24
Company Update June 3, 2015 © MorphoSys - June 2015 Jefferies 2015 Healthcare Conference 1

Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

Company Update June 3, 2015

© MorphoSys - June 2015

Jefferies 2015 Healthcare Conference

1

Page 2: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 3: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 4: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 5: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 6: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 7: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 8: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

-100

-50

0

50

100

150

200

MOR208 Tumor Shrinkage

Perc

enta

ge c

hang

e in

indi

cato

r le

sion

fr

om b

asel

ine

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

Page 9: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 10: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 11: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 12: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 13: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

MOR202 Next Steps

© MorphoSys - June 2015 13

NEXT

16 mg/kg cohort MOR202 + dexamethazone

Combination cohorts with pomalidomide and with lenalidomide

Page 14: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 15: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis 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 - June 2015 15

Page 16: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 17: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 18: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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)

Page 19: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

% Am

yloi

d ch

ange

fr

om b

asel

ine

Page 20: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 21: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 22: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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

Page 23: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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 √

Page 24: Jefferies 2015 Healthcare Conference · Pipeline . Up to 10 new INDs . Potential in-licensing of additional programs . Guselkumab . Data from 3 pivotal trials in psoriasis expected

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