company update - morphosys · mor103 gsk gm-csf rheumatoid arthritis mor208 - cd19 all, cll, nhl...

Company Update

© MorphoSys - February 2015

February 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.

2

Investment Case


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

3

MorphoSys is committed to developing

a valuable pipeline of truly differentiated therapeutic antibodies

built using proprietary technologies

The MorphoSys Pipeline

22 Clinical Programs, 94 Total

© MorphoSys - February 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


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)


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

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


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


PF-05082566 Pfizer 4-1BB Solid Tumors, NHL (+rituximab)

Solid tumors, combination with

PD-1 inhibitor MK-3475

Partnered Clinical Pipeline (II)


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

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”

8

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


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


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

mylo

id c

hange

from

base

line

The MorphoSys Proprietary Portfolio


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

11

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

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


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


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


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


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


Shareholdings


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


in EUR million Guidance 2014 9-Month 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


20162015

Potential data events based on clinical trial design & MorphoSys estimates Partnered Programs

MOR Programs

20

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


CNTO6785


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


LFG316

MCP

LFG316

Geographic Atrophy

APPENDIX


Pipeline Programs: Business Structure


Partner provides target

MorphoSys technology used to develop

optimized antibody lead candidate

Partner responsible for development and

commercialization

MorphoSys receives milestone & royalties

MorphoSys selects program at

target stage (discovery) or

later (in-licensing)

MorphoSys is fully responsible for pre-clinical

and clinical development

Various partnering strategies

Partner Programs MOR Programs

Discovery Market Market

PartneringPartner

Discovery

22

MOR103

Novel Mode of Action in Rheumatoid Arthritis


Results from Phase 1b/2a Trial in RA

- DAS28 Scores over 16 weeks -

Very fast onset of therapeutic effect

Durable response

Clean safety profile

Week

Mean c

hange f

rom

base

line

Administration of MOR103

23

DRUG HuCAL IgG1 targeting GM-CSF

GM-CSF is a key inflammatory

mediator in RA and other

inflammatory conditions

Targets monocytes & macrophages

Ultra-high affinity

DATA Phase 1b/2a trial in RA patients

showed excellent efficacy, durable

response & clean safety profile

Fast onset of therapeutic effect

Phase 1b in MS completed, results

were presented at ACTRIMS-ECTRIMS

meeting in September 2014

Global license agreement with GSK

NEXT Phase 2b study in RA

MOR208 Phase 1 Study in R/R CLL

High Single Agent Overall Response Rate


Best Response, n (%) 0.3 - 9 mg/kg

(N=11)

12 mg/kg

(N=16)

Total

(N=27)

Response by IWCLL 2008 criteria (CT scan)

Complete Response 0 0 0

Partial Response 2 (18%) 6 (38%) 8 (30%)

Stable Disease 7 (64%) 10 (62%) 17 (63%)

Progressive Disease 2 (18%) 0 2 (7%)

ORR in 12mg/kg (recommended phase 2 dose): 38% (IWCLL2008)

Responses by NCI96 criteria (physical exam)

Complete Response 0 0 0

Partial Response 6 (55%) 12 (75%) 18 (67%)

Stable Disease 5 (45%) 4 (25%) 9 (33%)

Progressive Disease 0 0 0

MOR208 shows encouraging single-agent efficacy!

Woyach et al. Blood 2014

† patients that have completed two cycles of treatment and subsequently received disease response assessment

MOR208 Phase 2 in R/R NHL

Efficacy Results by Subtype


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%)

MOR208 is efficacious as single agent in NHL

Blum et al. #3089, ASH 2014

Novartis Alliance: Landmark Deal


Novartis pays…

Approx. €20m p.a. technology license

including HuCAL internalization fees

Approx. €20m p.a. in research funding

Over €250m milestones (probability adjusted)

Royalties on all resulting drugs

Novartis gets…

Preferred access to HuCAL for use in over

100 discovery programs

Timeline

May 2004: Initial deal, including equity stake

November 2007: Major expansion

November 2017: End, subject to 2-year extension option

Excluded

Most infectious disease targets

NEW ANTIBODY

PLATFORM

Next generation antibody platform

Higher quality antibodies, greater diversity

Patent protected until 2031

New Technologies Intensify Focus on Making

Truly Differentiated Drugs


Alliance with Lanthio Pharma

to develop lanthipeptide

libraries for drug discovery

MorphoSys fully owns the

lanthipeptide technology

Minority equity position

Most important target class

Challenging for antibodies

MorphoSys secures access to

stabilized GPCRs from

Heptares

27

Ylanthia

Antibodies Against GPCRs Lanthipeptides

NEW DEVELOPMENTS

Covering Analysts


Institution Contact

Baader Helvea Dr. Olav Zilian

Bank of America Merrill Lynch Ms. Sarah Potter

Close Brother Seydler Mr. Igor Kim

Commerzbank Mr. Daniel Wendorff

Deutsche Bank Mr. Gunnar Romer

Edison Dr. Mick Cooper

Goldman Sachs Mr. Steve Chesney

Independent Research GmbH Mr. Christoph Schöndube

J.P. Morgan Cazenove Ms. Diana Na

Kempen & Co. Mr. Sachin Soni / Mr. Mark Pospisilik

Landesbank Baden-Württemberg Mr. Timo Kürschner

28

Forthcoming Events & Conferences


Feb 11-12, 20152015 Leerink Partners Global

Healthcare Conference

New York, USAFeb 26, 2015

YE 2014 Results ConferenceMar 3-4, 2015

Credit Suisse Healthcare Conference

London, UK

April 16, 2015

8th Kempen Lifesciences Conference

New York, USA

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

company update - morphosys · mor103 gsk gm-csf rheumatoid arthritis mor208 - cd19 all, cll, nhl...

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