160830 mor-company update - morphosys...adcc and adcp status/clinical data: clinical data from...

Company Update

August 2016

Safe Harbor

© MorphoSys AG, Company Update - August 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.

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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− 27 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 - August 2016 3

Powerful Technology Base Ensures Pipeline Sustainability


Innovative Targets GPCRs, ion channels

Immune checkpoints

MHC-presented, tumor-associated peptides

Source of novel targets

Proprietary Platforms Human antibody library

Protein optimization

Lanthipeptides

DIFFERENTIATED DRUG CANDIDATES

In addition, 23 partnered programs in preclinic, and 45 partnered programs in discovery


The MorphoSys Pipeline27 Clinical Product Candidates, 104 TotalProgram Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3Guselkumab (CNTO1959) Janssen (J&J) IL23p19 PsoriasisGantenerumab Roche Amyloid-ß Alzheimer’s diseaseMOR208 - CD19 ALL, CLL, NHLMOR202 - CD38 Multiple myelomaMOR103/GSK3196165 GSK GM-CSF InflammationAnetumab Ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumorsBI–836845 BI IGF-1 Solid tumorsBimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseasesBHQ880 Novartis DKK-1 Multiple myelomaBPS804 Mereo/Novartis Sclerostin Brittle bone syndromeCNTO3157 Janssen (J&J) - InflammationCNTO6785 Janssen (J&J) - InflammationElgemtumab (LJM716) Novartis HER3 CancerTarextumab (OMP-59R5) Oncomed Notch 2 Solid tumorsTesidolumab (LFG316) Novartis C5 Eye diseasesVAY736 Novartis BAFF-R InflammationUtomilumab (PF-05082566) Pfizer 4-1BB Solid tumorsMOR209/ES414 Aptevo PSMA/CD3 Prostate cancerMOR106 Galapagos - InflammationBAY1093884 Bayer TFPI HemophiliaNOV-7 Novartis - Eye diseasesNOV-8 Novartis - InflammationNOV-9 Novartis - Diabetic eye diseasesNOV-10 Novartis - CancerNOV-11 Novartis - Blood disordersNOV-12 Novartis - Prevention of thrombosisVantictumab (OMP-18R5) Oncomed Fzd 7 Solid tumorsMOR107 (LP2) - AT2-R FibrosisImmuno-oncology program Merck - CancerImmuno-oncology program Immatics - Cancer6 MOR programs - - Various

90 Partnered Discovery Programs13 MOR Programs1 Outlicensed Program

Most advanced development stage

The MOR Portfolio5 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 Cancer MHC-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

RAGM-CSF

Osteoarthritis of the hand

FTD, orphan status US & EU

Orphan status US & EU

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MOR208First- & 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

− Signaling via PI3K/AKT and c-Myc− Especially important for an extended treatment

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 ADCC, ADCP and direct cytotoxicity Straightforward manufacturing Strong pre-clinical support for combo therapy

ADCC

ADCC, antibody dependent cellular cytotoxicity; ADCP, antibody dependent cell phagocytosis

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Response Rate in evaluable patients*n (%)

DLBCLn=35

iNHL incl. FLn=45

Disease Control Rate (DCR) 14 (40%) 33 (73%)

Overall Response (ORR) 9 (36%) 13 (33%)

Complete response (CR) 2 (6%) 5 (11%)

Partial response (PR) 7 (20%) 8 (18%)

Stable disease (SD) 5 (14%) 20 (44%)

*Investigator assessed


MOR208 in R/R NHLStrong Single Agent Efficacy

Jurczak et al., Abstract #7545, ASCO 2016

DCR was considered to be a relevant efficacy endpoint as the majority of patients with stable disease had marked target lesion shrinkage but as per study design were not treated beyond cycle 3

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MOR208Comprehensive Clinical Development Plan


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 studyMOR208 (12 mg/kg) + bendamustine vs.rituximab + bendamustine; 2nd line R/R; N~330

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

MOR208 (9mg/kg) + lenalidomide; R/R, naive & Richter’s TransformationMOR208 + ibrutinib in ibrutinib failures

MOR208 (12 mg/kg); N=92

} N~80 (Ohio State Univ. IIT)

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MOR202A 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

Status/Clinical Data: Clinical data from ongoing phase 1/2a study in

multiple myeloma were presented at ASCO 2016

MOR202 (8 mg/kg) plus Pom/Dex in r/r multiple myeloma (MM) patients shows two complete responses (CR) out of four patients treated per protocol

MOR202 (8 mg/kg) plus Len/Dex in MM shows two partial responses (PR) and one very good partial response (VGPR) out of the four patients

MOR202 administered in doses of up to 16 mg/kg as a 2-hour intravenous infusion with low incidence of infusion-related reactions (IRR)


ADCC = Antibody-Dependent Cell-Mediated Cytotoxicity; ADCP = Antibody-Dependent Cell-Mediated Phagocytosis; CDC = Complement-Dependent cytotoxicity

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Clinical Programsfrom Partnered Discovery Alliances (I)


Program Partner Target Indication Phase 1 Phase 2 Phase 3Guselkumab Janssen/J&J IL23p19 Psoriasis (VOYAGE 1)(CNTO1959) Psoriasis (VOYAGE 2)

Psoriasis (NAVIGATE)Pustular/Erythrodermic psoriasisModerate to severe plaque-type psoriasisPalmoplantar pustulosisActive psoriatic arthritis

Gantenerumab Roche Amyloid-ß Mild Alzheimer‘s diseaseProdromal Alzheimer‘s diseaseGenetically predisposed Safety, Tolerability, and PK (sc)

Anetumab Ravtansine Bayer Mesothelin Mesothelioma (MPM)(BAY94-9343) Adenocarcinoma

Solid tumors, with pemetrexed and cisplatin Advanced malignancies (Japan)Ovarian cancer, with doxorubicinSolid tumors with hepatic/renal impairmentECG & drug interaction (with itraconazole)

BI-836845 BI IGF-1 Metastatic breast cancerCRPC + enzalutamideSolid tumors, Japanese patientsEGFR mutant NSCLC

BHQ880 Novartis DKK-1 MM (renal insufficiency)Smoldering MM

Bimagrumab Novartis ActRIIB Hip fracture surgery(BYM338) Sarcopenia (dose-ranging)

Sarcopenia (withdrawal extension study)BPS804 Mereo/Novartis Sclerostin Osteoporosis

Hypophosphatasia (HPP)Osteogenesis Imperfecta

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Clinical Programsfrom Partnered Discovery Alliances (II)


Program Partner Target Indication Phase 1 Phase 2 Phase 3CNTO3157 Janssen/J&J Asthma

Safety/PharmacokinticCNTO6785 Janssen/J&J COPD

Rheumatoid ArthritisLFG316 Novartis C5 Age-related geographic atrophy(tesidolumab) Geographic atrophy (combo with CLG561)

PanuveitisParoxysmal nocturnal hemoglobinuriaTransplant Associated Microangiopathy (TAM) Kidney Transplantation

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

HER2+ cancer, combo with trastuzumabTarextumab Oncomed/GSK Notch 2 Small cell lung cancer (Pinnacle)(OMP-59R5) Solid tumorsUtomilumab Pfizer 4-1BB JAVELIN Medley(PF-05082566) Solid tumors, NHL (+rituximab)

Solid tumors, with PD-1i MK-3475 Advanced solid tumors, with mogamulizumabSolid tumors, with PF04518600 (OX-40)

VAY736 Novartis BAFF-R Pemphigus vulgarisPrimary Sjögren‘s syndromeRheumatoid Arthritis

BAY1093884 Bayer TFPI Bleeding disordersNOV-7 Novartis n.d. Eye diseaseNOV-8 Novartis n.d. InflammationNOV-9 Novartis n.d. Diabetic eye diseaseNOV-10 Novartis n.d. CancerNOV-11 Novartis n.d. Blood disordersVantictumab Oncomed/Bayer Fzd 7 Metastatc breast cancer(OMP-18R5) Pancreatic cancer (combo)

NSCL

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Guselkumab (CNTO1959)A Janssen Anti-Inflammatory Program

© MorphoSys AG, Company Update - June 2016 13

Guselkumab A HuCAL antibody specific for IL-23, does not

bind IL-12 IL-23 blockade inhibits production of multiple

cytokines 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

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 + IL-23 with STELARA®

Potential for long-term, drug-free efficacy PASI: Psoriasis Area and Severity Index

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 cancersPre-clinic Anetumab ravtansine potently inhibited growth of

human mesothelioma models in vivoPhase 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

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Pipeline Set to Deliver a Lot of Clinical Data


Based on published information and MorphoSys estimates

PHAS

E 1

PHAS

E 2

PHAS

E 3

2016 2017

LFG316Panuveitis

GuselkumabPsoriasis (VOYAGE 2)

GuselkumabPsoriasis (VOYAGE 1)

GuselkumabPsoriasis (NAVIGATE)

BI-836845EGFR mutant NSCLC

BimagrumabSarcopenia (dose ranging)

LJM716ESCC (+ BYL716)

Anetumab RavtansineAdvanced malignancies (JP)

GuselkumabPustular/Erythrodermic Psoriasis

PF-05082566Solid tumors (+ MK-3475)

GuselkumabPsoriatic Arthritis

VAY736Pemphigus Vulgaris

VAY736Primary Sjögren‘s Syndrome (PD)

BI-836845Metastatic breast cancer

TarextumabSmall cell lung cancer

BI-836845CRPC (+ enzalutamide)

BAY-1093884Bleeding disorders

BimagrumabHip fracture surgery

PF-05082566NHL/solid tumors (+ rituximab)

LJM716+ trastuzumab

MOR208CLL (IIT)

MOR208DLBCL (+ lenalidomide)

MOR103/GSK3196165RA

MOR208NHL

MOR209Prostate cancer

MOR202Multiple Myeloma

MOR202Multiple Myeloma (+LEN/POM)

GantenerumabSafety, Tolerability, & PK

Anetumab RavtansineMesothelioma (MPM)

LFG316GA (+ CLG561)

Anetumab Ravtansine+ pemetrexed & cisplatin

LJM716+ BYL716 + trastuzumab

BimagrumabsIBM

Partnered Discovery Programs MOR Programs Outlicensed programs

MOR106Inflammation

Anetumab RavtansineOvarian cancer (+ doxorubicin)

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Anetumab RavtansineHepatic/renal impairment

MOR103/GSK3196165Osteoarthritis

LJM716ESCC (+ BYL719)

LFG316Kidney Transplantation

VantictumabNSCLC & Pancreatic Cancer

Financial Guidance 2016


in EUR million 2015A H1 2016 Guidance 2016

Group Revenues 106.2 24.3 47 to 52

Proprietary R&D Expenses (incl. Technology Development) 56.6 28.3 76 to 83

EBIT 17.2 -19.2 -58 to -68

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

298.4 279.7

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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 startsPhase 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 cancer Continuation 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 OsteoarthritisRA

Start of phase 1b/2a in osteoarthritis of the handData from the phase 2b in RA in 2017

Pipeline Up to 5 new program startsAround 5 clinical milestones

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APPENDIX


MOR103/GSK3196165Anti-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 remissionIndications 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

% EU

LAR

resp

onse

Phase Ib/IIa study, n=96

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

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MOR209/ES414A 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 withEmergent BioSolutions

Adjustment of dosing regimenand administration

Reduction of MorphoSys’s cost sharing and reduced milestone payments

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

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Guselkumab


Trial Phase Patients Prim. Compl. Primary Outcome Measures

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (VOYAGE 1)

3Active, notrecruiting

841 09/2015 • The percentage of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 comparing the guselkumab group and the placebo group

• The percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response comparing the guselkumab group and the placebo group

A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Re-treatment (VOYAGE 2)


998 05/2016 • Percentage of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 comparing the guselkumab group and the placebo group

• Percentage of participants with a Psoriasis Area and Severity Index (PASI) 90 Response comparing the guselkumab group and the placebo group

A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (NAVIGATE)


876 05/2016 • The number of visits at which participants achieve an Investigator's Global Assessment (IGA) response of 0 or 1 and at least a 2 grade improvement (from Week 16) among randomized participants with an inadequate (IGA≥2) response to ustekinumabat Week 16

An Efficacy and Safety Study of CNTO1959 (Guselkumab) in the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis

3Recruiting

20 01/2017 • Percentage of Participants with Treatment Success at Week 16

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

3Recruiting

225 01/2018 • Change From Baseline in Palmo-Plantar Area and Severity Index (PPPASI) Total Score at Week 16

An Efficacy and Safety of CNTO 1959 (Guselkumab) in Participants With Moderate to Severe Plaque-type Psoriasis

3Recruiting

226 09/2018 • Number of Participants who Achieve an Investigator's Global Assessment (IGA) Score of 0 or 1

• Number of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

2Recruiting

150 07/2017 • Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24

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Covering Analysts


Institution Contact

Baader Helvea Bruno Bulic

Bryan Garnier Mickael Chane-Du

Commerzbank Daniel Wendorff

Deutsche Bank Gunnar Romer

Edison Maxim Jacobs

Goldman Sachs Keyur Parekh

Independent Research GmbH Bernhard Weininger

J.P. Morgan Cazenove James Gordon

Kempen & Co. Anastasia Karpova

Landesbank Baden-Württemberg Timo Kürschner

Oddo Seydler Igor Kim

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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 27-404Fax +49 (0)89 / 899 27-5404Email [email protected]

Thank You

www.morphosys.com

160830 mor-company update - morphosys...adcc and adcp status/clinical data: clinical data from...

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