On November 15, 2023 MorphoSys AG (FSE: MOR; NASDAQ: MOR) reported results for the third quarter and the first nine months of 2023 (Press release, MorphoSys, NOV 15, 2023, View Source/en/news/morphosys-ag-reports-first-nine-months-and-third-quarter-2023-financial-results" target="_blank" title="View Source/en/news/morphosys-ag-reports-first-nine-months-and-third-quarter-2023-financial-results" rel="nofollow">View Source [SID1234637713]).
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"With pelabresib, MorphoSys has the potential to meaningfully improve upon current first-line treatments for patients with myelofibrosis. We look forward to showcasing the topline results of our pivotal MANIFEST-2 study by the end of November and, shortly thereafter, in our detailed oral presentation at ASH (Free ASH Whitepaper) 2023," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "Sales of Monjuvi remain on track for its approved indication, allowing us to narrow our full-year 2023 guidance target. Our mid- to late-stage pipeline offers promising value-creating opportunities, with two additional pivotal studies expected to read out over the next two years."
Monjuvi/Minjuvi Highlights:
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 23.4 million (€ 21.5 million) for the third quarter 2023 (Q3 2022: US$ 22.2 million (€ 21.9 million)) and US$ 67.8 million (€ 62.6 million) for first nine months 2023 (9M 2022: US$ 64.1 million (€ 60.2 million)).
Minjuvi royalty revenue of € 1.2 million for sales outside of the U.S. in the third quarter 2023 and € 4.1 million for the first nine months of 2023.
Conference Highlights:
Topline results from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK inhibitor-naïve adult patients with myelofibrosis are expected by the end of November.
Following the release of the topline MANIFEST-2 study results, detailed findings from the study will be presented during an oral session on Sunday, December 10, 2023, at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, USA. During ASH (Free ASH Whitepaper) 2023, MorphoSys will host an in-person investor event with the company’s management team and medical experts to review the detailed study findings. The event, taking place on Monday, December 11, at the Hilton Bayfront Hotel, will start with a networking breakfast at 6:30 a.m. PST and continue with a formal presentation at 7:00 a.m. PST (10:00 a.m. EST / 4:00 p.m. CET). A webcast will also be available for those not attending the Annual Meeting in person, accessible on the Investors section of MorphoSys’ website (www.morphosys.com).
Beyond the MANIFEST-2 study, seven additional abstracts on pelabresib and tafasitamab were accepted for presentation and publication at ASH (Free ASH Whitepaper) 2023.
Tulmimetostat Highlight:
In September 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for tulmimetostat, an investigational next-generation dual inhibitor of EZH2 and EZH1, for the treatment of patients with advanced, recurrent or metastatic endometrial cancer harboring AT-rich interacting domain containing protein 1A (ARID1A) mutations and who have progressed on at least one prior line of treatment.
Events After the End of the Third Quarter of 2023:
MorphoSys updated its financial guidance for 2023 financial year on October 25, 2023.
Financial Results for the Third Quarter of 2023 (IFRS):
Total revenues for the third quarter 2023 were € 63.8 million compared to € 95.8 million for the same period in 2022. The decrease resulted from lower revenues from licenses compared to prior year.
in € million* Q3 2023 Q2 2023 Q3 2022 Q-Q Δ Y-Y Δ
Total revenues 63.8 53.2 95.8 20 % (33) %
Monjuvi product sales 21.5 21.7 21.9 (1) % (2) %
Royalties 34.0 26.8 29.7 27 % 14 %
Licenses, milestones and other 8.3 4.6 44.1 80 % (81) %
* Differences due to rounding.
Cost of Sales: In the third quarter of 2023, cost of sales was € 15.1 million compared to € 8.1 million for the comparable period in 2022.
Research and Development (R&D) Expenses: In the third quarter 2023, R&D expenses were € 63.2 million (Q3 2022: € 77.8 million). The decrease mainly resulted from lower expenses for external services.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2023 were € 19.9 million (Q3 2022: € 23.5 million). The selling expenses decreased due to streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 15.0 million (Q3 2022: € 15.6 million).
Impairment of Goodwill: In the third quarter 2023, an impairment of goodwill in the amount of € 1.6 million was recorded, which initially resulted from an acquisition in financial year 2010 (Q3 2022: € 0.0 million).
Operating Loss: Operating loss amounted to € 51.0 million in the third quarter 2023 (Q3 2022: operating loss of € 29.3 million).
Consolidated Net Loss: For the third quarter 2023, consolidated net loss was € 119.6 million (Q3 2022: consolidated net loss of € 122.9 million).
Financial Results for the first nine months 2023 (IFRS):
Revenues for the first nine months of 2023 were € 179.3 million (9M 2022: € 196.7 million). The decrease resulted from lower revenues from licenses compared to prior year. Revenues include € 62.6 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months 2023 included € 4.1 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 78.3 million from Tremfya sales which is fully passed on to Royalty Pharma.
in € million* 9M 2023 9M 2022 Y-Y Δ
Total revenues 179.3 196.7 (9) %
Monjuvi product sales 62.6 60.2 4 %
Royalties 82.4 70.8 16 %
Licenses, milestones and other 34.2 65.6 (48) %
* Differences due to rounding.
Cost of Sales: For the first nine months of 2023, cost of sales were € 43.8 million compared to € 33.2 million in 2022. 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 2023, R&D expenses were € 203.3 million compared to € 203.8 million in 2022.
SG&A Expenses: Selling expenses decreased in the first nine months of 2023 to € 58.8 million compared to € 69.4 million in 2022. The selling expenses decreased due to streamlining and focusing of selling efforts. G&A expenses amounted to € 42.9 million compared to € 42.6 million in the first nine months of 2022.
Impairment of Goodwill: In the first nine months of 2023, an impairment of goodwill in the amount of € 1.6 million was recorded, which initially resulted from an acquisition in financial year 2010 (9M 2022: € 0.0 million).
Operating Loss: Operating loss amounted to € 171.1 million in the first nine months of 2023 compared to an operating loss of € 152.3 million in 2022.
Consolidated Net Loss: For the first nine months of 2023, consolidated net loss was € 238.0 million compared to a net loss of € 480.5 million in 2022.
Cash and Other Financial Assets: As of September 30, 2023, the Company had cash and other financial assets of € 642.2 million compared to € 907.2 million on December 31, 2022.
Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2023, no change compared to December 31, 2022.
Updated Full Year 2023 Financial Guidance:
The updated financial guidance was issued on October 25, 2023.
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. net 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.
*The Previous Financial Guidance 2023 was initially provided on January 5, 2023.
Additional information related to 2023 Financial Guidance:
Tremfya royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys, as 100% of the royalties will be passed on to Royalty Pharma.
MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S.
MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2023.
MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the "Licenses, milestones and other" category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. MorphoSys does not provide guidance for these sales.
Operational Outlook:
The following events and development activities are upcoming and planned for 2024 and beyond:
Topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) are expected by the end of November;
Primary analysis data from the Phase 3 study (inMIND) of tafasitamab in patients with indolent lymphoma (r/r FL/MZL) in 2024;
Primary analysis data from the pivotal Phase 3 study (frontMIND) of tafasitamab in previously untreated DLBCL in the second half of 2025.
MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2023)
in € million Q3 2023 Q3 2022 Δ 9M
2023 9M
2022 Δ
Revenues 63.8 95.8 (33) % 179.3 196.7 (9) %
Product Sales 21.5 21.9 (2) % 62.6 60.2 4 %
Royalties 34.0 29.7 14 % 82.4 70.8 16 %
Licenses, Milestones and Other 8.3 44.1 (81) % 34.2 65.6 (48) %
Cost of Sales (15.1) (8.1) 86 % (43.8) (33.2) 32 %
Gross Profit 48.7 87.7 (44) % 135.5 163.5 (17) %
Total Operating Expenses (99.7) (117.0) (15) % (306.6) (315.8) (3) %
Research and Development (63.2) (77.8) (19) % (203.3) (203.8) 0 %
Selling (19.9) (23.5) (15) % (58.8) (69.4) (15) %
General and Administrative (15.0) (15.6) (4) % (42.9) (42.6) 1 %
Impairment of Goodwill (1.6) — n/a (1.6) — n/a
Operating Profit / (Loss) (51.0) (29.3) 74 % (171.1) (152.3) 12 %
Other Income 2.1 10.6 (80) % 4.9 19.8 (75) %
Other Expenses (0.8) (7.5) (89) % (3.1) (23.0) (87) %
Finance Income (22.5) 70.3 >(100)% 39.1 87.1 (55) %
Finance Expenses (44.6) (167.5) (73) % (101.2) (415.4) (76) %
Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets 0.0 0.6 (100) % 0.6 (0.4) >(100)%
Share of Loss of Associates accounted for using the Equity Method (2.3) (0.3) >100% (6.6) (0.3) >100%
Income Tax Benefit / (Expenses) (0.5) 0.1 >(100)% (0.5) 4.1 >(100)%
Consolidated Net Profit / (Loss) (119.6) (122.9) (3) % (238.0) (480.5) (50) %
Earnings per Share, Basic and Diluted (in €) (3.50) (3.60) (3) % (6.97) (14.07) (50) %
Cash and other financial assets (end of period) 642.2 907.2 * (29) % 642.2 907.2 * (29) %
* Value as of December 31, 2022
MorphoSys will hold its conference call and webcast tomorrow, November 16, 2023, at 2:00pm CET (1:00pm GMT/8:00am ET) to present the results for the third quarter and the first nine months 2023.
Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call:
View Source;linkSecurityString=36bda1015
Please dial in 10 minutes before the beginning of the conference.
The live webcast (audio and presentation) can be directly accessed via View Source or via the Investors section under "Events & Conferences" on MorphoSys’ website, View Source and after the call, a slide-synchronized audio replay of the conference call will be available at the same location.
The statement for the third quarter and the first nine months 2023 (IFRS) are available for download at:
View Source/en/investors/financial-information