- Two New U.S. FDA Approvals in FY2023 Q3: FRUZAQLA for Adults
With Previously Treated Metastatic Colorectal Cancer and ADZYNMA
for Ultra-Rare Blood Clotting Disorder cTTP
- Strong Commercial Execution Maximizing Value of Existing
Portfolio:
- ENTYVIO® Pen Launched in U.S. for Ulcerative Colitis; U.S.
FDA Approval Decision on Crohn’s Disease Filing Expected in early
FY2024
- QDENGA ® Dengue Vaccine Now Launched in 21
Countries
- LIVTENCITY ® Approved in China for Refractory
Post-Transplant CMV
- Revenue Growth of +4.6% at Actual Exchange Rate (AER); Flat
at Constant Exchange Rate (CER)
- Core Operating Profit Change of -12.7% at CER, Reflecting
Generic Impact, Lower Coronavirus Vaccines Revenue and Increased
Investment in R&D and Data, Digital & Technology
- Life-Cycle Management Approvals for HYQVIA® and GAMMAGARD
LIQUID® in January Support Forward Momentum of Growth & Launch
Products
- Confirms Full-Year Management Guidance
Takeda (TOKYO:4502/NYSE:TAK) today announced financial results
for the third quarter of fiscal year 2023 (period ended December
31, 2023). With year-to-date strong momentum in its Growth &
Launch Products (+12.7% at CER) offsetting the significant revenue
impact of generic entrants, Takeda remains on track towards its
full-year Management Guidance.
Takeda chief financial officer, Costa Saroukos,
commented: “In FY2023 Q3 we made further progress in our vision
to discover and deliver life-transforming treatments, receiving two
new U.S. FDA approvals and broadening the reach of our existing
portfolio with multiple life-cycle management approvals for our
Growth & Launch Products.
“We remain on track towards our full-year Management Guidance at
CER, reflecting significant generic impact, lower coronavirus
vaccines revenue and investment in R&D and data, digital and
technology to secure our long-term competitiveness, as well as
continued strong momentum in our Growth & Launch Products.
“We continue to improve our debt profile with 100% of our debt
now at fixed interest rates averaging 1.6%, and our financial
foundation remains strong as we enter the fourth quarter of
FY2023.”
FINANCIAL HIGHLIGHTS
Results for FY2023 Q3 YTD Ended
December 31, 2023
(Billion yen, except percentages and per
share amounts)
REPORTED
CORE(c)
(Non-IFRS)(a)
FY2023 Q3 YTD
vs. PRIOR YEAR
(Actual % change)
FY2023 Q3 YTD
vs. PRIOR YEAR
(Actual % change)
vs. PRIOR YEAR
(CER % change(d))
Revenue
3,212.9
+4.6%
3,212.9
+4.6%
+0.0%
Operating Profit
224.1
-44.2%
865.6
-9.3%
-12.7%
Margin
7.0%
-6.1pp
26.9%
-4.1pp
Net Profit
147.1
-48.6%
643.6
-9.0%
-12.2%
EPS (yen)
94
-48.9%
412
-9.7%
-12.9%
Operating Cash Flow
437.8
-36.0%
Free Cash Flow (Non-IFRS)(a)(b)
36.3
-93.8%
(a) Further information regarding certain
of Takeda’s Non-IFRS measures is posted on Takeda’s investor
relations website at
https://www.takeda.com/investors/financial-results/quarterly-results/.
(b) We define Free Cash Flow as cash flows
from operating activities, subtracting acquisition of property,
plant and equipment (“PP&E”), intangible assets and investments
as well as removing any other cash that is not available to
Takeda’s immediate or general business use, and adding proceeds
from sales of PP&E, as well as from sales of investments and
businesses, net of cash and cash equivalents divested.
(c) Core results adjust our reported
results calculated and presented pursuant to IFRS to exclude the
effect of items unrelated to Takeda’s core operations, such as, to
the extent applicable for each line item, non-recurring items,
purchase accounting effects and transaction related costs, as well
as amortization and impairment of intangible assets and other
operating income and expenses.
(d) CER (Constant Exchange Rate) change
eliminates the effect of foreign exchange rates from year-over-year
comparisons by translating Reported or Core results for the current
period using corresponding exchange rates in the same period of the
previous fiscal year.
FY2023 OUTLOOK
On track towards full-year FY2023
Management Guidance
(Billion yen except per share amounts)
FY2023
FORECAST (Unchanged
from
October 2023)
FY2023
MANAGEMENT GUIDANCE
Core Change at CER
(Non-IFRS) (Unchanged from May 2023)
Revenue
3,980.0
Core Revenue
3,980.0
Low-single-digit % decline
Reported Operating Profit
225.0
Core Operating Profit
1,015.0
Low-10s % decline
Reported Net Profit
93.0
Reported EPS (yen)
59
Core EPS (yen)
447
Low-20s % decline
Free Cash Flow*
400.0-500.0
Annual Dividend per Share (yen)
188
*Free Cash Flow forecast reflects expenditures related to the
acquisition of TAK-279 from Nimbus and in-licensing of FRUZAQLA
(fruquintinib) from HUTCHMED.
Additional Information About Takeda’s FY2023 Q3 Earnings
Results For more details on Takeda’s FY2023 Q3 results and
other financial information, including key assumptions in FY2023
forecast and management guidance, please visit:
https://www.takeda.com/investors/financial-results/quarterly-results/
For more information on Takeda’s commercial progress across the
five key business areas and pipeline updates, please visit:
https://takeda.info/qr2023_q3_qfr_en
About Takeda Takeda is focused on creating better health
for people and a brighter future for the world. We aim to discover
and deliver life-transforming treatments in our core therapeutic
and business areas, including gastrointestinal and inflammation,
rare diseases, plasma-derived therapies, oncology, neuroscience and
vaccines. Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
Important Notice For the purposes of this notice, “press
release” means this document, any oral presentation, any question
and answer session and any written or oral material discussed or
distributed by Takeda Pharmaceutical Company Limited (“Takeda”)
regarding this press release. This press release (including any
oral briefing and any question-and-answer in connection with it) is
not intended to, and does not constitute, represent or form part of
any offer, invitation or solicitation of any offer to purchase,
otherwise acquire, subscribe for, exchange, sell or otherwise
dispose of, any securities or the solicitation of any vote or
approval in any jurisdiction. No shares or other securities are
being offered to the public by means of this press release. No
offering of securities shall be made in the United States except
pursuant to registration under the U.S. Securities Act of 1933, as
amended, or an exemption therefrom. This press release is being
given (together with any further information which may be provided
to the recipient) on the condition that it is for use by the
recipient for information purposes only (and not for the evaluation
of any investment, acquisition, disposal or any other transaction).
Any failure to comply with these restrictions may constitute a
violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns
investments are separate entities. In this press release, “Takeda”
is sometimes used for convenience where references are made to
Takeda and its subsidiaries in general. Likewise, the words “we”,
“us” and “our” are also used to refer to subsidiaries in general or
to those who work for them. These expressions are also used where
no useful purpose is served by identifying the particular company
or companies.
The product names appearing in this document are trademarks or
registered trademarks owned by Takeda, or their respective
owners.
Forward-Looking Statements This press release and any
materials distributed in connection with this press release may
contain forward-looking statements, beliefs or opinions regarding
Takeda’s future business, future position and results of
operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often
include words such as “targets”, “plans”, “believes”, “hopes”,
“continues”, “expects”, “aims”, “intends”, “ensures”, “will”,
“may”, “should”, “would”, “could”, “anticipates”, “estimates”,
“projects” or similar expressions or the negative thereof. These
forward-looking statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those expressed or implied
by the forward-looking statements: the economic circumstances
surrounding Takeda’s global business, including general economic
conditions in Japan and the United States; competitive pressures
and developments; changes to applicable laws and regulations,
including global health care reforms; challenges inherent in new
product development, including uncertainty of clinical success and
decisions of regulatory authorities and the timing thereof;
uncertainty of commercial success for new and existing products;
manufacturing difficulties or delays; fluctuations in interest and
currency exchange rates; claims or concerns regarding the safety or
efficacy of marketed products or product candidates; the impact of
health crises, like the novel coronavirus pandemic, on Takeda and
its customers and suppliers, including foreign governments in
countries in which Takeda operates, or on other facets of its
business; the timing and impact of post-merger integration efforts
with acquired companies; the ability to divest assets that are not
core to Takeda’s operations and the timing of any such
divestment(s); the extent to which our internal energy conservation
measures and future advancements in renewable energy or low carbon
energy technology will enable us to reduce our greenhouse gas
emissions; and other factors identified in Takeda’s most recent
Annual Report on Form 20-F and Takeda’s other reports filed with
the U.S. Securities and Exchange Commission, available on Takeda’s
website at:
https://www.takeda.com/investors/sec-filings-and-security-reports/
or at www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this report or any other
forward-looking statements it may make, except as required by law
or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
report may not be indicative of, and are not an estimate, forecast,
guarantee or projection of Takeda’s future results.
Financial information and Certain Non-IFRS Financial
Measures Takeda’s financial statements are prepared in
accordance with International Financial Reporting Standards
(“IFRS”).
This press release and materials distributed in connection with
this press release include certain financial measures not presented
in accordance with IFRS, such as Core Revenue, Core Operating
Profit, Core Net Profit, Core EPS, Constant Exchange Rate (“CER”)
change, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow.
Takeda’s management evaluates results and makes operating and
investment decisions using both IFRS and non-IFRS measures included
in this presentation. These non-IFRS measures exclude certain
income, cost and cash flow items which are included in, or are
calculated differently from, the most closely comparable measures
presented in accordance with IFRS. By including these non-IFRS
measures, management intends to provide investors with additional
information to further analyze Takeda’s performance and core
results, including when controlling for the effect of fluctuations
in exchange rates. Takeda’s non-IFRS measures are not prepared in
accordance with IFRS and such non-IFRS measures should be
considered a supplement to, and not a substitute for, measures
prepared in accordance with IFRS (which we sometimes refer to as
“reported” measures). Investors are encouraged to review the
definitions and reconciliations of non-IFRS financial measures to
their most directly comparable IFRS measures, which are in the
financial appendix at the end of Takeda's FY2023 Q3 investor
presentation (available at
takeda.com/investors/financial-results/quarterly-results/).
Medical information This press release contains
information about products that may not be available in all
countries, or may be available under different trademarks, for
different indications, in different dosages, or in different
strengths. Nothing contained herein should be considered a
solicitation, promotion or advertisement for any prescription drugs
including the ones under development.
Please refer to slide 17 of Takeda’s FY2023 Q3 investor
presentation (available at
takeda.com/investors/financial-results/quarterly-results/) for the
definition of Growth & Launch Products.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240131987348/en/
Investor Relations Christopher O’Reilly
Christopher.oreilly@takeda.com +81 (0) 3-3278-2543
Media Relations Brendan Jennings
Brendan.jennings@takeda.com +81 (0) 3-3278-2111
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