140909 mor-company update long - morphosys · mor103 gsk gm-csf inflammation mor208 - cd19 cancer...

Company Update

September 2014

© MorphoSys - September 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 portfolio with 10 programs, including 3 clinical candidates

Broad partnered pipeline based on proprietary HuCAL/Ylanthia technologies

MorphoSys is committed to developing a valuable pipeline of truly differentiated therapeutic antibodies built using proprietary technologies.

3

The MorphoSys Pipeline20 Clinical Programs, 93 Total

© MorphoSys - September 2014 4

Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3Bimagrumab (BYM338) Novartis ActRIIB MusculoskeletalGantenerumab Roche Amyloid-ß CNSMOR103 GSK GM-CSF InflammationMOR208 - CD19 CancerBHQ880 Novartis DKK-1 CancerCNTO3157 Janssen - InflammationCNTO6785 Janssen - InflammationGuselkumab (CNTO1959) Janssen IL23p19 InflammationLFG316 Novartis C5 OphthalmologyLJM716 Novartis HER3 CancerNOV–3 Novartis - not discl.Tarextumab (OMP-59R5) OncoMed Notch 2 CancerVAY736 Novartis BAFF-R InflammationMOR202 Celgene CD38 CancerBAY94-9343 Bayer Mesothelin (ADC) CancerBI–836845 BI IGF-1 CancerNOV–7 Novartis - OphthalmologyNOV–8 Novartis - InflammationPF-05082566 Pfizer 4-1BB CancerVantictumab (OMP-18R5) OncoMed Fzd 7 CancerMOR209/ES414 Emergent PSMA/CD3 Prostate CancerMOR106 Galapagos - Inflammation27 programs Various - VariousImmuno-oncology program Merck Serono - Cancer4 MOR programs Various - Various39 programs Various - Various

83 Partnered Programs10 MOR Programs

Most advanced development stage

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

5

INNOVATIVE PRODUCT PIPELINE


The MorphoSys Proprietary Portfolio


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

Fully partnered (tiered, double-digit royalties)

MOR103 GSK GM-CSF Rheumatoid Arthritis

Multiple Sclerosis

Co-development & co-promotion

MOR202 Celgene CD38 Multiple Myeloma

MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer

Unpartnered

MOR208 CD19 ALL

NHL

CLL (IST)

Early-stage programs

MOR106 Galapagos n.d. Inflammation

Immuno-oncologyprogram

Merck Serono n.d. Cancer

4 Programs n.d. Various

7

Joint Development and Commercialization:Rights and Responsibilities


… gets worldwide commercialization rights

excluding the U.S. and Canada tiered royalties up to 20% on sales in the

U.S. and Canada

… is responsible for joint development 64% of total development costs

… gets commercialization rights for the U.S. and

Canada upfront payment of US$ 20 million milestone payments, low single digit

royalties on product sales in MorphoSys’s territory

… is responsible for phase 1 clinical trial in prostate cancer

patients 36% of total development costs manufacturing and supply of the compound

8

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

DIFFERENTIATION

Redirects T cells to kill tumor cells expressing PSMA in vitro and in vivo

Reduced cytokine release upon T-cell activation compared to other formats

Prolonged serum half-life in mouse and NHP compared to antibody fragments

STATUS

IND filed; phase 1 clinical trial to be initiated in mCRPC in the U.S. and Australia

License agreement with Emergent to co-develop and commercialize MOR209/ES414

MOR209/ES414 Inhibits Tumor Growth andImproves Survival in Pre-clinical Model


Subcutaneous Xenograft Model (MDA-PCa-2b) Design

MDA-PCa-2b is a PSMA-expressing human prostate cancer cell line

Complete inhibition of tumor growth in 3- and 30-µg groups

Delay of tumor growth in 0.3 µg ES414 treatment group

Increased overall survival

Tumor Volume

0

250

500

750

1000

1250

1500

Mea

nTu

mor

volu

me

(mm

3 )

Overall Survival

Perc

ents

u rv i

val

0

20

40

60

80

100

30 g ES414

0.3 g ES4143 g ES414

Vehicle

Data: Emergent BioSolutions

MOR202A Novel Antibody for Multiple Myeloma


DRUG High affinity HuCAL antibody targeting CD38 Binds to a unique epitope

DIFFERENTIATION Ability to kill MM cells in vitro and across

multiple pre-clinical in vivo models (ADCC & ADCP) Strong synergy with IMiDs in pre-clinical models

(CD38 upregulation on MM cells and effector cell activation)

2 hour infusion

STATUS Phase 1/2a dose-escalation trial in relapsed or

refractory MM patients ongoing Combination trials with pomalidomide and

lenalidomide planned Additional cohorts with weekly dosing schedule,

with and without dexamethasone ongoing Global co-development and European

co-promotion agreement with Celgene

MOR202 Shows High ADCC and ADCP Activity as Single Agent

MOR208A 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 NHL: Up to 30 R/R patients each in FL, MCL, DLBCL & other indolent NHL, presentation of data end of 2014

Phase 2 ALL: 30 R/R patients

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 0Partial Response 2 1 3 12 18 (66.7)Stable Disease 1 1 1 1 0 4 8 (29.6)Progressive Disease 0Unknown 1 (3.7)Response by IWCLL 2008 criteria (CT scan)Complete Response 0Partial 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)

12

Program Partner Target Indication Phase 1 Phase 2 Phase 3Bimagrumab Novartis ActRIIB sIBM(BYM338) Cachexia (Cancer)

Cachexia (COPD)

Sarcopenia

Hip Fracture Surgery

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

HER2+ CancerHER2+ Cancer, combination with trastuzumabHER2+ Cancer, combination with BYL719 + trastuzumabSolid 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 3Gantenerumab Roche Amyloid-ß Prodromal AD

Mild ADGenetically predisposedAD, Japanese patientsBiovailability

Guselkumab Janssen/J&J IL23p19 Psoriasis(CNTO1959) Rheumatoid Arthritis

Palmoplantar PustulosisCNTO3157 Janssen/J&J n.d. Asthma

Safety/PharmacokineticCNTO6785 Janssen/J&J n.d. COPD

Rheumatoid ArthritisTarextumab Oncomed/GSK Notch 2 Pancreatic Cancer(OMP-59R5) Small Cell Lung Cancer

Solid Tumors Vantictumab Oncomed/Bayer Fzd 7 Solid Tumors(OMP-18R5) Breast Cancer

Pancreatic CancerNSCLC

BAY94-9343 Bayer Mesothelin Solid TumorsBI-836845 BI IGF-1 Cancer

Breast CancerSolid TumorsEGFR mutant NSCLCCRPC + enzalutamideCancer, Japanese patients

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

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 (completed) COPD-related cachexia Sarcopenia (completed) Hip Fracture Surgery

Listed by Novartis as “planned filing 2016”M. Schuelke at al, N Engl J Med 2004;350:2682-8

15

GantenerumabA 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 1Effect of gantenerumab on

amyloid load as indexed by PET SUVR at end of treatment

% Am

yloi

d ch

ange

from

bas

elin

eData: Courtesy of Roche

16

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

17

Most Advanced Programs All HaveBlockbuster Potential


Program Indication Forecast Peak Sales*

MOR103 Rheumatoid Arthritis $3.2bn

MOR202 Multiple Myeloma $2.1bn

MOR208NHLCLLALL

$790m$350m$250m

Bimagrumab

sIBMCancer CachexiaCOPD CachexiaSarcopeniaHip Fracture Surgery

$400m$1.3bn$1.0bn$1.6bntbd

Gantenerumab Alzheimer’s Disease $15bn

Guselkumab PsoriasisRheumatoid Arthritis

$950m$1.6bn

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

$1.4bn

$4.3bn

$2.6bn

18

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: 26,378,584 (August 31, 2014)

Shareholdings by Investor Type

20

Key Financials


in EUR million Guidance 2014 Q2 2014

Group Revenues 58 to 63 30.5

Investment in Proprietary R&D 36 to 41 14.9

EBIT -11 to -16 0.4

Cash, cash equivalents & marketable securities as well as other financial assets as of June 30, 2014

374.0

21

Phas

e3

Phas

e1

Phas

e2

Clinical Trials Scheduled for Completion


20152014

Potential data events based on clinical trial design & MorphoSys estimates

GantenerumabAD/Japan

CNTO3157Asthma

GantenerumabBioavailability

GuselkumabPsoriasis

BimagrumabCachexia (COPD)

GuselkumabRA (vs. Stelara)

GuselkumabPalmoplantar pustulosis

VantictumabBreast cancer

VantictumabNSCLC

CNTO6785COPD

BimagrumabsIBM

BI – 836845Cancer, Japan

LJM716Solid tumors/Mono

LJM716Solid tumors/Combo

CNTO3157Safety/PK

LFG316MCP

CNTO6785RA

VantictumabPancreatic cancer

BI – 836845Solid umors

MOR103Multiple sclerosis

MOR208NHL

BimagrumabCachexia (Cancer)

LJM716Solid tumors/Mono

Partnered ProgramsMOR Programs

TarextumabSolid tumors

BAY94-9343 (ADC)Solid tumors

22

VantictumabPancreatic cancer

MOR202Multiple Myeloma

TarextumabSolid tumors

BI – 836845Cancer

Upcoming Milestones


Proprietary Portfolio Clinical data for MOR103 phase 1b study in MS to be presented at ACTRIMS

ECTRIMS (September 2014)

First clinical data for MOR208 study in NHL (Q4)

Additional pre-clinical data for MOR202 (Q4)

Start of phase 1 in mCRPC for MOR209/ES414 (Q4 / Q1 2015)

Partnered Programs Start of phase 3 study for guselkumab in psoriasis expected (Q4)

Start of phase 2 study for BI–836845 expected (Q4)

APPENDIX


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

25

MOR103Novel 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, results to be presented at ACTRIMS-ECTRIMS meeting in September

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

Mea

n ch

ange

fro

m b

asel

ine

Administration of MOR103

26

CD38 An Ideal Target for Hematologic Diseases


* considered CD38-positive when 20 or 30% of cells exhibit CD38-expression (Meta analysis of several publications)

** PTLD = post-transplant lymphoproliferative disorders¥ >90% of MM cells are positive for CD38

sources: medscape.com, medlibes.com, trialx.com©hematologyatlas.com

$ Waldenstrom Macroglobulinemia

$

CD38 is expressed across multiple leukemia indications

27

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 Humira

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

PGA score(cleared (0) orminimal (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)

28

Novartis Alliance: Landmark Deal


Timeline May 2004: Initial deal, including equity stake November 2007: Major expansion November 2017: End, subject to 2-year extension option

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

Excluded Most infectious disease targets

29

HuCAL: The Most Successful Antibody Library Technology in the Industry


HuCALHuman Combinatorial

Antibody Library

Most successful antibody libraryHuCAL antibodies in clinic19

Transforming R&D productivitySuccess rate from target to IND40%

Modular gene structure enables systematic creation of drug quality antibodies

30

NEW DEVELOPMENTS

NEW ANTIBODY PLATFORM

Next generation antibody platform

Higher quality antibodies, greater diversity

Patent protected until 2031

Ylanthia

New Technologies Intensify Focus on Making Truly Differentiated Drugs


Alliance with Lanthio Pharmato develop lantipeptide librariesfor drug discovery

Preferred rights to exclusive license

Minority equity position

Most important target class

Challenging for antibodies

MorphoSys secures access tostabilized GPCRs from Heptares

Antibodies Against GPCRs Lantipeptides

31

Covering Analysts


Institution Contact

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

Helvea Dr. Olav Zilian

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

32

Forthcoming Events & Conferences


Sep 8, 2014 Commerzbank Life Science DayFrankfurt, Germany

Sep 17-19, 2014 Bank of America Merrill Lynch Global Healthcare Conference 2014London, UK

Sep 22-24, 2014 Berenberg and Goldman Sachs Third Annual German Corporate ConferenceMunich, Germany

Sep 23-25, 2014 Baader Bank Germany Investment Conference Munich, Germany

Nov 7, 2014 Publication of 9-Months´ Report 2014

Nov 18, 2014 HSBC Healthcare Day 2014Frankfurt, Germany

33

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-LöserHead of Corporate Communications & IR

Phone +49 (0)89 / 899 27-122Fax +49 (0)89 / 899 27-5122Email [email protected]

Thank You

www.morphosys.com

140909 mor-company update long - morphosys · mor103 gsk gm-csf inflammation mor208 - cd19 cancer...

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