Table of Contents

Quarterly Securities Report(The third quarter of 145th Business Term)for The Nine-month Period and Three-month
Quarter Ended December 31, 2021

TAKEDA PHARMACEUTICAL COMPANY LIMITEDAND ITS SUBSIDIARIESTable of Contents
Index
Page

[Cover]A. Company Information

1

I. Overview of Takeda

2
2
3

1. Key Consolidated Financial Data
2. Business Overview
II. Operating and Financial Review
1. Risk Factors
2. Analysis on Business Performance, Financial Position and Cash Flows
3. Material Contracts
III. Information on the Company
1. Information on the Company’s Shares
2. Members of the Board of Directors
IV. Financial Information
1. Condensed Interim Consolidated Financial Statements
2. Others
B. Information on Guarantors of the Company

4
4
4
22
23
23
25
26
27
48
49

Table of Contents[Cover][Document Filed][Applicable Law]
[Filed with][Filing Date][Fiscal period]

Quarterly Securities Report
Article 24-4-7, paragraph 1 of the Financial Instruments and Exchange Act of Japan
Director, Kanto Local Finance Bureau

February 10, 2022
The third quarter of 145th Business Term(from October 1, 2021 to December 31, 2021)[Company Name]
Takeda Pharmaceutical Company Limited[Title and Name of Representative] Christophe Weber, Representative Director, President & Chief Executive Officer[Address of Head Office]1-1, Doshomachi 4-chome, Chuo-ku, Osaka(The above address is the registered head office location and the ordinary business
operations are conducted at the “Nearest Place of Contact”)[Telephone Number]
Not applicable[Name of Contact Person]
Not applicable[Nearest Place of Contact]
1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo(Global Headquarters)[Telephone Number]+81-3-3278-2111 (Main telephone number)[Name of Contact Person]
Norimasa Takeda, Chief Accounting Officer & Corporate Controller, Global Finance[Place for public inspection]
Takeda Pharmaceutical Company Limited (Global Headquarters)(1-1, Nihonbashi Honcho 2-chome, Chuo-ku, Tokyo)
Tokyo Stock Exchange, Inc.
(2-1, Nihonbashi Kabutocho, Chuo-ku, Tokyo)
Nagoya Stock Exchange, Inc.
(8-20, Sakae 3-chome, Naka-ku, Nagoya)Fukuoka Stock Exchange(14-2, Tenjin 2-chome, Chuo-ku, Fukuoka)
Sapporo Stock Exchange(14-1, Minamiichijonishi 5-chome, Chuo-ku, Sapporo)-1-

Table of Contents

A. Company Information
I. Overview of Takeda
1. Key Consolidated Financial Data
JPY (millions), unless otherwise indicatedNine-month period
Nine-month period
For the year ended
ended December 31, ended December 31,
March 31,
Term

2020

2021

Revenue<Three-month period ended December 31>
Profit before tax
Net profit for the period
Net profit attributable to owners of the Company<Three-month period ended December 31>
Total comprehensive income for the period
Total equity
Total assets
Basic earnings per share (JPY)<Three-month period ended December 31>
Diluted earnings per share (JPY)
Ratio of equity attributable to owners of the Company tototal assets (%)
Net cash from (used in) operating activities
Net cash from (used in) investing activities
Net cash from (used in) financing activities
Cash and cash equivalents at the end of the period

2,427,538
836,753
235,357
179,027
178,907
92,359169,450
4,639,428
12,286,137
114.5759.08
113.72

2,695,717
901,294356,618
241,541
241,41757,770459,0445,331,822
12,698,519
154.0936.91
153.0337.7
609,971
100,199(718,282)
617,635

42.0
747,521(172,487)(826,465)
724,341(Note 1)
(Note 2)2021

3,197,812
366,235
376,171
376,005
697,416
5,177,177
12,912,293
240.72238.9640.1
1,010,931
393,530(1,088,354)
966,222

All amounts shown are rounded to the nearest million JPY.
The key consolidated financial data for the nine-month period ended December 31, 2020 and 2021 are based on thecondensed interim consolidated financial statements prepared in accordance with IAS 34.

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Table of Contents
2. Business Overview
There has been no significant change in our business for the nine-month period ended December 31, 2021.
Changes in number of our group companies were as follows:
During the three-month period ended June 30, 2021, Takeda added 1 subsidiary while deconsolidated 9 entities mainly due
to the mergers and liquidations of subsidiaries acquired in the acquisition of Shire plc. In addition, Takeda added 1
associate accounted for using the equity method and excluded 1 entity from associates accounted for using the equity
method.
During the three-month period ended September 30, 2021, Takeda deconsolidated 14 entities mainly due to the mergers
and liquidations of subsidiaries acquired in the acquisition of Shire plc. In addition, Takeda added 1 associate accounted forusing the equity method.
During the three-month period ended December 31, 2021, Takeda added 4 subsidiaries in association with the acquisitionof the associate accounted for using the equity method and deconsolidated 3 entities due to the mergers and liquidation ofsubsidiaries. In addition, Takeda excluded 2 entities from associate accounted for using the equity method.
As a result, as of December 31, 2021, Takeda consisted of 239 entities comprised of 218 consolidated subsidiaries(including partnerships), 20 associates accounted for using the equity method, and Takeda Pharmaceutical Company
Limited.

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Table of Contents
II. Operating and Financial Review
1. Risk Factors
For the nine-month period ended December 31, 2021, there were no unusual changes in our business performance, financial
position, and cash flows, as well as no significant changes in the risk factors compared to what we reported in our Annual
Securities Report for the year ended March 31, 2021 which was filed in Japan.
For the impact of the spread of COVID-19 and Takeda’s initiatives in response, please refer to "2. Analysis on Business
Performance, Financial Position and Cash Flows (3) Management Policy, Management Environment and Management
Issues."2. Analysis on Business Performance, Financial Position and Cash Flows(1) Consolidated Financial Results (April 1 to December 31, 2021):
Billion JPY or percentage
Change versus the same period of theprevious fiscal year

FY2020 Q3YTDFY2021 Q3YTDRevenue

2,427.5

2,695.7

268.2

11.0 %

Cost of sales(740.9)(798.5)(57.6)

7.8 %Selling, general and administrative expenses(641.3)(662.9)(21.7)

3.4 %Research and development expenses
Amortization and impairment losses on intangible
assets associated with products(342.5)(382.5)(39.9)

11.7 %(307.6)(323.6)(16.1)

5.2 %Other operating income

118.5

34.3

(84.3)(71.1)%

Other operating expenses(155.1)(100.0)55.1(35.5)%

Operating profit

358.7

462.5

103.7

28.9 %

Finance income and (expenses), net
Share of loss of investments accounted for using
the equity method(115.4)(100.6)14.8(12.8)%

(8.0)

(5.3)

2.8

(34.4)%

Profit before tax

235.4

356.6

121.3

51.5 %

Income tax expenses(56.3)(115.1)(58.7)

104.3 %Net profit for the period

179.0

241.5

62.5

34.9 %

Revenue. Revenue for the nine-month period ended December 31, 2021 was 2,695.7 billion JPY, an increase of 268.2 billion
JPY, or 11.0%, compared to the same period of the previous fiscal year. Excluding the impact from fluctuations in foreignexchange rates, which was calculated by translating revenue of the nine-month period ended December 31, 2021 using
corresponding exchange rates in the same period of the previous fiscal year, the increase in revenue was 6.1%. In April 2021,
Takeda completed the sale of a portfolio of diabetes products in Japan to Teijin Pharma Limited for 133.0 billion JPY, which
was recorded as revenue and accounted for 5.5 percentage points (“pp”) of the increase in revenue. Excluding this selling pricefrom revenue for the nine-month period ended December 31, 2021, the increase was 5.6%.
Each of our core therapeutic areas (i.e. Gastroenterology (“GI”), Rare Diseases, Plasma-Derived Therapies (“PDT”)
Immunology, Oncology, and Neuroscience) contributed to positive revenue growth; however, Rare Diseases would havedeclined if not for the positive impact of the depreciation of the yen. Intensified competition impacted some products in thisarea, especially treatments for Rare Hematology. Overall, throughout the nine-month period ended December 31, 2021, theglobal spread of COVID-19 did not have a material effect on our revenue.
During the third quarter of the fiscal year ending March 31, 2022, LIVTENCITY (for post-transplant cytomegalovirus(“CMV”) infection/disease) was launched in the U.S. in December 2021, following the launch of EXKIVITY (for non-small
cell lung cancer) in the U.S. in September 2021.
Revenue outside of our core therapeutic areas increased by 36.7 billion JPY, or 8.2%, compared to the same period of theprevious fiscal year to 482.2 billion JPY, largely due to the 133.0 billion JPY selling price of the diabetes portfolio in Japan,
offsetting the impact from divestitures. Revenue from distributing Moderna’s COVID-19 vaccine, SPIKEVAX Intramuscular
Injection, in Japan also contributed to the growth.

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Table of ContentsYear-on-year change in revenue for this nine-month period in each of our main therapeutic areas was primarily attributable tothe following products:•

GI. In Gastroenterology, revenue was 665.7 billion JPY, a year-on-year increase of 76.9 billion JPY, or 13.1%. Growth
was driven by Takeda’s top-selling product ENTYVIO (for ulcerative colitis (“UC”) and Crohn’s disease (“CD”)), withsales of 395.4 billion JPY, a year-on-year increase of 76.1 billion JPY, or 23.8%. Sales in the U.S. increased by 46.7
billion JPY, or 21.3%, to 266.0 billion JPY driven by increase in the first line biologic inflammatory bowel disease(“IBD”) population both in UC and CD. Sales in Europe and Canada increased by 21.7 billion JPY, or 26.9%, to 102.2
billion JPY. In the Growth and Emerging Markets, the increase in sales was primarily driven by Brazil and China. Sales of
TAKECAB (for acid-related diseases) were 78.4 billion JPY, an increase of 14.2 billion JPY, or 22.2%, versus the same
period of the previous fiscal year. This increase was mainly driven by the expansion of new prescriptions in the Japanesemarket due to TAKECAB’s efficacy in reflux esophagitis and the prevention of recurrence of gastric and duodenal ulcers
during low-dose aspirin administration. Sales of GATTEX/REVESTIVE (for short bowel syndrome) were 56.6 billion
JPY, an increase of 6.5 billion JPY, or 12.9%, primarily due to increased market penetration and new country launches
including Japan. Sales of AMITIZA (for chronic constipation) decreased by 13.0 billion JPY, or 68.8%, to 5.9 billion
JPY, due to generic entrants in the U.S. in January 2021.

•

Rare Diseases. In Rare Diseases, revenue was 462.9 billion JPY, a year-on-year increase of 16.2 billion JPY, or 3.6%.
Revenue in Rare Metabolic increased by 11.6 billion JPY, or 9.5%, compared to the same period of the previous fiscal
year to 133.4 billion JPY. Sales of enzyme replacement therapies ELAPRASE (for Hunter syndrome), VPRIV (forGaucher disease) and REPLAGAL (for Fabry disease) increased primarily in Europe and Growth and Emerging Markets.
Revenue in Rare Hematology decreased by 7.0 billion JPY, or 3.2%, to 211.6 billion JPY. Sales of ADVATE decreasedby 7.8 billion JPY, or 8.0%, to 89.3 billion JPY. Sales of ADYNOVATE/ADYNOVI increased by 2.1 billion JPY, or
4.8%, to 45.9 billion JPY, partially helped by the positive impact of the depreciation of the yen. Both products were
impacted by the competitive landscape in the hemophilia A non-inhibitors market in the U.S. FEIBA sales decreased by
5.3 billion JPY, or 15.4%, to 29.0 billion JPY, negatively impacted by the difference in timing of government tenders in
Growth and Emerging Markets.
Revenue in Hereditary Angioedema (“HAE”) was 117.7 billion JPY, a year-on-year increase of 11.4 billion JPY, or
10.7%. Sales of TAKHZYRO were 78.4 billion JPY, an increase of 12.5 billion JPY, or 19.0%, versus the same period of
the previous fiscal year primarily due to expansion of the prophylactic market, continued geographic expansion and strong
patient uptake. Sales of CINRYZE decreased by 2.6 billion JPY, or 14.8%, to 14.7 billion JPY, primarily due toconversion to TAKHZYRO and a shift to newer agents marketed by competitors.

•

PDT Immunology. In Plasma-Derived Therapies (“PDT”) Immunology, revenue increased by 50.2 billion JPY, or 16.0%,
compared to the same period of the previous fiscal year to 363.2 billion JPY. Aggregate sales of immunoglobulin products
were 278.3 billion JPY, an increase of 30.3 billion JPY, or 12.2%, compared to the same period of the previous fiscal
year. In particular, sales of GAMMAGARD LIQUID (for the treatment of primary immunodeficiency (“PID”) andmultifocal motor neuropathy (“MMN”)) increased due to higher demand versus the same period of the previous fiscal
year. In addition, CUVITRU and HYQVIA, which are SCIG (subcutaneous immunoglobulin) therapies, marked double
digit growth. Aggregate sales of albumin products including HUMAN ALBUMIN and FLEXBUMIN (primarily used for
hypovolemia and hypoalbuminemia) were 61.5 billion JPY, an increase of 17.9 billion JPY, or 41.0%, versus the same
period of the previous fiscal year driven by higher China sales following the resolution of the supply interruption which
impacted HUMAN ALBUMIN for release in China in the second half of the previous fiscal year.

•

Oncology. In Oncology, revenue was 359.1 billion JPY, a year-on-year increase of 40.6 billion JPY, or 12.8%. Sales of
VELCADE (for multiple myeloma) increased by 8.6 billion JPY, or 11.3% versus the same period of the previous fiscal
year to 84.5 billion JPY. U.S. sales increased by 9.6 billion JPY, or 13.3%, versus the same period of the previous fiscal
year. This reflects a rebound in demand after lower sales in the first quarter of the previous fiscal year, when prescribers
favored orally administered products over infusions or injections early in the COVID-19 pandemic. In addition, increased
use of VELCADE as part of initial treatment for new patients contributed to the growth this year in the U.S. Royalty
income outside the U.S. decreased due to continued generic erosion. Sales of NINLARO (for multiple myeloma) were
70.7 billion JPY, an increase of 2.9 billion JPY, or 4.2%, versus the same period of the previous fiscal year. In the U.S.,
NINLARO’s profile as an effective oral treatment led to a temporary increase in demand early in the COVID-19
pandemic in 2020 because its oral administration facilitated treatment in the at-home setting. This benefit has been less
impactful in the U.S. this year; however, there have been strong demand increases in other countries, particularly in
China. Sales of LEUPLIN/ENANTONE (generic name: leuprorelin) (for endometriosis, uterine fibroids, premenopausal
breast cancer, prostatic cancer, etc.), an off-patented product, increased by 7.0 billion JPY, or 9.2%, versus the same
period of the previous fiscal year to 82.2 billion JPY mainly driven by an increased supply in the U.S. which was partially
offset by a decrease in Japan due to generic erosion and competition. Sales of ADCETRIS (for malignant lymphomas)-5-

Table of Contents
increased by 7.4 billion JPY, or 16.7% versus the same period of the previous fiscal year to 51.8 billion JPY, led by strong
growth in sales in Growth and Emerging Markets, particularly in China where it was approved in May 2020. Sales of
ALUNBRIG (for non-small cell lung cancer) were 10.1 billion JPY, an increase of 3.6 billion JPY, or 56.2% due to newlaunches and market penetration around the world.
•

Neuroscience. In Neuroscience, revenue was 362.6 billion JPY, a year-on-year increase of 47.5 billion JPY, or 15.1%.
Sales of VYVANSE/ELVANSE (for attention deficit hyperactivity disorder (“ADHD”)) were 245.0 billion JPY, an
increase of 42.6 billion JPY, or 21.0%, versus the same period of the previous fiscal year. VYVANSE/ELVANSE has
been negatively affected by COVID-19 during the course of the pandemic, most notably during periods when stay-athome restrictions have been in place reducing patient visits, subsequent diagnoses and creating temporary discontinuationof medication. The trend has been fluctuating throughout 2020 and into 2021; however, there has been a positive impact
from increasing prescriptions versus the same period of the previous fiscal year. Sales of TRINTELLIX (for major
depressive disorder (“MDD”)) were 63.0 billion JPY, an increase of 10.4 billion JPY, or 19.6%, versus the same period of
the previous fiscal year, primarily due to increasing prescriptions in the U.S. and in Japan. The increase of these products
was partially offset by the decrease of other neuroscience products such as REMINYL (for Alzheimer's disease),
attributable to the continued impact of competition from generic products.

Revenue by Geographic Region:

Revenue:
Japan*1
United States
Europe and Canada
Asia (excluding Japan)
Latin America
Russia/CIS
Other*2
Total

Billion JPY; percentages are portion of total revenue
FY2020 Q3YTDFY2021 Q3YTD
435.1
17.9 %
530.2
19.7 %
1,189.0
49.0 %
1,297.0
48.1 %
500.0
20.6 %
541.0
20.1 %
119.2
4.9 %
139.8
5.2 %
95.4
3.9 %
93.5
3.5 %
38.7
1.6 %
43.6
1.6 %
50.2
2.1 %
50.6
1.9 %
2,427.5
100.0 %
2,695.7
100.0 %

*1 The 133.0 billion JPY selling price of the sale of diabetes portfolio in Japan is included in the nine-month period ended December 31, 2021.
*2 Other includes the Middle East, Oceania and Africa.

Cost of Sales. Cost of Sales increased by 57.6 billion JPY, or 7.8%, to 798.5 billion JPY. The increase was primarily due tothe depreciation of the yen and a sales increase of products with higher cost of sales ratio as compared to the same period of
the previous fiscal year. The increase was partially offset by a 42.5 billion JPY decrease in non-cash charges related to theunwind of the fair value step up on acquired inventory recognized in connection with the acquisition of Shire plc. The Cost ofSales Ratio decreased by 0.9 pp compared to the same period of the previous fiscal year to 29.6%. The main reason for thedecrease in the Cost of Sales Ratio was the effect of the sale of a portfolio of diabetes products in Japan with the selling priceof 133.0 billion JPY being recorded in revenue.
Selling, General and Administrative (SG&A) expenses. SG&A expenses increased by 21.7 billion JPY, or 3.4%, to 662.9
billion JPY compared to the same period of the previous fiscal year, mainly due to the impact from the depreciation of the yen
in the current period.
Research and Development (R&D) expenses. R&D expenses increased by 39.9 billion JPY, or 11.7%, to 382.5 billion JPY
compared to the same period of the previous fiscal year, mainly due to further investment in prioritized new molecular entities
as well as the impact from the depreciation of the yen in the current period.
Amortization and Impairment Losses on Intangible Assets Associated with Products. Amortization and Impairment Losses
on Intangible Assets Associated with Products increased by 16.1 billion JPY, or 5.2%, to 323.6 billion JPY compared to thesame period of the previous fiscal year mainly due to impairment charges related to certain in-process R&D assets recorded in
the current period.
Other Operating Income. Other Operating Income was 34.3 billion JPY, a decrease of 84.3 billion JPY, or 71.1%, comparedto the same period of the previous fiscal year, mainly driven by a 60.2 billion JPY revaluation gain recorded in the same periodof the previous fiscal year triggered by an update to previously recognized liabilities for pipeline compound SHP647 andcertain associated rights ("SHP647"), to reflect management’s decision to terminate the clinical trial program following the-6-Table of Contents
European Commission’s decision in May 2020 to release Takeda’s obligation to divest SHP647. The decrease was also driven
by the effect of a 37.2 billion JPY divestiture gain on the sale of non-core assets in Asia Pacific, Europe, and Canada recordedin the same period of the previous fiscal year.
Other Operating Expenses. Other Operating Expenses were 100.0 billion JPY, a decrease of 55.1 billion JPY, or 35.5%,
compared to the same period of the previous fiscal year. This is mainly attributable to a 27.3 billion JPY decrease in
restructuring expenses mainly attributable to lower Shire integration costs. There was also a 18.7 billion JPY loss recognizedin the same period of the previous year from changes in the fair value of financial assets associated with contingent
consideration arrangements from the divestment of XIIDRA.
Operating Profit. As a result of the above factors, Operating Profit increased by 103.7 billion JPY, or 28.9% compared to thesame period of the previous fiscal year to 462.5 billion JPY.
Net Finance Expenses. Net Finance Expenses were 100.6 billion JPY in the current period, a decrease of 14.8 billion JPY, or
12.8%, compared to the same period of the previous fiscal year. The decrease is mainly due to a decrease in interest expense
primarily driven by the reduction in outstanding balances of bonds and loans and a gain on prior equity method investments
related to the acquisition of Maverick Therapeutics, Inc. in April 2021.
Share of Loss of Investments Accounted for Using the Equity Method. Share of Loss of Investments Accounted for Using
the Equity Method was 5.3 billion JPY, a decrease of 2.8 billion JPY, or 34.4%, compared to the same period of the previous
fiscal year, mainly due to Takeda's share of impairment loss recognized by Teva Takeda Pharma Ltd. in the same period of theprevious fiscal year resulting from the reassessment of the recoverable amount of relevant assets triggered by the decision todivest a part of its generics business and a manufacturing plant.
Income Tax Expenses. Income Tax Expenses were 115.1 billion JPY, an increase of 58.7 billion JPY, or 104.3%, compared tothe same period of the previous year. This increase was primarily due to a tax charge of 64.6 billion JPY for tax and interest,
net of 0.5 billion JPY of associated tax benefit, arising from tax assessment involving Irish taxation of the break fee Shire
received from AbbVie in connection with the terminated offer to acquire Shire made by AbbVie in 2014 as well as higher
pretax earnings in the current period. These increases were partially offset by an increase in tax credits and a decrease inunitary tax in overseas subsidiaries in the current period versus the same period of the previous year.
Net Profit for the Period. Net Profit for the Period increased by 62.5 billion JPY, or 34.9%, compared to the same period of
the previous fiscal year to 241.5 billion JPY.

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Table of Contents

Underlying Results (April 1 to December 31, 2021)
Definition of Core and Underlying Growth
Takeda uses the concept of Underlying Growth for internal planning and performance evaluation purposes.
Underlying Growth compares two periods (fiscal quarters or years) of financial results under a common basis and is used bymanagement to assess the business. These financial results are calculated on a constant currency basis using a full year plan
rate and exclude the impacts of divestitures and other amounts that are unusual, non-recurring items or unrelated to ourongoing operations. Although these are not measures defined by IFRS, Takeda believes Underlying Growth is useful toinvestors as it provides a consistent measure of our performance.
Takeda uses "Underlying Revenue Growth", "Underlying Core Operating Profit Growth", and "Underlying Core EPS Growth"
as key financial metrics.
Underlying Revenue represents revenue on a constant currency basis and excluding non-recurring items and the impact ofdivestitures that occurred during the reported periods presented.
Underlying Core Operating Profit represents Core Operating Profit (as defined below) on a constant currency basis and further
adjusted to exclude the impacts of divestitures that occurred during the reporting periods presented.
Underlying Core EPS represents net profit based on a constant currency basis, adjusted to exclude the impact of divestitures,
items excluded in the calculation of Core EPS (as defined below), divided by the outstanding shares (excluding treasury
shares) as of the end of the comparative period.
Core Revenue represents revenue adjusted to exclude significant items unrelated to Takeda's core operations.
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 andimpairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as non-recurring
items, purchase accounting effects and transaction related costs.
Core EPS represents net profit adjusted to exclude the impact of items excluded in the calculation of Core Operating Profit,and other non-operating items (e.g. amongst other items, fair value adjustments and the imputed financial charge related tocontingent consideration) that are unusual, non-recurring in nature or unrelated to Takeda’s ongoing operations and the tax
effect of each of the adjustments, divided by the average outstanding shares (excluding treasury shares) of the reporting
periods presented.
Underlying Results
FY2021 Q3YTD
Underlying Revenue Growth
Underlying Core Operating Profit Growth
Underlying Core Operating Profit Margin
Underlying Core EPS Growth

+7.1%
+5.4%
29.4%
+9.9%

Underlying Revenue Growth was 7.1% compared to the same nine-month period of the previous fiscal year. Underlying
revenue attributable to Takeda’s 14 global brands* grew by 12.0%, which constitute approximately 42% of the total
Underlying revenue, led by ENTYVIO, TAKHZYRO, HUMAN ALBUMIN/FLEXBUMIN, GAMMAGARD LIQUID/KIOVIG and CUVITRU.
* Takeda's 14 global brands
GI: ENTYVIO, GATTEX/REVESTIVE, ALOFISEL
Rare Diseases: NATPARA/NATPAR, ADYNOVATE/ADYNOVI, TAKHZYRO, ELAPRASE, VPRIVPDT Immunology: GAMMAGARD LIQUID/KIOVIG, HYQVIA, CUVITRU, HUMAN ALUBUMIN/FLEXBUMIN
Oncology: NINLARO, ALUNBRIG-8-

Table of Contents
Underlying Revenue Growth by Therapeutic Area
GI
Rare Diseases
Rare Metabolic
Rare Hematology
Hereditary Angioedema
PDT Immunology
Oncology
Neuroscience
Other
Total

+7.6%
-1.0%
+5.2%
-7.6%
+5.4%
+10.3%+8.2%+10.0%+10.6%+7.1%(Note) Underlying Revenue represents revenue on a constant currency basis and excluding non-recurring items and the impact ofdivestitures. Please refer to II. Operating and Financial Review, 2. Analysis on Business Performance, Financial Position andCash Flows, (1) Consolidated Financial Results (April 1 to December 31, 2021), Revenue., for the revenue of each core
therapeutic areas and sales of major products before underlying adjustments.

The impact of major non-recurring items and divestitures excluded to calculate Underlying Revenue:•

Revenue of select over-the-counter and non-core products in Asia Pacific is excluded from the same period of theprevious fiscal year as the divestiture was completed in November 2020.

•

Revenue of select non-core prescription pharmaceutical products predominantly in Europe is excluded from the same
period of the previous fiscal year as the divestiture was completed in December 2020.

•

Revenue of select over-the-counter and non-core products in Latin America is excluded from the same period of theprevious fiscal year as the divestiture was completed in January 2021.

•

Net sales from TACHOSIL, a surgical patch, are excluded from the same period of the previous fiscal year as thedivestiture was completed in January 2021.

•

Revenue of select over-the-counter and non-core products predominantly in Europe is excluded from the same period of
the previous fiscal year as the divestiture was completed in March 2021.

•

Revenue of the former subsidiary, Takeda Consumer Healthcare Company Limited is excluded from the same period of
the previous fiscal year as the divestiture was completed in March 2021.

•

Net sales from a portfolio of diabetes products in Japan (NESINA, LIOVEL, INISYNC and ZAFATEK) are excluded
from the same period of the previous fiscal year as the divestiture was completed at the beginning of April 2021. In
addition, the non-recurring item of the 133.0 billion JPY selling price as the result of the completion of the divestiture is
excluded from the current period.

•

Revenue of select non-core prescription pharmaceutical products in China is excluded from both the current period andthe same period of the previous fiscal year as the divestiture was publicly announced and had been expected to complete
within the first half of the current fiscal year. It is now expected to complete in the second half of the current fiscal year.

Underlying Core Operating Profit Growth was 5.4% over the same nine-month period of the previous fiscal year, attributable
to Underlying Revenue Growth.
Core Operating Profit for the current period, which excludes items unrelated to Takeda's core operations such as the sale of aportfolio of diabetes products in Japan, was 757.9 billion JPY.
Underlying Core Operating Profit Margin for the current period was 29.4%.
Underlying Core EPS Growth for the current period was 9.9%.

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Table of Contents(2) Consolidated Financial Position
Assets. Total Assets as of December 31, 2021 were 12,698.5 billion JPY, reflecting a decrease of 213.8 billion JPY comparedto the previous fiscal year-end. Cash and cash equivalents decreased by 241.9 billion JPY and Intangible Assets decreased by
117.2 billion JPY mainly due to amortization. These decreases were partially offset by an increase in Goodwill of 134.1 billion
JPY mainly due to the effect of foreign currency translation.
Although there was a decline in share price during the three-month period ended December 31, 2021 that eliminated oursurplus in market capitalization compared to the carrying value of our one cash-generating unit (CGU), we concluded there
was no indication of goodwill impairment as of December 31, 2021.
Liabilities. Total Liabilities as of December 31, 2021 were 7,366.7 billion JPY, reflecting a decrease of 368.4 billion JPY
compared to the previous fiscal year-end. Bonds and Loans decreased by 280.5 billion JPY to 4,354.9 billion JPY* primarily
as a result of the repayment of loans and the redemption of bonds. In addition, Other Financial Liabilities decreased by 114.7
billion JPY.
*

The carrying amount of Bonds was 3,653.7 billion JPY and Loans was 701.2 billion JPY as of December 31, 2021.
Breakdown of Bonds and Loans carrying amount is as follows.

Bonds:Name of Bond
(Face Value if Denominated in
Foreign Currency)
Unsecured US dollar denominated seniornotes (1,520 million USD)
Unsecured US dollar denominated seniornotes (5,500 million USD)
Unsecured Euro denominated senior notes(3,750 million EUR)
Unsecured US dollar denominated seniornotes (3,250 million USD)

Issuance
June 2015
September 2016
November 2018
November 2018

Hybrid bonds (subordinated bonds)
Unsecured US dollar denominated seniornotes (7,000 million USD)
Unsecured Euro denominated senior notes(3,600 million EUR)

June 2019

Unsecured JPY denominated senior bonds
Total

Maturity
June 2022 ~June 2045
September 2023 ~September 2026
November 2022 ~November 2030
November 2023 ~November 2028

Carrying Amount(Billion JPY)
175.1
606.6
486.3
372.3
498.0

July 2020

June 2079
March 2030 ~July 2060
July 2027 ~July 2040

October 2021

October 2031

249.3
3,653.7

Execution

July 2020

800.1
466.0

Loans:Name of Loan
(Face Value if Denominated in
Foreign Currency)

Carrying Amount(Billion JPY)

Syndicated loans

April 2016

Maturity
April 2023 ~April 2026

Syndicated loans
Syndicated loans(1,500 million USD)

April 2017

April 2027

113.5

April 2017
March 2016 ~April 2017

April 2027
March 2023 ~March 2026

172.4

Bilateral loans
Other
Total

200.0

210.0
5.3
701.2

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Table of Contents
On May 17, 2021, Takeda redeemed the remaining 200 million USD of unsecured U.S. dollar-denominated senior notes issuedin July 2017 in advance of their original maturity date of January 18, 2022. Following this, on June 11, 2021, Takeda prepaid
2,000 million USD of the Japan Bank for International Cooperation loan (“JBIC Loan”) amount of 3,700 million USD (thatwas entered into on December 3, 2018) in advance of its original maturity date of December 11, 2025. On August 10, 2021,
Takeda redeemed 1,500 million EUR of unsecured senior notes issued in November 2018 in advance of their original maturity
date of November 21, 2022. On October 14, 2021, Takeda issued 10-year unsecured senior bonds with an aggregate principal
amount of 250 billion JPY and a maturity date of October 14, 2031. Following this, on December 13, 2021 Takeda prepaid theremaining 1,700 million USD amount outstanding on the JBIC Loan in advance of its original maturity date of December 11,
2025.
Equity. Total Equity as of December 31, 2021 was 5,331.8 billion JPY, an increase of 154.6 billion JPY compared to theprevious fiscal year-end. This was mainly due to an increase of 215.5 billion JPY in Other Components of Equity mainly due
to fluctuation in currency translation adjustments reflecting the depreciation of yen. This increase was partially offset by adecrease in Retained Earnings of 43.0 billion JPY and an increase in Treasury Shares of 31.5 billion JPY. The decrease in
Retained Earnings resulted primarily from dividend payments of 284.2 billion JPY whereas Net Profit for the Period wasrecorded.
Consolidated Cash Flow

Net cash from (used in) operating activities
Net cash from (used in) investing activities
Net cash from (used in) financing activities
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the year
Effects of exchange rate changes on cash and cash equivalents
Net increase (decrease) in cash and cash equivalents resulting from atransfer from (to) assets held for sale
Cash and cash equivalents at the end of the period

Billion JPY
FY2020 Q3YTDFY2021 Q3YTD
610.0
747.5
100.2
(172.5)(718.3)(826.5)(8.1)(251.4)637.6
966.2(11.8)
9.5
(0.1)
617.6

—
724.3

Net cash from operating activities was 747.5 billion JPY for the current period compared to 610.0 billion JPY for the same
period of the previous year. The increase of 137.6 billion JPY was primarily driven by higher net profit for the period adjusted
for non-cash items and other adjustments, including the income relating to the release from the obligation to divest the pipeline
compound SHP 647 and certain associated rights in the same period of the previous year. In addition, there was a decrease intrade and other receivables mainly due to the trade receivables sales program put in place in the current period. Thesefavorable impacts were partially offset by a decrease in provisions due to payments.
Net cash used in investing activities was 172.5 billion JPY for the current period compared to net cash from investing
activities of 100.2 billion JPY for the same period of the previous year. This increase in net cash used of 272.7 billion JPY wasmainly due to a decrease of 122.8 billion JPY in proceeds from sales of business, net of cash and cash equivalents divested
reflecting the sales of the non-core assets in the same period of the previous year, a decrease of 57.7 billion JPY in proceedsfrom sales and redemptions of investments, and an increase of 49.7 billion JPY in acquisition of businesses, net of cash andcash equivalents acquired.
Net cash used in financing activities was 826.5 billion JPY for the current period compared to 718.3 billion JPY for the same
period of the previous year. The increase of 108.2 billion JPY was mainly due to a decrease in proceeds from issuance ofbonds and long-term loans of 930.2 billion JPY as a result of the issuance of U.S. dollar-denominated senior notes of 7,000
million USD and Euro-denominated senior notes of 3,600 million EUR in the same period of the previous year compared to
the 250 billion JPY issuance of senior bond in the current period. In addition, purchase of treasury shares increased by 50.4
billion JPY mainly due to the share buybacks in the current period. These were partially offset by a decrease in repayments ofbonds and long-term loans of 754.1 billion JPY and the favorable impact from short-term loans and commercial papers of 85.0
billion JPY.

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Table of Contents(3) Management Policy, Management Environment and Management Issues
There was no significant change in management policy, management environment and management issues for the nine-month
period ended December 31, 2021.
Impact of the spread of the novel coronavirus infectious disease (COVID-19) and Takeda’s initiatives in response are as
follows:(i) Impact of COVID-19 on Takeda’s Operations and Financial Condition
Takeda continues to respond to the COVID-19 pandemic and provide industry support in a number of ways. Whilevaccines are becoming more broadly available, we continue to strictly adhere to local public health guidance across ourgeographies in addition to the existing protocols we have had in place for almost two years, and monitor any potential
impacts of effects and evolution of COVID-19, including new variants like Omicron, on our business activities.
In monitoring demand for our products, we have seen limited impact as many of our medicines are for severe chronic orlife-threatening diseases, without the requirement of a hospital elective procedure. In terms of our global supply chain,based on current assessments, we have not seen, nor do we anticipate, any material potential supply distribution issues dueto the COVID-19 outbreak. Where appropriate and in accordance with local public health guidance and regulations, ourfield employees have resumed some face-to-face engagements with customers, with the majority of all interactions stillvirtual. Clinical trial activities that were temporarily paused during the previous fiscal year have generally been resumed
while we continue to monitor the evolution of the pandemic.
As we continue to monitor developments in the financial markets, we currently do not anticipate any material liquidity or
funding-related issues.
(ii) Takeda’s Initiatives to Mitigate the Impact of COVID-19
Guided by our values, Takeda's response to COVID-19 continues to focus on protecting the health and safety of ouremployees, our ability to ensure our medicines are available to patients who rely on them and playing our part to reducetransmission and support the communities where our employees live and work.
Major updates to Takeda’s initiatives in response to the spread of COVID-19 in the current period are as below.

•

The highly contagious Omicron variant has temporarily slowed the roll out of a new hybrid working model in parts ofthe business. Moving forward, implementation of this model will vary by job function, and on the local level, given
differences in public health guidance and regulations, changes in population and epidemiology over time andstandards of practice in the community.

•

Takeda has undertaken a number of efforts to help the world respond to COVID-19. This includes bringing
COVID-19 vaccines to Japan through two partnerships. The first partnership is with Novavax, for the development,
manufacturing, and commercialization of its COVID-19 vaccine candidate, NVX-CoV2373 (development code inJapan: TAK-019) in Japan. In September 2021, Takeda concluded the agreement with the Government of Japan’s
Ministry of Health, Labour and Welfare (MHLW) to provide 150 million doses of Novavax’ COVID-19 vaccine
candidate manufactured in Japan by Takeda subject to licensing and approval, starting in early calendar year 2022. In
December 2021, Takeda submitted a New Drug Application (NDA) to the MHLW in Japan for TAK-019.
The second partnership is with Moderna and the MHLW to import and distribute Moderna’s mRNA COVID-19
vaccine (SPIKEVAX Intramuscular Injection (former product name: COVID-19 Vaccine Moderna Intramuscular
Injection)) in Japan. Since May 2021, Takeda has been distributing the Moderna COVID-19 vaccine in Japan. In
October 2021, Takeda and Moderna published an investigation report prompted by the recall of three lots of theModerna COVID-19 vaccine in Japan based on the observation of foreign particles in unpunctured vials from a single
lot. The report concluded that the event does not pose an undue risk to patient safety or adversely affect the benefit/
risk profile of the product.
Takeda will continue distribution of the vaccine in Japan in 2022 via an additional three-way agreement with
Moderna and the MHLW. Specifically, the parties reached to an agreement in December 2021, to import anddistribute 18 million additional doses of Moderna's COVID-19 vaccine, bringing the total to 93 million doses in 2022.

(iii) FY2021 Q3YTD financial impact from COVID-19
Overall, the global spread of COVID-19 did not have a material effect on our financials for the nine-month period ended
December 31, 2021. Over the course of the pandemic, there have been adverse effects due to COVID-19 observed incertain therapeutic areas, especially in Neuroscience during periods when stay-at-home restrictions have been in place,reducing patient visits to medical care providers. This was notable especially in the early months of the previous fiscal
year. The trend has fluctuated since then, and we have not yet seen a full recovery to pre-COVID-19 levels, however, acertain number of our life-saving medicines have shown resilience and have grown even under such an environment. We
have not experienced a material disruption from the rapid spread of COVID-19 due to the Omicron variant.
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Table of Contents(4) Research & Development Activities and Results
Research and development expenses for the nine-month period ended December 31, 2021 were 382.5 billion JPY.
Takeda’s R&D engine is focused on translating science into highly innovative, life-changing medicines that make a criticaldifference to patients. Takeda supports dedicated R&D efforts across three areas: Innovative Biopharma, Plasma-Derived
Therapies (PDT) and Vaccines. The R&D engine for Innovative Biopharma is the largest component of our R&D
investment and has produced exciting new molecular entities (NMEs) that represent potential best-in-class and/or first-inclass medicines in areas of high unmet medical need across our core Therapeutic Areas (oncology, rare genetics andhematology, neuroscience, and gastroenterology (GI)). Over the past several years, and more recently bolstered by ouracquisition of Shire, we have also harnessed the potential of cell and gene therapies by investing in new capabilities andnext-generation platforms internally and through a network of partnerships.
Takeda’s pipeline is positioned to support both near-term and sustained growth of the company. Once first approval isachieved, there is ongoing R&D support for geographical expansion and additional indications, as well as post-marketing
commitment and potential additional formulation work. Takeda’s R&D team works closely with the commercial functions
to maximize the value of marketed products and reflect commercial insights in its R&D strategies and portfolio.
Major progress on R&D events since April 2021 are listed as follows:
R&D pipeline
Oncology
In Oncology, Takeda endeavors to deliver novel medicines to patients with cancer worldwide through a commitment tobreakthrough innovation and a passion for improving the lives of patients. Takeda focuses on three key areas in oncology:(1) building on its foundational expertise in hematologic malignancies through continued investment in lifecycle
management programs for marketed products NINLARO, ADCETRIS, and ICLUSIG, as well as in pipeline assets in
Multiple Myeloma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, and other blood cancers; (2) further developing
its portfolio in lung cancer with the marketed products ALUNBRIG, EXKIVITY, and development programs in targetedlung cancer populations; and (3) pursuing novel immuno-oncology targets and next-generation platforms, as well as
exploring innovative cell therapies harnessing the power of the innate immune system.
NINLARO / Generic name: ixazomib–

In May 2021, Takeda announced that it received approval from the Japanese Ministry of Health, Labour andWelfare (MHLW) for a partial amendment to the manufacturing and marketing approval of NINLARO to expand
the eligible patient population for this medicine to those requiring a maintenance therapy after first-line treatment
for multiple myeloma without prior stem cell transplant. The approval is based primarily on the results of the
TOURMALINE-MM4 study, a randomized and placebo-controlled double-blind multicenter international Phase III
clinical trial. The study achieved its primary endpoint, demonstrating a statistically significant improvement inprogression-free survival (PFS) in adult patients with multiple myeloma receiving NINLARO maintenance who
had not undergone stem cell transplantation. The safety profile of NINLARO as a maintenance therapy is similar to
its established safety profile in the monotherapy setting, and, notably, no new concerns were identified in the
TOURMALINE-MM4 study.

ICLUSIG / Generic name: ponatinib–

In June 2021, Takeda presented primary analysis data from the Phase II OPTIC (Optimizing Ponatinib Treatment
in CML) trial during an oral session at the virtual 57th American Society of Clinical Oncology (ASCO) Annual
Meeting, and as an oral session at the virtual 26th European Hematology Association (EHA) Annual Meeting. The
OPTIC trial, which evaluated treatment in patients with resistant disease, with and without mutations, met its
primary endpoint. The study demonstrated that the optimal benefit-risk profile for ICLUSIG in patients with CPCML is achieved with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-ABL1IS, dose reduction to 15mg. The results also suggest a clinically manageable safety and arterial occlusive event (AOE) profile for
ICLUSIG.

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Table of Contents
ALUNBRIG / Generic name: brigatinib–

In June 2021, Takeda announced that ALUNBRIG can be used for first-line treatment of patients with non-small
cell lung cancer (NSCLC) who are ALK fusion gene positive (ALK-positive) as determined by the companion
diagnostic ALK fusion protein kit, Ventana OptiView ALK (D5F3) (Ventana) in Japan. Ventana, developed by
Roche Diagnostics, which uses as its assay principle the immunohistochemical staining method (IHC method),
received an additional indication through a partial change of the drug's manufacturing and marketing approval toinclude its use to ALUNBRIG. The additional approval of ALUNBRIG for the indication of Ventana, in addition to
the Fluorescence In Situ Hybridization (FISH) diagnostic, will provide a wider range of ALK-positive NSCLC
patients with the opportunity to be treated with ALUNBRIG.

ADCETRIS / Generic name: brentuximab vedotin–

In September 2021, Takeda announced that it submitted a Supplemental New Drug Application (sNDA) of
ADCETRIS in the first-line treatment of CD30-positive Hodgkin lymphoma in pediatric patients in Japan. Thisapplication is based on the results of a global Phase 1/2 trial (C25004 Trial) evaluating the efficacy and safety of
ADCETRIS in combination with AVD (doxorubicin, vinblastine and dacarbazine) as a first-line therapy in
pediatric patients with previously untreated advanced-stage Hodgkin lymphoma.

CABOMETYX / Generic name: cabozantinib–

In August 2021, Takeda and Ono Pharmaceutical (Ono) announced that the companies received an approval fromthe Japanese Ministry of Health. Labour and Welfare (MHLW) for CABOMETYX and Ono’s OPDIVO(nivolumab), a human anti-human PD-1 monoclonal antibody, in combination therapy for the treatment ofunresectable or metastatic renal cell carcinoma (RCC), for a partial change in approved items of the manufacturingand marketing approval. This approval is based on results from the global, multi-center, randomized, open-label
Phase 3 CheckMate-9ER study, evaluating OPDIVO and CABOMETYX combination therapy versus sunitinib
alone in patients with previously untreated advanced or metastatic RCC. In this study, OPDIVO andCABOMETYX combination therapy demonstrated a significant and clinically meaningful improvement in the
primary endpoint of progression-free survival (PFS) as assessed by the blind independent central review (BICR),
compared to sunitinib alone at the final analysis, as well as the secondary endpoints of overall survival (OS) andobjective response rate (ORR) as assessed by the BICR. The safety profiles of OPDIVO and CABOMETYX
combination therapy observed in the study were consistent with the previously reported safety profile of eachproduct.

ZEJULA / Generic name: niraparib–

In September 2021, Takeda announced that it has received approval from the Japanese Ministry of Health. Labourand Welfare (MHLW) to manufacture and market ZEJULA tablets 100mg (ZEJULA tablets) as an additional
formulation for ZEJULA capsules 100mg (ZEJULA capsules), an oral poly (ADP-ribose) polymerase (PARP)
inhibitor. The approval was granted based on the results of a human bioequivalence trial (3000-01-004 trial) and an
dissolution study that confirmed the equivalence of ZEJULA capsules and ZEJULA tablets. ZEJULA capsules
require refrigerated storage, however the newly approved ZEULA tablets can be stored at room temperature.

EXKIVITY / Generic name: mobocertinib–

In May 2021, Takeda announced updated data from the Phase 1/2 trial of mobocertinib in patients with epidermal
growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lungcancer (mNSCLC) who received prior platinum-based chemotherapy. The results showed mobocertinib continued
to demonstrate clinically meaningful benefit after over a year of follow up and were presented at the virtual 57th
American Society of Clinical Oncology (ASCO) Annual Meeting. Results showed a median overall survival (OS)of 24 months with a median follow up of 14 months, and responses were observed across diverse EGFR Exon20
insertion variants. Other key data points such as confirmed objective response rate (ORR), a median duration of
response (DoR) and a disease control rate (DCR), remained consistent with previously reported data. The safety
profile observed was manageable and consistent with previous findings.

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Table of Contents–

In July 2021, Takeda announced that Center for Drug Evaluation (CDE) of the National Medical Products
Administration of China (NMPA) has accepted the New Drug Application (NDA) for mobocertinib and granted
priority review for this Class-1 innovative drug, for the treatment of adult patients with non-small cell lung cancer(NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

–

In September 2021, Takeda announced that the U.S. Food and Drug Administration (FDA) has approved
EXKIVITY for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer(NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDAapproved test, whose disease has progressed on or after platinum-based chemotherapy. The FDA approval is basedon results from the platinum-pretreated population in the Phase 1/2 trial of EXKIVITY, which consisted of 114
patients with EGFR Exon20 insertion+ NSCLC who received prior platinum-based therapy and were treated at the
160 mg dose once- daily. EXKIVITY, which was granted priority review and received Breakthrough Therapy
Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved
oral therapy specifically designed to target EGFR Exon20 insertion mutations. This indication is approved underAccelerated Approval based on overall response rate (ORR) and duration of response (DoR). Continued approval
for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The FDA simultaneously approved Thermo Fisher Scientific’s Oncomine Dx Target Test as an next-generation
sequencing (NGS) companion diagnostic for EXKIVITY to identify NSCLC patients with EGFR Exon20
insertions.

Development code: TAK-924 / Generic name: pevonedistat–

In September 2021, Takeda announced the Phase 3 PANTHER (Pevonedistat-3001) study did not achieve predefined statistical significance for the primary endpoint of event-free survival (EFS). The trial evaluated whether
the combination of pevonedistat plus azacitidine as first-line treatment for patients with higher-risk myelodysplastic
syndromes (MDS), chronic myelomonocytic leukemia (CMML) and low-blast acute myeloid leukemia (AML)
improved EFS versus azacitidine alone. An event in the trial was defined as death or transformation to AML inparticipants with higher-risk MDS or CMML, whichever occurred first, and death in participants with AML.
Takeda discontinued all research and development.

Rare Genetics & Hematology
In Rare Genetics & Hematology, Takeda focuses on several areas of high unmet medical need. In hereditary angioedema,
Takeda aspires to transform the treatment paradigm, including through TAKHZYRO, with continued investment in lifecycle
management programs including evaluating Takhzyro in Bradykinin-mediated angioedema with normal C1-inhibitor. In rare
hematology, Takeda focuses on addressing today’s needs in the treatment of bleeding disorders, including through
ADVATE and ADYNOVATE/ADYNOVI, as well as on the development of pipeline assets including TAK-755 for thetreatment of immune thrombotic thrombocytopenic purpura (iTTP) and congenital thrombotic thrombocytopenic purpura(cTTP). In rare metabolic diseases, Takeda is developing treatments for lysosomal storage disorders (LSDs), with a portfoliothat includes commercial products such as ELAPRASE and REPLAGAL, and late-stage investigational therapies andpipeline candidates. We are also building differentiated gene therapy capabilities for the development and delivery offunctional cures to patients with rare diseases.
TAKHZYRO / Generic name: lanadelumab–

In July 2021, Takeda announced the results from two final analyses from the Phase 3 HELP (Hereditary
Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE), which evaluated the long-term safety(primary endpoint) and efficacy of TAKHZYRO (lanadelumab) 300 mg every two weeks for up to 2.5 years. In thefirst analysis, the mean (min, max) reduction in the attack rate compared to baseline observed in the study
population (N=212) was of 87.4 percent (-100; 852.8), and the median reduction was 97.7 percent and patients
received treatment for a mean (standard deviation) duration of 29.6 (8.2) months. At steady state – day 70 to theend of the treatment period – attack rates were further reduced to a mean of 92.4 percent and a median reduction of
98.2 percent. An additional analysis further suggests TAKHZYRO was a well-tolerated treatment that prevented
HAE attacks over an extended planned 132 week treatment period across specific HAE patient demographic anddisease characteristic subgroups. These data were presented at the 2021 European Academy of Allergy and Clinical
Immunology (EAACI) Hybrid Congress.

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Table of Contents
REPLAGAL / Generic name: agalsidase alfa–

In November 2021, Takeda and Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Dainippon Pharma) announced
that Takeda will assume the manufacturing and marketing authorization (and the marketing rights) of REPLAGAL
3.5mg for Fabry disease, an α-galactosidase enzyme intravenous (IV) infusion, from Sumitomo Dainippon Pharma
as of February 15, 2022 in Japan.

FIRAZYR / Generic name: icatibant–

In December 2021, Takeda announced that it has submitted an application for a revision to the marketing approval
for the selective bradykinin B2 receptor blocker FIRAZYR for the treatment of pediatric patients with hereditaryangioedema (HAE) in Japan. This application is based primarily on a Japanese Phase III open-label study and an
overseas Phase III open-label study evaluating the safety, efficacy and pharmacokinetics of subcutaneousadministration of FIRAZYR in children mainly aged between two and 18 years. The Japanese pediatric treatment
response in the Japanese Phase III open-label study was similar to the pediatric treatment response in Japanese andoverseas adults and in the overseas Phase III open-label study.

VONVENDI / Generic name: von Willebrand factor (Recombinant)–

In January 2022, Takeda announced that the U.S. Food & Drug Administration (FDA) approved VONVENDI for
routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebranddisease (VWD) receiving on-demand therapy. The approval is based on data from a prospective, open-label,international multicenter study to evaluate efficacy and safety of prophylactic treatment of VONVENDI in
reducing the frequency of bleeding episodes in 10 adult patients diagnosed with severe Type 3 VWD who werepreviously treated on-demand. VONVENDI is now indicated for routine prophylaxis in adults with severe Type 3
VWD receiving on-demand therapy, as well as on-demand and perioperative bleed management in adults with
VWD.

LIVTENCITY / Generic name: maribavir–

In May 2021, Takeda announced that the U.S. Food and Drug Administration (FDA) accepted a New Drug
Application (NDA), granting priority review, for maribavir for the treatment of CMV infections that are refractorywith or without resistance (R/R), in solid organ transplant (SOT) or hematopoietic cell transplant (HCT) recipients.
The application is based on the pivotal Phase 3 TAK-620-303 (SOLSTICE) trial. Maribavir has been granted
Orphan Drug Designation by the FDA for treatment of clinically significant CMV viremia and disease in at-riskpatients. The FDA has also granted maribavir Breakthrough Therapy Designation as a treatment for CMV infection
and disease in transplant patients resistant or refractory to prior therapy.

–

In June 2021, Takeda announced the results from a new subgroup analysis of SOT recipients in the Phase 3
TAK-620-303 (SOLSTICE) trial, for the investigational drug maribavir, at the American Transplant Congress(ATC) 2021 Virtual Connect. More than twice (55.6%, 79/142) as many SOT recipients with R/R CMV infection
at baseline treated with maribavir achieved confirmed CMV viremia clearance at Study Week 8 (end of treatment
phase) compared to those treated with conventional antiviral therapies (26.1%, 18/69) (investigator assigned
treatment; IAT consists of one or a combination of ganciclovir, valganciclovir, foscarnet or cidofovir) (adjusted
difference [95% CI]: 30.5% [17.3, 43.6]). The results presented showed consistent efficacy in SOT recipients
receiving maribavir in heart, lung and kidney transplants.

–

In October 2021, Takeda announced that the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs
Advisory Committee (AMDAC) voted unanimously to recommend use of maribavir for the treatment of refractory
cytomegalovirus (CMV) infection and disease with genotypic resistance to ganciclovir, valganciclovir, foscarnet or
cidofovir in transplant recipients. The committee also voted unanimously to recommend use of maribavir for thetreatment of refractory CMV infection and disease without genotypic resistance to ganciclovir, valganciclovir,
foscarnet or cidofovir in transplant recipients. Both recommendations were based on the results of the Phase 2 andPhase 3 TAK-620-303 (SOLSTICE) trials. The New Drug Application (NDA) for maribavir is currently underPriority Review by the FDA. The FDA will consider the vote as part of its review of the NDA and is not bound by
the AMDAC’s recommendation.

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Table of Contents–

In November 2021, Takeda announced that the U.S. Food and Drug Administration (FDA) approved
LIVTENCITY for the treatment of adults and pediatric patients (12 years of age or older and weighing at least 35kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without
genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. Prior to FDA approval,
LIVTENCITY was granted Orphan Drug Designation by the FDA for treatment of clinically significant CMV
viremia and disease in at-risk patients, as well as Breakthrough Therapy Designation as a treatment for CMV
infection and disease in transplant patients resistant or refractory to prior therapy. Takeda is also investigating
LIVTENCITY as a first-line treatment of CMV in hematopoietic stem cell transplant recipients in an ongoing
Phase 3 clinical trial.

–

In December 2021, Takeda announced that the data from the pivotal Phase 3 SOLSTICE clinical trial of
LIVTENCITY in post-transplant refractory CMV infections with or without resistance (R/R) were published in thejournal of Clinical Infectious Diseases. The SOLSTICE study primary endpoint was met, with 55.7% (131/235) ofadult patients on LIVTENCITY achieving confirmed CMV DNA level below the lower limit of quantification(<LLOQ, i.e. <137 IU/mL) at the end of Study Week 8 (end of treatment phase) in comparison with 23.9%(28/117) of patients on conventional antiviral therapies (one or a combination of ganciclovir, valganciclovir,
foscarnet or cidofovir); adjusted difference [95% CI]: 32.8% [22.80 to 42.74]; P<0.001. The key secondary
endpoint of the composite achievement of CMV DNA level <LLOQ and symptom control at Week 8 maintained
through Week 16 was met, with a higher proportion of patients in the LIVTENCITY arm (18.7%, 44/235) meetingthe endpoint compared to those on conventional antiviral therapies (10.3%, 12/117); adjusted difference [95% CI]:
9.5% [2.02 to 16.88]; P=0.013.

Neuroscience
In Neuroscience, Takeda is focusing its R&D investments on potentially transformative treatments for neurological andneuromuscular diseases of high unmet need, and building its pipeline through a combination of in-house expertise andpartnerships. By harnessing advances in disease biology understanding, translational tools, and innovative modalities,
Takeda is primarily focusing on rare neurology, in particular, on potential investigative therapies for sleep-wake disorders
such as narcolepsy and idiopathic hypersomnia with a franchise of orexin-2 receptor agonists (TAK-994, TAK-861,
TAK-925, etc.), and rare epilepsies with soticlestat (TAK-935). Other rare neurology diseases of focus include Amyotrophic
Lateral Sclerosis, Huntington’s disease and other ataxias. Takeda also makes targeted investments to potentially address
well-defined segments of neurodegenerative diseases (e.g., Parkinson’s Disease).
Development code: TAK-994–

In July 2021, Takeda announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy
Designation (BTD) to TAK-994, its Phase 2 investigational oral orexin agonist, which is designed to selectively
target orexin 2 receptors. TAK-994 is currently being studied in an ongoing Phase 2 (TAK-994-1501) study for thetreatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1), a chronic neurologicaldisorder that alters the sleep-wake cycle. The TAK-994 BTD was based, in part, on early phase and preliminary
clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved
objective and subjective measurements of daytime wakefulness in NT1 patients.

–

In October 2021, Takeda announced that a safety signal has emerged in Phase 2 studies of TAK-994(TAK-994-1501 study and TAK-994-1504 study). As an immediate precautionary measure, Takeda has suspended
dosing of patients and has decided to stop both Phase 2 studies early. This allows for the timely interpretation of thebenefit/risk profile of TAK-994 and to determine next steps for the program.

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Table of Contents
Gastroenterology (GI)In Gastroenterology, Takeda focuses on delivering innovative, life-changing therapeutics for patients with gastrointestinal
and liver diseases. Takeda is maximizing the potential of our inflammatory bowel disease (IBD) franchise around
ENTYVIO, including development of a subcutaneous formulation as well as a needle free device. Takeda is also expanding
its position with GATTEX / REVESTIVE, and ALOFISEL, which is in ongoing P-3 trials to support further potential
geographic expansion, including in the U.S. Furthermore, Takeda is progressing a pipeline built through partnerships
exploring opportunities in IBD, celiac disease, select liver diseases, and motility disorders.
ENTYVIO / Generic name: vedolizumab– In October 2021, Takeda announced the update on the U.S. development program for the investigational
subcutaneous (SC) formulation of ENTYVIO as a maintenance therapy in adults with moderate to severe ulcerative
colitis (UC). Through our ongoing interactions with the U.S. Food and Drug Administration (FDA), Takeda hasreceived feedback which has provided clarity on the regulatory package and critical elements for the resubmission of
the Biologics License Application (BLA) for Entyvio SC, and we are moving forward accordingly. We are reviewing
our development program timelines and currently anticipate potential approval in FY 2023.
–

In December 2021, Takeda announced that the Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) has recommended the approval of intravenous (IV) ENTYVIO for the treatmentof adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal
pouch-anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic
therapy. The positive opinion from the CHMP was based on the EARNEST trial, recently presented at the United
European Gastroenterology’s annual meeting, UEG Week Virtual 2021, which assessed the safety and efficacy of
ENTYVIO IV in the treatment of active chronic pouchitis. Moreover, information from a number of retrospective
studies of historical data indicating that ENTYVIO can have a positive impact on patients with inflammation of thepouch was also included in the application. In January 2022, European Commission (EC) approved ENTYVIO as thefirst treatment indicated for active chronic pouchitis across the European Union.

GATTEX / REVESTIVE / Generic name: teduglutide– In June 2021, Takeda announced that it obtained approval from the Japanese Ministry of Health, Labour and Welfare(MHLW) to manufacture and market REVESTIVE 3.8 mg for subcutaneous injection as a treatment for short bowel
syndrome. The approval is mainly based on the results of several trials conducted overseas, as well as Phase 3
clinical trials (SHP633-302, SHP633-305, SHP633-306, and SHP633-307) conducted in pediatric and adult patientsin Japan.
– In November 2021, Takeda announced that it submitted the New Drug Application to the Japanese Ministry of
Health, Labour and Welfare (MHLW) for the low dose formulation (0.95 mg) as an additional dosage for
REVESTIVE as a treatment for short bowel syndrome (SBS). This new formulation would allow REVESTIVE to beadministered to SBS patients weighing less than 10 kg, or less than 20 kg with moderate or severe renal impairment(creatinine clearance of less than 50 mL/min), who cannot be dosed with the 3.8 mg formulation.
ALOFISEL / Generic name: darvadstrocel– In September 2021, Takeda announced that it has received approval from the Japanese Ministry of Health, Labourand Welfare (MHLW) to manufacture and market ALOFISEL for the treatment of complex perianal fistulas inpatients with non-active or mildly active luminal Crohn’s disease (CD). This product is indicated for the treatment ofpatients who have shown an inadequate response to at least one existing medicinal treatment. The approval is basedon data from two trials , the Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial, conducted in Europe
and Israel. ALOFISEL is the first expanded human allogeneic adipose-derived mesenchymal stem cell therapy to beapproved in Japan, which exhibits immunomodulatory and local anti-inflammatory effects at the site of inflammation.
Development code: TAK-721 (Planned trade name: Eohilia) / Generic name: budesonide oral suspension–
In December 2021, Takeda announced that it has received a Complete Response Letter (CRL) from the U.S. Foodand Drug Administration (FDA) in response to its New Drug Application (NDA) for TAK-721 for the treatment of
eosinophilic esophagitis, a chronic inflammatory disease of the esophagus. The CRL indicates the FDA has
completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. In
addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback. Takeda
announced the discontinuation of this program in February 2022.

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Plasma-Derived Therapies (PDT)
Takeda created a dedicated PDT business unit with a focus to manage the business end-to-end, from plasma collection to
manufacturing, R&D, and commercialization. In PDT, we aspire to develop life-saving plasma derived treatments which areessential for patients with a variety of rare and complex chronic diseases. The dedicated R&D organization in PDT ischarged with maximizing the value of existing therapies, identifying new targeted therapies, and optimizing efficiencies ofcurrent product manufacturing. Near-term, our priority is focused on delivering value from our broad immunoglobulin
portfolio (HYQVIA, CUVITRU, GAMMAGARD and GAMMAGARD S/D) through pursuit of new indications,geographic expansions, and enhanced patient experience through integrated healthcare technologies. In our hematology andspecialty care portfolio, our priority is pursuing new indication and formulation development opportunities for
PROTHROMPLEX (4F-PCC), FEIBA, CEPROTIN and ARALAST. Additionally, we are developing next generation
immunoglobulin products with 20% fSCIg (TAK-881), IgG Low IgA (TAK-880) and pursuing other early stage
opportunities that would add to our diversified commercial portfolio of more than 20 therapeutic products distributed
worldwide.
Development code: CoVIg-19 (previously TAK-888) / Generic name: anti-SARS-CoV-2 polyclonal hyperimmune
immunoglobulin–

In April 2021, The CoVIg-19 Plasma Alliance announced that the Phase 3 Inpatient Treatment with AntiCoronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and
Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. No serious
safety signals were raised in the trial. The study aimed to determine whether an investigational anti-coronavirus
hyperimmune intravenous immunoglobulin (H-Ig) medicine could reduce the risk of disease progression when
added to standard of care treatment including remdesivir in hospitalized adult patients at risk for serious
complications. Analyses remain ongoing and NIAID and the INSIGHT Network intend to publish the full results ofthe trial soon. Following the outcome of the ITAC trial, the CoVIg-19 Plasma Alliance’s work has now concluded.

Vaccines
In Vaccines, Takeda is applying innovation to tackle some of the world’s most challenging infectious diseases such as
dengue, COVID-19, zika, and norovirus. To support the expansion of our pipeline and the development of our programs, wehave entered into partnerships with government organizations in Japan and the U.S., and leading global institutions. Suchpartnerships have been essential in building the critical capabilities that will be necessary to deliver on our programs andrealize their full potential.
SPIKEVAX (formerly COVID-19 Vaccine Moderna) Intramuscular Injection / Development code: mRNA-1273 (Japanesedevelopment code: TAK-919)–

In May 2021, Takeda announced positive interim results from the ongoing Phase 1/2 immunogenicity and safety
clinical trial of TAK-919 in Japan have been submitted to the Japan Pharmaceuticals and Medical Devices Agency(PMDA). Takeda currently has a three-way agreement with Moderna, Inc. (Moderna) and the Government ofJapan’s Ministry of Health Labour and Welfare (MHLW) to import and distribute 50 million doses of TAK-919 inJapan. This interim analysis showed binding antibody and neutralizing antibody titres were elevated at 28 days
after the second dose in 100% of people vaccinated with two 0.5ml doses of TAK-919 given 28 days apart. The
vaccine candidate was generally well-tolerated with no significant safety concerns reported. The study results were
submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to be evaluated as part of the New
Drug Application submitted in March 2021, which also includes safety and efficacy results from Moderna’s pivotal
Phase 3 COVE trial conducted in the U.S.

–In May 2021, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted
special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of
COVID-19 Vaccine Moderna Intramuscular Injection in Japan. The approval is based on positive clinical data fromTakeda’s Phase 1/2 immunogenicity and safety clinical trial of COVID-19 Vaccine Moderna Intramuscular
Injection in Japan, which showed an immune response consistent with results from Moderna’s pivotal Phase 3
COVE trial conducted in the United States. Takeda has started distribution in Japan.

–

In July 2021, Takeda announced an additional agreement with Moderna and the Government of Japan’s Ministry of
Health, Labour and Welfare (MHLW) to import and distribute an additional 50 million doses of COVID-19
Vaccine Moderna Intramuscular Injection in Japan from as early as the beginning of 2022. This agreement includes
the potential to secure and supply vaccines corresponding to COVID-19 variants or booster products, should they
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be successfully developed by Moderna and licensed by the MHLW. Takeda will import and distribute the totaling
100 million doses including the additional 50 million doses in 2022 and 50 million doses announced in October,
2020.
–

In July 2021, Takeda announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) accepted thechange in age indication in the package insert for COVID-19 Vaccine Moderna Intramuscular Injection to expand
to 12 years of age and older. This change is based on the results of Moderna's Phase 2/3 study conducted in 3,732
subjects aged 12 to 17 years in the United States. The serum neutralizing antibody titer and neutralizing antibody
titer response rate 28 days after the second vaccination of adolescents (12 to 17 years old), which are the primary
endpoints, showed non-inferiority to young adults (18 to 25 years old) in the overseas phase 3 study (mRNA-1273P301 study). Additionally, the results indicating a high preventive effect at the vaccine efficacy rate 2 weeks after
the second vaccination, which was set as a secondary endpoint. No significant safety concerns were reported, as
was the case with the results of clinical studies in patients aged 18 years or older.

–

In December 2021, Takeda announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted
regulatory approval for a 50 µg booster dose of SPIKEVAX Intramuscular Injection, previously known as
COVID-19 Vaccine Moderna Intramuscular Injection, in Japan for administration at least six months after
completion of the primary series in those who are 18 years and older. The approval is based on previously-reported
positive Moderna Phase 2 study results. Moderna’s Phase 2 study was amended to offer a 50 µg booster dose tointerested participants aged 18 years and older six to eight months following their second dose of the primary seriesof Moderna’s COVID-19 vaccine. The results showed that a booster dose of the vaccine greatly increased
neutralizing titers measured against the original virus strain compared to pre-boost levels. The reactogenicity
profile observed following the booster dose was similar to the second dose of the primary series and the safety
profile was also similar to that following any dose of Moderna’s COVID-19 vaccine of the primary series.

–

In December 2021, Takeda announced a third agreement with Japan’s Ministry of Health, Labour and Welfare(MHLW) and Moderna to import and distribute 18 million additional doses of SPIKEVAX Intramuscular Injectionin Japan in 2022. Takeda previously announced a three-way agreement with Moderna and MHLW to distribute 50
million doses of SPIKEVAX in Japan in 2021, and announced a second agreement for Takeda to import anddistribute an additional 50 million doses in 2022, totaling 100 million doses between the two agreements. Due tothe approval of the 50 microgram booster dose described in the foregoing paragraph, which is half of the dosage
level used in the initial two-dose series of the vaccine (100 microgram per dose), the doses per vial for the second
50 million doses will increase, meaning Takeda will be able to deliver 75 million booster doses (at 15 doses pervial). With this third agreement for 18 million doses (at 15 doses per vial), Takeda will now deliver a total of 93
million doses to Japan in 2022.

Development code: NVX-CoV2373 (Japanese development code: TAK-019) / Generic name: COVID-19 vaccine–

In September 2021, Takeda announced the agreement that the Japanese Ministry of Health, Labour and Welfare(MHLW) will purchase 150 million doses of Novavax, Inc. (Novavax)’s vaccine candidate (TAK-019 in Japan)
manufactured in Japan by Takeda subject to licensing and approval. Takeda is establishing the capability to
manufacture TAK-019 at its facilities in Japan and aims to begin distribution in early calendar year 2022. Novavax
is licensing and transferring manufacturing technologies to enable Takeda to manufacture the vaccine antigen andis supplying the Matrix-MTM adjuvant to Takeda for fill/finish together with the antigen. Takeda is responsible for
the Japanese clinical trial and regulatory submission and will distribute TAK-019 in Japan should it be approved by
the MHLW.

–In December 2021, Takeda announced the submission of a New Drug Application (NDA) to the Ministry of
Health, Labour and Welfare (MHLW) in Japan for TAK-019. The NDA submission includes an analysis from theongoing Phase 1/2 immunogenicity and safety clinical trial of TAK-019 in Japan as well as safety and efficacy datafrom Novavax’ global clinical trial program with more than 50,000 participants, including two pivotal Phase 3
trials, one conducted in the U.K. and another trial conducted in the U.S. and Mexico. Takeda’s interim trial results
showed that two 0.5 ml doses given 21 days apart induced robust anti-SARS-CoV-2 immune responses in healthy
Japanese adults. No serious adverse events were reported in the TAK-019 group and the vaccine candidate was also
well-tolerated. These results are consistent with previously reported global clinical trial results of Novavax’
recombinant protein COVID-19 vaccine candidate (NVX-CoV2373). Takeda submitted all available Chemistry,
Manufacturing and Controls (CMC), non-clinical and clinical data as of December 2021. Some additional CMC
data will be subsequently submitted to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) during the
NDA review period. Through its partnership with Novavax including technology transfer, Takeda is establishing
the capability to manufacture TAK-019 at its facilities in Japan and aims to begin distribution in early calendar year
2022, pending regulatory approval.
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Development code: TAK-003 / Generic name: Dengue vaccine–

In May 2021, Takeda announced that TAK-003 demonstrated continued protection against dengue illness andhospitalization, regardless of an individual’s previous dengue exposure, with no important safety risks identified
through three years after vaccination in the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue
Efficacy Study (TIDES) trial. TIDES enrolled more than 20,000 healthy children and adolescents ages four to 16
years in dengue-endemic countries in Latin America and Asia. Safety and efficacy results from the 36-monthfollow-up exploratory analysis of TIDES were presented at the 17th Conference of the International Society ofTravel Medicine (CISTM). Through three years (36 months after the second dose), observations of varied vaccine
efficacy by serotype remained consistent with previously reported results. No evidence of disease enhancement wasobserved. TAK-003 was generally well tolerated, and there were no important safety risks observed. TIDES safety
and efficacy data through 36-months follow-up was included in regulatory submissions to the European Union anddengue-endemic countries and will be part of additional filings planned for 2021, including in the United States.

Building a sustainable research platform / Enhancing R&D collaboration
In addition to our concentrated efforts to increase our in-house R&D capabilities, external partnerships with third-party
partners are a key component of our strategy for enhancing our R&D pipeline. Our strategy to expand and diversify our
external partnerships allows us to take part in research of a wide variety of new products and increases the chances that wewill be able to take part in a major research-related breakthrough.
–In July 2021, Takeda and PeptiDream Inc. announced an expansion of its research collaboration and exclusive
license agreement, announced in December 2020, to create peptide-drug conjugates (PDCs) for several central
nervous system (CNS) targets, which play important roles in chronic neurodegenerative diseases. This new
collaboration expands the use of the TfR1 binding peptide ligands for CNS targets associated withneurodegeneration allowing Takeda to conjugate the peptides with therapeutic cargoes optimized to cross the
blood-brain barrier (BBB). A significant challenge to the development of effective medicines for neurodegenerative
diseases is the ability to deliver therapeutic molecules across the BBB into the brain. Peptide carriers that bind to
TfR1 when conjugated to various therapeutic payloads facilitate the transport of the payload across the BBB into
the brain, and thereby significantly improve functional benefit. This TfR1 BBB shuttle approach has the potential
to accelerate the development of therapies for which BBB penetration remains challenging. This approach may alsoenable broad brain region biodistribution that is frequently needed to effectively treat many neurodegenerative
diseases for which few, if any, effective drugs currently exist.

–

In July 2021, Takeda and Frazier Healthcare Partners announced a collaboration to launch HilleVax, Inc. (HilleVax),
a biopharmaceutical company to develop and commercialize Takeda’s norovirus vaccine candidate. Takeda has
granted a license to HilleVax for the exclusive development and commercialization rights to its norovirus vaccine
candidate, HIL-214 (formerly TAK-214), worldwide outside of Japan, in exchange for upfront consideration, as well
as future cash milestones and royalties on net sales. Takeda will retain commercialization rights in Japan and
HilleVax will integrate certain Japan development activities into its global development. HIL-214, which is a viruslike particle (VLP) based vaccine candidate, completed a randomized, placebo-controlled Phase 2b field efficacy
study in 4,712 adult subjects in which HIL-214 was well-tolerated and demonstrated clinical proof of concept inpreventing moderate-to-severe cases of acute gastroenteritis from norovirus infection.1 To date, the candidate has
been studied in nine human clinical trials with safety data from over 4,500 subjects and immunogenicity data fromover 2,000 subjects.

–

In September 2021, Takeda and Mirum Pharmaceuticals, Inc. (Mirum) announced that the companies have enteredinto an exclusive licensing agreement for the development and commercialization of maralixibat chloride(maralixibat) (US trade name: LIVMARLI ), an apical sodium dependent bile acid transporter (ASBT) inhibitor, inJapan for Alagille syndrome (ALGS), progressive familial intrahepatic cholestasis (PFIC), and biliary atresia (BA).
Maralixibat, an investigational, orally administered medication, is being evaluated globally in ALGS, PFIC, and BA.
Under the terms of the agreement, Takeda will be responsible for regulatory approval and commercialization of
maralixibat in Japan. Takeda will also be responsible for development, including conducting clinical studies incholestatic indications.

–

In September 2021, Takeda and JCR Pharmaceuticals Co., Ltd. (JCR) announced a geographically-focused exclusive
collaboration and license agreement to commercialize JR-141 (pabinafusp alfa), an investigational, next-generation
recombinant fusion protein of an antibody against the human transferrin receptor and iduronate-2-sulfatase (IDS)
enzyme for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis type II or MPS II). JR-141,
applied with J-Brain Cargo, JCR’s proprietary blood-brain barrier (BBB) technology, is engineered to transport thetherapeutic enzyme across the BBB to directly reach the brain and address both the somatic and neuronopathic
manifestations of the disease, which can lead to progressive cognitive decline. Under the terms of the exclusive- 21 -

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collaboration and license agreement, Takeda will exclusively commercialize JR-141 outside of the United States,
including Canada, Europe, and other regions (excluding Japan and certain other Asia-Pacific countries). The twocompanies will collaborate to bring this therapy to patients as quickly as possible upon completion of the global
Phase 3 program, which will be conducted by JCR. Takeda receives an option under a separate option agreement,
which allows Takeda to acquire an exclusive license to commercialize JR-141 in the U.S. upon completion of thePhase 3 program.
–

In October 2021, Takeda announced the exercise of its option to acquire GammaDelta Therapeutics Limited(“GammaDelta”), a company focused on exploiting the unique properties of gamma delta (γδ) T cells for
immunotherapy. Through the acquisition, Takeda will obtain GammaDelta’s allogeneic variable delta 1 (Vδ1)
gamma-delta (γδ) T cell therapy platforms, which includes both blood-derived and tissue-derived platforms, inaddition to early-stage cell therapy programs. The deal is expected to be finalized in Q1 of Takeda’s fiscal year
2022. Closing of the transaction is contingent on completion of review under antitrust laws, including the HartScott-Rodino Antitrust Improvements Act of 1976 (HSR) in the U.S. Takeda received HSR clearance for thetransaction from the United States Federal Trade Commission (FTC) in January, 2022.

–

In January 2022, Takeda announced the exercise of its option to acquire Adaptate Biotherapeutics Ltd.
(“Adaptate”), a UK company focused on developing antibody-based therapeutics for the modulation of variabledelta 1 (Vδ1) gamma delta (γδ) T cells. Through the acquisition, Takeda will acquire Adaptate’s antibody-based γδ
T cell engager platform, including pre-clinical candidate and discovery pipeline programs. Adaptate’s γδ T cell
engagers are designed to specifically modulate γδ T cell-mediated immune responses at tumor sites while sparing
damage to healthy cells. The planned acquisition of Adaptate follows Takeda’s recently exercised option to acquire
GammaDelta Therapeutics and is intended to further accelerate the development of innovative γδ T cell-based
therapies. The deal is expected to be finalized in Q1 of Takeda’s fiscal year 2022.

3. Material Contracts
The material contracts entered into, amended or terminated during the three-month period ended December 31, 2021 are
as follows:
On October 14, 2021, Takeda issued 10-year unsecured senior bonds with an aggregate principal amount of 250 billion
JPY and a maturity date of October 14, 2031.
On December 13, 2021 Takeda prepaid the remaining 1,700 million USD outstanding JBIC Loan (Note) amount, andcanceled the JBIC Loan.
(Note) This agreement was entered into, with the Japan Bank for International Cooperation, on December 3, 2018.

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III. Information on the Company
1. Information on the Company’s Shares(1) Total number of shares and other related information
1) Total number of shares
Total number of sharesauthorized to be issued (Shares)

Class

Common stockTotal

3,500,000,000
3,500,000,0002) Number of shares issued
Number of shares
outstanding(As of December 31, 2021)

Number of shares
outstanding as of the fillingdate(February 10, 2022)

Common stock

1,582,252,525

1,582,252,525

Tokyo, Nagoya (both listedon the first section), Fukuoka,
Sapporo, New YorkThe number of shares per one
unit of shares is 100 shares.

Total

1,582,252,525

1,582,252,525

—

—

Class

(Note1)(Note2)

Stock exchange on
which the Company islistedDescription

The Company's American Depositary Shares (ADS) are listed on the New York Stock Exchange.
The number of shares outstanding as of the filing date does not include newly issued shares exercised bystock acquisition rights from February 1, 2022 to the filing date of Quarterly Securities Report (February 10,2022).

(2) Status of stock acquisition rights
1) Contents of stock option plans
Not applicable.
2) Status of other stock acquisition rights
Not applicable.
(3) Exercise status of bonds with stock acquisition rights containing a clause for exercise price adjustments
Not applicable.
(4) Changes in the total number of issued shares and the amount of share capital and capital reserve

Date

Change in the
total number ofissued shares(Thousand of
shares)Balance of thetotal number ofissued shares(Thousand of
shares)Change inshare capital
JPY (millions)

Balance ofshare capital
JPY (millions)

Change incapital reserve
JPY (millions)

Balance ofcapital reserve
JPY (millions)—

1,582,253—

1,676,263—

1,668,276

From July 1, 2021 to
December 31, 2021
(Note) 1(Note) There was no increase in the total number of issued shares, share capital or capital reserve due to the exercise ofstock acquisition rights from January 1, 2022 to January 31, 2022.
(5) Major shareholders
No information required in the 3rd quarter.

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Table of Contents(6) Information on voting rights
1) Total number of shares
As of December 31, 2021
Number of shares
Number of voting(Shares)rights (Units)——

Classification
Shares without voting rights
Shares with restricted voting rights(Treasury stock and other)
Shares with restricted voting rights(Others)

—

—

—

—

—

—

15,511,200——

287,000———

Shares with full voting rights(Treasury stock and other)(Treasury stock)
Common stock(Crossholding stock)
Common stock

Shares with full voting rights(Others)

Common stock

1,565,190,800

15,651,908

Shares less than one unit

Common stock

1,263,525—

1,582,252,525——
15,651,908

Number of issued shares
Total number of voting rights(Note1)(Note2)(Note3)

Description—

Shares less than one unit
(100 shares)——

Based on the resolution at the Board of Directors Meeting on October 28, 2021, the Company acquired
15,335,700 of treasury stocks by open-market repurchase through a trust bank from November 2, 2021 toNovember 30, 2021.
"Shares with full voting rights (Others)" includes 7,018,000 (voting rights: 70,180) and 2,143,100 (voting
rights: 21,431) of the shares held by the ESOP and BIP trust, respectively.
"Shares less than one unit" includes 63 of the shares as the treasury stock, and 140 and 102 of the shares heldby the ESOP and BIP trust, respectively.

2) Treasury stock and other
As of December 31, 2021
Number ofshares held
under own
name (Shares)

Number ofshares held
under the nameof others(Shares)

Total shares
held (Shares)

Percentage of
total issued
shares issued(%)

1-1, Doshomachi 4chome, Chuo-ku, Osaka

15,511,200—

15,511,200

0.98

Amato Pharmaceutical
Products, Ltd.

5-3, Shinsenri Higashimachi 1-chome,
Toyonaka-city, Osaka

275,000—

275,000

0.02

Watanabe Chemical, Co.,Ltd.

6-1, Hiranomachi 3chome, Chuo-ku,
Osaka-city, Osaka

12,000—12,0000.00

15,798,200—

15,798,200

1.00

Name of shareholders(Treasury stock)
Takeda Pharmaceutical
Company Limited(Crossholding stock)

Total(Note1)

Address

Based on the resolution at the Board of Directors Meeting on October 28, 2021, the Company acquired
15,335,700 of treasury stocks by open-market repurchase through a trust bank from November 2, 2021 toNovember 30, 2021.

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Table of Contents(Note2)

In addition to the above treasury stock and shares less than one unit of 63 shares, 7,018,140 of the shares heldby the ESOP trust and 2,143,202 of the shares held by the BIP trust are included in treasury stock on thecondensed interim consolidated financial statements.

2. Members of the Board of Directors
No changes from the latest Annual Securities Report.

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IV. Financial Information
Basis of Preparation of the Condensed Interim Consolidated Financial Statements
Takeda has prepared the condensed interim consolidated financial statements in accordance with IAS 34 “Interim Financial
Reporting” based on the provision of Article 93 of Ordinance on Terminology, Forms and Preparation Methods of Quarterly
Consolidated Financial Statements (Ordinance of the Ministry of Finance No. 64, 2007 in Japan).

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Table of Contents
1. Condensed Interim Consolidated Financial Statements(1) Condensed Interim Consolidated Statements of Profit or Loss

Note

Revenue
Cost of sales
Selling, general and administrative expenses
Research and development expenses
Amortization and impairment losses on
intangible assets associated with products
Other operating income
Other operating expenses
Operating profit
Finance income
Finance expenses
Share of profit (loss) of investments
accounted for using the equity method
Profit before tax
Income tax expenses
Net profit for the period
Attributable to:
Owners of the Company
Non-controlling interests
Net profit for the period
Earnings per share (JPY)
Basic earnings per share
Diluted earnings per share

4

5
6

7
8, 15

9
9

JPY (millions, except per share data)
Nine-month Period Ended
Three-month Period Ended
December 31,
December 31,
2020
2021
2020
2021
2,427,538
2,695,717
836,753
901,294(740,862)(798,466)(253,142)(281,404)(641,275)(662,932)(222,644)(231,078)(342,544)(382,459)(117,566)(128,378)(307,570)
118,532(155,090)
358,72958,030(323,632)
34,269(100,034)
462,463
42,949(99,473)
49,069(49,856)
143,141
28,402(118,087)
14,734(40,596)
116,484
4,145(173,389)(143,539)(62,669)(46,706)(8,013)
235,357(56,330)
179,027(5,255)356,618(115,077)
241,541922
109,796(17,358)
92,438(1,730)72,193(14,373)
57,820178,907120
179,027

241,417124
241,541

92,35979
92,43857,77051
57,820114.57113.72154.09153.03

59.08
58.61

36.91
36.68

See accompanying notes to condensed interim consolidated financial statements.

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Table of Contents(2) Condensed Interim Consolidated Statements of Comprehensive Income

Net profit for the period
Other comprehensive income (loss)
Items that will not be reclassified to profit or loss:
Changes in fair value of financial assets measured at fairvalue through other comprehensive income

JPY (millions)Nine-month Period Ended
Three-month Period
December 31,
Ended December 31,
2020
2021
2020
2021
179,027
241,541
92,43857,820Remeasurement of defined benefit pension plans
Items that may be reclassified subsequently to profit or loss:
Exchange differences on translation of foreign operations
Cash flow hedges
Hedging cost
Share of other comprehensive income (loss) of investments
accounted for using the equity method
Other comprehensive income for the period, net of tax
Total comprehensive income for the period
Attributable to:
Owners of the Company
Non-controlling interests
Total comprehensive income for the period

69,336(4,879)64,457(5,951)(2,912)(8,862)

37,984(2,120)35,864(10,220)(1,210)(11,430)(42,370)(21,596)(10,288)

206,582
13,958
5,969(10,967)(15,707)
3,256

139,883
2,406
185

220
(74,034)(9,577)
169,450(145)
226,365
217,503
459,044

123(23,295)
12,569105,007(108)
142,365
130,935
188,756

169,301
149

458,887
157

105,029(22)

188,689
66

169,450

459,044

105,007

188,756

See accompanying notes to condensed interim consolidated financial statements.

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Table of Contents(3) Condensed Interim Consolidated Statements of Financial Position
JPY (millions)
Note
ASSETS
Non-current assets:
Property, plant and equipment
Goodwill
Intangible assets
Investments accounted for using the equity method
Other financial assets
Other non-current assets
Deferred tax assets
Total non-current assets
Current assets:
Inventories
Trade and other receivables
Other financial assets
Income taxes receivable
Other current assets
Cash and cash equivalents
Assets held for sale
Total current assets
Total assets
LIABILITIES AND EQUITY
LIABILITIES
Non-current liabilities:
Bonds and loans
Other financial liabilities
Net defined benefit liabilities
Income taxes payable
Provisions
Other non-current liabilities
Deferred tax liabilities
Total non-current liabilities
Current liabilities:
Bonds and loans
Trade and other payables
Other financial liabilities
Income taxes payable
Provisions
Other current liabilities
Total current liabilities
Total liabilities

As of March 31, 2021

As of December 31, 2021

1,453,917
4,033,917
3,909,106
112,468
235,882
100,341
353,769
10,199,400

1,493,587
4,167,993
3,791,875
104,507230,305
79,645352,715
10,220,626

753,881811,324

783,091
36,59829,623
122,789966,222
20,6892,712,893
12,912,293

715,515
27,55540,602
138,352
724,341
20,2032,477,893
12,698,519

12

4,613,218
517,677
158,857
33,69038,74856,898542,852
5,961,940

4,231,939
461,692
169,803
30,874
34,04270,486558,6075,557,443

12

22,153343,838
248,053
145,203471,278
542,651
1,773,176
7,735,116

122,936
351,185
189,298
185,441
421,481
538,913
1,809,254
7,366,697

10

11

15

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Table of Contents
JPY (millions)
Note
EQUITY
Share capital
Share premium
Treasury shares
Retained earnings
Other components of equity
Equity attributable to owners of the company
Non-controlling interests
Total equity
Total liabilities and equity

13
13
13

As of March 31, 2021

As of December 31, 2021

1,668,145
1,688,424(59,552)
1,509,906
366,1145,173,037
4,140
5,177,177
12,912,293

See accompanying notes to condensed interim consolidated financial statements.

- 30 -

1,676,263
1,697,562(91,013)
1,466,926
581,592
5,331,330
493
5,331,822
12,698,519

Table of Contents(4) Condensed Interim Consolidated Statements of Changes in Equity
Nine-month period ended December 31, 2020 (From April 1 to December 31, 2020)
JPY (millions)
Equity attributable to owners of the Company
Other components of equity

Note

As of April 1, 2020

SharecapitalSharepremium

TreasurysharesRetainedearnings

Exchangedifferencesontranslationof foreign
operations

1,668,123

1,680,287(87,463)

1,369,972

91,848Net profit for the period

Changes infair value offinancialassetsmeasured atfair value
through othercomprehensive
income22,891Cashflowhedges(22,730)

Hedging
cost

Remeasureme
nts of defined
benefitpension plans

555—

178,907

Other comprehensive income (loss)
Comprehensive income (loss) for the period

—

—

22

22

—

178,907

Noncontrollinginterests

Total
equity

Total

Total

92,564

4,723,483

4,003

4,727,486—

178,907120

179,027(42,191)

69,348(21,596)(10,288)(4,879)(9,606)(9,606)29(9,577)(42,191)

69,348(21,596)(10,288)(4,879)(9,606)

169,301

149

169,450

Transaction with owners:
Issuance of new shares
Acquisition of treasury shares(2,138)

Disposal of treasury shares
Dividends

(0)

2

13

(283,718)

Transfers from other components of equity

41,407

Share-based compensation
Exercise of share-based awards
Total transactions with owners
As of December 31, 2020

(46,286)

4,879

28,119

—

44

44

—

(2,138)(2,138)—2—(283,718)2(77)(283,795)(41,407)———

28,11928,119(29,772)

30,032—260

22(1,631)

27,896(242,311)—(46,286)

—

—

4,879

(41,407)(257,431)(77)(257,508)

1,668,145

1,678,656(59,567)

1,306,568

49,65745,953(44,326)(9,733)—41,551

4,635,353

4,075

4,639,428

See accompanying notes to condensed interim consolidated financial statements.

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260

Table of Contents
Nine-month period ended December 31, 2021 (From April 1 to December 31, 2021)
JPY (millions)
Equity attributable to owners of the Company
Other components of equity

Note

As of April 1, 2021

SharecapitalSharepremium

TreasurysharesRetainedearnings

Exchangedifferencesontranslationof foreign
operations

1,668,145

1,688,424(59,552)

1,509,906

400,798

Net profit for the period

Changes infair value offinancialassetsmeasured atfair value
through othercomprehensive
income41,983CashflowhedgesHedging
cost

Remeasureme
nts of defined
benefitpension plans(68,075)(8,592)—

241,417

Other comprehensive income (loss)
Comprehensive income (loss) for the period

—

—

8,118

14,036—

241,417

Noncontrollinginterests

Total
equity

Total

Total

366,1145,173,037

4,140

5,177,177—

241,417124

241,541

206,337(5,883)

13,9585,969(2,912)

217,470

217,47033

217,503206,337(5,883)

13,9585,969(2,912)

217,470

458,887

157

459,044

Transaction with owners:
Issuance of new shares

13

Acquisition of treasury shares

13(54,451)

Disposal of treasury shares
Dividends

(0)

1

13

(284,246)

Changes in ownership(2,143)

Transfers from other components of equity

1,992

Share-based compensation

As of December 31, 2021

2,912

32,057

Exercise of share-based awards
Total transactions with owners(4,904)—

22,154

22,154—(54,451)(54,451)

—

1

1

—

(284,246)(284,246)—(2,143)(1,992)—(3,804)(5,948)——32,05732,057(36,955)

22,989—(13,966)

8,118

9,138

(31,461)(284,397)—(4,904)

—

—

2,912

(1,992)(300,594)(3,804)(304,399)

1,676,263

1,697,562(91,013)

1,466,926

607,135

31,196(54,116)(2,623)—

581,592

5,331,330

493

5,331,822

See accompanying notes to condensed interim consolidated financial statements.

- 32 -(13,966)

Table of Contents(5) Condensed Interim Consolidated Statements of Cash Flows

Notes
Cash flows from operating activities:
Net profit for the period
Depreciation and amortization
Impairment losses
Equity-settled share-based compensation
Change in estimate of liabilities related to SHP647
Loss (gain) on sales and disposal of property, plant and equipment
Gain on divestment of business and subsidiaries

5

Change in fair value of financial assets and liabilities associated with contingent consideration
arrangements, net
Finance (income) and expenses, net
Share of loss of investments accounted for using the equity method
Income tax expenses
Changes in assets and liabilities:
Decrease (increase) in trade and other receivables
Decrease (increase) in inventories
Decrease in trade and other payables
Increase (decrease) in provisions
Increase (decrease) in other financial liabilities
Other, net
Cash generated from operations
Income taxes paid
Tax refunds and interest on tax refunds received
Net cash from operating activities
Cash flows from investing activities:
Interest received
Dividends received
Acquisition of property, plant and equipment
Proceeds from sales of property, plant and equipment
Acquisition of intangible assets
Acquisition of investments
Proceeds from sales and redemption of investments
Acquisition of businesses, net of cash and cash equivalents acquired
Proceeds from sales of business, net of cash and cash equivalents divested
Other, net
Net cash from (used in) investing activities- 33 -

6

JPY (millions)Nine-month Period Ended December
31,
2020
2021
179,027420,281
10,11828,119(60,179)(3,435)(38,273)

241,541
430,877
14,66632,057—258(1,095)

8,888
115,359
8,013
56,330(9,683)
100,589
5,255
115,077(49,908)
6,059(5,082)
66,84425,939(11,810)756,290(174,694)
28,375609,971

82,243(39,268)(1,797)(70,098)(51,158)(858)
848,607(107,224)
6,138
747,521752
215(75,041)
42,818(49,469)(9,479)73,717—
124,969(8,283)
100,199

2,468
2,598
(87,673)412(46,541)(7,600)16,065(49,672)
2,138(4,683)(172,487)

Table of Contents

Notes
Cash flows from financing activities:
Net decrease in short-term loans and commercial papers
Proceeds from issuance of bonds and long-term loans
Repayments of bonds and long-term loans
Payments for settlement of forward rate agreement related to bonds
Acquisition of treasury sharesInterest paid
Dividends paid
Repayments of lease liabilities
Other, net
Net cash used in financing activities
Net decrease in cash and cash equivalents
Cash and cash equivalents at the beginning of the year
(Consolidated statements of financial position)
Effects of exchange rate changes on cash and cash equivalents
Cash and cash equivalents at the end of the period
Cash and cash equivalents reclassified to assets held for sale
Cash and cash equivalents at the end of the period(Consolidated statements of financial position)

JPY (millions)Nine-month Period Ended
December 31,
2020
2021
(84,997)
1,179,515(1,389,102)(34,830)(2,138)(84,185)(274,679)(27,710)(156)(718,282)(8,112)(2)
249,334(635,047)—(52,538)(84,917)(273,024)(29,904)(366)(826,465)(251,430)

637,614(11,797)
617,705(70)

966,2229,549
724,341—

617,635

724,341

See accompanying notes to condensed interim consolidated financial statements.

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Table of Contents
Notes to Condensed Interim Consolidated Financial Statements
1.

Reporting Entity

Takeda Pharmaceutical Company Limited (the “Company”) is a public company incorporated in Japan. The Company and its
subsidiaries (collectively, “Takeda”) is a global, values-based, R&D-driven biopharmaceutical company with an innovative
portfolio, engaged primarily in the research, development, production and global commercialization of pharmaceutical products.
Our intent is to translate science into highly innovative life transforming medicines. Takeda has grown both organically andthrough acquisitions, completing a series of major transactions that have resulted in growth in our areas of therapeutic, geographic
and pipeline focus. Takeda’s principal pharmaceutical products include medicines in the following key business areas:
gastroenterology (“GI”), rare diseases, Plasma-Derived Therapies (“PDT”), oncology, and neuroscience.
2.

Basis of Preparation(1) ComplianceTakeda has prepared the condensed interim consolidated financial statements in accordance with IAS 34 “Interim Financial
Reporting” as issued by the International Accounting Standards Board (“IASB”).
The condensed interim consolidated financial statements do not contain all the information required in consolidated financial
statements as of the end of a fiscal year. Therefore, the condensed interim consolidated financial statements should be used withthe consolidated financial statements as of and for the fiscal year ended March 31, 2021.
(2) Approval of Financial Statements
Takeda’s condensed interim consolidated financial statements as of and for the period ended December 31, 2021 were approved
on February 10, 2022 by Representative Director, President & Chief Executive Officer (“CEO”) Christophe Weber and Director& Chief Financial Officer Costa Saroukos.
(3) Functional Currency and Presentation Currency
The condensed interim consolidated financial statements are presented in Japanese yen (“JPY”), which is the functional currencyof the Company. All financial information presented in JPY has been rounded to the nearest million, except when otherwise
indicated. In tables with rounded figures, sums may not add up due to rounding.
(4) Use of Judgments, Estimates and Assumptions
The preparation of the condensed interim consolidated financial statements requires management to make certain judgments,
estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities,
revenues and expenses, as well as the disclosure of contingent assets and liabilities. Actual results could differ from theseestimates.
These estimates and underlying assumptions are reviewed on a continuous basis. Changes in these accounting estimates arerecognized in the period in which the estimates are revised and in any future periods affected.
The condensed interim consolidated financial statements are prepared based on the same judgments and estimations as well as theaccounting estimates and assumptions applied and described in Takeda’s consolidated financial statements for the fiscal year
ended March 31, 2021.
Although the COVID-19 pandemic could potentially impact business activities within Takeda due to its further spread, the overall
impact on Takeda’s condensed interim consolidated financial results has been limited to date. Therefore, the pandemic did nothave a significant impact on accounting estimates and assumptions used for the preparation of the condensed interim consolidated
financial statements. Takeda will continue to reassess estimates and assumptions as the situation evolves.
3.

Significant Accounting Policies

Significant accounting policies adopted for the condensed interim consolidated financial statements are the same as those adopted
for the consolidated financial statements of the fiscal year ended March 31, 2021.
Takeda calculated income tax expenses for the nine-month period ended December 31, 2021, based on the estimated averageannual effective tax rate.

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Table of Contents
4.

Operating Segment and Revenue Information

Takeda comprises a single operating segment and is engaged in the research, development, manufacturing, marketing and outlicensing of pharmaceutical products. This is consistent with how the financial information is viewed in allocating resources,
measuring performance, and forecasting future periods by the CEO who is Takeda’s Chief Operating Decision Maker.
(1) Disaggregation of Revenue Information
Takeda’s revenue from contracts with customers is comprised of the following:
Revenue by Type of Good or Service

Sales of pharmaceutical products
Out-licensing and service income
Total

JPY (millions)Nine-month Period Ended December 31,
2020
2021
2,358,501
2,485,164
69,037
210,552
2,427,538
2,695,717

Sales of pharmaceutical products
Out-licensing and service income
Total

JPY (millions)Three-month period ended December 31,
2020
2021
813,997
873,882
22,756
27,412
836,753
901,294

Revenue by Therapeutic Area and Product
JPY (millions)Nine-month Period Ended December 31,
2020
2021
Gastroenterology:
ENTYVIOTAKECAB-F (1)GATTEX/REVESTIVE
DEXILANTPANTOLOC/CONTROLOC (2)ALOFISEL
OthersTotal Gastroenterology
Rare Diseases:
Rare Metabolic:
ELAPRASE
REPLAGALVPRIVNATPARA/NATPAR
Total Rare Metabolic
Rare Hematology:
ADVATEADYNOVATE/ADYNOVIFEIBARECOMBINATE- 36 -

319,30764,13450,14943,45832,383565
78,815588,811395,373
78,37356,635
40,13630,068
1,353
63,745
665,683

51,531
38,874
28,868
2,503
121,776

57,71439,56832,171
3,926
133,378

97,112
43,76534,235
10,45789,31545,873
28,9789,586

Table of Contents
JPY (millions)Nine-month Period Ended December 31,
2020
2021
33,00537,840218,574
211,592

OthersTotal Rare Hematology
Hereditary Angioedema:
TAKHZYROFIRAZYR
OthersTotal Hereditary Angioedema
OthersTotal Rare Diseases
PDT Immunology:
Immunoglobulin
Albumin
OthersTotal PDT Immunology
Oncology:
VELCADELEUPLIN/ENANTONENINLAROADCETRISICLUSIG
ALUNBRIG
OthersTotal Oncology
Neuroscience:
VYVANSE/ELVANSE
TRINTELLIX
OthersTotal Neuroscience
Other:AZILVA-F (1)
LOTRIGA
Others (3)Total Other
Total
(1)

65,891
20,10020,366
106,357—446,70778,425
21,471
17,842
117,738190
462,897

248,031
43,59921,410313,040

278,309
61,49023,448363,247

75,89275,25567,86344,38526,2596,483
22,325
318,462

84,45982,21570,74751,786
26,687
10,12733,075359,096

202,430
52,68059,988315,098

244,994
63,03054,607
362,630

62,79324,466358,161445,420
2,427,538

60,05724,753397,354482,163
2,695,717

The figures include the amounts of fixed dose combinations and blister packs.
Generic name: pantoprazole(3)
The figure for the nine-month period ended December 31, 2020 includes the revenue of Takeda Consumer Healthcare Company
Limited, which was divested on March 31, 2021.
The figure for the nine-month period ended December 31, 2021 includes the 133,043 million JPY selling price on sales of four
diabetes products (NESINA, LIOVEL, INISYNC and ZAFATEK) in Japan to Teijin Pharma Limited recorded as revenue. As
Takeda transferred only the assets, marketing rights and, eventually, marketing authorization associated with the pharmaceuticalproducts which do not entail transfer of employees or associated contracts, Takeda applied IFRS 15 to the transaction andrecorded the selling price in revenue.
(2)- 37 -

Table of Contents
JPY (millions)Three-month period ended December 31,
2020
2021
Gastroenterology:
ENTYVIOTAKECAB-F (1)GATTEX/REVESTIVE
DEXILANTPANTOLOC/CONTROLOC (2)ALOFISEL
OthersTotal Gastroenterology
Rare Diseases:
Rare Metabolic:
ELAPRASE
REPLAGALVPRIVNATPARA/NATPAR
Total Rare Metabolic
Rare Hematology:
ADVATEADYNOVATE/ADYNOVIFEIBARECOMBINATE
OthersTotal Rare Hematology
Hereditary Angioedema:
TAKHZYROFIRAZYR
Other
Total Hereditary Angioedema
Other
Total Rare Diseases
PDT Immunology:
Immunoglobulin
Albumin
OthersTotal PDT Immunology
Oncology:
VELCADELEUPLIN/ENANTONENINLAROADCETRISICLUSIG
ALUNBRIG
OthersTotal Oncology
Neuroscience:
VYVANSE/ELVANSE- 38 -

112,333
24,182
16,93015,055
10,918284
29,283208,985

139,465
29,261
19,80014,432
10,207554
22,874
236,594

17,215
13,907
10,034997
42,15322,901
13,635
11,182
1,446
49,16433,704
14,264
13,663
3,535
10,59975,76528,027
15,906
8,804
3,288
13,98170,00522,1494,952
6,326
33,427—
151,345

30,8957,126
5,461
43,481
190
162,839

85,36415,028
6,748
107,140

96,992
19,746
8,481
125,219

25,88025,38923,506
13,815
9,414
2,215
8,193
108,41229,35028,362
24,942
17,644
8,826
3,888
12,367125,380

69,81085,714

Table of Contents
JPY (millions)Three-month period ended December 31,
2020
2021
17,72522,98019,772
20,218107,307
128,912

TRINTELLIX
OthersTotal Neuroscience
Other:AZILVA-F (1)
LOTRIGA
Others (3)Total Other
Total

22,866
8,808
121,890
153,564
836,753

19,704
8,690
93,955
122,350
901,294(1)

The figures include the amounts of fixed dose combinations and blister packs.
Generic name: pantoprazole(3)
The figure for the three-month period ended December 31, 2020 includes the revenue of Takeda Consumer Healthcare
Company Limited, which was divested on March 31, 2021.
(2)(2) Geographic Information
Takeda’s revenue from contracts with customers is based in the following geographic locations:
JPY (millions)Nine-month Period Ended December 31,
2020
2021
435,112530,245
1,188,965
1,297,020
499,962
540,978
119,178
139,770
95,41493,54538,724
43,58250,18350,5772,427,538
2,695,717

Japan
U.S.
Europe and Canada
Asia (excluding Japan)
Latin America
Russia/CIS
Other
Total

“Other” includes the Middle East, Oceania and Africa. This disaggregation provides revenue attributable to countries or regions
based on the customer location.
JPY (millions)Three-month period ended December 31,
2020
2021
152,729
139,377
402,847
458,644
172,801
187,007
40,88750,06336,44532,174
17,063
18,494
13,981
15,536
836,753
901,294

Japan
U.S.
Europe and Canada
Asia (excluding Japan)
Latin America
Russia/CIS
Other
Total

“Other” includes the Middle East, Oceania and Africa. This disaggregation provides revenue attributable to countries or regions
based on the customer location.

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Table of Contents
5.

Other Operating Income

Other Operating Income for the nine-month period ended December 31, 2020 was 118,532 million JPY, including 60,179 million
JPY revaluation gain triggered by an update to previously recognized liabilities for pipeline compound SHP647 and certain
associated rights ("SHP647") to reflect a change in expected future costs, such as program termination costs, to reflect
management’s decision to terminate the clinical trial program following the European Commission’s decision in May 2020 torelease Takeda’s obligation to divest SHP647. Takeda also recorded a 37,203 million JPY divestiture gain from divestiture of
non-core assets in Asia Pacific, Europe, and Canada due to completion of the deals.
Other Operating Income for the nine-month period ended December 31, 2021 was 34,269 million JPY, including a gain fromchange in fair value of financial assets and liabilities associated with contingent consideration arrangements as well as acompensation for damages from a litigation and a legal settlement.
6.

Other Operating Expenses

Other operating expenses was 155,090 million JPY and 100,034 million JPY for the nine-month period ended December 31, 2020
and 2021, respectively.
Restructuring expenses such as reductions in the workforce and consolidation of sites included in other operating expenses were
86,435 million JPY and 59,102 million JPY for the nine-month period ended December 31, 2020 and 2021, respectively.
Restructuring expenses for the nine-month period ended December 31, 2020 and nine-month period ended December 31, 2021
included Shire integration costs related to the acquisition of Shire plc.
Other operating expenses also included 11,480 million JPY and 12,395 million JPY of pre-launch inventory write-offs for thenine-month period ended December 31, 2020 and 2021, respectively.
In addition, for the nine-month period ended December 31, 2020, Takeda recorded 18,666 million JPY loss from changes in thefair value of financial assets associated with contingent consideration arrangements driven by the impact of Novartis' withdrawalof the Marketing Authorisation Application in Europe for Xiidra (dry eye medication), which Takeda sold to Novartis in July
2019 (Note 14).
7.

Share of Loss of Investments Accounted for Using the Equity Method

Share of loss of investments accounted for using the equity method for the nine-month period ended December 31, 2020 included
a loss of 14,861 million JPY related to Takeda's shareholding ratio of the impairment loss recognized by Teva Takeda PharmaLtd., a business venture of Takeda and Teva Pharmaceutical Industries Ltd., which operates the long listed products business andthe generics business.
The impairment loss was recorded resulting from the reassessment of the recoverable amount of relevant assets triggered by thedecision to divest a part of its generics business and a manufacturing plant, as well as by a revision of forecast in the long-listed
drug business.
8.

Income Tax Expenses

The effective tax rate for the nine-month period ended December 31, 2021 was 32.3% compared to 23.9% for the nine-month
period ended December 31, 2020. This increase was primarily due to a tax charge of 64.6 billion JPY for tax and interest, net of
0.5 billion JPY of associated tax benefit, arising from tax assessment involving Irish taxation of the break fee Shire received from
AbbVie in connection with the terminated offer to acquire Shire made by AbbVie in 2014. This increase was partially offset by anincrease in tax credits and a decrease in unitary tax on overseas subsidiaries in the current period versus the same period of theprevious year.

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Table of Contents
9.

Earnings Per Share

The basis for calculating basic and diluted earnings per share (attributable to owners) is as follows:
Nine-month Period Ended
December 31,
2020
2021
Net profit for the period attributable to owners of the Company
Net profit for the period attributable to owners of the Company (million JPY)
Net profit used for calculation of earnings per share (million JPY)
Weighted average number of ordinary shares outstanding during the period (thousands ofshares) [basic]
Dilutive effect (thousands of shares)
Weighted average number of ordinary shares outstanding during the period (thousands ofshares) [diluted]
Earnings per share
Basic earnings per share (JPY)
Diluted earnings per share (JPY)

178,907178,907

241,417
241,417

1,561,600
11,623

1,566,730
10,886

1,573,223

1,577,616

114.57113.72154.09153.03Three-month Period Ended
December 31,
2020
2021
Net profit for the period attributable to owners of the Company
Net profit for the period attributable to owners of the Company (million JPY)
Net profit used for calculation of earnings per share (million JPY)
Weighted average number of ordinary shares outstanding during the period (thousands ofshares) [basic]
Dilutive effect (thousands of shares)
Weighted average number of ordinary shares outstanding during the period (thousands ofshares) [diluted]
Earnings per share
Basic earnings per share (JPY)
Diluted earnings per share (JPY)10.

92,35992,35957,77057,7701,563,356
12,346

1,565,162
9,758

1,575,702

1,574,920

59.08
58.61

36.91
36.68

Trade and Other Receivables

In December 2021, Takeda put in place a program to sell certain trade receivables to a select group of banks on a non-recourse
basis. Under this program, trade receivables sold are derecognized at the point of sale when the risks and rewards of ownershiphave been transferred.
Trade receivables due from customers that Takeda has the option to factor are classified as investments in debt instruments
measured at fair value through other comprehensive income (“FVTOCI”) since they are held to collect and sell. As of
December 31, 2021, trade receivables measured at FVTOCI were 41,247 million JPY.
11.

Disposal Groups Held for Sale

The disposal groups held for sale as of March 31, 2021 and December 31, 2021 consisted of a group of assets and liabilities suchas related to a portfolio of non-core prescription pharmaceutical assets sold in China. As of December 31, 2021, the corresponding
assets such as goodwill and intangible assets were 20,203 million JPY.

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12.

Bonds and Loans(1) Bonds
During the nine-month period ended December 31, 2021, the Company issued unsecured bonds as outlined below.
Unsecured Senior Bonds
Issue Amount

250,000 million JPY

CouponIssue Price

0.400% per annum
100% of the principle amount

Maturity Date

October 14, 2031

During the nine-month period ended December 31, 2021, Takeda redeemed the following bonds in advance of the original
maturity dates.
Principal Amount in
Instrument
Issuance
Redemption date
contractual currency
USD Unsecured Senior Notes
2018 EUR Unsecured
Senior Notes - fixed rate

July 2017

May 17, 2021

200 million USD

November 2018

August 10, 2021

1,500 million EUR(2) Loans
During the nine-month period ended December 31, 2021, Takeda prepaid the following borrowings in advance of theoriginal maturity dates.
Principal Amount in
Instrument
Issuance
Repayment date
contractual currency
USD Japan Bank for International
January 2019
June 11, 2021
2,000 million USD
Cooperation 2019
USD Japan Bank for International
January 2019
December 13, 2021
1,700 million USD
Cooperation 201913.

Equity and Other Equity Items(1) Issuance of shares
During the nine-month period ended December 31, 2021, the Company issued 3,874 thousand shares of common stock
under the Long Term Incentive Plan for the Company Group employees overseas. The issuance of these shares resulted in
an increase in share capital of 7,138 million JPY and share premium of 7,138 million JPY. The shares of the Company
common stock were converted into the Company’s American Depositary Shares and settled with employees.
(2) Acquisition of treasury shares
During the nine-month period ended December 31, 2021, Takeda acquired 15,336 thousand shares of its common stock for
49,980 million JPY in accordance with the resolution on the acquisition of its own shares at the Board of Directors Meeting
held on October 28, 2021.

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Table of Contents(3) Dividends
Total dividends
declared and paid
JPY (millions)

Dividends
per share(JPY)

Q1 2020

141,858

Q3 2020

Dividends declared and paid
April 1, 2020 to December 31, 2020

Basis date

Effective date

90.00

March 31, 2020

June 25, 2020

141,860

90.00

September 30, 2020

December 1, 2020

Q1 2021

141,859

90.00

March 31, 2021

June 30, 2021

Q3 2021

142,387

90.00

September 30, 2021

December 1, 2021

April 1, 2021 to December 31, 2021

14.

Financial Instruments(1) Fair Value Measurements
Derivative and non-derivative financial instruments measured at fair value are categorized in the following three-tier fairvalue hierarchy that reflects the significance of the inputs in making the measurements. Level 1 is defined as observable
inputs, such as quoted prices in active markets for an identical asset or liability. Level 2 is defined as inputs other thanquoted prices in active markets within Level 1 that are directly or indirectly observable. Level 3 is defined as unobservable
inputs.
As of December 31, 2021
Assets:Financial assets measured at fair value throughprofit or loss
Derivatives
Investments in convertible notes
Investments in debt instruments
Financial assets associated with contingent
consideration arrangements
Derivatives for which hedge accounting is applied
Financial assets measured at fair value through OCI
Trade receivables
Equity instruments
Total

Level 1

Liabilities:
Financial liabilities measured at fair value throughprofit or loss
Derivatives
Financial liabilities associated with contingent
consideration arrangements
Derivatives for which hedge accounting is applied
Total- 43 -JPY (millions)Level 2
Level 3

Total

—
—
—

37,687———
10,7791,052

37,687
10,779
1,052

—
—

—
13,30727,640—27,64013,307—
82,572
82,572

41,247—
92,242—57,01096,482

41,247
139,583
271,296

—

2,841

—

2,841

—
—
—

—
33,55736,39820,237—
20,237

20,23733,55756,635

Table of Contents(2) Valuation Techniques
The fair value of derivatives is measured based on Treasury management system valuation models or the Black-Scholesmodel, whose significant inputs are based on observable market data.
The fair value of the investment in convertible notes is measured using techniques such as the discounted cash flow andoption pricing models.
The fair value of trade receivables, which are due from customers that Takeda has the option to factor, are measured basedon invoiced amount.
Equity instruments and investments in debt instruments are not held for trading. If equity instruments or investments indebt instruments are quoted in an active market, the fair value is based on price quotations at the period-end-date. If equity
instruments or investments in debt instruments are not quoted in an active market, the fair value is calculated utilizing an
adjusted net assets book value method or multiples of EBITDA approach based on available information as of each periodend-date and company comparable. The principal input that is not observable and utilized for the calculation of the fairvalue of equity instruments and investments in debt instruments classified as Level 3 is the EBITDA rate used for the
EBITDA multiples approach, which ranges from 5.7 times to 10.2 times.
Financial assets and liabilities associated with contingent consideration arrangements are valued at fair value at the time ofthe divestiture or the acquisition date of business combination. When the contingent consideration arrangement meets thedefinition of a financial asset or liability, it is subsequently re-measured to fair value at each closing date. The
determination of the fair value is based on models such as scenario-based methods and discounted cash flows. The key
assumptions take into consideration the probability of meeting each performance target, forecasted revenue projections, andthe discount factor. The financial assets associated with contingent consideration arrangements are recognized mainly in
relation to the divestiture of XIIDRA. The financial liabilities associated with contingent consideration arrangements are
discussed in Note (5) Financial liabilities associated with contingent consideration arrangements.

(3) Transfers between levels
Takeda recognizes transfers between levels of the fair value hierarchy, at the end of the reporting period during which thechange has occurred. There were transfers from Level 3 to Level 1 recorded in the nine-month period ended December 31,
2021. These transfers resulted from the investments in the companies whose shares were previously not listed on an equity
or stock exchange and had no recent observable active trades in the shares. During the nine-month period ended
December 31, 2021, the companies listed their equity shares on an exchange and are currently actively traded in the market.
As the equity shares have a published price quotation in an active market, the fair value measurement was transferred fromLevel 3 to Level 1 on the fair value hierarchy during the nine-month period ended December 31, 2021. There were no othertransfers between levels of the fair value hierarchy during the nine-month period ended December 31, 2021.

(4) Level 3 fair values
Takeda invests in equity instruments mainly for research collaboration. The following table shows a reconciliation from theopening balances to the closing balances for Level 3 financial asset fair values for the period ended December 31, 2021.
The disclosure related to the Level 3 financial liabilities which are financial liabilities associated with contingent
consideration arrangements are included in (5) Financial liabilities associated with contingent consideration arrangements.
There are no significant changes in fair value during the changes in certain assumptions which influence the fair value
measurement for level 3 financial assets.

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As of the beginning of the period
Changes recognized as finance income
Changes in fair value of financial assets
associated with contingent consideration due toother elements than time value
Changes in fair value of financial assets
measured at fair value through OCI andexchange differences on translation of foreign
operations
Purchases
Sales
Transfers to Level 1
Transfers to investments accounted for using theequity method

JPY (millions)Nine-month Period Ended December 31, 2021
Financial assets associatedwith contingent
consideration arrangements
Equity instruments
25,44652,468665—

As of the end of the period

545

—

984
—
—
—

20,692
7,113(299)(21,674)—(1,290)27,64057,010(5) Financial liabilities associated with contingent consideration arrangements
Financial liabilities associated with contingent consideration arrangements represent consideration related to businesscombinations or license agreements that are payable only upon future events such as the achievement of development
milestones and sales targets, including pre-existing contingent consideration arrangements of the companies that are
acquired by Takeda. At each reporting date, the fair value of contingent consideration is re-measured based on riskadjusted future cash flows discounted using an appropriate discount rate.
As of December 31, 2021, the balance primarily relates to pre-existing contingent consideration arrangements from Shire's
historical acquisition. The pre-existing contingent consideration acquired from Shire through Shire’s historical acquisitions
is due upon the achievement of certain milestones related to the development, regulatory, first commercial sale and othersales milestones of products at various stages of development and marketing. The fair value of the contingent consideration
payable could increase or decrease due to changes in certain assumptions which underpin the fair value measurements. The
assumptions include probability of milestones being achieved.
The fair value of financial liabilities associated with contingent consideration arrangements are classified as Level 3 in thefair value hierarchy. The following table shows a reconciliation from the opening balances to the closing balances forfinancial liabilities associated with contingent consideration arrangements for the period ended December 31, 2021. There
are no significant changes in fair value during the changes in certain assumptions which influence the fair value
measurement for financial liabilities associated with contingent consideration arrangements.
JPY (millions)Nine-month Period Ended
December 31, 2021
27,7706,110(8,567)(5,941)
865
20,237

As of the beginning of the period
Additions arising from business combinations
Changes in the fair value during the period
Settled during the period
Foreign currency translation differences
As of the end of the period- 45 -

Table of Contents(6) Financial instruments not measured at fair value
The carrying amount and fair value of financial instruments that are not measured at fair value in the condensed interim
consolidated statements of financial position are as follows. Fair value information is not provided for financial
instruments, if the carrying amount is a reasonable estimate of fair value due to the relatively short period of maturity ofthese instruments.
JPY (millions)
As of December 31, 2021
Carrying
amountFair value
3,653,673
3,890,646
701,203
697,514

Bonds
Long-term loans

Long-term financial liabilities are recognized at their carrying amount. The fair value of bonds is measured at quotes whose
significant inputs to the valuation model used are based on observable market data. The fair value of loans is measured at
the present value of future cash flows discounted using the applicable market rate on the loans in consideration of the credit
risk by each group classified in a specified period. The fair value of bonds and long-term loans are classified as Level 2 in
the fair value hierarchy.
15.

Commitments and Contingent Liabilities

Irish Revenue Commissioners assessment
Shire received a tax assessment from the Irish Revenue Commissioners on November 28, 2018 for 398 million EUR. This
assessment relates to the tax treatment of a 1,635 million USD break fee Shire received from AbbVie, Inc. (“AbbVie”) in
connection with the terminated offer to acquire Shire made by AbbVie in 2014. Takeda appealed the assessment to the Tax
Appeals Commission (“TAC”) and the appeal was heard by the TAC in late 2020. On July 30, 2021 (IST), Takeda received aruling on the matter from the TAC, with the TAC ruling in favor of Irish Revenue Commissioners. While Takeda intends toappeal the TAC ruling and continues to assert that the AbbVie break fee is not subject to Irish tax, Takeda has recorded a tax
provision for 488 million EUR in current liabilities as income taxes payable, representing the 398 million EUR tax liability
asserted by Irish Revenue Commissioners plus accrued interest for the nine-month period ended December 31, 2021.
Litigation
Takeda is involved in various legal and administrative proceedings. There were no significant updates during the nine-month
period ended December 31, 2021 except for the matters below.
Intellectual property
ADYNOVATEOn December 5, 2016, Bayer Healthcare LLC (“Bayer”) filed a lawsuit in the U.S. District Court for the District of Delaware
against Baxalta Incorporated and Baxalta US Inc. (collectively “Baxalta”), which are now subsidiaries of Takeda, and Nektar
Therapeutics (“Nektar”) filed alleging infringement of U.S. Patent No. 9,364,520 in connection with the sales of ADYNOVATE[antihemophilic factor (recombinant), PEGylated]. The case was tried before a jury beginning on January 28, 2019. The jury
found in favor of Bayer determining that the patent is infringed. The jury further awarded damages in the amount of 155.2 million
USD. Takeda has filed an appeal with the Court of Appeals of the Federal Circuit (CAFC) in September 2019. The CAFC upheld
the District Court’s decision on March 1, 2021. The Appeal Mandate was issued on April 7, 2021. On May 14, 2021, Takeda
settled this litigation and related pending litigations. The settlement allows both Baxalta and Bayer to continue selling theirrespective products. Takeda also made a payment in settlement of these cases but the settlement had no material impact on
Takeda’s condensed interim consolidated statements of profit or loss as Takeda had established a provision against this case as ofMarch 31, 2021.
NINLARO
Takeda received a paragraph IV notice letter from Sun Pharmaceutical Industries Limited (“Sun”) on January 17, 2020. Sun
alleged that U.S. Patent numbers 7,442,830, 8,859,504, and 9,175,017 are invalid, unenforceable, and/or will not be infringed.
Takeda filed a complaint against Sun in the U.S. District Court for the District of Delaware on February 27, 2020. On June 18,
2021, Takeda entered into a settlement agreement with Sun. The impact of the settlement was not material to Takeda’s condensed
interim consolidated statements of profit or loss.

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16.

Subsequent Events

On January 28, 2022, Takeda provided a notice of redemption to the holders of 1,500 million USD in unsecured U.S. dollardenominated senior notes issued in September 2016 in advance of their original maturity date of September 23, 2023. The
redemption date of the unsecured senior notes will be March 24, 2022. The impact from the accelerated debt prepayment on the
consolidated statements of profit or loss is not expected to be material.

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2. Others
Interim Dividend
In accordance with the provision of Article 29 of the Articles of Incorporation of the Company, Takeda made the following
resolution on an interim dividend for the 145th fiscal year (from April 1, 2021 to March 31, 2022) at the meeting of the Board of
Directors held on October 28, 2021, and paid the interim dividend.
(a)
(b)
(c)

Total amount of interim dividends
Interim dividend per share
Effective date/ Payment start date- 48 -

142,387,003,440 JPY
90.00 JPY
December 1, 2021

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B. Information on Guarantors of the Company
Not applicable.

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