EQS-News: MorphoSys AG / Key word(s): Quarterly / Interim Statement
Planegg/Munich, Germany, November 16, 2022
MorphoSys AG Reports First Nine Months and Third Quarter 2022 Financial Results
Conference call and webcast (in English) tomorrow, November 17, 2022, at 2:00pm CET (1pm GMT/8:00am ET)
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the third quarter and the first nine months of 2022.
"As we approach the end of this year, I am proud of what we have achieved so far. I want to highlight the progress we have made with the patient enrollment of our pivotal studies for pelabresib and tafasitamab as well as the preliminary phase 1/2 results we released for tulmimetostat suggesting anti-tumor activity across multiple tumors", said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are highly engaged to ensure increasing awareness and use of Monjuvi for appropriate patients with relapsed or refractory diffuse large B-cell lymphoma. Looking ahead we are focused on continued execution and delivering on the pelabresib pivotal study timeline."
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 22.2 million (€ 21.9 million) for the third quarter 2022 (Q3 2021: US$ 22.0 million (€ 18.6 million)) and US$ 64.1 million (€ 60.2 million) for first nine months 2022 (9M 2021: US$ 55.5 million (€ 46.4 million)).
Minjuvi royalty revenue of € 0.9 million for sales outside of the U.S. in the third quarter 2022 and € 2.3 million for the first nine months of 2022.
Conference Data Highlights:
New data presented at SOHO conference in September 2022
Preliminary results of tulmimetostat (CPI-0209) study presented in October 2022
Pelabresib and tafasitamab presentations and posters at ASH in December 2022
On August 31, 2022, MorphoSys announced Tim Demuth, M.D., Ph.D. as new Chief Research and Development Officer, following the retirement of Malte Peters, M.D. Tim Demuth started his new role on October 1, 2022.
Significant Events After the End of the Third Quarter of 2022:
On October 27, 2022, MorphoSys’ license partner GSK provided an update on the ContRAst phase III program for otilimab in moderate to severe rheumatoid arthritis.
On November 14, 2022, MorphoSys' license partner Roche disclosed that the GRADUATE studies with gantenerumab in early Alzheimer's disease did not meet the primary endpoint of slowing clinical decline.
Financial Results for the Third Quarter of 2022 (IFRS):
Total revenues for the third quarter 2022 were € 95.8 million compared to € 41.2 million for the same period in 2021. This increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio.
Cost of Sales: In the third quarter of 2022, cost of sales was € 8.1 million compared to € 7.5 million for the comparable period in 2021.
Research and Development (R&D) Expenses: In the third quarter 2022, R&D expenses were € 77.8 million (Q3 2021: € 64.4 million). The increase in R&D expenses is primarily due to higher investments to support the advancement of clinical programs.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2022 were € 23.5 million (Q3 2021: € 32.4 million). The decrease was driven by higher investments in 2021 made into the commercial organization, the first full year after the Monjuvi launch. General and administrative (G&A) expenses amounted to € 15.6 million (Q3 2021: € 19.4 million). The decrease was driven by the transaction costs for the Constellation acquisition which was completed in the third quarter of 2021.
Operating Loss: Operating loss amounted to € 29.3 million in the third quarter 2022 (Q3 2021: operating loss of € 82.4 million).
Consolidated Net Loss: For the third quarter 2022, consolidated net loss was € 122.9 million (Q3 2021: consolidated net loss of € 112.8 million).
Financial Results for the first nine months (IFRS):
Revenues for the first nine months of 2022 were € 196.7 million (9M 2021: € 126.7 million). The increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio. Revenues include € 60.2 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months included € 2.3 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 68.5 million from Tremfya® sales which is fully passed on to Royalty Pharma.
Cost of Sales: For the first nine months of 2022, cost of sales were € 33.2 million compared to € 22.7 million in 2021. The increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S.
R&D Expenses: In the first nine months of 2022, R&D expenses were € 203.8 million compared to € 138.2 million in 2021. The R&D expenses increased primarily due to higher development activity and the inclusion of expenses from the Constellation acquisition since Q3 2021.
SG&A Expenses: Selling expenses decreased in the first nine months of 2022 to € 69.4 million compared to € 89.0 million in 2021. The decrease was primarily driven by higher investments made into the commercial organization in 2021, the first full year after the Monjuvi launch. G&A expenses amounted to € 42.6 million compared to € 60.1 million in the first nine months of 2021. The decrease was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements in 2021.
Operating Loss: Operating loss amounted to € 152.3 million in the first nine months of 2022 compared to an operating loss of € 183.3 million in 2021.
Consolidated Net Loss: For the first nine months of 2022, consolidated net loss was € 480.5 million compared to a net loss of € 133.5 million in 2021.
Cash and Other Financial Assets: As of September 30, 2022, the Company had cash and other financial assets of € 1,038.1 million compared to € 976.9 million on December 31, 2021.
Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2022, no change compared to December 31, 2021.
Updated Full Year 2022 Financial Guidance:
Additional information related to 2022 Financial Guidance:
MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2022)
*Value as of December 31, 2021
MorphoSys will hold its conference call and webcast tomorrow, November 17, 2022, at 2:00pm CET (1:00pm GMT/8:00am EST) to present the results for the third quarter and the first nine months 2022.
Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:
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 "Events & Conferences" on MorphoSys' website, https://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 third quarter and the first nine months 2022 (IFRS) are available for download at:
In the United States, Monjuvi® (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 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 Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination 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, the UK and Canada.
Tremfya® is a registered trademark of Janssen Biotech, Inc.
XmAb® is a registered trademark of Xencor, Inc.
Forward Looking Statements
For more information, please contact:
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|EQS News ID:||1489653|
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