ASCENTAGE PHARMA GROUP INTERNATIONAL Q4 FY2025 earnings call

Business Update - 2025 was a breakout year for Ascentage with over 90% revenue growth to $82.1 million, year-end cash balance of $353.2 million with cash runway through 2027. First zero-listed biopharmaceutical company on Nasdaq after Hong Kong listing in 2019. Successfully raised ~$3.226 billion through IPO and follow-on offering. First dual commercial product, established ~300 staff commercial team. Achieved major R&D milestones like SOVA approval as global first single-agent BCR2 inhibitor, Gloral-4 phase III registration trial cleared globally, Polaris 1 phase III registration trial cleared globally with strong data at ASH, over-empatient granted breakthrough designation, FDA and CDE IND clearance for novel BDK degrader APG3288. Build a world-class innovative, highly de-risked, and super late-stage pipeline with seven novel compounds, including Orvambactinib and Lisovacast in global registration trials. - Commercial Scale - Built over 270 commercial team by year end in China, covered 1,500 hospitals and over 800 DDP pharmacies, with dual commercial products driving revenue transition from investment and BD income to 100% commercial stage product revenue. - R&D Highlights - NISTOPO class actively advancing global phase three registration trials. SOVA approval as single agent for CLSL after BDK inhibitor, Glora 2 and 3 received FDA EMA and CDE clearance. Glora 4 is first-line high-risk MDS global phase III registration trial. Oren Bartendip approved with full NRDL coverage, conducting Polaris 2 for CML and Polaris 1 for pH positive ALL with excellent data. Novel BDK degrader APG3288 received FDA and CDE clearance, pushed in US and China for multiple indications.

In 2025, total revenue was over $82.1 million, with 90% growth. Olivarambatinib sales were $62.2 million, representing 81% year-over-year growth, accounting for 81% of total revenue. Lasapta Clax had first five-month sales of $10.1 million. Olivarambatinib's revenue growth was driven by full NRDL listing covering CML with or without mutation, reaching $62.2 million with 81% Y/Y growth, covering more hospitals, DTV Pharmacy, and Tier 1 hospitals. Lasapta Clax, approved in July 2025, had first five-month sales of $10.1 million due to established commercial infrastructure ahead of approval.

Clinical Development - 2026 major focus on advanced enrollment for GLORA and GLORA4 registration trials, and Polaris 1 trial. Aim to achieve complete enrollment and file NDA in 2027. Push greater APG32-ATA global phase one study for safety, tolerability, PK, and potential efficacy data. Advance ED inhibitor APG591A in oncology and anemia. - Commercial - Continue to drive sales growth for Orambartinib and server class to tier one hospitals and more pharmacies. Strive for server class to achieve NRDL coverage in China in 2026.

Q: Brian Cheng from JP Morgan asked about enrollment in registrational studies like GLORA4 in MDS with lisaptoclax and Polaris 1 study in pH-positive ALL, and next data milestones.

A: Dr. Yang said Glora IV MDS Phase III registration trial protocol cleared by multiple regulatory agencies, first-line treatment for naive newly diagnosed high-risk MDS, only phase three regression trial globally with good enrollment support. Polaris-1 is first-line pH-positive ALL with part one data at ASH showing 64% MRD-negative CR rate, almost double.

Q: Brian Cheng also asked about commercial growth opportunities for Orambartinib and SantaClex franchise in China.

A: Head of commercial Jichao said key drivers include NRDL coverage benefiting patient affordability, expanding hospital and D2C pharmacy access, scaling commercial organization with team growing to over 270 people covering over 1,500 hospitals, and sata class approved in China with sales in first five months.

Q: Brian Cheng asked about BTK degrader differentiation and phase one study.

A: Dr. Yang said preclinical data shows better selectivity and potency compared to others, BTK degrader has broad oncology advocacy, potential for single agent indications and combinations, and non-oncology indications like autoimmune diseases.

Q: Byron Amin from Piper Sunder asked about olirambatinib's market share in China versus eskiminib and panatinib, and growth rate in 2026.

A: Dr. Yang said 2025 was first year for NRDL coverage, patient population tripled, NRDR coverage benefits patients, Asinamibs and Ponatinib not under NRDR coverage, 2026 sees continued expansion and growth of revenue for olirambatinib in China.

Q: Byron Amin also asked about olivarumbatinib's fit in US CML treatment landscape and global pivotal trial data in 2027.

A: Dr. Yang said CML market globally is big, Merck's acquisition of Terns is good stimulation, Takeda will be partner for Orinbactinib, GLORA4, Polaris 2 and 1 trials have chance to file NDA in 2027.

Q: Gregory Renza from Tourist Securities asked about Oberlin Badanib's profile and progress in second line, earlier lines in CML.

A: Dr. Yang said O1-Bactinib has unique advantage based on clinical data, different from other drugs in terms of patient population, dose, and efficacy in certain mutations, progress in second line and earlier lines ongoing.

Q: Jeet Mukherjee from BTIG asked about China opportunity target hospitals and BTK degrader non-oncology plans.

A: Dr. Yang said aim to cover at least 80% of cells potential in China with around 2,000 hospitals, already covered 1,500, BTK degrader has potential in oncology and non-oncology including autoimmune diseases and CNS diseases.

Q: Matthew Beigler from OTCO asked about CLL market direction and BTK-degrader and lisaptoclax combination.

A: Dr. Yang said BDK inhibitor and BCR2 inhibitor combination offer fixed duration and long-term benefit, BTK degrader combined with server class offers fixed duration and clinical cure potential, and combination with BCR2 inhibitor offers benefit for hard-to-treat diseases.

Q: Christopher Leao from Lucid Capital Markets asked about Takeda's go-no-go decision and Lasataclax partnership.

A: Dr. Yang said current agreement is exclusive global partnership, open to partnerships for Lasataclax to benefit commercialization.

Q: Michael King from Rodman and Renshaw asked about market dynamics of allosteric inhibitors in CML space.

A: Dr. Yang said current data shows Asinimax doing well but other allosteric inhibitors have limitations in terms of mutation coverage and trial progress, our focus is on being best in second line for CML.