bofaml 2015 health care conference - morphosys · guselkumab data from 3 pivotal trials in...
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Company UpdateMay 12, 2015
© MorphoSys - May 2015
BofAML 2015 Health Care Conference
1
Safe Harbor
© MorphoSys - May 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
The MorphoSys Pipeline
23 Clinical Programs, 99 Total
© MorphoSys - May 2015 3
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
Acquisition of Lanthio Pharma
© MorphoSys - May 2015 4
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 II type 2 (AT2) receptor-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
Lanthio Pharma
Groningen, Holland
Founded: 2010
10 employees
MOR Proprietary Programs
© MorphoSys - May 2015
Program Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3
Unpartnered
MOR208 CD19 NHL
CLL
ALL
MOR202 CD38 Multiple myeloma
Co-development & co-promotion with Emergent BioSolutions
MOR209/ES414 PSMA/CD3 Prostate cancer
Licensed to GSK (tiered, double-digit royalties)
MOR103 GM-CSF Inflammation
Early-stage programs
MOR106 Inflammation
MOR107 (LP2) AT2 Receptor Fibrosis
8 Programs Various
5
FTD, orphan status US & EU
Orphan status US & EU
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 - May 2015 6
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
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
Anetumab Ravtansine Bayer Mesothelin Solid tumors
(BAY94-9343)
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 - May 2015 7
Financial Guidance 2015
© MorphoSys - May 2015
in EUR millions 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- & long-term financial assets352.8 349.7
8
What to Expect in 2015 & 2016
© MorphoSys - May 2015 9
MOR202Data from phase 1/2a trial at ASCO 2015
Start phase 1/2a LEN & POM combo cohorts
Pipeline Up to 10 new INDs
Potential in-licensing of additional compounds
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
MOR208Updated 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 trials
ALL: Start phase 2 pediatric IST - MOR208 plus NK cell transfusion
PH
ASE
2PH
ASE 3
PH
ASE 1
Clinical Trials Scheduled for Completion
© MorphoSys - May 2015
20162015
Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs
MOR Programs
10
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
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
MOR208
A Novel Antibody to Treat B cell Malignancies
© MorphoSys - May 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 DLBDL and CLL/SLL
CLINICAL Phase 2 clinical development in NHL, CLL and ALL
NHL
Focus on 4 sub-types DLBCL, FL, MCL and other iNHL
Encouraging single agent activity
CLL
Encouraging single agent activity
ALL
Signs of activity, but ORR not sufficient to justify continuation with mono-therapy:
Phase 2 mono-therapy trial in ALL discontinued
NEXT NHL
Updated phase 2 mono-therapy data at ASCO
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
* Patients who have completed two cycles of treatment and subsequently received disease response assessment
MOR208 Demonstrates Efficacy in DLBCL, FL
and iNHL
© MorphoSys - May 2015 13
Efficacy outcome, n (%) DLBCL
(n=35)
FL
(n=31)
iNHL
(n=11)
MCL
(n=12)
Overall
(n=89)
Complete Response 2 (6%) 1 (3%) 1 (9%) 0 4 (4%)
Partial Response 7 (20%) 6 (19%) 3 (27%) 0 16 (18%)
Stable Disease 5 (14%) 14 (45%) 3 (27%) 6 (50%) 28 (31%)
Progressive Disease 11 (31%) 4 (13%) 3 (27%) 5 (42%) 23 (26%)
Not evaluable 10 (29%) 6 (19%) 1 (9%) 1 (8%) 18 (20%)
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%)
Blum et al. #3089, ASH 2014
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 Cycle 3Maintenance
(bi-weekly or monthly)> PR> SD
MOR208 is Superior to Other CD19 & CD20
MAbs in Relapsed/Refractory CLL
© MorphoSys - May 2015 14
α-CD19 MAbs α-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
SD, PD &
Non-evaluable
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)
mPFS
(mo.)15 nr 10.7 8 5.5
MOR202
A Novel Antibody for Multiple Myeloma
© MorphoSys - May 2015 15
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)
2 hour infusion time
MorphoSys regained all rights from Celgene
DATA Strong synergy with IMiDs (lenalidomide and
pomalidomide) and proteasome inhibitors
(bortezomib) in pre-clinical models
NEXT First clinical data to be presented at ASCO
2015 (mono-therapy)
Additional cohorts with weekly dosing
schedule, with and without dexamethasone
ongoing
Combination cohorts with pomalidomide and
lenalidomide to start in H1 2015; Celgene will
supply both IMiDs on preferred terms
MOR202 Shows High ADCC and ADCP
Activity as Single Agent
MOR209/ES414 - A Bi-specific
Immunotherapeutic Against Prostate Cancer
© MorphoSys - May 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 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
Bimagrumab (BYM338)
A Novartis Musculoskeletal Program
© MorphoSys - May 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 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 - May 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
Specificity may provide better risk/benefit profile
Dosing schedule sc q8w or even less frequently
Being developed in psoriasis and psoriatic arthritis
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 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
Gantenerumab
A Roche Alzheimer’s Disease Program
© MorphoSys - May 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
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
mylo
id c
hange
from
base
line