Year End Results 2016 & Outlook 2017 · Could become first MorphoSys antibody on the market, if ......
Transcript of Year End Results 2016 & Outlook 2017 · Could become first MorphoSys antibody on the market, if ......
Year End Results 2016 & Outlook 2017MorphoSys AG
MARCH 9, 2017
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
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
Agenda
© MorphoSys AG, Year End Results 2016 & Outlook 2017 4
HIGHLIGHTS FY 20161.
FINANCIALS FY 20162.
OUTLOOK & GUIDANCE FY 20173.
APPENDIX4.
© MorphoSys AG, Year End Results 2016 & Outlook 2017 5
Highlights FY 2016
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
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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12
Partnered Discovery Programs
Proprietary Development Programs
7
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
Proprietary Portfolio (2/3)
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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
Proprietary Portfolio (3/3)
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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
Late-stage Partner Discovery Programs
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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
© MorphoSys AG, Year End Results 2016 & Outlook 2017 12
Financials FY 2016
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
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
PROPRIETARY DEVELOPMENT
Segment Reporting
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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
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
© MorphoSys AG, Year End Results 2016 & Outlook 2017 17
Outlook & Guidance FY 2017
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
Expected Newsflow 2017 (1/2)Proprietary Development Segment
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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
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
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
© MorphoSys AG, Year End Results 2016 & Outlook 2017 22
Appendix
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