First Quarter Interim Statement

JANUARY-MARCH

2021

3M

2

Group Interim Statement

Contents

MorphoSys Group:

First Quarter Interim Statement January - March 2021

3 Summary

5 Group Interim Statement

  1. Operating Business Performance
  1. Human Resources
  1. Financial Analysis
    13 Subsequent Events
    14 Financial Guidance

15 Group Interim Statement

  1. Consolidated Statement of Profit or Loss (IFRS) - (unaudited)
  2. Consolidated Balance Sheet (IFRS) - (unaudited)
  1. Consolidated Statement of Changes in Stockholders' Equity (IFRS) - (unaudited)
  1. Consolidated Statement of Cash Flows (IFRS) - (unaudited)

Group Interim Statement

3

Summary of the First Quarter of 2021

Operating Highlights for the First Quarter of 2021

  • On January 5, 2021, MorphoSys and Incyte announced the acceptance of the Swiss Agency for Therapeutic Products (Swissmedic) of the marketing authorization application (MAA) for tafasitamab.
  • On January 12, 2021, MorphoSys and Incyte announced the acceptance of Health Canada of the New Drug Submission (NDS) for tafasitamab.
  • On January 25, 2021, MorphoSys and I-Mab announced the dosing in the United States of the first patient in a phase 1 dose-finding study of MOR210/TJ210 as monotherapy in patients with relapsed or refractory advanced solid tumors.
  • On March 2, 2021, MorphoSys announced that its licensee GSK had published preliminary results from the OSCAR (Otilimab in Severe COVID-19 Related Disease) study of otilimab for the treatment of severe pulmonary COVID-19-related disease.

Financial Results for the First Quarter of 2021

  • Group revenue in the first quarter of 2021 reached € 47.2 million (3M 2020: € 251.2 million) and
    operating expenses amounted to € 71.7 million (3M 2020: € 44.4 million).

Cash and investments totaled € 1,215.0 million as of March 31, 2021 (December 31, 2020:

  • € 1,244.0 million).

  • The Company confirmed its financial guidance for the 2021 financial year.

Corporate Developments

  • On January 6, 2021, MorphoSys announced the appointment of Mr. Sung Lee as the Company's Chief Financial Officer (CFO), effective as of February 2, 2021.

Significant Events after the end of the First Quarter

  • On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the Phase 3 inMIND study in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL).

MorphoSys - I/2021

4

Group Interim Statement

MorphoSys Product Pipeline as of March 31, 2021

Our Clinical Pipeline

Clinical Programs Developed by Partners (Selection)

MorphoSys - I/2021

Group Interim Statement

5

Group Interim Statement:

January 1 - March 31, 2021

Operating Business Performance

MorphoSys' commercial activities are currently focused on Monjuvi® (tafasitamab-cxix) in the U.S. On July 31, 2020, Monjuvi in combination with lenalidomide received FDA accelerated approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low-grade lymphoma, and who are not eligible for autologous stem cell transplantation (ASCT). We are co-promoting Monjuvi together with our partner Incyte in the United States.

MorphoSys' development activities are currently focused on the following clinical candidates:

  • Tafasitamab - an antibody for the treatment of B-cell malignancies and the Company's most advanced program.
  • Felzartamab - currently being evaluated in autoimmune diseases by MorphoSys. In November 2017 MorphoSys entered into a regional license agreement with I-Mab for the development in China, Hong Kong, Macao and Taiwan. I-Mab is currently pursuing development in multiple myeloma.

In addition to MorphoSys's own pipeline, the following programs, among others, are being further developed by our partners:

  • Otilimab, an antibody that GlaxoSmithKline (GSK) is currently conducting clinical trials for the treatment of rheumatoid arthritis. The program originated as a proprietary MorphoSys program and was fully out- licensed to GSK in 2013. GSK is currently also evaluating the efficacy and safety of otilimab in patients with severe pulmonary disease associated with COVID-19 in a clinical trial (OSCAR).
  • MOR210/TJ210 was out-licensed to I-Mab in November 2018 for China and certain other countries in Asia. On September 17, 2020, the FDA approved the IND application for MOR210/TJ210 for the treatment of patients with relapsed or refractory advanced solid tumors, and on January 25, 2021, we announced with I-Mab that the first patient was dosed in the U.S.

Tafasitamab (MOR208, formerly XmAb5574) is a humanized monoclonal antibody directed against the CD19 antigen. CD19 is selectively expressed on the surface of B-cells, which belong to a group of white blood cells. CD19 enhances B-cell receptor signaling, which is an important factor in B-cell survival and growth, making CD19 a potential target structure for the treatment of B-cell malignancies.

Operational Development

On January 5, 2021, MorphoSys and Incyte announced that the Swiss Agency for Therapeutic Products (Swissmedic) had accepted the marketing authorization application (MAA) for tafasitamab and on January 12, 2021, MorphoSys and Incyte announced that Health Canada had accepted the New Drug Submission (NDS) for tafasitamab. Both applications are based on data from the L-MIND study of tafasitamab in combination with lenalidomide for the treatment of patients with relapsed or refractory DLBCL and data from the RE-MIND study, a retrospective observational study of relapsed or refractory DLBCL. Both applications seek approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab

MorphoSys - I/2021

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MorphoSys AG published this content on 07 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2021 10:19:01 UTC.