Friday, May 17, 2019

Takeda Reports FY2018 Full Year Results and Issues FY2019 Guidance

 • Excellent FY2018 results driven by key growth products and strict Opex discipline, with Legacy Takeda1 greatly exceeding original guidance and absorbing Shire acquisition-related costs

• 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.
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.”

1References 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

2Gastroenterology (GI), Rare Diseases, Plasma-Derived Therapies, Oncology, and Neuroscience

3Entyvio, Gattex/Revestive, Alofisel, Vpriv, Elaprase, Natpara/Natpar, Adynovate, Takhzyro, HyQvia, Cuvitru, Gammagard Liquid/Kiovig, Albumin/Flexbumin, Ninlaro, Alunbrig

4Schreiber S, et al. J Crohns Colitis 2019;13(Supplement_1):S612–3 (abst OP34). [Oral presentation]

5Biologics Licensing Application in the U.S.; Marketing Authorization Line Extension Application in the EU

6Divestments 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.

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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

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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

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.

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Investor Relations
Takeda Pharmaceutical Company Limited
Takashi Okubo, +81-(0)3-3278-2306

Media Relations
Takeda Pharmaceutical Company Limited
Kazumi Kobayashi, +81 (0)3-3278-2095

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