MorphoSys AG Reports First Nine Months and Third Quarter 2023 Financial Results
- Positive points include the expected Phase 3 MANIFEST-2 topline results, the FDA Fast Track designation for tulmimetostat, and the strong cash and financial assets position of € 642.2 million as of September 30, 2023.
- None.
– Phase 3 MANIFEST-2 topline results expected by the end of November, with detailed findings in oral presentation at ASH 2023
– Monjuvi®
–
–
Conference call and webcast (in English) tomorrow, November 16, 2023, at 2:00 pm CET (1:00 pm GMT/8:00 am ET)
PLANEGG/
“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 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)
Minjuvi royalty revenue of
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) Annual Meeting in
Beyond the MANIFEST-2 study, seven additional abstracts on pelabresib and tafasitamab were accepted for presentation and publication at ASH 2023.
Tulmimetostat Highlight:
In September 2023, the
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
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
Research and Development (R&D) Expenses: In the third quarter 2023, R&D expenses were
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2023 were
Impairment of Goodwill: In the third quarter 2023, an impairment of goodwill in the amount of
Operating Loss: Operating loss amounted to
Consolidated Net Loss: For the third quarter 2023, consolidated net loss was
Financial Results for the first nine months 2023 (IFRS):
Revenues for the first nine months of 2023 were
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
R&D Expenses: In the first nine months of 2023, R&D expenses were
SG&A Expenses: Selling expenses decreased in the first nine months of 2023 to
Impairment of Goodwill: In the first nine months of 2023, an impairment of goodwill in the amount of
Operating Loss: Operating loss amounted to
Consolidated Net Loss: For the first nine months of 2023, consolidated net loss was
Cash and Other Financial Assets: As of September 30, 2023, the Company had cash and other financial assets of
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
|
Previous 2023
|
2023 Guidance Insights |
Monjuvi |
|
|
|
Gross margin for Monjuvi |
Approx. |
|
|
R&D expenses |
|
|
2023 anticipated to be incrementally higher than 2022 due to the expansion of the pelabresib development program. |
SG&A 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
|
|
9M
|
|
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 |
) |
|
> |
|
(6.6 |
) |
|
(0.3 |
) |
|
> |
||
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:
Please dial in 10 minutes before the beginning of the conference.
The live webcast (audio and presentation) can be directly accessed via https://www.webcast-eqs.com/morphosys-2023-q3 or via 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 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:
https://www.morphosys.com/en/investors/financial-information
About MorphoSys
At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated. MorphoSys is headquartered in Planegg,
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 The Leukemia and Lymphoma Society®.
About Monjuvi (tafasitamab-cxix)
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
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 MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the
XmAb® is a registered trademark of Xencor, Inc.
About Tulmimetostat
Tulmimetostat (CPI-0209) is an investigational compound designed to exert anti-tumor activity by inhibiting the function of enhancer of zeste homolog 1 and 2 (EZH2 and EZH1) proteins to reactivate silenced genes like tumor suppressor genes. Tulmimetostat is being tested as a once-daily oral treatment in a Phase 1/2 trial (NCT04104776) in patients with advanced solid tumors or lymphomas, including ARID1A-mutated ovarian clear cell carcinoma and endometrial carcinoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, BAP1-mutated mesothelioma and castration-resistant prostate cancer. The primary objectives of the trial include determining the maximum tolerated dose and/or recommended Phase 2 dose and evaluating antitumor activity of tulmimetostat monotherapy. The safety and efficacy of tulmimetostat have not been established in a pivotal trial.
Forward Looking Statements
This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, 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 MorphoSys' 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. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the
View source version on businesswire.com: https://www.businesswire.com/news/home/20231115052300/en/
Media Contacts:
Thomas Biegi
Vice President
Tel: +49 (0)89 / 899 27 26079
thomas.biegi@morphosys.com
Eamonn Nolan
Director, Communications
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com
Investor Contact:
Dr. Julia Neugebauer
Head of Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com
Source: MorphoSys AG
FAQ
What are the topline results expected by the end of November?
What is the U.S. FDA Fast Track designation for?
How much cash and other financial assets does the company have as of September 30, 2023?
What were the Monjuvi U.S. net product sales for the third quarter of 2023?
