Year End Results 2016 & Outlook 2017 · Could become first MorphoSys antibody on the market, if ......

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Year End Results 2016 & Outlook 2017 MorphoSys AG MARCH 9, 2017

Transcript of Year End Results 2016 & Outlook 2017 · Could become first MorphoSys antibody on the market, if ......

Page 1: Year End Results 2016 & Outlook 2017 · Could become first MorphoSys antibody on the market, if ... Metastatic breast cancer Guselkumab Psoriasis (VOYAGE 2) Guselkumab Psoriasis Anetumab

Year End Results 2016 & Outlook 2017MorphoSys AG

MARCH 9, 2017

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Today on the Call

© MorphoSys AG, Year End Results 2016 & Outlook 2017 2

Dr. Marlies Sproll

Chief Scientific

Officer

Dr. Simon Moroney

Chief Executive

Officer

Jens Holstein

Chief Financial

Officer

Anke Linnartz

Head of

Corporate

Communications

& IR

Dr. Malte Peters

Chief

Development

Officer

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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.

© MorphoSys AG, Year End Results 2016 & Outlook 2017 3

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Agenda

© MorphoSys AG, Year End Results 2016 & Outlook 2017 4

HIGHLIGHTS FY 20161.

FINANCIALS FY 20162.

OUTLOOK & GUIDANCE FY 20173.

APPENDIX4.

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© MorphoSys AG, Year End Results 2016 & Outlook 2017 5

Highlights FY 2016

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First partnered antibody of MorphoSys filed for approval (guselkumab/Janssen)

Record-high of 114 programs in R&D

Proprietary antibodies MOR208 and MOR202 with promising data in blood cancer indications

Pipeline supported by financial resources of about EUR 360 million after successful capital increase

Further execution of strategy to becoming a fully-integrated biopharmaceutical company

Financial guidance fully achieved

Highlights 2016: Successful Execution of Strategy

© MorphoSys AG, Year End Results 2016 & Outlook 2017 6

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

Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis

Gantenerumab Roche Amyloid-ß Alzheimer’s disease

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

CNTO3157 Janssen - Inflammation

CNTO6785 Janssen - Inflammation

Elgemtumab (LJM716) Novartis HER3 Cancer

MOR103/GSK3196165 GSK GM-CSF Inflammation

MOR202 - CD38 Multiple myeloma

MOR208 - CD19 DLBCL, CLL/SLL

Tarextumab (OMP-59R5) OncoMed Notch 2 Cancer

Tesidolumab (LFG316) Novartis C5 Eye diseases

Utomilumab (PF-05082566) Pfizer 4-1BB Solid tumors

VAY736 Novartis BAFF-R Inflammation

Xentuzumab (BI-836845) BI IGF-1 Solid tumors

BAY1093884 Bayer TFPI Hemophilia

MOR209/ES414 Aptevo PSMA/CD3 Prostate cancer

MOR106 Galapagos IL-17C Atopic dermatitis

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

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

Our Pipeline (December 31, 2016)29 Clinical Product Candidates

© MorphoSys AG, Year End Results 2016 & Outlook 2017

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Partnered Discovery Programs

Proprietary Development Programs

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Proprietary Portfolio (1/3)

© MorphoSys AG, Year End Results 2016 & Outlook 2017 8

PHASE 1/2a PHASE 2

DLBCL, CLL/SLL

An Fc-enhanced antibody directed against CD19

Three phase 2 combination trials started in 2016

DLBCL: L-MIND (combination with lenalidomide),

B-MIND (combination with bendamustine)

CLL/SLL: COSMOS (combination with idelalisib)

MOR208

MULTIPLE MYELOMA (MM)

A differentiated antibody targeting CD38

Ongoing phase 1/2a study in r/r MM patients

Encouraging efficacy data

Potentially best-in-class safety and convenience

MOR202

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Proprietary Portfolio (2/3)

© MorphoSys AG, Year End Results 2016 & Outlook 2017 9

PHASE 1 PHASE 1

MOR209/ES414

ATOPIC DERMATITIS

Co-development with Galapagos

Start of clinical development in 2016

Targeting IL-17C, implicated in a number of inflammatory

skin disorders

Lead indication: atopic dermatitis

MOR106

PROSTATE CANCER

Co-development with Aptevo Therapeutics

Ongoing phase 1 clinical study started enrollment under amended study

design in Q4 2016

Innovative bispecific anti-PSMA/anti-CD3 antibody based on Aptevo’s

proprietary platform

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Proprietary Portfolio (3/3)

© MorphoSys AG, Year End Results 2016 & Outlook 2017 10

PHASE 1 PHASE 2

MOR107

INFLAMMATION

Anti-GM-CSF antibody

Developed by GSK (fully out-licensed in 2013)

Phase 2b trial in rheumatoid arthritis (RA) advancing,

two phase 2a studies started in RA and hand

osteoarthritis

MOR103/GSK3196165

THERAPEUTIC AREA NOT DISCLOSED

Agonist of the angiotensin II receptor type 2 (AT2-R)

Phase 1 trial in healthy volunteers started in 2017

First lanthipeptide in MorphoSys’s clinical pipeline

Promising preclinical data in various therapeutic settings

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Late-stage Partner Discovery Programs

© MorphoSys AG, Year End Results 2016 & Outlook 2017 11

PHASE 2 REGISTRATION

Guselkumab

MESOTHELIOMA/SOLID TUMORS

HuCAL-based ADC targeting mesothelin

Partnered discovery project developed by Bayer

Pivotal phase 2 trial started in malignant pleural

mesothelioma, expected read-out in 2017

Estimated launch (according to Bayer) in 2019

Anetumab Ravtansine

PSORIASIS

Partnered discovery project developed by Janssen/J&J

Regulatory filing for psoriasis submitted to FDA and EMA

Could become first MorphoSys antibody on the market, if

approved

Phase 2 study in psoriatic arthritis met primary endpoint,

plans to advance into phase 3

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© MorphoSys AG, Year End Results 2016 & Outlook 2017 12

Financials FY 2016

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Financial Results 2016 Fully in Line With Guidance

© MorphoSys AG, Year End Results 2016 & Outlook 2017 13

IN € MILLION GUIDANCE 2016 REPORTED 2016

47 to 52 49.7

76 to 83 78.5

-58 to -68 -59.9

Group Revenues

Proprietary R&D Expenses

(incl. Technology Development)

EBIT

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FY2016: Income Statement*

© MorphoSys AG, Year End Results 2016 & Outlook 2017 14

IN € MILLION 2016 2015

Revenues 49.7 106.2 (53%)

Research and Development Expenses 95.7 78.7 22%

General & Administrative Expenses 14.1 15.1 (7%)

Total Operating Expenses 109.8 93.7 17%

Other Operating Income 0.2 4.7 (96%)

EBIT (59.9) 17.2 >(100%)

Finance Income 1.4 3.8 (63%)

Finance Expenses 1.3 0.4 >100%

Income Tax (Expenses) (0.5) (5.7) 91%

Consolidated Net Profit/(Loss) (60.4) 14.9 >(100%)

Diluted Net Profit/(Loss) per Share (in €) (2.27) 0.57 >(100%)

Revenue and EBIT in 2015 contain a non-recurring contribution of approx. € 59 million from the realization of deferred revenue resulting from the termination

of the MOR202 co-development and co-promotion agreement with Celgene in March 2015.

* Differences due to rounding

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PROPRIETARY DEVELOPMENT

Segment Reporting

© MorphoSys AG, Year End Results 2016 & Outlook 2017 15

PARTNERED DISCOVERYIN € MILLION

46.3

22.1 20.4

49.1

17.2

31.0

IN € MILLION

59.9* 56.6

10.7*0.6

78.5

77.6

* Segment revenue and EBIT for 2015 in Proprietary Development segment contain a non-recurring contribution of approx. €59million from the realization of

deferred revenue resulting from the termination of the MOR202 co-development and co-promotion agreement with Celgene in March 2015.

Revenues R&D EBITRevenues R&D EBIT

2015 20162015 20162015 2016

2015 20162015 20162015 2016

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FY2016: Balance Sheet*

© MorphoSys AG, Year End Results 2016 & Outlook 2017 16

IN € MILLION DEC 31, 2016 DEC 31, 2015

Assets

Cash and Cash Equivalents 73.9 90.9

Available-for-sale Financial Assets 63.4 64.3

Bonds, Available-for-sale 6.5 33.1

Financial Assets classified as Loans & Receivables 136.1 94.6

Other Current Assets 28.2 17.2

Total Current Assets 308.1 300.1

Financial Assets classified as Loans & Receivables,

Net of Current Portion 79.5 15.5

Other Non-current Assets 76.0 84.5

Total Non-current Assets 155.5 100.0

Total Assets 463.6 400.1

Liabilities & Stockholders’ Equity

Total Current Liabilities 38.3 27.5

Total Non-current Liabilities 9.8 9.9

Total Stockholders’ Equity 415.5 362.7

Total Liabilities & Stockholders’ Equity 463.6 400.1

* Differences due to rounding

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© MorphoSys AG, Year End Results 2016 & Outlook 2017 17

Outlook & Guidance FY 2017

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Financial Guidance 2017

© MorphoSys AG, Year End Results 2016 & Outlook 2017 18

IN € MILLION REPORTED FY 2016 GUIDANCE 2017

49.7 46 to 51

78.5 85 to 95

-59.9 -75 to -85

Group Revenues

Proprietary R&D Expenses

(incl. Technology Development)

EBIT

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Expected Newsflow 2017 (1/2)Proprietary Development Segment

© MorphoSys AG, Year End Results 2016 & Outlook 2017 19

Initiation of pivotal phase 3 B-MIND study in r/r DLBCL

First preliminary data of phase 2 trial of MOR208 in combination with

lenalidomide in r/r DLBCL (L-MIND study)

Initiation of another study arm of ongoing phase 2 with MOR208 in r/r

CLL/SLL to test MOR208 with further combination partner (COSMOS trial)

Completion of phase 1/2a dose-escalation trial in r/r multiple myeloma

Update planned at medical conference around mid-2017

Continuation of phase 1 trial of MOR209/ES414 with adapted dose

regimen in prostate cancer (mCRPC)

Completion of phase 1 trial co-developed with Galapagos in atopic

dermatitis

Completion of phase 1 study in healthy volunteers

Data expected from phase 2b study in rheumatoid arthritis and from

phase 2a study in hand osteoarthritis, both conducted by GSK

MOR208 DLBCL, CLL/SLL

MOR202Multiple

Myeloma

MOR106Atopic

dermatitis

MOR107 not disclosed

MOR103/

GSK3196165

RA,

Osteoarthritis

MOR209/

ES414Prostate cancer

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Expected Newsflow 2017 (2/2)Partnered Discovery Segment

© MorphoSys AG, Year End Results 2016 & Outlook 2017 20

Could become first antibody on the market based on HuCAL technology

Promising phase 3 data published by Janssen at AAD meeting on March 3,

2017 show significant improvements in skin clearance

Pivotal phase 2 results in mesothelioma expected in the second half of

2017

Potential launch in 2019

New pivotal phase 3 studies planned to start in 2017 in patients with

prodromal to mild Alzheimer’s disease

Planned studies underline commitment to Amyloid-ß hypothesis

Anti-41BB antibody against cancer

Two-component study started in DLBCL, i.e. phase 1 directly followed by

phase 3 in combination with various agents to fully exploit immune-

oncological potential

Guselkumab Janssen/J&J

Anetumab

RavtansineBayer

Utomilumab Pfizer

Gantenerumab Roche

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Marketed products delivering lucrative royalty stream

Revenues from products fuel pipeline and R&D engine

Becoming a commercial, product-based biopharmaceutical company

Our Future

© MorphoSys AG, Year End Results 2016 & Outlook 2017 21

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© MorphoSys AG, Year End Results 2016 & Outlook 2017 22

Appendix

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Expected Pipeline NewsflowUp to 39 Clinical Data Points Expected in 2017*

© MorphoSys AG, Year End Results 2016 & Outlook 2017

PHASE 1 PHASE 2 PHASE 3 REGISTRATION

Anetumab RavtansineCancer

Anetumab RavtansineCancer

(+ pemetrexed/cisplatin)

Anetumab RavtansineMesothelioma (MPM)

BI-836845Metastatic breast cancer

GuselkumabPsoriasis (VOYAGE 2)

GuselkumabPsoriasis

Anetumab RavtansineOvarian cancer

(+ doxorubicin)

Anetumab RavtansineHepatic/renal

impairment

BI-836845Prostate cancer

(+ enzalutamide)

GuselkumabActive psoriatic arthritis

GuselkumabPsoriasis (NAVIGATE)

BAY-1093884Bleeding disorders

BI-836845Multiple cancer types

(EGFR mutant NSCLC)

Tesidolumab (LFG316) Panuveitis

Tesidolumab (LFG316) Geographic atrophy

(+ CLG561)

GuselkumabPustular / Erythrodermic

Psoriasis

GantenerumabAlzheimer’s disease

Elgemtumab (LJM716)Breast cancer

(+ BYL716/trastuzumab)

Elgemtumab (LJM716)Esophageal cancer

(+ BYL716)

MOR103/GSK3196165Rheumatiod arthritis

GuselkumabModerate to severe plaque

psoriasis (POLARIS)

Tesidolumab (LFG316) Kidney Transplantation

MOR106Inflammation

MOR103/GSK3196165Rheumatiod arthritis

MOR103/GSK3196165Osteoarthritis

GuselkumabSevere plaque psoriasis

Elgemtumab (LJM716)Breast/gastric cancer

NOV-7Eye diseases

MOR202Multiple Myeloma

MOR208DLBCL (+ lenalidomide)

Utomilumab

(PF-05082566)NHL/solid tumors

(+ rituximab)

Utomilumab

(PF-05082566)Solid tumors

(+ MK-3475)

Tarextumab

(OMP-59R5)Small cell lung cancer

VAY736Rheumatoid arthritis

Vantictumab

(OMP-18R5)Lung Cancer (NSCLC)

Vantictumab

(OMP-18R5)Pancreatic cancer

VAY736Primary Sjögren´s

Syndrome (PD)

VAY736Pemphigus Vulgaris

MOR107

Lanthipeptide

(Lanthio Pharma)

Partnered Discovery Programs

Proprietary Development Programs

* Anticipated primary completion dates, according to clinicaltrials.gov

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www.morphosys.com

Thank You

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.

Anke Linnartz

Head of Corporate Communications & IR

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

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

Email [email protected]

© MorphoSys AG, Year End Results 2016 & Outlook 2017 24