Engineering the Medicines of Tomorrow - MorphoSys AG · This presentation includes forward-looking...
Transcript of Engineering the Medicines of Tomorrow - MorphoSys AG · This presentation includes forward-looking...
Engineering the Medicines of TomorrowCompany Update
AUGUST 2017
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, Company Update – August 2017 2
Investment Highlights
© MorphoSys AG, Company Update – August 2017
Collaborations
from academia to
top tier pharma
Over 100 programs
ongoing, 29 in the clinic
Lucrative milestone
& royalty potential
Novel antibody and
peptide formats
Strong balance sheet
Leading Antibody Platform
First Products Nearing Market
Successful Partnering Track Record
Innovative Technologies
Well-Capitalized
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PARTNERED DISCOVERY
Maximising utilization of the technology
Lucrative source of revenue from license fees
and royalties
Strategy
© MorphoSys AG, Company Update – August 2017
PROPRIETARY DEVELOPMENT
Focus on oncology/inflammation
Selective co-development programs
Retained rights translate into higher revenue
potential
TECHNOLOGY PLATFORMS: HuCAL & Ylanthia; Lanthipeptides; Novel Targets
Developing Treatments for Patients Suffering from Serious Diseases
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Our Clinical Pipeline29 Product Candidates in Clinical Development
© MorphoSys AG, Company Update – August 2017
Partnered Discovery Programs
Proprietary Development Programs
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PROGRAM PARTNER TARGET DISEASE AREA PHASE 1 PHASE 2 PHASE 3 LAUNCH
Guselkumab (CNTO1959) 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
CNTO3157 Janssen - Inflammation
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
MOR209/ES414 Aptevo PSMA/CD3 Prostate cancer
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
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* MOR103/GSK3196165 is out-licensed to GSK
Proprietary Development: MOR208An Fc-Enhanced Anti-CD19 Antibody to Treat Blood Cancer
© MorphoSys AG, Company Update – August 2017
KEY FEATURES
CD19 is a crucial survival molecule on the
surface of B-cells
MOR208 shows excellent drug-like properties
− Fc modification enhances target cell killing
− Straight-forward manufacturing
− 15 day half-life
CLINICAL
MOR208 has a very good safety profile
− Opportunity to be used with multiple
combination partners
− Supports use in frail patients
Encouraging clinical efficacy guides further
development addressing unmet needs in B-cell
malignancies
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INDICATION 2016 2017 2018
MOR208: Clinical Development Plan
© MorphoSys AG, Company Update – August 2017
*R/R = relapsed/refractory
Non-Hodgkin’s Lymphoma(NHL)
MOR208 monotherapy in
R/R* NHL (12mg/kg); N=92
Diffuse Large B-cell Lymphoma (DLBCL)
Chronic LymphocyticLeukemia(CLL)
MOR208 (9mg/kg) + lenalidomide; in CLL
MOR208 + ibrutinib in ibrutinib-resistant CLL
Proprietary program trial IIT: Investigator-initiated trial, John Byrd, Ohio State University
Lenalidomide + MOR208 (12mg/kg) in R/R* DLBCL; N=80L-MIND
Bendamustine + MOR208 (12mg/kg) vs. bendamustine + rituximab in
R/R* DLBCL; N~330; pivotal phase 3 part started in 2017B-MIND
MOR208 (12mg/kg) + idelalisib in R/R* CLL BTKi-failures
MOR208 (12mg/kg) + venetoclax in R/R* CLL BTKi-failuresCOSMOS
Anticipated Interim Reporting
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Exploiting Synergies Between MOR208 and Approved Anti-Cancer Agents
27%
0
20
40
60
80
100
MOR208 Shows Promising Clinical Data
© MorphoSys AG, Company Update – August 2017
iNHL
(12mg/kg)
n=45
DLBCL
(12mg/kg)
n=35
44%
18%
11%
Best
Overa
ll R
esp
onse
[%]
ORR 26% ORR 29%
14%
60%
20%
6%
Complete response
Partial response
Progressive Disease/Not evaluable
Stable disease
Response Rates Deepened in Combination Study in Diffuse Large B-Cell Lymphoma (DLBCL)
PHASE 2 STUDY (MONOTHERAPY) IN
R/R NON-HODGKIN’S LYMPHOMA (NHL)
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PHASE 2 L-MIND STUDY
(IN COMBINATION WITH LENALIDOMIDE) IN R/R DLBCL*
0
20
40
60
80
100
Best
Overa
ll R
esp
onse
[%]
ORR 56%
12%(n=4)
32%(n=11)
24%(n=8)
32%(n=11)
n=34
R/R = relapsed/refractory
iNHL = indolent non-Hodgkin‘s lymphoma
*From ongoing phase 2 trial: Kami Maddocks, at ASCO, June 5, 2017: Abstract #7514
Proprietary Development: MOR202A Differentiated Anti-CD38 Antibody to Treat Multiple Myeloma
© MorphoSys AG, Company Update – August 2017 9
KEY FEATURES
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
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
EFFICACY
MOR202 Shows Promising Clinical Data*Clear Differentiation vs. Other CD38 Antibodies
*From ongoing phase 1/2a trial: Raab et al., Poster Presentation at ASCO, June 5, 2017: Abstract #8024
© MorphoSys AG, Company Update – August 2017 10
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
MOR202/DEXMOR202/
POMALIDOMIDE/DEX
MOR202/
LENALIDOMIDE/DEX
Number of patients 18 13 17
Median prior therapies 5 4 3
Overall response rate
(ORR)
28% 46% 71%
Median progression free
survival (PFS)
4.7 months 17.5 months not yet reached
Patients still on study 0 8 9
DEX = Dexamethasone
TremfyaTM (Guselkumab): FDA Granted ApprovalFirst Approved Partnered Program Available since End of July 2017
© MorphoSys AG, Company Update – August 2017
DRUG
First in class IL-23-specific antibody
Partnered discovery project with Janssen
KEY FEATURES
Potential to provide unique value to patients: high levels of
complete or almost complete skin clearance in phase 3 studies
Less intensive dosing regimens vs. anti-IL-17 class
Specificity for IL-23 spares Th1 pathway targeted by STELARA®,
which binds IL-12 & IL-23
LATEST UPDATES FROM JANSSEN
Trade name TremfyaTM
Available to patients in the US
Phase 3 study head-to-head vs. Cosentyx® started
Phase 3 study in psoriatic arthritis (PsA) to start enrolment soon
New phase 3 studies in psoriatic arthritis & Crohn’s announced
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STELARA® is a registered trademarks of Johnson & Johnson; TremfyaTM is a trademark by Janssen Biotech; Cosentyx® is a registered trademark of Novartis AG
VOYAGE 1: PHASE 3 PSORIASIS STUDY RESULTS
GuselkumabCompelling Efficacy in Phase 3 Trial
© MorphoSys AG, Company Update – August 2017
Data courtesy of
Week 48
P<0.001 vs. ADAWeek 24
P<0.001 vs. ADAWeek 16
P<0.001 vs. ADA
Adalimumab (Humira®):
80 mg at week 0, followed
by 40 mg at week 1 and q2w
thereafter through week 48
Patients achieving skin improvements - measured by Psoriasis Area and
Severity Index (PASI 90) through Week 48 (in %)
Guselkumab:
100 mg at weeks 0, 4, 12
and q8w thereafter through
week 48
Guselkumab (n=329) Placebo Guselkumab (n=174) Adalimumab (n=334)
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Humira® is a registered trademark of AbbVie Biotechnology Ltd.
Selected Other Clinical AssetsTargeting Multiple Diseases with High Unmet Medical Need
© MorphoSys AG, Company Update – August 2017
COMPOUND PARTNER TARGET DISEASE AREA STATUS
Gantenerumab Roche Amyloid-β Alzheimer’s disease Phase 3
Utomilumab
(PF–05082566)Pfizer 4-1BB Cancer Phase 2
MOR103/GSK3196165 GSK GM-CSFRheumatoid arthritis
Hand osteoarthritisPhase 2
BI-836845 BI IGF-1 Solid tumors Phase 2
Bimagrumab Novartis ActRIIB
Hip fracture surgery
Sarcopenia
Type 2 diabetes
Phase 2
Elgemtumab
(LJM716)Novartis HER3 Cancer Phase 2
MOR106 Galapagos IL-17C Atopic dermatitis Phase 1
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Partnered Discovery Programs
Proprietary Development Programs
Expected Pipeline NewsflowUp to 30 Clinical Data Points Expected until Year-end 2017*
© MorphoSys AG, Company Update – August 2017 14
PHASE 1 PHASE 2 PHASE 3 LAUNCH
Anetumab RavtansineCancer
BAY-1093884Bleeding disorders
Anetumab RavtansineMesothelioma (MPM)
Elgemtumab (LJM716)Esophageal cancer
(+ BYL716)
GuselkumabPsoriasis (VOYAGE 2)
GuselkumabPsoriasis
Elgemtumab (LJM716)Breast cancer
(+ BYL716/trastuzumab)
Elgemtumab (LJM716)Breast/gastric cancer
GuselkumabActive psoriatic arthritis
(PsA)
MOR103/GSK3196165Osteoarthritis
GuselkumabPsoriasis (NAVIGATE)
GantenerumabAlzheimer’s disease
(sc, impact of speed)
Gantenerumab Alzheimer’s disease (sc)
MOR103/GSK3196165Rheumatiod arthritis
MOR103/GSK3196165Rheumatiod arthritis
(Japan)
GuselkumabModerate to severe plaque
psoriasis (POLARIS)
MOR106Atopic dermatitis
MOR107Not disclosed
(trial ongoing)
MOR103/GSK3196165Rheumatiod arthritis
MOR202Multiple Myeloma
(trial ongoing)
GuselkumabSevere plaque psoriasis
NOV-7Eye diseases
Tesidolumab
(LFG316) Kidney Transplantation
MOR208DLBCL (+ lenalidomide)
(trial ongoing)
MOR208CLL (+ lenalidomide)
(IIT)
Utomilumab
(PF-05082566)Solid tumors (+ MK-3475)
Utomilumab
(PF-05082566)NHL/solid tumors
(+ rituximab)
Tarextumab
(OMP-59R5)Small cell lung cancer
Tesidolumab (LFG316) Geographic atrophy
(+ CLG561)
Utomilumab
(PF-05082566)
Solid tumors
(+ mogamulizumab)
Vantictumab
(OMP-18R5)Pancreatic cancer
Tesidolumab (LFG316) Paroxysmal nocturnal
hemoglobinuria
Tesidolumab (LFG316) Panuveitis
Vantictumab
(OMP-18R5)Lung Cancer (NSCLC)
Vantictumab
(OMP-18R5)Breast cancer
VAY736Rheumatoid arthritis
Xentuzumab
(BI-836845)Prostate cancer
(+ enzalutamide)
Xentuzumab
(BI-836845)Multiple cancer types
(EGFR mutant NSCLC)
Xentuzumab
(BI-836845)Breast cancer
Partnered Discovery Programs
Proprietary Development Programs
* Anticipated data readouts and/or primary completion dates,
according to clinicaltrials.gov and/or MorphoSys‘s own estimates
Positive data readout
Negative data readout
Financial Guidance 2017* Re-confirmation
*As stated before, revenues from potential future collaborations and/or licensing partnerships, nor effects from potential in-licensing or co-development
deals for new development candidates are not included. Included is a milestone payment for the TremfyaTM approval. Royalties for TremfyaTM cannot be
accurately projected shortly after the approval, guidance will be reviewed as soon as the revenue uptake allows for reliable projections for FY 2017.
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IN € MILLION FY 2016 Q1-Q2 2017 GUIDANCE 2017
49.7 23.6 46 to 51
78.5 37.9 85 to 95
-59.9 -30.3 -75 to -85
359.5 334.8
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)
© MorphoSys AG, Company Update – August 2017
TODAY
Our Future
© MorphoSys AG, Company Update – August 2017
OUR FUTURE
First product candidate in
registration in the US and Europe
Maturing clinical pipeline
set to deliver a lot of data
Powerful technology platform
delivering differentiated
drug candidates
Marketed products delivering lucrative
royalty stream
Revenues fuel pipeline and R&D engine
First commercial footprint established
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© MorphoSys AG, Company Update – August 2017
Appendix
17
Clinical ProgramsOngoing Clinical Trials (1)
© MorphoSys AG, Company Update – August 2017
PROGRAM PARTNER TARGET INDICATION PHASE 1 PHASE 2 PHASE 3
Guselkumab Janssen/J&J IL23p19 Plaque psoriasis (VOYAGE 1)
(CNTO1959) Plaque psoriasis (VOYAGE 2)
Plaque psoriasis (NAVIGATE)
Pustular/Erythrodermic psoriasis
Plaque psoriasis
Plaque psoriasis (POLARIS)
Palmoplantar pustulosis
Moderate to severe plaque psoriasis (efficacy & safety)
Moderate to severe plaque psoriasis (ECLIPSE)
Psoriatic arthritis (PsA)
Gantenerumab Roche Amyloid-ß Mild Alzheimer's disease (Marguerite RoAD)
Prodromal Alzheimer's disease
Genetically predisposed for Alzheimer's disease (DIAN)
Safety, tolerability and pharmacokinetics (sc)
Pain, tolerability, safety and pharmacokinetics (sc)
Bioavailability (sc)
MOR208 - CD19 Diffuse large B cell lymphoma (DLBCL) (B-MIND)
Chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL) (COSMOS)
Diffuse large B cell lymphoma (DLBCL) (L-MIND)
Chronic lymphocytic leukemia (CLL) (IIT study)
Anetumab Ravtansine Bayer Mesothelin Mesothelioma (MPM)
(BAY94-9343) Cancer multi-indications
BHQ880 Novartis DKK-1 Multiple myeloma (MM) (renal insufficiency)
Smoldering multiple myeloma
Bimagrumab Novartis ActRIIB Muscular atrophy hip fracture surgery
(BYM338) Sarcopenia (dose-ranging)
Sarcopenia (withdrawal extension study)
Type 2 diabetes
BPS804 Mereo/Novartis Sclerostin Osteoporosis
Hypophosphatasia (HPP)
Brittle bone disease
Brittle bone disease (Type I, III, IV) (ASTEROID)
Brittle bone disease (Type I, III, IV) (METEOROID)
CNTO3157 Janssen/J&J Asthma
Safety and pharmacokinetic
CNTO6785 Janssen/J&J Chronic obstructive pulmonary disease (COPD)
Rheumatoid arthritis (RA)
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Partnered Discovery Programs MOR Proprietary Development Programs
Clinical ProgramsOngoing Clinical Trials (2)
© MorphoSys AG, Company Update – August 2017
* MOR103/GSK3196165 is fully outlicensed to GSK
PROGRAM PARTNER TARGET INDICATION PHASE 1 PHASE 2 PHASE 3
Elgemtumab Novartis HER3 ESCC (combo with BYL719)
(LJM716) HER2+ cancer (combo with BYL719 & trastuzumab)
HER2+ cancer (combo with trastuzumab)
MOR103/GSK3196165* GSK GM-CSF Rheumatoid arthritis (RA)
Rheumatoid arthritis (RA) (mechanistic study)
Hand osteoarthritis
Rheumatoid arthritis (RA) (combo with methotrexate)
MOR202 - CD38 Multiple myeloma (MM)
Tesidolumab Novartis C5 Age-related geographic atrophy
(LFG316) Geographic atrophy (combo with CLG561)
Panuveitis
Paroxysmal nocturnal hemoglobinuria
Transplant associated microangiopathy (TAM)
Renal disease patients awaiting kidney transplant
Utomilumab Pfizer 4-1BB Solid tumors (JAVELIN medley) (combo with avelumab)
(PF-05082566) Advanced Malignancies (combo with avelumab and PF-04518600)
Solid tumors, NHL (combo with rituximab)
Solid tumors (combo with pembrolizumab)
Solid tumors (combo with mogamulizumab)
Solid tumors (combo with PF04518600)
Diffuse large B cell lymphoma (DLBCL) (combo with avelumab)
VAY736 Novartis BAFF-R Pemphigus vulgaris
Primary Sjögren's syndrome
Rheumatoid arthritis (RA)
ADCC Mediated B Cell dEpletion and BAFF-R Blockade (AMBER)
Primary Sjögren's syndrome (efficacy & safety)
Xentuzumab (BI-836845) BI IGF-1 Breast cancer
Castration-resistant prostate cancer (CRPC)(combo with enzalutamide)
Solid tumors (Japan)
Solid tumors (combo with abemaciclib)
EGFR mutant non-small cell lung cancer (NSCLC)
BAY1093884 Bayer TFPI Hemophilia
MOR106 Galapagos IL-17C Atopic dermatitis
MOR107 (LP2-3) Lanthio Pharma AT2-R Not disclosed
MOR209 Aptevo PSMA/CD3 Prostate cancer
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Partnered Discovery Programs MOR Proprietary Development Programs
Clinical ProgramsOngoing Clinical Trials (3)
© MorphoSys AG, Company Update – August 2017
PROGRAM PARTNER TARGET INDICATION PHASE 1 PHASE 2 PHASE 3
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 disorders
NOV-12 Novartis n.d. Prevention of thrombosis
NOV-13 Novartis n.d. Cancer
NOV-14 Novartis n.d. Asthma
Vantictumab Oncomed/Bayer Fzd 7 Breast cancer (combo with paclitaxel)
(OMP-18R5) Pancreatic cancer (combo with nap-paclitaxel & gemcitabine)
Non-small-cell lung carcinoma (NSCLC) (combo with docetaxel)
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Partnered Discovery Programs MOR Proprietary Development Programs
Covering Analysts
© MorphoSys AG, Company Update – August 2017
INSTITUTION CONTACT
Berenberg Klara Fernandes
Bryan Garnier TBD
Commerzbank Daniel Wendorff
Deutsche Bank Gunnar Romer
Edison Maxim Jacobs
Goldman Sachs Tim Woodward
HSBC Steve McGarry
Independent Research GmbH Bernhard Weininger
J.P. Morgan Cazenove James Gordon
Kempen & Co. Anastasia Karpova
Landesbank Baden-Württemberg Timo Kürschner
Oddo BHF Igor Kim
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Financial Calendar 2017
© MorphoSys AG, Company Update – August 2017 22
DATE TITLE
March 9, 2017 Publication of year-end results 2016
May 3, 2017 Publication of first quarter interim statement 2017
May 17, 2017 Annual General Meeting 2017
August 3, 2017 Publication of half-year report 2017
November 7, 2017 Publication of third quarter interim statement 2017
www.morphosys.com
Thank You
MOR208, MOR202, MOR209/ES414, MOR106, MOR103, anetumab ravtansine, guselkumab, 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.
Anke Linnartz
Head of Corporate Communications & IR
Phone +49 (0)89 / 899 27-404
Fax +49 (0)89 / 899 27-5404
Email [email protected]