Seikagaku Corporation · TSE:4548
Seikagaku — FY2023 Earnings Presentation
24 slides from Seikagaku's earnings presentation, May 16, 2024
Slide 1: Financial Results for the Fiscal Year 2023
Financial Results for the Fiscal Year 2023 (April 1, 2023 – March 31, 2024) （TSE：4548）
Slide 2: Contents
Exploring the Innovative Contents Promise of Glycoscience FY2023 Results P3-8 Research and Development P14-19 Overview SI-6603 (Lumbar disc herniation) Domestic Pharmaceuticals SI-614 (Dry Eye) Overseas Pharmaceuticals SI-722(Interstitial cystitis and bladder pain syndrome) Bulk Products / CDMO, Roy
Slide 3: FY2023 Results
Exploring the Innovative Promise of Glycoscience FY2023 Results 3
Slide 4: Overview
FY2023 Results Exploring the Innovative Promise of Glycoscience Overview Net sales：Up 8.2% on sales volume growth from domestic pharmaceuticals and from ARTZ for China and other overseas pharmaceuticals, in addition to an increase in royalty income Operating Income：Down 79.5% due mainly to an invent
Slide 5: Domestic Pharmaceuticals
FY2023 Results Exploring the Innovative Promise of Glycoscience Domestic Pharmaceuticals FY2023 Results Sales up, with volume increases for ARTZ and the Sales trend OPEGAN Series, compensating for the impact of NHI (Millions of Yen) + 7.3% (Sales） price reductions Joint-function improving agent (Uni
Slide 6: Overseas Pharmaceuticals
FY2023 Results Exploring the Innovative Promise of Glycoscience Overseas Pharmaceuticals FY2023 Results Sales up, with volume growth from ARTZ for China Sales trend and SUPARTZ FX compensating for lower sales of + 17.9% (Millions of Yen) (Sales） Gel-One ＜Breakdown＞ U.S. (Value basis) *Foreign exchan
Slide 7: Bulk Products / CDMO, Royalty, LAL Business
FY2023 Results Exploring the Innovative Promise of Glycoscience Bulk Products / CDMO, Royalty, LAL Business Bulk Products / CDMO LAL Business FY2023 Results：+ 5.7% FY2023 Results：- 4.3% *Foreign exchange impact on Bulk Products/CDMO: approx. +70million yen *Foreign exchange impact on LAL Business :
Slide 8: Trend in R&D Expenses
FY2023 Results Exploring the Innovative Promise of Glycoscience Trend in R&D Expenses Continuing to focus on drug discovery specializing in Glycoscience Undertaking improvement in R&D efficiency (Millions of Yen) 30.0% 29.7% 29.2% 28.3% 26.7% 26.7% 25.2% 23.8% 8,000 21.1% 8,408 9,005 6,000 8,649 7,8
Slide 9: FY2024 Forecasts
Exploring the Innovative Promise of Glycoscience FY2024 Forecasts 9
Slide 10: Overview
FY2024 Forecasts Exploring the Innovative Promise of Glycoscience Overview Net sales：Projected year-on-year increase from higher royalty income Operating Income：Projected increase due to the revenue growth and lower R&D expenses Ordinary Income：Projected increase due to the revenue growth Net Income
Slide 11: Domestic Pharmaceuticals
FY2024 Forecasts Exploring the Innovative Promise of Glycoscience Domestic Pharmaceuticals FY2024 Forecast Sales projected to remain at the prior-year level Sales trend due to NHI price reductions, despite higher - 0.8% (Millions of Yen) （Sales） volumes of ARTZ and other products Joint-function impr
Slide 12: Overseas Pharmaceuticals
FY2024 Forecasts Exploring the Innovative Promise of Glycoscience Overseas Pharmaceuticals FY2024 Forecast Projected decrease due mainly to bringing forward Sales tend - 10.0% of shipments of ARTZ for China to FY2023 (Millions of Yen) （Sales） ＜Breakdown＞ ＊Foreign exchange impact: approx. -5million G
Slide 13: Bulk Products / CDMO, Royalty, LAL Business
FY2024 Forecasts Exploring the Innovative Promise of Glycoscience Bulk Products / CDMO, Royalty, LAL Business Bulk Products / CDMO LAL Business FY2024 Forecast：- 6.9% (Year-on-Year) FY2024 Forecast：+ 12.3% (Year-on-Year) ＊Foreign exchange impact: approx. +135million Overseas ＊Foreign exchange impact
Slide 14: Research and Development
Exploring the Innovative Promise of Glycoscience Research and Development 14
Slide 15: Pipeline List
Research and Development 糖質科学で未来を創る Pipeline List Appli- Market Development code/ PI PIPII PII PIII PIII approval Indication (Product name) cation SI-6603 Lumbar Disk Herniation SI-6603 （Condoliase） US SI-614 SI-614 Dry eye US （Modified Hyaluronate） SI-613 SI-613 Target Market US：Knee Osteoarthritis
Slide 16: SI-6603 (Treatment for Lumbar Disc Herniation)
Research and Development 糖質科学で未来を創る SI-6603 (Treatment for Lumbar Disc Herniation) Biologics License Application for SI-6603 accepted by the U.S. Food and Drug Administration (FDA) Proceed with a response to regulatory review in order to obtain approval Development status Administration image ▶ Phas
Slide 17: SI-614 (Dry Eye)
Research and Development 糖質科学で未来を創る SI-614 (Dry Eye) Received the results from a Phase III study in the U.S. Currently considering the future development policy Development status Administration image ▶ Phase III study in the U.S. • Statistically significant improvement in the primary endpoint was n
Slide 18: SI-722 (Interstitial cystitis and bladder pain syndrome)
Research and Development 糖質科学で未来を創る SI-722 (Interstitial cystitis and bladder pain syndrome) Subject enrollment for Phase I/II studies in the U.S. completed Currently considering the future development policy Administration image Development status ▶ Phase I/II studies in the U.S. ・Subject enrollmen
Slide 19: SI-449 (Adhesion Barrier / Medical Device)
Research and Development 糖質科学で未来を創る SI-449 (Adhesion Barrier / Medical Device) Received the results from pivotal and pilot studies in Japan Proceed with preparations for an application for approval Administration image Development status ▶ Japan pivotal study (field of gastroenterological surgery) P
Slide 20: Other Topics
Exploring the Innovative Promise of Glycoscience Other Topics 20
Slide 21: Progress Against the Mid-Term Management Plan in Fiscal 2023
Other Topics Exploring the Innovative Promise of Glycoscience Progress Against the Mid-Term Management Plan in Fiscal 2023 Ⅰ Maximize the product value of SI-6603 (treatment for lumbar disc herniation) Topline results indicating statistically significant improvement in the primary endpoint obtained
Slide 22: New Initiatives for Construction of a Global Production System
Other Topics Exploring the Innovative Promise of Glycoscience New Initiatives for Construction of a Global Production System Acceleration of Initiatives for Establishment of a Production System in North America Strengthening of investment for construction of a production system for products in devel
Slide 23: Basic Policy on Profit Distribution
Other Topics Exploring the Innovative Promise of Glycoscience Basic Policy on Profit Distribution Make investments for sustained profit growth and corporate value enhancement and pay stable dividends Shareholder returns Consider dividend increases with ¥26 per share as a guideline, taking into accou
Slide 24: Cautionary Notes
■Cautionary Notes This material contains forward-looking statements regarding future management strategies or performance forecasts. These descriptions are based on judgments derived from information that is currently available to Seikagaku and are subject to risk and uncertainty. Actual results and