– Entered into Business Combination Agreement
to be acquired by Novartis for € 68.00 per share in cash,
representing a total equity value of € 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
– € 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 € 68.00 per share
in cash, representing a total equity value of € 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 € 27.5 million (3M 2023: € 24.3 million). Group
revenues mainly included revenues from royalties in the amount of €
27.0 million (3M 2023: € 20.9 million), Additional Group revenues
from continued operations are attributable to licenses, milestones,
and other sources, amounting to € 0.5 million (3M 2023: € 3.5
million).
Cost of Sales: Cost of sales in the first quarter of 2024
amounted to € 2.8 million (3M 2023: € 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 € 85.2 million (Q1 2023: € 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 € 18.5 million (Q1
2023: € 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 € 185.5 million (Q1 2023: € 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 € 264.4
million in the first quarter 2024 (Q1 2023: operating loss of €
56.1 million).
Consolidated Net Loss: For the first quarter 2024,
consolidated net loss was € 311.0 million (Q1 2023: consolidated
net loss of € 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 (€ 5.9 million) prior to the sale of tafasitamab to
Incyte on February 5, 2024.
Minjuvi royalty revenue of € 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 € 170 million to
€ 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 € 90 million and € 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 € million
Q1 2024
Q1 2023
Δ
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
/ (Impairment Losses) on Financial Assets
0.1
0.5
(80
)%
Share of Loss of Associates accounted for
using the Equity Method
(1.5
)
(2.5
)
(40
)%
Income Tax Benefit / (Expenses)
1.6
0.0
n/a
Consolidated Net Profit / (Loss) from
Continued Operations
(311.0
)
(32.2
)
>100%
Consolidated Net Profit / (Loss) from
Discontinued Operations
(3.9
)
(12.2
)
(68
)%
Earnings per Share, Basic and Diluted (in
€) from continued operations
(8.27
)
(0.94
)
>100%
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 €
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240429848432/en/
Media Contacts: Thomas Biegi Senior Vice President,
Corporate Affairs Tel.: +49 (0)89 / 899 27 26079
thomas.biegi@morphosys.com Eamonn Nolan Senior Director, Corporate
Communications & Investor Relations Tel: +1 617-548-9271
eamonn.nolan@morphosys.com Investor Contact: Dr. Julia
Neugebauer Vice President, Global 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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