• In FY2019, continued momentum of key growth products in Takeda’s five key business areas2 is expected to largely offset significant loss of exclusivity headwinds
• Strong base for future growth with a balanced portfolio of 14 global brands3, an innovative R&D engine to deliver a sustainable pipeline, and a commitment to margin expansion and deleveraging targets
OSAKA, Japan-Thursday 16 May 2019 [ AETOS Wire ]
(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TOKYO:4502)(NYSE:TAK):
FY2018 Full Year Results
Legacy Takeda Underlying Revenue +5.3%; Consolidated reported revenue +18.5%
- Underlying Revenue growth for Legacy Takeda was solid at +5.3%, with significant contributions from key growth products such as ENTYVIO (+34.8%) and NINLARO (+36.1%).
- Consolidated reported revenue increased +18.5% to 2,097.2 billion yen. This was mainly due to the inclusion of Legacy Shire’s results from January 8, 2019, which was offset by the one-time negative impact from applying Takeda’s distribution channel policies to Legacy Shire products.
Legacy Takeda Underlying Core Earnings margin expanded +540 basis points
- Legacy Takeda underlying Core Earnings grew +38.7%, with Opex discipline driving three fourths of the +540bps margin expansion. Legacy Takeda’s underlying Core Earnings margin has now expanded +960bps based on simple addition of gains in the last two years, driven by key growth products and execution of the Global Opex Initiative.
- Legacy Takeda operating profit grew +70.3% mainly driven by business momentum. Large one-time gains in FY2017 from the divestiture of Wako Pure Chemical and the transfer of additional products to the Teva JV were matched by increased gains on sales of real estate and the divestitures of Multilab and Techpool in FY2018.
- Consolidated reported operating profit decreased -15.2% to 205.0 billion yen, and consolidated reported EPS declined -52.6% to 113 yen per share, mainly impacted by significant non-cash purchase accounting expenses. The strong performance in Legacy Takeda reported operating profit entirely absorbed Shire acquisition-related costs incurred in FY2018.
Innovative R&D engine delivered important pipeline milestones
- ENTYVIO demonstrated superior efficacy versus adalimumab in ulcerative colitis head-to-head VARSITY study4. Regulatory applications for a subcutaneous formulation filed in the U.S. for ulcerative colitis and Europe for ulcerative colitis and Crohn’s disease.5
- Approvals in FY2018 for TAKHZYRO in the U.S. and Europe as well as ALUNBRIG in Europe. Important label expansions for ADCETRIS to include previously untreated Hodgkin lymphoma approved in Japan and Europe, as well as TRINTELLIX in the U.S. to include data on speed of processing and Treatment Emergent Sexual Dysfunction.
- Innovative pipeline has delivered 15 New Molecular Entity clinical stage-ups since April 2018.
- 44 new collaborations with biotech and academia in FY2018, and announced 3 leading-edge cell-therapy partnerships.
Disposing non-core assets to generate cash and focus the business
- Consolidated Free Cash Flow +4.6% to 378.1 billion yen, including 200.9 billion yen from the sale of real estate, marketable securities, and non-core businesses Techpool and Multilab.
- On May 8, 2019, Takeda announced agreements to divest XIIDRA to Novartis for $3.4 billion upfront in cash and up to an additional $1.9 billion in potential milestones, and TACHOSIL to Ethicon for €358 million upfront with a long-term Manufacturing Services Agreement.6
- Takeda intends to use proceeds from the disposal of non-core assets to reduce debt and accelerate deleveraging toward its target of 2.0x net debt/adjusted EBITDA in 3 to 5 years.
Christophe Weber, President and Chief Executive Officer of Takeda, commented:
“Fiscal
2018 was an important year in the history of Takeda as we completed the
acquisition of Shire to create a competitive, values-based,
R&D-driven global biopharmaceutical leader. I am delighted to say
that throughout the year, while we have focused on planning and
executing the integration, we have also maintained strong business
momentum, as demonstrated by our excellent financial results.
The integration of Shire is progressing as planned, aligned with Takeda’s values and culture. We have also identified opportunities to realize greater cost synergies, and already have made progress on our divestment strategy for non-core assets.
The integration of Shire is progressing as planned, aligned with Takeda’s values and culture. We have also identified opportunities to realize greater cost synergies, and already have made progress on our divestment strategy for non-core assets.
Looking ahead, I believe we have a strong and resilient foundation for the future growth of the business. We are focused on our five key business areas of GI, Rare Diseases, Plasma-Derived Therapies, Oncology and Neuroscience, and our revenue over the medium term will be driven by a balanced portfolio including 14 global brands. Our innovative pipeline is also delivering, as shown by the 15 clinical stage-ups over the past year, and we are committed to executing towards our margin expansion and deleveraging targets.
With our business area focus, R&D engine, and financial strength, Takeda is well positioned to deliver long-term value to patients and our shareholders.”
|
1
|
|
References
to “Legacy Takeda” exclude Legacy Shire financials (which have been
consolidated into Takeda’s results from January 8, 2019 to March 31,
2019), costs incurred by Legacy Takeda and Legacy Shire related to the
acquisition, and financial impact from purchase accounting. References
to “Legacy Shire” are to the businesses acquired in Takeda’s acquisition
of Shire, which was completed on January 8, 2019, and to the results of
those businesses before or after the completion of the acquisition, as
the context requires
|
|
2
|
Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience
|
|
|
3
|
Entyvio,
Gattex/Revestive, Alofisel, Vpriv, Elaprase, Natpara/Natpar, Adynovate,
Takhzyro, HyQvia, Cuvitru, Gammagard Liquid/Kiovig, Albumin/Flexbumin,
Ninlaro, Alunbrig
|
|
|
4
|
Schreiber S, et al. J Crohns Colitis 2019;13(Supplement_1):S612–3 (abst OP34). [Oral presentation]
|
|
|
5
|
Biologics Licensing Application in the U.S.; Marketing Authorization Line Extension Application in the EU
|
|
|
6
|
Divestments
of XIIDRA and TACHOSIL expected to close the second half of calendar
year 2019, subject to customary closing conditions, including the
satisfaction of legal, regulatory and, where applicable, local works
council requirements.
Click here for the full press release.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK)
is a global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to bringing Better Health and a
Brighter Future to patients by translating science into
highly-innovative medicines. Takeda focuses its R&D efforts on four
therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and
Neuroscience. We also make targeted R&D investments in
Plasma-Derived Therapies and Vaccines. We are focusing on developing
highly innovative medicines that contribute to making a difference in
people's lives by advancing the frontier of new treatment options and
leveraging our enhanced collaborative R&D engine and capabilities to
create a robust, modality-diverse pipeline. Our employees are committed
to improving quality of life for patients and to working with our
partners in health care in approximately 80 countries and regions.
For more information, visit https://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 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.
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. In particular, this press release contains forecasts and
management estimates related to the financial and operational
performance of Takeda, including statements regarding forecasts for
Revenue, Operating profit, Adjusted EBITDA, Profit before income taxes,
Net profit attributable to owners of Takeda, Basic earnings per share,
Amortization and impairment and other income/expense, Underlying
Revenue, Underlying Core Earnings margin, Underlying Core EPS and Net
Debt. Without limitation, forward looking statements often include the
words such as “targets”, “plans”, “believes”, “hopes”, “continues”,
“expects”, “aims”, “intends”, “will”, “may”, “should”, “would”, “could”
“anticipates”, “estimates”, “projects” or words or terms of similar
substance or the negative thereof. Any forward-looking statements in
this document are based on the current assumptions and beliefs of Takeda
in light of the information currently available to it. Such
forward-looking statements do not represent any guarantee by Takeda or
its management of future performance and involve known and unknown
risks, uncertainties and other factors, including but not limited to:
the economic circumstances surrounding Takeda’s business, including
general economic conditions in Japan, the United States and worldwide;
competitive pressures and developments; applicable laws and regulations;
the success of or failure of product development programs; decisions of
regulatory authorities and the timing thereof; changes in exchange
rates; claims or concerns regarding the safety or efficacy of marketed
products or products candidates; and post-merger integration with
acquired companies, any of which may cause Takeda’s actual results,
performance, achievements or financial position to be materially
different from any future results, performance, achievements or
financial position expressed or implied by such forward-looking
statements. For more information on these and other factors which may
affect Takeda’s results, performance, achievements, or financial
position, see “Item 3. Key Information—D. Risk Factors” in Takeda’s
Registration Statement on Form 20-F filed with the U.S. Securities and
Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov.
Neither Takeda nor its management gives any assurances that the
expectations expressed in these forward-looking statements will turn out
to be correct, and actual results, performance or achievements could
materially differ from expectations. Persons receiving this press
release should not place undue reliance on forward looking statements.
Takeda undertakes no obligation to update any of the forward-looking
statements contained in this press release or any other forward-looking
statements it may make. Past performance is not an indicator of future
results and the results of Takeda in this press release may not be
indicative of, and are not an estimate, forecast or projection of
Takeda’s future results.
Certain Non-IFRS Financial Measures
This press
release and materials distributed in connection with this press release
include certain IFRS financial measures not presented in accordance with
International Financial Reporting Standards (“IFRS”),
such as Underlying Revenue, Core Earnings, Underlying Core Earnings,
Core Net Profit, Underlying Core Net Profit, Underlying Core EPS, Net
Debt, EBITDA, Adjusted EBITDA and Operating Free Cash Flow. Takeda’s
management evaluates results and makes operating and investment
decisions using both IFRS and non-IFRS measures included in this press
release. 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, core results and underlying trends. 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
reconciliation of non-IFRS financial measures to their most directly
comparable IFRS measures.
Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/quarterly-announcements-2018/
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.
Financial information
Takeda’s
financial statements are prepared in accordance with International
Financial Reporting Standards (“IFRS”). The financial statements of
Shire plc (“Shire”) are presented in accordance with accounting
principles generally accepted in the United States (“U.S. GAAP”).
Therefore, the respective financial information of Takeda and Shire are
not directly comparable.
The Shire
acquisition closed on January 8, 2019, and our consolidated results for
the fiscal year ended March 31, 2019 include Shire’s results from
January 8, 2019 to March 31, 2019. References to “Legacy Takeda”
businesses are to our businesses held prior to our acquisition of Shire.
References to “Legacy Shire” businesses are to those businesses
acquired through the Shire acquisition.
Furthermore,
this presentation refers to Takeda’s Adjusted EBITDA and Shire’s
Non-GAAP EBITDA. Takeda’s Adjusted EBITDA is not a measure presented in
accordance with IFRS, and Shire’s Non-GAAP EBITDA is not a measure
presented in accordance with U.S. GAAP. The most closely comparable
measure presented in accordance with IFRS (for Takeda) is net profit for
the year and in accordance with U.S. GAAP (for Shire) is net income.
Please see slides 58 and 74 for a further description of Takeda’s
Adjusted EBITDA and Shire’s Non-GAAP EBITDA and a reconciliation to the
respective most closely comparable measures presented in accordance with
IFRS and U.S. GAAP. Takeda’s Adjusted EBITDA and Shire’s Non-GAAP
EBITDA are not directly comparable, because (1) Takeda’s results are
based on IFRS and Shire’s results are based on U.S. GAAP and (2)
Takeda’s Adjusted EBITDA and Shire’s Non-GAAP EBITDA are defined
differently.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190513005951/en/
Contacts Investor Relations Takeda Pharmaceutical Company Limited Takashi Okubo, +81-(0)3-3278-2306 takeda.ir.contact@takeda.com Media Relations Takeda Pharmaceutical Company Limited Kazumi Kobayashi, +81 (0)3-3278-2095 kazumi.kobayashi@takeda.com |
