OSAKA, Japan & CAMBRIDGE, Mass. -Friday 15 January 2021 [ AETOS Wire ]
− Goal to Reach JPY5 Trillion ($47 Billion) Revenue by FY20301, Representing 50% Growth from FY2019
− Wave 1 Pipeline Portfolio Includes 12 New Molecular Entities Targeted for Launch by FY2024 Representing Best-in-Class/First-in-Class Therapies with Significant Market Potential
− Rapid Deleveraging On Track to Achieve Target of 2x Net Debt / adjusted EBITDA within Fiscal Years 2021 to 2023
(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) provided an update on the progress of its continued transformation and growth today at the virtual 39th Annual J.P. Morgan Healthcare Conference. President and Chief Executive Officer, Christophe Weber, shared details on Takeda’s portfolio and pipeline strategy and financial outlook, including key programs expected to contribute to the company’s revenue growth over the next decade.
“In 2020, Takeda demonstrated the resilience of our business model, the depth of our portfolio and the commitment of our employees as we continued to serve patients and communities globally while overcoming challenges posed by the COVID-19 pandemic,” said Christophe Weber, Takeda president and chief executive officer. “As a values-based and R&D-driven biopharmaceutical company celebrating 240 years in 2021, we remain focused on bringing life-transforming treatments to patients worldwide by delivering on our highly innovative pipeline and our continued commitment to patients, our people and the planet.”
Highly Innovative Pipeline Supports Sustained Growth
Takeda has built a world-class, state-of-the-art, externally-facing R&D engine and has generated an innovative and modality diverse pipeline of approximately 40 clinical-stage new molecular entities (NMEs). Takeda’s pipeline portfolio has the potential to contribute significantly to revenue growth and the company has a goal to reach JPY5 trillion ($47 billion) revenue by FY20301, representing 50% growth from FY2019.
The majority of revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique NMEs, representing potential best-in-class/first-in-class therapies and its existing 14 global brands.
Takeda’s Wave 1 programs include five that have received a Breakthrough Therapy designation and three that were granted fast track designation by the U.S. Food and Drug Administration (FDA). In addition, one program was designated under the SAKIGAKE Designation System by the Japanese Ministry of Health, Labour and Welfare and another program was the first breakthrough designation granted by the Chinese Food and Drug Administration to a multinational biopharmaceutical company. Twelve pivotal milestones, including five pivotal data readouts, are expected through fiscal year 2022 with additional near-term development milestones expected across all Wave 1 programs.
Beyond the Wave 1 pipeline, Takeda’s research engine, which comprises internal research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline that will provide sustained growth in FY2025 and beyond. These Wave 2 early-clinical and preclinical programs are designed to provide transformative or curative potential for targeted populations with high unmet need across core therapeutic areas. They are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.
Key Wave 1 Pipeline Assets Have Significant Market Potential
TAK-003
Takeda's tetravalent dengue vaccine candidate (TAK-003) has the
potential to help address the massive global burden of dengue including
key priorities for dengue control such as protection of seronegative
individuals (persons not previously exposed to dengue) and prevention of
hospitalization. TAK-003 is based on a live-attenuated dengue serotype 2
virus, which provides the genetic “backbone” for all four vaccine
viruses. The TAK-003 development program includes the pivotal Phase 3
Tetravalent Immunization against Dengue Efficacy Study (TIDES), a
double-blind, randomized, placebo-controlled trial evaluating the safety
and efficacy of two doses of TAK-003 in the prevention of
laboratory-confirmed symptomatic dengue fever of any severity and due to
any of the four dengue virus serotypes in children and adolescents. The
TIDES trial is continuing, and safety and efficacy will be assessed
over a total of four and a half years. Dengue is the fastest spreading
mosquito-borne viral disease and was recognized by WHO to be one of the
top ten threats to global health in 2019. Approximately half of the
world's population now lives under the threat of dengue, which is
estimated to cause 390 million infections each year.
TAK-755
Takeda’s TAK-755 has the potential to be a transformative therapy for
thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening
clotting disorder defined by low or absent circulating ADAMTS13 activity
(an enzyme essential for regulation of normal blood clotting). There is
very high unmet need for new therapies for both congenital and
immune-mediated TTP, and TAK-755 is the first and only ADAMTS13
replacement therapy currently in development for both types of TTP. If
approved, TAK-755 could be the only replacement therapy to rapidly and
completely correct ADAMTS13 levels, and positively impact morbidity and
mortality. If approved, TAK-755 has the potential to be first-in-class
and the therapeutic choice for prophylaxis in congenital TTP, and a
best-in-class therapy for the treatment of immune-mediated TTP. TAK-755
could simplify treatment, avoid adverse events related to plasma-derived
therapy and plasma exchange, and provide the potential for at-home
therapy. Data readouts are currently expected in 2021 for a phase 2
trial in immune-mediated TTP and in 2022 for a pivotal Phase 3 trial in
congenital TTP.
TAK-007
Developed in collaboration with the University of Texas MD Anderson
Cancer Center, Takeda’s TAK-007 is a chimeric antigen receptor (CAR)
natural killer (NK) cell therapy ‘armored’ with IL-15 targeting CD19
positive B-cell malignancies. The vision is for TAK-007 to be an
allogeneic therapy, meaning the NK cells are taken from a non-related
healthy donor rather than the patient themselves. As a result, TAK-007
has the potential to be manufactured in advance and stored for
off-the-shelf-use. MD Anderson’s CAR-NK CD19 is being studied in a phase
1/2 trial in patients with relapsed or refractory non-Hodgkin’s
lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In the ongoing
phase 1/2 trial, CAR-NK therapy has not been associated with the severe
cytokine release syndrome (CRS) or neurotoxicity observed with existing
CAR-T cell therapies and has the potential to be administered in an
outpatient setting. A TAK-007 pivotal study is expected to begin
enrolling patients with relapsed or refractory B-cell malignancies in
2021. There are currently no approved CAR NK therapies and no allogeneic
cell therapies approved to treat cancer.
TAK-994 & TAK-925
TAK-994 is the first oral selective orexin 2 receptor agonist to enter
clinical development for the treatment of narcolepsy type 1 (NT1), a
rare neurologic condition characterized by excessive daytime sleepiness,
cataplexy (signs and symptoms of the disease) and is due to a loss of
orexin producing neurons. TAK-994 is currently being evaluated in an
ongoing Phase 2 clinical trial in narcolepsy (SPARKLE-1501). If
approved, TAK-994 may be the first treatment to address the underlying
biology of the disease. TAK-925 (IV formulation) has published
proof-of-concept data in NT1, narcolepsy type 2 (NT2), and shift work
sleep disorder. Data for idiopathic hypersomnia and obstructive sleep
apnea will be disclosed in the future.
Financial Strength
Takeda is committed to maintaining investment grade credit ratings and
remains on track towards its medium-term target of 2x Net Debt/adjusted
EBITDA ratio within the fiscal years 2021 to 2023, with rapid
de-leveraging driven by strong cash flow and proceeds from non-core
asset divestitures. In the first half of FY2020, Takeda exceeded its
$10B non-core asset divestiture target with 11 deals and up to ~$11.6
billion of non-core disposals announced since January 2019, while
further de-leveraging in H1 FY2020 led to a 3.7x net debt/adjusted
EBITDA ratio at the end of the period.
Takeda has solid growth momentum and potential for accelerated underlying growth over the medium term. Takeda is also on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021, further supporting margin performance to meet its medium-term underlying core operating profit margin target in the mid-30s. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.
Slides from the J.P. Morgan Healthcare Conference presentation and a link to the audio webcast can be accessed on Takeda’s website at: https://www.takeda.com/investors/ir-events/.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK)
is a global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to discover and deliver
life-transforming treatments, guided by our commitment to patients, our
people and the planet. Takeda focuses its R&D efforts on four
therapeutic areas: Oncology, Rare Genetic and Hematology, Neuroscience,
and Gastroenterology (GI). 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. 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
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part of any offer, invitation or solicitation of any offer to purchase,
otherwise acquire, subscribe for, exchange, sell or otherwise dispose
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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
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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
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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;
the success of or failure of product development programs; decisions of
regulatory authorities and the timing thereof; 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); 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/ reports/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release 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 press release may not be
indicative of, and are not an estimate, forecast, guarantee 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 Operating Profit, Underlying Core
Operating Profit, Core Net Profit, Underlying Core EPS, 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 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, including reconciliations to the most comparable measures presented under IFRS, is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/
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.
1 Includes incremental revenues on a non-PTS (probability of technical success) basis (i.e., figures represent best case scenarios, including technical success that Takeda does not currently consider probable to occur and should not be seen as a forecast or target figure). On a PTS-adjusted basis, Takeda expects revenue CAGR to be in the low single digits between FY2019 and FY2030. Does not include any potential impacts imposed by the Most Favored Nation Model interim final rule issued by the U.S. Centers for Medicare & Medicaid Services (CMS) on November 20, 2020, which are currently being assessed.
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Contacts
Media Contacts:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095
Media Outside Japan
Holly Campbell
holly.campbell@takeda.com
+1 617-588-9013
Investor Relations:
Christopher O’Reilly
christopher.oreilly@takeda.com
+81 (0) 3-3278-2543
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