Seikagaku CorporationTSE: 4548

Financial Results for the Fiscal Year 2025

· Issued by Seikagaku Corporation

Exploring the Innovative Promise of Glycoscience

Financial Results for the Fiscal Year 2025

(April 1, 2025 – March 31, 2026)

(TSE:4548)

  • FY2025 Results P2-6
    • Overview

    • Domestic Pharmaceuticals

    • Overseas Pharmaceuticals

    • Bulk Products / CDMO, Royalty, LAL Business

  • FY2026 Forecasts P7-12
  • Overview

  • Domestic Pharmaceuticals

  • Overseas Pharmaceuticals

  • Bulk Products / CDMO, Royalty, LAL Business

    • Research and Development P13-18
      • SI-6603 (Lumbar disc herniation)

      • Gel-One (Osteoarthritis of the knee and the hip)

      • SI-722(Interstitial cystitis and bladder pain syndrome)

      • SI-449 (Adhesion Barrier)

    • Other Topics P19-22
      • Summary of the Mid-term Management Plan (Fiscal 2022 to Fiscal 2025)

      • Basic Policy on Profit Distribution

    • Appendix P23-24

Contents

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

E x p l o r i n g t h e I n n o v a t i v e

FY2025 Results

P r o m i s e o f G l y c o s c i e n c e

  • Net sales: Down 6.9% on a steep decline in royalty income and lower sales of overseas pharmaceuticals, despite growth from the LAL business.

  • Income: Operating income and ordinary income down due to the decrease in net sales. Net income up 21.3% due to a review of deferred tax assets recognized on the balance sheet in light of the outlook for FY2026.

    Net Sales by Business Segment

    Overseas Sales Ratio

    (Millions of Yen)

    FY2024

    Results

    FY2025

    Results

    % of Change

    -6.9%

    Net Sales

    39,374

    36,645

    Operating Income

    1,333

    -660

    ー%

    Ordinary Income

    1,933

    1,679

    -13.1%

    Net income

    1,214

    1,473

    +21.3%

    Net Income per Share

    ¥22.25

    ¥26.99

    ー

    39,374

    -6.9%

    (Millions of Yen)

    12,152

11,860

2,598

3,254

3,192

9,369

9,804

11,868

11,919

36,645

*excluding royalty income

38.0%

62.0%

FY2024

Other Performance Indicators

FY 2024 FY 2025 % of

Domestic Pharma

Overseas Pharma

Bulk Products / CDMO

Royalty

Change

LAL

FY2025

Domestic Overseas

38.3%

61.7%

R&D Expenses(Millions of Yen) 7,643 7,010 -8.3%

Ratio of R&D expenses to sales

( excluding royalty income)

Exchange rate at end of period (US$1 )

Ave. exchange rate during

the period (US$1 )

20.8% 19.1% -1.7pt

¥149.5 ¥159.9 +¥10.4

¥152.6 ¥150.8 -¥1.8

FY2024 FY2025

Domestic Overseas

3

FY2025 Results

Overview

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

FY2025 Results

Domestic Pharmaceuticals

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

    • Revenue staying at prior-year level due to an increase in sales of ARTZ attributable to shipment timing, despite the impact of lower unit prices of the OPEGAN series.

      Sales Comparison

      ARTZ(Joint-function improving agent)

      (Millions of Yen)

      ARTZ Dispo OPEGAN series others

      -0.4%

      11,919 11,868

      • Market environment:

        • Market size for injectable hyaluronic acid preparations projected to remain at the prior-year level due to factors such as the spread of non-injectable treatment options, despite a rising number of patients due to the burgeoning elderly population.

        • Top share maintained. (approx. 80%*)

          Maintaining trust by leveraging status as an original drug through appropriate provision

          of information to medical institutions together with the sales partner.

          Continuous holding of seminars at academic conferences.

      • Seikagaku sales: Up due to shipment timing.

        OPEGAN series(Ophthalmic viscoelastic devices)

      • Market environment:

        • Because of use mainly for cataract surgery, market expansion trend accompanying growth in the elderly population.

        • Top share maintained. (approx. 50%*)

          Pursuit of further market penetration in cooperation with the sales partner.

      • Seikagaku sales: Down year on year due to lower unit prices.

        FY2024 FY2025

        *Source:Copyright © 2026 IQVIA. Calculated based on JPM April 4

        2024 –March 2026 by SKK , Reprinted with permission

        FY2025 Results

        Overseas Pharmaceuticals

        E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

    • Revenue down 4.4% year on year due to lower sales of SUPARTZ FX, despite higher sales of Gel-One, both products for the U.S. market.

Gel-One in the U.S

SUPARTZ FX in the U.S

ARTZ in China

(Millions of Yen)

Products for the U.S.

Sales Comparison

  • Market environment:

    • Market growth against a backdrop of expansion of the elderly population, but uncertainty surrounding the impact of government policies on the pharmaceutical industry.

    • Single-injection and 2-5 multiple injection products available, with single-injection products making

      Others

      -4.4%

      up about half the total market.

      9,804

      9,369
      • Seikagaku continue sales promotion activities appropriate for each product, gazing the trend of

competing products.

  • Seikagaku sales:

    • Gel-One (single-injection viscosupplement): Up due to shipment timing.

    • SUPARTZ FX (five-injection viscosupplement):

      Down year on year. In addition to shipment timing, the impact of a shift to products that require fewer injections (one to three injections) is presumed.

      ARTZ in China

  • Market environment:

    • Despite gradual market growth against the backdrop of expansion of the elderly population, future trend difficult to forecast due to expansion of the centralized procurement system by the national government and provinces.

      FY2024 FY2025

    • Appropriately providing information to medical institutions and at relevant academic conferences and continuing activities to expanded sales while earning trust as an original product.

FY2025 Results

Bulk Products / CDMO, Royalty, LAL Business

Bulk Products / CDMO

Royalties

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Net Sales: 3,254 million yen (Up 1.9% year on year, Foreign exchange impact: -99 million yen)

  • Seikagaku sales increased mainly in contract development and

    manufacturing services.

  • Net Sales: 1 million yen. (Down 99.9% year on year)

  • 2,598 million yen in the same period of the previous year.

    LAL Business

  • Net sales up 2.5% year on year thanks to strong sales in Japan and overseas.

    Sales Comparison

    • Market environment:

Overseas Domestic

+2.5%

FY2024

(Millions of Yen)

11,860

12,152

FY2025

  • Endotoxin-detecting reagents

    Used mainly for quality control in pharmaceutical manufacturing processes.

    Stable growth is expected from both conventional products derived from horseshoe crab blood and products manufactured using non-animal-derived raw materials, including Pyrosmart NextGen (PSNG).

  • Beta-glucan-detecting in vitro reagent

Used mainly as a diagnostic for deep fungal infections.

Sales growing, mainly in the U.S. Increased the number of countries where the products is sold and expand the product range with further growth forecast.

  • Seikagaku sales:

Strong sales of endotoxin-detecting reagents and Fungitell (a beta-glucan-detecting in vitro

reagent) in Japan and overseas.

E x p l o r i n g t h e I n n o v a t i v e

FY2026 Forecasts

P r o m i s e o f G l y c o s c i e n c e

  • Projected year-on-year revenue and income increases, mainly from higher royalty income and LAL business growth.
    • Net sales: Projected increase from higher royalty income and LAL business growth, despite lower sales of domestic and overseas pharmaceuticals.

    • Operating income: Projected increase due to the revenue growth, despite increased costs due to rising raw material and energy prices, as well as higher repair and maintenance expenses aimed at ensuring stable operating rates.

    • Ordinary income: Projected increase due to the revenue growth coupled with sales of investment securities.

    • Net income: Projected increase, with growth lagging behind ordinary income growth due to projected higher tax expenses.

      Net sales by Business Segment

      (Millions of Yen)

      FY2025

      Results

      FY2026

      Forecasts

      % of Change

      +14.2%

      Net Sales

      36,645

      41,850

      Operating Income

      -660

      2,050

      ー %

      8

      Ordinary Income

      1,679

      4,200

      +150.0%

      Net income

      1,473

      2,250

      +52.7%

      Net Income

      per Share

      ¥26.99

      ¥41.21

      ー

      R&D Expenses

      (excluding royalty income)

      7,010

      7,300

      +4.1%

      Average Exchange

      Rate (1US$)

      ¥150.8

      ¥155.0

      +¥4.2

      (Millions of Yen)

      +14.2% 41,850

      36,645

      11,700

      11,868

      8,550

      9,369

      3,650

      4,650

      3,254

      13,300

      12,152

      Domestic Pharmaceuticals

      Overseas Pharmaceuticals

      Bulk Products / CDMO

      Royalty

      LAL

      Exchange rate sensitivity (against the US dollar)

      Net sales: Approx ¥180 million / Operating income: Approx. ¥80 million

      FY2025 FY2026

      (Forecast)

      FY2026 Forecasts

      Overview

      E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

      FY2026 Forecasts

      Domestic Pharmaceuticals

      E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • No major change in the market environment, but net sales projected decrease 1.4% year on year due to a decline in

    unit prices continuing from the previous year.

  • Planned start of shipments of CS Barrier, an adhesion barrier approved in April 2026.

    Sales Comparison

    ARTZ(Joint-function improving agent)

    (Millions of Yen)

    ARTZ Dispo OPEGAN series others

    -1.4%

    12,100

    11,919

    11,868

    11,700

    FY2023 FY2024 FY2025 FY2026

    (Forecast)

    • Market environment:

      • Market size for injectable hyaluronic acid preparations projected to remain at the prior-year level due to factors such as the spread of non-injectable treatment options, despite a rising number of patients due to the burgeoning elderly population.

    • Seikagaku sales:

      Projected to decline due to lower unit prices, despite volume at the prior-year level.

      OPEGAN series(Ophthalmic viscoelastic devices)

    • Market environment:

      • Because of use mainly for cataract surgery, market expansion trend accompanying growth in the elderly population.

    • Seikagaku sales:

      Projected at the prior-year level due to a volume increase, despite lower unit prices.

      Other Product-Related Topics

    • cs barrier® (adhesion barrier, SI-449)

    Projected to start shipping, but with the shipment date uncertain, depending on the timing of insurance reimbursement.

    For this reason, the contribution to sales is expected to be limited.

    9

    FY2026 Forecasts

    Overseas Pharmaceuticals (1)

    E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Net sales projected to decline 8.7% year on year, mainly due to lower sales of Gel-One for the U.S. and ARTZ for China.

    Sales Comparison

    (Millions of Yen)

    Gel-One in the U.S SUPARTZ FX in U.S

    ARTZ in China Others

    -8.7%

    United States

    • Market environment:

      • Market growth against a backdrop of expansion of the elderly population, but uncertainty surrounding the impact of government policies on the pharmaceutical industry.

        10,059

        9,804

        9,369

        8,550
      • Single-injection and 2-5 multiple injection products available, with single-injection products making up about half the total market.

      • Seikagaku continue sales promotion activities appropriate for each product, gazing the

        trend of competing products.

    • Seikagaku sales:

      • Gel-One (single-injection viscosupplement):

        Projected decline due to market environment intensification. Planned strengthening of sales promotion activities in cooperation with the sales partner.

      • SUPARTZ FX (five-injection viscosupplement):

    Projected at the prior-year level.

    FY2026 Forecasts

    Overseas Pharmaceuticals (2)

    E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Net sales projected to decline 8.7% year on year, mainly due to lower sales of Gel-One for the U.S. and ARTZ for China.

    Sales Comparison

    (Millions of Yen)

    Gel-One in the U.S SUPARTZ FX in U.S

    ARTZ in China Others

    -8.7%

    China

    • Market environment:

      • Despite gradual market expansion driven by growth in the elderly population, intense price competition has emerged, largely as a result of the expansion of centralized procurement by the national government and provincial authorities.

        10,059

        9,804

        9,369

        8,550
      • Appropriately providing information to medical institutions and at relevant academic conferences and continuing activities to expanded sales while earning trust as an original product.

    • Seikagaku sales:

      • ARTZ for China (5-injection product):

        Projected temporary decline due to intensified competition with lower-priced products following the expansion of the tender system, as well as inventory adjustments by sales partner.

        Other Product-Related Topics

    • SI-6603 in the U.S.

    Regulatory approval and start of shipments expected during FY2026, but with the shipping date uncertain.

    For this reason, the contribution to sales is expected to be limited.

    FY2026 Forecasts

    Bulk Products / CDMO, Royalty, LAL Business

    Bulk Products / CDMO

    Royalties

    E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Net Sales: 3,650 million yen (Up 12.2% year on year, Foreign exchange impact: +200 million yen)

  • Mainly from a projected increase in CDMO sales and the impact of yen

    depreciation.

  • Net Sales: 4,650 million yen.

  • 1 million yen in the same period of the previous year.

    LAL Business

    • No major change in the market from FY2025. Projected 9.4% increase year on year due to higher sales overseas.

      Sales Comparison

      • Market environment:

    Overseas Domestic

    (Millions of Yen)

    +9.4%

    10,271

    11,860

    12,152

    13,300
    • Endotoxin-detecting reagents

      Used mainly for quality control in pharmaceutical manufacturing processes.

      Stable growth is expected from both conventional products derived from horseshoe crab blood and products manufactured using non-animal-derived raw materials, including Pyrosmart NextGen (PSNG).

    • Beta-glucan-detecting in vitro reagent

Used mainly as a diagnostic for deep fungal infections.

Sales growing, mainly in the U.S. Increased the number of countries where the products is sold and expand the product range with further growth forecast.

  • Seikagaku sales:

    Projected increase due to higher sales of endotoxin-detecting reagents, mainly PSNG, and

    Fungitell (a beta-glucan-detecting in vitro reagent).

    FY2023 FY2024 FY2025 FY2026

    (Forecast)

    E x p l o r i n g t h e I n n o v a t i v e

    Research and Development

    P r o m i s e o f G l y c o s c i e n c e

    13

    Research and Development

    Pipeline List

    Development code/

    Indication (Product name)

    SI-6603

    Lumbar Disk Herniation

    (Condoliase)

    Gel-One

    Osteoarthritis of the knee

    (Cross-linked hyaluronate hydrogel)

    Gel-One

    Osteoarthritis of the hip

    (Cross-linked hyaluronate hydrogel)

    PI PII PIII Appli-

    cation

    SI-6603 US

    Gel-One

    JP(knee joint)

    Gel-One

    JP(hip joint)

    Market approval

    E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

    Target Market

    JP

    US

    SI-722

    Interstitial cystitis and bladder pain syndrome

    (Steroid compound sodium chondroitin sulfate)

    Development code/

    Indication (Product name)

    SI-449

    Adhesion Barrier

    (Cross-linked Chondroitin Sulfate)

    Pilot

    Pivotal

    Application

    SI-449 JP

    Market approval

    SI-722

    14

    US

    PI/II

    14

    :SI-6603 Biologics License Application resubmitted to the U.S. Food and Drug Administration (FDA) (Mar. 2026)

    :SI-449 Marketing approval as a medical device obtained (Apr. 2026)

    Research and Development

    SI-6603 (Treatment for Lumbar Disc Herniation)

    E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

    • Resubmitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in March 2026.

    • Steadily proceed with a response to regulatory review in order to obtain approval.

      Administration image

      SI-6603

      Nerve

Nerve root under pressure

Spine

Extruded pulposus (hernia)

Development statusApplication to the FDA resubmitted in the U.S.
      • March 2025: CRL received from FDA.

      • No observations made concerning efficacy or safety, but additional observations made concerning the manufacturing facility and control of the drug substance and drug product.

Expected Features

Relieving symptoms by decreasing intradiscal pressure and reducing the

pressure on the nerve root by single injection.

It can be administered without general anesthesia, and the administration can be less invasive for the patient compared to surgical technique because of direct intradiscal injection.

Dev. Code:SI-6603 / Generic name:Condoliase / Indication:Lumbar disc herniation Method of use:Injection into lumbar disc (under X-ray observation)

New patients with lumbar disc herniation:3 to 5 million per year (Seikagaku estimates)

15

  • Intra-articular injection whose main ingredient is a cross-linked hyaluronate hydrogel made using

    Seikagaku’s unique cross-linking technology.

  • Phase III clinical studies are ongoing in Japan.

    Gel-One

    Development statusPhase III studies in Japan
    • Initiated Phase III clinical studies of the knee joint and hip joint in February 2025.

    • Conclusion of an agreement on joint development and sales partnership

      with Ono Pharmaceutical Co., Ltd. In August 2025.

      Expected Features

      Designed to remain in the local joint environment for a long time after injection in the knee joint cavity, with pain reduction from a single injection confirmed in U.S. clinical studies.

      At this time, no other hyaluronic acid monotherapy is indicated for

      osteoarthritis.

      <Gel-One summary >

      Dev. Code:Gel-One / Generic name:Cross-linked hyaluronate hydrogel Indication:Osteoarthritis of the knee and the hip/ Method of use:Injection into the joint cavity

      Estimated Japan patients:Osteoarthritis of the knee Approx. 8 million*1、Osteoarthritis of the hip 1.2 to 5.1 million (prevalence rate of

      1.0% to 4.3%*2 extrapolated to the population of Japan)

*1:Clinical Practice Guidelines for the Management of Knee Osteoarthritis 2023 16

*2:Clinical Practice Guidelines for the Management of hip Osteoarthritis

Research and Development

Gel-One(Osteoarthritis of the knee and hip)

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

Research and Development

SI-722 (Interstitial cystitis and bladder pain syndrome)

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Phase I/II clinical studies in the U.S. completed. Currently considering the future development policy.

Administration image

SI-722 injection into the bladder

Using sustained release of steroids to provide

long-lasting improvement

Development status

Phase I/II studies in the U.S. Completed

・Subject enrollment complete in January 2021, and tolerability confirmed.

(a primary objective)

Expected Features

Designed for sustained release by bonding steroids to chondroitin sulfate. Anti-inflammatory effects of steroids under sustained release should provide sustainable relief of frequent urination and bladder pain.

<SI-722 summary>

Dev. Code:SI-722 / Generic name:Steroid conjugated with chondroitin sulfate Indication:Interstitial cystitis and bladder pain syndrome / Method of use:Injection into the bladder Estimated U.S. patients :1.3 million (Seikagaku estimates)

Research and Development

SI-449 (Adhesion Barrier / Medical Device)

E x p l o r i n g t h e I n n o v a t i v e P r o m i s e o f G l y c o s c i e n c e

  • Application for marketing approval as a medical device submitted in August 2025, and approval obtained in April 2026.

  • “cs barrier®” decided as the product name.

  • Will proceed with preparations for market introduction together with the sales partner (Covidien Japan, Inc.).

Development status

Abdominal

wall

Application of SI-449

Administration image

Prevents adhesion by

absorbing moisture and swelling

Internal organ

marketing approval for a medical device in Japan

・Submitted an application for marketing approval as a medical device in

August 2025.

・Obtained marketing approval for a medical device in April 2026

Proceed with development with a view to global development.Expected Features

linking technology.

A powdered adhesion barrier agent primarily composed of cross-linked chondroitin sulfate created using our own glycosaminoglycan cross-

Leveraging pulverized characteristics to respond to healthcare needs through

the spreading use of laproscopic surgery.

Dev. Code:SI-449 /

Product name:Adhesion barrier / Method of use :Intra-abdominal application (powdered formulation) Adhesion barrier market:Japan: ¥14 billion, Global: ¥100 billion (Seikagaku estimates)

Generic name:Cross-linked chondroitin sulfate

E x p l o r i n g t h e I n n o v a t i v e

Other Topics

P r o m i s e o f G l y c o s c i e n c e

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