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Company Update September 9, 2015 2015 Wells Fargo Securities Healthcare Conference 1

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Page 1: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Company Update

September 9, 2015

2015 Wells Fargo Securities

Healthcare Conference

1

Page 2: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Safe Harbor

© MorphoSys - September 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

Page 3: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Partnered Pipeline Providing Strong Foundation and Multiple Near-Term Catalysts

Phase 3 data for bimagrumab (Novartis) and guselkumab (J&J/Janssen) expected in 2016

Over 20 clinical studies likely to be completed before the end of 2016

Multiple Therapeutic Programs with

Best-in-Class Potential

MOR208: Aimed at Shortcomings of Current Lymphoma and Leukemia Treatments

Promising single agent results in NHL and CLL

Comprehensive set of combo trials commencing in 2015 & 2016

Pivotal trial aimed to start in 2017

3

Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics

Broad Pipeline of Differentiated Proprietary Therapeutics

MOR202: Unique CD38 antibody in multiple myeloma

MOR209: Bi-specific antibody in Phase 1 for mCRPC; MOR106 & MOR107 in pre-clinic

Continued investment in technology leadership drives pipeline growth

© MorphoSys - September 2015

Experienced Team Driving the Next Stage of Growth

Cross-functional team with long track record of leadership

Deep expertise in biopharmaceutical discovery, development & manufacturing

Page 4: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

The MOR Portfolio

© MorphoSys - September 2015

Program Indication Target Discovery Preclinic Phase 1 Phase 2 Phase 3

Unpartnered

MOR208 NHL

CD19CLL

ALL

MOR202 Multiple myeloma CD38

MOR107 Fibrosis AT2-R

7 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

Immuno-oncology alliance(Immatics)

Cancer Various

4

Page 5: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

MOR208: Addressing Shortcomings in Treating

B-Cell Malignancies

© MorphoSys - September 2015 5

DRUG Fc-enhanced, humanized IgG1 antibody

Fc modification leads to dramatically enhanced B cell depletion via ADCC,

phagocytosis, direct cytotoxicity

Convenient dosing schedule, straightforward manufacturing

Fast Track Designation in DLBCL; FDA & EMA Orphan Drug Status in DLBCL & CLL

TARGET

CD19

CD19 has a strong rationale in B cell malignancies

Constant expression levels of CD19 across all B cell cancers in contrast to CD20

Patients show down-regulation of CD20 after anti-CD20 treatment; CD19 down-

regulation is not described

Novel TKIs efficacious but characterized by challenging side effects; patients

relapsing on TKIs have very unfavorable prognosis

Page 6: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

SD, PD &

Non-evaluable

MOR208 Could Be Superior to Other CD19 &

CD20 MAbs in Relapsed/Refractory CLL

© MorphoSys - September 2015 6

anti-CD19 MAbs anti-CD20 MAbs

38%24% 30%

23%13%

MOR20812mg/kg(n=16)

MEDI-551phase 1/212mg/kg(n=26)

Obinutuzumabphase 2(n=20)

Ofatumumabphase 3(n=196)

Rituximab(n=110)

Response Rates Based on IWCLL2008 Criteria

ORR

MEDI-551 data source: Poster

ASCO 2013, 12mg/kg dosing group

Obinutuzumab data source:

GAUGUIN study, Cartron et al,

Blood 2014

Ofatumumab data source: control

arm in ibrutinib vs. O phase 3

trial (RESONATE, ASCO 2014)

Rituximab data source: Late

breaking abstract #6, ASH 2013

Criteria: Hallek et al 2008

(including CT)

[NR – not reported]

mPFS

(mo.)14 NR 10.7 8 5.5

Page 7: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

MOR208: Multiple Studies to Start in 2015/2016

7© MorphoSys - September 2015

2015 2016 2017 2018*

NHL

DLBCL

CLL

ALL

Phase 2: MOR208 (12mg/kg) plus lenalidomide (N=80)

Phase 2: MOR208 mono

(N=92)

Safety evaluation leading into anticipated pivotal study

(12 mg/kg MOR208 plus bendamustine), N~320

Ph. 2 (ongoing OSU IIT): R/R & naive CLL & Richter’s Transformation, MOR208 (9mg/kg) plus LEN, N=50

Phase 2: MOR208 (12mg/kg) plus idelalisib, BTKi-failures, N=120

Phase 2 (St. Jude’s IIT): Pedriatic ALL, MOR208 (12mg/kg) plus NK cells, N=13

*no outlook given beyond 2018

STATUS Phase 2 trial with LEN in 2nd line R/R DLBCL to start in Q4 2015

Phase 2 trial with IDE in CLL in BTKi-failures to start in Q1 2016

Phase 3 combo trial with BEN in 2nd line R/R DLBCL aimed to start in 2017

Update on NHL monotherapy planned at ASH 2015

Phase 3Phase 2

IIT

Page 8: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

MOR202: A Novel Antibody for Multiple

Myeloma

© MorphoSys - September 2015 8

OPPORTUNITY Multiple myeloma (MM) treatment – a large commercial opportunity

leading already generate > US $ 5.0 billion in worldwide sales

CD38 market peak sales are expected in US$ billions worldwide

First clinical data hint at a balanced and potentially best-in-class

safety/efficacy profile

DRUG High affinity HuCAL IgG1 antibody

Potent ADCC and ADCP, full killing activity on MM cells and low killing activity on

healthy/effector cells, and low/no CDC

Strong synergy with IMiDs and proteasome inhibitors in pre-clinical models

Best-in-class infusion tolerability as consistent 2-hour infusion

MorphoSys regained all rights from Celgene

TARGET

CD38

Antibody binds to a unique epitope on CD38

CD38 has a compelling scientific rationale based on the highest expression levels

of any antibody target in MM

Clinical PoC for anti-CD38 antibodies established

Page 9: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

2015 2016 2017 2018*

MM

MOR202: Clinical Development Plan

© MorphoSys - September 2015 9

STATUS Phase 1/2a clinical trial in MM ongoing

Cohorts ongoing:

MOR202 16mg/kg weekly + Dex

MOR202 + LEN + Dex

MOR202 + POM + Dex

Encouraging early signs of activity already at low doses

Higher level of activity expected at further doses giving full target saturation

Phase 1/2a MOR202 (8 and 16mg/kg) plus lenalidomide or pomalidomide and

confirmation cohorts (N~24)

Phase 1/2a MOR202 mono, dose escalation,

plus confirmation cohorts (N~62)

Phase 3: MOR202 combination therapy

Phase 3Phase 2

*no outlook given beyond 2018

Page 10: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

TARGET

PSMA/CD3

PSMA expressed in normal and hyperplastic prostate tissue, expression levels

increase with prostate cancer progression

CD3 on cytotoxic T-cells

OPPORTUNITY Prostate cancer is the most common and second most lethal cancer in men

Current treatments provide only a 2-4.5 months increase in OS for metastatic

CRPC patients

Global market for mCRPC therapeutics expected to exceed US$ 5.1 billion in 2022

MOR209/ES414: A Bi-specific

Immunotherapeutic Against Prostate Cancer

© MorphoSys - September 2015 10

DRUG Bi-specific ADAPTIR antibody

Directs T cells to kill PSMA+ tumor cells in vitro and in vivo

Reduced cytokine release on T cell activation in preclinical

models compared to other formats

Prolonged serum half-life in mouse and NHP compared to

antibody fragments

Page 11: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

2015 2016 2017 2018*

mCRP

MOR209/ES414: New Treatment Option in

mCRPC

© MorphoSys - September 2015 11

STATUS Preclinical studies successfully concluded, promising results presented in 2013

Pharmacologically active and well tolerated

Shows activity at very low doses

Phase 1 in mCRPC in the U.S. and Australia ongoing

Stage 1: identify MTD of MOR209/ES414 administered iv

Stage 2: evaluate clinical activity in patients that have or have not received prior

chemotherapy

NEXT First clinical data expected in 2016

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

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

Phase 3 preparationsPhase 3Phase 2

*no outlook given beyond 2018

Page 12: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Leveraging Technology Leadership

© MorphoSys - September 2015 12

Antibodies Peptides GPCR target Immuno-oncology

Slonomics – 2010

Enables very

efficient antibody

optimization

Ylanthia - 2011

Largest Fab

antibody library

Based on the

expertise gained in

building and using

HuCAL in drug

discovery and

development

LanthioPharma - 2015

Stabilized peptide

technology

complements

existing antibody

drug discovery

platform

Heptares – 2013

Delivers challenging

GPCRs in stabilized

form as drug

targets

G7 Therapeutics -

2015

Delivers tailor-

made GPCRs as

drug targets

MerckSerono - 2014

Antibodies against

immune

checkpoints

Immatics - 2015

Antibody-based

therapies targeting

tumor-associated

peptides

MorphoSys Group Technologies Collaborations

Page 13: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Programs Being Developed by Partners (I)

© MorphoSys - September 2015 13

Program Partner Target Indication Phase 1 Phase 2 Phase 3

Bimagrumab Novartis ActRIIB sIBM (52 weeks)

(BYM338) sIBM (long-term study)

Cachexia (COPD)

Cachexia (cancer)

Hip fracture surgery

Sarcopenia

BHQ880 Novartis DKK-1 MM (renal insufficiency)

Smoldering MM

BPS804 Mereo/Novartis Sclerostin Osteoporosis

Hypophosphatasia (HPP)

Osteogenesis Imperfecta

LFG316 Novartis C5 Wet AMD

Geographic atrophy

Multifocal Choroiditis and Panuveitis

Dry AMD

Paroxysmal nocturnal hemoglobinuria

VAY736 Novartis BAFF-R Pemphigus vulgaris

Primary Sjögren's syndrome

Primary Sjögren's syndrome

LJM716 Novartis HER3 ESCC (combo with BYL719)

HER2+ cancer (combo with BYL719 &

trastuzumab)

HER2+ cancer, combination with

trastuzumab

HER2+ 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 disordersContract DiscoveryOutlicensed

Page 14: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Programs Being Developed by Partners (II)

© MorphoSys - September 2015 14

Program Partner Target Indication Phase 1 Phase 2 Phase 3

MOR103 GlaxoSmithKline GM-CSF Rheumatoid Arthritis

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

Genetically predisposed

CNTO3157 Janssen/J&J n.d. Asthma

Safety/Pharmacokinetic

CNTO6785 Janssen/J&J n.d. COPD

Rheumatoid arthritis

Tarextumab Oncomed/GSK Notch 2 Pancreatic cancer (ALPINE)

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

Solid tumors

Vantictumab Oncomed/Bayer Fzd 7 Solid tumors

(OMP-18R5) Breast cancer

Pancreatic cancer

NSCLC

BAY94-9343 Bayer Mesothelin Solid tumors

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

PF-05082566 Pfizer 4-1BB Solid tumors, NHL (+rituximab)

Solid tumors, combination with PD-1

inhibitor MK-3475

Advanced solid tumors, combo with

mogamulizumabContract DiscoveryOutlicensed

Page 15: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Bimagrumab (BYM338): A Novartis

Musculoskeletal Program

© MorphoSys - September 2015 15

[*] A Amato et al; Neurology; Nov 7, 2014, online

[1] Statistically significant difference

DRUG Lead indication: sporadic inclusion body

myositis (sIBM)

FDA breakthrough therapy designation

Orphan drug designation

CLINICAL

DATA

Potential novel treatment of sIBM

Phase 2 results in sIBM[*]:

Muscle mass increased substantially from

baseline, approx. 5% more than placebo

Muscle gain was functional as supported

by parallel increases in strength and 6-

minute walking distance

NEXT Pivotal study in sIBM with 240 patients

ongoing, completion scheduled in Q4 2015

Data expected in H1 2016

Listed by Novartis as “planned filing 2016”

Phase 2 read-outs in hip fracture surgery,

sarcopenia expected in 2016

Supportive initial data in sIBM

Data courtesy by Novartis

Page 16: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

CLINICAL

DATA

Potential to provide unique value to patients:

Highest levels of durable skin clearance with

less intensive 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

Guselkumab (CNTO1959): A Janssen

Anti-Inflammatory Program

© MorphoSys - September 2015 16

DRUG 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

NEXT Phase 3 data in 2016

Anticipated regulatory filing in 2016

Page 17: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Financial Guidance 2015

© MorphoSys - September 2015

in € million 2014A H1 2015 Guidance 2015

Group Revenues 64.0 82.6 101 to 106

Proprietary R&D Expenses

(incl. Technology Development)36.4 25.3 56 to 63

EBIT -5.9 46.1 9 to 16

Cash, cash equivalents & marketable securities

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

assets

352.8 324.9

17

Page 18: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

Clinical Trials Scheduled for Completion

© MorphoSys - September 2015 18

PH

ASE

2PH

ASE 3

PH

ASE 1

20162015

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

MOR Programs

LJM716

ESCC, combo w/BYL719

LFG316

Dry AMD

MOR208

NHL (mono - update)

Guselkumab

Psoriasis (VOYAGE 2)

Guselkumab

Psoriasis (VOYAGE 1)

Bimagrumab

sIBM

Guselkumab

Psoriasis (NAVIGATE)

MOR202

Multiple myeloma

MOR208

ALL (mono)

MOR208 - IST

CLL (combo with len)

LFG316

PNH

LJM716

HER2+ cancer (combo)

LJM716

HER2+ cancer (combo)

LJM716

Advanced solid tumors

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

Advanced solid tumors

LFG316

MCP

MOR209

Prostate cancer√

Page 19: Company Update...Committed to Bringing to Market Differentiated Antibody and Peptide Therapeutics Broad Pipeline of Differentiated Proprietary Therapeutics MOR202: Unique CD38 antibody

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