DGAP-News: MorphoSys AG / Key word(s): Quarterly / Interim Statement MorphoSys AG Reports First Quarter 2021 Results 2021-05-05 / 22:03 The issuer is solely responsible for the content of this announcement. =---------------------------------------------------------------------------------------------------------------------- Media Release Planegg/Munich, Germany, May 5, 2021 MorphoSys AG Reports First Quarter 2021 Results . Monjuvi^U.S. net product sales of EUR 12.9 million (USUSD 15.5 million) . Tremfya royalties of EUR 11.6 million . Reaffirming group revenue guidance of EUR 150 to EUR 200 million . Conference call and webcast (in English) tomorrow, May 6, 2021 at 2:00pm CEST (1:00pm BST/8:00am EDT) MorphoSys AG (FSE:MOR; NASDAQ:MOR) reports financial results for the first quarter of 2021. "For 2021, our focus is on three key areas: executing on the Monjuvi launch; rapidly advancing the tafasitamab backbone strategy through additional clinical studies; and expanding our pipeline," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "While we experienced headwinds from the pandemic in the first quarter, we are cautiously optimistic that the COVID-19 impact in the U.S. will start to diminish in the second half of 2021. We are confident in the potential of Monjuvi given its broad second-line label and overall profile in the r/r DLBCL setting. We are also making important progress initiating key trials for both tafasitamab and felzartamab this year." Tafasitamab Highlights . Monjuvi^(R) (tafasitamab-cxix) U.S. net product sales of EUR 12.9 million (USUSD 15.5 million). . Monjuvi was granted a product-specific HCPCS J-Code, effective April 1, 2021. . 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 seek approval for tafasitamab, in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplantation (ASCT). Pipeline Highlights Felzartamab: . M-PLACE study of felzartamab in autoimmune membranous nephropathy ongoing: the safety run-in phase was completed and the full enrollment phase opened. . In February 2021, the first patient with autoimmune membranous nephropathy was dosed with felzartamab in the New-PLACE study, a phase 2 study evaluating different treatment schedules to identify the regimen for the pivotal study. Otilimab: . On March 2, 2021, we announced that our partner GSK reported preliminary results of the OSCAR study using otilimab for the treatment of severe pulmonary COVID-19 related disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings. The dosing of the first patient in the expanded study triggered milestone payments totaling EUR 16 million to MorphoSys. MOR210: . On January 25, 2021, MorphoSys and I-Mab announced that the first patient has been dosed in a phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MOR210/ TJ210 monotherapy in patients with relapsed or refractory advanced solid tumors in the United States. Corporate Updates . On January 6, 2021, MorphoSys announced the appointment of Sung Lee as Chief Financial Officer, effective as of February 2, 2021. Significant Events After The Reporting Period . On April 19, 2021, MorphoSys and Incyte announced that the first patient has been dosed in the placebo-controlled Phase 3 inMIND study evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab in patients with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). First Quarter 2021 Financial Results (IFRS) Total revenues for the quarter ended March 31, 2021 were EUR 47.2 million compared to EUR 251.2 million for the comparable period in 2020. The year-over-year decline was driven by the upfront payment of the collaboration and license agreement with Incyte in the first quarter 2020 for the out-licensing of tafasitamab outside the USA. in EUR million 3M 2021 3M 2020 Change Total revenues 47.2 251.2 (81%) Monjuvi product sales 12.9 - - Royalties 11.6 9.3 25% Licenses, milestones and other 22.7 241.9 (91%)
Cost of Sales: In the first three months of 2021, cost of sales increased to EUR 5.0 million (3M 2020: EUR 3.3 million).
Research and Development (R&D) Expenses: In the first three months of 2021, research and development expenses were EUR 33.3 million (3M 2020: EUR 21.5 million). Growth over 2020 reflects the increased investment to support the advancement of proprietary programs and consisted primarily of expenses for external laboratory services and personnel expenses.
Selling, General and Administrative (SG&A) Expenses: Selling expenses increased in the first three months of 2021 to EUR 28.2 million (3M 2020: EUR 12.8 million) and general and administrative expenses remained almost unchanged at EUR 10.3 million (3M 2020:EUR 10.1 million). The year-over-year increase in selling expenses was primarily driven by the full quarter impact of the expenses for services provided by Incyte as part of the joint U.S. marketing activities for Monjuvi.
Operating Loss: Operating loss amounted to EUR 29.6 million in the first three months of 2021 (3M 2020: operating profit of EUR 203.5 million).
Consolidated Net Loss: For the first three months of 2021, consolidated net loss was EUR 41.6 million (3M 2020: consolidated net profit of EUR 195.5 million).
Cash and Investments: As of March 31, 2021, the Company had cash and investments of EUR 1,215.0 million compared to EUR 1,244.0 million on December 31, 2020.
Number of shares: The number of shares issued remained unchanged since year-end 2020 and totaled 32,890,046. Financial Guidance and Operational Outlook for 2021
in EUR million Financial Guidance 2021 Group Revenues 150 to 200* Operating Expenses 355 to 385** R&D expense as a % of Operating Expenses 45 to 50%
*Group revenues includes the announced EUR 16 million milestone payments from GSK, but excludes other potential significant milestones from development partners and/or licensing partnerships. This revenue guidance is subject to a number of uncertainties including the potential for variability from the first full year of the Monjuvi product launch, the limited visibility that MorphoSys has on the Tremfya royalty stream as well as the ongoing COVID-19 pandemic and the impact on our as well as our partner's business operations.
**Operating expenses is comprised of R&D and SG&A, inclusive of Incyte's share of Monjuvi selling costs in the USA.
MorphoSys expects for Tafasitamab the following events and activities in 2021: . Continuation of the phase 1b trial with tafasitamab in previously untreated DLBCL (firstMIND); . Initiation of a pivotal phase 3 trial of tafasitamab in previously untreated DLBCL (frontMIND); . Continuation of the phase 3 inMIND trial of tafasitamab in patients with relapsed or refractory follicular lymphoma
(FL) or marginal zone lymphoma (MZL); . Investigation of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL, first-line
DLBCL and relapsed or refractory follicular lymphoma (r/r FL) jointly with Incyte and Xencor; . Continuation of the L-MIND study of tafasitamab and evaluate the long-term efficacy and safety data; . Continuation of the phase 3 B-MIND study of tafasitamab in combination with bendamustine for r/r DLBCL; . Presentation of data from the 3-year follow up of L-MIND as well as other abstracts at several scientific
conferences (e.g. ASCO, EHA); . Decision on the European Marketing Authorization Application (MAA), seeking approval of tafasitamab in combination
with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with r/r DLBCL which is
currently under review; . Support of Incyte in submitting marketing authorization applications in other markets. MorphoSys Group Key Figures (IFRS, March 31, 2021)
in EUR million 3M 2021 3M 2020 Change Revenues 47.2 251.2 (81%) Monjuvi product sales 12.9 - - Royalties 11.6 9.3 25% Licenses, milestones and other 22.7 242.0 (91%) Cost of Sales (5.0) (3.3) 52% Gross Profit 42.1 248.0 (83%) Total Operating Expenses: (71.7) (44.4) 61% Research and Developlment (33.3) (21.5) 55% Selling (28.2) (12.8) > 100% General and Administrative (10.3) (10.1) (2%) Operating Profit / (Loss) (29.6) 203.5 > (100%) Consolidated Net Profit (+) / (Loss) (41.6) 195.5 > (100%) Earnings per Share, Basic and Diluted (in EUR) (1.27) Earnings per Share, Basic (in EUR) - 6.12 - Earnings per Share, diluted (in EUR) - 6.11 - Cash and investments (end of period) 1,215.0 1,244.0* (2%)
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