engineering the medicines of tomorrow - morphosys ag · partnered discovery ... axi-cel evaluable...

$: Engineering the Medicines of Tomorrow - MorphoSys AG · PARTNERED DISCOVERY ... AXI-CEL Evaluable patient population R/R DLBCL n=44 R/R DLBCL n=108 R/R DLBCL n=32 R/R DLBCL n=59 Refractory$
Engineering the Medicines of TomorrowCompany Update

NOVEMBER 2017

This presentation includes forward-looking statements.

© MorphoSys AG, Company Update – November 2017

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/Tremfya®).

2

Investment Highlights


Collaborations

from academia to

top tier pharma

Over 100 programs

ongoing, 28 in the clinic

Lucrative revenue

potential

Novel antibody and

peptide formats

Strong balance sheet

Leading Antibody Platform

First Antibody on Market

Successful Partnering Track Record

Innovative Technologies

Well-Capitalized

3

Business ModelBuilding a Commercial, Product-Based Biopharmaceutical Company

© MorphoSys AG, Company Update – November 2017 4

PARTNERED DISCOVERY

Maximising utilization of the technology

Lucrative source of revenue from license fees

and royalties

PROPRIETARY DEVELOPMENT

Proprietary R&D with focus on

oncology/inflammation

Selective co-development programs

Retained rights translate into higher revenue

potential

TECHNOLOGY PLATFORMS: HuCAL & Ylanthia; Lanthipeptides; Novel Targets

MorphoSys at Exciting Stage of DevelopmentRich Pipeline Set to Drive Substantial Growth


Value

Partnered Discovery

Maximizing utilization of the technology

Proprietary Development

Retained commercial rights

Time

Our Clinical Pipeline28 Product Candidates in Clinical Development, First Compound Launched


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

Tremfya® (Guselkumab) 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

CNTO6785 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 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) Lanthio Pharma 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-13 Novartis - Cancer

NOV-14 Novartis - Asthma

PRV-300 (CNTO3157) ProventionBio TLR-3 Inflammation

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

12

13

2

*MOR103/GSK3196165 is fully outlicensed to GSK.

Partnered Discovery Programs

Proprietary Development Programs

MOR208: Most Advanced Proprietary Antibody ProgramNext Generation Anti-CD19 Antibody for B Cell Malignancies

7

THE DRUG CANDIDATE

IgG1k antibody, in-licensed from Xencor

Fc-engineered for enhanced ADCC & phagocytosis

DLBCL: L-MIND

Very promising phase 2 data:

− ORR: 52%

− CR: 32%

− mPFS: 11.3 months

FDA Breakthrough Therapy Designation

DLBCL: B-MIND

Phase 3 ongoing

CLL: COSMOS

Two arm phase 2 study ongoing

MOR208

Fc-enhancement

ADCC

ADCP

directcytotoxicity

ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity

ADCP: Antibody-Dependent Cell-Mediated Phagocytosis


MOR208: Current Development PlanOpportunity Across Spectrum of B Cell Malignancies

8© MorphoSys AG, Company Update – November 2017

INDICATION TRIAL / PHASE DESIGN TIMELINE

DLBCL L-MIND

Phase 2

Lenalidomide + MOR208 (12mg/kg) in

relapsed or refractory DLBCL pts ineligible

for HDCT and ASCT; N=80

Under discussion

with FDA

B-MIND

Phase 2/3

Bendamustine + MOR208 (12mg/kg) vs.

bendamustine + rituximab in relapsed or

refractory DLBCL pts ineligible for HDCT and

ASCT; N~330

Interim analysis:

Q4 2018

Primary endpoint:

Q4 2019

CLL COSMOS

Phase 2

MOR208 (12mg/kg) + idelalisib in relapsed or

refractory CLL BTKi-failures

MOR208 (12mg/kg) + venetoclax in relapsed

or refractory CLL BTKi-failures

Medical conferences

2018

DLBCL Front line Under evaluation

Indolent

lymphomas

Under evaluation

MOR208: Synergy with LEN in DLBCLBreakthrough Therapy Designation Awarded by FDA

9

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=44R/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

52% 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

11.3 2.7 2.8 3.6 - -

Median overall

survival,

months

- - 10.2 - 6.6 -


Disclaimer: No clinical data exist that directly compare these therapies, please note limitations of cross-trial comparisons

*Single-Arm phase 2 study of MOR208 combined with lenalidomide in patients with R/R DLBCL: L-MIND, ASH Abstract 2017 as of November 1, 2017

*R/R = relapsed/refractory; DLBCL = Diffuse Large B-cell Lymphoma

ASH 2017

MOR202: A Proprietary Anti-CD38 AntibodyA Differentiated Antibody for Multiple Myeloma & Potentially Other Cancers


THE DRUG CANDIDATE

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

STATUS

Currently in partnering discussions ADCC: Antibody-Dependent Cell-Mediated Cytotoxicity

ADCP: Antibody-Dependent Cell-Mediated Phagocytosis

ADCC

ADCP

*From ongoing phase 1/2a trial: Raab et al., Poster Presentation at ASCO, June 5, 2017: Abstract #8024

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

MOR202: Promising Efficacy in R/R Multiple MyelomaResponse Data are Comparable to Competing Antibodies

11

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


12

*Raab et al., Poster Presentation at ASCO, June 5, 2017: Abstract #8024 / ** 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


SAFETY

MOR202 appears to be well tolerated with a very low incidence of infusion related reactions, mainly

limited to the first infusion (IRR: 6%, grade 1 and 2)

CONVENIENCE

Short & predictable infusion time of 2 hours at highest doses

45% 47% 50%

SIRIUS**POLLUX***EQUULEUS****

11%6%

0%

MOR202 q1w + Dex*MOR202 q1w + LEN/Dex*MOR202 q1w + POM/Dex*

INFUSION RELATED REACTIONS (IRR) IN %

Low Incidence of Infusion-Related Reactions, Short Infusion Time

MOR202: Very Competitive Safety Profile

MOR106: Phase 1 Study in Atopic DermatitisFirst Promising Signs of Clinical Activity


*Patients with moderate-to-severe atopic dermatitis

THE DRUG CANDIDATE

Ylanthia antibody against IL17C, 50/50 co-development with Galapagos

CLINICAL

Top line results published end of September 2017:

− Generally well-tolerated with no clinically relevant safety signals

− At the highest dose level, 5 out of 6 patients (83%) reached an improvement of at least 50% in atopic dermatitis symptoms (EASI-50) by week 4

− Results support progression to Phase 2 study

Single

ascending dose

Multiple

ascending dose

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

follow up

11-week

follow up

Placebo (n=14)

Patients*, 3 cohorts, weekly i.v. infusion for 4 weeks (n=18)

Placebo (n=6)

Tremfya® (Guselkumab)A Potential Blockbuster in Inflammatory Indications

14

THE DRUG

HuCAL antibody specific for IL23, developed by Janssen

STATUS

Available to patients in the U.S. since end of July 2017

Approval in Europe granted on November 23, 2017

First royalties will be reflected in Q4 2017 results

DIFFERENTIATION

First-in-class IL23-specific antibody with 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

PHASE 3 TRIALS

Head-to-head vs. Cosentyx® in psoriasis: ongoing

Psoriatic arthritis: 2 trials ongoing

Crohn’s disease: planned


Financial Guidance 2017* Re-confirmation

*Revenues from potential future collaborations and/or licensing partnerships, and effects from potential in-licensing or co-development deals for new development candidates are not

included. Included is a milestone payment for the Tremfya® approval. As first royalty reporting from Janssen has not been received yet, royalties on net sales for Tremfya® cannot be

accurately projected at this point in time. Hence the guidance for the FY 2017 does not include any assumptions on royalty income for sales of Tremfya®.

15

IN € MILLION FY 2016 Q1-Q3 2017 GUIDANCE 2017

49.7 38.6 46 to 51

78.5 80.5 85 to 95

(59.9) (53.8) (75) to (85)

359.5 319.5 -

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)


Expected Newsflow


MOR208Dec. 11, 2017

Presentation of phase 2 L-MIND data at ASH

Dec. 12, 2017

Management-led investor call on MOR208 data and strategy

Q1 2018

Update on Breakthrough Therapy designation

2018

CLL phase 2 data

2018

B-MIND interim analysis

Our Future

17

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


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. Tremfya® is a trademark of Janssen Biotech, Inc.

Anke Linnartz

Head of Corporate Communications & IR

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

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

Email [email protected]

engineering the medicines of tomorrow - morphosys ag · partnered discovery ... axi-cel evaluable...

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