company update - morphosys · ... november 2013 this presentation includes forward-looking...

24
Company Update November 12, 2013 Eigenkapitalforum 2013 © MorphoSys - November 2013

Upload: vankhanh

Post on 29-Oct-2018

214 views

Category:

Documents


0 download

TRANSCRIPT

Company Update November 12, 2013

Eigenkapitalforum 2013

© MorphoSys - November 2013

Safe Harbour

© MorphoSys - November 2013

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 Proposition

© MorphoSys - November 2013

Financially robust

Recurring cash-flows

Strong balance sheet

Very promising clinical assets with significant ownership

MOR202: Celgene alliance for co-development/European co-promotion

MOR103: Successful out-licensing to GSK

MOR208: In Phase 2 for B-cell malignancies

Deep partnered pipeline with several potential blockbusters

21 programs in clinical development

Gantenerumab, bimagrumab, guselkumab…

3

Technology

© MorphoSys - November 2013 4

HuCAL: The Most Successful Antibody Library

Technology in the Industry

© MorphoSys - November 2013

HuCAL: Most successful antibody library with output of >20 clinical programs

Transforming R&D productivity with success rates from target to IND of 40%

Successfully partnered with many of the leading pharmaceutical companies

Pharma partner

Target

HuCAL antibody drug

candidate

R&D funding

Technology licence fees

Milestones and royalties

5

New Technologies

Enabling the Creation of Differentiated Drugs

© MorphoSys - November 2013 6

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

Innovative Product Pipeline

© MorphoSys - November 2013 7

The MorphoSys Pipeline

21 Clinical Programs, 82 Total

© MorphoSys - November 2013

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

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103 GSK GM-CSF Rheumatoid Arthritis

MOR208 - CD19 CLL, NHL, ALL

BHQ880 Novartis DKK-1 Cancer

CNTO3157 Janssen/J&J - Asthma

CNTO6785 Janssen/J&J - Rheumatoid Arthritis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

LFG316 Novartis C5 Eye Disease

NOV – 3 Novartis - not discl.

OMP-59R5 OncoMed/GSK Notch 2 Cancer

VAY736 Novartis BAFF-R Inflammation

MOR103 GSK GM-CSF Multiple Sclerosis

MOR202 Celgene/MOR CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

LJM716 Novartis HER3 Cancer

NOV - 7 Novartis - Eye Disease

PFE – 1 Pfizer - Cancer

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

22 Programs Various Partners - Various Indications

39 Programs Various Partners

3 Proprietary Pr. - Various Indications

75 Partnered Programs

7 MOR Programs

8

MOR103

Global License Agreement with GSK

© MorphoSys - November 2013

MOR103

Human antibody to treat inflammatory conditions, e.g.

rheumatoid arthritis (RA), multiple sclerosis (MS)

Revenues with approved drugs in RA exceed $20bn

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

MOR202

Co-development Agreement with Celgene

© MorphoSys - November 2013 10

MOR202

Human antibody to treat multiple myeloma (MM)

Revenues with approved drugs in MM exceed $2bn

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

currently ongoing

MorphoSys and Celgene sign global co-development and

European co-promotion agreement (Costs: 1/3 MOR, 2/3 Celgene)

MorphoSys receives…

EUR 70.8 million upfront payment

Celgene pays EUR 46.2 million for 3.4% stake in MOR at EUR

57.90 per share (53% premium to pre-announcement price)

Up to EUR 511 million in success-based payments

Co-promotion in Europe with 50:50 profit share; tiered double

digit royalties in rest-of-world

MOR208 (XmAb5574)

A Novel Anti-Cancer Antibody

© MorphoSys - November 2013

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 rapid &

sustained B-cell depletion

Minor modification means convenient dosing schedule,

straightforward manufacturing

Clinical Development

Phase 1 study successfully completed

Phase 2 trials in ALL and NHL ongoing

Combination therapy study in CLL being considered

11

The MorphoSys Pipeline

21 Clinical Programs, 82 Total

© MorphoSys - November 2013

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

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103 GSK GM-CSF Rheumatoid Arthritis

MOR208 - CD19 CLL, NHL, ALL

BHQ880 Novartis DKK-1 Cancer

CNTO3157 Janssen/J&J - Asthma

CNTO6785 Janssen/J&J - Rheumatoid Arthritis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

LFG316 Novartis C5 Eye Disease

NOV – 3 Novartis - not discl.

OMP-59R5 OncoMed/GSK Notch 2 Cancer

VAY736 Novartis BAFF-R Inflammation

MOR103 GSK GM-CSF Multiple Sclerosis

MOR202 Celgene/MOR CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

LJM716 Novartis HER3 Cancer

NOV - 7 Novartis - Eye Disease

PFE – 1 Pfizer - Cancer

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

22 Programs Various Partners - Various Indications

39 Programs Various Partners

3 Proprietary Pr. - Various Indications

75 Partnered Programs

7 MOR Programs

12

Bimagrumab (BYM338)

A Novartis Musculoskeletal Program

© MorphoSys - November 2013

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

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

13

The MorphoSys Pipeline

21 Clinical Programs, 82 Total

© MorphoSys - November 2013

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

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103 GSK GM-CSF Rheumatoid Arthritis

MOR208 - CD19 CLL, NHL, ALL

BHQ880 Novartis DKK-1 Cancer

CNTO3157 Janssen/J&J - Asthma

CNTO6785 Janssen/J&J - Rheumatoid Arthritis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

LFG316 Novartis C5 Eye Disease

NOV – 3 Novartis - not discl.

OMP-59R5 OncoMed/GSK Notch 2 Cancer

VAY736 Novartis BAFF-R Inflammation

MOR103 GSK GM-CSF Multiple Sclerosis

MOR202 Celgene/MOR CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

LJM716 Novartis HER3 Cancer

NOV - 7 Novartis - Eye Disease

PFE – 1 Pfizer - Cancer

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

22 Programs Various Partners - Various Indications

39 Programs Various Partners

3 Proprietary Pr. - Various Indications

75 Partnered Programs

7 MOR Programs

14

Gantenerumab: A HuCAL Antibody Being

Developed by Roche for Alzheimer’s Disease

© MorphoSys - November 2013

Large Market and Unmet Need

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

15

Gantenerumab: The Most Advanced Antibody in

Development for Alzheimer’s Disease

© MorphoSys - November 2013

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

16

The MorphoSys Pipeline

21 Clinical Programs, 82 Total

© MorphoSys - November 2013

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

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal

Gantenerumab Roche Amyloid-ß Alzheimer’s Disease

MOR103 GSK GM-CSF Rheumatoid Arthritis

MOR208 - CD19 CLL, NHL, ALL

BHQ880 Novartis DKK-1 Cancer

CNTO3157 Janssen/J&J - Asthma

CNTO6785 Janssen/J&J - Rheumatoid Arthritis

Guselkumab (CNTO1959)

(2 programs) Janssen/J&J IL23p19

Psoriasis

Rheumatoid Arthritis

LFG316 Novartis C5 Eye Disease

NOV – 3 Novartis - not discl.

OMP-59R5 OncoMed/GSK Notch 2 Cancer

VAY736 Novartis BAFF-R Inflammation

MOR103 GSK GM-CSF Multiple Sclerosis

MOR202 Celgene/MOR CD38 Multiple Myeloma

BAY94-9343 Bayer Healthcare Mesothelin (ADC) Cancer

BI – 1 BI - not discl.

LJM716 Novartis HER3 Cancer

NOV - 7 Novartis - Eye Disease

PFE – 1 Pfizer - Cancer

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

22 Programs Various Partners - Various Indications

39 Programs Various Partners

3 Proprietary Pr. - Various Indications

75 Partnered Programs

7 MOR Programs

17

Guselkumab

A Janssen Anti-Inflammatory Program

© MorphoSys - November 2013 18

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”

Strong Financials

© MorphoSys - November 2013 19

Shareholdings

© MorphoSys - November 2013

87%

6% 3%

Institutional & Retail Investors - 87%

Novartis - 6%

Celgene - 3%

Treasury Stock - 2%

Management & Supervisory Boards - 2%

Capital Increases Q3 2013

August 2013

Investor: Celgene

Number of new shares: 797,150

Price: €57.90 per share

September 2013:

Investor: Institutional Investors (US/EU)

Number of new shares: 1,514,066

Price: €55.76 per share (at market)

MorphoSys AG (FSE: MOR, Prime Standard, TecDAX; OTC: MPSYY)

Shares issued: 26,119,309 (October 31, 2013)

Shareholdings by Investor Type

20

Key Financials

© MorphoSys - November 2013

in EUR million 9-Month 2013 Guidance 2013*

Group Revenues 63.6 74 – 78

EBIT 14.6 7 to 10

Cash, cash equivalents & marketable securities

as well as other financial assets

as of September 30, 2013

401.9

* Updated on October 24, 2013

21

Outstanding Recent Progress

© MorphoSys - November 2013 22

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

Pivotal study started in Q3 2013

NOV-7

Seventh program enters clinic from Novartis alliance

2013

MOR208

CLL (extension arm)

Gantenerumab

AD/Japan

Clinical Trials Scheduled for Completion

© MorphoSys - November 2013

Potential data events based on clinical trial design & MorphoSys estimates

Bimagrumab

Sarcopenia

BHQ880

Smoldering MM

MOR208

B-ALL

Bimagrumab

Cachexia (cancer)

LFG316

AMD

Guselkumab

RA (vs. Stelara)

LFG316

Wet 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

23

MOR202

Multiple myeloma

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