Full Press Release Details
ASCENTAGE PHARMA REPORTS FULL YEAR 2024 UNAUDITED
FINANCIAL RESULTS AND BUSINESS UPDATES
ROCKVILLE, MD and SUZHOU, China, March 27, 2025 - Ascentage
Pharma Group International (Ascentage Pharma) (NASDAQ: AAPG; HKEX: 6855) (referred hereinto as "Ascentage Pharma," the "Company,"
"we," "us" or "our"), a global, integrated biopharmaceutical company engaged in discovering, developing
and commercializing therapies to address global unmet medical needs primarily in hematological malignancies, today reported its unaudited
financial results for the year ended December 31, 2024, and provided updates on key clinical and commercial developments.
Dr. Dajun Yang, Chairman and Chief Executive Officer
of Ascentage Pharma, said, "As we reflect on our achievements in 2024, I am delighted to report that Ascentage Pharma has made remarkable
strides in advancing our mission to deliver innovative therapies to patients worldwide. The commercialization of olverembatinib in China
has gained significant traction in 2024 and is poised for growth in 2025 as all approved indications of olverembatinib are now covered
under China's National Reimbursement Drug List (NRDL), markedly enhancing affordability and accessibility for patients across China."
He continued, "Our momentum continued with
the advancement of lisaftoclax. In November 2024, the New Drug Application (NDA) for lisaftoclax for the treatment of relapsed and/or
refractory chronic lymphocytic leukemia (R/R CLL) and small lymphocytic lymphoma (SLL) was accepted by the Center of Drug Evaluation (CDE)
of China's National Medical Products Administration (NMPA) with Priority Review designation. This acceptance marks a pivotal step
toward bringing this novel therapy to patients in need."
"Our clinical development programs also
achieved significant progress over the past year. In February 2024, olverembatinib received clearance by the U.S. Food and Drug Administration
(FDA) to initiate a global registrational Phase III clinical trial (POLARIS-2), for patients with Chronic Myeloid Leukemia in Chronic
Phase (CML-CP) with or without T315I mutation who have previously failed tyrosine kinase inhibitor (TKI) treatment. In 2024, we also received
clearance to commence two registrational Phase III clinical trials for APG-2449, a focal adhesion kinase (FAK), third generation anaplastic
lymphoma kinase (ALK) and receptor tyrosine kinase C-ros oncogene 1 (ROS1) inhibitor, for treatment of patients with non-small cell lung
cancer (NSCLC). At the moment, we are conducting ten global registrational trials, including two that were cleared by the FDA, for our
three late-stage products, olverembatinib, lisaftoclax and APG-2449. These milestones highlight our commitment to addressing unmet medical
needs through rigorous clinical innovation."
"We believe Ascentage Pharma is on a transformative
path to becoming a global leader in oncology innovation. The commercialization of olverembatinib in China, the progress of lisaftoclax,
the continued development of our other clinical-stage small molecule drug assets, and our strategic agreement with Takeda Pharmaceuticals
International AG (Takeda) reflect the strength of our pipeline and our ability to execute on our goals. In 2025, we remain focused on
accelerating the development and delivery of life-changing therapies, expanding our global footprint, and creating sustainable value for
Key Business and Pipeline Updates
(HQP1351), a novel, next-generation TKI and the first third-generation BCR-ABL1 TKI, has been approved
in China for treatment of patients with CML-CP or Chronic Myeloid Leukemia in Accelerated Phase (CML-AP) with T315I mutations and CML-CP
that is resistant and/or intolerant to first and second-generation TKIs.
Anticipated progress
(APG-2575) is a novel, oral Bcl-2 inhibitor developed to treat a variety
of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.
Anticipated progress
APG-2449 is a novel, orally active, small-molecule
FAK, the third generation of ALK and receptor tyrosine kinase ROS1 triple ligase TKI.
Full Year 2024 Unaudited Financial Results
Revenue for the year ended December 31, 2024 was
US$134.3 million, compared to US$30.5 million for the year ended December 31, 2023, which represented an increase of US$103.8 million,
or 342%. The increase in revenue was primarily attributable to an option payment of US$100 million received in June 2024 from Takeda pursuant
to the Exclusive Option Agreement, sales of olverembatinib of US$33.0 million, a 52% year-over-year increase, commercialization rights
income from Innovent Biologics (Suzhou) Co., Ltd. and management fee income.
Selling and distribution expenses for the year
ended December 31, 2024 were US$26.9 million, compared to US$26.8 million for the year ended December 31, 2023, which represented an increase
of US$0.1 million, or 0.3%. The increase was attributable to selling and distribution expenses incurred in the commercialization of olverembatinib
Research and development expenses for the year
ended December 31, 2024 were US$129.8 million, compared to
US$97.3 million for the year ended December 31,
2023, which represented an increase of US$32.5 million, or 34.0%. The increase was attributable to higher clinical research expenses.
Administrative expenses for the year ended December
31, 2024 were US$25.6 million, compared to US$24.9 million for the year ended December 31, 2023, which represented an increase of US$0.7
million, or 3.3%. The increase was due to the increase in the agency fees for the U.S. initial public offering.
Finance costs for the year ended December 31,
2024 were US$8.8 million, compared to US$13.2 million for the year ended December 31, 2023, which represented a decrease of US$4.4 million,
or 32.9%. The decrease was due to the interest rate incurred in relation to bank borrowings.
Other expenses for the year ended December 31,
2024 were US$1.2 million, compared to US$0.7 million for the year ended December 31, 2023, which represented an increase of US$0.5 million,
or 74.4%. The increase was primarily attributable to the increase in donation expenses.
Loss for the year ended December 31, 2024 was
US$55.6 million, compared to US$127.4 million for the year ended December 31, 2023, which represented a decrease of US$71.8 million, or
56.2%. The loss per share attributable to ordinary equity holders was $0.18 per ordinary share for the year ended December 31, 2024, compared
to $0.45 per ordinary share for the year ended December 31, 2023.
Cash and bank balances for the year ended December 31, 2024 were US$172.8
million, compared to US$150.5 million for the year ended December 31, 2023, which represented an increase by US$22.3 million, or 15.3%.
The increase was primarily due to the US$100.0 million intellectual property income and option payment under the Exclusive Option Agreement
and US$75.0 million equity investment from Takeda. Part of the Takeda option payment was treated as intellectual property income.
Following our initial public offering in January
2025, which resulted in net proceeds of $132.5 million, as of March 27, 2025, we believe that these net proceeds, together with our existing
cash and cash equivalents, our loan facilities, future sales and other potential payments, will enable us to fund our operating expenses
and capital expenditure requirements through 2027.
Statement Regarding Unaudited Financial Information
This press release includes unaudited annual financial
information as of and for the year ended December 31, 2024, which has not been audited or reviewed by the Company's auditors. The
unaudited information for the year ended December 31, 2024, is preliminary, based on the information available at this time and subject
to changes in connection with the completion of the audit of the Company's financial statements. As such, the Company's actual
results and financial condition as reflected in the financial statements that will be included in the Company's Annual Report on
Form 20-F for the year ended December 31, 2024, may be adjusted or presented differently from the financial information herein and the
variations could be material. The unaudited consolidated financial statements include the accounts of the Company and its subsidiaries.
All periods presented have been accounted for in conformity with IFRS accounting standard and pursuant to the rules and regulations of
the U.S. Securities and Exchange Commission (the "SEC").
Currency and Exchange Rate Information
Unless otherwise indicated, translations from
RMB to U.S. dollars for 2024 and 2023 are made at RMB7.2993 to US$1.00 and RMB 7.2672 to US$1.00, representing the noon buying rate in
the City of New York, as certified by the Federal Reserve Bank of New York, on December 31, 2024 and June 28, 2024, respectively. Ascentage
Pharma makes no representation that the RMB or U.S. dollar amounts referred to in this press release could have been or could be converted
into U.S. dollars or RMB, as the case may be, at any particular rate or at all.
Ascentage Pharma will be holding a conference call and audio webcast
presentation to discuss its full-year results.
The English conference call and webcast will be held at 8:00 am EDT
/ 8:00 pm HKT on March 27, 2025. To access the English conference call, please register in advance here to
obtain a local or toll-free phone number and your personal identification number. A live webcast of the English conference call will
be available at: Full Year 2024 Financial Results.
Ascentage Pharma will host a Chinese (Mandarin) investor event at 9:30
am HKT on Friday, March 28, 2025 / 9:30 pm EDT on Thursday, March 27, 2025, which will also be available simultaneously via conference
call and webcast. To access the Chinese investor event or conference call, please register in advance here.