company update · actual results could differ materially from those included in the forward-looking...

Company UpdateNovember 24, 2015

Deutsches Eigenkapitalforum 2015

Safe Harbor

© MorphoSys AG, Company Update - November 2015

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 AG, Company Update - November 2015 3

The MorphoSys Pipeline

25 Clinical Product Candidates, 104 Total

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

Bimagrumab (BYM338) Novartis ActRIIB sIBM (musculoskeletal)

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

MOR208 - CD19 ALL, CLL, NHL

MOR103/GSK3196165 GSK GM-CSF Inflammation

MOR202 - CD38 Multiple myeloma

BHQ880 Novartis DKK-1 Multiple myeloma

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

LFG316 Novartis C5 Eye diseases

LJM716 Novartis HER3 Cancer

BPS804 Mereo/Novartis Sclerostin Brittle bone syndrome

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

VAY736 Novartis BAFF-R Inflammation

MOR209/ES414 Emergent PSMA/CD3 Prostate cancer

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

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

MOR106 Galapagos - Inflammation

MOR107 (LP2) - AT2-R Fibrosis

Immuno-oncology program Merck Serono - Cancer

Immuno-oncology program Immatics - Cancer

6 MOR programs - - Various

90 Partnered Programs

13 MOR Programs

1 Outlicensed Program

Most advanced development stage

In addition, 26 partnered programs in pre-clinic, and 43 partnered programs in discovery

The MOR Portfolio


Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3

Unpartnered

MOR208 NHL

CD19CLL

ALL

MOR202 Multiple myeloma CD38

MOR107 Fibrosis AT2-R

Immuno-oncology program(Immatics)

Cancer Various

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

4

FTD, orphan status US & EU

Orphan status US & EU

MOR208

First- & Best-in Class Potential


Fc-enhanced, humanized IgG1 antibody targeting CD19

CD19 is target of choice for B-cell malignancies

CD20 down-regulated after anti-CD20 treatment

CD19 down-regulation not described

Fc modification leads to dramatically enhanced B cell

depletion

antibody dependent cellular cytotoxicity (ADCC)

phagocytosis

direct cytotoxicity

Convenient dosing schedule, straightforward manufacturing

Strong pre-clinical support for combo therapy

Major medical need in DLBCL and CLL

DLBCL: Ca. 40% treated with chemo-immune

therapy/ASCT eventually relapse, becoming

refractory to current agents*

CLL: Patients who are discontinued after BTKi

treatment relapse very quickly and have a

very poor prognosis

MOR208

Comprehensive Clinical Development Plan

6© MorphoSys AG, Company Update - November 2015

Indication 2015 2016 2017 2018

NHL

DLBCL

CLL

ALL

Phase 2

Phase 2/3

IIT: Investigator-initiated trial

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

Safety evaluation leading into anticipated pivotal study

MOR208 (12 mg/kg) + bendamustine; 2nd line R/R; N~320

MOR208 (12mg/kg) + idelalisib; BTKi-failures; N=120

MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s Transformation; N=50 (Ohio State Univ. IIT)

MOR208 (12mg/kg) + NK cells; pediatric ALL; N=13 (St Jude’s IIT)

MOR208 (12 mg/kg); N=92

MOR202

A Novel Antibody for Multiple Myeloma


HuCAL IgG1 antibody binding unique epitope

on CD38

One of only three CD38 antibodies in clinic

Potent ADCC and ADCP

Full killing of MM cells

Low killing of healthy/effector cells

Strongly synergistic with IMiDs and proteasome

inhibitors in pre-clinical models

Best-in-class infusion tolerability as consistent

2-hour infusion

Multiple myeloma (MM) treatment: a large

commercial opportunity

Leading therapies already generate over

$5.0bn in worldwide sales

Estimated to reach $10.2bn by 2020

MOR202

Clinical Development Plan

8© MorphoSys AG, Company Update - November 2015

Indication 2015 2016 2017 2018

Multiple

myeloma

Phase 2

Phase 2/3

MOR202 combo study to be based on Phase 2

MOR202 monotherapy, dose escalation &

confirmation cohorts; N~62*

MOR202 (8 & 16mg/kg) + lenalidomide & confirmation cohorts; N~24**

MOR202 (8 & 16mg/kg) + pomalidomide & confirmation cohorts; N~24*

* Patients who have failed at least 2 prior therapies

** Patients who have failed at least 1 prior therapy

Indication 2015 2016 2017 2018

mCRPC*

Phase 3 preparations

MOR209/ES414

A Novel Bi-specific Antibody for Prostate Cancer


Bi-specific ADAPTIR antibody targeting

PSMA on prostate cancer cells, levels increase with progression

CD3 on cytotoxic T cells

Compelling pre-clinical data

Encouraging activity in vitro and in vivo

Less cytokine release on T cell activation in pre-clinical models

compared to other formats

Prolonged half-life in mouse and NHP compared to other

formats

* Metastatic castration-resistant prostate cancer

Phase 1/2a

Phase 3

MOR209/ES414: Phase 1/2 dose extension (N~80)

MOR209/ES414: Phase 1/2 dose escalation (N~50)

Clinical Programs Pursued by Partners (I)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

Bimagrumab Novartis ActRIIB sIBM (52 weeks)

(BYM338) sIBM (extension)

sIBM (long-term study)

Hip fracture surgery

Sarcopenia

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

(CNTO1959) Psoriasis (VOYAGE 2)

Psoriasis (NAVIGATE)

Pustular/Erythrodermic Psoriasis

Moderate to severe psoriasis

Active psoriatic arthritis

Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s disease

Prodromal Alzheimer‘s disease

Genetically predisposed

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

LFG316 Novartis C5 Age-related AMD

Geographic atrophy

Panuveitis

Paroxysmal nocturnal hemoglobinuria

LJM716 Novartis HER3 ESCC (combo with BYL719)

HER2+ cancer (combo BYL719 & trastuzumab)

HER2+ cancer, combo with trastuzumab

Partnered discovery programs

Clinical Programs Pursued by Partners (II)


Program Partner Target Indication Phase 1 Phase 2 Phase 3

MOR103/GSK3196165 GlaxoSmithKline GM-CSF Rheumatoid Arthritis

Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)

(OMP-59R5) Small cell lung cancer (Pinnacle)

Solid tumors

BAY1093884 Bayer TFPI Bleeding disorders

BAY94-9343 Bayer Mesothelin Solid tumors

Anetumab Ravtansine Advanced malignancies (Japan)

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

EGFR mutant NSCLC

Breast cancer

CRPC + enzalutamide

Various solid cancer

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 Solid tumors, NHL (+rituximab)Solid tumors, combo with PD-1i MK-3475

Advanced solid tumors, with mogamulizumab

Advanced malignancies, with avelumab

VAY736 Novartis BAFF-R Pemphigus vulgaris

Primary Sjögren‘s syndrome

Primary Sjögren‘s syndrome

Vantictumab Oncomed/Bayer Fzd 7 Solid tumors

(OMP-18R5) Breast cancer

Pancreatic cancer

NSCL

Out-licensed programPartnered discovery programs

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

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

GM-CSF plays a key role in

activation of macrophages at the

site of injury or inflammation

Bimagrumab (BYM338)

A Novartis Musculoskeletal Program


Bimagrumab

HuCAL antibody specific for ActRIIB, antagonizes

myostatin binding

Lead indication: sporadic inclusion body myositis (sIBM)

FDA breakthrough therapy designation

Orphan drug designation

Current Status

Pivotal study in sIBM with 240 patients ongoing,

completion scheduled for Q4 2015

Phase 3 data expected in H1 2016

Listed by Novartis as “planned filing 2016”

Phase 2 read-outs in sarcopenia expected in 2016

M. Schuelke at al, N Engl J Med 2004;350:2682-8

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

Five Phase 3 clinical trials ongoing

First Phase 3 data expected in 2016

Anticipated filing in 2016

Source: Jetten AM, Nucl Recept Signal, 2009

Clinical Trials Scheduled for Completion


PH

ASE

2PH

ASE 3

PH

ASE 1

Potential data events based on clinical trial design & MorphoSys estimates Partnered Discovery Programs

MOR Programs

LJM716

ESCC, combo w/BYL719

LFG316

PanuveitisMOR208

NHL (mono - update)

Guselkumab

Psoriasis (VOYAGE 2)

Guselkumab

Psoriasis (VOYAGE 1)

Bimagrumab

sIBM

Guselkumab

Psoriasis (NAVIGATE)

MOR202

Multiple myeloma

MOR208 - IST

CLL (combo with len)

LFG316

PNH

LJM716

HER2+ cancer (combo)

LJM716


CNTO6785

Rheumatoid arthritis

CNTO6785

COPD

Tarextumab

Pancreatic cancer

Tarextumab

Solid tumors

Vantictumab

Solid tumorsVantictumab

Pancreatic cancer

Vantictumab

NSCLC

Vantictumab

Breast cancer

BAY94-9343

Solid tumors

BI-836845

Solid tumors (Japan)

BI-836845

NSCLC

BI-836845

Various solid cancer

BI-836845


MOR209

Prostate cancer

√

√

√

Bimagrumab

Sarcopenia

2015 2016

LFG316

Age-related AMD

√

Financial Guidance 2015


in € million 2014A 9M 2015 Guidance 2015

Group Revenues 64.0 93.9 101 to 106

Proprietary R&D Expenses

(incl. Technology Development)36.4 39.9 56 to 63

EBIT -5.9 34.7 9 to 16

Cash, cash equivalents & marketable securities

as well as other short-term and long-term financial

assets

352.8 317.7

16

What to Expect?


MOR208

Updated data from phase 2 mono-therapy trial at ASH 2015

DLBCL: Phase 2 lenalidomide combo trial to start in Q4 2015

Phase 3 bendamustine combo trial expected to start in 2017

CLL: Phase 2 idelalisib combo trial to start in Q1 2016

ALL: Phase 2 pediatric IIT with NK cell transfusion to start in H1 2016

MOR202 Updated data from phase 1/2a trial at ASH 2015

MOR209 First phase 1 data expected in 2016

BimagrumabData from pivotal trial in sporadic inclusion body myositis expected early 2016

Filing expected in 2016

GuselkumabData from 3 pivotal trials in psoriasis expected 2016

Filing expected in 2016

PipelineMOR106 & MOR107 to start clinical development in 2016

Potential in-licensing of additional compounds

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

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