Ascentage Pharma (6855) H2 2024 earnings summary

Executive summary

• 2024 marked a transformational year with global expansion, strengthened financial position, and late-stage clinical progress for olverembatinib and lisaftoclax, both advancing to commercial or NDA review stages targeting multiple hematological malignancies.

• Eleven global registrational trials are ongoing, with two FDA-cleared and multiple indications targeted.

• Strategic partnership with Takeda for olverembatinib ex-China rights brought $100 million upfront, $75 million equity at a 25% premium, up to $1.2 billion in milestones, and 12%-19% royalties, validating global potential.

• Nasdaq IPO in January 2025 raised $132.5 million, further strengthening the balance sheet and supporting global expansion.

• NDA for lisaftoclax accepted with Priority Review in China; commercialization planned for 2025.

Financial highlights

• Total revenue reached $134 million (RMB980.7 million) in 2024, up 342% year-over-year, driven by Takeda's option payment and robust olverembatinib sales.

• Olverembatinib sales in China grew 52% year-over-year to $33 million (RMB241 million), supported by expanded NRDL coverage and hospital access.

• Net loss narrowed significantly to $56 million (RMB405.7 million), reflecting improved operating leverage and expense control.

• R&D expenses totaled $130 million (RMB947.2 million), with spending increases kept under control.

• Year-end cash and equivalents exceeded $170 million ($172.8 million/RMB1,261.2 million), bolstered by $132.5 million IPO proceeds.

Outlook and guidance

• Sufficient liquidity and future payments expected to support operations and capital expenditures through 2027.

• Olverembatinib sales in China expected to grow in 2025, supported by expanded NRDL coverage and increased patient access.

• Near-term milestones include continued enrollment in three phase III registration trials for olverembatinib and multiple global trials for lisaftoclax and APG-2449.

• Plans to launch lisaftoclax in China for R/R CLL in 2025 and seek FDA clearance for first-line MDS trial in the U.S.

• Strategic focus on expanding global footprint and maximizing pipeline value through partnerships.