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29.04.2024 22:01:24 - dpa-AFX: EQS-News: MorphoSys AG Reports First Quarter 2024 Financial Results (english)
MorphoSys AG Reports First Quarter 2024 Financial Results
EQS-News: MorphoSys AG / Key word(s): Quarterly / Interim Statement
MorphoSys AG Reports First Quarter 2024 Financial Results
29.04.2024 / 22:01 CET/CEST
The issuer is solely responsible for the content of this announcement.
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Media Release
Planegg/Munich, Germany, April 29, 2024
MorphoSys AG Reports First Quarter 2024 Financial Results
* Sold all tafasitamab rights worldwide to Incyte
* EUR 631.9 million in cash and other financial assets as of March 31, 2024
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter
of 2024.
"The proposed acquisition by Novartis is advancing steadily, and we continue
to anticipate its closure in the first half of 2024. The acceptance period
for the acquisition is currently underway, and both our Management Board and
Supervisory Board unanimously recommend that our shareholders accept the
offer and tender their shares given the highly attractive and equitable
offer price," said Jean-Paul Kress, M.D., Chief Executive Officer of
MorphoSys. "Utilizing its extensive resources, broad scientific experience
and worldwide presence, Novartis will help maximize commercial and expedite
development opportunities across our promising oncology programs."
Novartis' Public Takeover Offer Highlights:
On February 5, 2024, MorphoSys announced the intention of Novartis BidCo AG,
a wholly owned indirect subsidiary of Novartis AG (hereinafter collectively
referred to as "Novartis"), to submit a voluntary public takeover offer for
all outstanding MorphoSys no-par value bearer shares at an offer price of EUR
68.00 per share in cash, representing a total equity value of EUR 2.7 billion.
The offer price corresponds to a premium of 94% and 142% on the
volume-weighted average price during the last month and three months,
respectively, as of the unaffected January 25, 2024, closing price.
On March 13, 2024, MorphoSys confirmed the receipt of antitrust clearance in
Germany and Austria. Subsequently, on March 22, 2024, MorphoSys announced
the receipt of U.S. antitrust clearance. As a result, all mandatory
antitrust approvals for the proposed acquisition have been obtained.
On April 11, 2024, Novartis published its offer document. Following the
publication of the offer document, the MorphoSys Management Board and
Supervisory Board issued a joint reasoned statement, recommending that
shareholders accept the offer and tender their MorphoSys shares. The
acceptance period for shareholders commenced with the publication of the
offer document on April 11, 2024, and will end on May 13, 2024, at 24:00
hours CEST and 18:00 hours EDT (also on May 13, 2024).
Medical Conferences Highlights:
On April 24, 2024, MorphoSys announced that new efficacy and safety data
from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET
inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK
inhibitor-naïve patients with myelofibrosis will be highlighted during an
oral presentation on Friday, May 31, at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting. Additionally, new data from the
Phase 2 study of tulmimetostat, an investigational next-generation dual
inhibitor of EZH2 and EZH1, in patients with advanced solid tumors or
hematologic malignancies will be showcased in a poster presentation at ASCO
2024 on Saturday, June 1.
Financial Results for the First Quarter of 2024 (IFRS):
The financial results presented for the first quarter of 2024 relate to
continuing business operations of MorphoSys. Due to the announcement on
February 5, 2024, of the sale and transfer of all rights worldwide related
to tafasitamab to Incyte Corporation ("Incyte"), the entire tafasitamab
business has been classified as discontinued operations. Consequently, the
figures reported for the first quarter of 2023 were adapted due to this
change in presentation.
Group Revenues: Group revenues from continued operations amounted to EUR 27.5
million (3M 2023: EUR 24.3 million). Group revenues mainly included revenues
from royalties in the amount of EUR 27.0 million (3M 2023: EUR 20.9 million),
Additional Group revenues from continued operations are attributable to
licenses, milestones, and other sources, amounting to EUR 0.5 million (3M
2023: EUR 3.5 million).
Cost of Sales: Cost of sales in the first quarter of 2024 amounted to EUR 2.8
million (3M 2023: EUR 1.0 million). The year-on-year increase is mainly
attributable to higher personnel costs.
Research and Development (R&D) Expenses: In the first quarter 2024, R&D
expenses were EUR 85.2 million (Q1 2023: EUR 65.4 million). The increase
consists mainly in personnel expenses resulting from probable effects of
both an accelerated vesting of certain share-based compensation programs and
the recognition of remuneration-related provisions following the proposed
acquisition by Novartis.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the
first quarter 2024 were EUR 18.5 million (Q1 2023: EUR 3.4 million). The
increase in selling expenses is mainly due to the probable effects of
accelerated vesting of certain share-based payment programs and the
recognition of remuneration-related provisions following the proposed
acquisition by Novartis. General and administrative (G&A) expenses amounted
to EUR 185.5 million (Q1 2023: EUR 10.6 million). The increase in general and
administrative expenses is mainly due to the probable effects of accelerated
vesting of certain share-based payment programs and the recognition of
remuneration-related provisions following the proposed acquisition by
Novartis. Expenses resulting from external services mainly increased due to
the expected transaction costs in connection with the proposed acquisition
by Novartis.
Operating Loss: Operating loss amounted to EUR 264.4 million in the first
quarter 2024 (Q1 2023: operating loss of EUR 56.1 million).
Consolidated Net Loss: For the first quarter 2024, consolidated net loss was
EUR 311.0 million (Q1 2023: consolidated net loss of EUR 32.2 million).
Monjuvi/Minjuvi® Update (Discontinued Operations):
On February 5, 2024, MorphoSys entered into a purchase agreement with Incyte
to sell and transfer all rights worldwide related to tafasitamab to Incyte.
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 6.4 million (EUR 5.9
million) prior to the sale of tafasitamab to Incyte on February 5, 2024.
Minjuvi royalty revenue of EUR 0.6 million for sales outside of the U.S. prior
the sale of tafasitamab to Incyte on February 5, 2024.
Since February 5, 2024, all research and development activities in
connection with tafasitamab are in the responsibility of Incyte, and hence
MorphoSys does no longer recognize research and development expenses from
such activities.
Full Year 2024 Financial Guidance:
As a consequence of the sale and transfer of tafasitamab to Incyte on
February 5, 2024, MorphoSys' 2024 financial guidance published on January
30, 2024, cannot be maintained and therefore was revoked. For the time
being, MorphoSys will no longer make a forecast for the gross margin or
revenues from Monjuvi product sales, as no such revenues are expected to be
realized this year.
For 2024, MorphoSys expects R&D expenses of EUR 170 million to EUR 185 million
on a standalone basis. R&D expenses mainly represent our investments in the
development of pelabresib and tulmimetostat. Selling, administrative and
general expenses are expected to be between EUR 90 million and EUR 105 million
on a standalone basis. Potential effects from the implementation of the
Novartis takeover offer, including any first quarter 2024 related provisions
and expenses associated with the change of control, 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:
MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2024)
Earnings per Share, Basic and Diluted (in EUR) (8.27) (0.94) >100%
Conference call
Due to the pending acquisition of MorphoSys by Novartis, MorphoSys will not
be hosting its quarterly conference call and does not expect to do so in
future quarters. Earnings materials are publicly available on the Investor
Relations page of our website at www.morphosys.com/en/investors. Please
direct any questions to MorphoSys Investor Relations using the contact
information provided below.
About MorphoSys
At MorphoSys, we are driven by our mission: More life for people with
cancer. As a global 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 been approved by
any regulatory authorities. Its safety and efficacy have not been
established.
The development of pelabresib was funded in part by The Leukemia and
Lymphoma Society®.
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).
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.
Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2
trial sponsor.
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 (EZH1 and EZH2) proteins to reactivate tumor suppressor genes or
silencing the oncogenic pathways. 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.
About Tafasitamab
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. 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 U.S., and Minjuvi® in Europe
and Canada.
XmAb® is a registered trademark of Xencor, Inc.
Additional Information and Where to Find It
This communication is neither an offer to purchase nor a solicitation of an
offer to sell shares of MorphoSys AG (the "Company"). Following approval by
the German Federal Financial Supervisory Authority (the "BaFin"), Novartis
BidCo AG (formerly known as Novartis data42 AG) (the "Bidder") has published
an offer document containing the final terms and further provisions
regarding the offer to purchase all outstanding Company no-par value bearer
shares, including all no-par value bearer shares represented by American
Depositary Shares, at an offer price of EUR 68.00 per share in cash (the
"Takeover Offer"). The Bidder and Novartis AG have also filed with the U.S.
Securities and Exchange Commission (the "SEC") a Tender Offer Statement on
Schedule TO containing the offer document, the means to tender and other
related documents (together, the "Takeover Offer Documents"). The Takeover
Offer is being made solely pursuant to the Takeover Offer Documents, which
contain the full terms and conditions of the Takeover Offer. The Company's
management board and supervisory board have issued a joint reasoned
statement in accordance with sec. 27 of the German Securities Acquisition
and Takeover Act and the Company has filed a Solicitation/Recommendation
Statement on Schedule 14D-9 with the SEC (together with the joint reasoned
statement, the "Recommendation Statements"). THE COMPANY'S STOCKHOLDERS AND
OTHER INVESTORS ARE URGED TO READ THE TAKEOVER OFFER DOCUMENTS AND THE
RECOMMENDATION STATEMENTS, AS WELL AS OTHER DOCUMENTS FILED WITH THE SEC,
BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY
BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TAKEOVER OFFER. The Tender
Offer Statement on Schedule TO and the Solicitation/Recommendation Statement
on Schedule 14D-9 are available for free at the SEC's website at
www.sec.gov. Additional copies may be obtained for free by contacting the
Bidder or the Company. Free copies of these materials and certain other
offering documents are available on the Company's website in English at
morphosys.com/en/investors/Novartis-TakeoverOffer and in German at
morphosys.com/de/investoren/Novartis-TakeoverOffer, by mail to MorphoSys AG,
Semmelweisstrasse 7, 82152 Planegg, Germany or by phone at +49 89 8992 7179.
In addition to the Takeover Offer Documents and the Recommendation
Statements, the Company files other information with the SEC. The Company's
filings with the SEC are also available for free to the public from
commercial document-retrieval services and at the website maintained by the
SEC at www.sec.gov and are also available free of charge under the "SEC
Filings" section of the Company's website at www.morphosys.com/en/investors.
In order to reconcile certain areas where German law and U.S. law conflict,
Novartis AG and the Bidder obtained no action and exemptive relief from the
SEC to conduct the Takeover Offer in the manner described in the Takeover
Offer Documents.
Acceptance of the Takeover Offer by stockholders residing outside Germany
and the United States of America may be subject to further legal
requirements. With respect to the acceptance of the Takeover Offer outside
Germany and the United States, no responsibility is assumed for the
compliance with such legal requirements applicable in the respective
jurisdiction.
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 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; the effects of the Takeover Offer on relationships with
employees, other business partners or governmental entities; that the Bidder
and Novartis AG may not realize the potential benefits of the Takeover
Offer; transaction costs associated with the Takeover Offer; that the
Company's expectations may be incorrect; the inherent uncertainties
associated with competitive developments, clinical trial and product
development activities and regulatory approval requirements; the Company's
reliance on collaborations with third parties; estimating the commercial
potential of the Company's development programs; and other risks indicated
in the risk factors included in the Company's filings with the SEC,
including the Company's Annual Report on Form 20-F, as well as the
Solicitation/Recommendation Statement on Schedule 14D-9 filed by the Company
and the Tender Offer Statement on Schedule TO and related Takeover Offer
Documents filed by the Bidder and Novartis AG. 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 communication. The Company and the Bidder
expressly disclaim any obligation to update any such forward-looking
statements in this communication 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.
For more information, please contact:
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29.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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The issuer is solely responsible for the content of this announcement.
The EQS Distribution Services include Regulatory Announcements,
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1892061 29.04.2024 CET/CEST
EQS-News: MorphoSys AG / Key word(s): Quarterly / Interim Statement
MorphoSys AG Reports First Quarter 2024 Financial Results
29.04.2024 / 22:01 CET/CEST
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
Media Release
Planegg/Munich, Germany, April 29, 2024
MorphoSys AG Reports First Quarter 2024 Financial Results
* Entered into Business Combination Agreement to be acquired by Novartis
for EUR 68.00 per share in cash, representing a total equity value of EUR
2.7 billion
* Received all mandatory antitrust approvals for the proposed acquisition
by Novartis
* Shareholder acceptance period for the Novartis offer has commenced and
will end on May 13, 2024, at 24:00 hours CEST
* Sold all tafasitamab rights worldwide to Incyte
* EUR 631.9 million in cash and other financial assets as of March 31, 2024
MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the first quarter
of 2024.
"The proposed acquisition by Novartis is advancing steadily, and we continue
to anticipate its closure in the first half of 2024. The acceptance period
for the acquisition is currently underway, and both our Management Board and
Supervisory Board unanimously recommend that our shareholders accept the
offer and tender their shares given the highly attractive and equitable
offer price," said Jean-Paul Kress, M.D., Chief Executive Officer of
MorphoSys. "Utilizing its extensive resources, broad scientific experience
and worldwide presence, Novartis will help maximize commercial and expedite
development opportunities across our promising oncology programs."
Novartis' Public Takeover Offer Highlights:
On February 5, 2024, MorphoSys announced the intention of Novartis BidCo AG,
a wholly owned indirect subsidiary of Novartis AG (hereinafter collectively
referred to as "Novartis"), to submit a voluntary public takeover offer for
all outstanding MorphoSys no-par value bearer shares at an offer price of EUR
68.00 per share in cash, representing a total equity value of EUR 2.7 billion.
The offer price corresponds to a premium of 94% and 142% on the
volume-weighted average price during the last month and three months,
respectively, as of the unaffected January 25, 2024, closing price.
On March 13, 2024, MorphoSys confirmed the receipt of antitrust clearance in
Germany and Austria. Subsequently, on March 22, 2024, MorphoSys announced
the receipt of U.S. antitrust clearance. As a result, all mandatory
antitrust approvals for the proposed acquisition have been obtained.
On April 11, 2024, Novartis published its offer document. Following the
publication of the offer document, the MorphoSys Management Board and
Supervisory Board issued a joint reasoned statement, recommending that
shareholders accept the offer and tender their MorphoSys shares. The
acceptance period for shareholders commenced with the publication of the
offer document on April 11, 2024, and will end on May 13, 2024, at 24:00
hours CEST and 18:00 hours EDT (also on May 13, 2024).
Medical Conferences Highlights:
On April 24, 2024, MorphoSys announced that new efficacy and safety data
from the Phase 3 MANIFEST-2 trial of pelabresib, an investigational BET
inhibitor, in combination with the JAK inhibitor ruxolitinib in JAK
inhibitor-naïve patients with myelofibrosis will be highlighted during an
oral presentation on Friday, May 31, at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting. Additionally, new data from the
Phase 2 study of tulmimetostat, an investigational next-generation dual
inhibitor of EZH2 and EZH1, in patients with advanced solid tumors or
hematologic malignancies will be showcased in a poster presentation at ASCO
2024 on Saturday, June 1.
Financial Results for the First Quarter of 2024 (IFRS):
The financial results presented for the first quarter of 2024 relate to
continuing business operations of MorphoSys. Due to the announcement on
February 5, 2024, of the sale and transfer of all rights worldwide related
to tafasitamab to Incyte Corporation ("Incyte"), the entire tafasitamab
business has been classified as discontinued operations. Consequently, the
figures reported for the first quarter of 2023 were adapted due to this
change in presentation.
Group Revenues: Group revenues from continued operations amounted to EUR 27.5
million (3M 2023: EUR 24.3 million). Group revenues mainly included revenues
from royalties in the amount of EUR 27.0 million (3M 2023: EUR 20.9 million),
Additional Group revenues from continued operations are attributable to
licenses, milestones, and other sources, amounting to EUR 0.5 million (3M
2023: EUR 3.5 million).
Cost of Sales: Cost of sales in the first quarter of 2024 amounted to EUR 2.8
million (3M 2023: EUR 1.0 million). The year-on-year increase is mainly
attributable to higher personnel costs.
Research and Development (R&D) Expenses: In the first quarter 2024, R&D
expenses were EUR 85.2 million (Q1 2023: EUR 65.4 million). The increase
consists mainly in personnel expenses resulting from probable effects of
both an accelerated vesting of certain share-based compensation programs and
the recognition of remuneration-related provisions following the proposed
acquisition by Novartis.
Selling, General and Administrative (SG&A) Expenses: Selling expenses in the
first quarter 2024 were EUR 18.5 million (Q1 2023: EUR 3.4 million). The
increase in selling expenses is mainly due to the probable effects of
accelerated vesting of certain share-based payment programs and the
recognition of remuneration-related provisions following the proposed
acquisition by Novartis. General and administrative (G&A) expenses amounted
to EUR 185.5 million (Q1 2023: EUR 10.6 million). The increase in general and
administrative expenses is mainly due to the probable effects of accelerated
vesting of certain share-based payment programs and the recognition of
remuneration-related provisions following the proposed acquisition by
Novartis. Expenses resulting from external services mainly increased due to
the expected transaction costs in connection with the proposed acquisition
by Novartis.
Operating Loss: Operating loss amounted to EUR 264.4 million in the first
quarter 2024 (Q1 2023: operating loss of EUR 56.1 million).
Consolidated Net Loss: For the first quarter 2024, consolidated net loss was
EUR 311.0 million (Q1 2023: consolidated net loss of EUR 32.2 million).
Monjuvi/Minjuvi® Update (Discontinued Operations):
On February 5, 2024, MorphoSys entered into a purchase agreement with Incyte
to sell and transfer all rights worldwide related to tafasitamab to Incyte.
Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 6.4 million (EUR 5.9
million) prior to the sale of tafasitamab to Incyte on February 5, 2024.
Minjuvi royalty revenue of EUR 0.6 million for sales outside of the U.S. prior
the sale of tafasitamab to Incyte on February 5, 2024.
Since February 5, 2024, all research and development activities in
connection with tafasitamab are in the responsibility of Incyte, and hence
MorphoSys does no longer recognize research and development expenses from
such activities.
Full Year 2024 Financial Guidance:
As a consequence of the sale and transfer of tafasitamab to Incyte on
February 5, 2024, MorphoSys' 2024 financial guidance published on January
30, 2024, cannot be maintained and therefore was revoked. For the time
being, MorphoSys will no longer make a forecast for the gross margin or
revenues from Monjuvi product sales, as no such revenues are expected to be
realized this year.
For 2024, MorphoSys expects R&D expenses of EUR 170 million to EUR 185 million
on a standalone basis. R&D expenses mainly represent our investments in the
development of pelabresib and tulmimetostat. Selling, administrative and
general expenses are expected to be between EUR 90 million and EUR 105 million
on a standalone basis. Potential effects from the implementation of the
Novartis takeover offer, including any first quarter 2024 related provisions
and expenses associated with the change of control, 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:
* Following the anticipated close of the proposed acquisition by Novartis
in the first half of 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
the European Medicines Agency in the second half of 2024.
MorphoSys Group Key Figures (IFRS, end of the first quarter: March 31, 2024)
in EUR million Q1 2024 Q1
2023
Revenues 27.5 24.3 13 %
Royalties 27.0 20.9 29 %
Licenses, Milestones and Other 0.5 3.5 (86)
%
Cost of Sales (2.8) (1.0) >100%
Gross Profit 24.7 23.3 6 %
Total Operating Expenses (289.1) (79.4) >100%
Research and Development (85.2) (65.4) 30 %
Selling (18.5) (3.4) >100%
General and Administrative (185.5) (10.6) >100%
Operating Profit / (Loss) (264.4) (56.1) >100%
Other Income 0.8 2.1 (62)
%
Other Expenses (0.4) (1.8) (78)
%
Finance Income 9.6 50.8 (81)
%
Finance Expenses (56.8) (25.2) >100%
Income from Reversals of Impairment Losses / 0.1 0.5 (80)
(Impairment Losses) on Financial Assets %
Share of Loss of Associates accounted for using (1.5) (2.5) (40)
the Equity Method %
Income Tax Benefit / (Expenses) 1.6 0.0 n/a
Consolidated Net Profit / (Loss) from Continued (311.0) (32.2) >100%
Operations
Consolidated Net Profit / (Loss) from (3.9) (12.2) (68)
Discontinued Operations %
Earnings per Share, Basic and Diluted (in EUR) (8.27) (0.94) >100%
from continued operations
Cash and other financial assets (end of period) 631.9 680.5 (7) %
*
* Value as of December 31, 2023
Conference call
Due to the pending acquisition of MorphoSys by Novartis, MorphoSys will not
be hosting its quarterly conference call and does not expect to do so in
future quarters. Earnings materials are publicly available on the Investor
Relations page of our website at www.morphosys.com/en/investors. Please
direct any questions to MorphoSys Investor Relations using the contact
information provided below.
About MorphoSys
At MorphoSys, we are driven by our mission: More life for people with
cancer. As a global 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 been approved by
any regulatory authorities. Its safety and efficacy have not been
established.
The development of pelabresib was funded in part by The Leukemia and
Lymphoma Society®.
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).
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.
Constellation Pharmaceuticals, Inc., a MorphoSys company, is the MANIFEST-2
trial sponsor.
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 (EZH1 and EZH2) proteins to reactivate tumor suppressor genes or
silencing the oncogenic pathways. 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.
About Tafasitamab
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. 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 U.S., and Minjuvi® in Europe
and Canada.
XmAb® is a registered trademark of Xencor, Inc.
Additional Information and Where to Find It
This communication is neither an offer to purchase nor a solicitation of an
offer to sell shares of MorphoSys AG (the "Company"). Following approval by
the German Federal Financial Supervisory Authority (the "BaFin"), Novartis
BidCo AG (formerly known as Novartis data42 AG) (the "Bidder") has published
an offer document containing the final terms and further provisions
regarding the offer to purchase all outstanding Company no-par value bearer
shares, including all no-par value bearer shares represented by American
Depositary Shares, at an offer price of EUR 68.00 per share in cash (the
"Takeover Offer"). The Bidder and Novartis AG have also filed with the U.S.
Securities and Exchange Commission (the "SEC") a Tender Offer Statement on
Schedule TO containing the offer document, the means to tender and other
related documents (together, the "Takeover Offer Documents"). The Takeover
Offer is being made solely pursuant to the Takeover Offer Documents, which
contain the full terms and conditions of the Takeover Offer. The Company's
management board and supervisory board have issued a joint reasoned
statement in accordance with sec. 27 of the German Securities Acquisition
and Takeover Act and the Company has filed a Solicitation/Recommendation
Statement on Schedule 14D-9 with the SEC (together with the joint reasoned
statement, the "Recommendation Statements"). THE COMPANY'S STOCKHOLDERS AND
OTHER INVESTORS ARE URGED TO READ THE TAKEOVER OFFER DOCUMENTS AND THE
RECOMMENDATION STATEMENTS, AS WELL AS OTHER DOCUMENTS FILED WITH THE SEC,
BECAUSE THEY CONTAIN IMPORTANT INFORMATION WHICH SHOULD BE READ CAREFULLY
BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TAKEOVER OFFER. The Tender
Offer Statement on Schedule TO and the Solicitation/Recommendation Statement
on Schedule 14D-9 are available for free at the SEC's website at
www.sec.gov. Additional copies may be obtained for free by contacting the
Bidder or the Company. Free copies of these materials and certain other
offering documents are available on the Company's website in English at
morphosys.com/en/investors/Novartis-TakeoverOffer and in German at
morphosys.com/de/investoren/Novartis-TakeoverOffer, by mail to MorphoSys AG,
Semmelweisstrasse 7, 82152 Planegg, Germany or by phone at +49 89 8992 7179.
In addition to the Takeover Offer Documents and the Recommendation
Statements, the Company files other information with the SEC. The Company's
filings with the SEC are also available for free to the public from
commercial document-retrieval services and at the website maintained by the
SEC at www.sec.gov and are also available free of charge under the "SEC
Filings" section of the Company's website at www.morphosys.com/en/investors.
In order to reconcile certain areas where German law and U.S. law conflict,
Novartis AG and the Bidder obtained no action and exemptive relief from the
SEC to conduct the Takeover Offer in the manner described in the Takeover
Offer Documents.
Acceptance of the Takeover Offer by stockholders residing outside Germany
and the United States of America may be subject to further legal
requirements. With respect to the acceptance of the Takeover Offer outside
Germany and the United States, no responsibility is assumed for the
compliance with such legal requirements applicable in the respective
jurisdiction.
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 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; the effects of the Takeover Offer on relationships with
employees, other business partners or governmental entities; that the Bidder
and Novartis AG may not realize the potential benefits of the Takeover
Offer; transaction costs associated with the Takeover Offer; that the
Company's expectations may be incorrect; the inherent uncertainties
associated with competitive developments, clinical trial and product
development activities and regulatory approval requirements; the Company's
reliance on collaborations with third parties; estimating the commercial
potential of the Company's development programs; and other risks indicated
in the risk factors included in the Company's filings with the SEC,
including the Company's Annual Report on Form 20-F, as well as the
Solicitation/Recommendation Statement on Schedule 14D-9 filed by the Company
and the Tender Offer Statement on Schedule TO and related Takeover Offer
Documents filed by the Bidder and Novartis AG. 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 communication. The Company and the Bidder
expressly disclaim any obligation to update any such forward-looking
statements in this communication 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.
For more information, please contact:
Media Contacts: Thomas Biegi Investor Contacts: Dr. Julia Senior Vice President, Corporate Neugebauer Vice President, Global Affairs Tel.: +49 (0)89 / 899 27 Investor Relations Tel: +49 (0)89 / 26079 899 27 179 (1)thomas.biegi@morphosys.com (1)julia.neugebauer@morphosys.com 1. 1. mailto:thomas.biegi@morphosys.co mailto:julia.neugebauer@morphosys.c m om Eamonn Nolan Senior Director, Corporate Communications & Investor Relations Tel: +1 617-548-9271 (1)eamonn.nolan@morphosys.com 1. mailto:eamonn.nolan@morphosys.co m
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29.04.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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Language: English
Company: MorphoSys AG
Semmelweisstr. 7
82152 Planegg
Germany
Phone: +49 (0)89 899 27-0
Fax: +49 (0)89 899 27-222
E-mail: investors@morphosys.com
Internet: www.morphosys.com
ISIN: DE0006632003
WKN: 663200
Indices: MDAX, TecDAX
Listed: Regulated Market in Frankfurt (Prime Standard);
Regulated Unofficial Market in Berlin, Dusseldorf,
Hamburg, Hanover, Munich, Stuttgart, Tradegate
Exchange; Nasdaq
EQS News ID: 1892061
End of News EQS News Service
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1892061 29.04.2024 CET/CEST
| Name | WKN | Börse | Kurs | Datum/Zeit | Diff. | Diff. % | Geld | Brief | Erster | Schluss | |
|---|---|---|---|---|---|---|---|---|---|---|---|
 |
MORPHOSYS AG O.N. | 663200 | Xetra | 69,500 | 16.05.24 17:13:57 | +1,550 | +2,28% | 69,250 | 69,500 | 67,300 | 67,950 |
