– Topline data from the Phase 3 MANIFEST-2
study expected in early 2024
– Monjuvi® U.S. net product sales of US$ 25.3
million (€ 24.7 million) for the fourth quarter of 2022 and US$
89.4 million (€ 84.9 million) for the full year of 2022
– € 907.2 million in cash and other financial
assets as of December 31, 2022
– Conference call and webcast (in English)
tomorrow, March 16, 2023, at 1:00pm CET (12:00pm GMT/8:00am
EDT)
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the
fourth quarter and the full year 2022.
“2022 was a defining year for MorphoSys. We made advances in our
pipeline by progressing our Phase 3 clinical trials, including
pelabresib in myelofibrosis and tafasitamab in lymphomas. We also
out-licensed highly promising, early and mid-stage product
candidates, enabling us to concentrate exclusively on our work in
oncology,” said Jean-Paul Kress, M.D., Chief Executive Officer of
MorphoSys. “In 2023, we will continue to prioritize the Phase 3
study of pelabresib in myelofibrosis, on our way to sharing topline
data in early 2024 and exploring its potential use in other myeloid
diseases. We remain steadfast in our commitment to developing and
delivering novel therapies that are safer and more effective for
cancer patients, and we look forward to the future."
Pelabresib Highlights:
On January 9, 2023, MorphoSys announced that topline data from
the ongoing Phase 3 MANIFEST-2 study are expected to be available
in early 2024.
MorphoSys presented at ASH 2022 results from analyses of the
ongoing MANIFEST study in patients with myelofibrosis. The latest
analyses include longer-term data showing durable improvements in
both spleen volume and symptom score beyond 24 weeks, with
pelabresib plus ruxolitinib in JAK inhibitor-naïve patients.
Monjuvi/Minjuvi® Highlights:
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 25.3
million (€ 24.7 million) for the fourth quarter 2022 (Q4 2021: US$
23.6 million (€ 20.5 million)) and US$ 89.4 million (€ 84.9
million) for the full year of 2022 (2021: US$ 79.1 million (€ 66.9
million)).
Minjuvi royalty revenue of € 0.7 million for sales outside of
the U.S. in the fourth quarter 2022 and € 3.0 million for the full
year of 2022.
Tafasitamab Data:
At the ASH conference in December 2022, final safety and
efficacy results from firstMIND, a Phase 1b, open-label, randomized
safety study combining tafasitamab or tafasitamab plus lenalidomide
with standard R-CHOP were presented, showing no new safety signals
and providing additional information on progression-free survival
at 24 months for patients with newly diagnosed diffuse large B-cell
lymphoma (DLBCL) treated with tafasitamab plus lenalidomide and
R-CHOP. Two additional analyses also suggested that sensitive
assays to detect minimal residual disease have prognostic value at
the end of first-line therapy.
Corporate Developments:
On December 6, 2022, MorphoSys’ fully owned subsidiary
Constellation Pharmaceuticals, Inc. entered into a global licensing
agreement with Novartis to research, develop, and commercialize its
preclinical inhibitors of a novel cancer target. Under the terms of
the agreement, Novartis will assume full responsibility for all
subsequent research, development, and commercialization activities
for the program. As part of the agreement, MorphoSys received an
immediate upfront payment of US$ 23 million. On achievement of
development, regulatory, and commercial milestones, MorphoSys will
be eligible to receive milestone payments from Novartis in addition
to mid-single to low-double-digit royalties on program net
sales.
On December 20, 2022, MorphoSys announced that Sung Lee, the
company’s Chief Financial Officer and Management Board member, has
decided to leave MorphoSys to move back to California. His last day
with MorphoSys will be March 17, 2023.
Significant Events After the End of the
Fourth Quarter of 2022:
On March 2, 2023, MorphoSys announced that it will stop work and
operations on its pre-clinical research programs to optimize its
cost structure. MorphoSys will reduce its workforce at the
company’s headquarters in Planegg, Germany, by approximately 17%.
This action, along with other steps taken over the past year,
enables MorphoSys to focus resources on its mid- to late-stage
oncology pipeline.
On March 14, 2023, MorphoSys announced that Lucinda Crabtree,
Ph.D., will join as Chief Financial Officer and member of the
Management Board. She will start in the third quarter 2023 at the
latest.
Charlotte Lohmann was appointed as Chief Legal Officer on March
1, 2023 and will serve as a member of MorphoSys’ Management Board
ad interim.
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 U.S. by our
partner Incyte and € 96.9 million from Tremfya® sales which is
fully passed on to Royalty Pharma.
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 U.S. and Minjuvi
outside of the U.S. and expenses related to activities to optimize
the Monjuvi supply chain.
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 December 31, 2022,
the Company had cash and other financial assets of € 907.2 million
compared to € 976.9 million on December 31, 2021.
Number of shares: The number of shares issued totaled
34,231,943 on December 31, 2022, no change compared to December 31,
2021.
Full Year 2023 Financial
Guidance:
Amounts in million
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. 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 Key Figures (IFRS, end
of financial year: December 31, 2022)
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 Goodwill
—
(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 December 31, 2021
MorphoSys will hold its conference call and webcast tomorrow,
March 16, 2023, at 1:00pm CET (12:00pm GMT/8:00am EDT) to present
the results for the fourth quarter and the full year 2022.
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=3478238&linkSecurityString=469447192
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 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.
Consolidated Financial Statements 2022 (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 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 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, 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.
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 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
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