On February 4, 2020 Takeda Pharmaceutical Company Limited reported the (Press release, Takeda, FEB 4, 2020, View Source [SID1234553842]).

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Underlying Revenue declined -1.2% vs FY2018 Q3 YTD pro-forma2, expected to recover in Q4 resulting in flat to slightly increasing for the full year

Takeda’s 14 global brands, with reported revenue of 836.4 billion yen in aggregate, posted a strong year- over-year underlying revenue growth of +20%, driven by ENTYVIO (+35.4%), TAKHZYRO (+622.2%), and NINLARO (+28.9%).
Underlying revenue growth year-to-date was solid in the key business areas of GI (+10%), Plasma Derived Therapy (PDT) Immunology (+5%), Oncology (+7%), and Neuroscience (+5%), while Rare Diseases declined (-11%) for the following reasons:
Rare Hematology (-14%) continues to be impacted as expected by intensified competition and increasing price pressure.
Hereditary Angioedema (HAE) (-11%) continues to be negatively affected by stocking in the prior fiscal year, as well as generic entry for FIRAZYR.
Rare Metabolic (-4%) continue to be impacted by NATPARA which was recalled in the U.S. in September 2019.
Please refer to note iii to the table entitled "Reported Results for FY2019 Q3 YTD (April – December)" below for Core Operating Profit definition.
FY2018 Q3 YTD pro-forma baseline represents the sum of Takeda revenue for FY2018 Q3 YTD (Apr-Dec) plus Shire revenue for the same period, where Shire revenue was converted to JPY at the rate of $1 = 111 JPY (average FX rate for FY2018) and converted from US GAAP to IFRS with no material difference; Takeda revenue and Shire revenue was adjusted to remove the revenue from divested assets. Please see the appendix for more details.

Underlying Core Operating Profit Margin of 30.9% for FY2019 Q3 YTD driven by cost synergies and OPEX efficiencies

Reported Operating Profit declined year-over-year -42.9% to 162.5 billion yen, largely impacted by non-cash purchase accounting expenses including the unwinding of inventory step-up and amortization of intangible assets. Reported Operating Profit was also impacted by significant one-time costs related to the Shire integration.
Core Operating Profit increased year-over-year +129.9% to 792.2 billion yen, primarily due to the consolidation of Shire, while also benefitting from the strong performance of Takeda 14 global brands, cost synergies and improved OPEX efficiency.
Underlying Core Operating Profit Margin year-to-date was 30.9% reflecting continued OPEX discipline and cost synergies.
Underlying Core EPS year-to-date was 359 yen.
R&D Engine Delivered Several Important Pipeline Milestones in Q3

Wave 1 pipeline assets achieving important milestones:
Phase 3 study start for TAK-788 in treatment naïve Non-Small-Cell Lung Cancer (NSCLC) with exon 20 insertion mutations, and pevonedistat (TAK-924) in unfit Acute Myeloid Leukemia.
Updated Dengue vaccine candidate TAK-003 results from the phase 3 study were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting.
Announced partnership with MD Anderson Cancer Center which includes the development of ongoing Phase 1/2a Study of TAK-007, a CD19 CAR-NK.
Global Brands generating additional data in new indications:
Phase 3 trial of NINLARO (TOURMALINE-MM4) as first line maintenance therapy met primary endpoint (PFS) in multiple myeloma patients not treated with stem cell transplantation.
ALUNBRIG ongoing phase 3 data continued to show reduction in disease progression after two years as a first line treatment in adults with advanced anaplastic lymphoma kinase-positive (ALK+) NSCLC who had not received a prior ALK inhibitor.
Continued emphasis on divesting non-core assets and deleveraging to focus the business

Net debt / adjusted EBITDA at 4.1x having paid full-year dividend and tax on XIIDRA proceeds.
Negotiations ongoing for further potential non-core asset divestments.

Costa Saroukos, Chief Financial Officer, commented:
"Takeda’s third quarter results demonstrated a continuation of our solid year-to-date financial and business performance, driven by our 14 global brands, powerful R&D engine, and OPEX improvements that will help to ensure our sustainable growth. We are again increasing our full year guidance to reflect strong business momentum and faster than anticipated realization of synergies.

Now operating as One Takeda, we continue to execute as anticipated on our business priorities to drive long-term value, including the realization of $2 billion in cost synergies by the end of FY 2021, divest $10 billion in non-core assets to optimize our portfolio, and rapidly de-leverage our net debt / adjusted EBITDA towards our goal of 2x within fiscal years ending March 2022 – March 2024. In parallel, our R&D engine continues to advance highly innovative medicines that make a critical difference to patients through both Takeda’s global brands and new molecular entities, with multiple important data readouts on the horizon. Executing on these priorities will maximize value creation for all of our stakeholders and position Takeda for continued success."

Reported Results for FY2019 Q3 YTD (April – December)

Underlying results 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.
Growth versus FY2018 Q3 YTD pro-forma. FY2018 Q3 YTD pro-forma baseline represents the sum of Takeda revenue for FY2018 Q3 YTD (Apr-Dec) plus Shire revenue for the same period, both adjusted to remove the revenue from divested assets, converted to JPY at the rate of $1 = 111 JPY (average FX rate for FY2018), and converted from US GAAP to IFRS with no material differences. Please see the appendix for more details.
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.
Attributable to the owners of the company.
FY2019 Management Guidance: Upgrading guidance to reflect positive business momentum

Constant Exchange Rate growth (applying FY2018 full year average foreign exchange rate of 111 JPY/USD) compared to baseline of JPY 3,300 billion (Rounded pro-forma April 2018-March 2019 combined revenue of Legacy Takeda and Legacy Shire, converted at April 2018-March 2019 average exchange rate of 111 JPY/USD; also adjusted to remove the revenue from divested assets such as Techpool, Multilab, and TACHOSIL from Legacy Takeda, and the oncology portfolio and XIIDRA from Legacy Shire) and converted from US GAAP to IFRS, without material differences.