MORPHOSYS AG Cash and Investments: As of June 30, 2021, the Company had cash and investments of EUR 1,129.2 million compared to EUR 1,244.0 million on December 31, 2020. Pro forma cash after the closing of the Constellation and Royalty Pharma transactions, including the sale of ordinary shares, was EUR 1,168.0 million.
Number of shares: The number of shares issued totaled 32,892,540 at the end of Q2 2021 (year-end 2020: 32,890,046). After the share capital increase on July 16, 2021, to implement the purchase of 1,337,552 new ordinary shares by Royalty Pharma, the number of shares issued totaled 34,227,598.
Adjusted Financial Guidance and Operational Outlook for 2021
in EUR million Prior Financial Guidance
Updated Financial Guidance 2021 (ex-Constellation)
Group Revenues* 155 to 180 150 to 200
435 to 465
Operating Expenses** (includes one-time transaction costs 355 to 385
of EUR 36.0 million)
R&D expense as a % of Operating Expenses excluding 52 to 57% 45 to 50%
one-time transaction costs
*Group revenues include full year Tremfya royalties and exclude any royalties from potential tafasitamab sales outside of the U.S. as well as any significant milestones from development partners and/or licensing partnerships other than those that were already recorded in the half-year. 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 U.S.
MorphoSys expects the following events and activities in 2021:
Tafasitamab:
- Continuation of the phase 1b trial with tafasitamab in previously untreated DLBCL (firstMIND);
- Continuation of the pivotal phase 3 frontMIND trial of tafasitamab in previously untreated DLBCL;
- Continuation of the pivotal phase 3 inMIND trial of tafasitamab in patients with relapsed or refractory follicular lymphoma (r/r 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 (study start expected end of 2021/early 2022);
- 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;
- Decision of the European Commission on the Marketing Authorization Application (MAA), seeking conditional marketing authorization 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 for tafasitamab.
Felzartamab:
- Continuation of the M-PLACE and the NewPLACE study in patients with membranous nephropathy;
- Presentation of data from the M-PLACE study at a scientific conference in Q4 2021;
- Start of clinical study in patients with IgA nephropathy (IGNAZ study).
Constellation programs:
- Continuation of the MANIFEST phase 2 study of pelabresib in patients with myelofibrosis;
- Continuation of the MANIFEST-2 phase 3 clinical study with pelabresib in combination with ruxolitinib in patients with primary myelofibrosis;
- Continuation of a Phase 1/2 clinical trial of?CPI-0209 in patients with advanced solid and hematological tumors.
MorphoSys Group Key Figures (IFRS, June 30, 2021)
in EUR million Q2 2021 Q2 2020 Change H1 2021 H1 2020 Change
Revenues 38.2 18.4 >100% 85.4 269.7 (68%)
Monjuvi product sales 14.9 - - 27.8 - -
Royalties 13.7 10.8 27% 25.4 20.1 26%
Licenses, milestones and other 9.6 7.6 26% 32.3 249.5 (87%)
Cost of Sales (10.1) 7.2 >100% (15.2) 4.0 >100%
Gross Profit 28.1 25.7 9% 70.2 273.6 (74%)
Total Operating Expenses: (99.5) (74.0) (34%) (171.2) (118.5) (44%)
Research and Development (40.5) (30.9) (31%) (73.8) (52.4) (41%)
Selling (28.5) (29.3) 3% (56.6) (42.1) (34%)
General and Administrative (30.5) (13.8) > (40.8) (23.9) (71%)
(100%)
Operating Profit / (Loss) (71.4) (48.4) (48%) (101.0) 155.1 >
(100%)
Other Income 1.7 (0.4) >100% 2.8 10.0 (72%)
(1.4) (1.3) (8%) (3.4) (1.6) >
Other Expenses (100%)
Finance Income 102.4 17.5 >100% 116.3 28.1 >100%
Finance Expenses 2.9 (25.1) >100% (36.8) (34.4) (7%)
Income from Reversals of Impairment Losses / (Impairment Losses) on 0.2 (0.3) >100% 0.3 (0.8) >100%
Financial Assets
(13.5) 4.9 > 1.0 23.3 (96%)
Income Tax Benefit / (Expenses) (100%)
Consolidated Net Profit (+) / (Loss) 20.9 (53.1) >100% (20.7) 179.8 >
(100%)
Earnings per Share, Basic and Diluted (in EUR) - (1.62) - (0.63) - -
Earnings per Share, Basic (in EUR) 0.64 - - - 5.56 -
Earnings per Share, diluted (in EUR) 0.61 - - - 5.54 -
Cash and investments (end of period) 1,129.2 1,061.8 6% 1,129.2 1,244.0* (9%) *Value as of December 31, 2020
MorphoSys will hold its conference call and webcast tomorrow, July 29, 2021, to present the results for the second quarter and first half year of 2021 and the further outlook for 2021.
Dial-in number for the conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT: Germany: +49 69 201 744 220 For UK residents: +44 203 009 2470 For US residents: +1 877 423 0830 (All numbers reachable from any geography) Participant PIN: 72989449# Please dial in 10 minutes before the beginning of the conference.
A live webcast and slides will be made available at the Investors section under "Presentations and Conferences" on MorphoSys' website at http://www.morphosys.com and after the call, a slide-synchronized audio replay of the conference will be available at the same location.
The statement for the second quarter/first 6 months of 2021 (IFRS) is available online: http://www.morphosys.com/Reports
About Tafasitamab Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb^ (R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).
Monjuvi^(R) (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide 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 transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi^(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.
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