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MorphoSys AG Year End Results 2014 & Outlook 2015 © MorphoSys - Year End Results 2014 & Outlook 2015 February 26, 2015 1

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Page 1: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

MorphoSys AGYear End Results 2014 & Outlook 2015

© MorphoSys - Year End Results 2014 & Outlook 2015

February 26, 2015

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Page 2: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Today on the Call

© MorphoSys - Year End Results 2014 & Outlook 2015

Simon Moroney

CEO

Jens Holstein

CFO

Claudia Gutjahr-Löser

Head of Corporate

Communications & IR

Arndt Schottelius

CDO

Marlies Sproll

CSO

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Page 3: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Safe Harbour

© MorphoSys - Year End Results 2014 & Outlook 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.

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Page 4: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Contents

© MorphoSys - Year End Results 2014 & Outlook 2015 4

Review 2014

Pipeline

Technology & Target Sourcing

Financials

Outlook 2015

Financial Guidance

Pipeline

Technology & Target Sourcing

Page 5: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Pipeline Stronger Than Ever

94 Antibodies in development

+11

9 Clinical candidates10 3

+2 +1

16

new

Clinical trials of HuCAL antibodies initiated in 2014

© MorphoSys - Year End Results 2014 & Outlook 2015

2016/17 First market entry of HuCAL antibody

5

Phase 1 Phase 2 Phase 3

Page 6: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

The MorphoSys Proprietary Portfolio

© MorphoSys - Year End Results 2014 & Outlook 2015

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Fully out-licensed (tiered, double-digit royalties)

MOR103/GSK3196165 GSK GM-CSF Rheumatoid Arthritis

Multiple Sclerosis

Co-development & co-promotion

MOR202 Celgene CD38 Multiple Myeloma

MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer

Unpartnered

MOR208 CD19 ALL

NHL

CLL (IST)

Early-stage programs

MOR106 Galapagos n.d. Inflammation

Immuno-oncology

programMerck Serono n.d. Cancer

4 Programs n.d. Various

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Page 7: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

2014

Main Proprietary Pipeline Developments (I)

© MorphoSys - Year End Results 2014 & Outlook 2015 7

Compelling Clinical Phase 2 Monotherapy Data

CLL

ORR of 38% at the recommended dose despite short treatment

Best ORR seen for a CD19 or CD20 antibody in comparable studies

Median PFS at recommended dose: 37 weeks

Median PFS in expansion cohort: 60 weeks

NHL

DLBCL: ORR of up to 36% within evaluable patients

FL: ORR of up to 28% within evaluable patients

Regulatory Milestones

Orphan drug status in both Europe and the US for CLL and DLBCL

FDA fast track designation in DLBCL

MOR208

Page 8: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

2014

Main Proprietary Pipeline Developments (II)

© MorphoSys - Year End Results 2014 & Outlook 2015

Fully out-licensed to GSK

Final phase 1b data in MS

presented in September

Data confirmed safety

profile seen in RA trial

All responsibility now with

GSK

MOR103(GSK3196165)

MOR202 MOR209

Co-development with Celgene

Expansion of clinical

development plan

Addition of weekly dosing

regimen (+/- dexamethasone)

Combination cohorts with

lenalidomide and with

pomalidomide scheduled to

start mid-2015

Preclinical data package

supports these combinations

Co-development with Emergent

In-licensing agreement based

on compelling preclinical data

package

MOR209 about to start phase 1

Addition to future commercial

portfolio – all rights outside of

North America with MorphoSys

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Page 9: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

The MorphoSys Proprietary Portfolio

© MorphoSys - Year End Results 2014 & Outlook 2015

Program Partner Target Indication Discovery Preclinic Phase 1 Phase 2 Phase 3

Fully out-licensed (tiered, double-digit royalties)

MOR103/GSK3196165 GSK GM-CSF Rheumatoid Arthritis

Multiple Sclerosis

Co-development & co-promotion

MOR202 Celgene CD38 Multiple Myeloma

MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer

Unpartnered

MOR208 CD19 ALL

NHL

CLL (IST)

Early-stage programs

MOR106 Galapagos n.d. Inflammation

Immuno-oncology

programMerck Serono n.d. Cancer

4 Programs n.d. Various

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Page 10: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

YE2014 - Partnered Pipeline

© MorphoSys - Year End Results 2014 & Outlook 2015

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

BHQ880 Novartis DKK-1 Multiple myeloma

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

LFG316 Novartis C5 Eye diseases

LJM716 Novartis HER3 Cancer

NOV–3 Novartis - not discl.

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

VAY736 Novartis BAFF-R Inflammation

Anetumab Ravtansine Bayer Mesothelin (ADC) Solid tumors

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

PF-05082566 Pfizer 4-1BB Solid tumors

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

25 programs Various - Various

40 programs Various - Various

Most advanced development stage

10

3

8

8

84 Partnered Programs

Page 11: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

2014 - Main Partnered Pipeline Developments

© MorphoSys - Year End Results 2014 & Outlook 2015 11

Bimagrumab

Novartis

Guselkumab

Janssen

Gante-

nerumab

Roche

LJM716

Novartis

Breakthrough therapy

designation in sIBM

Pivotal trial initiated

(planned filing in 2016)

Further five trials in four

other indications

Phase 3 trial in prodromal AD

patients stopped based on

pre-planned futility analysis

Additional phase 3 trial in

patients with mild AD

initiated in Q1 2014

Positive phase 2b data in

psoriasis reported

Five phase 3 trials and two

phase 2 trials ongoing

Planned filing in 2017

HuCAL antibody against

HER3 in phase 2 clinical

development

Planned filing ≥2019

PF-

05082566

Pfizer

HuCAL antibody against

checkpoint target 4-1BB

Combination trial with

Merck’s PD-1 ongoing

Page 12: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Technology Development and Target Sourcing

© MorphoSys - Year End Results 2014 & Outlook 2015 12

Acquisition of the Lanthipeptide Library Technology

Feasibility study completed

Technology being applied in selected discovery projects

Positive example for Innovation Capital initiative

Relationship with Moulder Center of Temple University

Collaboration for target identification and validation

MorphoSys has options on therapeutic antibody candidates

emerging from the collaboration

Investments in Ylanthia Platform & Beyond

All in-house programs now based on Ylanthia

Best technology for our future antibody generation requirements

Access to antibodies against new target classes, e.g. GPCRs

Investments in bi-specific antibody technology

Page 13: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Financial Review and Financial Outlook 2014

© MorphoSys - Year End Results 2014 & Outlook 2015 13

Page 14: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Financial Highlights in 2014

64.0 Revenues

-5.9 EBIT

352.8 Cash & other assets

© MorphoSys - Year End Results 2014 & Outlook 2015 14

in € million

Page 15: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

FY2014: Income Statement

© MorphoSys - Year End Results 2014 & Outlook 2015

in € million* 2014 2013

Continuing Operations

Revenues 64.0 78.0

Total Research and Development Expenses 56.0 49.2

General & Administrative Expenses 14.1 18.8

Total Operating Expenses 70.1 67.9

Other Operating Income/(Expense) 0.2 (0.1)

EBIT (5.9) 9.9

Finance Income 1.8 0.9

Finance Expenses 0.2 0.1

Income Tax Expense 1.3 (3.3)

Profit/(Loss) for the Year from Continuing Operations (3.0) 7.4

Profit/(Loss) for the Year from Discontinued Operations 0 6.0

Consolidated Net Profit/(Loss) (3.0) 13.3

Diluted Net Profit/(Loss) per Share (in €) (0.12) 0.54

* Differences due to rounding

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Page 16: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Segment Reporting

© MorphoSys - Year End Results 2014 & Outlook 2015 16

Proprietary Development Partnered Discovery

Page 17: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

FY2014: Balance Sheet

© MorphoSys - Year End Results 2014 & Outlook 2015

in € million* Dec 31, 2014 Dec 31, 2013

Assets

Cash, Cash Equivalents# 32.2 71.9

Available-for-sale Financial Assets# 106.1 188.4

Bonds, Available-for-sale# 7.5 11.1

Other Receivables# 157.1 119.5

Other Current Assets 19.5 15.8

Total Non-current Assets# 104.1 41.1

Total Assets 426.5 447.7

Liabilities & Stockholders’ Equity

Total Current Liabilities 32.7 35.4

Total Non-current Liabilities 45.0 60.1

Total Stockholders’ Equity 348.8 352.1

Total Liabilities & Stockholders’ Equity 426.5 447.7

* Differences due to rounding

# As of 31/12/2014, MorphoSys held liquid funds and marketable securities as well as other short-

term and long-term financial assets in the amount of €352.8 million (31/12/2013: €390.7 million)

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Page 18: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Outlook 2015

© MorphoSys - Year End Results 2014 & Outlook 2015

Page 19: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Financial Guidance 2015

© MorphoSys - Year End Results 2014 & Outlook 2015

in € million 2014

(Updated Guidance)2014A Guidance 2015

Group Revenues 58 to 63 64.0 58 to 63

Proprietary R&D Expenses

(incl. Technology Development)36 to 41 36.4 48 to 58

EBIT -5 to -8 -5.9 -20 to -30

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Page 20: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Positioned for Future Growth

© MorphoSys - Year End Results 2014 & Outlook 2015

Partnered

Discovery

Proprietary

Development

Development

Capabilities

Significant Investment

in

Proprietary R&D

Portfolio of Truly Differentiated Biopharmaceuticals

20

Page 21: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Proprietary Portfolio Outlook (I)

© MorphoSys - Year End Results 2014 & Outlook 2015

Finalize phase 2 in NHL

(monotherapy)

Updated phase 2 results at

medical conferences

Initiate two combination

trials in DLBCL in H2 2015

MOR208 + lenalidomide

MOR208 +

bendamustine

Continued interactions

with the FDA

Phase 2 combination trial

of MOR208 with

lenalidomide (IST)

continues

First clinical data possible

in 2015

MorphoSys to set up new

combination trial early

2016

Discontinue ongoing

phase 2 monotherapy trial

in B-ALL

Initiate pediatric phase 2

trial (IST) using MOR208 +

NK cell transfer from

parental donor

Collaboration with St. Jude

Children's Research

Hospital (USA)

21

MOR208DLBCL

MOR208CLL

MOR208ALL

Page 22: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Proprietary Portfolio Outlook (II)

© MorphoSys - Year End Results 2014 & Outlook 2015

MOR202MM

MOR209mCRPC

MOR106Inflammatory /

Autoimmune Diseases

Continue Phase 1b/2 trial in

multiple myeloma

First clinical data to be

presented at ASCO

(abstract submitted)

Initiate pomalidomide &

lenalidomide combination

cohorts mid-2015

MOR209/ES414 about to

enter phase 1

Phase 1 trial to recruit up

to 130 patients in the US

and Australia

Weekly administration

First clinical data expected

in 2016

Ylanthia antibody in

collaboration with Galapagos

Move towards clinic

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Page 23: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Ylanthia access +

development

capabilities as a

currency

Tapping New Product Sources Through

New Alliances

© MorphoSys - Year End Results 2014 & Outlook 2015

Proprietary

Portfolio

more to

come

23

Page 24: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Clinical Trials Scheduled for Completion

© MorphoSys - Year End Results 2014 & Outlook 2015

Based on clinical trial design published on www.clinicaltrials.gov

Phase

3Phase

2Phase

1

Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec

Bimagrumab

sIBM

LJM716

HER2+ cancer (combo)

CNTO6785

Rheumatoid ArthritisCNTO6785

COPD

Tarextumab

Solid tumors

Vantictumab

Pancreatic cancer

Vantictumab

NSCLC

Vantictumab

Breast cancer

Anetumab Ravtansine

Solid tumors

BI-836845

Various solid tumors

LFG316

MCP

LFG316

Geographic Atrophy

LJM716

Advanced solid tumors

24

Page 25: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

MOR208

MOR202

Significant R&D Investment for Future Growth

© MorphoSys - Year End Results 2014 & Outlook 2015

Completion of phase 2 in NHL

Start of 2 combo trials in DLBCL

Support IST trials in CLL and ALL

Preparation of combo trial in CLL

MOR209 Technology

Continuation of phase 1/2a trial

in MM

Additional cohorts

(weekly dosing and combo with

pomalidomide & lenalidomide

Phase 1 clinical trial in mCRPC

25

MOR106

Continuation of preclinical

development

Merck

Serono

Continuation of co-development

alliance

Initiation and continuation of new

programs in antibody discovery

and preclinical development

Continuation of development of

lanthipeptide technology

Development of a bi-specific

platform

Discovery

Page 26: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Q&A Session

Year End Results 2014 & Outlook

© MorphoSys - Year End Results 2014 & Outlook 2015

Page 27: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

Take Home Messages

© MorphoSys - February 2015 27

Strengthening of Proprietary Portfolio

Advancing clinical development of MOR208, MOR202 and MOR209

In-licensing of new targets and compounds

Strategy

Execution of long-term plan to build one of the broadest and most valuable

biopharmaceutical pipelines in the biotech industry

Create exceptional new therapies to help patients

Maturing of Partnered Pipeline

Clinical data for several programs

Read-outs from pivotal studies of bimagrumab and guselkumab

Page 28: MorphoSys AG · Outlook 2015 Financial Guidance Pipeline Technology & Target Sourcing. Pipeline Stronger Than Ever ... MOR209/ES414 Emergent PSMA/CD3 Prostate Cancer Unpartnered MOR208

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.

Thank You

www.morphosys.com

Corporate Communications & Investor Relations

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

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

Twitter@MorphoSys

Email [email protected]