– Phase 3 MANIFEST-2 topline results expected
by the end of November, with detailed findings in oral presentation
at ASH 2023
– Monjuvi® U.S. net product sales of US$ 23.4
million (€ 21.5 million) for the third quarter of 2023
– U.S. FDA granted Fast Track designation for
tulmimetostat in ARID1A-mutated endometrial cancer
– € 642.2 million in cash and other financial
assets as of September 30, 2023
Conference call and webcast (in English) tomorrow, November 16,
2023, at 2:00 pm CET (1:00 pm GMT/8:00 am ET)
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the
third quarter and the first nine months of 2023.
“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) 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) Annual Meeting in San Diego, USA. During ASH
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 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:
https://services.choruscall.it/DiamondPassRegistration/register?confirmationNumber=2512285&linkSecurityString=36bda1015
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, 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 at X and LinkedIn.
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 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).
Please see the U.S. full Prescribing Information for Monjuvi for
important safety information.
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 and Canada.
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 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.
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
MorphoSys (NASDAQ:MOR)
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MorphoSys (NASDAQ:MOR)
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