OSAKA, Japan--(뉴스와이어)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced financial results for the first half of fiscal year 2020 (period ended September 30, 2020).

TAKEDA PRESIDENT & CHIEF EXECUTIVE OFFICER CHRISTOPHE WEBER commented:

“Takeda’s performance in the first half of FY2020 demonstrates the resilience of our business model, the depth of our portfolio and the commitment of our employees, who continue to serve patients and communities globally while overcoming challenges created by the COVID-19 pandemic.

“Our results were once again driven by underlying growth of our 14 global brands across the five key business areas, which enabled us to generate strong margins and cash flow. Our R&D Engine continued to advance our Wave 1 pipeline, with 7 new regulatory filings anticipated within the next 12 months, and we expanded our cell therapy capabilities, both of which will help drive Takeda’s future growth. We also exceeded our divestiture target, with more than $11 billion of non-core disposals announced since January 2019, enabling us to continue to rapidly reduce debt.

“Takeda continues to focus on developing potential therapies to treat COVID-19 with, for example, the enrollment of the first patients in the CoVIg-19 Plasma Alliance Phase 3 clinical trial — an outstanding achievement in such a short time.

“We are confirming our full-year management guidance and raising forecasts for free cash flow, reported operating profit and reported earnings per share, reflecting our confidence in Takeda’s growth momentum. This is borne out by today’s encouraging results, despite the challenges posed by the COVID-19 pandemic. I am proud of all that we continue to achieve at Takeda and look forward to continuing to build on our strengths in the second half of FY2020.”

FINANCIAL AND BUSINESS HIGHLIGHTS

Results for H1 FY2020 Ended September 30, 2020 [1],[2],[3],[4] (To view the table, please visit https://bwnews.pr/37QtniZ)

1 Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

2 Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.

3 Free Cash Flow represents cash flows from operating activities, excluding acquisition of plant, property and equipment, and including proceeds from sales of plant, property and equipment, as further adjusted to exclude the acquisition of intangible assets and the acquisition of investments, and to include the proceeds from sales and redemption of investments and proceeds from sales of business, net of cash and cash equivalents divested.

4 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/

Takeda delivered a resilient performance in H1 FY2020

Reported revenue, at JPY 1,590.8 billion (~$15.1B)[1], was impacted primarily by foreign exchange and divestitures, however Takeda delivered underlying revenue growth of 0.5% in the first half of FY2020, consistent with full year guidance of “low-single-digit growth”.

We delivered reported operating profit of JPY 215.6 billion (~$2.0B)[1], which grew 97.7%, reflecting lower purchase price accounting (PPA) and integration costs. Core operating profit, which adjusts for PPA and non-recurring items, declined year-on-year to JPY 507.6 billion (~$4.8B)[1] owing to foreign exchange impact and divestitures. The core operating profit margin was 31.9%. Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, grew to 31.6% year-on-year, driven by synergies and OPEX efficiencies.

Takeda’s reported net profit was JPY 86.5 billion, a 15.8% increase compared with the same period in the prior year.[2] This is attributable mainly to lower purchase price accounting and integration costs.

Operating cash flow increased by 14.9% to JPY 392.0 billion. Free cash flow, which also reflects capital expenditures and proceeds from asset sales, was JPY 425.5 billion (~$4.0B)[3], with the year-on-year growth rate impacted by the JPY 375.5 billion cash received for Xiidra® in July 2019. Further de-leveraging in H1 led to a 3.7x net debt/adjusted EBITDA ratio at the end of the period.

The overall impact of the global spread of COVID-19 on Takeda’s consolidated financial results for the six-month period ended September 30, 2020 was not material. An adverse effect on revenue has been observed in some of our therapeutic areas, such as Neuroscience, for reasons such as patients visiting their medical care providers less frequently for non-life-threatening and chronic diseases. However, we have seen expansion of certain products with a more convenient administration profile. Voluntary suspension of certain business activities such as business travel and events in response to COVID-19 led to lower spending, which resulted in limited impact on Takeda’s profit. We continue to drive towards achieving our key deliverables in FY2020, while recognizing the potential for delays due to the pandemic, as detailed in Takeda’s Quick Report for the quarter ended September 30, 2020, released today. For the latest Takeda communications regarding COVID-19, please click here (https://bit.ly/34GhQkk) to visit the COVID-19 Information Center on Takeda’s website.

COMMERCIAL UPDATES ACROSS OUR FIVE KEY BUSINESS AREAS

Takeda’s five key business areas — Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience — with JPY 1,298.9 billion of reported revenue representing approximately 82% of total H1 revenues - delivered year-on-year underlying revenue growth of 4.0%. Our 14 global brands, with reported revenue of JPY 595.9 billion in aggregate, delivered a 15.4% increase in underlying revenue growth compared to a year before.

Gastroenterology

The Gastroenterology franchise with JPY 379.8 billion in reported revenue represented 24% of sales, spearheaded by exceptional growth through expanded patient share of gut-selective ENTYVIO in the U.S., EU, and Japan.

Rare Diseases

The Rare Diseases franchise with JPY 295.4 billion in reported revenue represented 19% of sales, with the hereditary angioedema portfolio experiencing double digit growth driven by continued strong performance and successful launches of TAKHZYRO. The competitive landscape in Rare Hematology, including a -19% decline in ADVATE sales partially driven by ADYNOVATE and competitive uptake, was in line with our expectations. Additionally, Takeda is working closely with the FDA on a proposed plan to resupply NATPARA in the U.S. and anticipates that the required device modifications and product testing will likely delay availability beyond 2020.

PDT Immunology

PDT Immunology with JPY 205.9 billion in reported revenue represented 13% of sales, driven by strong Gammagard-Liquid demand in the U.S. and subcutaneous IG worldwide. Albumin sales decreased versus H1 last year (-13%) due to phasing and high FY19 H1 sales as a result of supply dynamics in China following a blackout period. However, we expect this to recover in H2, driven by demand and capacity expansion.

Oncology

Oncology with JPY 210.0 billion in reported revenue represented 13% of sales as our portfolio continues to expand indications in metastatic non-small cell lung cancer, chronic myeloid leukemia, myeloma, and ovarian cancer.

Neuroscience

Neuroscience with JPY 207.8 billion in reported revenue represented 13% of sales, with slowing momentum attributable to COVID-19 stay-at-home restrictions that reduced patient visits and diagnoses and created opportunities for discontinuing medication. A normalization of sales was noted toward the end of Q2.

Global Brand Highlights (To view the table, please visit https://bwnews.pr/37QtniZ)

COST SAVINGS AND DIVESTITURES

Operational efficiencies and cost savings supported margin performance and we are on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021. Takeda is deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.7x at the end of Q2, down from 3.8x in March 2020. We are on course to meet our medium-term deleveraging goal of 2x within FY2021-FY2023.

Takeda exceeded its $10B non-core asset divestiture target and has announced 10 deals since January 2019 to date for a total aggregate value of up to ~$11.3 billion, including:

· Agreement to divest Takeda Consumer Healthcare Company Limited to Oscar A-Co KK, a company controlled by funds managed by The Blackstone Group Inc. and its affiliates for a total value of JPY 242.0 billion. The transaction is expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions. (Press release https://bit.ly/31VgQHe)

· Agreement to divest non-core assets in Europe and Canada to Cheplapharm for approximately $562 million, subject to customary legal and regulatory closing conditions (Press Release https://bit.ly/31VykTA)

· Agreement to divest its TACHOSIL Fibrin Sealant Patch to Corza Health, Inc. Takeda will receive €350 million in cash upon closing of the transaction expected by March 31, 2021, which is subject to customary legal and regulatory closing conditions. (Press release https://bit.ly/3oE8PQH)

Additionally, Takeda exceeded its $700 million target for incremental cash from real estate and securities, receiving $1.1 billion to date.

PIPELINE UPDATE: MOMENTUM IN OUR DYNAMIC R&D GROWTH ENGINE

Takeda has built a world-class R&D engine leveraging our internal research capabilities, while also actively engaging with innovative ecosystems around the world to translate science into highly innovative medicines. The main drivers for targeted new product launches are 12 unique New Molecular Entities (NMEs) in Wave 1, which represent several potential best-in-class / first-in-class therapies targeted for launch by FY2024 with aggregate potential peak sales of more than $10 billion.

As announced in the Q1 FY2020 results release, Takeda has seven of these potential Wave 1 NME filings targeted for the next 12 months: TAK-721, TAK-609, CoVIg-19, TAK-003, mobocertinib, pevonedistat and maribavir.

During Q2, Takeda’s R&D engine continued to advance its Wave 1 pipeline and expanded its capabilities in cell therapy. Wave 1 Q2 highlights include:

· TAK-721 completed the rolling NDA submission and remains on track to be the first FDA-approved agent to treat eosinophilic esophagitis.

· The CoVIg-19 Plasma Alliance began enrolling patients in the ITAC Phase 3 clinical trial to evaluate the safety, tolerability and efficacy of its investigational anti-coronavirus H-Ig medicine for treating hospitalized adults at risk for serious complications of COVID-19. (Press release https://bit.ly/3oG6RiI)

· TAK-003 is on track for a regulatory filing for Dengue vaccine in endemic countries in Asia and Latin America, and in the EU in Q4 FY2020.

· Mobocertinib (TAK-788) demonstrated ten-month follow-up results from the Phase 1/2 trial presented at the virtual European Society for Medical Oncology Conference (ESMO) and achieved a duration of response (DoR) of more than one year in the trial’s study population of patients with epidermal growth factor receptor (EGFR) Exon20 insertion+ metastatic NSCLC (mNSCLC). (Press release https://bit.ly/3kCg1KC)

· Soticlestat (TAK-935/OV935): Our Phase 2 ELEKTRA Study of Soticlestat in partnership with Ovid Therapeutics Inc. met its primary endpoint for reducing seizure frequency in children with Dravet Syndrome or Lennox-Gastaut Syndrome. (Press release https://bit.ly/3myluTm)

· TAK-994, the first oral OX2R agonist, is in phase 2 enrolling NT1 and NT2 patients. Final data is targeted for 2H FY21.

Other notable updates

We expanded our cell therapy manufacturing capabilities in Boston, Massachusetts to support next-generation clinical programs including TAK-007, TAK-940 and TAK-102. This expansion provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas. Five collaborative oncology cell therapy programs are expected to be in clinical development by the end of FY2021 and Takeda has already initiated clinical studies testing its CAR-T candidates, TAK-940 and TAK-102 in Q2. (Press release https://bit.ly/35LOW1x, website https://bit.ly/37UefRG)

We are excited about the transformative medium-term potential of a number of our major R&D programs, including:

· TAK-999: Takeda and Arrowhead Pharmaceuticals entered into a collaboration to develop TAK-999, a first-in-class GalNAc based RNAi designed to treat the underlying cause of Alpha-1 Antitrypsin-Associated Liver Disease. (Press release https://bit.ly/3oz5nXo)

· TAK-981, a first-in-class small molecule inhibitor of sumoylation that activates type 1 interferon signaling and lymphocyte activation, is being explored in more than 10 expansion cohorts with adaptive trial designs in a broad range of tumor types with a high unmet need. Emerging data demonstrated the therapy is well tolerated and responses have been observed in single-agent dose-escalation in solid tumors and in combination with rituximab in Non-Hodgkin’s lymphoma.

Takeda will share further pipeline progress at our upcoming Wave 1 Pipeline Market Opportunity call on December 8, 2020.

KEY CORPORATE INITIATIVE

Takeda is accelerating its digital transformation through a collaboration with Accenture and AWS that will leverage cloud and data-driven insights to improve our productivity across our value chain, increase operational agility, reduce technology costs, and develop the workforce of the future.

We are investing in developing capabilities and hiring new talent in emerging fields of data and digital. We will also train employees in cloud, advanced analytics, robotic process automation (RPA), agile and innovation sprint methodologies. By moving 80% of applications to the cloud, we will remove non-differentiating technology, reduce our internal data center footprint, and decrease capital expenditures. (Press release https://bit.ly/31VyTNc)

FIGHTING COVID-19 UPDATE

Guided by our values, Takeda's response to COVID-19 has focused on protecting the health and safety of our employees, striving to ensure our medicines are available to patients who rely on them and playing our part to reduce transmission and support the communities where our employees live and work. Takeda has also undertaken a number of efforts to help the world respond to COVID-19, including: (To view the table, please visit https://bwnews.pr/37QtniZ)

FY2020 GUIDANCE

Updating Full-Year Reported Forecast; Core and Underlying Guidance Confirmed

(To view the table, please visit https://bwnews.pr/37QtniZ)

Takeda has solid growth momentum heading into H2 2020 and potential for accelerated underlying growth and achieving an underlying core operating profit margin in the mid-30s over the medium term.

Core and underlying guidance for FY2020 remains unchanged. Takeda upgraded its reported operating profit, reported net profit, and reported EPS forecast for FY2020 to reflect assumptions for one-time gains from several announced divestitures that were not included in the previous forecast but are now expected to be recognized within the current fiscal year, with the exception of the sale of shareholdings in Takeda Consumer Healthcare Company Limited.[4] The reported revenue forecast for FY2020 has been reduced from JPY 3,250.0 billion to 3,200.0 billion, owing primarily to the impact of foreign exchange.

Key assumptions in FY2020 forecast

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of our 14 global brands, and accelerated realization of cost synergies.

FY2020 guidance also reflects the following key assumptions, including (i) that there will not be an additional 505(b)2 competitor for subcutaneous VELCADE launched in the U.S. within FY2020; (ii) includes the impact of divestitures disclosed by Takeda as through October 29, 2020, with the exception of the divestment of Takeda Consumer Healthcare Company; and (iii) management’s current expectations regarding COVID-19.

Based on currently available information, Takeda believes that its financial results for FY2020 will not be materially affected by COVID-19 and, accordingly, Takeda's FY2020 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2020, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in additional impacts on Takeda’s business, results of operations or financial condition, as well as resulting in significant deviations from Takeda’s FY2020 forecast.

For more details on Takeda's Q2 FY2020 results and other financial information, please visit: https://www.takeda.com/investors/reports/quarterly-announcements/

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 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, Rare Diseases, 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 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. 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; 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 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.

Financial information

Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). The revenue of Shire plc (“Shire”), which was historically, presented by Shire in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”), has been conformed to IFRS, without material difference.

[1] USD included for reference, calculated at JPY/USD of 105.6

[2] During FY2019, Takeda completed the purchase price allocation for the assets acquired and the liabilities assumed as part of the Shire acquisition. Accordingly, PL statements for FY2019 Q2 were retrospectively adjusted.

[3] USD included for reference, calculated at JPY/USD of 105.6

[4] In August 2020, Takeda announced that it entered into an agreement to divest Takeda Consumer Healthcare Company Limited (“TCHC”), a wholly-owned subsidiary of Takeda focused on the consumer health care market primarily in Japan, to Blackstone for a total value of 242.0 billion JPY. The transaction is expected to close by March 31, 2021, subject to customary legal and regulatory closing conditions. Takeda anticipates a pre-tax gain of approximately 140.0 billion JPY on the sale of shares of TCHC, to be recognized when the transfer of shares is executed and completed, however, it is not included in the revised forecast for the fiscal year ending March 31, 2021. Takeda will continue to assess the appropriate timing of inclusion of this event into its forecast, in consideration of the certainty of exact timing of deal closing.

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