capital markets day 2017 - morphosys ag · 2017. 9. 13. · bring mor208 to market as quickly as...

Capital Markets Day 2017MorphoSys AG

SEPTEMBER 2017

Dr. Malte Peters

CDO

Today’s Speakers

© MorphoSys AG, Capital Markets Day – September 2017

Dr. Markus Enzelberger

Interim CSO

Dr. Simon Moroney

CEO

Jens Holstein

CFO

2

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.

The compounds discussed in this slide presentation are investigational

products being developed by MorphoSys and its partners and are not currently

approved by the U.S. Food and Drug Administration (FDA), European Medicine

Agency (EMA) or any other regulatory authority (except for

guselkumab/TremfyaTM).

3

Agenda

© MorphoSys AG, Capital Markets Day – September 2017 4

INTRODUCTION1.

PROPRIETARY PORTFOLIO – ADVANCED CANDIDATES2.

PROPRIETARY PORTFOLIO – PROMISING DISCOVERY ASSETS3.

PARTNERED PIPELINE4.

FINANCIALS5.

Q&A6.


Dr. Simon Moroney

Introduction

MorphoSys is at an exciting stage of its development

World-class technology platforms paying off in pipeline

Building our proprietary development portfolio & capabilities

Financially strong, able to invest

On track to become a fully-integrated biopharmaceutical company

Today’s Key Messages


Our Future


A fully-integrated

biopharmaceutical company

Attractive partner for big pharma

and biotech

Innovative science and technology

driving expansion of proprietary

portfolio

Commercializing own products in

selected geographies

Lucrative milestone & royalty

streams from deep partnered

pipeline

PARTNERED DISCOVERY

Maximizing utilization of technology

Lucrative source of revenue from licence fees,

milestones & royalties

PROPRIETARY DEVELOPMENT

Focus on oncology/inflammation

Retained rights translate into greater

revenue potential

StrategyBusiness Model Provides Lucrative Growth Opportunities


Value

Time

PARTNERED

DISCOVERY

PROPRIETARY

DEVELOPMENT

Our Clinical Pipeline28 Product Candidates in Clinical Development, First Launched


* MOR103/GSK3196165 is out-licensed to GSK

Partnered Discovery ProgramsProprietary Development Programs

PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 LAUNCHED

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR208 - CD19 DLBCL, CLL/SLL

Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors

BHQ880 Novartis DKK-1 Multiple myeloma

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome

CNTO3157 Janssen - Inflammation


Elgemtumab (LJM716) Novartis HER3 Cancer

MOR103/GSK3196165* GSK GM-CSF Inflammation

MOR202 - CD38 Multiple myeloma

Tesidolumab (LFG316) Novartis C5 Eye diseases

Utomilumab (PF-05082566) Pfizer CD137 (4-1BB) Cancer

VAY736 Novartis BAFF-R Inflammation

Xentuzumab (BI-836845) BI IGF-1 Solid tumors

BAY1093884 Bayer TFPI Hemophilia

MOR106 Galapagos IL-17C Inflammation

MOR107 (LP2-3) - AT2-R Not disclosed

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases

NOV-10 Novartis - Cancer

NOV-11 Novartis - Blood disorders

NOV-12 Novartis - Prevention of thrombosis


NOV-14 Novartis - Asthma

Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors

13

12

2

Expected Pipeline NewsflowUp to 30 Clinical Data Points Expected to Year-end 2017*


PHASE 1 PHASE 2 PHASE 3 LAUNCH

Anetumab RavtansineCancer

BAY-1093884Bleeding disorders

Anetumab RavtansineMesothelioma (MPM)

Elgemtumab (LJM716)Esophageal cancer

(+ BYL716)

GuselkumabPsoriasis (VOYAGE 2)

GuselkumabPsoriasis

Elgemtumab (LJM716)Breast cancer

(+ BYL716/trastuzumab)

Elgemtumab (LJM716)Breast/gastric cancer

GuselkumabActive psoriatic arthritis

(PsA)

MOR103/GSK3196165Osteoarthritis

GuselkumabPsoriasis (NAVIGATE)

GantenerumabAlzheimer’s disease

(sc, impact of speed)

Gantenerumab Alzheimer’s disease (sc)

MOR103/GSK3196165Rheumatiod arthritis


(Japan)

GuselkumabModerate to severe plaque

psoriasis (POLARIS)

MOR106Atopic dermatitis

MOR107Not disclosed

(trial ongoing)


MOR202Multiple Myeloma

(trial ongoing)

GuselkumabSevere plaque psoriasis

NOV-7Eye diseases

Tesidolumab

(LFG316) Kidney Transplantation

MOR208DLBCL (+ lenalidomide)

(trial ongoing)

MOR208CLL (+ lenalidomide)

(IIT)

Utomilumab

(PF-05082566)Solid tumors (+ MK-3475)

Utomilumab

(PF-05082566)NHL/solid tumors

(+ rituximab)

Tarextumab

(OMP-59R5)Small cell lung cancer

Tesidolumab (LFG316) Geographic atrophy

(+ CLG561)

Utomilumab

(PF-05082566)

Solid tumors

(+ mogamulizumab)

Vantictumab

(OMP-18R5)Pancreatic cancer

Tesidolumab (LFG316) Paroxysmal nocturnal

hemoglobinuria

Tesidolumab (LFG316) Panuveitis

Vantictumab

(OMP-18R5)Lung Cancer (NSCLC)

Vantictumab

(OMP-18R5)Breast cancer

VAY736Rheumatoid arthritis

Xentuzumab

(BI-836845)Prostate cancer

(+ enzalutamide)

Xentuzumab

(BI-836845)Multiple cancer types

(EGFR mutant NSCLC)

Xentuzumab

(BI-836845)Breast cancer

Partnered Discovery Programs

Proprietary Development Programs

* Anticipated data readouts and/or primary completion dates,

according to clinicaltrials.gov and/or MorphoSys‘s own estimates

Positive data readout

Negative data readout

BRING MOR208 TO MARKET AS QUICKLY AS POSSIBLE

Secure approval in DLBCL

Build commercial capabilities

Partner in non-MOR geographies

SECURE FUTURE DEVELOPMENT OF MOR202

Optimize outcome from ongoing partnering activities

ADVANCE NEXT GENERATION OF PRODUCT CANDIDATES

Prioritize investment behind highest-value assets

Focus on most promising target/drug opportunities at intersection of oncology and immunology

Our Priorities



Dr. Malte Peters

Proprietary Portfolio –

Advanced Candidates

Strategic Priorities for MorphoSys Development Team


Secure approval of MOR208 in DLBCL and increase value

by investigating additional indications

Support partnering of MOR202

Build world-class development organization

Prioritize focus on speed to bring pipeline of

innovative drugs to market

Changing Paradigm in Clinical DevelopmentMake Drug Development Faster


Phase 1 Phase 2 Phase 3

Proof of concept Pivotal

TRADITIONAL

MODERN

Design phase 1 such that phase 3 is successful

Use translational medicine tools

Pharmacokinetics/pharmacodynamics in place

Include this thinking in early development

discussions

Portfolio of Proprietary Development SegmentFive Clinical Candidates


* MOR103/GSK3196165 is out-licensed to GSK


MOR208 - CD19 • DLBCL B-MIND

• DLBCL L-MIND

• CLL

MOR103/GSK3196165* GSK GM-CSF Inflammation

MOR202 - CD38Multiple

myeloma

MOR106 Galapagos IL-17C Atopic

Dermatitis

MOR107 - AT2-R Not disclosed

MOR209 (co-development with Aptevo Therapeutics), a bi-specific antibody against PSMA and CD3, was

terminated following a portfolio review.

MOR208: Anti-CD19 studied in Hematological CancersA Next Generation Anti-CD19 Antibody with Enhanced Effector Functions


W Jurczak et al.; ASH 2016

BACKGROUND

IgG1k antibody

In-licensed from Xencor

Humanized and affinity optimized with Xencor

technology

Fc-engineered for enhanced ADCC &

phagocytosis

MODE OF ACTION

ADCC, phagocytosis, direct cytotoxicity

STRONG PRECLINICAL PACKAGE

Highly active as single agent in vitro and in

vivo

Strong rationale for multiple combination

therapies

MOR208

Fc-enhancement

ADCC

ADCP

directcytotoxicity

ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity

ADCP: Antibody-Dependent Cell-Mediated Phagocytosis

Development Plan for MOR208 Focuses on DLBCLDLBCL Patients have a Poor Prognosis and are Difficult to Treat


1: US, EU14, Israel, Japan, Canada

MOST FREQUENT MALIGNANT LYMPHOMA WORLDWIDE

VERY AGGRESSIVE TUMOR

RELAPSED OR REFRACTORY DLBCL

No standard therapy available

Patients are difficult to treat and prognosis is dismal

POTENTIALLY ELIGIBLE PATIENTS BASED ON INCIDENCE1

2nd line: 33,000 patients

3rd line and higher: 16,000 patients

Patients with R/R DLBCL have a Poor Prognosis


PARAMETER WITZIG ET AL

LEN

CZUCZMAN ET

AL LEN

WANG ET AL

RTX + LEN

VACIRCA ET AL

RTX + BEN

CRUMP ET AL

META-ANALYSIS

Evaluable

patient

population

R/R DLBCL

n=108

R/R DLBCL

n=51

R/R DLBCL

n=32

R/R DLBCL

n=59

Refractory

DLBCL

n=635

Objective

response rate

28% 27% 28% 46% 26%

Complete

response rate

7% 10% 22% 15% 8%

Median PFS,

months

2.7 3.1 2.8 3.6 -

Median overall

survival, months

- 7.1 10.2 - 6.6

MOR208Clinical Development Plan for NHL and DLBCL


NHL MOR208 monotherapy in

R/R NHL

DLBCL

Lenalidomide + MOR208 in R/R DLBCLL-MIND

Phase 3 pivotal study opened in June 2017

Bendamustine + MOR208 vs. bendamustine + rituximab in

R/R DLBCL

B-MIND

INDICATION 2016 2017 2018

MOR208 Showed Encouraging PFS Results as Single Agent


W Jurczak et al., ASH 2016

DLBCL iNHL

Results from NHL Trial


Lenalidomide with MOR208: Phase 2 in R/R DLBCL

A Phase 2, single-arm, open-label, multicentre study to evaluate the safety

and efficacy of lenalidomide combined with MOR208 in patients

with relapsed or refractory diffuse large B cell lymphoma (R/R DLBCL)

L-MINDStudy Design


Response assessment after cycles 2, 4, 6 and 12, thereafter every 3 cycles. ASCT, autologous stem cell transplant; HDCT,

high-dose chemotherapy; R/R DLBCL, relapsed or refractory diffuse large B cell lymphoma; SD, stable disease, IV,

intravenous; PO, per os.

PATIENTS WITH

R/R DLBCL:

have received

1-3 prior

regimens

are not

eligible for

HDCT and

ASCT

MOR208

12mg/kg IV

Days 1,15

MOR208

12mg/kg IV

Days

1,8,15,22

Lenalidomide

25mg PO

Days 1-21

Cycle 1 - 3 Cycle 4 -12

Disease

control

(≥SD)

Additional

antibody

treatment

phase

Survival

follow-up

MOR208

12mg/kg IV

Days 1,15

Objective Response RateMOR208/Lenalidomide is a Novel Combination that Showed ORR of 56% in a

Phase 2 Study in DLBCL


CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease.

G Salles et al.; ASCO 2017

CR: 32%

(n=11)

PR: 24%

(n=8)

SD: 12% (n=4)

PD/NE: 32%

(n=11)

0

20

40

60

80

100

n=34

ORR: 56%

Best

Overa

ll R

esp

onse

(%

)

Time on Study and Best ResponsePatients Stay on Study for a Long Time


CR, complete response; NE, not evaluable; PD, progressive disease; PR, partial response; SD, stable disease

G Salles et al.; ASCO 2017

Median time to response 1.8 months, median time to CR 3.4 months

16 out of 19 responders (10 out of 11 CRs) ongoing

SD

PR

CR

Ongoing patients

n=34

MOR208 SAFETY PROFILE TO DATE IN COMBINATION WITH LENALIDOMIDE

Most frequently observed toxicity was neutropenia (36%)

Addition of MOR208 did not result in increased lenalidomide toxicity

Lenalidomide dose reductions were seen in 27%

MOR208 IN COMBINATION WITH LENALIDOMIDE HAS THE POTENTIAL TO BE A SUITABLE

THERAPY FOR R/R DLBCL PATIENTS, INCLUDING ELDERLY AND FRAIL PATIENTS

MOR208/Lenalidomide Appears to be Well Toleratedin a Phase 2 Study


MOR208/LEN is a Novel Drug Combination in DLBCLSignificantly Increased Response Rate Compared to Standard of Care and

New Therapies


Caution should be applied in making cross trial comparisons

PARAMETER L-MIND

MOR00208

+ LEN

WITZIG ET AL

LEN ALONE

WANG ET AL

RTX + LEN

VACIRCA ET AL

RTX + BEN

CRUMP ET AL

META-ANALYSIS

NEELAPU

AXI-CEL

Evaluable

patient

population

R/R DLBCL

n=34R/R DLBCL

n=108

R/R DLBCL

n=32

R/R DLBCL

n=59

Refractory

DLBCL

n=635

Refractory

DLBCL

n=77

Objective

response rate

56% 28% 28% 46% 26% 82%/36%

Total/@6 Mo

Complete

response rate

32% 7% 22% 15% 8 49%/31%

Total/@6 Mo

Median PFS,

months

Update will be

provided at ASH2.7 2.8 3.6 - -

Median overall

survival,

months

- - 10.2 - 6.6 -


Bendamustine with MOR208: Phase 2/3 in R/R DLBCL

A phase 2/3, randomised, multicentre study of MOR208 with bendamustine

versus rituximab with bendamustine in patients with relapsed or refractory

diffuse large B cell lymphoma (R/R DLBCL) who are not eligible for high-dose

chemotherapy (hdc) and autologous stem-cell transplantation (ASCT)

B-MINDPhase 2/3 Trial of MOR208 in R/R DLBCL


Phase 3 part of the trial was opened for recruitment in June 2017

Cycle 1 - 6

RELAPSED/REFRACTORY

DIFFUSE LARGE B CELL

LYMPHOMA

(R/R DLBCL)

Patients after failure of ASCT

or not eligible for HDCT and

ASCT

At least one prior regimen

included an anti-CD20

antibody

1-3 prior regimen

ECOG 0 to 2

N=330

R 1:1

Until PD, max. 24 cycles

MOR208

+ Bendamustine MOR208

Rituximab

+ BendamustineRituximab

MOR208Regulatory Status


MOR208 received Orphan Drug Designation for the treatment of DLBCL in the US

(December 2014) and the EU (January 2015)

MOR208 received Fast Track Designation from the FDA for the treatment of R/R DLBCL (October

2014)

June 2017: B-MIND was cleared for start of phase 3 recruitment in the US

Exploring fast to market strategy with FDA for L-MIND

MOR208: Additional Development Opportunities


DLBCL

More advanced patient population

Primary refractory DLBCL patients

CLL

Phase 1b COSMOS study ongoing in combination with idelalisib and venetoclax

Follicular lymphoma

Mantle cell lymphoma

Marginal zone lymphoma

Combination therapies with immuno-oncology compounds in hematological cancers

MOR202A Differentiated Anti-CD38 Antibody to Treat Multiple Myeloma


KEY FEATURES

Targets a unique epitope on CD38

ADCC & ADCP cell-killing mechanisms

Low NK cell depletion, which may translate into

longer duration of response

CLINICAL

Very low rate of infusion-related reactions

Short infusion time

Enduring & deepening clinical responses:

− Responses ongoing in 65% of patients

− Longest time on study with ongoing

response: >19 months

Potential in other oncology indications and auto-

immune diseases

ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity

ADCP: Antibody-Dependent Cell-Mediated Phagocytosis

ADCC

ADCP

PRIMARY

Assess the safety profile and establish the maximum tolerated dose (MTD) and/or recommended dose

of MOR202 in patients with R/R MM*:

− In combination with dexamethasone (Dex)

− In combination with pomalidomide (POM)/Dex

− In combination with lenalidomide (LEN)/Dex

Assess immunogenicity of MOR202

SECONDARY

Assess preliminary efficacy, pharmacokinetics and pharmacodynamics of MOR202 monotherapy and in

combination with Dex, POM/Dex and LEN/Dex in patients with R/R MM

Objectives for MOR202


*R/R MM, relapsed or refractory multiple myeloma


Infusion related reactions (IRRs)

MOR202

+ DexSIRIUS*

MOR202

+ LEN/DexPOLLUX# MOR202

+ POM/DexEQUULEUS$

Number of

patientsn=18 n=106 n=17 n=283 n=13 n=103

Grade G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4 G1/2 G3/4

IRRs, n (%) 2 (11) 0 42 (40) 5 (5) 1 (6) 0 112 (42) 15 (5) 0 0 48 (47) 3 (3)

6%

47%

MOR202 q1w + LEN/Dex

POLLUX

11%

45%

MOR202 q1w + Dex

SIRIUS

0%

50%

MOR202 q1w + POM/Dex

EQUULEUS

Lower Incidence of IRRs for MOR202 than for Daratumumab

*Lonial et al., Lancet, 2016 / # Dimopoulos et al., NEJM, 2016 / $ Chari et al., Blood, 2017

No clinical data exist that directly compare these

therapies, please note limitations of cross-trial comparisons

MOR202q1w + POM/DEX COHORTSMOR202q1w + DEX COHORTS MOR202q1w + LEN/DEX COHORTS

Efficacy EvaluationResponse Data are Comparable to Daratumumab


CR, complete response; NE, not evaluable; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease;

VGPR, very good partial response; MR, marginal response; modified from Raab et al, ASCO 2017; ITT population shown

VGPR: 11%

PR: 17%

MR: 11%

SD: 50%

PD: 6%

NE: 6%

n=18

ORR:

28%

Best

Overa

ll R

esp

onse

s (%

)

CR: 6%

VGPR: 18%

PR: 47%

SD: 6%

PD: 6%

NE: 18%

n=17

ORR:

71%

CR: 15%

VGPR: 8%

PR: 23%

MR: 23%

PD: 8%

NE: 15%

n=13

SD: 8%

ORR:

46%

100

80

60

40

20

0

MORPHOSYS HAS SUED JANSSEN BIOTECH AND GENMAB FOR PATENT INFRINGEMENT

Suit includes U.S. patents 8,263,746 and 9,200,061

Patents cover

− Antibodies with particular features that bind to CD38, and

− Methods of treating hematologic cancer associated with undesired presences of CD38-positive cells

by administering antibodies that bind to a specific region of CD38

Not in suit - new patent due to issue September 12, 2017

MorphoSys seeks redress for the infringing manufacture, use and sale of daratumumab

CURRENT STATUS OF LITIGATION

Defendants motions to dismiss filed at the outset of the litigation were not granted

Early Markman Ruling regarding “specifically binds within” favours MorphoSys

Second Markman Hearing held on August 28, 2017 – decision pending

Fact discovery in progress, currently due to be completed by Fall 2017

Expert discovery currently due to be completed by Winter 2018

Trial currently scheduled for August 2018

CD38 Patent Litigation


MOR106: Anti-IL-17C for Atopic DermatitisThe MorphoSys–Galapagos Collaboration


&

MOR106 arises from a strategic discovery and co-development alliance between MorphoSys and

Galapagos

Galapagos provides the disease-related biology including cellular assays and targets discovered

using its target discovery platform

MorphoSys contributes its Ylanthia antibody technology to generate fully human antibodies

directed against the target and contributes full CMC development of this compound

MorphoSys and Galapagos co-develop MOR106 50/50

MOR106 is Effective in Two Animal Models Relevant for Atopic Dermatitis


Skin severity score: composite score of erythema, excoriation & scaling

CALCIPOTRIOL INDUCED ATOPIC DERMATITIS

ON MURINE EAR SKIN

FLAKY TAIL MOUSE MODEL

0 1 2 3 4 5 60

3

6

9isotype

3mg/kg MOR106

30mg/kg MOR106

DEX

**

*****

****

*

Weeks

Skin

severi

ty s

co

re

Psoriasis and Atopic DermatitisApproved Antibody Therapies


Data based on Artisan Healthcare Analysis, January 2017

Market Forecast

Mod–severe Population

Current Antibody

Therapies

Double from 2014-2024 to $7.3 bn (7MM)

9-17 m

anti-IL-4R

• Dupixent® (dupilumab)

Atopic Dermatitis

Double from 2015-2025 to $16 bn (7MM)

3 m

anti-TNFα

• Cimzia® (certolizumab pegol)

• Enbrel® (etanercept)

• Humira® (adalimumab)

• Remicade® (infliximab)

• Simponi® (golimumab)

anti-IL-17A or anti-IL-17RA

• Cosentyx® (secukinumab)

• Siliq® (brodalumab)

• Taltz® (ixekizumab)

anti-IL-12/23 or anti-IL-23

• Stelara® (ustekinumab)

• TremfyaTM (guselkumab)

Psoriasis

MOR106 Phase 1 Studies in Atopic Dermatitis


Primary & secondary objectives: safety/tolerability & pharmacokinetics

Exploratory objectives:

Eczema Area & Severity Index (EASI), Scoring Atopic Dermatitis (SCORAD), Investigator Global

Assessment (IGA), serum TARC (CCL17)

Topline results expected shortly

ATOPIC DERMATITIS:

Inflammatory skin disease characterized by red, dry skin causing severe itch

(35M patients in US, Europe and Japan)

Single

ascending

dose

Multiple

ascending

dose

7-week

follow up

10-week

follow up

Healthy males, 7 cohorts, i.v. infusion (n=42)

4 WEEKS

Placebo (n=14)

Patients, 3 cohorts, weekly i.v. infusion (n=18)

Placebo (n=6)

MOR103/GSK3196165A Novel anti-GM-CSF Antibody for Inflammatory Diseases


Clinicaltrials.gov

Global agreement with GSK (June 2013) to develop and commercialize MOR103/GSK3196165

GSK with responsibility for all development and commercialization of the compound

MorphoSys:

− Received € 22.5 million upfront payment in 2013

− Is eligible for € 423 million milestones (on achievement of certain developmental, regulatory,

commercial and sales-based milestones)

− Is eligible for tiered, double-digit royalties on net sales

STUDY INDICATION PHASEEST. PRIMARY

COMPLETION DATE

Efficacy & safety in patients with active

moderate to severe rheumatoid arthritis

Rheumatoid

arthritis2 August 2017

Mechanistic study Rheumatoid

arthritis2 October 2017

Pharmacokinetics and safety in Japanese

patients

Rheumatoid

arthritis2 December 2017

Efficacy and safety in inflammatory

hand osteoarthritisOsteoarthritis 2 December 2017

Strategic Priorities for MorphoSys Development Team


Secure approval of MOR208 in DLBCL and increase value

by investigating additional indications

Support partnering of MOR202

Build world-class development organization

Prioritize focus on speed to bring pipeline of

innovative drugs to market


Dr. Markus Enzelberger

Proprietary Discovery Assets

& Partnered Pipeline

Technology Platform Serves Pipeline GrowthDifferentiated Drugs for Treatments of Patients Suffering from Serious Diseases


MORPHOSYS’S TECHNOLOGICAL LEADERSHIP

25 years of antibody discovery expertise

− 6 generations of antibody libraries

− ≥ 100 therapeutic projects

− ≥ 25 collaboration partners

− 28 product candidates in clinical development,

thereof 1 product launched

Latest library Ylanthia

− Largest phage antibody library in the industry

− Built to deliver fully human antibodies with

convincing developability profile

− Covering huge epitope space

− Designed for difficult targets

Broad assay and disease model experience in

multiple indications

Differentiated

drugs for

treatments of

patients

suffering from

serious diseases

Proprietary pipeline

with 13 programs,

thereof 5 in the clinic

Partnered pipeline

with 100 programs,


GOAL:

1 new IND

every 18

months

C5A/C5AR AXIS: EFFECT ON TUMOR MICRO-

ENVIRONMENT

Tumor cells produce C5a

C5a attracts MDSCs through C5aR

Release of immunosuppressive cytokines

Generation of an immunosuppressive TME at site

of primary tumor as well as in metastatic niche

Impairment of T cell functions

Antibodies in Immuno-OncologyProgram Targeting C5aR Aiming to Unleash the Power of Immune Defense


EFFECT OF C5AR BLOCKADE

Reversion of immunosuppression

Enabling patient’s immune system to fight

cancer

Enabling other checkpoint inhibitors to deliver

their full potential

TME: Tumor microenvironment

MDSC: Myeloid-derived suppressor cells

SELECTED PATIENT DATA

C5aR in Immuno-OncologyRecently Published Data Implicate a Role for C5a/C5aR in Cancer


1 Cho et al., 2014; 2 Vadrevu et al., 2014; 3 Corrales et al., 2012; 4 Xi et al., 2016

Ovarian Cancer

Higher C5aR expression levels (mRNA) in tumor samples correlated with shorter overall survival1

Breast Cancer

Detection of myeloid-derived suppressor cells and complement depositions in tumor draining lymph

nodes of breast cancer patients2

Non-Small Cell Lung Cancer (NSCLC)

Significantly increased C5a plasma levels in NSCLC patients3

Metastatic Renal Cell Carcinoma

High tumoral C5a levels associated with poor overall survival4

SYNERGISTIC EFFECT OF ANTI-C5AR IN

COMBINATION WITH ANTI-PD-1 IN ANIMAL

MODELS

Therapeutic efficacy of a combination of anti-

PD-1 & anti-C5aR was shown in a preclinical

model of colon cancer

MORPHOSYS THERAPEUTIC C5AR PROGRAM

Fully human, highly specific anti-C5aR antibody

in fully silent IgG format

Inhibits migration and activation of immune

cells

Good pharmacokinetics in rodents

C5aR Blockade in Immuno-OncologyOvercoming Resistance Mechanisms by Tumor Microenvironment, Boosting T/NK Cell Response


The C5aR lead candidate will enter preclinical and CMC

development this year and is expected to enter the clinic in 2019

Days

Fra

cti

on s

urv

ival

MC38 Syngeneic Colon Cancer

0 10 20 30 40 500.0

0.2

0.4

0.6

0.8

1.0Negative ControlAnti-C5aR surrogateAnti-PD-1Anti-C5aR surrogate

+anti-PD-1

Number of truly specific tumor-associated

targets is very low

Cancer cells present unique, highly specific

peptides of protein (neo)epitopes via the HLA

complex on the cell surface

Opens a truly new target universe to be targeted

by biologics

MorphoSys technology enables generation of

antibodies with high affinity and specificity for

cancer cells, without harming healthy tissue

T Cell-Receptor Mimicking AntibodiesOpening a New Target Universe in Cancer


Peptide/HLA

(human leukocyte antigen) complex

T Cell-Receptor Mimicking AntibodiesForging Strategic Alliances


MORPHOSYS’S

TECHNOLOGICAL

LEADERSHIP

IMMATICS

XPRESIDENT platform to identify tumor-associated

peptides directly from primary human tumor material

Huge database of peptides presented on healthy tissues

STATUS OF 1ST PROGRAM

Peptide/HLA on various tumor types but not normal tissue

High affinity, high specificity antibodies identified

Lead candidate selection ongoing

Differentiated

drug candidates

against tumor-

specific peptide/

HLA complexes MD ANDERSON CANCER CENTER

ECLIPSE: Evolution of Cancer, Leukemia, and Immunity

Platform to identify target molecules on leukemia cells

Substantial specimen bank from patients & healthy donors

STATUS OF 1ST PROGRAM

Target class: Peptide/HLA complex

Antibody selection initiated

Ylanthia®

MorphoSys’s Technological LeadershipBispecific Platforms for Oncology Applications


MorphoSys’s proprietary anti-CD3 binding

moieties

Optimized pharmacokinetics and biophysical

properties

Potentially increased therapeutic window

MorphoSys’s proprietary anti-4-1BB binding

moieties

Optimized pharmacokinetics and biophysical

properties

Selectively stimulating NK & tumor specific

T cells within the tumor environment

Avoiding systemic side effects

Anti-4-1BB Bispecific FormatAnti-CD3 Bispecific Format

Technology Platform Serves Pipeline GrowthWith Differentiated Drugs for Treatments of Patients Suffering from Serious Diseases


MORPHOSYS’S TECHNOLOGICAL LEADERSHIP

25 years of antibody discovery expertise

− 6 generation of antibody libraries

− ≥ 100 therapeutic projects

− ≥ 25 collaboration partners

− 28 product candidates in clinical development,

thereof 1 product launched

Latest library Ylanthia

− Largest phage antibody library in the industry

− Built to deliver fully human antibodies with

convincing developability profile

− Covering huge epitope space

− Designed for targeting difficult targets

Broad assay and disease model experience in

multiple indications

Differentiated

Drugs for

Treatments of

Patients

Suffering from

Serious Diseases

Proprietary pipeline

with 13 programs,


Partnered pipeline

with 100 programs,


GOAL:

1 new IND

every 18

month

Late-Stage Partnered ProgramsParticipating in the Most Exciting Pharma Market Opportunities


GUSELKUMAB (TREMFYATM)

Psoriasis

Psoriatic Arthritis

Crohn’s Disease

UTOMILUMAB

Immuno-Oncology

GANTENERUMAB

Alzheimer’s Disease

Guselkumab/TremfyaTM

The First HuCAL Antibody on the Market


Partnered Discovery project with Janssen targeting IL23p19

FDA approval for psoriasis July 13, 2017

Available to patients in the US since end of July 2017

DIFFERENTIATION POTENTIAL

Superiority vs. Humira® in head to head phase 3 trial (VOYAGE 1)

Superiority in Humira® (VOYAGE 2) and STELARA® (NAVIGATE)

inadequate responders

Convenience: 8-weekly vs. 2-weekly dosing

SAFETY

Consistent profile across all trials

5 year, long term extension ongoing with Janssen

STATUS

Head to head phase 3 trial vs. Cosentyx® ongoing

Start of phase 3 psoriatic arthritis trial anticipated shortly

Phase 3 study planned for Crohn’s disease

UtomilumabUnleashing T Cells and NK Cells to Fight Cancer


Source: Pfizer Fact Sheet

Partnered Discovery project with Pfizer against solid tumors

Targets CD137 (4-1BB) expressed by cell types of hemato-

poietic lineage, e.g. T cells, B cells, T regs, NK cells, DCs

FUNCTION

T cells

− Induction of proliferation

− Upregulation of anti-apoptotic pathways

Dendritic cells

− Induction of maturation and upregulation of co-stimulatory

molecules

− Production of pro-inflammatory cytokines

NK cells

− Enhancement of cytotoxicity

STATUS

Multiple clinical trials in different combinations & indications

GantenerumabA HuCAL Antibody Binding Aggregated Forms of Amyloid-beta


Partnered Discovery project with Roche

developed against Alzheimer’s disease

HuCAL antibody against amyloid-beta (Ab),

that binds N-terminus and middle of Ab

peptide

Binds/disrupts amyloid plaque and oligomers

In phase 1, gantenerumab clears brain amyloid

very efficiently in mild-to-moderate

Alzheimer’s disease patients

Alzheimer’s DiseaseClearance Mechanisms of Anti-Ab Immunotherapy - Evolving Picture


Citron M. 2010, Nat Rev Drug Discov 9: 387-98

GantenerumabGantenerumab in the Competitive Environment

56

1 DeMattos et al, 2001, PNAS 98: 8850-8855; 2 Miles et al., 2013, Scientific Reports 3:1302; 3 Ultsch et al., 2016, Scientific Reports; 4 Adolfsson et al., 2012, Neuroscience

32: 9677-9689; 5 Sevigny et al., 2016, Nature 537: 50-56; 6 Bohrmann et al., 2012, J Alzheimer’s Disease 28: 49-69; 7 Interim analysis presented at CTAD 2016

Aducanumab has shown dose-dependent amyloid plaque reduction and clinical benefit measured by

CDR-SB and MMSE7

In titration arm to 10 mg/kg IV over 12 months, similar clinical decline benefit as in 10 mg/kg flat dose

was achieved while serious adverse events of ARIA-E rate in APOE carriers dropped from 56% to 35% 7

Good rationale for much higher dose (supported by PK studies) and improved dosing scheme

Confidence that higher dose of gantenerumab can be achieved with manageable ARIA-E rate and will

result in clinical benefit for patients

Graduate I/II trials with higher dose will start in 2017

Antibody Company EpitopeRelative Binding Profiles

IsotypeMonomers Oligomers Plaques

Solanezumab1 terminated Eli Lilly 13-28 +++ IgG1

Bapineuzumab2 terminated Pfizer/J&J 1-5 + +++ + IgG1

Crenezumab3,4 Roche/AC Immune 12-23 + +++ + IgG4

Aducanumab5 Biogen/Neurimmune 3-6 ++ +++ IgG1

Gantenerumab6 Roche/MorphoSys 1-10, 19-26 ++ +++ IgG1

ARIA-E: Amyloid-related imaging abnormalities-edema; APOE: Apolipoprotein E epsilon; CDR-SB: Clinical Dementia Rating-Sum of Boxes; MMSE: Minimal Mental

State Examination Score


Partnered Clinical Pipeline23 Product Candidates in Clinical Development, Thereof One Launched



Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

Anetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumors

BHQ880 Novartis DKK-1 Multiple myeloma

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome



Elgemtumab (LJM716) Novartis HER3 Cancer

Tesidolumab (LFG316) Novartis C5 Eye diseases

Utomilumab (PF-05082566) Pfizer CD137 (4-1BB) Cancer

VAY736 Novartis BAFF-R Inflammation

Xentuzumab (BI-836845) BI IGF-1 Solid tumors

BAY1093884 Bayer TFPI Hemophilia

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases


NOV-11 Novartis - Blood disorders

NOV-12 Novartis - Prevention of thrombosis


NOV-14 Novartis - Asthma

Vantictumab (OMP-18R5) OncoMed Fzd 7 Solid tumors

11

10


Jens Holstein

Financials

Financials 2017 Guidance Re-confirmed


*Cash, cash equivalents & marketable securities as well as other short-term and long-term financial assets.

As stated before, this does not include revenues from potential future collaborations and/or licensing partnerships, nor effects from potential in-licensing or

co-development deals for new development candidates. Included is a milestone payment for the TremfyaTM approval. Royalties for TremfyaTM cannot be

accurately projected shortly after the approval, guidance will be reviewed as soon as the revenue uptake allows for reliable projections for FY 2017.

IN € MILLION FY 2016 Q1-Q2 2017 GUIDANCE 2017

49.7 23.6 46 to 51

78.5 37.9 85 to 95

-59.9 -30.3 -75 to -85

359.5 334.8 -

Group Revenues

Proprietary R&D Expenses

(incl. Technology Development)

EBIT

Cash, cash equivalents & marketable

securities as well as other short-term

and long-term financial assets

(end of reporting period)

42.7

48.043.6 42.3 43.6

1.9 3.05.4 4.0 5.67.0

26.9

15.0

59.9

0.6

2012 2013 2014 2015 2016 2017e

51.9 78.0 64.0 106.2 49.7 46-51

Revenue Development by Segment


Proprietary Development:

Partnering deals

Partnered Discovery:

Success-based paymentsPartnered Discovery:

Funded research & licensing fees

TOTAL REVENUES

IN € MILLION

Areas of Revenues – Evolving Business Model

Own Revenues and Royalties to Become Drivers of Cash Flow

61© MorphoSys AG, Capital Markets Day – September 2017

up to 2016 Partnering

DealsMilestones R&D Funding

2021 onwardsProduct SalesRoyaltiesMilestones

Partnering

Deals

increasing financial impact p.a.

2017-2020Royalties

Partnering

DealsMilestonesR&D Funding

R&D Funding

Focus on Proprietary Portfolio


Number of Programs in

Proprietary Development

from early to late stage

MOR103

Early Stage, Discovery &

Technology Development

Late Stage

79

56

32

22

36

2012 20142013 20162015

5 6 10 14 14

INVESTMENT

IN € MILLION

Supported by Increase in Proprietary R&D

TremfyaTM First HuCAL Antibody on the Market


Source: Johnson & Johnson Pharmaceutical Business Review Day; www.fiercepharma.com; clinicaltrials.gov

First Commercialized Product from Partnered Discovery Segment

Janssen/J&J assumes wholesale acquisition cost (WAC) of US$ 58,100 (per patient per year)

Addressable adult patients with moderate-severe plaque psoriasis are 679,000 (US)

We see blockbuster potential for TremfyaTM not only for the US psoriasis market, but also in other

jurisdictions and indications

INDICATION PHASE STATUSEST. PRIMARY

COMPLETION DATE

Psoriasis vs. Cosentyx® 3 recruiting September 2018

Pustular psoriasis 3 active, not recruiting August 2018

Palmoplantar pustulosis 3 recruiting January 2018

Psoriatic arthritis 3 not yet recruiting October 2019

Crohn’s disease 3 planned n/a

Financial OutlookMultiple Generators for Future Growth


R&D

Funding

Partnering

Deals

Product

Revenues

Royalties

Milestones

MorphoSys has evolved significantly with late

stage poprietary and partnered assets expected

to generate substantially growing cash flows.


Q&A-Session


Dr. Simon Moroney

Wrap Up

www.morphosys.com

Thank You

MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, gantenerumab and all other product candidates mentioned here are investigational drugs and have not been

approved by the FDA or other ex-US regulatory agencies. HuCAL® , HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high

potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.

TremfyaTM and STELARA® are trademarks of Janssen Research & Development, LLC; Humira® is a trademark of Abbvie Inc.; Cosentyx® is a trademark of Novartis AG;

Dupixent® is a trademark of Sanofi Biotechnology; Cimzia® is a trademark of UCB Pharma, S.A.; Enbrel® is a trademark of Immunex Corporation/Wyeth LLC; Remicade®

is a trademark of Janssen Biotech, Inc./Centocor Inc.; Simponi® is a trademark of Johnson & Johnson; Siliq® is a trademark of Amgen Inc.; Taltz ® is a trademark of Eli

Lilly and Company.

Anke Linnartz

Head of Corporate Communications & IR

Phone +49 (0)89 / 899 27-404

Fax +49 (0)89 / 899 27-5404

Email [email protected]

capital markets day 2017 - morphosys ag · 2017. 9. 13. · bring mor208 to market as quickly as...

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