MorphoSys AG Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update
– Topline data from the Phase 3 MANIFEST-2 study expected in early 2024
– Monjuvi®
– € 907.2 million in cash and other financial assets as of
– Conference call and webcast (in English) tomorrow,
“2022 was a defining year for
Pelabresib Highlights:
On
Monjuvi/Minjuvi ® Highlights:
Monjuvi (tafasitamab-cxix)
Minjuvi royalty revenue of € 0.7 million for sales outside of the
Tafasitamab Data:
At the ASH conference in
Corporate Developments:
On
On
Significant Events After the End of the Fourth Quarter of 2022:
On
On
Financial Results for the Fourth Quarter of 2022 (IFRS):
Total revenues for the fourth quarter 2022 were € 81.6 million compared to € 52.9 million for the same period in 2021. This increase resulted mainly from higher revenues from the global licensing agreement with Novartis executed in the fourth quarter 2022.
in € million* |
|
Q4 2022 |
|
Q3 2022 |
|
Q4 2021 |
|
Q-Q Δ |
|
Y-Y Δ |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
81.6 |
|
95.8 |
|
52.9 |
|
(15) % |
|
54 % |
Monjuvi product sales |
|
24.7 |
|
21.9 |
|
20.5 |
|
13 % |
|
20 % |
Royalties |
|
29.1 |
|
29.7 |
|
23.2 |
|
(2) % |
|
25 % |
Licenses, milestones and other |
|
27.9 |
|
44.1 |
|
9.3 |
|
(37) % |
|
> 100% |
* Differences due to rounding. |
|
|
|
|
|
|
|
|
|
|
Cost of Sales: In the fourth quarter of 2022, cost of sales was € 15.4 million compared to € 9.5 million for the same period in 2021. The fourth quarter of 2022 includes € 5.1 million of expenses related to activities to optimize the Monjuvi supply chain.
Research and Development (R&D) Expenses: In the fourth quarter 2022, R&D expenses were € 94.0 million compared to € 87.0 million for the same period in 2021. The increase is primarily due to clinical trial material expenses in the fourth quarter 2022 partially offset by lower personnel costs.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the fourth quarter 2022 were € 23.0 million compared to € 32.5 million for the same period in 2021. 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 € 17.5 million compared to € 18.2 million for the same period in 2021.
Operating Loss: Operating loss amounted to € 68.4 million in the fourth quarter 2022 compared to a loss of € 325.0 million for the same period in 2021. The lower year-over-year operating loss was primarily driven by the impairment of goodwill amounting to € 230.7 million recognized in the fourth quarter 2021.
Consolidated Net Profit / Loss: For the fourth quarter 2022, consolidated net profit was € 329.4 million compared to a net loss of € 381.0 million for the same period in 2021. The consolidated net profit in the fourth quarter 2022 was driven mainly by the recognition of finance income triggered by the reduction in financial liabilities from collaborations.
Financial Results for the Full Year 2022 (IFRS):
Total Revenues for the full year 2022 were € 278.3 million compared to € 179.6 million in 2021. The increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio and Novartis. Royalties in 2022 include € 3.0 million from the sale of Minjuvi outside of the
in € million* |
|
2022 |
|
2021 |
|
Y-Y Δ |
|
|
|
|
|
|
|
Total revenues |
|
278.3 |
|
179.6 |
|
55 % |
Monjuvi product sales |
|
84.9 |
|
66.9 |
|
27 % |
Royalties |
|
99.9 |
|
65.6 |
|
52 % |
Licenses, milestones and other |
|
93.5 |
|
47.2 |
|
98 % |
* Differences due to rounding. |
|
|
|
|
|
|
Cost of Sales: For the full year 2022, cost of sales were € 48.6 million compared to € 32.2 million in 2021. The increase was primarily driven by higher sales of Monjuvi in the
R&D Expenses: For the full year 2022, R&D expenses were € 297.8 million compared to € 225.2 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 for the full year 2022 were € 92.4 million compared to € 121.5 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 € 60.1 million for 2022 compared to € 78.3 million in 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 € 220.7 million for the full year 2022 compared to a loss of € 508.3 million in 2021. The lower year-over-year operating loss was primarily driven by the impairment of goodwill amounting to € 230.7 million recognized in 2021.
Consolidated Net Loss: For the full year 2022, consolidated net loss was € 151.1 million compared to a net loss of € 514.5 million in 2021. The lower consolidated net loss in 2022 was driven mainly by the recognition of finance income triggered by the reduction in financial liabilities from collaborations.
Cash and Other Financial Assets: As of
Number of shares: The number of shares issued totaled 34,231,943 on
Full Year 2023 Financial Guidance:
Amounts in million |
2023 Financial Guidance |
2023 Guidance Insights |
Monjuvi |
|
100% of Monjuvi |
Gross margin for Monjuvi |
75% to 80% |
100% of Monjuvi |
R&D expenses |
€ 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 |
45% to 50% of mid-point of SG&A expenses represent Monjuvi |
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 theU.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 theU.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. As such,MorphoSys does not provide guidance for these sales
Operational Outlook:
The following events and development activities planned for 2023 and beyond include the following:
- full patient enrollment for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) in 2023 with topline results anticipated in early 2024;
- 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
in € million |
|
Q4 2022 |
|
Q4 2021 |
|
Δ |
|
2022 |
|
2021 |
|
Δ |
Revenues |
|
81.6 |
|
52.9 |
|
54 % |
|
278.3 |
|
179.6 |
|
55 % |
Product Sales |
|
24.7 |
|
20.5 |
|
20 % |
|
84.9 |
|
66.9 |
|
27 % |
Royalties |
|
29.1 |
|
23.2 |
|
25 % |
|
99.9 |
|
65.6 |
|
52 % |
Licenses, Milestones and Other |
|
27.9 |
|
9.3 |
|
>100% |
|
93.5 |
|
47.2 |
|
98 % |
Cost of Sales |
|
(15.4) |
|
(9.5) |
|
62 % |
|
(48.6) |
|
(32.2) |
|
51 % |
Gross Profit |
|
66.2 |
|
43.4 |
|
53 % |
|
229.6 |
|
147.4 |
|
56 % |
Total Operating Expenses |
|
(134.6) |
|
(368.4) |
|
(63) % |
|
(450.4) |
|
(655.8) |
|
(31) % |
Research and Development |
|
(94.0) |
|
(87.0) |
|
8 % |
|
(297.8) |
|
(225.2) |
|
32 % |
Selling |
|
(23.0) |
|
(32.5) |
|
(29) % |
|
(92.4) |
|
(121.5) |
|
(24) % |
General and Administrative |
|
(17.5) |
|
(18.2) |
|
(4) % |
|
(60.1) |
|
(78.3) |
|
(23) % |
Impairment of |
|
— |
|
(230.7) |
|
(100) % |
|
— |
|
(230.7) |
|
(100) % |
Operating Profit / (Loss) |
|
(68.4) |
|
(325.0) |
|
(79) % |
|
(220.7) |
|
(508.3) |
|
(57) % |
Other Income |
|
(7.8) |
|
3.4 |
|
>(100)% |
|
12.0 |
|
8.2 |
|
46 % |
Other Expenses |
|
7.4 |
|
(1.7) |
|
>(100)% |
|
(15.6) |
|
(6.4) |
|
>100% |
Finance Income |
|
325.0 |
|
(2.7) |
|
>(100)% |
|
412.1 |
|
96.6 |
|
>100% |
Finance Expenses |
|
249.5 |
|
(89.0) |
|
>(100)% |
|
(165.9) |
|
(181.5) |
|
(9) % |
Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets |
|
0.4 |
|
(0.2) |
|
>(100)% |
|
— |
|
0.3 |
|
(100) % |
Share of Loss of Associates accounted for using the Equity Method |
|
(4.0) |
|
— |
|
n/a |
|
(4.3) |
|
— |
|
n/a |
Income Tax Benefit / (Expenses) |
|
(172.7) |
|
34.4 |
|
>(100)% |
|
(168.6) |
|
76.6 |
|
>(100)% |
Consolidated Net Profit / (Loss) |
|
329.4 |
|
(381.0) |
|
>(100)% |
|
(151.1) |
|
(514.5) |
|
(71) % |
Earnings per Share, Basic and Diluted (in €) |
|
— |
|
(11.16) |
|
n/a |
|
(4.42) |
|
(15.40) |
|
(71) % |
Earnings per Share, Basic |
|
9.64 |
|
— |
|
n/a |
|
— |
|
— |
|
n/a |
Earnings per Share, Diluted |
|
8.93 |
|
— |
|
n/a |
|
— |
|
— |
|
n/a |
Cash and other financial assets (end of period) |
|
907.2 |
|
976.9 * |
|
(7) % |
|
907.2 |
|
976.9 * |
|
(7) % |
|
|
|
|
|
|
|
|
|
|
|
|
|
* Value as of
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
Consolidated Financial Statements 2022 (IFRS) are available for download at:
https://www.morphosys.com/en/investors/financial-information
About
At
About Pelabresib
Pelabresib (CPI-0610) is an investigational selective small molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is being investigated as a treatment for myelofibrosis and has not yet been evaluated or approved by any regulatory authorities.
About Monjuvi(tafasitamab-cxix)
Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010,
In
In
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
Tremfya® is a registered trademark of
XmAb® is a registered trademark of Xencor, Inc.
Forward Looking Statements
This communication contains certain forward-looking statements concerning the
View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005609/en/
Media Contacts:
Thomas Biegi
Vice President
Tel.: +49 (0)89 / 899 27 26079
thomas.biegi@morphosys.com
Director, Communications
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com
Investor Contacts:
Dr.
Head of Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Source: