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Transcript
June 2015
Company Update
© MorphoSys - June 2015
1
Safe Harbor
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 2015
2
Investment Case
MorphoSys is committed to developing
a valuable pipeline of truly differentiated therapeutic antibodies
built using proprietary technologies
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
Strong balance sheet and recurring cash-flows
 Sustains investment in R&D
© MorphoSys - June 2015
3
Highlights from ASCO2015
MOR208
 Encouraging single-agent activity
 Well tolerated with a low level of infusion
reactions
 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
so far of 14.2 months
− ORR in FL: 26% (30%*) - longest response
so far of 15.4 months
MOR202
 Early signs of clinical activity with cases of
long-lasting tumor control
 Safe and tolerable in weekly and biweekly
doses
 Best-in-class infusion tolerability as consistent
2-hour infusion with no infusion reaction in
combo with Dex
 First clinical data hint towards a balanced and
potentially best-in-class safety/efficacy
profile
 Preclinical data demonstrate synergistic
potential with immunomodulatory agents
 Start of combination trials with lenalidomide
and bendamustine in H2 2015
 Dose escalation is ongoing; combination with
pomalidomide and lenalidomide plus
dexamethasone to start shortly
* in evaluable patients
© MorphoSys - June 2015
4
The MorphoSys Pipeline
23 Clinical Programs, 99 Total
Most advanced development stage
Program
Partner
Target
Disease Area
Bimagrumab (BYM338)
Guselkumab (CNTO1959)
Gantenerumab
MOR103
MOR208
BHQ880
CNTO3157
CNTO6785
LFG316
LJM716
NOV–3
Tarextumab (OMP-59R5)
VAY736
MOR202
MOR209/ES414
Anetumab Ravtansine (BAY94-9343)
BI–836845
NOV–7
NOV–8
NOV-9
NOV-10
PF-05082566
Vantictumab (OMP-18R5)
MOR106
MOR107 (LP2)
27 programs
Immuno-oncology program
7 MOR programs
39 programs
Novartis
Janssen
Roche
GSK
Novartis
Janssen
Janssen
Novartis
Novartis
Novartis
OncoMed
Novartis
Emergent
Bayer
BI
Novartis
Novartis
Novartis
Novartis
Pfizer
OncoMed
Galapagos
Various
Merck Serono
Various
ActRIIB
IL23p19
Amyloid-ß
GM-CSF
CD19
DKK-1
C5
HER3
Notch 2
BAFF-R
CD38
PSMA/CD3
Mesothelin (ADC)
IGF-1
4-1BB
Fzd 7
AT2-R
-
sIBM (musculoskeletal)
Psoriasis
Alzheimer’s disease
Inflammation
ALL, CLL, NHL
Multiple myeloma
Inflammation
Inflammation
Eye diseases
Cancer
not discl.
Solid tumors
Inflammation
Multiple myeloma
Prostate cancer
Solid tumors
Solid tumors
Eye diseases
Inflammation
Diabetic eye diseases
Cancer
Solid tumors
Solid tumors
Inflammation
Fibrosis
Various
Cancer
Various
Various
© MorphoSys - June 2015
Discovery
Preclinic
Phase 1
Phase 2
Phase 3
85 Partnered Programs
14 MOR Programs
5
The MorphoSys Proprietary Portfolio
Program
Indication
Discovery Preclinic
Phase 1 Phase 2 Phase 3 Next Event
Unpartnered
MOR208
MOR202
NHL
FTD, orphan status US & EU
CLL
Orphan status US & EU
Phase 2 mono-therapy
data update
Start DLBCL combo trials
Data from IST combo trial
Start of new combo trials
ALL
Phase 2 IST + NK cells
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
MOR107
Fibrosis
Immuno-oncology
program
Cancer
7 Programs
Various
© MorphoSys - June 2015
Start of phase 1 in 2016
6
MOR208
A Novel Antibody to Treat B cell Malignancies
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
CLINICAL Phase 2 clinical development in NHL, CLL and ALL
 NHL
− ORR* in DLBCL: 36% - longest response so far of 14.2 months
− ORR* in FL: 30% - longest response so far of 15.4 months
 CLL
− Combination trial with lenalidomide (IST) is ongoing
 ALL
− Signs of activity, but ORR not sufficient to justify continuation with mono-therapy:
Phase 2 mono-therapy trial in ALL discontinued
NEXT
 NHL - DLBCL: Initiate two combo trials, + lenalidomide & + bendamustine, H2 2015
 CLL: Initiate combo trials, Q4 2015/Q1 2016
 ALL: Initiate pediatric phase 2 IST, + NK cell transfer from parental donor (with
St. Jude Children's Research Hospital, USA), H2 2015
* in evaluable patients
© MorphoSys - June 2015
7
MOR208 Demonstrates Efficacy in DLBCL, FL
and iNHL
Efficacy outcome, n (%)
DLBCL
(n=35)
FL
(n=34)
iNHL
(n=11)
MCL
(n=12)
Overall
(n=92)
Complete Response
2 (6%)
2 (6%)
2 (18%)
0
6 (7%)
Partial Response
7 (20%)
7 (21%)
1 (9%)
0
15 (16%)
Stable Disease
5 (14%)
17 (50%)
4 (36%)
6 (50%)
32 (35%)
Progressive Disease
11 (31%)
4 (12%)
3 (27%)
5 (42%)
23 (25%)
Not evaluable
10 (29%)
4 (12%)
1 (9%)
1 (8%)
16 (17%)
ORR
9 (26%)
9 (26%)
3 (27%)
0
21 (23%)
ORR, evaluable patients*
9 (36%)
9 (30%)
3 (30%)
0
21 (31%)
* Patients who have completed two cycles of treatment and subsequently received disease response assessment
 International, multi-center, open-label phase 2 study
 12 mg/kg MOR208 weekly
 Two-stage design (total of 120 patients)
− Stage 1: 10 patients per subgroup
− Stage 2: 20 patients per subgroup (with at least 2 PR in stage 1)
Cycle 1
Cycle 2
© MorphoSys - June 2015
> SD
Cycle 3
> PR
Raab et al. #8574, ASCO 2015
Maintenance
(bi-weekly or monthly)
8
Tumor Shrinkage
200
Percentage change in indicator lesion
from baseline to nadir
Tumor shrinkage data represent mean values of measurements
performed by two independent central radiologists
150
Data available for 60 patients
100
DLBCL (n=19)
FL (n=25)
Other iNHL (n=7)
MCL (n=9)
50
0
-50
-100
Very encouraging single-agent activity in patients with R-R NHL
© MorphoSys - June 2015
9
MOR202
A Novel Antibody for Multiple Myeloma
DRUG
 High affinity HuCAL antibody targeting CD38
 Binds to a unique epitope
 Ability to kill MM cells in vitro and across
multiple in vivo models (ADCC & ADCP)
 Best-in-class infusion tolerability as consistent
2-hour infusion
 MorphoSys regained all rights from Celgene
DATA
 Strong synergy with IMiDs (lenalidomide and
pomalidomide) and proteasome inhibitors
(bortezomib) in pre-clinical models
 First clinical data hint towards a balanced and
potentially best-in-class safety/efficacy profile
NEXT
 First promising clinical data presented at ASCO
2015 (mono-therapy)
 Additional cohorts with weekly dosing schedule,
with and without dex ongoing
 Combination cohorts with pomalidomide and
lenalidomide to start in H1 2015; Celgene will
supply both IMiDs on preferred terms
© MorphoSys - June 2015
MOR202 Shows High ADCC and ADCP
Activity as Single Agent
10
Preliminary Efficacy:
Maximal Change in M-protein
Data from patients in cohorts
5–8 who have received >1
treatment cycles
DEX, dexamethasone; MR, Minor Response; PD, progressive disease; SD, stable disease, VGPR, very good partial response
Encouraging activity and long lasting tumor control already
demonstrated with low doses of MOR202
© MorphoSys - June 2015
11
MOR209/ES414 - A Bi-specific
Immunotherapeutic Against Prostate Cancer
DRUG
 Bi-specific anti-PSMA/anti-CD3 immunotherapeutic:
− targeting PSMA on prostate cancer cells
− targeting CD3 on cytotoxic T cells
 Redirects T cells to kill tumor cells expressing PSMA
in vitro and in vivo
DATA
 Reduced cytokine release upon T cell activation
compared to other formats
 Prolonged serum half-life in mouse and NHP
compared to antibody fragments
 Well-tolerated in NHP single-dose and repeat-dose
studies
NEXT
 Phase 1 in mCRPC in the U.S. and Australia initiated
− Stage 1: identify MTD of MOR209/ES414
administered iv
− Stage 2: evaluate clinical activity in patients that
have or have not received prior chemotherapy
© MorphoSys - June 2015
12
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
NOV-9
NOV-10
Novartis
Novartis
Novartis
Novartis
n.d.
n.d.
n.d.
n.d.
© MorphoSys - June 2015
Indication
Phase 1
sIBM (52 weeks)
sIBM (long-term study)
Cachexia (COPD)
Cachexia (cancer)
Hip fracture surgery
Sarcopenia
MM (renal insufficiency)
Smoldering MM
Wet AMD
Geographic atrophy
MCP
n.d.
Pemphigus vulgaris
Primary Sjögren's syndrome
RRMS
ESCC (combo with BYL719)
HER2+ cancer (combo with
BYL719 & trastuzumab)
HER2+ cancer, combination with
trastuzumab
HER2+ cancer
Advanced solid tumors
Eye disease
Inflammation
Diabetic eye disease
Cancer
Phase 2
Phase 3
13
Partnered Clinical Pipeline (II)
Program
Guselkumab
(CNTO1959)
Partner
Janssen/J&J
Target
IL23p19
Gantenerumab
Roche
Amyloid-ß
CNTO3157
Janssen/J&J
n.d.
CNTO6785
Janssen/J&J
n.d.
Tarextumab
(OMP-59R5)
Oncomed/GSK
Notch 2
Vantictumab
(OMP-18R5)
Oncomed/Bayer
Fzd 7
BAY94-9343
BI-836845
Bayer
BI
Mesothelin
IGF-1
PF-05082566
Pfizer
4-1BB
© MorphoSys - June 2015
Indication
Phase 1
Psoriasis (VOYAGE 1)
Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
Pustular/Erythrodermic Psoriasis
Moderate to severe psoriasis
Active psoriatic arthritis
Mild Alzheimer‘s disease
Genetically predisposed
Asthma
Safety/Pharmacokinetic
COPD
Rheumatoid arthritis
Pancreatic cancer (ALPINE)
Small cell lung cancer (Pinnacle)
Solid tumors
Solid tumors
Breast cancer
Pancreatic cancer
NSCLC
Solid tumors
Solid tumors, Japanese patients
EGFR mutant NSCLC
Breast cancer
CRPC + enzalutamide
Various solid cancer
Advanced solid tumors
Solid tumors, NHL (+rituximab)
Solid tumors, combination with
PD-1 inhibitor MK-3475
Advanced solid tumors, combo
with mogamulizumab
Phase 2
Phase 3
14
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
CLINICAL  Potential novel treatment of sIBM
DATA
 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
sIBM patient who has typical prominent
weakness and atrophy of quadriceps and
finger flexors[2]
 Listed by Novartis as “planned filing 2016”
 Phase 2 read-outs in hip fracture surgery,
sarcopenia expected in 2016
[1] A Amato et al; Neurology; Nov 7, 2014, online
[2] WK Engel and V Askanas; Neurology 2006; 20-29
© MorphoSys - June 2015
15
Guselkumab (CNTO1959)
A Janssen Anti-Inflammatory Program
DRUG




HuCAL antibody specific for IL-23, doesn’t bind IL-12
Specificity may provide better risk/benefit profile
Dosing schedule sc q8w or even less frequently
Being developed in psoriasis and psoriatic arthritis
CLINICAL  Phase 2b results in psoriasis at week 16
DATA
− Up to 86% of patients achieved a Physician's
Global Assessment (PGA) score of cleared or minimal
disease at week 16 (primary endpoint)
− Significantly higher levels of efficacy at all doses
compared to placebo group
NEXT
 Three Phase 3 trials scheduled for completion in 2016
 “Planned filings 2013–2017” (J&J analyst day 2013)
Clinical response to a single dose of
10 mg of guselkumab administered
at baseline[1]
[1] H Sofen et al; J Allergy Clin Immunol 2014;
133: 1032-40
Results from phase 2b study: 293 patients with mild-to-moderate plaque psoriasis
@week 16
PGA 0 or 1
PASI 75
PASI 90
© MorphoSys - June 2015
Placebo
7%
5%
2%
5 mg
50 mg
200 mg
at week 0, 4, then every 12 weeks
34%
79%
83%
44%
81%
81%
34%
45%
57%
15 mg
100 mg
every 8 weeks
61%
86%
76%
79%
34%
62%
Humira
58%
70%
44%
16
Gantenerumab
A Roche Alzheimer’s Disease Program
 HuCAL antibody against amyloid-ß, binds Nterminus and middle of peptide
 Binds/disrupts amyloid plaque and oligomers;
binds peptide only weakly
CLINICAL  In phase 1, gantenerumab clears brain amyloid
DATA
very efficiently in mild-to-moderate AD patients
 Phase 3 SCarlet RoAD trial in prodromal patients
discontinued based on pre-planned 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
% Amyloid change
from baseline
DRUG
Data from Phase 1
Effect of gantenerumab on amyloid load
as indexed by PET SUVR at end of
treatment
 Data from the SCarlet RoAD study will be shared
by Roche with the medical community after full
review and analysis
Data: Courtesy of Roche
© MorphoSys - June 2015
17
Acquisition of Lanthio Pharma
History
 2012
− MOR takes minority stake in Lanthio Pharma
− Collaboration to develop lanthipeptide libraries for drug
discovery
 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
Technology & Portfolio
 Library of constrained peptides (lanthipeptides)
 Emerging compound class which offers the potential to
address many types of target and disease categories
 Three discovery-stage programs
© MorphoSys - June 2015
Lanthio Pharma
 Groningen, Netherlands
 Founded: 2010
 10 employees
18
Shareholdings
Shareholdings by Investor Type (Dec. 2014)
Stock Information
 Prime Standard, TecDAX
 FSE: MOR (ISIN: DE0006632003)
 OTC: MPSYY
 Ticker:
− Bloomberg: MOR:GR
− Reuters: MORG.DE
− Thomson ONE: MOR-XE
 Shares issued: 26,462,834 (March 31, 2015)
Institutional Investors - 74%
Retail Investors - 16%
Novartis - 4%
Celgene - 3%
Treasury Stock - 1%
Management & Supervisory Board - 2%
© MorphoSys - June 2015
19
Financial Guidance 2015
2014A
Q1 2015
Guidance 2015
Group Revenues
64.0
70.4
101 to 106
Proprietary R&D Expenses
(incl. Technology Development)
36.4
10.4
56 to 63
EBIT
-5.9
52.8
9 to 16
Cash, cash equivalents & marketable securities
as well as other short-term and long-term financial
assets
352.8
349.7
in € million
© MorphoSys - June 2015
20
What to Expect in 2015 & 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
MOR202
MOR209
Data from phase 1/2a trial at ASCO 2015 √
Start phase 1/2a LEN & POM combo cohorts and data updates
First phase 1 data expected in 2016
Bimagrumab
Data from pivotal trial in sporadic inclusion body myositis expected early 2016
Guselkumab
Data from 3 pivotal trials in psoriasis expected 2016
Pipeline
© MorphoSys - June 2015
Up to 10 new INDs
Potential in-licensing of additional compounds
21
PHASE 2
PHASE 3
Clinical Trials Scheduled for Completion
Guselkumab
Psoriasis (VOYAGE 1)
Bimagrumab
sIBM
Guselkumab
Psoriasis (VOYAGE 2)
CNTO6785
Rheumatoid arthritis
Bimagrumab
Hip fracture surgery
CNTO6785
COPD
MOR208
ALL (mono)
LFG316
MCP
MOR208
NHL (mono - update)
LFG316
Geographic atrophy
MOR208 - IST
CLL (combo with len)
Bimagrumab
Sarcopenia
√
PHASE 1
BAY94-9343
Solid tumors
Tarextumab
Solid tumors
LJM716
Advanced solid tumors
Vantictumab
Breast cancer
MOR202
Multiple myeloma
LJM716
ESCC, combo w/BYL719
VAY736
RRMS
√
√
√
BI-836845
NSCLC
BI-836845
Solid tumors (Japan)
Vantictumab
NSCLC
Vantictumab
Solid tumors
Vantictumab
Pancreatic cancer
LJM716
HER2+ cancer (combo)
2015
Potential data events based on clinical trial design & MorphoSys estimates
© MorphoSys - June 2015
Tarextumab
Pancreatic cancer
BI-836845
Advanced solid tumors
BI-836845
Various solid tumors
LJM716
HER2+ cancer (combo)
Guselkumab
Psoriasis (NAVIGATE)
MOR209
Prostate cancer
2016
Partnered Programs
MOR Programs
22
APPENDIX
© MorphoSys - June 2015
23
MOR208 is Superior to Other CD19 & CD20
MAbs in Relapsed/Refractory CLL
Response Rates Based on IWCLL2008 Criteria
α-CD19 MAbs
α-CD20 MAbs
SD, PD &
Non-evaluable
ORR
38%
MOR208
12mg/kg
(n=16)
mPFS
(mo.)
15
© MorphoSys - June 2015
24%
30%
MEDI-551
phase 1/2
12mg/kg
(n=26)
Obinutuzumab
phase 2
(n=20)
nr
10.7
23%
Ofatumumab
phase 3
(n=196)
8
13%
Rituximab
(n=110)
5.5
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)
24
Covering Analysts
Institution
Contact
Baader Helvea
Dr. Olav Zilian
Bank of America Merrill Lynch
Ms. Sarah Potter
Commerzbank
Mr. Daniel Wendorff
Deutsche Bank
Mr. Gunnar Romer
Edison
Dr. Mick Cooper
Goldman Sachs
Mr. Keyur Parekh
Independent Research GmbH
Mr. Christoph Schöndube
J.P. Morgan Cazenove
Ms. James Gordon
Kempen & Co.
Mr. Sachin Soni / Mr. Mark Pospisilik
Landesbank Baden-Württemberg
Mr. Timo Kürschner
Oddo Seydler Research
Mr. Igor Kim
© MorphoSys - June 2015
25
Forthcoming Events & Conferences
September 8, 2015
September 9-10, 2015
September 16-18, 2015
September 21-23, 2015
Commerzbank, Sector Conference
Frankfurt, Germany
Wells Fargo Healthcare Conference
Boston, USA
BAML Global Healthcare Conference
London, GB
Berenberg & Goldman Sachs
Annual German Corporate Conference
Munich, Germany
© MorphoSys - June 2015
26
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 investors@morphosys.com
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.