Company Update - MorphoSys AG€¦ · 7.4 25.0 68.2 30.4 0 10 20 30 40 50 60 70 80 Week 4 Placebo...

Company Update May 22, 2013

Bio€quity Europe 2013

© MorphoSys - May 2013

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

MorphoSys: The Investment Case


Technology-driven Alliances

Proven HuCAL platform

Major alliance with

Novartis

Ongoing investment in

new technologies

Broad Product Pipeline

21 clinical programs

Promising proprietary programs MOR103, MOR202, MOR208

Multiple clinical read-outs pending

3

Financially Strong

Secure cash-flows

Strong balance sheet

Innovative Product Pipeline

© MorphoSys - May 2013 4

80 Therapeutic Antibody Programs

21 Clinical Programs


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

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) - GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

BHQ880 Novartis DKK-1 Cancer

BYM338 Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

MOR208 - CD19 CLL, NHL, ALL

MOR202 - CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

CNTO3157 Janssen/J&J - Asthma

CNTO – 5 Janssen/J&J - Inflammation

VAY736 Novartis BAFF-R Inflammation

LJM716 Novartis HER3 Cancer

Vantictumab (OMP-18R5) OncoMed/Bayer Fzd 7 Cancer

PFE – 1 Pfizer - Cancer

NOV - 7 Novartis - Ophthalmology

21 Programs Various Partners - Various Indications

38 Programs Various Partners - Various Indications 73 Partnered Programs

7 Proprietary Programs

5

MOR103

A Novel Anti-Inflammatory Antibody


Large Market and Unmet Need in Rheumatoid Arthritis

Approved biologics, mostly anti-TNF therapies, generate $20bn

in annual sales

30-40% of patients do not adequately respond to anti-TNFs

50% of responders stop responding within 2 years

MOR103

Ultra-high affinity HuCAL IgG1 targeting GM-CSF

Potential for superior efficacy and better safety than current

treatments

Intellectual Property

Exclusive license to a US patent covering anti-GM-CSF antibodies

for the treatment of chronic inflammatory conditions

US patent on MOR103 composition of matter

6

7.4

25.0

68.2

30.4

0

10

20

30

40

50

60

70

80

Week 4

Placebo

MOR103 0.3mg/kg

MOR103 1.0mg/kg

MOR103 1.5mg/kg

MOR103 Shows Impressive Efficacy, Fast Onset

of Action & Clean Safety Profile


ACR20 Response at week 4*

% o

f pati

ents

* Full Analysis Set, N= 96

p<0.0001 Efficacy

ACR20 ranks amongst highest observed

for a biologic in RA after 4 weeks

1.0 mg/kg dose cohort shows efficacy

potential

Imaging confirms anti-inflammatory

activity

Safety

Related adverse events more frequent

in placebo group than in active

treatment group

Majority of AEs were of mild intensity

No treatment-related SAEs in the

active treatment groups

7

MOR103

Looking Ahead


Rheumatoid arthritis

Expect even higher efficacy on

longer treatment

development in moderate to severe patients

Potential for monthly or even less frequent dosing

Multiple sclerosis

Phase 1b study in MS patients ongoing

GM-CSF is the only non-redundant inflammatory cytokine in EAE

Major unmet need in progressive forms of the disease

Subcutaneous formulation

Phase 1 study in healthy volunteers shows good PK and bioavailability

Partnering

Negotiations ongoing

8

MOR208 (XmAb5574)

A Novel Anti-Cancer Antibody


Large Market and Unmet Need

Large unmet medical need in NHL, CLL & ALL

Revenues with approved drugs for B cell malignancies

exceed $5bn

MOR208

Anti-CD19 antibody in-licensed from Xencor

CD19 expressed earlier than CD20 potential greater

efficacy vs. anti-CD20s

Proprietary modification in Fc region increased

ADCC rapid & sustained B-cell depletion

Minor modification means convenient dosing schedule,

straightforward manufacturing

Blinatumomab data validate CD19 as target for B-cell

malignancies

9

MOR208

Phase 1/2a Trial in CLL/SLL


Trial Design

Phase 1, multi-center, US study in heavily pre-treated, relapsed

or refractory CLL/SLL patients

Dosage 0.3 mg/kg - 12 mg/kg; days 1&4, weeks 2-8

Results

Acceptable safety profile

Responses observed in 67% of patients by physical exam

4/27 (15%) partial responses and 20/27 (74%) patients with

stable disease (IWCLL 2008 criteria including CT)

Full results from trial extension expected around mid-year 2013

Phase 2

Phase 2 trials in ALL and NHL ongoing

Combination therapy study in CLL being considered

10

MOR202

A Novel Antibody for Multiple Myeloma



Revenues with approved drugs in MM exceed $2bn

Responders eventually relapse or become refractory to existing

therapies

MOR202

High affinity HuCAL antibody targeting CD38

Competitive Profile

Preclinical data show strong synergy in combinations of MOR202

with Velcade or Revlimid

New pre-clinical data presented at ASH

Clinical Development

Phase 1/2a clinical trial in relapsed or refractory MM patients

currently ongoing

82 patients, at sites in Germany and Austria

11

Gantenerumab: A HuCAL Antibody Being

Developed by Roche for Alzheimer’s Disease



Alzheimer’s disease is estimated to affect 25 million people worldwide

Increasing with aging population

Once symptoms for AD dementia have appeared, it may be too late to treat

Picture: Courtesy of Roche

12

Gantenerumab: The Most Advanced Antibody in

Development for Alzheimer’s Disease


Gantenerumab

High affinity HuCAL antibody targeting amyloid-β

Binds & breaks down amyloid-β fibrils and plaques

Clinical Development

Phase 1: gantenerumab reduces brain amyloid 3x

faster than other amyloid-targeting substances

Potentially pivotal Phase 3 study ongoing

770 prodromal patients, 2 doses, placebo-

controlled

104 weeks on drug

CDR-SOB, ADAS-COG, change in brain amyloid

Roche have hinted at conducting an interim

analysis in 2013

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

13

Technology-driven Alliances


Proprietary Technology Platform Underpins

Lucrative Alliances


MorphoSys has successfully partnered its human antibody technology HuCAL with many

of the leading pharmaceutical companies

Lucrative model

Makes MOR cash-flow positive

Funds proprietary R&D

Future upside from milestones & royalties

Pharma partner

Target

HuCAL antibody drug

candidate

R&D funding

Technology licence fees

Milestones and royalties

15

New Technology

1. Slonomics & Ylanthia


Slonomics

Best technology for protein libraries

secured in Sloning acquisition

Deals have already paid for acquisition Pfizer, Novozymes, unnamed pharma

Ylanthia

Totally new antibody platform

Higher quality antibodies, greater

diversity faster lead generation

US patent granted January 2013

16

New technologies now part of expanded Novartis strategic alliance

Through 2017: EUR 20m annual license fees; EUR 20m FTE funding;

milestones; royalties

MOR free to partner platform broadly

New Technology

2. Antibodies Targeting GPCRs


G-Protein Coupled Receptors comprise the most important

drug target class

Over 25% of approved drugs hit GPCRs

Only one marketed antibody targets a GPCR

No reliable method of making antibodies against GPCRs

Collaboration with Heptares

MorphoSys secures access to stabilized GPCRs produced by

Heptares

MorphoSys will make and offer antibodies against GPCRs

Heptares option on antibody program

UK-based GPCR drug

discovery and

development company

Proprietary StaR®

technology platform

generates stabilized

receptors

Opens way to reliable

anti-GPCR antibody

generation

New Technology

3. Lantipeptides


Lantipeptides

Cyclic peptides made in bacteria

Rigidity improves binding characteristics, proteolytic

stability

Collaboration with Lanthio Pharma

MorphoSys will develop lantipeptide libraries for drug

discovery; preferred rights to exclusive licence

Complements antibody capability

MorphoSys has minority equity position in Lanthio Pharma

Groningen, Holland-

based start-up

Focused on

lantipeptides

Lantipeptides are

constrained peptides

showing high target

selectivity and

improved drug-like

properties

Strong Financials


Key Financials


in € million Q1 2013 Guidance 2013

Group Revenues 16.9 48 – 52*

Total Operating Expenses 14.6 70 - 74

thereof Investment in Proprietary R&D 7.0 32 to 37

EBIT 1.9 -18 to -22*

Cash & Marketable Securities and Interest-bearing

Assignable Loans as of March 31, 2013 177.4

* Does not include out-licensing of MOR103, which could lead to significant

out-performance

Sale of AbD Serotec to BioRad completed January 10, 2013, for approx. € 53 million

20

Shareholdings


52%

6%

20%

18,5%

Institutional Investors - 52%

Novartis - 6%

Treasury Stock - 1.5%

Management & Supervisory Boards - 2%

Retail Investors - 20%

Unidentified Investors - 18.5%

2% 1.5%

Geographic Split of Institutional Holdings

USA: 58%

Scandinavia: 12%

United Kingdom: 10%

Switzerland: 7%

Benelux: 6%

Germany: 5%

MorphoSys AG (FSE: MOR, Prime Standard, TecDAX

Shares issued: 23,358,228 (March 31, 2013) / Treasury stock: 339,890 (May 2, 2013)

Shareholdings by Investor Type

Expected Progress in Proprietary Portfolio 2013


MOR103

Partnership for further development

Multiple sclerosis Phase 1b study continues

MOR208

ALL Phase 2 study to commence

NHL Phase 2 study to commence

Clinical data from Phase 1b extension

MOR202

MM Phase 1/2a study continues

First clinical data expected

Partnership

Clinical data

Clinical data

2013

Clinical Trials Scheduled for Completion


BYM338

COPD

BYM338

Cancer

Potential data events based on clinical trial design & MorphoSys estimates

BYM338

Sarcopenia

BHQ880

Smoldering MM

MOR208, B-ALL

Phase 2

LFG316

MCP

LFG316

AMD

NOV-3

Phase 2

CNTO1959

RA versus Stelara

LFG316

AMD

LFG316

AMD

CNTO1959

Psoriasis

LJM716

Combo

LJM716

Single

OMP-59R5

Solid Tumors

BI-1

Phase 1

BI-1

Phase 1

CNTO1959

Psoriasis / Japan

BAY94-9343

Solid Tumors

Gantenerumab

Liquid vs. Lyophilized

Gantenerumab

Japanese AD Patients

OMP-18R5

Solid Tumors

NOV-3

Phase 2

NOV-3

Phase 2

MOR208, CLL

Phase 1/2a Extension

Gantenerumab

Phase 2/3 interim

23

MOR103, MS

Phase 1b

Phase 3

Phase 2

Phase 1

Partnered

Proprietary

Phase 2

Phase 1

2013 2014 H2 2012

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 AG€¦ · 7.4 25.0 68.2 30.4 0 10 20 30 40 50 60 70 80 Week 4 Placebo...

Documents

Transcript of Company Update - MorphoSys AG€¦ · 7.4 25.0 68.2 30.4 0 10 20 30 40 50 60 70 80 Week 4 Placebo...