Engineering the Medicines of TomorrowJens Holstein, Chief Financial OfficerJefferies 2019 Global Healthcare ConferenceJune 5, 2019
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This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including its financial guidance for 2019, the commencement, timing and results of clinical trials and release of clinical data both in respect of its proprietary product candidates and of product
candidates of its collaborators, the development of commercial capabilities, in particular with respect to tafasitamab (MOR208) and the transition of MorphoSys to a fully integrated biopharmaceutical company, the expected time of launch of tafasitamab, interaction with regulators, including the potential approval of MorphoSys’s current or future drug candidates, including discussions with the FDA regarding the potential approval to market
tafasitamab, and expected royalty and milestone payments in connection with MorphoSys’s collaborations. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the
actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In
addition, even if MorphoSys’s results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may
result in differences are that MorphoSys’s expectations regarding its 2019 results of operations may be incorrect, MorphoSys’s expectations regarding its development programs may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development
activities and regulatory approval requirements (including that MorphoSys may fail to obtain regulatory approval for tafasitamab and that data from MorphoSys’s ongoing clinical research programs may not support registration or further development of its product candidates due to safety, efficacy or other reasons), MorphoSys’s reliance on collaborations with third parties, estimating the commercial potential of its development programs and other
risks indicated in the risk factors included in MorphoSys’s Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements
speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such
statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
The compounds discussed in this slide presentation are investigational products being developed by MorphoSys and its partners and are not currently approved by the U.S. Food and Drug Administration (FDA), European Medicine Agency (EMA) or any other regulatory authority (except for
guselkumab/Tremfya®).
This presentation includes forward-looking statements.
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
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Engineering the Medicines of Tomorrow
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
MorphoSys at a Glance
Dual Listing
Germany: Frankfurt Stock Exchange
USA: Nasdaq, New York
Locations
Headquarter near Munich, Germany
MorphoSys US Inc., Boston, U.S.
Partnered Discovery
Use of our technology in behalf of partners
Proprietary Development
Development of own drug candidates
Proprietary Development
Partnered Discovery
Other (G&A, Selling)
Employees: 329(As of March 31, 2019)
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To Become a Fully-Integrated Biopharmaceutical Company
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Our Strategy
Broad pipeline: 29 products in
the clinic
Solid financial position
First product on the market:
Tremfya®
Main focus:MOR208,
tafasitamab
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* Phase 1 in healthy volunteers completed; currently in preclinical investigation
29 Product Candidates in Clinical Development, One Product Launched
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Our Clinical Pipeline
Program Partner Target Disease area Phase 1 Phase 2 Phase 3 LaunchedTremfya® (guselkumab) Janssen IL-23p19 PsoriasisGantenerumab Roche Amyloid-ß Alzheimer’s diseaseTafasitamab (MOR208) - CD19 Hematological malignanciesMOR202 I-Mab Biopharma CD38 Multiple myelomaAnetumab ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumorsBAY1093884 Bayer TFPI HemophiliaBHQ880 Novartis DKK-1 Multiple myelomaBimagrumab (BYM338) Novartis ActRIIB Metabolic diseasesCNTO6785 Janssen - InflammationIanalumab (VAY736) Novartis BAFF-R InflammationMOR103/GSK3196165 GSK GM-CSF InflammationMOR106 Novartis/Galapagos IL-17C InflammationMAA868 Anthos Therapeutics Factor XI Cardiovascular diseasesSetrusumab (BPS804) Mereo/Novartis Sclerostin Brittle bone syndromeTesidolumab (LFG316) Novartis C5 Eye diseasesUtomilumab (PF-05082566) Pfizer 4-1BB CancerXentuzumab (BI-836845) BI IGF-1 Solid tumorsBAY2287411 Bayer Mesothelin CancerElgemtumab (LJM716) Novartis HER3 CancerMOR107 (LP2-3)* - AT2-R Not disclosedNOV–7 (CLG561) Novartis - Eye diseasesNOV–8 Novartis - InflammationNOV-9 (LKA651) Novartis - Diabetic eye diseasesNOV-10 (PCA062) Novartis - CancerNOV-11 Novartis - Blood disordersNOV-13 (HKT288) Novartis - CancerNOV-14 Novartis - AsthmaPRV-300 (CNTO3157) ProventionBio TLR-3 InflammationVantictumab (OMP-18R5) OncoMed Fzd 7 Cancer
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Partnered Discovery ProgramsProprietary Development ProgramsOut-licensed Proprietary Development Programs
Most advanced development stage
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Proprietary Development Programs
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
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* For Development in China, Hong Kong, Macao, Taiwan and (MOR210 only) South Korea** A phase 1 study in healthy volunteers was completed; currently in preclinical investigation
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Portfolio of Proprietary Development Segment
Program Partner Target Disease area Preclinical Phase 1 Phase 2 Phase 3
Tafasitamab (MOR208) - CD19 B cell malignanices
MOR202 I-MabBiopharma* CD38 Multiple myeloma
MOR106 Novartis/Galapagos IL-17C Atopic dermatitis
MOR103/ GSK3196165 GSK GM-CSF Inflammation
MOR107** - AT2-R Oncology under investigation
MOR210 I-Mab Biopharma* C5aR Oncology
6 proprietary or co-developed programs in discovery
Proprietary Development ProgramsOut-licensed Proprietary Development Programs
8© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Tafasitamab (MOR208): Proprietary Antibody in Hematological Cancers
The Drug Candidate
Main Focus of the Company
BTD based on L-MIND study since October 2017
Aim to bring Tafasitamab to the market as fast as possible
Design of the Antibody
Proprietary antibody targeting CD19
Fc-enhanced to drive target cell-killing
Promising Preclinical and Clinical Package
Depletes B cells in in vitro and in vivo models
Preclinical data supports multiple combination therapies
Current clinical development
Phase 2 L-MIND and Phase 3 B-MIND in r/r DLBCL
Phase 2 COSMOS in r/r CLL/SLL
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iNHL – Indolent Non-Hodgkin Lymphoma
Phase 2 Study with FDA Breakthrough Therapy Designation
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
L-MIND: Tafasitamab + Lenalidomide
Fc-enhanced to improve effector funtion
Mediates direct cell death
Encouraging single agent activity in r/r DLBCL & iNHL patients
Tafasitamab
Lenalidomide
Activation and expansion of immune cells
Mediates direct cell death
Well studied as anti-lymphoma agent, alone or in combination
lenalidomide
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SEER database, 2016; Crump et al. Blood. 2017; Van den Neste et al. BMT 2016; Farooq et al. British J Heam 2017; Figure partially adapted from Friedberg J American Soc Hem Education Book, 2011
Treatment Algorithm Highlights Unmet Medical Need
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Diffuse Large B Cell Lymphoma
40%
50%
60%
50%
~40%
50%
60%
90%
10%
DLBCL
R-CHOP
Cure
Relapsed/refractory Non
HDCT/SCT candidates
HDCT/SCT candidates
50%
Responders
Cure
Relapse Non
responders
Not R-CHOP candidates
DLBCL: Approx. 28,000 cases/year in the U.S.
Tafasitamab initial addressable U.S. market
About 8,500 patients
11© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
L-MIND Primary Analysis Data (Data cut-off Nov. 30, 2018)
80 patients
Objective response rate (ORR): 60%
Complete response rate (CR): 43%
Partial response rate (PR): 17%
Median progression free survival (mPFS): 12.1 months
Median duration of response (mDoR): 21.7 months
Median follow up: 17.3 months
Detailed presentation of the data set at the ICML in Lugano on June 22, 2019
Very Encouraging Responses in Difficult-to-Treat Patients
L-MIND: Tafasitamab + Lenalidomide
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More information about ongoing trials at clinicaltrials.gov
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Tafasitamab: Clinical Development Plan in DLBCL
2017 2018 2019 2020 2021
Lenalidomide + tafasitamab in r/r DLBCL patients ineligible for HDCT and ASCTL-MINDPhase 2
BTD Rolling Submission Planned
Potential Approval in the U.S.
B-MINDPhase 2/3
Bendamustine + tafasitamab vs. bendamustine + rituximab in r/r DLBCL patients ineligible for HDCT and ASCT
tafasitamab + R-CHOP vs. tafasitamab + Len + R-CHOP in treatment-naïve DLBCL pts.FRONT LINE
Planned Phase 1b
Planned Pivotal Phase 2/3
Interim Analysis Potential Primary Analysis
Allcomers(N = 330)
Biomarker amendment (N = 450)
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Partnered in China; Opportunity in Cancer & Autoimmune Disease
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
MOR202: A HuCAL Antibody Directed Against CD38
Partnered with I-Mab
I-Mab: Exclusive development/commercialization rights in China, Taiwan, Hong Kong and Macao
Collaboration economics
$20m upfront
Up to $100m milestones
Tiered, double digit royalties
Clinical development
I-Mab
Phase 3: MOR202 + LEN in r/r multiple myeloma
Phase 2 (pivotal): MOR202 in 3rd-line r/r multiple myeloma
MorphoSys
Plans for phase 2 study in autoimmune disorder in Q3, 2019
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Promising Signs of Clinical Activity in Atopic Dermatitis
MOR106: Ylanthia Antibody Directed Against IL-17C
The Product Candidate
Antibody targeting IL-17C, a cytokine implicated in a number of inflammatory disorders
Originates from 50/50 co-development with Galapagos
First publicly disclosed program against this cytokine
Results from the phase 1 study in atopic dermatitis patients
EASI, % change from baseline, pooled patients over all cohorts (median)
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
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Lucrative Deal Will Substantially Strengthen Development of MOR106
* All payments shared with Galapagos 50/50
MOR106: Partnering Deal with Novartis
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Worldwide, exclusive partnership with Novartis*
Up-front: €95m
Milestones: up to approx. €850m
Royalties: tiered, low teens to low twenties
Novartis: R&D, manufacturing & commercialization costs
Clinical Development
MOR, Galapagos: Current studies in atopic dermatitis (AtD):
Phase 2: “IGUANA”, ~240 patients, moderate to severe AtD
Phase 2: “GECKO“, combination with topical steroids
Phase 1: Study with a subcutaneous formulation
MOR and Galapagos to start additional studies in AtD
Novartis
Responsible for subsequent development
Will explore potential of MOR106 in additional indications
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Partnered Discovery Programs
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
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* Phase 1 in healthy volunteers completed; currently in preclinical investigation
29 Product Candidates in Clinical Development, One Product Launched
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Our Clinical Pipeline
Program Partner Target Disease area Phase 1 Phase 2 Phase 3 LaunchedTremfya® (guselkumab) Janssen IL-23p19 PsoriasisGantenerumab Roche Amyloid-ß Alzheimer’s diseaseTafasitamab (MOR208) - CD19 Hematological malignanciesMOR202 I-Mab Biopharma CD38 Multiple myelomaAnetumab ravtansine (BAY94-9343) Bayer Mesothelin (ADC) Solid tumorsBAY1093884 Bayer TFPI HemophiliaBHQ880 Novartis DKK-1 Multiple myelomaBimagrumab (BYM338) Novartis ActRIIB Metabolic diseasesCNTO6785 Janssen - InflammationIanalumab (VAY736) Novartis BAFF-R InflammationMOR103/GSK3196165 GSK GM-CSF InflammationMOR106 Novartis/Galapagos IL-17C InflammationMAA868 Anthos Therapeutics Factor XI Cardiovascular diseasesSetrusumab (BPS804) Mereo/Novartis Sclerostin Brittle bone syndromeTesidolumab (LFG316) Novartis C5 Eye diseasesUtomilumab (PF-05082566) Pfizer 4-1BB CancerXentuzumab (BI-836845) BI IGF-1 Solid tumorsBAY2287411 Bayer Mesothelin CancerElgemtumab (LJM716) Novartis HER3 CancerMOR107 (LP2-3)* - AT2-R Not disclosedNOV–7 (CLG561) Novartis - Eye diseasesNOV–8 Novartis - InflammationNOV-9 (LKA651) Novartis - Diabetic eye diseasesNOV-10 (PCA062) Novartis - CancerNOV-11 Novartis - Blood disordersNOV-13 (HKT288) Novartis - CancerNOV-14 Novartis - AsthmaPRV-300 (CNTO3157) ProventionBio TLR-3 InflammationVantictumab (OMP-18R5) OncoMed Fzd 7 Cancer
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Partnered Discovery ProgramsProprietary Development ProgramsOut-licensed Proprietary Development Programs
Most advanced development stage
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Janssen’s Anti-IL-23 for Immune-Mediated Diseases
The Drug
First-in-class anti-IL-23 human monoclonal antibody
Generated using MorphoSys’s HuCAL technology
Growing Royalty Stream
Royalty income 2019 expected between EUR 23 to 30m
Broad Clinical Development
Tremfya® (Guselkumab)
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Phase 1 Phase 2 Phase 3 Approved/ Launched
Familial adenomatous polyposis
Crohn’s disease Hidradenitis
suppurativa Ulcerative colitis
Plaque psoriasis (adults & pediatric patients) Pustular/erythrodermic
psoriasis Psoriatic arthritis
Psoriasis (U.S., EU, Canada, Brazil, Australia, Japan) Psoriatic arthritis
(Japan) Palmoplantar pustulosis
(Japan)
50
100
150
200
250
Tremfya® sales reported by Janssen
Q1 Q1Q2 Q3 Q4
2018 2019
US-
$
19
*Revenues are expected to include royalty income from Tremfya® ranging from EUR 23-30 million on constant USD currency.
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Financials
In € millionReported FY 2018
(March 13, 2019)Q1 2019
(May 7, 2019)Guidance 2019
(Issued March 13, 2019)
76.4 13.5 43 to 50*
98.3 22.6 95 to 105
-59.1 -23.6 -127 to -137
Group Revenues
Proprietary R&D Expenses (incl. Technology Development)
EBIT
Total ordinary shares issued as of April 30, 2019: 31,839,572
Germany, Frankfurt Stock Exchange: MOR
U.S., Nasdaq Global Market: MOR
Cash Position End of Q1 2019: EUR 431.2 m
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Tafasitamab
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Expected Newsflow 2019/2020
Proprietary Program Expected Newsflow
Tafasitamab(MOR208)
L-MIND (DLBCL) Planned BLA submission by end of 2019; review expected mid-2020 Data from synthetic Len-only control arm Continue interactions with European authorities
Commercial capabilities: Proceed build-up in the U.S.
B-MIND (amended trial DLBCL) Discussions with FDA about biomarker assay expected mid-2019 Pre-planned interim analysis in H2 2019
1st line DLBCL Start of Phase 1b planned in H2 2019 Pivotal Phase 2/3 planned to start mid-2020
COSMOS (CLL): Continue ongoing study and present data in 2019
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* For development in China, Hong Kong, Taiwan, Macao ** Fully out-licensed ***According to clinicaltrials.gov
Expected Newsflow 2019/2020
Proprietary Program Expected Newsflow
MOR202(I-Mab Biopharma*)
MOR: Start of clinical development in an autoimmune disease mid-2019 I-Mab: Start of additional studies in multiple myeloma I-Mab: start of clinical development in systemic lupus erythematosus
MOR106(Novartis/Galapagos**)
Primary completion of Phase 2 IGUANA and Phase 1 bridging study Start of further studies in atopic dermatitis by MOR and GLPG
MOR103/GSK3196165(GSK**) Start of a phase 3 in RA by GSK expected in H2 2019
MOR107 Continue preclinical investigations with a focus on oncology
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
MOR202 / MOR106 / MOR103 / MOR107 / Partnered Discovery
Partnered Discovery Expected Newsflow
Partnered Discovery Phase 2 readouts for multiple programs***
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To Become a Fully-Integrated Biopharmaceutical Company
© MorphoSys AG, Jefferies 2019 Global Healthcare Conference, 5 June 2019
Our Strategy
Expand tafasitamab into other lines and indications
Build U.S. commercial capabilities for anticipated 2020 launch of tafasitamab
Drive other programs in proprietary portfolio forward
Continue to advance tafasitamab to regulatory approval
Fully-integrated biopharma company
MOR208, MOR202, MOR106, MOR103, anetumab ravtansine, 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. Tremfya® is a trademark of Janssen Biotech, Inc.
www.morphosys.com
Thank You
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