Takeda Accelerates Transformation: Solid FY2019 Results, Confidence in FY2020 Growth Momentum

Takeda Pharmaceutical Company Limited (TOKYO: 4502) (NYSE: TAK) (“Takeda”) today announced financial results for the year ended March 31, 2020 (FY2019). As a top 10 global R&D-driven biopharmaceutical company, Takeda is demonstrating its innovation and values in its response to COVID-19 and in positioning itself for long-term success.

• FY2019 reported revenue JPY 3,291 billion, up 57% in first full year following acquisition of Shire.
• FY2019 reported operating profit greatly exceeded initial guidance to reach over JPY 100 billion, despite significant non-cash acquisition-related impact.
• Core operating profitⁱ increased 110% year on year to JPY 962 billion.
• Takeda raised its cost synergy target to $2.3 billion and is on track to deliver on its targets to rapidly pay down debt and continue to divest non-core assets.
• Free cash flow up sharply by 156% to JPY 968 billion, enabling Takeda to sustain its well-established dividend policy of 180 yen per share.
• Takeda delivered positive reported net profit of JPY 44 billion for FY2019.
• Reported operating profit forecast to more than triple to JPY 355 billion in FY2020; Takeda’s growth momentum expected to continue this year and accelerate in the medium term.

Takeda President and Chief Executive Officer Christophe Weber commented:

“Our transformation into a top 10 global biopharmaceutical company accelerated this year and helped us deliver another set of excellent results. We’re fully operating as one Takeda, with growth driven by our five key business areas and a geographic footprint aligned with global market opportunities. Above all, we’re a values-based company that is translating science into life-changing medicines.

“In line with our values, Takeda is taking a lead in meeting the challenges of the COVID-19 outbreak. We initiated a global industry alliance, sharing our world-class Plasma-Derived Therapy R&D, plasma collection and manufacturing capabilities to work collaboratively with other global and regional plasma companies to accelerate development of CoVIg-19, a potential plasma-derived therapy for patients at risk from serious complications of COVID-19. Clinical trials are on track to begin in the summer and if successful, CoVIg-19 has the potential to be one of the earliest approved treatment options.”

“Our guidance for FY2020 reflects confidence in Takeda’s growth momentum,” Weber continued. “We are positioned for success with our next wave of growth driven by promising product candidates in our R&D pipeline targeted for launch in the next five years, and a potentially transformative early-stage pipeline for longer-term growth.”

HIGHLIGHTS

Solid Results as Takeda’s Transformation Accelerated in FY2019

Reported Results for FY2019 Ended March 31, 2020^ii,iii,iv

(billion yen)	REPORTED		CORE		UNDERLYING
	FY2019	vs. PRIOR YEAR	FY2019	vs. PRIOR YEAR
Revenue	3,291.2	+56.9 %	3,291.2	+56.9 %	+1.6 % y-o-y (pro-forma)
Operating Profit	100.4	-57.8 %	962.2.	+109.5 %
Margin	3.1 %	-8.3pp	29.2%	+7.3 pp	28.9%
Net Profit	44.2	-67.3 %	602.2	+87.4 %
EPS (JPY)	28 yen	-79.8%	387 yen	+52 yen	395 yen
Free Cash Flow	968.0	+156.0%

• 5 key business areas, which represent approx. 79% of total FY2019 revenues, grew 6% year on year pro forma on an underlying basis.
• Our leading GI therapy, ENTYVIO, our treatment for rare hereditary angioedema, TAKHZYRO, and our Plasma-Derived Therapies all delivered strong growth. Notable contributors to underlying FY2019 growth include:
  • ENTYVIO +33% (Gastroenterology);
  • TAKHZYRO +318% (Rare Diseases);
  • NINLARO +29% (Oncology);
  • TRINTELLIX +25% (Neuroscience); and
  • ALBUMIN/FLEXBUMIN +20% (PDT Immunology).
• Our PDT Immunology business area delivered a strong improvement with 9% underlying revenue growth year-on-year.
  • Revenue growth of Immunoglobulin products accelerated to 17% in Q4 on a pro forma underlying basis compared to the same period last year, driven by successful expansion of subcutaneous IG (SCIG).
• During Q4 Takeda received approval for ENTYVIO (Vedolizumab) in China for the treatment of patients with moderate to severe active Ulcerative Colitis (UC) and Crohn's Disease (CD).
• Reported operating profit was over JPY 100 billion, greatly exceeding initial guidance, despite significant non-cash items related to the acquisition of Shire.
• Cost synergies and operating expenditure efficiencies contributed to a 110% increase in core operating profit year-on-year to nearly 1 trillion yen (JPY 962 billion), and to a 7 percentage point improvement in underlying core operating margin from 22% last year to 28.9% for FY2019.
• Strong free cash flow of nearly 1 trillion yen (JPY 968 billion) from operations and divestitures enabled debt repayment of JPY 701 billion and supported a 180 yen per-share dividend, in line with Takeda’s long-standing dividend policy.

FY2020 Guidance: Growth Momentum Expected to Continue

(billion yen)	FY2019 Results	FY2020 Forecast	Underlyingv (Management Guidance)
Revenue	3,291.2	3,250.0	Low-single-digit growth
Reported Operating Profit	100.4	355.0
Core Operating Profit	962.2	984.0	High-single-digit growth
Core Operating Profit Margin	29.2%	30.3%	Low-30s%
Reported EPS (Yen)	28	39
Core EPS (Yen)	387	420	Low-teen growth
Annual Dividend per Share (Yen)	180	180

Takeda has strong growth momentum heading into FY2020 and prospects for accelerated underlying revenue and underlying core operating profit growth and underlying core operating profit margin in the mid-30s over the medium term.

FY2020 reported operating profit is forecast to more than triple as the company will be less impacted by the non-cash acquisition related expenses taken in FY2019. Takeda expects underlying core operating profit growth in the high single digits and underlying core earnings per share growth in the low teens for FY2020. Takeda expects to maintain its dividend to shareholders of 180 yen per share.

Company guidance reflects management’s expectations for continued business momentum across Takeda’s 5 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 to launch in the U.S. within FY2020; (ii) no impact of any potential further divestitures beyond what has already been disclosed by Takeda; and (iii) management’s current expectations regarding COVID-19.

To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease COVID-19, despite the various effects on its operations as detailed in Takeda’s Quick Report for the quarter and year ended March 31, 2020, released today. 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 result in significant deviations from Takeda’s FY2020 forecast.

Strategic Update: Multi-year Transformation to Top 10 Global Biopharma Company

Takeda’s FY2019 results underscore the extent of our multi-year transformation. Since FY2014, Takeda has risen from a top 20 to a top 10 global biopharmaceutical company in revenue terms, with revenues nearly doubling to JPY 3,291 billion. Underlying core operating margin has improved by 12 percentage points in that time and is on a medium-term trajectory to industry top-tier levels.

Takeda’s prospects are driven by a much-transformed global business platform and innovation engine for delivering patient impact and shareholder value. The business is focused on 5 key business areas with growing brands – Gastroenterology (21% of FY2019 sales), Rare Diseases (20%), Plasma Derived Therapies (12%), Oncology (13%), and Neuroscience (13%), with growing brands and a strong R&D pipeline of promising therapies in these areas.

Takeda’s geographic footprint is now strongly aligned with global biopharmaceutical industry growth opportunities: United States (48% of FY2019 sales), Japan (18%); Europe and Canada (20%) and Growth and Emerging Markets (14%). Our increased scale strengthens our competitive position and platform for growth from developing and delivering innovative therapies in key geographic markets.

Strong Progress on Cost Synergies, Deleveraging and Divestiture Programs

The integration of Shire is now almost complete, and we are operating fully as one Takeda. We raised our cost synergy target to an annual run rate of $2.3 billion from $2.0 billion by the end of FY2021, with a run rate of $1.1 billion of cost savings already achieved. Takeda paid down JPY 701 billion debt in FY2019, including JPY 230 billion of prepayments, bringing the net debt to EBITDA ratio down to 3.8x as of March 31, 2020 from 4.7x as of March 31, 2019. The company’s $10 billion divestiture program is on track, with 5 transactions worth up to $7.7 billion completed or announced to date.

Next Wave of Growth with Strong R&D Pipeline

Takeda has built a world-class, state-of-the-art 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 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 FY 2024 with potential peak sales of >$10 billion. Our research engine is quickly advancing next generation therapies designed to provide transformative or curative potential for targeted populations with high unmet needs for FY 2025 onward. These programs are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.

• 14 global brands with more than 20 ongoing pivotal studies in new indications / geographies.
• Expanding in China with more than 15 planned approvals over the next 5 years.
• 12 best-in-class / first-in-class NMEs with potential approval through FY 2024 and 9 ongoing registration enabling studies.
• Sustained growth (FY2025 and beyond) through ~30 clinical-stage early development NMEs and next generation platforms.
• 38 new R&D collaborations with biotech and academia signed in FY2019, adding to the more than 200 partnerships already in place.

For more details on Takeda's FY2019 results and other financial information, please visit: https://www.takeda.com/investors/reports/quarterly-announcements/

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, 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.

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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/quarterly-announcements-2019/

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.
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.
This press release includes certain pro forma information giving effect to the Shire acquisition as if it had occurred on April 1, 2018. This pro forma information has not been prepared in accordance with Article 11 of Regulation S-X. This pro forma information is presented for illustrative purposes and is based on certain assumptions and judgments based on information available to us as of the date hereof, which may not necessarily have been applicable if the Shire acquisition had actually happened as of April 1, 2018. Moreover, this pro forma information gives effect to certain transactions and other events which are not directly attributable to the Shire acquisition and/or which happened subsequently to the Shire acquisition, such as divestitures and the effects of the purchase price allocation for the Shire acquisition, and therefore may not accurately reflect the effect on our financial condition and results of operations if the Shire acquisition had actually been completed on April 1, 2018. Therefore, undue reliance should not be placed on the pro forma information included herein.

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i	Please refer to definitions on page 2 of this press release and in Takeda’s financial statements for more details.
ii	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.
iii	Underlying growth for the fiscal year ended March 31, 2020 versus the previous fiscal year ended March 31, 2019, pro-forma. The pro-forma baseline represents the sum of Takeda revenue for the previous fiscal year (April 2018 to March 2019) plus Legacy Shire revenue from April 2018 through the acquisition date (January 8, 2019), both adjusted to remove the revenue from divested assets, with Legacy Shire revenue converted to JPY at the rate of 1 USD = 111 JPY (average FX rate for the previous fiscal year ended March 31, 2019) and converted from US GAAP to IFRS with no material differences.
iv	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.
v	Underlying growth adjusts for divestitures (assets divested in FY2019 and disclosed divestitures expected to close in FY2020) and applies a constant exchange rate (FY2019 full year average FX rate).

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Contact information

Investor Relations:
Takashi Okubo
takashi.okubo@takeda.com
+81-(0)3-3278-2306

Media Contacts:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Tsuyoshi Tada
tsuyoshi.tada@takeda.com
+1 (617) 551-2933