On October 25, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported preliminary Monjuvi U.S. Net Product Sales and Gross Margin for the third quarter of 2023 and provided an update to its financial guidance for 2023 (Press release, MorphoSys, OCT 25, 2023, View Source [SID1234636339]).

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Preliminary Monjuvi (tafasitamab-cxix) U.S. Net Product Sales are US$ 23.4 million (€ 21.5 million) for the third quarter of 2023 and US$ 67.8 million (€ 62.6 million) for the first nine months of 2023, a 5% and 6% increase from the same periods in 2022, respectively (US$ 22.2 million in Q3 2022 and US$ 64.1 million in the first nine months of 2022). Preliminary Gross Margin for Monjuvi U.S. Net Product Sales for Q3 2023 is 65%, due to the recognition of one-time write-offs for raw material used in the production of Monjuvi.

For the full year of 2023, MorphoSys now expects Monjuvi U.S. Net Product Sales to be US$ 85 to US$ 95 million (previously: US$ 80 to US$ 95 million) and Gross Margin for Monjuvi U.S. Net Product Sales to be approximately 75% (previously: 75% to 80%). All other aspects of the guidance for 2023 remain unchanged.

"Sales of Monjuvi continue to be on track for it’s approved indication in relapsed or refractory diffuse large B-cell lymphoma, and give us confidence to narrow our guidance target," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We remain in a solid financial position and continue to be highly judicious with our expenses even as we progress our phase 3 trials, including preparations for the pivotal MANIFEST-2 trial that will read out later this year."

The previous financial guidance for 2023 was provided by MorphoSys on January 5, 2023 and was last reiterated on August 9, 2023 and can be found at www.morphosys.com.

Full financial results for the third quarter of 2023 will be published on November 15, 2023, followed by a conference call on November 16, 2023.

Full Year 2023 Financial Guidance:

Updated 2023 Financial Guidance Previous 2023 Financial Guidance 2023 Guidance Insights
Monjuvi U.S. Net Product Sales US$ 85m to 95m US$ 80m to 95m 100% of Monjuvi U.S. product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
Gross Margin for Monjuvi U.S. Net Product Sales Approx. 75% 75% to 80% 100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte.
R&D expenses € 290m to 315m € 290m to 315m 2023 anticipated to be incrementally higher than 2022 due to the expansion of the pelabresib development program.
SG&A expenses € 140m to 155m € 140m to 155m 45% to 50% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses.