Berenberg and Goldman Sachs Second German ... - MorphoSys … Com… · Sale of AbD, GSK & Celgene deals Two Major Alliances for Proprietary Antibodies ... BAY94-9343 Bayer Healthcare

Company Update September 24, 2013

Berenberg and Goldman Sachs

Second German Corporate Conference

© MorphoSys - September 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

Highlights


Strong Financial Performance

Recurring cash-flows

Sale of AbD, GSK & Celgene deals

Two Major Alliances for Proprietary Antibodies

Alliance with Celgene for co-development & co-promotion of MOR202

Successful out-licensing of MOR103 to GSK

Pipeline Progress

21 programs in clinical development

3

Innovative Product Pipeline

© MorphoSys - September 2013 4

The MorphoSys Pipeline

21 Clinical Programs, 81 Total


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

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103

(2 programs) GSK GM-CSF

Rheumatoid Arthritis

Multiple Sclerosis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis


BHQ880 Novartis DKK-1 Cancer

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

NOV – 3 Novartis - not discl.

LFG316 Novartis C5 Ophthalmology

OMP-59R5 OncoMed/GSK Notch 2 Cancer

CNTO3157 Janssen/J&J - Asthma

CNTO6785 Janssen/J&J - Rheumatoid Arthritis

MOR208 - CD19 CLL, NHL, ALL

MOR202 Celgene/MOR CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

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

22 Programs Various Partners - Various Indications

38 Programs Various Partners

3 Proprietary Pr. - Various Indications

74 Partnered Programs

7 MOR Programs

5

HuCAL: The Most Successful Antibody Library

Technology in the Industry

HuCAL Human Combinatorial

Antibody Library

Most successful antibody library HuCAL programs in clinic 20

Transforming R&D productivity Success rate from target to IND 40%

Modular gene structure enables systematic

creation of drug quality antibodies


MOR202

A Novel Antibody for Multiple Myeloma


Large Market and Unmet Need

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

Clinical Development

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

currently ongoing

Strategic Alliance with Celgene

Joint development of MOR202 globally and co-promotion in Europe

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Alliance with Celgene for MOR202


Scope Global co-development and European

co-promotion agreement

Costs: 1/3 MorphoSys, 2/3 Celgene

Up-front MOR receives EUR 70.8 million

Equity Celgene pays EUR 46.2 million for 3.4%

stake in MOR at EUR 57.90 per share

53% premium to pre-announcement price

Milestones Up to EUR 511 million in development,

regulatory and sales milestones

Commercialization Co-promotion in Europe with 50:50 profit

share

Exclusive Celgene in rest-of-world,

tiered double digit royalties to MOR

8

MOR103

Global License Agreement with GSK


MOR103

Ultra-high affinity HuCAL IgG1 targeting GM-CSF

Potential for superior efficacy and better safety than current

treatments

Phase 1b/2a trial in RA successfully completed

Phase 1b in MS ongoing

GSK assumes global responsibility for clinical 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

9

0

10

20

30

40

50

60

70

0 1 2 3 4

MOR103 1.0 mg/kgmavrilimumabHumiraOrenciaActemra

MOR103

Compelling Clinical Data


Time (weeks)

% o

f pati

ents

ACR20*

Very fast onset of therapeutic effect

DAS28

Durable response

Week

Mean c

hange f

rom

base

line

Clean safety profile

* Data from separate clinical studies

10

Administration of MOR103

MOR208 (XmAb5574)

A Novel Anti-Cancer Antibody



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

11

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 in Q3 2013

Phase 2

Phase 2 trials in ALL and NHL ongoing

Combination therapy study in CLL being considered

12






MOR103



Multiple Sclerosis



Psoriasis






















7 MOR Programs

13

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

14

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

Phase 3 study (Roche)

770 prodromal patients, 2 doses (105mg &

225mg s.c.), placebo-controlled

104 weeks on drug, with an option for an

additional 2 years of treatment

Primary Endpoint: Change in the Clinical

Dementia Rating Scale Sum of Boxes (CDR-SOB)

Data expected 2016

Phase 3 study (Dominantly Inherited Alzheimer

Network)

Genetically pre-disposed subjects

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

15






MOR103



Multiple Sclerosis



Psoriasis






















7 MOR Programs

16

Bimagrumab (BYM338)

A Novartis Musculoskeletal Program


Bimagrumab is a HuCAL antibody against ActRIIB

Novartis received FDA breakthrough therapy

designation for sporadic inclusion body myositis (sIBM)

Phase 2 study showed that bimagrumab

substantially benefited patients with sIBM

Results will be presented at the American

Neurological Association meeting on Oct. 14, 2013

In Phase 2 development for

Sporadic inclusion body myositis

Cancer-related cachexia

COPD-related cachexia

Sarcopenia

Mechanically ventilated patients

Recently Highlighted by Novartis

“Imagine the equivalent of 8 or 10 weeks of exercise

in one injection”

Listed as a “planned filing 2016” Source: www.actionduchenne.org

17






MOR103



Multiple Sclerosis



Psoriasis






















7 MOR Programs

18

Guselkumab

A Janssen Anti-Inflammatory Program


Guselkumab is a HuCAL antibody against IL-23

Phase 2 development for psoriasis

Phase 2 study vs. Stelara in rheumatoid arthritis

Specific for IL-23

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

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

Highlighted at Janssen’s Last Analyst Day

Listed under “planned filings 2013 – 2017”

Sources: Jetten AM, Nucl Recept Signal, 2009

19

Technology


New Technologies

Enabling the Creation of Differentiated Drugs


Ylanthia

Totally new antibody platform

Higher quality antibodies, greater

diversity faster access to superior

drug leads

US patent granted January 2013

Differentiated Drug Candidates

Lantipeptides

Alliance with Lanthio Pharma to

develop lantipeptide libraries for drug

discovery

Preferred rights to exclusive license

MorphoSys has minority equity position

New Target Classes

Antibodies Against GPCRs

MorphoSys secures access to stabilized GPCRs produced by Heptares

MorphoSys will make and offer antibodies against GPCRs

Most important target class; challenging for antibodies

Strong Financials


Shareholdings


52%

6%

3%

20%

15%

Institutional Investors - 52%Novartis - 6%Celgene - 3%Treasury Stock - 2%Management & Supervisory Boards - 2%Retail Investors - 20%Unidentified Investors - 15%

2% 2%

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; OTC: MPSYY)

Shares issued: 24,591,443 (August 31, 2013)

Shareholdings by Investor Type

23

Key Financials


in EUR million H1 2013 Guidance 2013*

Group Revenues 48.2 74 – 78

EBIT 17.3 2 to 6

Cash & Marketable Securities and Interest-bearing

Assignable Loans as of June 30, 2013 166.3**

* Updated following MOR202 regulatory clearance (August 10, 2013)

** Cash position does not include any payments from GSK or Celgene, nor the proceeds

from the capital increase placed in September

24

Outstanding Recent Progress


MOR202

Co-development partnership with Celgene

MOR103

Partnership with GSK

MOR208

Promising Phase 1 data in CLL

Phase 2 studies in ALL and NHL started

Bimagrumab

Breakthrough therapy designation

NOV-7

Seventh program enters clinic from Novartis alliance

2013

25

MOR208

CLL (extension arm)

Gantenerumab

AD/Japan

Clinical Trials Scheduled for Completion


Potential data events based on clinical trial design & MorphoSys estimates

Bimagrumab

Sarcopenia

BHQ880

Smoldering MM

MOR208

B-ALL

Bimagrumab

Cachexia (cancer)

LFG316

MCP

LFG316

Wet AMD

Guselkumab

RA (vs. Stelara)

LFG316

AMD

Guselkumab

Psoriasis

Bimagrumab

Cachexia (COPD)

LJM716

Combo

OMP-59R5

Solid Tumors

BI-1

undisclosed

BI-1

undisclosed

Guselkumab

Psoriasis (Japan)

BAY94-9343 (ADC)

Solid Tumors

Gantenerumab

Liquid vs. Lyophilized

OMP-18R5

Solid Tumors

MOR103

Multiple sclerosis

2013

NOV-3

undisclosed

NOV-3

undisclosed

2014

Phase 2

Phase 1

Partnered

Proprietary

Phase 2

Phase 1

Guselkumab

Devices/Formulation

BHQ880

MM/Renal Insufficiency

Bimagrumab

Ventilated Patients

NOV-3

Undisclosed

LJM716

Single

Guselkumab

Palmoplantar Postulosis

CNTO3157

Asthma

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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

Documents

Berenberg and Goldman Sachs Second German ... - MorphoSys … Com… · Sale of AbD, GSK & Celgene deals Two Major Alliances for Proprietary Antibodies ... BAY94-9343 Bayer Healthcare