Financial Results for the Second Quarter of Fiscal Year 2025

Exploring the Innovative Promise of Glycoscience

（TSE：4548）

• 2Q of FY2025 Results P3-7

  • Overview

  • Domestic Pharmaceuticals

  • Overseas Pharmaceuticals

  • Bulk Products / CDMO, Royalty, LAL Business

• Research and Development P8-13

  • 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 P14-15

  • Status of Initiative for Constructing a Global Production System

• Appendix P16-19

  • FY2025 Forecasts

  • Basic Policy on Profit Distribution

  • Main products and Key Alliances with Companies in Japan and Overseas

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

2Q of FY2025 Results

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: Down 11.4% on a steep decline in royalty income, despite higher sales of domestic pharmaceuticals.

• Income: Down sharply due to the decrease in royalty income. Ordinary income and interim net income improved from the first quarter because of the sale of investment securities.

• No revision to the forecast because of anticipated sales of investment securities.

• Capital investment for establishing a global production system is proceeding as planned.

Net Sales by Business Segment

Overseas Sales Ratio

20,210

-11.4％

(Millions of Yen)

*excluding royalty income

FY2024 2Q

36.5%

63.5%

17,910

R& D Expenses

（Millions of Yen）

Ratio of R& D expenses to sales

( excluding royalty income)

Ave. exchange rate during the period (1USD）

FY2024

3,243 3,027 -6.6%

18.4％ 16.9％ -1.5Pt

¥152.6 ¥146.0 -¥6.6

FY2024 2Q FY2025 2Q

FY2025 2Q

Domestic Overseas

61.2%

38.8%

4

Overview for 2Q of FY2025

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

2Q of 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

• Net sales up 8.0% year on year, due mainly to higher sales of ARTZ attributable to shipment timing.

  Sales Comparison

  ARTZ（Joint-function improving agent）

  ARTZ Dispo
  OPEGAN series

  FY2024 2Q

  FY2025 2Q

  (Millions of Yen)

  others

  ＋8.0％

  5,402

  5,832

  11,600

  FY2025

  Forecasts

  • Market environment:

    ・Number of patients increasing accompanying a rising elderly population.

    However, slight declining market for hyaluronic acid injectable treatments due to factors including expansion of treatment options, such as topical preparations and oral medications.

    ・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.

*Source：Copyright © 2025 IQVIA. Calculated based on JPM April 2024 -September 2024, April 2025 - September 2025 by SKK , Reprinted with permission

• Seikagaku sales: Down due to a decrease in unit prices.

  5

  2Q of 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

  • Sales down 7.1% year on year on lower sales of SUPARTZ FX, a treatment of knee osteoarthritis for the U.S. market, despite higher sales of Gel-One in the U.S. and ARTZ in China.

  • Results for all of them attributable to shipment timing.

    Sales Comparison

    Products for the U.S.

    • Market environment:

-7.1％

(Millions of Yen)

9,650

・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 up

about half the total market.

・Seikagaku continue sales promotion activities appropriate for each product, gazing the trend of competing products.

• Seikagaku sales:

  4,757

  FY2024 2Q

  4,417

  FY2025 2Q

  FY2025

  Forecasts

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

  ・SUPARTZ FX (five-injection viscosupplement): Down due to shipment timing.

  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.

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

2Q of 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: 1,879 million yen (Up 17.4％ year on year, Foreign exchange impact: -101 million yen)

• Seikagaku sales increased mainly in contract development and manufacturing services.

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

• 2,588 million yen in the same period of the previous year.

  LAL Business

  • Sales down 1.4% year on year due to the impact of yen appreciation, despite continuing strong sales of Fungitell (a beta-glucan-detecting in vitro diagnostic).

    Sales Comparison

    • Market environment:

(Millions of Yen)

・Endotoxin-detecting reagents

Used mainly in quality control of pharmaceutical manufacturing processes.

-1.4％

5,863

5,779

Projected stable growth from conventional products produced using horseshoe crab blood as well as from recombinant products manufactured from non-animal-derived raw materials.

・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:

FY2024 2Q

FY2025 2Q

FY2025

Forecasts

Down due to yen appreciation year on year.

Research and Development

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

Pipeline List

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

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

Gel-One

JP（knee joint）

Gel-One

JP（hip joint）

Market approval

Target Market

SI-722

Interstitial cystitis and bladder pain syndrome

（Steroid compound sodium chondroitin

sulfate）

PI/II

9

Market

approval

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

• Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) (not approved).

• The Company will respond to the observations in preparation for obtaining approval aim to resubmit an application by March 2026 (within one year of receipt of the CRL).

  Administration image

  SI-6603

  Nerve

Development status

▶Response to resubmission 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.

Dev. Code：SI-6603 ／

Method of use：Injection into lumbar disc (under X-ray observation)

Generic name：Condoliase

／ Indication：Lumbar disc herniation

▶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.