OSAKA, Japan & CAMBRIDGE, Mass. - Thursday, 01. February 2024
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
(BUSINESS
WIRE /AETOSWire)-- 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%
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/
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Contacts
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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