SASB Index

SASB Area

Key KPI

2025 Actual

Affordability and Pricing (HC-MS-240)

Method of pricing disclosure (qualitative) + weighted-average price change rate

Qualitative disclosure completed / quantitative change rate not disclosed due to competitive sensitivity

Product Safety (HC-MS-250)

FDA recalls · MedWatch · MAUDE deaths · GMP enforcement actions

0 cases (3 consecutive years)

Ethical Marketing (HC-MS-270)

Legal losses from false marketing + off-label promotion ethics code

0 cases / USD 0 + Internal Ethics Code Section 3.2 in operation

Product Design and Lifecycle (HC-MS-410)

Assessment and management of chemicals in products + recovered / recycled weight

REACH SVHC · RoHS · ISO 10993 applied / infrastructure to be built in 2026–2027

Supply Chain Management (HC-MS-430)

Tier 1 facility participation in third-party audits 100% + traceability + key raw-material risk

Own facilities 100% / Tier 1 to be disclosed after 2026 SOP + EU MDR UDI + 5 risk-management items

Business Ethics (HC-MS-510)

Legal losses from corruption + ethics code for interactions with healthcare professionals

0 cases / USD 0 + integrated compliance with AdvaMed, MedTech Europe, and KMDIA

Topic

Disclosure Topic Name

Number of Metrics

HC-MS-240

Affordability & Pricing

2

HC-MS-250

Product Safety

4

HC-MS-270

Ethical Marketing

2

HC-MS-410

Product Design & Lifecycle Management

2

HC-MS-430

Supply Chain Management

3

HC-MS-510

Business Ethics

2

HC-MS-000

Activity Metrics

1

Code

Accounting Metric

2025 i-SENS

HC-MS-240a.2

Description of methods of communicating the price information of each product to customers or their agents

B2B OEM/ODM transactions are communicated directly to global medical device brand customers through individual supply agreements and quotations. Own-brand (CareSens, etc.) transactions are communicated to regional distributors through recommended retail prices (MSRP) and wholesale price lists. Insurance-listed items follow local insurance authority disclosure procedures. Pricing information for healthcare professionals is disclosed through academic society / exhibition catalogues and the official website.

HC-MS-240a.3

Weighted-average change rate of (1) list prices and (2) net prices of the product portfolio compared to the previous reporting period (%)

The weighted-average list-price and net-price change rates for the entire product portfolio are not disclosed due to competitive sensitivity. (1) BGM strip list prices are differentiated by OEM customer and country-level insurance reimbursement system, such that a single weighted average does not provide meaningful information. (2) CGM (Continuous Glucose Monitoring) sensors are in the stage of global pricing-policy integration after 2024, and a comparable baseline has not yet been finalized.

Code

Accounting Metric

2025 i-SENS

HC-MS-250a.1

Number of recalls and total units recovered (broken down by FDA Recall Class I · II · III)

0 cases for 3 consecutive years (2023, 2024, 2025). EU FSCA and MFDS recall events: 0.

HC-MS-250a.2

List of products listed in the FDA MedWatch Safety Alerts (qualitative disclosure)

0 cases (2023, 2024, 2025). Monitoring of the FDA MedWatch Safety Alerts database confirms no listing across the Company's BGM, CGM, and POCT lines.

HC-MS-250a.3

Number of deaths reported in connection with the products in the FDA MAUDE database

0 cases (2023, 2024, 2025). Monitoring of FDA MAUDE confirms no death reports associated with the Company's products.

HC-MS-250a.4

Number of enforcement actions taken in response to violations of Good Manufacturing Practice (GMP) for pharmaceuticals and medical devices or equivalent standards (by type)

FDA Warning Letters: 0; Consent Decrees: 0; Seizure and Injunction: 0. EU MDR Notified Body certification suspensions or cancellations: 0; Korean MFDS administrative actions: 0; Japan PMDA and China NMPA enforcement actions: 0 (2023, 2024, 2025). For reference, no FDA Form 483 was issued, but Form 483 is classified as an inspection observation under the SASB Implementation Guide and is outside the formal enforcement action classification.

Code

Accounting Metric

2025 i-SENS

HC-MS-270a.1

Total amount of monetary losses as a result of legal proceedings associated with false marketing claims

0 cases / USD 0 (2023·2024·2025)

HC-MS-270a.2

2025 i-Sens: In accordance with Article 3.2 ("Prohibition of Recommending Non-Approved Indications") of the internal Sales & Marketing Code of Conduct (revised in 2024), marketing activities for all BGM, CGM, and POCT product lines are strictly permitted only within the scope of indications approved by the MFDS, FDA, and EU MDR.All sales, marketing, and Medical Science Liaison (MSL) executives and employees are required to complete an annual mandatory training session on the prohibition of off-label promotion. Any violations are subject to referral to the HR Disciplinary Committee. During the reporting period, there were zero (0) detected cases of off-label marketing. For further details on compliance with global ethical codes, please refer to Section 10.2.

Integrated compliance with the AdvaMed Code of Ethics (2022 revision), EucoMed Code, and the Korea Medical Devices Industry Association (KMDIA) Code of Ethics.

Code

Accounting Metric

2025 i-SENS

HC-MS-410a.1

Qualitative disclosure of product End-of-Life (EOL) management — recovery, recycling, disposal strategy

Compliance with the EU Waste Electrical and Electronic Equipment (WEEE) Directive. Operation of a CGM sensor and battery recovery program. Response to EU PPWR (Packaging Regulation). See "EU PPWR Response" (03-3).

HC-MS-410a.2

(1) Devices and equipment, (2) Consumables weight (tonnes) quantitative disclosure

Partial disclosure — no weight-based tracking system in place during the reporting period. In connection with the CGM line expansion at the Songdo No. 2 Plant (Q1 2027), infrastructure for collecting weights by category for BGM strips, CGM sensors (consumables), and POCT devices is planned for build-out in 2026–2027.

Code

Accounting Metric

2025 i-SENS

HC-MS-430a.1

Percentage (%) of (1) own manufacturing facilities and (2) Tier 1 supplier manufacturing facilities that participate in third-party audit programs related to manufacturing and product quality

(1) Own facilities: 100% — Songdo Plant 1 and Songdo Plant 2 all lines hold ISO 13485:2016, MDSAP (Medical Device Single Audit Program, simultaneous certification in the U.S., Canada, Australia, Brazil, and Japan), EU MDR Annex IX QMS certification, and KGMP (Korean Medical Device GMP) certification. (2) Tier 1: Partially measured — ISO 13485 holding ratio of suppliers of key raw materials (enzymes, electrodes, reagents, housings) is being tracked; integrated dataset for third-party audit participation will begin disclosure from the following year after SOP (Standard Operating Procedure) refinement in 2026. For single-source dependency and BCP (Business Continuity Plan), see Section 10.4.

HC-MS-430a.2

Description of activities to maintain traceability throughout the distribution chain

Application of EU MDR UDI (Unique Device Identification, Regulation 2017/745) + FDA UDI + ISO 13485 7.5.8 Identification and Traceability + ISO 15197 BGM accuracy standard. Lot-level tracking of 2.4 billion BGM strips and integrated serial-number management of CGM sensors.

HC-MS-430a.3

Description of risk management related to the use of key raw materials

Management of risks for 5 key raw materials: (1) CGM enzyme (GDH-FAD) single-source risk — R&D in progress for dual sourcing; (2) Electrode precious-metal thin film price volatility — hedging and long-term contracts in operation; (3) BGM strip reagent stability — SOP for inventory turnover strengthened; (4) Conflict minerals (3TG: Tin, Tantalum, Tungsten, Gold) policy — compliance with OECD Due Diligence Guidance and annual Conflict Minerals Report; (5) Dual sourcing of Chinese Zhangjiagang raw materials — alternative source secured.

Code

Accounting Metric

2025 i-SENS

HC-MS-510a.1

Total monetary losses from legal proceedings related to bribery or corruption

0 cases / USD 0 (2023, 2024, 2025). No monetary losses from criminal, civil, or administrative proceedings related to the U.S. Foreign Corrupt Practices Act (FCPA), UK Bribery Act 2010, the Korean Improper Solicitation and Graft Act, or the Act on the Prevention of Corruption and the Establishment and Operation of the Anti-Corruption and Civil Rights Commission.

HC-MS-510a.2

Description of the ethics code governing interactions with healthcare professionals

The "Ethics Code on Interactions with Healthcare Professionals (HCPs)" (revised 2024) applies — integrated compliance with (1) AdvaMed Code of Ethics on Interactions with U.S. Health Care Professionals (revised 2022), (2) MedTech Europe Code of Ethical Business Practice, and (3) Korea Medical Devices Industry Association (KMDIA) Code of Ethics on Medical Device Transactions. All entertainment of healthcare professionals, gifts, lecture fees, advisory fees, and educational support items are subject to a pre-compliance approval system, annual limit monitoring, and mandatory annual training for sales and marketing employees. Clinical trials are subject to 100% prior approval by the Institutional Review Board (IRB). All transactions subject to U.S. Sunshine Act (Open Payments) reporting obligations are fully reported.

Code

Activity Metric

2025 i-SENS

HC-MS-000.A

Sales units by product category

2025 sales units: BGM strips approximately 2.4 billion units (lot-level tracking), BGM meters [not calculated], CGM sensors [not calculated], POCT devices and cartridges [not calculated]. For revenue-based category shares, see the 2025 Business Report — Revenue by Segment. Consolidated revenue: KRW 315.4 billion (2025).