deutsche bank dbaccess german, swiss & austrian conference · 2015-01-08 · safety profile...

Company Update June 13, 2014

Deutsche Bank

dbAccess German, Swiss & Austrian Conference

© MorphoSys - June 2014

Safe Harbour


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

Introduction to MorphoSys


Strong balance sheet and recurring cash-flows support investment in R&D

Exciting proprietary assets MOR103, MOR202 & MOR208

Broad partnered pipeline based on proprietary HuCAL technology

3

MorphoSys is committed to developing a valuable pipeline of truly differentiated

therapeutic antibodies built using proprietary technologies.

The MorphoSys Pipeline

20 Clinical Programs, 83 Total

© MorphoSys - June 2014 4

Most advanced development stage

Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

Gantenerumab Roche Amyloid-ß CNS

MOR103 GSK GM-CSF Inflammation

MOR208 - CD19 Cancer

BHQ880 Novartis DKK-1 Cancer

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

Guselkumab (CNTO1959) Janssen IL23p19 Inflammation

LFG316 Novartis C5 Ophthalmology

LJM716 Novartis HER3 Cancer

NOV – 3 Novartis - not discl.

OMP-59R5 OncoMed Notch 2 Cancer

VAY736 Novartis BAFF-R Inflammation

MOR202 Celgene CD38 Cancer

BAY94-9343 Bayer Mesothelin (ADC) Cancer

BI – 836845 BI IGF-1 Cancer

NOV – 7 Novartis - Ophthalmology

NOV – 8 Novartis - Inflammation

PF-05082566 Pfizer 4-1BB Cancer

Vantictumab (OMP-18R5) OncoMed Fzd 7 Cancer

24 Programs Various - Various

39 Programs Various - Various

77 Partnered Programs

6 MOR Programs

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

Partnering Partner

Discovery

INNOVATIVE

PRODUCT PIPELINE


The MorphoSys Proprietary Portfolio


Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

MOR103 GSK GM-CSF Rheumatoid Arthritis

Multiple Sclerosis

MOR202 Celgene CD38 Multiple Myeloma

MOR208 CD19 ALL

NHL

CLL (IST)

3 Programs Various

Fully partnered (tiered, double-digit royalties)

Co-development & Co-promotion

Un-partnered

Two Programs Partnered in Lucrative Deals

with Celgene and GSK


MOR103

Out-licensed on Phase 1b/2a data in RA

GSK

Responsible for development and

commercialization of MOR103 in all

indications

MorphoSys receives

EUR 22.5 million upfront payment

Up to EUR 423 million in success-based

payments

Tiered, double-digit royalties on net sales

MOR202

Global co-development and European

co-promotion agreement

Costs: 1/3 MorphoSys, 2/3 Celgene

Upfront payment of EUR 70.8m

Equity investment of EUR 46.2m

Up to EUR 511m in development,

regulatory and sales milestones

Co-promotion in Europe with 50:50 profit

share

Exclusive Celgene in rest-of-world, tiered

double digit royalties to MOR

MOR103

Novel Mode of Action in Rheumatoid Arthritis


DRUG

HuCAL IgG1 targeting GM-CSF

GM-CSF is a key inflammatory mediator in

RA and other inflammatory conditions

DIFFERENTIATION

Targets monocytes & macrophages

Ultra-high affinity

Fast onset of therapeutic effect

STATUS

Phase 1b/2a trial in RA patients showed

excellent efficacy, durable response & clean

safety profile

Phase 1b in MS completed

Global license agreement with GSK

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

MOR202

A Novel Antibody for Multiple Myeloma


DRUG

High affinity HuCAL antibody targeting CD38

Binds to a unique epitope

DIFFERENTIATION

Induces ADCC and ADCP

Strong synergy with lenalidomide &

bortezomib in pre-clinical models

2 hour infusion

STATUS

Phase 1/2a trial in relapsed or refractory MM

patients ongoing

Further clinical studies, including combos,

being planned

Global co-development and European

co-promotion agreement with Celgene

Taken from poster presented at ASH 2012 - Abstract #4018

MOR202 Combination with Lenalidomide

Significantly Prolongs Survival in a

Ramos in Vivo Mouse Model

MOR208

A Novel Antibody to Treat B-cell Malignancies


DRUG

Fc-enhanced, humanized antibody

targeting CD19

In-licensed from Xencor

DIFFERENTIATION

Fc modification leads to dramatically

enhanced B-cell depletion

Convenient dosing schedule

Straightforward manufacturing

STATUS

Phase 2 ALL: 30 R/R patients

Phase 2 NHL: Up to 30 R/R patients each

in FL, MCL, DLBCL & other indolent NHL

Phase 2 CLL: Lenalidomide combo in

R/R CLL and untreated CLL patients

(IST – Investigator sponsored trial by OSU)

Best Responses

(Phase 1 in CLL – presented@ASH2012)

Overall

response Total

Phase 1 4 (15%) 27

Phase 2a 8 (30%) 27

0.3

mg/kg

1

mg/kg

3

mg/kg

6

mg/kg

9

mg/kg

12

mg/kg Total (%)

Responses by NCI96

criteria (physical exam)

Complete Response 0

Partial Response 2 1 3 12 18 (66.7)

Stable Disease 1 1 1 1 0 4 8 (29.6)

Progressive Disease 0

Unknown 1 (3.7)

Response by IWCLL

2008 criteria (CT scan)

Complete Response 0

Partial Response 1 2 1 4 (14.8)

Stable Disease 1 1 2 1 1 14 20 (74)

Progressive Disease 1 1 2 (7.4)

Unknown 1 (3.7)

Preliminary Phase 2a Results (CLL)

Program Partner Target Indication Phase 1 Phase 2 Phase 3

Bimagrumab Novartis ActRIIB sIBM

(BYM338) Cachexia (Cancer)

Sarcopenia

Mechanically ventilated

Cachexia (COPD)

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

Head & Neck Squamous Cell

Carcinoma

HER2+ Cancer

HER2+ Cancer combination

with trastuzumab

Solid Tumors

NOV-7 Novartis n.d Eye Disease

NOV-8 Novartis n.d Inflammation

Partnered Clinical Pipeline (I)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

Gantenerumab Roche Amyloid-ß Prodromal AD

Mild AD

Genetically predisposed

Japanese AD patients

Biovailability

Guselkumab Janssen/J&J IL23p19 Psoriasis

(CNTO1959) Rheumatoid Arthritis

Palmoplantar Pustulosis

CNTO3157 Janssen/J&J n.d. Asthma

Safety/Pharmacokinetic

CNTO6785 Janssen/J&J n.d. COPD

Rheumatoid Arthritis

OMP-59R5 Oncomed/GSK Notch 2 Pancreatic Cancer

Small Cell Lung Cancer

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 Cancer

Cancer

Cancer

PFE-05082566 Pfizer 4-1BB Solid Tumors, NHL

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

DIFFERENTIATION

Novel mechanism of action

Phase 2 study showed that bimagrumab substantially

benefited patients with sIBM

STATUS

Pivotal study in sIBM ongoing

Phase 2 studies ongoing in:

Cancer-related cachexia

COPD-related cachexia

Sarcopenia

Mechanically ventilated patients

Listed by Novartis as “planned filing 2016”

M. Schuelke at al, N Engl J Med 2004;350:2682-8

Gantenerumab

A Roche Alzheimer’s Disease Program


DRUG

HuCAL antibody against amyloid-ß

Binds N-terminus and middle of peptide

DIFFERENTIATION

Binds/disrupts amyloid plaque and oligomers; binds

peptide only weakly

Gantenerumab reduces brain amyloid 3x faster than

other amyloid-targeting substances in mild-to-

moderate AD patients

STATUS

Phase 3 SCarlet RoAD trial with 770 prodromal

patients (2 doses, 104 weeks on drug)

Data expected in 2016

Phase 3 Marguerite RoAD trial with 1,000 patients

with mild AD

Estimated study completion date: 03/2019

Phase 3 DIAN network trial in genetically pre-

disposed patients

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

Data: Courtesy of Roche

Guselkumab (CNTO1959)

A Janssen Anti-Inflammatory Program


DRUG

HuCAL antibody against IL-23

DIFFERENTIATION

Guselkumab binds the p19 sub-unit of IL-23, while

Stelara binds the p40 sub-unit of IL-23 and IL-12

Higher specificity through selected inhibition of

IL-23 may provide better risk/benefit profile

STATUS

Phase 2 study in psoriasis successfully completed,

J&J plans to start phase 3

Two additional Phase 2 studies ongoing:

Active rheumatoid arthritis

Palmoplantar pustulosis

Listed under “planned filings 2013 – 2017”

(J&J analyst day 2013)

Source: Jetten AM, Nucl Recept Signal, 2009

Guselkumab Shows Significant Efficacy in Treat-

ment of Moderate to Severe Plaque Psoriasis


Results at week 16 presented at the 2014 AAD (phase 2b X-PLORE study)

Up to 86% of psoriasis patients achieved a Physician's Global Assessment (PGA) score of cleared or

minimal at week 16 (primary endpoint)

Significantly higher levels of efficacy at all doses studied compared to placebo group

Safety

Two serious infections in patients receiving guselkumab

One guselkumab-treated patient reported a malignancy

Three cardiovascular [CV] events in guselkumab-treated patients: one fatal myocardial infarction

[MI], one nonfatal MI, one cerebrovascular accident, all patients had multiple pre-existing CV risk

factors

@Week 16 Placebo 5 mg 50 mg 200 mg 15 mg 100 mg Adalimumab

at week 0, 4, then every 12 weeks every 8 weeks

PGA score

(cleared (0) or

minimal (1)

disease)

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%

AEs (SAEs) in % 50 (1) 50 (2) 56 (2)

Highlighted Programs All Have Blockbuster

Potential


Program Indication Forecast Peak Sales*

MOR103 Rheumatoid Arthritis $3.2bn

MOR202 Multiple Myeloma $2.1bn

MOR208

NHL

CLL

ALL

$790m

$350m

$250m

Bimagrumab

sIBM

Cancer cachexia

Ventilated patients

COPD Cachexia

Sarcopenia

$400m

$1.3bn

$600m

$1.0bn

$1.6bn

Gantenerumab Alzheimer’s Disease $15bn

Guselkumab Psoriasis

Rheumatoid Arthritis

$950m

$1.6bn

* Based on an external study by Defined Health using publicly available information

$1.4bn

$4.9bn

$2.6bn

FINANCIALS


Shareholdings


67%

22%

5% 3%

Institutional Investors - 67%

Retail Investors 22%

Novartis - 5%

Celgene - 3%

Treasury Stock - 1%

Management & Supervisory Boards - 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: 26,220,882 (March 31, 2013)

Fully diluted number of shares: 26,987,681

(March 31, 2013)

Shareholdings by Investor Type

Key Financials


in EUR million Guidance 2014 Q1 2014

Group Revenues 58 to 63 15.9

Investment in Proprietary R&D 36 to 41 7.3

EBIT -11 to -16 1.4

Cash, cash equivalents & marketable securities

as well as other financial assets as of March 31, 2014 380.4

21

Phase

3

Phase

1

Phase

2

Clinical Trials Scheduled for Completion


2015 2014

Potential data events based on clinical trial design & MorphoSys estimates

Gantenerumab AD/Japan

CNTO3157 Asthma

Gantenerumab Bioavailability

Guselkumab Psoriasis

Bimagrumab Cachexia (COPD)

Guselkumab RA (vs. Stelara)

Bimagrumab Ventilated patients

Guselkumab Palmoplantar pustulosis

OMP-18R5 Breast cancer

OMP-18R5 NSCLC

CNTO6785 COPD

Bimagrumab sIBM

BI – 836845 Cancer

NOV-3 undisclosed

LJM716 Solid tumors/Mono

LJM716 Solid tumors/Combo

CNTO3157 Safety/PK

LFG316 MCP

CNTO6785 RA

OMP-18R5 Pancreatic cancer

BI – 836845 Cancer

MOR103 Multiple sclerosis

MOR208 B-ALL

MOR202 Multiple Myeloma

VAY736 Multiple Sclerosis

Bimagrumab Cachexia (Cancer)

LJM716 Solid tumors/Mono

Partnered Programs

MOR Programs

OMP59-R5 Solid tumors

BI – 836845

Cancer

BAY94-9343 (ADC) Solid tumors

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

deutsche bank dbaccess german, swiss & austrian conference · 2015-01-08 · safety profile...

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