EQS-News: MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance and Reduces Financial Liability
EQS-News: MorphoSys AG
/ Key word(s): Forecast
Media Release
MorphoSys Reports Preliminary 2023 Monjuvi U.S. Net Product Sales and Gross Margin, Provides 2024 Financial Guidance and Reduces Financial Liability Preliminary 2023 Monjuvi U.S. net product sales of US$ 92.0 million (€ 85.0 million) and preliminary gross margin for Monjuvi U.S. net product sales of 69% Anticipated 2024 Monjuvi U.S. net product sales in the range of US$ 80 to 95 million Anticipated 2024 OpEx in the range of € 350 to 380 million and 2024 cash burn of approximately € 250 million (excluding debt and interest payments) Preliminary unaudited financial liability from the collaboration with Incyte of approximately € 114 million, representing a reduction of € 112 million MorphoSys AG (FSE: MOR; NASDAQ: MOR) today reported preliminary Monjuvi® (tafasitamab-cxix) U.S. net product sales and gross margin for Monjuvi U.S. net product sales for the full year of 2023 and provides its 2024 financial guidance. In this context, MorphoSys reduces its financial liability from the collaboration with its partner Incyte and credits finance income accordingly. Preliminary Monjuvi U.S. net product sales are US$ 24.1 million (€ 22.4 million) for the fourth quarter and US$ 92.0 million (€ 85.0 million) for the full year of 2023. Fourth quarter and full year 2023 financial results will be published on March 13, 2024. For the full year of 2024, MorphoSys expects Monjuvi U.S. net product sales in the range of US$ 80 to 95 million, aligned with the company’s original 2023 guidance. MorphoSys anticipates Monjuvi’s potential growth to come from new indications. These new indications are currently being investigated in two Phase 3 studies, inMIND (relapsed or refractory follicular lymphoma and marginal zone lymphoma) and frontMIND (first-line diffuse large B-cell lymphoma). Further, preliminary 2023 gross margin for Monjuvi U.S. net product sales is 69%, which is impacted by the recognition of one-time write-offs for inventory. “Patients with relapsed or refractory diffuse large B-cell lymphoma continued to benefit from Monjuvi in 2023, with sales reaching the higher end of our financial guidance. Beyond its approved indication, we believe Monjuvi’s potential growth will come from the new indications that are currently in Phase 3 studies, the first of which reads out later this year.” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “To maintain our strong financial position, we will continue to be judicious with our finances in 2024 by prioritizing areas that create the most immediate impact and value. As such, pelabresib in first-line myelofibrosis remains our primary focus following the positive Phase 3 MANIFEST-2 results. We are diligently preparing regulatory filings to submit to the U.S. Food and Drug Administration and the European Medicines Agency in the middle of 2024.” As a result of the latest Monjuvi sales expectations, the balance sheet item “Financial Liabilities from Collaborations” is being reduced from € 226 million (balance as of September 30, 2023) to approximately € 114 million (balance as of December 31, 2023; unaudited). Finance income is credited with the difference between the two amounts. The balance in the “Financial Liabilities from Collaborations” item reflects an accounting view of expected future profits from the U.S. net product sales of Monjuvi in the relapsed or refractory diffuse large B-cell lymphoma indication owed to Incyte. This reduction in the “Financial Liabilities from Collaborations” item has no impact on cash or cash runway. Monjuvi’s potential new indications are not and will not be reflected in the line item “Financial Liabilities from Collaborations.” With all of MorphoSys’ Phase 3 clinical programs now fully enrolled and additional cost optimization measures planned, MorphoSys’ anticipated 2024 operating expenses are expected to be lower compared to 2023. As a result, the company expects an anticipated 2024 cash burn of approximately € 250 million (excluding debt and interest payments). Full Year 2024 Financial Guidance:
Additional information related to 2024 Financial Guidance:
About MorphoSys About Monjuvi® (tafasitamab-cxix) Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Its safety and efficacy for these investigational uses have not been established in pivotal trials. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe and Canada. XmAb® is a registered trademark of Xencor, Inc.
About Pelabresib The development of pelabresib was funded in part by The Leukemia and Lymphoma Society®. About MANIFEST-2 The new key secondary endpoint, absolute change in TSS, was added to directly measure change in the average TSS from baseline to week 24 of treatment and is listed as the first key secondary endpoint in the MANIFEST-2 hierarchical testing scheme. The decision to update the MANIFEST-2 clinical trial protocol was made following a Type C meeting with the U.S. Food and Drug Administration (FDA) in September 2023. The final clinical protocol amendment is subject to approvals by health authorities outside of the U.S. Additional secondary endpoints include progression-free survival, overall survival, duration of the splenic and total symptom score response, hemoglobin response rate and improvement in bone marrow fibrosis, among others. Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2 trial sponsor. Forward-Looking Statements
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30.01.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
Language: | English |
Company: | MorphoSys AG |
Semmelweisstr. 7 | |
82152 Planegg | |
Germany | |
Phone: | +49 (0)89 899 27-0 |
Fax: | +49 (0)89 899 27-222 |
E-mail: | investors@morphosys.com |
Internet: | www.morphosys.com |
ISIN: | DE0006632003 |
WKN: | 663200 |
Indices: | SDAX, TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq |
EQS News ID: | 1825563 |
End of News | EQS News Service |
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1825563 30.01.2024 CET/CEST
MorphoSys AG Stock
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