健康づくり 幸せづくり

Making Health

is making happiness

69th

Business Report

From April 1st, 2022 to March 31st, 2023

Securities Code4559

Contents

To Our Shareholders…………………………………………… P.1

Summary of Our Business Operations (Consolidated)… …… P.3

Status of Research and Development………………………… P.5

Research and Development Pipeline… ……………………… P.6

Status of Production and Distribution /

Outlook for Fiscal Year 2023… ……………………………… P.7

Special Offers to Our Shareholders…………………………… P.8

Topics…………………………………………………………… P.9

Financial Statements (Consolidated)… ……………………… P.11

Company Information… ……………………………………… P.13

Share Information……………………………………………… P.14

Shareholder Memo

To Our Shareholders

We, Zeria Pharmaceutical Co., Ltd. ("Zeria") would like to express our thanks for your particular support.

We are pleased to report the business results of fiscal year 2022 (69th business operations) for the period from April 1st, 2022 to March 31st, 2023.

Chairman and CEO

President and COO

Sachiaki Ibe

Mitsuhiro Ibe

1

During the fiscal year under review, the Japanese economy saw a move toward recovery in private consumption and corporate capital investment as socioeconomic activities progressed toward normalization due to the effects of various policies under coexistence with the novel coronavirus (COVID-19). On the other hand, a full-scale recovery did not occur for the decrease of demand from foreign visitors to Japan due to the spread of infection of COVID-19. Moreover, the future impact on the Japanese economy from factors, such as surging energy and raw materials prices caused by the prolonged invasion by Russia into Ukraine, rising distribution costs, rapid yen depreciation, and a slowdown of the global economy, continues to be increasingly unclear.

In the pharmaceutical industry, the market environment for ethical pharmaceuticals has become even more severe due to strengthening of initiatives to curtail healthcare expenses, such as price revisions on a roughly annual basis and the promotion of the use of generic brand pharmaceuticals, even more than before. The market environment for OTC drugs also remained severe due to increasingly fierce market competition, as well as factors such as stagnant demand from foreign visitors to Japan.

Under such circumstances, the Zeria Group saw remarkable growth in overseas sales in the fiscal year under review, which is the final fiscal year of the 10th Mid-Term Management Plan (fiscal year 2020 to fiscal year 2022), amid the earnest acceleration of global expansion. DIFICLIR, a therapeutic agent for Clostridium difficile infections which is currently being sold primarily in Europe by Tillotts Pharma AG has contributed significantly to the overseas sales. On the other hand, in the domestic market, the Ethical Pharmaceuticals Business struggled due to the impact of price revisions, and the Consumer Healthcare Business was also not enough to produce sufficient results overall while it followed a track of recovery due to increased sales of the Hepalyse range and other drugs.

As a result of these activities, net sales for the current fiscal year were 68,383 million yen, up 14.9% from the previous fiscal year. Regarding profits, operating profit was 9,014 million yen, up 41.6% from the previous fiscal year, ordinary profit was 7,579 million yen, up 27.7% from the previous fiscal year, and profit attributable to owners of parent was 6,195 million yen, up 56.4% from the previous fiscal year, resulting in record highs in both net sales and profit.

In the current fiscal year, the overseas sales to net sales ratio was 47.4%, compared with 41.4% in the previous fiscal year.

Furthermore, amid the taking of proactive initiatives in M&A and alliances to strengthen the Zeria Group's business base, we were transferred approval from Astellas Pharma Inc. for the manufacturing and marketing of DIFICLIR, a therapeutic agent for Clostridium difficile infections, in Japan in April 2023 and commenced its sale (domestic sales name: Dafclir).

Net sales

Operating profit (

)/Ordinary profit (

)/

Profit attributable to owners of parent (

)

80,000

(Unit: ¥million)

10,000

(Unit: ¥million)

9,014

68,383

60,000

59,532

52,757

40,000

20,000

0

Fiscal Year 2020 Fiscal Year 2021 Fiscal Year 2022

8,000

7,579

6,366

5,935

6,000

6,195

4,000

3,475 3,208

3,961

3,143

2,000

0

Fiscal Year 2020 Fiscal Year 2021 Fiscal Year 2022

2

Summary of Our Business Operations (Consolidated)

Net sales

¥43,145million

up 16.6%

from the previous fiscal year

Net sales of major products

Consumer

Healthcare

Asacol

Business

63.1%

(Net sales

composition ratio)

DIFICLIR

Entocort

Ethical Pharmaceuticals Business

As for the main product, Asacol, a therapeutic agent for ulcerative colitis, sales in the domestic market faced challenging circumstances, owing to the impact of the price revisions and the competitive products. Despite this, sales increased overall as a result of strong performance in regions such as Northern Europe and the UK due to growth in sales of Asacol 1600 mg in overseas markets. Sales of Entocort (domestic sales name: Zentacort), an inflammatory bowel disease therapeutic agent, increased, as sales grew in various regions including Canada, and also Italy, where we established a local subsidiary in 2021 and transitioned to direct-distribution system. Although a generic drug was launched in some European countries in September 2022, the impact on our financial results for the current fiscal year was negligible. In addition, sales of DIFICLIR, a therapeutic agent for Clostridium difficile infections, achieved a

Acofide

Other

significant sales growth as a result of aggressive investment of sales resources in response to its recommendation as a first-line drug in the European guidelines for the treatment of infectious diseases.

Asacol

¥19.5 billion

DIFICLIR

¥8.3 billion

Entocort

¥5.6 billion

Acofide

¥3.1 billion

Consolidated net sales in

Ethical Pharmaceuticals Business (Unit: ¥million)

50,000

43,145

40,000

37,006

30,000

29,951

20,000

10,000

0

Fiscal Year 2020

Fiscal Year 2021

Fiscal Year 2022

With regard to Ferinject, an iron deficiency anemia therapeutic agent launched in the domestic market in September 2020, we are working to build the market, particularly in the obstetrics and gynecology and gastroenterology fields.

As a result, net sales in the business amounted to 43,145 million yen (up 16.6% from the previous fiscal year).

3

Net sales

¥25,085million

up 12.1%

from the previous fiscal year

Net sales of major products

Ethical

Hepalyse range

Pharmaceuticals

Business

Chondroitin

range

36.7%

range

(Net sales

WithOne

Other

composition ratio)

Hepalyse range

¥9.8 billion

Chondroitin range

¥5.4 billion

WithOne range

¥1.2 billion

Consolidated net sales in

Consumer Healthcare Business

(Unit: ¥million)

40,000

30,000

25,085

22,648

22,370

20,000

10,000

0

Fiscal Year 2020

Fiscal Year 2021

Fiscal Year 2022

Consumer Healthcare Business

As for the main product, Hepalyse range, although it continued to be affected by the COVID-19 pandemic and a stagnation in demand from foreign visitors to Japan, its sales increased owing to the recovery trend in the sales of both the pharmaceutical Hepalyse range and the Hepalyse W range for convenience stores. Sales of the Chondroitin range also remained steady due in part to aggressive advertising and promotional investments.

On the other hand, sales of the WithOne range of herbal laxatives struggled due to the impact of competitive products.

We also worked to strengthen our product lineup by launching sales of new products such as Hi Jelly Granules EX, a nutrient tonic that contains royal jelly as the active ingredient, and Viewclear Hi40 active, a chondroitin-content eye drops. We are working to increase brand awareness for Prefemin, a therapeutic agent for premenstrual syndrome (PMS), as the number of stores selling the product is expected to increase because it transferred to a Type-2 OTC drug in April 2023.

As a result, net sales in the business amounted to 25,085 million yen (up 12.1% from the previous fiscal year).

OTC drugs

Hepalyse® W series

4

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Disclaimer

ZERIA Pharmaceutical Co. Ltd. published this content on 25 July 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 July 2023 00:51:07 UTC.