2015 j.p.morgan healthcare conference · broadest antibody pipeline in the industry, based on hucal...
TRANSCRIPT
Company UpdateJanuary 14, 2015
© MorphoSys - January 2015
2015 J.P.Morgan Healthcare Conference
1
Safe Harbor
© MorphoSys - January 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 - January 2015
Strong balance sheet and recurring cash-flows
Sustains investment in R&D
Broadest antibody pipeline in the industry, based on HuCAL & Ylanthia
94 programs, 22 antibodies in clinical trials
Growing portfolio with currently 10 proprietary programs
Favorable economics
MorphoSys is committed to developing a valuable pipeline of truly differentiated therapeutic
antibodies built using proprietary technologies
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The MorphoSys Pipeline
22 Clinical Programs, 94 Total
© MorphoSys - January 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 Rheumatoid arthritis
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 Celgene CD38 Multiple myeloma
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
MOR209/ES414 Emergent PSMA/CD3 Prostate cancer
MOR106 Galapagos - Inflammation
25 programs Various - Various
Immuno-oncology program Merck Serono - Cancer
4 MOR programs - - Various
40 programs Various - Various
84 Partnered Programs
10 MOR Programs
Most advanced development stage
What to Expect in 2015/2016
© MorphoSys - January 2015 5
MOR208
Updated phase 2 mono-therapy data
Start of combination trials
MOR202
Clinical data from phase 1/2a trial
Start of combination cohorts
MOR209
Start of phase 1 trial
Potential in-licensing of additional compound(s)
Deals for access to targets and/or technologies
Readouts from 2 pivotal studies (bimagrumab & guselkumab)
Up to 10 new INDs
Clinical readouts for 10 partnered programs expected
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 - January 2015 6
Program Partner Target Indication Phase 1 Phase 2 Phase 3
Guselkumab Janssen/J&J IL23p19 Moderate to severe psoriasis
(CNTO1959) Psoriasis (VOYAGE 1)
Psoriasis (VOYAGE 2)
Psoriasis (NAVIGATE)
Rheumatoid arthritis
Palmoplantar pustulosis
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
Partnered Clinical Pipeline (II)
© MorphoSys - January 2015 7
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
© MorphoSys - January 2015
DRUG HuCAL antibody against ActRIIB
FDA breakthrough therapy designation for
sporadic inclusion body myositis (sIBM)
Orphan drug designation in sIBM
CLINICAL
DATA
Potential novel treatment of sIBM
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 ongoing, completion
scheduled in Q4 2015
Listed by Novartis as “planned filing 2016”
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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 - January 2015 9
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
Specificity may provide better risk/benefit profile
Dosing schedule sc q8w or even less frequently
CLINICAL
DATA
Phase 2b results in psoriasis at week 16
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 are scheduled for completion in ‘16
“Planned filings 2013–2017” (J&J analyst day ‘13)
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
Gantenerumab
A Roche Alzheimer’s Disease Program
© MorphoSys - January 2015
Data: Courtesy of Roche
10
DRUG HuCAL antibody against amyloid-ß, binds N-
terminus and middle of peptide
Binds/disrupts amyloid plaque and oligomers;
binds peptide only weakly
CLINICAL
DATA
In phase 1, gantenerumab clears brain amyloid
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 Data from the SCarlet RoAD 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
% A
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hange
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The MorphoSys Proprietary Portfolio
© MorphoSys - January 2015
Program Indication Discovery Preclinic Phase 1 Phase 2 Phase 3 Next Event
Fully partnered (tiered, double-digit royalties)
MOR103 RA Phase 2b study in RA
Multiple sclerosis
Co-development & co-promotion
MOR202 Multiple myelomaStart of combo cohorts
Data from phase 1/2a
MOR209/ES414 Prostate cancer Start of phase 1
Unpartnered
MOR208 ALL Data from phase 2 (mono)
NHLPhase 2 mono-therapy data update
Start of combo trials
CLL (IST) Data from combo trial
Early-stage programs
MOR106 Inflammation Start of phase 1 in 2016
Immuno-oncologyprogram
Cancer
4 Programs Various
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MOR208
A Novel Antibody to Treat B cell Malignancies
© MorphoSys - January 2015 12
DRUG Fc-enhanced, humanized antibody targeting CD19
Fc modification leads to dramatically enhanced B cell depletion
Convenient dosing schedule, straightforward manufacturing
Fast Track Designation in DLBCL, FDA & EMA Orphan Drug Status in CLL/SLL and DLBCL
CLINICAL
DATA
Phase 2 data for mono-therapy:
CLL: ORR of 38% (IWCLL 2008) within the recommended dose despite short
treatment (Median PFS in CLL within recommended dose: 37 weeks; 60 weeks in
expansion cohort)
DLBCL: ORR of up to 36% within evaluable patients
FL: ORR of up to 28% within evaluable patients
NEXT Updated phase 2 mono-therapy data
Start of combination trials
Efficacy outcome, n (%)DLBCL(n=35)
FL(n=31)
iNHL(n=11)
MCL(n=12)
Overall(n=89)
ORR (all pts in cohort) 9 (26%) 7 (23%) 4 (36%) 0 20 (22%)
ORR (evaluable patients†) 9 (36%) 7 (28%) 4 (40%) 0 20 (28%)
† patients that have completed two cycles of treatment and subsequently received disease response assessment
MOR208 is Superior to Other CD19 & CD20
Mabs in R/R CLL
© MorphoSys - January 2015 13
α-CD19 mabs α-CD20 mabs
38%24% 30%
23%13%
MOR20812mg/kg(n=16)
MEDI-551phase I/II12mg/kg(n=26)
Obinutuzumabphase II(n=20)
Ofatumumabphase III(n=196)
Rituximab(n=110)
Single-agent antibodies in R/R CLL*
ORR
SD, PD and
Non-evaluable/info
not available if SD
or PD
*IWCLL2008 criteria
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 III
trial (RESONATE, ASCO 2014)
Rituximab data source: Late
breaking abstract #6, ASH 2013
Criteria: Hallek et al 2008
(including CT)
MOR202
A Novel Antibody for Multiple Myeloma
© MorphoSys - January 2015 14
DRUG High affinity HuCAL antibody targeting CD38
Binds to a unique epitope with low
nanomolar affinity
Ability to kill MM cells in vitro and across
multiple pre-clinical in vivo models (ADCC &
ADCP)
2 hour infusion time
DATA Strong synergy with IMiDs (lenalidomide and
pomalidomide) in pre-clinical models (CD38
up-regulation on MM cells and effector cell
activation)
NEXT Additional cohorts with weekly dosing
schedule, with and without dexamethasone
ongoing
Clinical data to be presented in 2015
Combination cohorts with pomalidomide and
lenalidomide to start in H1 2015
MOR202 Shows High ADCC and ADCP
Activity as Single Agent
MOR202 Phase 1/2a Study Design
© MorphoSys - January 2015 15
MOR202* mono / + dexamethasone (dex)
Dose escalation, weekly dosing, up to 16mg/kg
MOR202* + lenalidomide + dex – dose escalation + confirmation
MOR202* + pomalidomide + dex – dose escalation + confirmation
* MOR202 is given by IV infusion over approximately 2h
H1 2015 H2 2015
MOR209/ES414 - A Bi-specific
Immunotherapeutic Against Prostate Cancer
© MorphoSys - January 2015 16
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 IND filed; phase 1 clinical trial to be initiated
in mCRPC in the U.S. and Australia
FINANCIALS
© MorphoSys - January 2015 17
Shareholdings
© MorphoSys - January 2015 18
Institutional Investors - 73%
Retail Investors - 16%
Novartis - 5%
Celgene - 3%
Treasury Stock - 1%
Management & Supervisory Board - 2%
Stock Information
Prime Standard, TecDAX
FSE: MOR (ISIN: DE0006632003)
OTC: MPSYY
Ticker:
Bloomberg: MOR:GR
Reuters: MORG.DE
Thomson ONE: MOR-XE
Shares issued: 26,456,834 (Dec 31, 2014)
Shareholdings by Investor Type (Dec. 2014)
Key Financials
© MorphoSys - January 2015
in EUR million Guidance 2014 Q3 2014
Group Revenues 58 to 63 46.9
EBIT -5 to -8 -3.7
Cash, cash equivalents & marketable securities
as well as other financial assets as of June 30, 2014364.3
19
2015 Financial guidance will be issued on February 26, 2015
Cash position at YE 2014 amounts to approximately EUR 353 million
PH
ASE
2PH
ASE 3
PH
ASE 1
Clinical Trials Scheduled for Completion
© MorphoSys - January 2015
20162015
Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs
MOR Programs
20
LJM716
ESCC, combo w/BYL719
VAY736
RRMSMOR208
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
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