MorphoSys AG Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
– Entered into Business Combination Agreement to be acquired by Novartis for € 68.00 per share in cash or € 2.7 billion equity value
– Sold all tafasitamab rights worldwide to Incyte
– Presented comprehensive Phase 3 MANIFEST-2 study results at ASH 2023 Annual Meeting, demonstrating pelabresib improves all four disease hallmarks of myelofibrosis
– Monjuvi®
– € 680.5 million in cash and other financial assets as of
–
PLANEGG/
“In 2023, we demonstrated the potential for pelabresib to shift the myelofibrosis treatment paradigm, as results from our Phase 3 MANIFEST-2 study showed that all four disease hallmarks were improved with the pelabresib and ruxolitinib combination therapy over standard of care,” said
Novartis’ Public Takeover Offer:
On
The offer will contain customary closing conditions, in particular a minimum acceptance threshold of 65% of MorphoSys’ share capital and antitrust clearances.
Pelabresib Highlights:
On
Monjuvi/Minjuvi® Highlights:
Monjuvi (tafasitamab-cxix)
On
Corporate Developments:
On
Financial Results for the Fourth Quarter of 2023 (IFRS):
Total revenues for the fourth quarter 2023 were € 59.0 million compared to € 81.6 million for the same period in 2022. The decrease resulted first and foremost from prior year revenues stemming from the execution of an out-licensing agreement with Novartis.
in € million* |
|
Q4 2023 |
|
Q3 2023 |
|
Q4 2022 |
|
Q-Q Δ |
|
Y-Y Δ |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
59.0 |
|
63.8 |
|
81.6 |
|
(8)% |
|
(28)% |
Monjuvi product sales |
|
22.4 |
|
21.5 |
|
24.7 |
|
4% |
|
(9)% |
Royalties |
|
34.0 |
|
34.0 |
|
29.1 |
|
0% |
|
17% |
Licenses, milestones and other |
|
2.6 |
|
8.3 |
|
27.9 |
|
(69)% |
|
(91)% |
* Differences due to rounding. |
|
|
|
|
|
|
|
|
|
|
Cost of Sales: In the fourth quarter of 2023, cost of sales was € 14.6 million compared to € 15.4 million for the comparable period in 2022.
Research and Development (R&D) Expenses: In the fourth quarter 2023, R&D expenses were € 80.3 million compared to € 94.0 million for the same period in 2022. The decrease mainly resulted from lower expenses for external services.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the fourth quarter 2023 were € 22.6 million compared to € 23.0 million for the same period in 2022. General and administrative (G&A) expenses amounted to € 22.9 million compared to € 17.5 million for the same period in 2022.
Operating Loss: Operating loss amounted to € 81.4 million in the fourth quarter 2023 compared to € 68.4 million for the same period in 2022.
Consolidated Net Loss: For the fourth quarter 2023, consolidated net loss was € 48.3 million compared to € 329.4 million for the same period in 2022.
Financial Results for the Full Year 2023 (IFRS):
Total Revenues for the full year 2023 were € 238.3 million compared to € 278.3 million in 2022. The decrease resulted first and foremost from prior year revenues stemming from the execution of out-licensing agreements with HI-Bio and Novartis. Royalties in 2023 include € 5.4 million from the sale of Minjuvi outside of the
in € million* |
|
2023 |
|
2022 |
|
Y-Y Δ |
|
|
|
|
|
|
|
Total revenues |
|
238.3 |
|
278.3 |
|
(14)% |
Monjuvi product sales |
|
85.0 |
|
84.9 |
|
0% |
Royalties |
|
116.4 |
|
99.9 |
|
17% |
Licenses, milestones and other |
|
36.9 |
|
93.5 |
|
(61)% |
* Differences due to rounding. |
|
|
|
|
|
|
Cost of Sales: For the full year 2023, cost of sales were € 58.4 million compared to € 48.6 million in 2022. The increase compared to the previous year is mainly due to one-off effects from write-downs on inventories in the amount of € 11.9 million recognized in 2023.
R&D Expenses: For the full year 2023, R&D expenses were € 283.6 million compared to € 297.8 million in 2022. The decrease of R&D expenses reflects our current clinical study progress as well as prioritization activities relating to our R&D portfolio.
SG&A Expenses: Selling expenses for the full year 2023 were € 81.4 million compared to € 92.4 million in 2022. The decrease is mainly due to the ongoing measures to streamline and focus sales efforts. G&A expenses amounted to € 65.8 million for 2023 compared to € 60.1 million in 2022. The increase was mainly driven by the increase in share-based payment expenses.
Operating Loss: Operating loss amounted to € 252.5 million for the full year 2023 compared to a loss of € 220.7 million in 2022.
Consolidated Net Loss: For the full year 2023, consolidated net loss was € 189.7 million compared to a net loss of € 151.1 million in 2022.
Cash and Other Financial Assets: As of
Under the Business Combination Agreement, Novartis agreed to use all such efforts which are from the perspective of a prudent business person reasonable and appropriate to provide
For the unlikely case that the proposed transaction with Novartis is not consummated, and
Number of Shares: The number of shares issued totaled 37,655,137 on
Financial Guidance 2024:
As a consequence of the sale and transfer of tafasitamab to Incyte on
For 2024, the Group expects R&D expenses of € 170 million to € 185 million. R&D expenses mainly represent our investments in the development of pelabresib and tulmimetostat. Selling, administrative and general expenses are expected to be between € 90 million and € 105 million. Any effects from the implementation of the Novartis takeover offer are not included in this forecast.
The overall forecast is subject to a number of uncertainties, including inflation and foreign currency effects.
Operational Outlook:
The following activity is planned for 2024:
-
Submit a New Drug Application for pelabresib in combination with ruxolitinib in myelofibrosis to the
U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application to theEuropean Medicines Agency in the middle of 2024.
MorphoSys Group
in € million |
|
Q4 2023 |
|
Q4 2022 |
|
Δ |
|
2023 |
|
2022 |
|
Δ |
Revenues |
|
59.0 |
|
81.6 |
|
(28)% |
|
238.3 |
|
278.3 |
|
(14)% |
Product Sales |
|
22.4 |
|
24.7 |
|
(9)% |
|
85.0 |
|
84.9 |
|
0% |
Royalties |
|
34.0 |
|
29.1 |
|
17% |
|
116.4 |
|
99.9 |
|
17% |
Licenses, Milestones and Other |
|
2.6 |
|
27.9 |
|
(91)% |
|
36.9 |
|
93.5 |
|
(61)% |
Cost of Sales |
|
(14.6) |
|
(15.4) |
|
(5)% |
|
(58.4) |
|
(48.6) |
|
20% |
Gross Profit |
|
44.4 |
|
66.2 |
|
(33)% |
|
179.9 |
|
229.6 |
|
(22)% |
Total Operating Expenses |
|
(125.8) |
|
(134.6) |
|
(7)% |
|
(432.4) |
|
(450.4) |
|
(4)% |
Research and Development |
|
(80.3) |
|
(94.0) |
|
(15)% |
|
(283.6) |
|
(297.8) |
|
(5)% |
Selling |
|
(22.6) |
|
(23.0) |
|
(2)% |
|
(81.4) |
|
(92.4) |
|
(12)% |
General and Administrative |
|
(22.9) |
|
(17.5) |
|
31% |
|
(65.8) |
|
(60.1) |
|
9% |
Impairment of |
|
(1.6) |
|
— |
|
n/a |
|
(1.6) |
|
— |
|
n/a |
Operating Profit / (Loss) |
|
(81.4) |
|
(68.4) |
|
19% |
|
(252.5) |
|
(220.7) |
|
14% |
Other Income |
|
0.1 |
|
(7.8) |
|
>(100)% |
|
5.0 |
|
12.0 |
|
(58)% |
Other Expenses |
|
(3.9) |
|
7.4 |
|
>(100)% |
|
(7.1) |
|
(15.6) |
|
(54)% |
Finance Income |
|
174.3 |
|
325.0 |
|
(46)% |
|
213.4 |
|
412.1 |
|
(48)% |
Finance Expenses |
|
(40.8) |
|
249.5 |
|
>(100)% |
|
(142.0) |
|
(165.9) |
|
(14)% |
Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets |
|
(0.1) |
|
0.4 |
|
>(100)% |
|
0.5 |
|
— |
|
n/a |
Share of Loss of Associates accounted for using the Equity Method |
|
(1.6) |
|
(4.0) |
|
(60)% |
|
(8.2) |
|
(4.3) |
|
91% |
Income Tax Benefit / (Expenses) |
|
1.6 |
|
(172.7) |
|
>(100)% |
|
1.2 |
|
(168.6) |
|
>(100)% |
Consolidated Net Profit / (Loss) |
|
48.3 |
|
329.4 |
|
(85)% |
|
(189.7) |
|
(151.1) |
|
26% |
Earnings per Share, Basic and Diluted (in €) |
|
— |
|
— |
|
n/a |
|
(5.53) |
|
(4.42) |
|
25% |
Earnings per Share, Basic (in €) |
|
1.28 |
|
9.64 |
|
(87)% |
|
— |
|
— |
|
n/a |
Earnings per Share, Diluted (in €) |
|
1.22 |
|
8.93 |
|
(86)% |
|
— |
|
— |
|
n/a |
Cash and other financial assets (end of period) |
|
680.5 |
|
907.2 |
|
(25)% |
|
680.5 |
|
907.2 |
|
(25)% |
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The live webcast (audio and presentation) can be directly accessed via https://www.webcast-eqs.com/morphosys-2023-ye or via the Investors section under "Events & Conferences" on the
Consolidated Financial Statements 2023 (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 approved by any regulatory authorities. Its safety and efficacy have also not been established in a pivotal trial.
The development of pelabresib was funded in part by
About MANIFEST-2
MANIFEST-2 (NCT04603495) is a global, double-blind, Phase 3 clinical trial that randomized 430 JAK inhibitor-naïve adult patients with myelofibrosis 1:1 to receive pelabresib in combination with ruxolitinib or placebo plus ruxolitinib. The primary endpoint of the study is a 35% or greater reduction in spleen volume (SVR35) from baseline at 24 weeks. The key secondary endpoints of the study are the absolute change in total symptom score (TSS) from baseline at 24 weeks and the proportion of patients achieving a 50% or greater improvement in total symptom score (TSS50) from baseline at 24 weeks. TSS is measured using the myelofibrosis self-assessment form (MFSAF) v4.0, which asks patients to report the severity of seven common symptoms, rating each of them on a scale from 0 (absent) to 10 (worst imaginable).
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
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.
About Tafasitamab
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010,
In
In
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 Incyte. Tafasitamab is marketed under the brand name Monjuvi® in the
XmAb® is a registered trademark of Xencor, Inc.
Additional Information and Where to Find it
The takeover offer described in this communication (the “Takeover Offer”) has not yet commenced. This communication is neither an offer to purchase nor a solicitation of an offer to sell shares of
In addition to the Offer to Purchase, including the means to tender and certain other Takeover Offer Documents, as well as the Solicitation/Recommendation Statement, the Company files other information with the
In order to reconcile certain areas where German law and
Acceptance of the Takeover Offer by stockholders residing outside
Forward Looking Statements
This communication contains certain forward-looking statements concerning the Company, the Bidder and the Takeover Offer that involve substantial risks and uncertainties. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “goal,” “may,” “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and similar expressions. In this communication, the Company’s forward-looking statements include statements about the parties’ ability to satisfy the conditions to the consummation of the Takeover Offer; statements about the expected timetable for the consummation of the Takeover Offer; the Company’s plans, objectives, expectations and intentions; and the financial condition, results of operations and business of the Company and Novartis AG.
The forward-looking statements contained in this communication represent the judgment of the Company as of the date of this communication and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of the Company, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if the Company's results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Those risks and uncertainties that could cause the actual results to differ from expectations contemplated by forward-looking statements include, among other things: uncertainties as to the timing of the Takeover Offer; uncertainties as to how many of the Company’s stockholders will tender their stock in the Takeover Offer; the possibility that competing offers will be made; the possibility that various conditions for the Takeover Offer may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the Takeover Offer; the effects of the Takeover Offer on relationships with employees, other business partners or governmental entities; that the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240313374964/en/
Media Contacts:
Thomas Biegi
Senior Vice President, Corporate Affairs
Tel.: +49 (0)89 / 899 27 26079
thomas.biegi@morphosys.com
Senior Director,
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com
Investor Contacts:
Dr.
Vice President, Global Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Source: