company update - morphosys ag · guselkumab janssen/j&j il23p19 psoriasis (voyage 1) (cnto1959)...

Company Update

May 2016

Safe Harbor

© MorphoSys AG, Company Update - May 2016

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 at a Glance

MorphoSys is developing a pipeline of truly differentiated

therapeutic antibodies built using proprietary technologies

Munich, Germany-based biopharmaceutical company

The industry’s largest antibody therapeutic pipeline assembled using

proprietary technologies:

104 active therapeutic programs

26 antibodies in clinical trials

Growing portfolio of attractive proprietary assets

Strong balance sheet with recurring cash-flows supports growing investment

in R&D

Successful track-record of partnering world-wide

Listed on the German TecDAX

© MorphoSys AG, Company Update - May 2016 3


The MorphoSys Pipeline

26 Clinical Product Candidates, 104 Total

Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3

Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR208 - CD19 ALL, CLL, NHL

MOR202 - CD38 Multiple myeloma

MOR103/GSK3196165 GSK GM-CSF Inflammation

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

BHQ880 Novartis DKK-1 Multiple myeloma

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

LFG316 Novartis C5 Eye diseases

LJM716 Novartis HER3 Cancer

Tarextumab (OMP-59R5) OncoMed Notch 2 Solid tumors

VAY736 Novartis BAFF-R Inflammation

MOR209/ES414 Emergent PSMA/CD3 Prostate cancer

MOR106 Galapagos - Inflammation

BAY1093884 Bayer TFPI Hemophilia

BI–836845 BI IGF-1 Solid tumors

NOV–7 Novartis - Eye diseases

NOV–8 Novartis - Inflammation

NOV-9 Novartis - Diabetic eye diseases

NOV-10 Novartis - Cancer

NOV-11 Novartis - Blood disorders

PF-05082566 Pfizer 4-1BB Solid tumors

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

MOR107 (LP2) - AT2-R Fibrosis

Immuno-oncology program Merck - Cancer

Immuno-oncology program Immatics - Cancer

6 MOR programs - - Various

90 Partnered Discovery Programs

13 MOR Programs

1 Outlicensed Program

Most advanced development stage

In addition, 24 partnered programs in pre-clinic, and 45 partnered programs in discovery

The MOR Portfolio

5 Clinical Product Candidates, 14 Total


Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3

Unpartnered

MOR208 DLBCLCD19

CLL

MOR202 Multiple myeloma CD38

MOR107 Fibrosis AT2-R

Immuno-oncology program

CancerMHC-associated peptides

6 Programs Various Various

Co-development & co-promotion

MOR209/ES414 (Emergent)

Prostate cancer PSMA / CD3

MOR106(Galapagos)

Inflammation Undisclosed

Immuno-oncology program(Merck Serono)

Cancer Undisclosed

Outlicensed to GSK

MOR103/GSK3196165

RA

GM-CSFOsteoarthritis of the hand

FTD, orphan status US & EU

Orphan status US & EU

MOR208

First- & Best-in Class Potential


CD19 is an ideal target in NHL because

CD19 is broadly and homogeneously expressed

Across different NHL subtypes incl. DLBCL and CLL

CD19 conveys a survival signal for B cells

Via B cell receptor signaling

CD19 expression seems to be preserved

Even after pretreatments targeting B cells

MOR208 is an Fc-enhanced, humanized IgG1 antibody

targeting CD19

Fc modification leads to dramatically enhanced B cell

depletion by

Antibody dependent cellular cytotoxicity (ADCC)

Antibody dependent cell phagocytosis (ADCP)

Direct cytotoxicity

Straightforward manufacturing

Strong pre-clinical support for combo therapy

ADCC

MOR208 in R/R CLL

Superior to Other CD19 and CD20 MAbs


38%

24%

30%

23%

13%

0%

10%

20%

30%

40%

50%

MOR20812mg/kg

(n=16)

MEDI-551phase 1/212mg/kg

(n=26)

Obinutuzumabphase 2(n=20)

Ofatumumabphase 3(n=196)

Rituximab(n=110)

14

10.7

8

5.5

0

5

10

15

ORR [%]*

PFS

[months]Sources:

MOR208: Woyach et al., Blood 2014

MEDI-551: Forero-Torres et al. ASH 2013

Obinutuzumab: Cartron et al., Blood 2014

Ofatumumab: Byrd et al., NEJM 2014

Rituximab: Furman et al., NEJM 2014

*IWCLL Criteria: Hallek et al., 2008

[NR – not reported]

anti-CD19 MAbs anti-CD20 MAbs

NR

Response Rate

in evaluable patients*

n (%)

DLBCL

n=25

iNHL incl. FL

n=40

Overall Response (ORR) 9 (36%) 12 (30%)

Complete response (CR) 2 (8%) 5 (13%)

Partial response (PR) 7 (28%) 7 (18%)

Stable disease (SD) 5 (20%) 21 (53%)

*Investigator assessed


MOR208 in R/R NHL

Strong Single Agent Efficacy

Jurczak et al., Abstract #1528, ASH 2015

MOR208 in R/R NHL

Very Promising Duration of Response


* Includes follicular lymphoma and other indolent NHLs

DLBCL, diffuse large B-cell lymphoma; NHL, non-Hodgkin’s lymphoma. Jurczak et al., Abstract #1528, ASH 2015

0.0 5.0 10.0 15.0 20.0 25.0

Months

Pati

ents

wit

hCR o

rPR

Duration of response

DLBCL, n=9Indolent NHL,* n=12

Time to response, n=21

Ongoing response, n=9

DLBCL

Duration of Response:

Longest: 20 months+

12 months: 67%

MOR208

Comprehensive Clinical Development Plan

10© MorphoSys AG, Company Update - May 2016

Indication 2016 2017 2018

NHL

DLBCL

CLL

Phase 2

Phase 2/3

IIT: Investigator-initiated trial

L-MIND: MOR208 (12mg/kg) + lenalidomide; 2nd line R/R; N=80

B-MIND: Safety evaluation leading into anticipated pivotal study

MOR208 (12 mg/kg) + bendamustine vs.

rituximab + bendamustine; 2nd line R/R; N~320

COSMOS: MOR208 (12mg/kg) + combo partner; BTKi-failures

MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation

MOR208 + ibrutinib in ibrutinib failures

MOR208

(12 mg/kg); N=92

} N=80 (Ohio State Univ. IIT)

MOR202

A Novel Antibody for Multiple Myeloma

Fully human monoclonal HuCAL IgG1 antibody

Targeting a unique epitope of CD38

Inducing potent immune effector mechanisms

ADCC and ADCP

One of only three CD38 antibodies in clinical

development

Strongly synergistic with IMiDs and proteasome

inhibitors in pre-clinical models


ADCC = Antibody-Dependent Cell-Mediated Cytotoxicity; ADCP = Antibody-Dependent Cell-Mediated Phagocytosis;

CDC = Complement-Dependent cytotoxicity

11

MOR202

Preliminary Phase 1/2a Data

12

Raab et al, #3035, ASH 2015


Data from patients treated with the clinically relevant dose regimens who received > 1 treatment cycle.

Dex, dexamethasone; LEN, Lenalidomide; MR, minor response; POM, Pomalidomide; PD, progressive disease; PR, partial

response; q1w, weekly; SD, stable disease; VGPR, very good partial response.

SD

SD

SD

SD

SD

PD

PD

SD

0 10 20 30 40 50 60

Weeks

MOR202 q1w + Dex cohorts

4 mg/kg + Dex

8 mg/kg + Dex

16 mg/kg + Dex

8 mg/kg + POM/Dex

8 mg/kg + LEN/Dex

PR

PR

MR

PR

VGPR

PR

VGPR

Pati

ents

Tre

ate

d

Response recorded

Ongoing patients

Single agent MOR202:

ORR = 33%

MOR202 & IMiD combos:

Clinical benefit rate of 67%

MOR202: Excellent Clinical Safety &

Convenience


MOR202 shows best-in-class infusion tolerability & infusion duration

MOR202 Daratumumab Isatuximab

Infusion time 2 h

6.5 h

(1st infusion)

(3.5 h @ 3rd infusion)

4 - 6 h

Infusion reactions

(IRRs) with Steroids

6%

(Grade 1 only) 70-77% 52%

MOR202: Raab et al., ASH 2015

Daratumumab: Lokhorst et al., NEJM 2015

Isatuximab: Martin et al., ASH 2015

MOR202: Pre-clinical Data Suggest Advantage in

Durability of Response


MOR202 shows best-in-class difference between MM cell killing and NK cell preservation

0

10

20

30

40

50


% s

pecif

ic k

illing

CD38-expressing MM cell line

0

5

10

15

20

25

30

35

40


% s

pecif

ic N

K c

ell k

illing

CD38-expressing NK cells

Clinical Programs

from Partnered Discovery Alliances (I)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

Bimagrumab Novartis ActRIIB sIBM (extension)

(BYM338) sIBM (long-term study)

Hip fracture surgery

Cachexia (COPD)

Sarcopenia (dose-ranging)

Sarcopenia (withdrawal extension study)

Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1)

(CNTO1959) Psoriasis (VOYAGE 2)

Psoriasis (NAVIGATE)

Pustular/Erythrodermic psoriasis

Moderate to severe plaque-type psoriasis

Palmoplantar pustulosis

Active psoriatic arthritis

Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease

Prodromal Alzheimer‘s disease

Genetically predisposed

Safety, Tolerability, and Pharmacokinetics

Anetumab Ravtansine Bayer Mesothelin Mesothelioma (MPM)

(BAY94-9343) Solid tumors, with pemetrexed and cisplatin

Advanced malignancies (Japan)

Ovarian cancer, with doxorubicin

Solid tumors with hepatic/renal impairment

BHQ880 Novartis DKK-1 MM (renal insufficiency)

Smoldering MM

BPS804 Mereo/Novartis Sclerostin Osteoporosis

Hypophosphatasia (HPP)

Osteogenesis Imperfecta

CNTO3157 Janssen/J&J n.d. Asthma

Safety/Pharmacokinetic

CNTO6785 Janssen/J&J n.d. COPD

Rheumatoid arthritis

Clinical Programs

from Partnered Discovery Alliances (II)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

LFG316 Novartis C5 Age-related geographic atrophy

Geographic atrophy (combo with CLG561)

Panuveitis

Paroxysmal nocturnal hemoglobinuria

Transplant Associated Microangiopathy (TAM)

LJM716 Novartis HER3 ESCC (combo with BYL719)HER2+ cancer (combo BYL719 & trastuzumab)

HER2+ cancer, combo with trastuzumab

Tarextumab Oncomed/GSK Notch 2 Small cell lung cancer (Pinnacle)

(OMP-59R5) Solid tumors

VAY736 Novartis BAFF-R Pemphigus vulgaris

Primary Sjögren‘s syndrome

Rheumatoid Arthritis

BAY1093884 Bayer TFPI Bleeding disorders

BI-836845 BI IGF-1 Solid tumors, Japanese patients

EGFR mutant NSCLC

Metastatic breast cancer

CRPC + enzalutamide

Advanced solid tumors

NOV-7 Novartis n.d. Eye disease

NOV-8 Novartis n.d. Inflammation

NOV-9 Novartis n.d. Diabetic eye disease

NOV-10 Novartis n.d. Cancer

NOV-11 Novartis n.d. Blood disorders

PF-05082566 Pfizer 4-1BB Advanced malignancies, with avelumabSolid tumors, NHL (+rituximab)

Solid tumors, with PD-1i MK-3475

Advanced solid tumors, with mogamulizumab

Solid tumors, with PF04518600 (OX-40)

Vantictumab Oncomed/Bayer Fzd 7 Solid tumors

(OMP-18R5) Metastatc breast cancer

Pancreatic cancer (combo)

NSCL

Guselkumab (CNTO1959)

A Janssen Anti-Inflammatory Program


Guselkumab

A HuCAL antibody specific for IL-23, does not bind IL-12

IL-23 blockade inhibits production of multiple cytokines

beyond IL-17A and preserves Th1 & Treg regulatory pathways

Being developed in psoriasis and psoriatic arthritis

Current Status

Six Phase 3 clinical trials ongoing

First Phase 3 data expected in 2016

Anticipated filing in 2016

Source: Jetten AM, Nucl Recept Signal, 2009

Guselkumab (CNTO1959)

Clinical Data


Highest levels of durable skin clearance with less intensive dosing regimens vs. anti-IL-17 class

Potential for similar safety profile vs. long-term blockade of IL-12 + 23 with STELARA®

Potential for long-term, drug-free efficacy

Data courtesy of Janssen

Anetumab Ravtansine (BAY94-9343)

A Bayer Anti-Cancer Program


Anetumab Ravtansine

ADC comprising

HuCAL anti-mesothelin G1 antibody conjugated to

potent maytansinoid tubulin inhibitor DM4

In development for mesothelioma & other solid cancers

Pre-clinic

Anetumab ravtansine potently inhibited growth of

human mesothelioma models in vivo

Phase 1

Anetumab ravtansine 6.5 mg/kg IV Q3W was well

tolerated and showed efficacy in patients with

previously treated mesothelioma

Phase 2

Started Q1, 2016

Second-line, malignant pleural mesothelioma

Estimated enrollment 210

Antibody-drug conjugate anti-tumor therapy

(A) General mechanism of action

(B) Structure of anetumab ravtansineData courtesy of Bayer Healthcare

Pipeline Set to Deliver a Lot of Clinical Data


Based on published information and MorphoSys estimates

PH

ASE 1

PH

ASE 2

PH

ASE 3

2016 2017

LFG316

Panuveitis

Guselkumab

Psoriasis (VOYAGE 2)

Guselkumab

Psoriasis (VOYAGE 1)

Guselkumab

Psoriasis (NAVIGATE)

LFG316

PNH

BI-836845

EGFR mutant NSCLC

BI-836845

Advanced solid tumors

Bimagrumab

Sarcopenia (dose ranging)

LJM716

ESCC + BYL716

Anetumab Ravtansine

Advanced malignancies

GuselkumabPustular/Erythrodermic Psoriasis

PF-05082566

Solid tumors + MK-3475

Guselkumab

Psoriatic Arthritis

VAY736

Pemphigus VulgarisVAY736Primary Sjögren‘s Syndrome (PD)

BI-836845

Metastatic breast cancer

Tarextumab

Small cell lung cancer

Bimagrumab

sIBM (extension)

BI-836845

CRPC + enzalutamide

BAY-1093884

Bleeding disorders

Bimagrumab

Hip fracture surgery

PF-05082566

NHL + rituximab

LJM716

+ trastuzumab

MOR208

CLL (IIT)

MOR208

DLBCL + lenalidomide

MOR103/GSK3196165

RA

MOR208

NHL

MOR209

Prostate cancer

MOR208

CLL + combo

MOR202

Multiple Myeloma

MOR202

Multiple Myeloma

Gantenerumab

Safety, Tolerability, & PK

Anetumab Ravtansine

Mesothelioma (MPM)

Anetumab Ravtansine

Solid tumors

LFG316

GA + CLG561

Anetumab Ravtansine

+ pemetrexed & cisplatin

LJM716

+ BYL716 + trastuzumab

LJM716

+ trastuzumab

PF-05082566Advanced solid tumors + avelumab

Bimagrumab

sIBM

Partnered Discovery Programs MOR Programs Outlicensed programs

MOR106

InflammationAnetumab RavtansineOvarian cancer + doxorubicin

Antibody library

Protein optimization

Lantipeptides

Powerful Technology Base Ensures Pipeline

Sustainability


Innovative Targets Proprietary Platforms

Differentiated

drug candidates

GPCRs, ion channels

Immune checkpoints

MHC-presented, tumor-associated peptides

Source of novel targets

Financial Guidance 2016


in EUR million 2015A Q1 2016Guidance

2016

Group Revenues 106.2 12.1 47 to 52

Proprietary R&D Expenses

(incl. Technology Development)56.6 14.6 76 to 83

EBIT 17.2 -9.7 -58 to -68

Cash, cash equivalents & marketable securities

as well as other short-term and long-term financial assets298.4 287.0

22

Coming Up


Bimagrumab sIBM Data from pivotal trial and regulatory filing expected

Guselkumab Psoriasis Data from 3 pivotal trials and regulatory filing expected

MOR208

DLBCL

Phase 2 lenalidomide combo trial L-MIND starts

Phase 2 bendamustine combo trial B-MIND:

Safety evaluation to start mid 2016

Pivotal study planned for 2017

CLL Phase 2 idelalisib combo trial in planning

MOR202 MM Updated data from phase 1/2a trial at ASCO 2016

MOR209 Prostate cancerContinuation of phase 1 trial under amended protocol, clinical data

in 2017

MOR106 Inflammation Start of phase 1 with Galapagos in H1 2016

MOR107 Fibrosis Start of phase 1 in Q4 2016

MOR103 Osteoarthritis

RA

Start of phase 1b/2a in osteoarthritis of the hand

Data from the phase 2b in RA in 2017

Pipeline Up to 5 new program starts

Around 5 clinical milestones

APPENDIX


MOR103/GSK3196165

Anti-inflammatory Program Licensed to GSK


MOR103/GSK3196165

HuCAL antibody specific for GM-CSF

GM-CSF is important in every step of macrophage

production and infiltration in the tissues

Good magnitude of effect with fast onset of action and

long duration post treatment

Effect size appears similar to or greater than anti-TNF

Targeting the macrophage in early RA

Potential for early use to induce remission

Indications

Lead indication: Rheumatoid arthritis (RA)

Potential for disease modification & analgesic activity in

hand osteoarthritis (HOA)

Current Status

BAROQUE (RA phase 2b) ongoing

Initial clinical read-out 2016

Phase 2 in hand osteoarthritis to start in 2016

0

20

40

60

80

Placebo 0.3 mg/kg 1.0 mg/kg 1.5 mg/kg

% EULAR good/moderate response at 4 weeks: Rapid onset of action

Week 4 Week 6 Week 8

% E

ULAR r

esp

onse

Phase Ib/IIa study, n=96

Behrens, et al. Ann Rheum Dis. 2015;74:1058-64

MOR209/ES414

A Novel Bi-specific Antibody for Prostate Cancer


Co-development Agreement with Emergent BioSolutions

Phase 1 clinical trial in mCRPC patients was started in March of 2015

Restructured Agreement with

Emergent BioSolutions

Adjustment of dosing regimen

and administration

Reduction of MorphoSys’s cost

sharing and reduced milestone

payments

Clinical development will continue in 2016 under an adapted clinical development plan.

Covering Analysts


Institution Contact

Baader Helvea Dr. Bruno Bulic

Commerzbank Mr. Daniel Wendorff

Deutsche Bank Mr. Gunnar Romer

Edison Mr. Maxim Jacobs

Goldman Sachs Mr. Keyur Parekh

Independent Research GmbH Mr. Bernhard Weininger

J.P. Morgan Cazenove Mr. James Gordon

Kempen & Co. Mr. Sachin Soni / Mr. Mark Pospisilik

Landesbank Baden-Württemberg Mr. Timo Kürschner

Oddo Seydler Mr. Igor Kim

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 27-404

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

Email [email protected]

Thank You

www.morphosys.com

company update - morphosys ag · guselkumab janssen/j&j il23p19 psoriasis (voyage 1) (cnto1959)...

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