Results Q1 2019 - MorphoSys · 2019-10-30 · Current clinical development I-Mab: Chinese region...

Results Q3 2019 MorphoSys AG

October 30, 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, interpretations by regulatory authorities of our clinical data and real-world

data analyses, 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 (MOR208), 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 (MOR208), 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 (MOR208) 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®). There is no guarantee any investigational product will be approved.

This presentation includes forward-looking statements.

© MorphoSys, Q3 2019 - October 30, 2019

3© MorphoSys, Q3 2019 - October 30, 2019

Agenda

Dr. Jean-Paul Kress

Chief Executive Officer

Jens Holstein

Chief Financial Officer

Dr. Malte Peters

Chief Development Officer

Dr. Sarah Fakih

Head of Corp Com & IR

Operational Review1.Dr. Jean-Paul Kress

Financials and Guidance2.Jens Holstein

Q&A Session3.Dr. Jean-Paul Kress

Jens Holstein

Dr. Malte Peters

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1) Revenues are expected to include royalty income from Tremfya® guided for €30-35m at constant USD exchange rate 2) Incl. Technology Development; BLA: Biologic

License Application; FDA: Food and Drug Administration


Q3 Key Take-aways

In € millionReported Q1-Q3 2019 Guidance 2019

(As of July 3, 2019)

60.7 65 to 721)

68.8 95 to 105

-56.3 -105 to -115

412.4

Group Revenues

Proprietary R&D Expenses2)

EBIT

Cash Position

Financial Results

Q3 2019 Highlights: Executing on our top priorities

Flawless submission of BLA for tafasitamab (MOR208)

Re-MIND: successful real-world data approach confirms regulatory strategy

Rolling submission for BLA initiated: preclinical data package submitted to FDA

Partnering tafasitamab

Primary goal to maximize the value of tafasitamab

Discussions with interested parties ongoing

Unlock the value of our proprietary pipeline

MOR202: start of clinical trial in autoimmune disease is imminent

Gantenerumab: positive aducanumab encouraging news for patients

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Operational Review Q3 2019

and Outlook 2019


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r/r: relapsed/refractory; DLBCL: diffuse large B cell lymphoma; LEN: lenalidomide

Investigational antibody developed in hematological malignancies

Re-MIND Topline Data

Outcome data of non-transplant eligible r/r DLBCL patients treated with LEN monotherapy in real-world setting

Qualification criteria met for 76 Re-MIND patients, 1:1 matching to 76 of 80 L-MIND patients

Data will be part of BLA submission which is on track to be completed by end of the year

Probability to survive twice as high in the tafasitamab-LEN combination versus the LEN-monotherapy


Tafasitamab: Proprietary Antibody Against CD19

lenalidomide

monotherapy

tafasitamab/lenalidomide

combination

67.1%objective

response rate34.2%

complete

response rate11.8% 39.5%

All data

investigator-assessed

Data based on 76

patients of each

cohort

median overall

survival9.3 mo NR

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DLBCL: diffuse large B cell lymphoma; LEN: lenalidomide; BEN: bendamustine; CLL: chronic lymphocytic leukemia; SLL: small lymphocytic lymphoma FDA: Food and Drug

Administration; EMA: European Medicines Agency

Investigational antibody developed in hematological malignancies

Current clinical development

L-MIND (phase 2), r/r DLBCL Tafasitamab + LEN

B-MIND (phase 3), r/r DLBCL Tafasitamab + BEN vs. rituximab + BEN

COSMOS (phase 2), r/r CLL/SLL Tafasitamab + idelalisib or venetoclax

2019/2020 catalysts

U.S.:

Rolling submission to FDA initiated: preclinical data package submitted

BLA submission to be completed by end-2019

Europe: Complete MAA submission to EMA by mid-2020

Clinical development

B-MIND: Pre-planned, event-driven interim analysis expected in Q4 2019

Frontline study DLBCL: Ph1b trial in Q4 2019, followed by pivotal ph2/3

COSMOS: Data planned to be presented at ASH in early December


Tafasitamab: Proprietary Antibody Against CD19

Fc-engineered antibody intended

to result in:

Increased recruitment of

effector cells

Enhanced elimination of

cancer cells

Development in hematological

malignancies

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LEN: lenalidomide; IND: investigational new drug; NMPA: National Medical Product Administration; PLA2R: Phospholipase-A2 receptor

Opportunity in autoimmune diseases & oncology

The product candidate

Antibody against CD38

Development in multiple myeloma and autoimmune diseases

Current clinical development

I-Mab: Chinese region

Pivotal phase 3 study: MOR202 + LEN in r/r 2L multiple myeloma

Pivotal phase 2 study: MOR202 in r/r 3L multiple myeloma

Q3 news flow

MorphoSys: First sites initiated for clinical trial in a chronic inflammatory

autoimmune disease (anti-PLA2R antibody positive membranous nephropathy)

I-Mab: IND clearances for MOR202 by Chinese NMPA to expand ongoing trials

to mainland China


MOR202: Proprietary Antibody Against CD38

Financials and deal terms

I-Mab: Exclusive development

and commercialization rights in

China, Taiwan, Hong Kong and

Macao

Up-front: $20m

Milestones: Up to $100m

Royalties: Tiered, double digit

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* All payments shared with Galapagos 50/50; IL: interleukin; DMC: Data Monitoring Comittee

Targeting inflammatory skin diseases

The product candidate

Antibody against IL-17C

Development in atopic dermatitis

Clinical development in atopic dermatitis: Stopped for futility

Phase 2 study GECKO Subcutaneous, combination with topical steroids

Phase 2 study IGUANA Intravenous, testing for safety and efficacy

Phase 1 study Bridging study for subcutaneous formulation

Phase 1/2 study Japanese ethno-bridging study (Angelfish)

Q3 news flow

Interim analysis for futility of phase 2 IGUANA study:

Low probability to meet the primary endpoint of the study

Observed lack of efficacy, no safety concerns

Joint decision of all three involved parties to stop clinical development in

atopic dermatitis

2019/2020 catalysts

Parties will explore the future strategy with MOR106


MOR106: Proprietary Antibody Against IL-17C

Financials and deal terms*

Co-developed with Galapagos

Worldwide, exclusive

partnership with Novartis

Up-front: €95m

Milestones: up to €850m

Royalties: tiered, low teens

to low twenties

Novartis carries all R&D,

manufacturing & commercial

costs

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The drug

Antibody against IL-23

Generated using MorphoSys’s HuCAL technology

2019/2020 catalysts

Tiered royalty stream

Janssen announced submission of supplemental BLA for Tremfya® to

U.S. FDA and MAA to EMA for treatment of psoriatic arthritis

Broad clinical development


Tremfya® (Guselkumab)

1) U.S., EU, Canada, Brazil, Australia, Japan; 2) Japan; IL: Interleukin; BLA: biologics license application; FDA: Food and Drug Administration; MAA: Marketing

Authorization Application; EMA: European Medicines Agency

Phase 1 Phase 2 Phase 3 Approved/ Launched

Familial adenomatous

polyposis

Crohn’s disease

Hidradenitis suppurativa

Ulcerative colitis

Plaque psoriasis

Pustular/erythrodermic

psoriasis

Psoriatic arthritis

Psoriasis1)

Psoriatic arthritis2)

Palmoplantar pustulosis2)

50

100

150

200

250

300

Tremfya® sales reported by Janssen

Q1 Q1Q2 Q3 Q4

2018 2019

US-$

Q2 Q3

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Financials Q3 & Q1-Q3 2019

Guidance 2019


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Rounding differences may occur


Consolidated Statement of Profit or Loss (IFRS)

In € million Q3 2019 Q3 2018 Change

Revenues 12.5 55.0 (77%)

Operating Expenses

Cost of Sales (1.0) (0.9) (11%)

Research and Development (25.9) (18.0) (44%)

Selling (4.4) (1.3) >(100%)

General and Administrative (9.0) (5.1) (76%)

Total Operating Expenses (40.3) (25.3) (59%)

Other Income / Expenses 0.8 0.4 >100%

Earnings before Interest and Taxes (EBIT) (27.0) 30.1 >(100%)

Finance Income 2.4 0.1 >100%

Finance Expenses (0.2) (0.1) (100%)

Income from Reversals of Impairment Losses /

(Impairment Losses) on Financial Assets 0.0 0.3 >(100%)

Income Tax Benefit / (Expenses) 0.6 (0.2) >100%

Consolidated Net (Loss) / Profit (24.2) 30.2 >(100%)

Earnings per share, basic and diluted (in €) (0.76) 0.96 >(100%)

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48,8

-18,6

30,3

1,4

-32,0 -30,4



Segment Reporting Q3 2019 and Q3 2018

Proprietary Development Partnered DiscoveryIn € million

6,2

-2,4

3,811,0

-2,3

8,8

In € million

Revenues OpEx EBITRevenues OpEx EBIT

2018

2019

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Consolidated Balance Sheet (IFRS)

In € million Sept 30, 2019 Dec 31, 2018

Assets

Current Assets

Cash and Cash Equivalents 58.5 45.5

Financial Assets at Fair Value trough Profit or Loss 58.0 44.6

Other Financial Assets at Amortized Cost 270.9 268.9

Other Current Assets 32.3 29.9

Total Current Assets 419.8 388.9

Non-current Assets

Other Financial Assets at Amortized Cost, Net of current portion 25.0 95.7

Other Non-current Assets 96.4 54.1

Total Non-current Assets 121.4 149.9

Total Assets 541.1 538.8

Liabilities & Stockholders’ Equity

Total Current Liabilities 53.8 45.9

Total Non-current Liabilities 44.2 4.5

Total Stockholders’ Equity 443.1 488.4

Total Liabilities & Stockholders’ Equity 541.1 538.8

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Key Financials (Q1-Q3 2018/2019)

In € million Q1-Q3 2019 Q1-Q3 2018 Change

Revenues 60.7 66.0 (8%)

Operating Expenses

Cost of Sales (10.9) (0.9) >(100%)

Research and Development (75.3) (61.0) (23%)

Selling (9.3) (3.6) >(100%)

General and Administrative (22.4) (14.5) (54%)

Total Operating Expenses (117.8) (80.0) (47%)

Earnings before Interest and Taxes (EBIT) (56.3) (13.0) >(100%)

Consolidated Net (Loss) / Profit (52.7) (12.8) >(100%)

Earnings per share, basic and diluted (in €) (1.67) (0.41) >(100%)

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1) Guidance update in connection with milestone payment of €22m from GSK after start of phase 3 clinical development program with otilimab (MOR103/GSK3196165) in

rheumatoid arthritis.

2) Revenues are expected to include royalty income from Tremfya® ranging from €30-35m on constant $ currency.


Financial Guidance 2019

In € million

Reported FY 2018 Reported Q1-Q3 2019 Guidance 20191)

(As of July 3, 2019)

76.4 60.7 65 to 722)

98.3 68.8 95 to 105

-59.1 -56.3 -105 to -115

Group Revenues

Proprietary R&D Expenses

(incl. Technology Development)

EBIT

Total ordinary shares issued as of September 30, 2019: 31,927,958

Germany, Frankfurt Stock Exchange: MOR

U.S., NASDAQ Global Market: MOR

Cash Position September 30, 2019: €412.4 m

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Q&A


Tafasitamab (MOR208), MOR202, MOR106, otilimab (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®, LanthioPep® and ENFORCERTM are trademarks of the MorphoSys Group. Tremfya® is a trademark

of Janssen Biotech, Inc.

www.morphosys.com

Thank You

Corporate Communications & IR

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

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

Email [email protected]

Results Q1 2019 - MorphoSys · 2019-10-30 · Current clinical development I-Mab: Chinese region...

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