engineering the medicines of tomorrow - jefferies group2).pdfengineering the medicines of tomorrow...

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 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


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


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


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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


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


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


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


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


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)


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Lucrative Deal Will Substantially Strengthen Development of MOR106

* All payments shared with Galapagos 50/50

MOR106: Partnering Deal with Novartis


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


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* Phase 1 in healthy volunteers completed; currently in preclinical investigation

29 Product Candidates in Clinical Development, One Product Launched


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)


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-

$

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*Revenues are expected to include royalty income from Tremfya® ranging from EUR 23-30 million on constant USD currency.


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


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


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


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

Corporate Communications & IRPhone +49 (0)89 / 899 27-404Fax +49 (0)89 / 899 27-5404

Email [email protected]

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