jefferies 2015 Healthcare Conference
1
Safe Harbor
© MorphoSys - June 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
Investment Case
© MorphoSys - June 2015
Strong balance sheet and recurring cash-flows Sustains investment in R&D
Broadest antibody pipeline in the industry, based on HuCAL & Ylanthia 99 programs, 23 antibodies in clinical trials
Growing portfolio with currently 14 proprietary programs Favorable economics
3
MorphoSys is committed to developing a valuable pipeline of truly differentiated therapeutic antibodies
built using proprietary technologies
The MorphoSys Pipeline 23 Clinical Programs, 99 Total
© MorphoSys - June 2015 4
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 MOR103 GSK GM-CSF Inflammation MOR208 - CD19 ALL, CLL, NHL BHQ880 Novartis DKK-1 Multiple myeloma CNTO3157 Janssen - Inflammation CNTO6785 Janssen - Inflammation LFG316 Novartis C5 Eye diseases LJM716 Novartis HER3 Cancer NOV–3 Novartis - not discl. Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors VAY736 Novartis BAFF-R Inflammation MOR202 - CD38 Multiple myeloma
MOR209/ES414 Emergent PSMA/CD3 Prostate cancer Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors 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 PF-05082566 Pfizer 4-1BB Solid tumors Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors MOR106 Galapagos - Inflammation MOR107 (LP2) - AT2-R Fibrosis 27 programs Various - Various Immuno-oncology program Merck Serono - Cancer 7 MOR programs - - Various 39 programs Various - Various
85 Partnered Programs 14 MOR Programs
Most advanced development stage
The MorphoSys Proprietary Portfolio
© MorphoSys - June 2015
Program Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Next Event
Unpartnered
MOR208 NHL Phase 2 mono-therapy data update Start DLBCL combo trials
CLL Data from IST combo trial Start of new combo trials
ALL Phase 2 IST + NK cells
MOR202 Multiple myeloma Phase 1/2a data update Start of combo cohorts
Co-development & co-promotion with Emergent BioSolutions
MOR209/ES414 Prostate cancer Phase 1 data
Licensed to GSK (tiered, double-digit royalties)
MOR103 Inflammation Start phase 2b study in RA
Early-stage programs
MOR106 Inflammation Start of phase 1 in 2016
MOR107 Fibrosis
Immuno-oncology program Cancer
7 Programs Various
5
FTD, orphan status US & EU
Orphan status US & EU
MOR208 A Novel Antibody to Treat B cell Malignancies
© MorphoSys - June 2015 6
THE DRUG
Fc-enhanced, humanized antibody targeting CD19
− Fc modification leads to dramatically enhanced B cell depletion
Convenient dosing schedule, straightforward manufacturing
Encouraging single agent activity in NHL and CLL
Fast Track Designation in DLBCL
FDA & EMA Orphan Drug Status in DLBCL and CLL
MOR208 Highlights from ASCO
© MorphoSys - June 2015 7
CLINICAL
Encouraging single-agent activity
Well tolerated
Matured data show six complete remissions with durable responses in DLBCL and FL:
− ORR in all subtypes: 23% (28%*)
− ORR in DLBCL: 26% (36%*)
− Longest response in DLBCL so far 14.2 months
− ORR in FL: 26% (30%*)
− Longest response in FL so far 15.4 months
* in evaluable patients
-100
-50
0
50
100
150
200
MOR208 Tumor Shrinkage
Perc
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to n
adir
DLBCL (n=19) FL (n=25) Other iNHL (n=7) MCL (n=9)
Data available for 60 patients
Tumor shrinkage data represent mean values of measurements performed by two independent central radiologists
© MorphoSys - June 2015 8
Very encouraging single-agent activity in patients with R-R NHL
MOR208 Next Steps
© MorphoSys - June 2015 9
NEXT
DLBCL: Initiate two combo trials, with lenalidomide & with bendamustine, in H2 2015
CLL: Initiate combo trials, Q4 2015/Q1 2016
ALL: Initiate pediatric phase 2 study, with NK cell transfer from parental donor (IST at St. Jude Children's Research Hospital, USA), in H2 2015
MOR202 A Novel Antibody for Multiple Myeloma
© MorphoSys - June 2015 10
THE DRUG
HuCAL antibody targeting CD38
Binds a unique epitope with high affinity
Kills MM cells in vitro and across multiple in vivo models (ADCC & ADCP)
Best-in-class infusion tolerability as consistent 2-hour infusion
Fully owned by MorphoSys
MOR202 Shows High ADCC and ADCP Activity as Single Agent
MOR202 Highlights from ASCO
© MorphoSys - June 2015 11
DATA
Early signs of clinical activity with cases of long-lasting tumor control
Safe and tolerable dosed weekly and biweekly
Best-in-class infusion tolerability as consistent 2-hour infusion with no infusion reaction in combo with dexamethazone
First clinical data hint towards a balanced and potentially best-in-class safety/efficacy profile
Preclinical data demonstrate synergistic potential with immunomodulatory agents
Preliminary Efficacy Maximal Change in M-protein
© MorphoSys - June 2015 12
Encouraging activity and long lasting tumor control already demonstrated with low doses of MOR202
Data from patients in cohorts 5–8 who have received at least 1 treatment cycle
DEX, dexamethasone; MR, Minor Response; PD, progressive disease; SD, stable disease, VGPR, very good partial response
MOR202 Next Steps
© MorphoSys - June 2015 13
NEXT
16 mg/kg cohort MOR202 + dexamethazone
Combination cohorts with pomalidomide and with lenalidomide
MOR209/ES414 - A Bi-specific Immunotherapeutic Against Prostate Cancer
© MorphoSys - June 2015 14
DRUG
Bi-specific anti-PSMA/anti-CD3 antibody
Redirects T cells to kill tumor cells expressing PSMA in vitro and in vivo
DATA Well-tolerated in NHP single-dose and repeat-dose studies
− Reduced cytokine release upon T cell activation compared to other formats
Prolonged serum half-life in mouse and NHP compared to antibody fragments
NEXT Phase 1 in mCRPC in U.S. and Australia ongoing
− Stage 1: identify MTD of MOR209/ES414 administered iv
− Stage 2: evaluate clinical activity in patients with & without prior chemotherapy
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
LFG316 Novartis C5 Wet AMD Geographic atrophy MCP
NOV-3 Novartis n.d. n.d. VAY736 Novartis BAFF-R Pemphigus vulgaris
Primary Sjögren's syndrome RRMS
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
Partnered Clinical Pipeline (I)
© MorphoSys - June 2015 15
Program Partner Target Indication Phase 1 Phase 2 Phase 3 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 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 mogamulizumab
Partnered Clinical Pipeline (II)
© MorphoSys - June 2015 16
Bimagrumab (BYM338) A Novartis Musculoskeletal Program
© MorphoSys - June 2015
DRUG
HuCAL antibody against ActRIIB
FDA breakthrough therapy designation for sporadic inclusion body myositis (sIBM)
Orphan drug designation in sIBM
CLINICALDATA
Phase 2 results in sIBM[1]:
− 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
Listed by Novartis as “planned filing 2016”
Phase 2 read-outs in hip fracture surgery, sarcopenia expected in 2016
17
sIBM patient who has typical prominent weakness and atrophy of quadriceps and finger flexors[2]
[1] A Amato et al; Neurology; Nov 7, 2014, online [2] WK Engel and V Askanas; Neurology 2006; 20-29
Guselkumab (CNTO1959) A Janssen Anti-Inflammatory Program
© MorphoSys - June 2015 18
Results from phase 2b study: 293 patients with mild-to-moderate plaque psoriasis
@week 16 Placebo 5 mg 50 mg 200 mg 15 mg 100 mg Humira at week 0, 4, then every 12 weeks every 8 weeks
PGA 0 or 1 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%
DRUG
HuCAL antibody specific for IL-23, doesn’t bind IL-12
Dosing schedule sc q8w or even less frequently
Being developed in psoriasis and psoriatic arthritis
CLINICAL DATA
NEXT Three Phase 3 trials scheduled for completion in 2016
“Planned filings 2013–2017” (J&J analyst day 2013)
Gantenerumab A Roche Alzheimer’s Disease Program
© MorphoSys - June 2015
Data: Courtesy of Roche
19
DRUG
HuCAL antibody against amyloid-ß, binds N-terminus and middle of peptide
Binds/disrupts amyloid plaque and oligomers; binds peptide only weakly
CLINICALDATA
Phase 1, gantenerumab cleared brain amyloid very efficiently in mild-to-moderate patients
Phase 3 trial in prodromal patients discontinued based on futility analysis
Phase 3 Marguerite RoAD trial with 1,000 patients with mild AD ongoing
DIAN network trial in genetically pre-disposed patients ongoing
NEXT Data from discontinued study will be shared by Roche with the medical community after full review and analysis
Data from Phase 1 Effect of gantenerumab on amyloid load as indexed by PET SUVR at end of treatment
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Acquisition of Lanthio Pharma
© MorphoSys - June 2015 20
History
2012
− MOR takes minority stake in Lanthio Pharma
2015: Acquisition of Lanthio Pharma
Most Advanced Program
LP2 (re-named MOR107)
− Pre-IND candidate for fibrotic diseases
− Potent angiotensin AT2 receptor (ATR2)-dependent activity in vivo
− Start of Phase 1 expected 2016
Lanthio Pharma Groningen, Holland Founded: 2010 10 employees
Financial Guidance 2015
© MorphoSys - June 2015
in € million 2014A Q1 2015 Guidance 2015
Group Revenues 64.0 70.4 101-106
Proprietary R&D Expenses (incl. Technology Development) 36.4 10.4 56-63
EBIT -5.9 52.8 9-16
Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets
352.8 349.7
21
What to Expect in 2015 & 2016
© MorphoSys - June 2015 22
MOR202 Data from phase 1/2a trial at ASCO 2015 Start phase 1/2a LEN & POM combo cohorts and data updates
Pipeline Up to 10 new INDs
Potential in-licensing of additional programs
Guselkumab Data from 3 pivotal trials in psoriasis expected 2016
Bimagrumab Data from pivotal trial in sporadic inclusion body myositis expected early 2016
MOR209 First phase 1 data expected in 2016
MOR208 Updated data from phase 2 mono-therapy trial at ASCO 2015 NHL: Start phase 2 LEN & BEN combo trials in DLBCL CLL: Start phase 2 combo trial ALL: Start phase 2 pediatric IST - MOR208 plus NK cell transfusion
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PHAS
E 2
PHAS
E 3
PHAS
E 1
Clinical Trials Scheduled for Completion
© MorphoSys - June 2015
2016 2015
Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs MOR Programs
23
LJM716 ESCC, combo w/BYL719
VAY736 RRMS
MOR208 NHL (mono - update)
Guselkumab Psoriasis (VOYAGE 2)
Guselkumab Psoriasis (VOYAGE 1)
Bimagrumab sIBM
Guselkumab Psoriasis (NAVIGATE)
Bimagrumab Hip fracture surgery
MOR202 Multiple myeloma
MOR208 ALL (mono)
MOR208 - IST CLL (combo with len)
Bimagrumab Sarcopenia
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 tumors
Vantictumab Pancreatic cancer
Vantictumab NSCLC
Vantictumab Breast cancer
BAY94-9343 Solid tumors
BI-836845 Solid tumors (Japan)
BI-836845 NSCLC
BI-836845 Various solid tumors
BI-836845 Advanced solid tumors
LFG316 MCP
LFG316 Geographic atrophy
MOR209 Prostate cancer √
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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