[Audio] Good morning everyone. Today I will be presenting the AF1 2024 Review Template for South Korea. I'm looking forward to discussing our progress in our plan to maximize market penetration of our Her2-Low mBC product by increasing public awareness and ensuring broad access across different indications with the goal of generating total revenue of $104 meters in the next two years. Let's get started..
[Audio] I would like to provide a brief overview of our ambitions for A-F-1 in South Korea for 2024 and 2025. Our primary focus is to accelerate the time frame to peak with the aim of achieving 80% market share within six months of Her2 plus mBC 2 liters plus reimbursement. To accomplish this we are taking a double-hit model approach with a dedicated sales team from A-Z-K and D-S-K-R and a single-hit model approach for LC. Additionally we plan to enhance Her2-Low prevalence rate create pathology training programs in collaboration with academic societies increase public awareness of Her2-Low and tumour-agnostic labels and guarantee broad access across various indications. In terms of market penetration we forecast CY46837 vials in 2024 and FY61443 vials in 2025..
[Audio] This slide gives an overall view of the AF1 2024 review template for South Korea. It reveals the milestones timeline and products that are under review. The products being evaluated are divided into four categories – disease line of therapy biomarker and tumor type. In total six products are being reviewed including those for 1st line 2nd line and 3rd and 4th lines of therapy for example DB-01 (Her2 plus Breast Cancer 3L) DG-01 (Her2 plus Gastric Cancer 3L) DB-03 (Her2 plus Breast Cancer 2L) DB-04 and DL-02 (Her2-Low Breast Cancer Her2m-NSCLC) and DPT-02 (Her2 plus Solid Tumors). The timeline for each review is detailed with the first review scheduled for April the second for July the third for May and the fourth for October..
[Audio] Our AF1 2024 review template for South Korea includes three main components gross and net price per vial Her2 plus metastatic breast cancer and indication therapy. Gross price per vial is stable until March 2024 and drops to 1069. Net price per vial follows the same pattern and decreases from 1067 in March 2024 to 612 in April 2024. Her2 plus metastatic breast cancer is at its highest with 12.71 share in 1Q26 and time to peak is 6 months for BC 2L BC 3 liters plus and 9 months for GC 3 liters. Respective D-O-T (month) is 22.1 12.0 and 5.0. Approval timeline of W1 P&R W2 RA DPT-02 RA and DB-06 RA are projected for April’24 May'24 March'25 and October'25..
AFI Total Alliance (2023) (in millions USD) Net Sales Costs of Sales Product Gross Margin PGM% Sales costs Sales Activity Sales Manpower Marketing Costs Marketing ActiviO' Marketing Manpower Medical Costs Medical Activity Medical Manpower Supply Chain costs Supply Chain Activity Supply Chain Manpower Total SMM costs Contribution Margin % of Net Sales Calendar Year 2024 Fiscal Year 2024 AFI 29.7 (4.6) 25.1 0.8 (2.5) (0.6) (1.9) (2.3) (1.7) (0.5) (1.3) (0.5) (0.8) (0.3) (0.1) (0.1) (6.4) 18.7 63% AF2 21.8 (3.7) 18.2 0.8 (2.5) (0.5) (2.0) (1.8) (1.2) (0.6) (1.4) (0.7) (0.7) (0.3) (0.2) (0.1) (6.0) 12.2 56% Variance 7.9 (0.9) 7.0 (0.1) (0.1) 0.0 (0.5) (0.5) 0.0 0.1 0.2 (0.0) 0.0 0.0 (0.0) (0.4) 6.6 AFI 37.3 (6.0) 31.3 0.8 (2.5) (0.4) (2.1) (2.3) (1.7) (0.6) (1.3) (0.5) (0.9) (0.4) (0.2) (0.2) (6.4) 24.9 67% Variance AF2 25.6 (5.0) 20.7 (2.5) (0.5) (2.0) (1.8) (1.2) (0.6) (1.5) (0.7) (0.8) (0.4) (0.2) (0.2) (6.1) 14.5 57% 11.7 (1.0) 10.7 (0.0) 0.1 (0.1) (0.5) (0.5) 0.2 0.3 (0.0) (0.0) (0.0) 0.0 (0.3) 10.4.
Regional P&L 2025. 6. REGIONAL VIEW. AFI Total Alliance (in millions USD) Net Sales Costs of Sales Product Gross Margin PGM% Sales & Market Access cost Sales Activity Sales Manpower Marketing Costs Marketing Activity Marketing Manpower Medical Costs Medical Activity Medical Manpower Supply Chain costs Marketing Activity Marketing Manpower Total SMM costs Contribution Margin % of Net Sales Calendar Year 2025 Fiscal Year 2025 AFI 56.4 (9.0) 47.4 0.8 (2.5) (0.4) (2.2) (2.3) (1.7) (0.6) (2.1) (1.0) (1.1) (0.4) (0.3) (0.2) (7.4) 40.0 71% Variance AF2 39.0 (8.1) 30.9 0.8 (2.2) (0.2) (2.0) (2.1) (1.5) (0.6) (1.8) (0.7) (1.1) (0.4) (0.2) (0.2) (6.5) 62% 17.4 (0.9) 16.5 (0.3) (0.2) (0.1) (0.2) (0.2) (0.4) (0.3) (0.1) 0.0 (0.0) 0.0 (0.8) 15.6 AFI 62.6 (10.0) 52.6 0.8 (2.5) (0.4) (2.2) (2.2) (1.7) (0.6) (2.2) (1.1) (1.2) (0.3) (0.2) (0.2) (7.3) 45.2 72% AF2 42.3 (9.0) 33.3 0.8 (2.5) (0.5) (2.0) (2.2) (1.6) (0.6) (1.9) (0.8) (1.1) (0.5) (0.3) (0.2) (7.1) 26.2 62% Variance 20.3 (1.1) 19.3 0.0 0.1 (0.1) (0.0) (0.0) (0.4) (0.3) (0.1) 0.1 0.1 0.0 (0.2) 19.1.
P&L Evolution. 7. REGIONAL VIEW. [image] AFI Total (in USD) Net Sa P Gros Ma rgin n•wketing n•wketing Me din/ ctivv±y Me din/ Q' pply Chain Total SMM C n Ma rgin 0.1) (1.0 0.1) 0.3) (1.0 (2.4 0.9) (1.3) 0.4) 0.9) (1.6) (112) 0.4) 0.7) 0.1) 0.6) 0.2) (3.7) (46) (25) (1.9) (23) (1.7) (1.3) (64) 2125 (9.0 47.4 (2.9 (2.2, (2.3) (1.7, (1.1) (7.4 2123 0.8) 0.2) 0.3) (1.2) (1.0) 0.1) 0.0) 0.2) (1.3) (3.7) (1.3) (1.1) 0.7) 0.6) 0.1) 0.5) 0.2) 0.1) (2.7) ans (1.0 21.3.
Quarterly Sales View by Tumor vs AF2’23. 8. Commentary.
FTE Evolution. 9. REGIONAL VIEW. Commentary. FTE Field Sales 3 MR joined from Jan’24 in AZK (36 FTE) 3 MR joined from Apr’24 in DSKR (36 FTE) 1.1 FTE increased from Apr’24 for LC launch readiness (AZK) FTE Sales Management AZK sales manager joined from Jan’24 DSKR sales manager joined from Apr’24 Invest +2 BM for new indication (DSKR 1 (Jan’24) / AZK 1(Apr’24)).
[Audio] In the 2024 fiscal year South Korea experienced an increase in medical costs of 0 point 3 million dollars related to preventive maintenance services as well as analytics and monitoring activities. This is in line with our objectives of delivering high-quality care while controlling operational costs..
[Audio] Our strategy for the year 2024 appears to have potential for a large upside in terms of increased revenue when looking at the table. We estimate our non-reimbursable market for DB-04 will raise by ten percent with an approximate increase of two thousand five hundred and eighty-five vials and one point four million in profit. We must measure our progress and consider the factors that will affect our success throughout the year. Thank you for your time and attention..