Santen Pharmaceutical : Reports Fiscal 2023 Consolidated Performance

Summary of Consolidated Financial Results for the Year Ended March 31, 2024 (IFRS)

Listed Company Name:	Santen Pharmaceutical Co.,Ltd
Exchanges Listed:	Tokyo (Prime Market)
Stock Code:	4536
URL:	https://www.santen.com/en
Representative:	Takeshi Ito, President and CEO
Contact:	Guillaume Sakuma, Global Head of IR ([phone])
Annual Shareholders Meeting (Scheduled):	June 25, 2024
Start of Distribution of Dividends (Scheduled):	June 26, 2024
Filing of Securities Report (Scheduled):	June 25, 2024
Preparation of Supplementary Material of the	Yes
Financial Results:
Holding of Presentation of Financial Results:	Yes (for securities analysts and institutional investors)
1. Consolidated Performance for the Fiscal Year Ended March 31, 2024		(JPY millions)
(1) Operating Results
(Core basis)
			Year to	Year to	Change
			March 2023	March 2024
	Revenue		279,037	301,965	+8.2％
	Core operating profit		44,242	62,778	+41.9％
	Core net profit for the year		33,235	48,513	+46.0％
	Core net profit for the year attributable to owners of the company	33,270	48,486	+45.7％
	Basic core earnings per share (yen)		85.86	132.13
	Diluted core earnings per share (yen)		85.68	131.70
(IFRS)
			Year to	Year to	Change
			March 2023	March 2024
	Revenue		279,037	301,965	+8.2％
	Operating profit (loss)		(3,090)	38,541	－
	Profit (loss) before tax		(5,799)	29,874	－
	Net profit (loss) for the year		(14,983)	26,703	－
	Net profit (loss) for the year attributable to owners of the company	(14,948)	26,642	－
	Total comprehensive income for the year		(5,696)	39,988	－
	Basic earnings per share (yen)		(38.60)	72.59
	Diluted earnings per share (yen)		(38.60)	72.37
	Profit to equity attributable to owners of the company (%)	(4.7％)	8.9％
	Profit before tax to total assets ratio (%)		(1.3％)	7.0％
	Operating profit to revenue ratio (%)		(1.1％)	12.8％
(2) Financial Position
			March 31,	March 31,
			2023	2024
	Total assets		421,179	435,699
	Total equity		293,297	305,369
	Total equity attributable to owners of the company	293,979	306,055
	Total equity attributable to owners of the company ratio (%)	69.8％	70.2％
	Equity per share attributable to owners of the company (yen)	783.30	843.24

(3) Cash Flows

	Year to	Year to
	March 2023	March 2024
Cash flows from operating activities	37,147	72,649
Cash flows from investing activities	(26,777)	(6,145)
Cash flows from financing activities	(37,220)	(34,031)
Cash and cash equivalents at end of year	57,903	94,582

2. Dividends

	Year to	Year to	(Forecasts)
	Year to
	March 2023	March 2024
	March 2025
Second quarter dividends per share (yen)	16.00	16.00	17.00
Year-end dividends per share (yen)	16.00	17.00	17.00
Annual dividends per share (yen)	32.00	33.00	34.00
Total dividends paid (full-year)	12,216	12,047
Payout ratio (consolidated)
－	45.5％	36.9％
Dividends paid on equity attributable to owners of the company	3.9％	4.1％
(consolidated)

3. Consolidated Forecasts of Results for the Fiscal Year Ending March 31, 2025(Core basis)

	Year to	Change
	March 2025
Revenue	297,000	(1.6％)
Core operating profit	55,000	(12.4％)
Core net profit for the year	41,250	(15.0％)
Core earnings per share (yen)	117.05

(IFRS)

	Year to	Change
	March 2025
Revenue	297,000	(1.6％)
Operating profit	44,500	15.5%
Profit before tax	45,000	50.6%
Net profit for the year	33,500	25.5%
Basic earnings per share (yen)
92.22

(Note)

1. Please refer to "1. Summary of Consolidated Results (1) Summary of Consolidated Results for the Fiscal Year ended March 31, 2024" on page 5 of the attached material for details of the reconciliation from IFRS basis figures to core-based figures.
2. At a meeting of the Board of Directors on May 9, 2024, the Board resolved to undertake a share repurchase. The share repurchase has been factored into the basic core earnings per share forecasts and basic earnings per share. Please refer to "3. Consolidated Financial Statements and Notes (5) Notes for Consolidated Financial Statements (page 22) " of the attached material for details.

*Notes

(1) Changes in significant subsidiaries during the period

(Changes in specified subsidiaries resulting in changes in scope of consolidation): No

(2) Changes in accounting policies and changes in accounting estimates

(i) Changes in accounting policies required by IFRS	: No
(ii) Changes in accounting policies other than (i)	: No
(iii) Changes in accounting estimates	: Yes

1. Number of ordinary shares issued
2. 1. Number of shares issued at the end of the period (including treasury shares)

Fiscal Year ended March 31, 2024	363,996,254 shares
Fiscal Year ended March 31, 2023	375,885,854 shares
(ii) Number of treasury shares at the end of the period
Fiscal Year ended March 31, 2024	786,780 shares
Fiscal Year ended March 31, 2023	345,065 shares
(iii) Average number of shares during the period
Fiscal Year ended March 31, 2024	366,889,585 shares
Fiscal Year ended March 31, 2023	387,420,468 shares

(NOTE)The number of treasury shares at the end of the period includes shares (41,909 shares at the end of the fiscal year ended March 31, 2023 and 49,311 shares at the end of the fiscal year ended March 31, 2024) owned in trust for the stock compensation system. Treasury shares are also included in the calculation of the average number of shares outstanding during the period.

(Reference) Summary of Non-consolidated Financial Results

Non-consolidated Financial Results for the Fiscal Year Ended March 31, 2024 (April 1, 2023 - March 31, 2024)

(1) Non-Consolidated Financial Results

(%: year-on-year change)

		Net sales		Operating income	Ordinary income	Net income
		JPY millions		%	JPY millions	%		JPY millions	%	JPY millions		%
Fiscal Year ended	195,238		(0.7)	28,013	13.0		31,272	15.5	18,680		－
March 31, 2024
Fiscal Year ended	196,589		3.0	24,798	15.9		27,068	20.2	(59,379)		－
March 31, 2023
		Per share		Fully diluted
		Net income	Net income per share
				Yen		Yen
Fiscal Year ended				50.88		50.74
March 31, 2024
Fiscal Year ended		(153.18)		－
March 31, 2023

(2) Non-consolidated Financial Position

	Total assets		Net assets	Equity ratio	Net assets per share
	JPY millions		JPY millions	%	Yen
Fiscal Year ended	271,848		187,505	68.9	515.75
March 31, 2024
Fiscal Year ended	282,904		199,261	70.3	529.72
March 31, 2023
(Reference) Equity
Fiscal Year ended March 31, 2024	187,325 million yen
Fiscal Year ended March 31, 2023	198,931 million yen

*This financial summary is not subject to audit by a certified public accountant or auditing firm.

*Explanations and other special notes concerning the appropriate use of business performance forecasts

(Notes on forward-looking statements)

The earnings forecasts and other forward-looking statements contained in this report are based on information currently available to the Company and on certain assumptions deemed to be reasonable by the Company. Actual results may differ from these forecasts due to various factors.

(Method of obtaining supplementary explanatory materials for financial results and results briefing contents) The Santen Group plans to hold a briefing on the results for securities analysts and institutional investors on Thursday, May 9, 2024. The materials used in this briefing will be posted on our website.

Accompanying Materials - Contents

1. Summary of Consolidated Results…………………………………………………………………....... 2

1. Summary of Consolidated Results for the Fiscal Year ended March 31, 2024………………... 2
2. Summary of Financial Position for the Fiscal Year ended March 31, 2024………………….... 8

(3)	Summary of Cash Flows for the Fiscal Year ended March 31, 2024……………………………	9
(4)	Basic Profit Distribution Policy and Dividends for the Current and Next Fiscal Years…………	9

1. 1. Outlook for the Fiscal Year Ending March 31, 2025 ……………………………………………… 10
2. Basic Approach to the Selection of Accounting Standards.....................…………………………... 11
3. Consolidated Financial Statements and Notes...........……………………………………………….. 12
4. 1. Consolidated Statements of Income and Comprehensive Income……………………………… 12
   2. Consolidated Statement of Financial Position......................…………………………………….. 13
   3. Consolidated Statement of Changes in Equity......................……………………………………. 15
   4. Consolidated Statements of Cash Flows..........................................................................……. 17

(5)	Notes for Consolidated Financial Statements	18
(Notes on Going Concern Assumption)....................………………………………………………. 18
(Basis of Presenting Consolidated Financial Statements)..................……………………………	18
(Changes in Accounting Estimates)..................……………………………………………………	19
(Segment Information and Others )......................…………………………………………………..	19
(Other Income)	…………………..	20
(Other Expenses)	……………	21
(Contingent Liabilities) ......................…………………………………………………………………. 22
(Earnings per Share)......................………………………………………………………………….. 22
(Significant Subsequent Events)......................…………………………………………………….. 23
4. Consolidated Reference......................…………………………………………………………………	24
(1)	Revenue of Major Products	24
(2) FOREX	24
(3)	Research & Development	25
(4)	Capital Expenditures, Depreciation and Amortization, Amortization on Intangible Assets
	Related to Products, and Research and Development Expenses	27

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1. Summary of Consolidated Results

1. Summary of Consolidated Results for the Fiscal Year ended March 31, 2024
   (I) Consolidated Results A) Core basis*1

			(JPY billions)
	FY2022	FY2023	Year-on-year change
Revenue	279.0	302.0	8.2％
Core operating profit	44.2	62.8	41.9％
Core net profit for the year	33.2	48.5	46.0％
Core net profit for the year attributable to	33.3	48.5	45.7％
owners of the company

[Revenue]

Revenue in the fiscal year ended March 31, 2024 increased by 8.2% year-on-year to ¥302.0 billion.

In the prescription pharmaceuticals business, sales grew globally by 8.0% year-on-year to ¥281.0 billion.

This is due to the Company's focus on expanding sales of mainstay products despite the impact of drug price revisions in Japan, as well as a recovery from the resurgence of COVID-19 in China in the previous fiscal year, and a solid performance from mainstay products in Asia/EMEA.

The breakdown of revenue is as follows:

Upper: Value
Lower: Year-on-year change						(JPY billions)
【】: Year-on-year change excluding FX impact
		Japan	China	Asia	EMEA	Americas	Total
Prescription		160.2	29.4	27.7	61.4	2.4	281.0
	(1.6%)	39.0%	19.1%	22.5%	(19.6%)	8.0%
pharmaceuticals
	【－】	【35.4%】	【12.1%】	【11.3%】	【(24.0%)】	【4.9%】
OTC		10.1	0.3	0.8		－	11.2
pharmaceuticals		5.2%	18.5%	8.4%	－	－	5.8%
Medical devices		3.6	0.1	0.1	3.3	0.7	7.8
	9.8%	1.0%	640.6%	40.7%	29.5%	24.1%
Others		1.8	0.1	0.1	－	－	1.9
	1.3%	6.5%	(12.1%)	－	－	0.7%
		175.6	29.9	28.7	64.8	3.1	302.0
Total		(1.0%)	38.6%	18.9%	23.3%	(11.8%)	8.2%
		【－】	【35.1%】	【11.9%】	【12.1%】	【(16.5%)】	【5.2%】

(NOTE)

Represents revenue from sales to external customers.

Classified into countries or regions based on customer location. China is not included in Asia. EMEA means Europe, the Middle East and Africa.

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• Japan

Revenue in the fiscal year ended March 31, 2024 decreased by 1.6% year-on-year to ¥160.2 billion. This was due to the mid-2% impact of drug price revisions, which was offset by the focus on growing mainstay products including Diquas LX and Alesion LX products. Revenues of major products are as follows.

Glaucoma and ocular hypertension
Tapros ophthalmic solution	¥5.9 billion (YoY -23.5%)
Tapcom ophthalmic solution	¥2.2 billion (YoY -17.3%)
Cosopt ophthalmic solution	¥4.0 billion (YoY -15.4%)
Eybelis ophthalmic solution	¥4.3 billion (YoY +11.3%)
Dry eye
Diquas ophthalmic solution*3(refer to Page 5)	¥20.1 billion (YoY +23.5%)
Allergy
Alesion ophthalmic solution*2(refer to Page 5)	¥29.3 billion (YoY -12.3%)
Intravitreal VEGF inhibitor
EYLEA*4(refer to Page 5)	¥72.7 billion (YoY +2.0%)
(solution for intravitreal injection)

• China

On a JPY basis, revenue in the fiscal year ended March 31, 2024 increased by 39.0% year-on-year (+35.4% excluding FX impact), to ¥29.4 billion, boosted by the strong performance of mainstay products reflecting a recovery from the resurgence of COVID-19 in the previous fiscal year. Revenues of major products are as follows.

Glaucoma and ocular hypertension
Tapros ophthalmic solution	¥1.8 billion (YoY +69.7%)
Dry eye
Diquas ophthalmic solution	¥3.3 billion (YoY +19.6%)
Hyalein ophthalmic solution	¥8.8 billion (YoY +36.9%)
Bacterial conjunctivitis
Cravit ophthalmic solution	¥8.8 billion (YoY +40.1%)

• Asia (excluding China)

On a JPY basis, revenue in the fiscal year ended March 31, 2024 increased by 19.1% year-on-year (+12.1% excluding FX impact), to ¥27.7 billion, due to steady growth of mainstay products in major countries including South Korea, as listed below.

Glaucoma and ocular hypertension
Tapros ophthalmic solution	¥2.4 billion (YoY +4.8%)
Tapcom ophthalmic solution	¥1.3 billion (YoY +26.8%)
Cosopt ophthalmic solution	¥6.9 billion (YoY +12.6%)
Dry eye
Diquas ophthalmic solution	¥2.5 billion (YoY +25.9%)
Ikervis	¥1.9 billion (YoY +24.8%)
Bacterial conjunctivitis
Cravit ophthalmic solution	¥3.2 billion (YoY +36.2%)

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• EMEA

On a JPY basis, revenue in the fiscal year ended March 31, 2024 increased by 22.5% year-on-year (+11.3% excluding FX impact), to ¥61.4 billion. This is mainly due to growth in sales of glaucoma products, the disease area in which Santen holds No.1 market share, as well as the impact of a reevaluation of the reimbursement claim settlement for Ikervis in the fiscal year under review. Revenues of major products are as follows.

Glaucoma and ocular hypertension
Tapros ophthalmic solution	¥8.4 billion	(YoY +10.0%)
Tapcom ophthalmic solution	¥5.7 billion	(YoY +26.8%)
Cosopt ophthalmic solution	¥14.8 billion	(YoY +14.4%)
Trusopt ophthalmic solution	¥3.6 billion	(YoY +4.6%)
Dry eye
Ikervis	¥10.2 billion	(YoY +92.3%)
Cationorm	¥2.9 billion	(YoY +11.3%)
Allergy
Verkazia	¥1.2 billion	(YoY +57.9%)

• Americas

On a JPY basis, revenue in the fiscal year ended March 31, 2024 decreased by 19.6% year-on-year(-24.0% excluding FX impact), to ¥2.4 billion. This is due to efforts to streamline sales and marketing activities.

Revenue in the fiscal year ended March 31, 2024 increased by 5.8% year-on-year to ¥11.2 billion.

Santen continues to focus on high-end products such as the Sante Medical series, Sante Beauteye series, and Soft Santear series as well as Hyalein S, which is a switch OTC product and Sante FX series.

Revenue in the fiscal year ended March 31, 2024 increased by 24.1% year-on-year to ¥7.8 billion, due to steady progress in sales of intraocular lenses such as LENTIS Comfort in Japan as well as the strong performance in EMEA of PRESERFLO MicroShunt. Revenues of major products are as follows.

LENTIS Comfort	¥1.3 billion (YoY -5.2%)
PRESERFLO MicroShunt	¥4.1 billion (YoY +70.6%)

Other revenues amounted to ¥1.9 billion. This is due to sales of supplements, and cleaning of dustless and aseptic clothing at consolidated subsidiary Claire Co., Ltd.

[Core operating profit]

Gross profit in the fiscal year ended March 31, 2024 increased by 7.7 % year-on-year to ¥178.9 billion. SG&A expenses in the fiscal year ended March 31, 2024 decreased by 2.9% year-on-year

(-6.9% excluding FX impact) to ¥90.8 billion.

R&D expenses in the fiscal year ended March 31, 2024 decreased by 10.7% year-on-year(-14.5% excluding FX impact) to ¥25.3 billion.

As a result, operating profit on a core basis in the fiscal year ended March 31, 2024 increased by 41.9 % year-on-year (+39.9% excluding FX impact) to ¥62.8 billion.

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*1 With the adoption of IFRS in the fiscal year ended March 31, 2015, the Santen Group discloses financial information on a core basis, which is calculated by excluding certain income and expense items from the IFRS basis, as an indicator of ordinary performance. The core basis is calculated by adjusting the following income and expense items, which are deducted from IFRS results, and the related income tax expenses.

• Amortization on intangible assets associated with products
• Other income
• Other expenses
• Finance income
• Finance expenses
• Share of profit (loss) of investments accounted for using equity method
• Expenses related to acquisitions of companies and initiatives for the resumption of growth such as productivity improvements and streamlining measures

*2 Includes Alesion LX

*3 Includes Diquas LX

*4 Co-promoted product of Bayer Yakuhin, Ltd. (MAH)

- 5 -

B) IFRS

			(JPY billions)
	FY2022	FY2023	Year-on-year change
Revenue	279.0	302.0	8.2％
Operating profit (loss)	(3.1)	38.5	－％
Net profit (loss) for the year	(15.0)	26.7	－％
Net profit (loss) for the year attributable	(14.9)	26.6	－％
to owners of the company

[Revenue]

There are no adjustments from the core basis.

[Operating profit]

For the adjustments from the core basis, with regard to expenses related to the streamlining of costs in the Americas, adjustments of ¥0.2 billion, ¥0.7 billion and ¥0.2 billion were made to Cost of Sales, SG&A and R&D expenses respectively.

Amortization on intangible assets associated with products in the fiscal year ended March 31, 2024 decreased by 0.5% year-on-year(-3.6% excluding FX impact) to ¥9.5 billion. This is mainly due to the amortization on intangible assets associated with products acquired from Merck & Co., Inc. (U.S.) in 2014, PRESERFLO MicroShunt acquired in connection with the acquisition of InnFocus, Inc. (U.S.) in 2016, Ikervis which Santen began selling in Europe in 2015, and Rhopressa / Rocklatan which Santen began selling in Europe in 2023.

Other income amounted to ¥1.5 billion. This is mainly due to the asset transfer of some products related to the prescription pharmaceutical business in the Americas.

Other expenses amounted to JPY15.3 billion. This is mainly due to the recording of impairment losses on intangible assets related to cell therapy products mainly composed of retinal progenitor cells given a review of the business plan, extraordinary expenses pertaining to the Early Retirement Program implemented in Japan, and also mainly due to the maximum streamlining of the pharmaceutical commercial business in the Americas.

As a result, operating profit on an IFRS basis in the fiscal year ended March 31, 2024 was ¥38.5 billion (operating loss of ¥3.1 billion for the previous fiscal year).

[Net profit for the year]

Finance income amounted to ¥1.6 billion. Finance expenses amounted to ¥2.7 billion.

Share of loss of investments accounted for using equity method amounted to ¥7.6 billion from recording of impairment losses on the equity method investments and profit and loss amount attributable to the equity held in Twenty Twenty Therapeutics LLC (U.S.) and Plano Pte. Ltd. (Singapore).

Income tax expenses amounted to ¥3.2 billion, down ¥6.0 billion year-on-year. This reflects the recognition of deferred tax assets related to the business environment of overseas subsidiaries and the performance trend outlook, despite the increase in profit before tax associated with the aforementioned increase in operating profit on an IFRS basis

As a result, net profit in the fiscal year ended March 31, 2024 was ¥26.7 billion (net loss of ¥15.0 billion for the previous fiscal year).

[Net profit for the year attributable to owners of the company]

Net profit attributable to owners of the company in the fiscal year ended March 31, 2024 was ¥26.6

billion (net loss for the year attributable to owners of the company of ¥14.9 billion for the previous fiscal year). The ratio to revenue was 8.8%.

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