– Monjuvi® U.S. net product sales of US$ 23.6 million (€ 21.7 million) for the second quarter of 2023
– Enrollment of Phase 3 MANIFEST-2 study of pelabresib in first-line myelofibrosis is complete, with topline data expected by the end of 2023
– Phase 3 studies frontMIND of tafasitamab in first-line diffuse large B-cell lymphoma and inMIND of tafasitamab in relapsed/refractory follicular lymphoma or marginal zone lymphoma are fully enrolled
– € 672.8 million in cash and other financial assets as of June 30, 2023
Conference call and webcast (in English) tomorrow, August 10, 2023, at 2:00pm CEST (1pm BST/8:00am EDT)
PLANEGG/MUNICH, Germany–(BUSINESS WIRE)–MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the second quarter and first half year of 2023.
“With topline data from the pivotal MANIFEST-2 trial now expected by year’s end, we hear increased excitement from physician and patient communities around pelabresib as a potential first-line treatment for myelofibrosis. We are also seeing evidence of possible clinical benefit with pelabresib in other myeloid diseases, with new proof-of-concept data in high-risk essential thrombocythemia released recently,” said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. “Sales of Monjuvi are on track for its approved indication in relapsed or refractory diffuse large B-cell lymphoma, and we see potential in the first-line setting, which is currently being investigated in a Phase 3 trial. We remain focused on progressing our promising mid- and late-stage clinical programs to address the critical needs of cancer patients.”
Pelabresib Highlight:
On April 4, 2023, MorphoSys announced the complete enrollment for MANIFEST-2, the ongoing Phase 3 study exploring the efficacy and safety of pelabresib, an investigational BET inhibitor, in combination with ruxolitinib versus ruxolitinib alone in patients with myelofibrosis who have not previously been treated with a JAK inhibitor (JAK inhibitor-naïve). 431 patients were enrolled in this study. The topline data from MANIFEST-2 are expected by the end of 2023.
Conferences/Data Highlight:
In June, MorphoSys presented clinical results of pelabresib, tafasitamab and tulmimetostat in oral presentations, posters and publications at the world’s largest oncology conference, the American Society of Clinical Oncology (ASCO) Annual Meeting, the European Hematology Association (EHA) Annual Meeting and the International Conference on Malignant Lymphoma (ICML). Presentations at EHA and ASCO showed new preliminary results from the Phase 2 MANIFEST study Arm 4 exploring pelabresib as a monotherapy in patients with high-risk essential thrombocythemia (ET) who are refractory or intolerant to hydroxyurea.
Monjuvi/Minjuvi® Highlights:
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 23.6 million (€ 21.7 million) for the second quarter 2023 (Q2 2022: US$ 23.3 million (€ 21.7 million)) and US$ 44.4 million (€ 41.1 million) for the first half of 2023.
Minjuvi royalty revenue of € 2.2 million for sales outside of the U.S. in the second quarter 2023 and € 2.9 million for the first half of 2023.
Corporate Developments:
The MorphoSys AG Annual General Meeting on May 17, 2023 re-elected Mr. George Golumbeski, Ph.D., and Mr. Michael Brosnan to the Company’s Supervisory Board. The shareholders approved all resolutions proposed by the Company´s Management and Supervisory Boards.
Events After the End of the Second Quarter of 2023:
On August 1, 2023, Incyte announced the full enrollment of the Phase 3 study inMIND. The inMIND study evaluates whether tafasitamab and lenalidomide combined with rituximab provides improved clinical benefit compared with lenalidomide combined with rituximab in patients with r/r follicular lymphoma (FL) or r/r marginal zone lymphoma (MZL).
Financial Results for the Second Quarter of 2023 (IFRS):
Total revenues for the second quarter 2023 were € 53.2 million compared to € 59.4 million for the same period in 2022. This decrease resulted mainly from lower sales of clinical vials.
|
in € million* |
|
Q2 2023 |
|
Q1 2023 |
|
Q2 2022 |
|
Q-Q Δ |
|
Y-Y Δ |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
53.2 |
|
62.3 |
|
59.4 |
|
(15) % |
|
(10) % |
|
Monjuvi product sales |
|
21.7 |
|
19.4 |
|
21.7 |
|
12 % |
|
0 % |
|
Royalties |
|
26.8 |
|
21.6 |
|
22.0 |
|
24 % |
|
22 % |
|
Licenses, milestones and other |
|
4.6 |
|
21.3 |
|
15.7 |
|
(78) % |
|
(71) % |
|
* Differences due to rounding. |
|
|
|
|
|
|
|
|
|
|
Cost of Sales: In the second quarter 2023, cost of sales were € 7.7 million compared to € 17.2 million for the comparable period in 2022. The year-on-year decrease resulted primarily from lower expenses related to sales of clinical vials to Incyte.
Research and Development (R&D) Expenses: In the second quarter 2023, R&D expenses were € 57.0 million compared to € 60.9 million in the second quarter 2022. The decrease mainly resulted from lower expenses for external services.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the second quarter 2023 were € 22.0 million compared to € 24.0 million in the second quarter 2022. The decrease was driven by streamlining and focusing of selling efforts. General and administrative (G&A) expenses in the second quarter 2023 amounted to € 17.0 million compared to € 12.4 million in the second quarter 2022. The increase is mainly attributable to personnel-related matters.
Operating Loss: Operating loss amounted to € 50.5 million in the second quarter 2023 (Q2 2022: operating loss of € 55.1 million).
Consolidated Net Loss: For the second quarter 2023, consolidated net loss was € 74.0 million (Q2 2022: consolidated net loss of € 235.0 million). Prior year’s net loss for the second quarter was significantly impacted by foreign exchange effects recorded in finance expenses.
Financial Results for the first six months 2023 (IFRS):
Total revenues for the first six months of 2023 were € 115.5 million (H1 2022: € 100.9 million). Revenues include € 41.1 million from the recognition of Monjuvi product sales in the U.S. Royalties in H1 2023 included € 2.9 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 45.5 million from Tremfya® sales which is fully passed onto Royalty Pharma.
|
in € million* |
|
H1 2023 |
|
H1 2022 |
|
Y-Y Δ |
|
|
|
|
|
|
|
|
|
Total revenues |
|
115.5 |
|
100.9 |
|
14 % |
|
Monjuvi product sales |
|
41.1 |
|
38.3 |
|
7 % |
|
Royalties |
|
48.4 |
|
41.0 |
|
18 % |
|
Licenses, milestones and other |
|
25.9 |
|
21.5 |
|
20 % |
|
* Differences due to rounding. |
|
|
|
|
|
|
Cost of Sales: For the first six months of 2023, cost of sales were € 28.7 million (H1 2022: € 25.1 million). The gross margin of Monjuvi U.S. net product sales amounted to 82% (H1 2022: 80%).
Research and Development (R&D) Expenses: In the first six months of 2023, R&D expenses were € 140.1 million compared to € 126.0 million for the same period in 2022. R&D expenses increased due to higher additional costs resulting from the positive development of patient recruitment in MorphoSys’ major ongoing clinical trials. In addition, the first quarter of 2023 included a one-time effect from severance payments related to the restructuring of the research department.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the first six months of 2023 were € 38.9 million (H1 2022: € 45.9 million). The year-over-year decrease was driven by streamlining and focusing of selling efforts. General and administrative (G&A) expenses amounted to € 27.9 million in the first six months of 2023 (H1 2022: € 27.0 million).
Operating Loss: Operating loss amounted to € 120.0 million in the first six months of 2023 (H1 2022: operating loss of € 123.1 million).
Consolidated Net Loss: For the first six months of 2023, consolidated net loss was € 118.4 million (H1 2022: consolidated net loss of € 357.6 million). Prior year’s net loss for the first six months was significantly impacted by foreign exchange effects recorded in finance expenses.
Cash and Other Financial Assets: As of June 30, 2023, the Company had cash and other financial assets of € 672.8 million compared to € 907.2 million on December 31, 2022.
Number of shares: The number of shares issued totaled 34,231,943 on June 30, 2023, remained unchanged since December 31, 2022.
Full Year 2023 Financial Guidance:
|
|
2023 Financial Guidance |
2023 Guidance Insights |
|
Monjuvi U.S. net product sales |
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 |
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 |
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 U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses. |
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 planned for 2023 and beyond include the following:
- topline results for the pivotal Phase 3 study (MANIFEST-2) of pelabresib in myelofibrosis (MF) by the end of 2023;
- 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 second quarter: June 30, 2023)
|
in € million |
|
Q2 2023 |
|
Q2 2022 |
|
Δ |
|
H1 2023 |
|
H1 2022 |
|
Δ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
53.2 |
|
59.4 |
|
(10) % |
|
115.5 |
|
100.9 |
|
14 % |
|
Product Sales |
|
21.7 |
|
21.7 |
|
0 % |
|
41.1 |
|
38.3 |
|
7 % |
|
Royalties |
|
26.8 |
|
22.0 |
|
22 % |
|
48.4 |
|
41.0 |
|
18 % |
|
Licenses, milestones and other |
|
4.6 |
|
15.7 |
|
(71) % |
|
25.9 |
|
21.5 |
|
20 % |
|
Cost of Sales |
|
(7.7) |
|
(17.2) |
|
(55) % |
|
(28.7) |
|
(25.1) |
|
14 % |
|
Gross Profit |
|
45.5 |
|
42.2 |
|
8 % |
|
86.8 |
|
75.8 |
|
15 % |
|
Total Operating Expenses |
|
(96.0) |
|
(97.3) |
|
(1) % |
|
(206.8) |
|
(198.8) |
|
4 % |
|
Research and Development |
|
(57.0) |
|
(60.9) |
|
(6) % |
|
(140.1) |
|
(126.0) |
|
11 % |
|
Selling |
|
(22.0) |
|
(24.0) |
|
(8) % |
|
(38.9) |
|
(45.9) |
|
(15) % |
|
General and Administrative |
|
(17.0) |
|
(12.4) |
|
37 % |
|
(27.9) |
|
(27.0) |
|
3 % |
|
Operating Profit / (Loss) |
|
(50.5) |
|
(55.1) |
|
(8) % |
|
(120.0) |
|
(123.1) |
|
(3) % |
|
Other Income |
|
0.6 |
|
7.8 |
|
(92) % |
|
2.7 |
|
9.2 |
|
(71) % |
|
Other Expenses |
|
(0.5) |
|
(11.8) |
|
(96) % |
|
(2.4) |
|
(15.5) |
|
(85) % |
|
Finance Income |
|
6.6 |
|
6.2 |
|
6 % |
|
61.6 |
|
16.7 |
|
>100% |
|
Finance Expenses |
|
(28.3) |
|
(185.1) |
|
(85) % |
|
(56.6) |
|
(248.0) |
|
(77) % |
|
Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets |
|
0.0 |
|
(1.0) |
|
(100) % |
|
0.6 |
|
(1.0) |
|
>(100)% |
|
Share of Loss of Associates accounted for using the Equity Method |
|
(1.8) |
|
— |
|
n/a |
|
(4.3) |
|
— |
|
n/a |
|
Income Tax Benefit / (Expenses) |
|
0.0 |
|
4.0 |
|
(100) % |
|
0.0 |
|
4.0 |
|
(100) % |
|
Consolidated Net Profit / (Loss) |
|
(74.0) |
|
(235.0) |
|
(69) % |
|
(118.4) |
|
(357.6) |
|
(67) % |
|
Earnings per Share, Basic and Diluted |
|
(2.16) |
|
(6.88) |
|
(69) % |
|
(3.47) |
|
(10.47) |
|
(67) % |
|
Cash and other financial assets (end of period) |
|
672.8 |
|
907.2 * |
|
(26) % |
|
672.8 |
|
907.2 * |
|
(26) % |
*Value as of December 31, 2022
MorphoSys will hold its conference call and webcast tomorrow, on August 10, 2023, at 2:00pm CEST (1:00pm BST/8:00am EDT) to present the results of the second quarter and first half of 2023 and the outlook for 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.
A live webcast and slides will be made available in the Investors section under “Events & Conferences” of the 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 second quarter and the first six months of 2023 (IFRS) is 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, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at www.morphosys.com and follow us on Twitter and LinkedIn.
About Monjuvi
Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. 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 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
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 U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
Contacts
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 Contacts:
Dr. Julia Neugebauer
Head of Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com