Note: This document has been translated from the Japanese original for reference purposes only. In the event of any discrepancy
between this translated document and the Japanese original, the original shall prevail.
May 9, 2024

Consolidated Financial Results
for the Fiscal Year Ended March 31, 2024
(Under Japanese GAAP)
Listed Company: Zeria Pharmaceutical Co., Ltd.
(Stock Exchange: Tokyo Stock Exchange)
Code Number: 4559
(URL: https://www.zeria.co.jp/)
Representative: Mitsuhiro Ibe, Representative Director, President & COO
Person in charge of reference: Tomoyuki Nishizawa, Director, Public Relations Division
TEL (03) 3661-1039
Scheduled date of ordinary general meeting of shareholders: June 27, 2024
Scheduled date to commence dividend payments: June 28, 2024
Scheduled date to submit the Securities Report: June 27, 2024
Preparation of supplementary documents to the financial results:
Yes
Holding of financial results presentation:
Yes (for analysts, institutional investors and the press)(Amounts under a million yen are truncated.)

1. Consolidated Financial Highlights (April 1, 2023 through March 31, 2024)(Percentage figures indicate changes from the previous year.)(1) Consolidated Financial Results
Net salesYear ended
March 31, 2024
March 31, 2023

Million yen
75,72568,383Operating profit
%
10.7
14.9

Million yen
9,621
9,014

%
6.7
41.6

Profit attributable toowners of parent
Million yen
%
7,731
24.8
6,195
56.4

Ordinary profit
Million yen
8,513
7,579

%
12.3
27.7

Note: Comprehensive income: For the year ended March 31, 2024: 16,089 million yen [25.1%]
For the year ended March 31, 2023: 12,857 million yen [329.6%]

Year ended
March 31, 2024
March 31, 2023

Basic earnings
per share
Yen
175.39140.26

Diluted earnings
per share
Yen––

Ordinary profit
to total assets

Return on equity
%

%

10.7
10.3

6.0
5.8

Operating profit
to net sales
%
12.7
13.2

Reference: Share of profit (loss) of entities accounted for using equity method: For the year ended March 31, 2024: (76) million yen
For the year ended March 31, 2023: – million yen(2) Consolidated Financial Position
Total assets
As ofMarch 31, 2024
March 31, 2023

Net assets

Million yen
150,533
135,034

Equity ratio

Million yen
79,82865,680

Reference: Equity: As of March 31, 2024: 79,622 million yen

Net assets per share%

Yen
1,806.33
1,484.79

Cash flows fromfinancing activities
Million yen(8,124)(7,415)

Cash and cash equivalents
at the end of term
Million yen
18,60416,09452.9
48.5

As of March 31, 2023: 65,449 million yen(3) Consolidated Cash Flows

Year ended
March 31, 2024
March 31, 2023

Cash flows fromoperating activities
Million yen
12,183
13,157

Cash flows frominvesting activities
Million yen(3,952)(2,574)

2. Dividends
Annual dividends

Year ended
March 31, 2023
March 31, 2024
Year ending
March 31, 2025
(Forecast)First
quarter
Yen––

Secondquarter
Yen
18.00
22.00

Third
quarter
Yen
–
–

–

23.00

–

Year-end

Total

Total
dividends paid
(Total)

Yen
22.00
22.00

Yen
40.00
44.00

Million yen
1,764
1,939

23.00

46.00

Payout ratio(Consolidated)

Dividend rate
for net assets(Consolidated)

%
28.5
25.1

%
2.9
2.7

26.0

3. Consolidated Financial Forecast for Fiscal Year Ending March 31, 2025 (April 1, 2024 through March 31, 2025)

Net salesFirst six months
Full year

Million yen
41,00083,000%
11.8
9.6(Percentage figures indicate changes from the same period of the previous year.)
Basic
Profit attributable toOperating profit
Ordinary profit
earnings perowners of parent
shareMillion yen%
Million yen%
Million yen
%
Yen
5,600
5.1
5,600
1.9
4,300
(20.3)
97.55
10,000
3.9
10,000
17.5
7,800
0.9
176.95* Notes(1) Changes in significant subsidiaries during the fiscal year ended March 31, 2024 (changes in specified subsidiaries resulting
in changes in scope of consolidation): None
Inclusion: – (Company name: –)Exclusion: – (Company name: –)(2) Changes in accounting policies, changes in accounting estimates, and restatement of prior period financial statements after
error corrections
1) Changes in accounting policies due to revisions to accounting standards and other regulations: None
2) Changes in accounting policies due to other reasons: None
3) Changes in accounting estimates: None
4) Restatement of prior period financial statements after error corrections: None

(3) Number of shares issued (common shares)
1) Number of shares issued as of the end of the term (including treasury shares):
As of March 31, 2024: 53,119,190 shares
As of March 31, 2023: 53,119,190 shares
2) Number of shares of treasury shares as of the end of the term:
As of March 31, 2024: 9,039,354 shares
As of March 31, 2023: 9,038,982 shares
3) Average number of shares during the term:
For the year ended March 31, 2024: 44,080,055 shares
For the year ended March 31, 2023: 44,173,346 sharesReference: Summary of Non-consolidated Financial Results
Non-consolidated Financial Highlights (April 1, 2023 through March 31, 2024)(Percentage figures indicate changes from the previous year.)(1) Non-consolidated Financial Results
Net salesYear ended
March 31, 2024
March 31, 2023

Operating profit

Million yen
34,01732,960%
3.2
3.1

Basic earnings
per share
Year ended
March 31, 2024
March 31, 2023

Million yen
1,176
1,793

Ordinary profit%(34.4)
129.2

Million yen
2,686
2,738

Profit
%
(1.9)
71.8

Million yen
1,636
2,157

%
(24.2)
55.0

Diluted earnings
per share

Yen
37.12
48.85

Yen
–
–

(2) Non-consolidated Financial Position
Total assets
As ofMarch 31, 2024
March 31, 2023

Million yen
92,94092,091

Reference: Equity: As of March 31, 2024: 40,035 million yen

Net assets

Equity ratio

Million yen
40,03538,023

Net assets per share
%

43.1
41.3

Yen
908.24862.59As of March 31, 2023: 38,023 million yen* Financial Results Reports Are Not Required to Be Audited by Certified Public Accountants or An Audit
Corporation.
* Cautionary Statement with Respect to Appropriate Use of Financial Forecast and Other Special Matters
The description about the future including the projection in this document is based on information available to the Company
at present and certain presumptions which the Company considers reasonable. Consequently, any descriptions herein do notconstitute assurances regarding actual results by the Company. The actual results for future terms may differ from theinformation in this document due to various factors. For the assumptions made in financial forecasts and cautions concerning
the use thereof, please refer to “1. Summary of Business Results (1) Summary of business results for the current fiscal year”
on page 2 of the Attached Material.

○Table of contents of attachments
1. Summary of Business Results ...................................................................................................................2(1) Summary of business results for the current fiscal year .....................................................................2(2) Overview of financial position for the current fiscal year ..................................................................3(3) Basic policy on profit distribution and dividends for the current and next fiscal year .......................5
2. Basic Policy on Selection of Accounting Standards..................................................................................5
3. Consolidated Financial Statements and Significant Notes Thereto........................................................... 6(1) Consolidated balance sheet .................................................................................................................6(2) Consolidated statement of income and consolidated statement of comprehensive income ................8
Consolidated statement of income ......................................................................................................8
Consolidated statement of comprehensive income .............................................................................9(3) Consolidated statement of changes in equity ....................................................................................10(4) Consolidated statement of cash flows ...............................................................................................12(5) Notes to consolidated financial statements .......................................................................................14(Notes on premise of a going concern) .............................................................................................14(Significant matters that form the basis for the preparation of consolidated financial statements) ..14
(Segment information, etc.) ..............................................................................................................18(Per share information) .....................................................................................................................22(Significant subsequent events) ........................................................................................................22
4. Other........................................................................................................................................................23(1) Sales of major products and merchandise Consolidated ...................................................................23(2) Status of pipeline of new drugs.........................................................................................................24

1

1. Summary of Business Results(1) Summary of business results for the current fiscal year(i) Business results for the current fiscal year
Net sales for the current fiscal year were 75,725 million yen (up 10.7% from the previous fiscal year). As
for profits, operating profit was 9,621 million yen (up 6.7% from the previous year), ordinary profit was
8,513 million yen (up 12.3% from the previous year), and profit attributable to owners of parent was
7,731 million yen (up 24.8% from the previous year).
In the current fiscal year, the overseas sales to net sales ratio was 51.5%, compared with 47.4% in theprevious fiscal year.
Next, we would like to report on the results by business segment.
(Ethical Pharmaceuticals Business)
As for our mainstay product, Asacol, a therapeutic agent for ulcerative colitis, sales in the domestic
market faced challenging circumstances, owing to the impact of the NHI drug price revision and thecompeting products. Despite this, sales increased overall as a result of strong performance in overseas
markets such as the UK due to growth in sales of high-dose Asacol 1600 mg tablets and the foreignexchange impact. Sales of DIFICLIR expanded substantially, especially in the European region. However,sales of Entocort, an inflammatory bowel disease therapeutic agent, declined after the launch of genericdrugs in certain countries outside Japan. Sales of Acofide, a drug for functional dyspepsia, were almost on
a par with the previous fiscal year.
As a result, net sales in the business amounted to 49,571 million yen (up 14.9% from the previous fiscal
year).
(Consumer Healthcare Business)
As for mainstay products, in the Hepalyse range, both the pharmaceutical Hepalyse range and the
Hepalyse W range for convenience stores performed well. Sales of the Chondroitin range and the
WithOne range of botanical laxative products also increased. In addition, new products such as dermatosis
treatments Prevaline α Quick Ointment and Prevaline α Quick Cream were launched during the fiscal year
ended March 31, 2024.
As a result, net sales in the business amounted to 25,998 million yen (up 3.6% from the previous fiscal
year).
(Other Business)
Net sales in this segment amounted to 154 million yen (up 1.6% from the previous fiscal year), mainly
due to insurance agency business and real estate lease revenue.
(Status of Research and Development)
In the Research and Development division, Zeria is carefully selecting development themes andproceeding with the evaluation of multiple projects including in-licensed, centered on the priority
gastrointestinal field under a global development structure in coordination with our Swiss subsidiary
Tillotts Pharma AG. In this context, we have initiated research and development of new development
themes that can be developed simultaneously in Japan and Europe.
As for Z-100, we are steadily advancing non-clinical trials and preparing for pilot clinical studies tofacilitate the clinical development for new indications.
Regarding Zeria’s own original drug Z-338 (generic name: Acotiamide), we obtained approval in two new
countries, El Salvador and Peru, for the indication of functional dyspepsia under a license agreement with
FAES FARMA, S.A., and in October 2023, we started sales in Mexico. In addition, the drug was approved2

in Thailand for the indication of functional dyspepsia under a license agreement with Meiji Seika PharmaCo., Ltd. Pharmaceutical Joint Stock Company of February 3rd, a subsidiary in Vietnam, has filed an
application for approval in Vietnam for the indication of functional dyspepsia. In addition, United Italian
Trading Corporation has filed a new application for approval in Singapore for the indication of functional
dyspepsia. Phase III trials are also being conducted for pediatric functional dyspepsia patients in Japan. In
addition, the Phase II trial of ZG-802, with the same ingredients, for the indication of underactive bladderis progressing without delay in Japan. The indication is said to have a significant impact on quality of life
(QOL), which has been attracting attention in recent years, but effective drug treatment has not been
confirmed worldwide. We will contribute to society by providing unmet treatment options through thedevelopment of the drug.
With regard to Ferinject, an iron deficiency anemia treatment in-licensed from Vifor (International) AG,
multiple database studies are being conducted to generate evidence using real-world data, andpreparations are underway for publication in this fiscal year.
We have filed an application for approval in Japan for ZG-801, a therapeutic agent for hyperkalemia inlicensed from Vifor (International) AG.
As for consumer healthcare products, we have sequentially launched new products, such as dermatosis
treatments Prevaline α Quick Ointment and Prevaline α Quick Cream.
As a result of these activities, research and development expenses for the current fiscal year were 3,726
million yen (up 7.8% from the previous fiscal year).
(ii) Future outlook
For the fiscal year ending March 31, 2025, we forecast net sales of 83,000 million yen (up 9.6% from theprevious year), operating profit of 10,000 million yen (up 3.9% from the previous year), ordinary profit of
10,000 million yen (up 17.5% from the previous year), and profit attributable to owners of parent of 7,800
million yen (up 0.9% from the previous year).
Net sales
In the Ethical Pharmaceuticals Business, the Company forecasts that sales will increase, with sales growth
expected in the overseas market for Asacol and DIFICLIR, our main products. In the Consumer
Healthcare Business, the Company expects sales to increase, contributed by sales growth in the Hepalyse
range and Chondroitin range as well as product groups following the mainstay products, such as the
WithOne range and the Masdent range of medicated toothpaste.
ProfitDespite expected impacts from rising energy and raw materials prices and increases in research anddevelopment expenses, milestone payments, and other expenses, we forecast an increase in operating
profit, ordinary profit, and profit attributable to owners of parent due to the increase in net sales.
(2) Overview of financial position for the current fiscal year(i) Assets, liabilities, and net assets
Total assets at the end of the current fiscal year were 150,533 million yen, an increase of 15,499 million
yen from the end of the previous fiscal year. Current assets increased 9,605 million yen to 57,809 million
yen from the end of the previous fiscal year, and non-current assets increased 5,893 million yen to 92,724
million yen from the end of the previous fiscal year. Major changes in current assets included an increaseof 4,104 million yen in cash and deposits and an increase of 3,757 million yen in accounts receivable trade. The changes in non-current assets were an increase of 1,926 million yen in property, plant andequipment, an increase of 1,209 million yen in intangible assets, and an increase of 2,758 million yen in
investments and other assets.
Total liabilities at the end of the current fiscal year were 70,704 million yen, an increase of 1,350 million
yen from the end of the previous fiscal year. Current liabilities increased 7,360 million yen to 54,518
3

million yen from the end of the previous fiscal year, and non-current liabilities decreased 6,009 million
yen to 16,186 million yen from the end of the previous fiscal year. The main changes in current liabilities
were an increase of 3,393 million yen in short-term borrowings, an increase of 1,277 million yen inaccounts payable - trade, an increase of 1,218 million yen in income taxes payable, and an increase of
1,440 million yen in other current liabilities including an increase in accounts payable - other. Mainchanges in non-current liabilities were a decrease of 6,597 million yen in long-term borrowings, anincrease of 1,256 million yen in deferred tax liabilities, and a decrease of 897 million yen in provision forloss on cancellation of contracts.
Net assets at the end of the current fiscal year were 79,828 million yen, an increase of 14,148 million yen
from the end of the previous fiscal year. This was due to profit attributable to owners of parent of 7,731
million yen, payment of 1,939 million yen as dividends declared at the end of the previous period and in
the current interim period, an increase of 2,316 million yen in valuation difference on available-for-salesecurities, and an increase of 6,644 million yen in foreign currency translation adjustment.
As a result, equity ratio at the end of the current fiscal year increased by 4.4% from the end of theprevious fiscal year to 52.9%.
(ii) Status of cash flows
Cash and cash equivalents (below, “cash”) at the end of the current fiscal year increased 2,510 million yen
from the beginning of the period to 18,604 million yen. This was due to net cash provided by operating
activities of 12,183 million yen, despite net cash used in investing activities of 3,952 million yen and net
cash used in financing activities of 8,124 million yen.
The status of each cash flow and its factors for the current fiscal year are as follows.
[Net cash provided by (used in) operating activities]
Net cash provided by operating activities amounted to 12,183 million yen in the current fiscal year (down973 million yen from the previous fiscal year). This was due to factors including profit before income
taxes of 9,508 million yen, depreciation of 6,341 million yen, and an increase in trade receivables of 2,075
million yen.
[Net cash provided by (used in) investing activities]
Net cash used in financing activities totaled 3,952 million yen in the current fiscal year (down 1,377
million yen from the previous fiscal year). This was due mainly to payments into time deposits of 1,668
million yen, purchase of property, plant and equipment of 2,900 million yen, and proceeds from sales andredemption of investment securities of 2,018 million yen.
[Net cash provided by (used in) financing activities]
Net cash used in financing activities totaled 8,124 million yen in the current fiscal year (down 709 million
yen from the previous fiscal year). This was mainly due to repayments of long-term borrowings of 5,778
million yen and dividends paid of 1,935 million yen.

4Trends in cash flow-related indicators
Fiscal year ended
March 31, 2022

Fiscal year ended
March 31, 2023

Fiscal year ended
March 31, 2024

Equity ratio (%)

44.2

48.5

52.9

Equity ratio based on market
value (%)

68.0

73.3

62.4

Ratio of interest-bearing debt tocash flow (years)

6.0

3.9

3.9

Interest coverage ratio (times)

29.4

43.8

27.3

(Notes) 1. Each indicator is calculated as follows.
(i)
Equity ratio: equity/total assets(ii) Equity ratio based on market value: market capitalization/total assets(iii) Ratio of interest-bearing debt to cash flow: interest-bearing debt/cash flow(iv) Interest coverage ratio: cash flow/interest payments
2. All of the above ratios are calculated based on consolidated financial figures.
3. Market capitalization is calculated based on the number of shares issued excluding treasury shares.
4. Operating cash flow is used for cash flow calculations.
5. Interest-bearing debt includes all liabilities on the consolidated balance sheets for which interest is paid.

(3) Basic policy on profit distribution and dividends for the current and next fiscal year
The Company considers the return of profit to shareholders as one of its most important management issues,and our basic profit distribution policy is to pay stable and consistent dividends.
Based on a full consideration of the financial results and other factors, we will pay a year-end dividend for thecurrent fiscal year of 22 yen per share. Accordingly, we intend to pay an annual dividend of 44 yen, including
an interim dividend of 22 yen (an increase of 4 yen compared to the annual dividend for the previous fiscal
year).
For the next fiscal year, we are planning for an annual dividend of 46 yen per share (an increase of 2 yencompared to the current fiscal year), including a dividend of 23 yen per share for both the interim and yearend dividend.

2. Basic Policy on Selection of Accounting Standards
In order to ensure comparability among companies and over time, the Group prepares its consolidated
financial statements in accordance with the Regulation on Terminology, Forms, and Preparation Methods ofConsolidated Financial Statements (excluding Chapters VII and VIII) (Ministry of Finance Order No. 28 of1976).
It is the Company’s policy to apply International Financial Reporting Standards in an appropriate manner,
taking into consideration various domestic and overseas circumstances.

53. Consolidated Financial Statements and Significant Notes Thereto(1) Consolidated balance sheet(Thousands of yen)
As of March 31, 2023
AssetsCurrent assets
Cash and deposits
Notes receivable - trade
Accounts receivable - trade
Merchandise and finished goods
Work in process
Raw materials and supplies
Other
Allowance for doubtful accounts
Total current assets
Non-current assets
Property, plant and equipment
Buildings and structures
Accumulated depreciation
Buildings and structures, net
Machinery, equipment and vehicles
Accumulated depreciation
Machinery, equipment and vehicles, net
LandConstruction in progress
Other
Accumulated depreciation
Other, net
Total property, plant and equipment
Intangible assets
Goodwill
Sales right
Trademark right
Other
Total intangible assets
Investments and other assets
Investment securities
Deferred tax assets
Retirement benefit asset
Other
Allowance for doubtful accounts
Total investments and other assets
Total non-current assets
Total assets

6

As of March 31, 2024

16,219,078
281,188
17,231,736
6,843,723
1,433,308
4,487,158
1,800,930(93,366)
48,203,757

20,323,724
259,626
20,989,675
7,569,173
1,842,077
5,078,508
1,915,485(169,241)57,809,029

25,304,071(18,336,259)
6,967,811
15,420,532(13,850,234)
1,570,297
12,359,997
1,619,218
6,307,809(4,233,758)
2,074,050
24,591,375

25,967,863(19,162,409)
6,805,453
16,368,028(14,588,020)
1,780,007
12,581,849
3,125,320
7,067,959(4,842,754)
2,225,205
26,517,836

5,299,798
28,157,670
7,457,373
1,015,828
41,930,669

4,262,818
29,496,467
8,030,138
1,350,281
43,139,706

6,849,304
136,295
12,927,173
442,420(46,460)
20,308,733
86,830,779
135,034,536

9,145,154
110,260
13,410,761
442,278(41,433)
23,067,020
92,724,563
150,533,593

(Thousands of yen)
As of March 31, 2023
Liabilities
Current liabilities
Accounts payable - trade
Short-term borrowings
Income taxes payable
Provision for bonuses
Other
Total current liabilities
Non-current liabilities
Long-term borrowings
Deferred tax liabilities
Provision for loss on cancellation of contracts
Retirement benefit liability
Asset retirement obligations
Other
Total non-current liabilities
Total liabilities
Net assets
Shareholders’ equity
Share capital
Capital surplus
Retained earnings
Treasury shares
Total shareholders’ equity
Accumulated other comprehensive income
Valuation difference on available-for-sale securities
Foreign currency translation adjustment
Remeasurements of defined benefit plans
Total accumulated other comprehensive income
Non-controlling interests
Total net assets
Total liabilities and net assets

7

As of March 31, 2024

1,996,122
34,890,470
749,106
1,554,662
7,967,956
47,158,318

3,273,950
38,283,719
1,967,210
1,584,737
9,408,853
54,518,471

14,541,480
5,190,743
897,300
234,465
56,031
1,275,486
22,195,507
69,353,826

7,943,800
6,447,412–
458,109
56,2391,280,768
16,186,329
70,704,801

6,593,398
11,685,121
53,462,589(18,264,989)
53,476,120

6,593,398
11,685,121
59,254,325(18,265,810)
59,267,035(314,469)
8,015,623
4,272,642
11,973,796
230,793
65,680,710
135,034,536

2,001,571
14,660,305
3,693,650
20,355,527
206,229
79,828,792
150,533,593

(2) Consolidated statement of income and consolidated statement of comprehensive income
Consolidated statement of income(Thousands of yen)
Fiscal year ended
March 31, 2023
Net sales
Cost of sales
Gross profit
Selling, general and administrative expenses
Operating profit
Non-operating income
Interest income
Dividend income
Recoveries of written off receivables
Other
Total non-operating income
Non-operating expenses
Interest expenses
Foreign exchange losses
Share of loss of entities accounted for using equity
methodOther
Total non-operating expenses
Ordinary profit
Extraordinary income
Gain on sale of non-current assets
Gain on sale of investment securities
Reversal of provision for loss on cancellation ofcontracts
Total extraordinary income
Extraordinary losses
Loss on retirement of non-current assets
Amortization of goodwill
Provision for loss on cancellation of contracts
Total extraordinary losses
Profit before income taxes
Income taxes - current
Income taxes - deferred
Total income taxes
ProfitProfit (loss) attributable to non-controlling interests
Profit attributable to owners of parent

8

Fiscal year ended
March 31, 2024

68,383,227
18,894,627
49,488,600
40,473,626
9,014,973

75,725,075
20,223,758
55,501,317
45,879,669
9,621,647

67,887228,766–
82,842
379,496

150,943
287,817
94,998
119,081652,840

337,281
1,416,679

457,801
1,182,086–

76,85561,0591,815,020
7,579,449

44,717
1,761,460
8,513,028

1,916
19,9402,229
499,617–977,204

21,856

1,479,051

6,135–
322,472
328,608
7,272,698
823,257
242,629
1,065,887
6,206,810
10,945
6,195,865

6,693
476,992–
483,685
9,508,394
1,970,382(157,196)
1,813,185
7,695,208(36,053)
7,731,262

Consolidated statement of comprehensive income(Thousands of yen)
Fiscal year ended
March 31, 2023
ProfitOther comprehensive income
Valuation difference on available-for-sale securities
Foreign currency translation adjustment
Remeasurements of defined benefit plans, net of tax
Total other comprehensive income
Comprehensive income
Comprehensive income attributable toComprehensive income attributable to owners of parent
Comprehensive income attributable to non-controllinginterests

9

Fiscal year ended
March 31, 2024

6,206,810

7,695,208(121,052)
4,826,049
1,946,105
6,651,102
12,857,913

2,316,041
6,657,591(578,992)
8,394,641
16,089,850

12,821,162

16,112,993

36,750(23,143)

(3) Consolidated statement of changes in equity
Fiscal year ended March 31, 2023
(Thousands of yen)
Shareholders’ equity
Share capital
Balance at beginning of
periodCapital surplus

Retained earnings

Treasury shares

Total shareholders’equity11,685,121

48,860,697(17,593,074)

49,546,143

6,593,398

Changes during period
Dividends of surplus(1,593,973)(1,593,973)

Profit attributable toowners of parent

6,195,865

6,195,865

Purchase of treasury
shares(671,914)(671,914)

Net changes in items otherthan shareholders’ equity
Total changes during period
Balance at end of period––

4,601,891(671,914)

3,929,976

6,593,398

11,685,121

53,462,589(18,264,989)

53,476,120

Accumulated other comprehensive income
Valuationdifference on
available-forsale securities
Balance at beginning of
period(193,416)

Foreign currency Remeasurements
translationof defined benefit
adjustment
plans
3,215,379

2,326,536

Total
accumulated
othercomprehensive
income5,348,499

Non-controllinginterests

Total net assets

197,832

55,092,474

Changes during period
Dividends of surplus(1,593,973)

Profit attributable toowners of parent

6,195,865

Purchase of treasury
shares(671,914)

Net changes in items otherthan shareholders’ equity(121,052)

4,800,244

1,946,105

6,625,297

32,961

6,658,258

Total changes during period(121,052)

4,800,244

1,946,105

6,625,297

32,961

10,588,235

Balance at end of period(314,469)

8,015,623

4,272,642

11,973,796

230,793

65,680,710

10

Fiscal year ended March 31, 2024
(Thousands of yen)
Shareholders’ equity
Share capital
Balance at beginning of
periodCapital surplus

Retained earnings

Treasury shares

Total shareholders’equity11,685,121

53,462,589(18,264,989)

53,476,120

6,593,398

Changes during period
Dividends of surplus(1,939,526)(1,939,526)

Profit attributable toowners of parent

7,731,262

7,731,262

Purchase of treasury
shares

(821)

(821)

Net changes in items otherthan shareholders’ equity
Total changes during period
Balance at end of period––

5,791,736(821)

5,790,915

6,593,398

11,685,121

59,254,325(18,265,810)

59,267,035

Accumulated other comprehensive income
Valuationdifference on
available-forsale securities
Balance at beginning of
period(314,469)

Foreign currency Remeasurements
translationof defined benefit
adjustment
plans
8,015,623

4,272,642

Total
accumulated
othercomprehensive
income11,973,796

Non-controllinginterests

Total net assets

230,793

65,680,710

Changes during period
Dividends of surplus(1,939,526)

Profit attributable toowners of parent

7,731,262

Purchase of treasury
shares(821)

Net changes in items otherthan shareholders’ equity

2,316,041

6,644,681(578,992)

8,381,730(24,564)

8,357,166

Total changes during period

2,316,041

6,644,681(578,992)

8,381,730(24,564)

14,148,081

Balance at end of period

2,001,571

14,660,305

3,693,650

20,355,527

206,229

79,828,792

11

(4) Consolidated statement of cash flows(Thousands of yen)
Fiscal year ended
March 31, 2023
Cash flows from operating activities
Profit before income taxes
Depreciation
Amortization of goodwill
Increase (decrease) in provision for bonuses
Increase (decrease) in provision for loss on cancellationof contracts
Increase (decrease) in retirement benefit liability
Interest and dividend income
Interest expenses
Foreign exchange losses (gains)
Loss (gain) on sale of investment securities
Decrease (increase) in trade receivables
Decrease (increase) in inventories
Increase (decrease) in trade payables
Decrease (increase) in other current assets
Increase (decrease) in other current liabilities
Decrease (increase) in retirement benefit asset
Other, net
SubtotalInterest and dividends received
Interest paid
Income taxes paid
Net cash provided by (used in) operating activities
Cash flows from investing activities
Payments into time deposits
Proceeds from withdrawal of time deposits
Purchase of property, plant and equipment
Purchase of intangible assets
Purchase of investment securities
Proceeds from sale and redemption of investment
securities
Purchase of shares of associates accounted for using
equity method
Other payments
Other proceeds
Net cash provided by (used in) investing activities

12

Fiscal year ended
March 31, 2024

7,272,698
5,431,037
717,233(67,288)9,508,394
6,341,193
1,214,257(100,880)

322,472(977,204)(27,233)(296,653)
337,281(106,464)(19,940)(171,927)(150,258)(207,545)
126,178
1,185,433(656,104)
36,895
13,725,813
296,668(300,687)(564,379)
13,157,415(154,069)(438,760)
457,801(143,268)(499,617)(2,075,167)(863,940)
1,052,362
66,807574,086(856,875)
2,443
13,107,561
438,760(446,719)(915,993)
12,183,609(125,000)
125,000(2,399,782)(257,954)(157,718)(1,668,141)
125,000(2,900,688)(998,098)(2,313)215,908

2,018,805–(623,336)(5,274)30,304(2,574,517)(13,129)
109,529(3,952,373)

(Thousands of yen)
Fiscal year ended
March 31, 2023
Cash flows from financing activities
Net increase (decrease) in short-term borrowings
Proceeds from long-term borrowings
Repayments of long-term borrowings
Repayments of lease liabilities
Purchase of treasury shares
Proceeds from share issuance to non-controllingshareholders
Dividends paid
Dividends paid to non-controlling interests
Net cash provided by (used in) financing activities
Effect of exchange rate change on cash and cash
equivalents
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period

13

Fiscal year ended
March 31, 2024

279,722500,000(5,628,975)(297,963)(673,928)(560,176)
500,000(5,778,110)(348,090)
(824)

–

815

(1,589,995)(3,929)(7,415,068)(1,935,396)(2,308)(8,124,090)

1,346,966

2,402,921

4,514,795
11,579,282
16,094,078

2,510,065
16,094,078
18,604,144

(5) Notes to consolidated financial statements(Notes on premise of a going concern)
Not applicable.
(Significant matters that form the basis for the preparation of consolidated financial statements)
1 Scope of consolidation(A) Number of consolidated subsidiaries: 18
Tillotts Pharma AG
Tillotts Pharma AB
Tillotts Pharma Ltd.
Tillotts Pharma UK Ltd.
Tillotts Pharma Czech s.r.o.
Tillotts Pharma Spain S.L.U.
Tillotts Pharma GmbH
Tillotts Pharma France SAS
Tillotts Pharma Italy srl
Pharmaceutical Joint Stock Company of February 3rd
ZPD A/S
Zeria Healthway Co., Ltd.
IONA INTERNATIONAL CORPORATION
Kenso-Seiyaku Co., Ltd.
Zevice Co., Ltd.
Zeriap Co., Ltd.
Two other consolidated subsidiaries
In the current fiscal year, one new subsidiary included in the scope of consolidation was established.
(B) Major non-consolidated subsidiaries
Zeria Shoji Co., Ltd.
Zeria Ecotech Co., Ltd.
Non-consolidated subsidiaries are excluded from the scope of consolidation because they are small
companies and their combined total assets, net sales, net income or loss, and retained earnings do nothave a material impact on the consolidated financial statements.
2

Application of equity method(A) Number of non-consolidated subsidiaries and affiliates accounted for by the equity method: 1
Mage Biologics Inc.
The Company’s consolidated subsidiary Tillotts Pharma AG, through a joint investment with TVM
Capital Life Science, newly established Mage Biologics Inc., to make it an affiliate company, and, asa result, it has been included as an entity accounted for by the equity method from the current fiscal
year.
There are no non-consolidated subsidiaries accounted for by the equity method.
(B) Names of major non-consolidated subsidiaries not accounted for by the equity method
Zeria Shoji Co., Ltd.
Zeria Ecotech Co., Ltd.
Non-consolidated subsidiaries not accounted for by the equity method are excluded from the scope ofequity method because their net income and retained earnings have a minimal effect on the
consolidated financial statements and they are insignificant in the aggregate.
(C) For Mage Biologics Inc., an equity-method affiliate, the financial statements for the most recent fiscal
year of the company are used because its fiscal year ends on a different date from the consolidated
fiscal year-end.

3

Fiscal year of consolidated subsidiaries
Of the consolidated subsidiaries, Tillotts Pharma AG, Pharmaceutical Joint Stock Company of February
3rd, ZPD A/S, and other overseas consolidated subsidiaries have a fiscal year ending December 31.
In preparing the consolidated financial statements, the financial statements of these subsidiaries as of
their fiscal year-end are used. However, adjustments necessary for consolidation are made for significant
14transactions that occurred between January 1 and March 31, the end of the consolidated fiscal year.
4

Matters related to accounting policies(A) Valuation standards and methods for significant assets(1) Investment securities
Other securities
Other than stocks and other securities without market priceꞏꞏꞏꞏꞏꞏ Market value method (unrealized gains or losses are reported as a separate component of
net assets, and the cost of securities sold is determined by the moving-average method)
Stocks and other securities without market priceꞏꞏꞏꞏꞏꞏ Cost method based on the moving-average method(2) Derivativesꞏꞏꞏꞏꞏꞏ Market value method(3) Inventoriesꞏꞏꞏꞏꞏꞏ Mainly stated at cost determined by the weighted average method (the carrying value on thebalance sheet is written down to reflect the effect of lower profit margins)(B) Depreciation and amortization method for significant depreciable assets(1) Property, plant and equipment (excluding leased assets)
The straight-line method is used for the Saitama Plant (including warehouses) and Tsukuba Plant,
and the declining-balance method is used for all others. However, buildings (excluding facilities
attached to buildings) acquired on or after April 1, 1998 and facilities attached to buildings andstructures acquired on or after April 1, 2016 are depreciated using the straight-line method.
Overseas consolidated subsidiaries use the straight-line method.
The useful lives of major assets are as follows.
Buildings and structures
3 to 50 years
Machinery, equipment and vehicles
2 to 15 years(2) Intangible assets (excluding leased assets)
The straight-line method is used.
Software for internal use is amortized by the straight-line method over the estimated useful life (5years).
(3) Leased assets
Finance lease transactions that do not transfer ownership are depreciated using the straight-line
method over the lease period with a residual value of zero.
(4) Long-term prepaid expenses
The straight-line method is used.
(C) Accounting for significant provisions(1) Allowance for doubtful accounts
To provide for possible bad debt expenses on trade receivables, etc. as of the end of the current
fiscal year, an allowance for doubtful accounts is provided in the amount deemed uncollectible
based on historical bad debt ratios for general receivables and on an individual assessment ofcollectibility for specific receivables for which there is concern about default.
(2) Provision for bonuses
To provide for bonuses to employees to be paid after the next fiscal year, an amount accrued forthe current fiscal year among the estimated future payments is recorded.
(3) Provision for loss on cancellation of contracts
To provide for losses due to contract cancellations, an allowance is provided for the estimatedamount of losses.
(D) Accounting for retirement benefits(1) Method of attributing estimated retirement benefits to periods of service
The estimated amount of retirement benefits is attributed to the period until the end of the current
fiscal year based on the benefit calculation method.
(2) Method of amortizing actuarial gains and losses and prior service cost
Prior service cost is amortized by the straight-line method over a fixed number of years (10 years)
within the average remaining service period of employees at the time the cost is incurred.
15

Actuarial gains and losses are amortized by the straight-line method over a fixed number of years(10 years) within the average remaining service period of employees at the time of their accrual,
starting from the following fiscal year of accrual.
(3) Accounting for unrecognized actuarial gains and losses and unrecognized prior service cost
Unrecognized actuarial gains and losses and unrecognized prior service cost are recognized inaccumulated other comprehensive income under net assets, remeasurements of defined benefit
plans, after adjusting for tax effects.
(E) Basis for recording significant income and expenses
The Group’s principal business is the manufacture and sale of products and the sale of merchandise in
the Ethical Pharmaceuticals Business and Consumer Healthcare Business. For the sale of theseproducts and merchandise, the Group usually recognizes revenue when the products and merchandise
are inspected and accepted by the customer, since it is considered that the customer has acquired
control over the products and merchandise and the performance obligation has been satisfied when the
products and merchandise are inspected and accepted by the customer. For sales in Japan, revenue isrecognized at the time of shipment if the period between the time of shipment and the time ofacceptance by the customer is a normal period of time. Revenue is measured at the amount ofconsideration promised in the contract with the customer, less any returns, discounts and rebates.
Deductions other than those for confirmed payments, such as rebates and sales incentives paid tocustomers, are estimated and recognized to the extent that it is probable that a material reversal will
not occur, taking into consideration the content of the contract and past results.
The consideration for transactions is received within one year of satisfaction of the performanceobligation and does not include a significant financial component.
Certain consolidated subsidiaries identify points granted to customers as performance obligations,
allocate the transaction price based on the independent sales price, and recognize revenue when the
points are used.
(F) Basis of translation of significant assets and liabilities denominated in foreign currencies into Japaneseyen
Receivables and liabilities denominated in foreign currencies are translated into yen at the spot
exchange rates prevailing on the consolidated balance sheet date, with translation differences
recognized as gains or losses. Assets and liabilities of overseas consolidated subsidiaries are translated
into yen at the spot exchange rate on the balance sheet date of the overseas consolidated subsidiaries,
and revenues and expenses are translated into yen at the average exchange rate during the accounting
period of the relevant overseas consolidated subsidiaries, with the translation differences included in
the foreign currency translation adjustments and non-controlling interests in net assets.
(G) Significant hedge accounting methods(1) Hedge accounting methods
In principle, deferred hedge accounting is applied. Forward exchange contracts that meet therequirements for allocation method are accounted for using the allocation method.
(2) Hedging instruments and hedged items
Forward exchange contracts are used as hedging instruments and forecasted import transactions
denominated in foreign currencies are used as hedged items.
(3) Hedging policy
The Company uses forward exchange contracts and other hedging instruments to hedge foreignexchange fluctuation risks of forecasted import transactions denominated in foreign currencies,
and hedging instruments, such as forward exchange contracts, are made within the scope of
forecasted import transactions denominated in foreign currencies that are hedged items.
(4) Evaluation of hedge effectivenessThe evaluation of hedge effectiveness is omitted because the hedging instruments are identical tothe material terms of the hedged forecasted transactions, and it can be assumed that the hedging
instruments will completely offset the market fluctuations at the inception of the hedge andcontinuously thereafter.
(H) Amortization method and period of goodwill
Goodwill of Tillotts Pharma AG, Pharmaceutical Joint Stock Company of February 3rd and ZPD A/S
16

is amortized by the straight-line method over 20 years.
(I)

Scope of cash in the consolidated statements of cash flows
Cash (cash and cash equivalents) in the consolidated statements of cash flows includes cash on hand,deposits that can be withdrawn on demand, and short-term investments with maturities of three months
or less at the time of acquisition that are readily convertible to cash and are exposed to insignificant
risk of changes in value.

17

(Segment information, etc.)[Segment information]
1. Overview of reportable segments
The Company’s reportable segments are components of the Company for which separate financial
statements are available and which are subject to periodic review by the Board of Directors in order todetermine the allocation of management resources and evaluate their performance.
The Company’s reportable segments are Ethical Pharmaceuticals Business and Consumer Healthcare
Business, as the Company’s business activities are focused on ethical and OTC drugs.
In the Ethical Pharmaceuticals Business, the Company conducts research, development,
manufacturing, and sales of ethical pharmaceuticals.
In the Consumer Healthcare Business, the Company conducts manufacturing, purchase, and sales of
OTC drugs, health foods, quasi-drugs, and cosmetics for self-medication.
2. Method of calculating net sales, profit or loss, assets, liabilities and other items by reportable segment
The accounting method for reported business segments is generally the same as that described in the“Significant matters that form the basis for the preparation of consolidated financial statements.”
Profits of reportable segments are based on operating profit (after amortization of goodwill), andintersegment revenues and transfers are based on prevailing market prices.
3. Information on net sales, profit or loss, assets, liabilities and other items by reportable segment
Previous fiscal year (April 1, 2022 to March 31, 2023)(Thousands of yen)
Reportable segment

Net sales
Sales to externalcustomers
Intersegment sales
and transfers
Total

Adjustment(Note 2)

EthicalPharmaceuticals Business

Consumer
Healthcare
Business

Total

43,145,144

25,085,823

68,230,968

152,258

68,383,227–

68,383,227

2,848

105

2,954

505,162

508,117(508,117)–

43,147,993

25,085,929

68,233,923

657,421

68,891,344(508,117)

68,383,227

13,691,964

242,317

13,934,282(4,919,308)

9,014,973

Segment profit

8,721,162

4,970,801

Segment assets

77,099,979

27,541,466 104,641,445

Other items
Depreciation
Amortization of
goodwill
Increase in property,
plant and equipment
and intangible
assets

Other(Note 1)

Amountrecorded inconsolidated
financialstatements(Note 3)

Total

4,962,023 109,603,468

25,431,067 135,034,536

4,363,627

866,949

5,230,576

86,122

5,316,699

114,337

5,431,037

512,008205,224

717,233–

717,233–

717,233

2,214,429

555,9072,770,337

82,3352,852,672

283,989

3,136,661(Notes) 1. “Other” is a business segment not included in the reportable segments and includes the insurance agency businessand real estate business.
2. (i) Adjustment of segment profit of (4,919,308) thousand yen is mainly corporate expenses such as general andadministrative expenses that are not allocated to each reportable segment.
(ii) Adjustment of segment assets of 25,431,067 thousand yen is mainly corporate assets not allocated to eachreportable segment.
3. Segment profit is adjusted with operating profit in the consolidated financial statements.
4. Depreciation and increase in property, plant and equipment and intangible assets include amortization andincrease in long-term prepaid expenses.

18

Current fiscal year (April 1, 2023 to March 31, 2024)(Thousands of yen)
Reportable segment

Net sales
Sales to externalcustomers
Intersegment sales
and transfers
Total

Adjustment(Note 2)

EthicalPharmaceuticals Business

Consumer
Healthcare
Business

Total

49,571,565

25,998,771

75,570,336

154,738

75,725,075–

75,725,075

13,688109

13,797596,435

610,233(610,233)–

49,585,253

25,998,880

75,584,134

751,174

76,335,308(610,233)

75,725,075

14,507,271

251,319

14,758,591(5,136,943)

9,621,647

Segment profit

9,246,965

5,260,306

Segment assets

88,276,477

28,525,641 116,802,118

Other items
Depreciation
Amortization of
goodwill
Increase in property,
plant and equipment
and intangible
assets

Other(Note 1)

Amountrecorded inconsolidated
financialstatements(Note 3)

Total

4,941,243 121,743,362

28,790,231 150,533,593

5,262,593

864,396

6,126,989

89,116

6,216,106

125,086

6,341,193

767,254447,0021,214,257–

1,214,257–

1,214,257

2,726,222

828,9093,555,131

35,5393,590,671

626,757

4,217,428(Notes) 1. “Other” is a business segment not included in the reportable segments and includes the insurance agency businessand real estate business.
2. (i) Adjustment of segment profit of (5,136,943) thousand yen is mainly corporate expenses such as general andadministrative expenses that are not allocated to each reportable segment.
(ii) Adjustment of segment assets of 28,790,231 thousand yen is mainly corporate assets not allocated to eachreportable segment.
3. Segment profit is adjusted with operating profit in the consolidated financial statements.
4. Depreciation and increase in property, plant and equipment and intangible assets include amortization andincrease in long-term prepaid expenses.

19[Related information]
Previous fiscal year (April 1, 2022 to March 31, 2023)
1. Information by product and service(Thousands of yen)

Sales to externalcustomers

Ethicalpharmaceuticals

Consumer healthcare
products

43,145,144

25,085,823

Other152,258

Total
68,383,227

2. Information by region(1) Net sales
Japan

UK

EuropeOther(Thousands of yen)Total

36,000,666

7,327,707

20,153,345

4,901,507

68,383,227(Notes) 1. Net sales are based on the location of customers and are classified by country or region.
2. Major countries or regions included in each category
Other: Asia, Africa, Oceania, Latin America, and North America(2) Property, plant and equipment
Japan

EuropeAsia

20,006,950

2,842,148

1,742,277(Thousands of yen)Total
24,591,375

Current fiscal year (April 1, 2023 to March 31, 2024)
1. Information by product and service(Thousands of yen)

Sales to externalcustomers

Ethicalpharmaceuticals

Consumer healthcare
products

49,571,565

25,998,771

Other
154,738

Total
75,725,075

2. Information by region(1) Net sales
Japan

UK

EuropeOther(Thousands of yen)Total

36,752,299

9,539,622

24,407,402

5,025,750

75,725,075(Notes) 1. Net sales are based on the location of customers and are classified by country or region.
2. Major countries or regions included in each category
Other: Asia, Africa, Oceania, Latin America, and North America(2) Property, plant and equipment
Japan

EuropeVietnam(Thousands of yen)Total

20,342,577

3,092,220

3,083,038

26,517,836[Information on impairment losses on fixed assets by reportable segment]
Previous fiscal year (April 1, 2022 to March 31, 2023)
Not applicable.
Current fiscal year (April 1, 2023 to March 31, 2024)
Not applicable.

20

[Information on amortization of goodwill and unamortized balance by reportable segment]
Previous fiscal year (April 1, 2022 to March 31, 2023)(Thousands of yen)
EthicalPharmaceuticals
Business
Amortization for thecurrent fiscal year
Balance at end of period

Consumer Healthcare
Business

Other

Total

512,008205,224–

717,233

3,569,444

1,730,353–

5,299,798

Current fiscal year (April 1, 2023 to March 31, 2024)(Thousands of yen)
EthicalPharmaceuticals
Business
Amortization for thecurrent fiscal year
Balance at end of period

Consumer Healthcare
Business

Other

Total

767,254447,002–1,214,257

2,845,990

1,416,828–

4,262,818(Note) Amortization for the current fiscal year in the Ethical Pharmaceuticals Business and Consumer Healthcare Businessincludes 476,992 thousand yen of amortization of goodwill, which is recorded as extraordinary losses in the
consolidated statement of income.

[Information on gain on bargain purchase by reportable segment]
Previous fiscal year (April 1, 2022 to March 31, 2023)
Not applicable.
Current fiscal year (April 1, 2023 to March 31, 2024)
Not applicable.

21

(Per share information)
Previous fiscal year
(April 1, 2022 to March 31, 2023)
Net assets per share(Yen)
Current fiscal year
(April 1, 2023 to March 31, 2024)

1,484.79

1,806.33

140.26175.39Profit per share(Notes) 1. Diluted profit per share is not shown in the above table, as there are no dilutive shares.
2. Basis for calculation of net assets per share is as follows.
Item

End of previous fiscal year
(March 31, 2023)

End of current fiscal year
(March 31, 2024)

Total net assets (thousand yen)

65,680,710

79,828,792

Amount deducted from total net
assets (thousand yen)

230,793

206,229[Of which, non-controllinginterests (thousand yen)][230,793][206,229]

Net assets related to common sharesat the end of the period (thousandyen)

65,449,916

79,622,562

Number of common shares issued
and outstanding (shares)

53,119,190

53,119,190

Number of treasury common shares(shares)

9,038,982

9,039,354

Number of common shares used for
calculation of net assets per share(shares)

44,080,208

44,079,836

Previous fiscal year
(April 1, 2022 to March 31, 2023)

Current fiscal year
(April 1, 2023 to March 31, 2024)

Profit attributable to owners of parent(thousand yen)

6,195,865

7,731,262

Profit attributable to owners of parent
related to common shares (thousandyen)

6,195,865

7,731,262

Average number of common shares
during the period (shares)

44,173,346

44,080,055

3. Basis for calculation of profit per share is as follows.
Item(Significant subsequent events)
Not applicable.

224. Other(1) Sales of major products and merchandise Consolidated(Thousands of yen)Previous fiscal year
April 1, 2022
to March 31, 2023
1. Ethical Pharmaceuticals
Business

Current fiscal year
April 1, 2023
to March 31, 2024

Percentage change(%)

43,145,144

49,571,565

Asacol

19,511,190

20,918,274

7.2

DIFICLIR

8,345,617

13,508,647

61.9

Entocort

5,688,312

5,416,293(4.8)

Acofide3,108,507

3,067,339

(1.3)

Other

6,491,516

6,661,010

2.6

25,085,823

25,998,771

3.6

Hepalyse range

9,848,681

10,968,611

11.4

Chondroitin range

5,421,820

5,752,050

6.1

WithOne range

1,266,766

1,292,304

2.0

Other

2. Consumer Healthcare
Business

14.9

8,548,555

7,985,805(6.6)

3. Other Business

152,258

154,738

1.6

Total

68,383,227

75,725,075

10.7

23

(2) Status of pipeline of new drugs
I.

Domestic

As of May 9, 2024

Stage

Development Code/
Generic Name

Development

Indications

Classification

OriginNDA filed

ZG-801/Patiromer
Sorbitex Calcium

Zeria

Hyperkalemia

Potassium binder

In-licensed

Phase IIIZ-338/Acotiamide

Zeria

Pediatric functional
dyspepsia

Upper gastrointestinal
motility modulator

Original

Phase II

ZG-802/Acotiamide

Zeria

Underactive bladder

Lower urinary tract
function modulator

Original

Phase II*
(InvestigatorInitiated Trial)

Z-338/Acotiamide

KyushuUniversity

Esophagogastricjunction outflow
obstruction

Upper gastrointestinal
motility modulator

Original*: Supported by a grant from Japan Agency for Medical Research and Development (AMED)II. Overseas
Stage

Development Code/
Generic Name

Development

Indications

Classification

OriginPhase III(Europe)

Z-338/Acotiamide

Zeria

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original

NDA approved(Honduras,
Dominican
Republic, Ecuador,
Chile, El Salvador,
Peru)

Z-338/Acotiamide

Faes Farma

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original(Out-licensed)

NDA approved(Thailand)

Z-338/Acotiamide

Meiji Seika
PharmaFunctional
dyspepsia

Upper gastrointestinal
motility modulator

Original(Out-licensed)

Z-338/Acotiamide

Pharmaceutical
Joint Stock
Company ofFebruary 3rd

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original

NDA filed(Singapore)

Z-338/Acotiamide

United Italian
Trading
Corporation
Pte. Ltd.

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original(Out-licensed)

NDA filed(Colombia, Costa
Rica, Guatemala,Panama, Nicaragua)Z-338/Acotiamide

Faes Farma

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original(Out-licensed)

NDA filed(Vietnam)

Launched in Overseas
Launch Date

Development Code/
Generic Name

Development

Indications

Classification

OriginOctober 2023
(Mexico)Z-338/Acotiamide

Faes Farma

Functional
dyspepsia

Upper gastrointestinal
motility modulator

Original(Out-licensed)

24