Ascentage Pharma Reports Full Year 2024 Unaudited Financial Results and Business Updates
-- Revenue in 2024 increased 342% year-over-year to US$134.3 million
(RMB980.7 million), attributable in part to Takeda's option payment and
strong sales growth of olverembatinib
-- Sales of olverembatinib in China in 2024 increased 52% year-over-year to
US$33.0 million
-- Completion of U.S. initial public offering on Nasdaq in January 2025,
resulting in US$132.5 million in net proceeds
-- Lisaftoclax accepted for New Drug Application (NDA) review with Priority
Review designation in China
-- Ten registrational trials in progress, including two cleared by FDA
-- English conference call and webcast at 8:00 am EDT / 8:00 pm HKT on March
27, 2025 and Chinese (Mandarin) investor event with simultaneous
conference call and webcast at 9:30 am HKT on March 28, 2025 / 9:30 pm
EDT on March 27, 2025
ROCKVILLE, Md. and SUZHOU, China, March 27, 2025 (GLOBE NEWSWIRE) -- 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 all stakeholders."
Key Business and Pipeline Updates
Olverembatinib (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.
Commercial progress
-- Revenue from sales of olverembatinib in China was US$33.0 million for the
year ended December 31, 2024, compared to US$21.9 million for the year
ended December 31, 2023, which represented an increase of US$11.1 million,
or 52%. As of December 31, 2024, the number of direct-to-pharmacy $(DTP)$
pharmacies and hospitals where olverembatinib is on formulary reached
734. In particular, the number of hospitals where olverembatinib is on
formulary increased 86% compared to December 31, 2023.
-- In November 2024, a new indication -- adult patients with CML-CP
resistant and/or intolerant of first-and second-generation TKIs -- for
olverembatinib was included in China's NRDL through the simplified
contract renewal procedure. Concurrently, the contracts for indications
of olverembatinib which has been included China's NRDL since 2022 were
renewed successfully. The current indications of olverembatnib eligible
for reimbursement includes adult patients with CML-CP or CML-AP with
T315I mutation, and adult patients with CML-CP that are resistant and/or
intolerant of first-and second-generation TKIs.
Clinical progress
-- After receiving clearance from the CDE of China's NMPA in May 2024, we
commenced enrollment in a registrational Phase III clinical trial of
olverembatinib for the treatment of patients with succinate dehydrogenase
(SDH)-deficient gastrointestinal stromal tumor (GIST) who have failed
prior systemic treatment (POLARIS-3).
-- After receiving clearance from the FDA in February 2024, we commenced
enrollment in a registrational Phase III clinical trial of olverembatinib
for previously treated CML-CP patients, both with and without T315I
mutation (POLARIS-2).
-- We continue enrollment in a registrational Phase III clinical trial of
olverembatinib in combination with chemotherapy versus imatinib in
combination with chemotherapy in patients with newly diagnosed
Philadelphia chromosome-positive ALL (Ph+ ALL) (POLARIS-1).
-- We obtained Breakthrough Therapy Designation (BTD) for olverembatinib in
March 2025 from the CDE of China's NMPA for combination with
low-intensity chemotherapy for the first-line treatment of
newly-diagnosed patients with Ph+ ALL.
Anticipated progress
-- We plan to seek clearance from the FDA to initiate a registrational Phase
III clinical trial in newly diagnosed Ph+ ALL patients.
Lisaftoclax (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.
Regulatory progress
-- NDA for lisaftoclax monotherapy for the treatment of R/R CLL or small SLL
was accepted with Priority Review designation by the CDE of China's NMPA
in November 2024.
Clinical progress
-- After lisaftoclax received initial clearance by the CDE of China's NMPA
in May 2024, we commenced enrollment of patients in a global, multicenter,
registrational Phase III clinical trial of lisaftoclax in combination
with azacitidine for the treatment of patients who are newly diagnosed
with higher risk $(HR)$ myelodysplastic syndrome (MDS) (GLORA-4).
-- We continue enrollment in a global registrational Phase III clinical
trial of lisaftoclax for the treatment of newly diagnosed old or unfit
patients with acute myeloid leukemia $(AML.UK)$ (GLORA-3).
-- We continue enrollment in a global registrational Phase III clinical
trial to evaluate lisaftoclax in combination with the BTK inhibitor
acalabrutinib, versus immunochemotherapy in treatment-naïve patients
with CLL/SLL (GLORA-2) to validate a fixed duration of combination
regimen as a first-line treatment.
-- We continue enrollment in a global registrational Phase III clinical
trial of lisaftoclax in combination with BTK inhibitors in patients with
CLL/SLL previously treated with BTK inhibitors (GLORA).
-- We continue Phase 1b/2 clinical trials of lisaftoclax in combination
therapies for the treatment of patients with multiple myeloma (MM) in
China and the United States.
Anticipated progress
-- We plan to seek clearance from the FDA to initiate a registrational Phase
III clinical trial for the treatment of patients who are newly diagnosed
with HR MDS.
APG-2449 is a novel, orally active, small-molecule FAK, the third generation of ALK and receptor tyrosine kinase ROS1 triple ligase TKI.
Clinical progress
-- APG-2449 was cleared by the CDE of NMPA in October 2024 to initiate two
registrational Phase III clinical trials to evaluate APG-2449 in patients
with NSCLC who are either resistant to or intolerant of second-generation
ALK TKIs or treatment-naïve patients with ALK-positive advanced or
locally advanced NSCLC.
Business Updates
-- We entered into an exclusive option agreement in June 2024 with Takeda
(Exclusive Option Agreement), pursuant to which Ascentage Pharma granted
Takeda an exclusive option to enter into an exclusive license for
olverembatinib. If exercised, the Exclusive Option Agreement would allow
Takeda to license global rights to develop and commercialize
olverembatinib in all territories outside of China, Hong Kong, Macau,
Taiwan and Russia.
-- We received a US$100 million intellectual property income and option
payment from Takeda in July 2024 under the Exclusive Option Agreement.
-- We completed a US$75 million equity investment from Takeda in June 2024.
-- We completed Ascentage Pharma's U.S. initial public offering of American
depositary shares in January 2025, resulting in net proceeds of US$132.5
million, after deducting underwriting discounts and commissions.
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 and other products.
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.
Conference Call
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.
The webcast for both conference calls will continue to be accessible on Ascentage Pharma's website at www.ascentage.com for 30 days.
About Ascentage Pharma
Ascentage Pharma is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in hematological malignancies. Ascentage Pharma has been listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK since October 2019 and has also been listed on the Nasdaq Global Market under the ticker symbol "AAPG" since January 2025.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma's opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma's filings with the SEC, including those set forth in the sections titled "Risk factors" and "Special note regarding forward-looking statements and industry data" in its final prospectus for its U.S. initial public offering, filed with the SEC on January 24, 2025, and other filings with the SEC that the Company made or makes from time to time, and with respect to non-U.S. investors only, the sections headed "Forward-looking Statements" and "Risk Factors" in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with The Stock Exchange of Hong Kong Limited it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company's management.
As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma's current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information
Investor Relations:
Hogan Wan, Head of IR and Strategy
Ascentage Pharma
Hogan.Wan@ascentage.com
+86 512 85557777
Stephanie Carrington
ICR Healthcare
Stephanie.Carrington@icrhealthcare.com
(646) 277-1282
Media Relations:
Sean Leous
ICR Healthcare
Sean.Leous@icrhealthcare.com
(646) 866-4012
Ascentage Pharma
Group
International
Consolidated
statements of
profit or loss
(Amounts in thousands of Renminbi ("RMB") and U.S.
dollar ("US$"), except for number of shares and per
share data)
For the years ended December 31
-----------------------------------------------
2022 2023 2024 2024
---------- --------- ---------- ------------
RMB RMB RMB US$
Unaudited) Unaudited)
REVENUE
Intellectual
property - - 678,415 92,942
Products 174,931 193,535 260,835 35,734
Others 34,780 28,449 41,400 5,672
-------- -------- --------- ---------
Total revenue 209,711 221,984 980,650 134,348
-------- -------- --------- ---------
Cost of sales
Products (18,926) (29,342) (27,031) (3,703)
Others (3,072) (1,201) (2,054) (281)
-------- -------- --------- ---------
Total cost of sales (21,998) (30,543) (29,085) (3,984)
-------- -------- --------- ---------
Gross profit 187,713 191,441 951,565 130,364
Other income and
gains 66,972 59,316 57,359 7,858
Selling and
distribution
expenses (157,421) (195,387) (195,998) (26,852)
Administrative
expenses (170,595) (181,076) (187,125) (25,636)
Research and
development
expenses (743,104) (706,972) (947,245) (129,772)
Other expenses (17,674) (5,203) (9,075) (1,243)
Finance costs (52,785) (96,057) (64,455) (8,830)
Share of
(loss)/profit of a
joint venture (278) 1,076 (281) (38)
-------- -------- --------- ---------
LOSS BEFORE TAX (887,172) (932,862) (395,255) (54,149)
Income tax
credit/(expense) 4,248 7,150 (10,425) (1,428)
-------- -------- --------- ---------
LOSS FOR THE YEAR (882,924) (925,712) (405,680) (55,577)
======== ======== ========= =========
Attributable to:
Ordinary equity
holders of the
Company (882,924) (925,637) (405,433) (55,543)
Non-controlling
interests - (75) (247) (34)
-------- -------- --------- ---------
(882,924) (925,712) (405,680) (55,577)
================= ======== ======== ========= =========
LOSS PER SHARE ATTRIBUTABLE TO ORDINARY EQUITY
HOLDERS OF THE COMPANY
Basic and diluted (3.35) (3.28) (1.34) (0.18)
======== ======== ========= =========
Ascentage Pharma
Group
International
Consolidated
statements of
comprehensive
loss
(Amounts in thousands of Renminbi and U.S. dollar,
except for number of shares and per share data)
For the years ended December 31
-----------------------------------------------
2022 2023 2024 2024
---------- --------- ---------- ------------
RMB RMB RMB US$
Unaudited) Unaudited)
LOSS FOR THE YEAR (882,924) (925,712) (405,680) (55,577)
OTHER
COMPREHENSIVE
INCOME
Other
comprehensive
income that may
be reclassified
to profit or
loss in
subsequent
periods, net of
tax:
Exchange
differences on
translation of
foreign
operations 25,832 20,593 2,829 388
Other
comprehensive
income that will
not be
reclassified to
profit or loss
in subsequent
periods, net of
tax:
Exchange
differences on
translation of
non-foreign
operations 35,665 5,666 4,120 564
-------- -------- --------- --------
OTHER
COMPREHENSIVE
INCOME FOR THE
YEAR, NET OF
TAX 61,497 26,259 6,949 952
-------- -------- --------- --------
TOTAL
COMPREHENSIVE
LOSS FOR THE
YEAR (821,427) (899,453) (398,731) (54,625)
======== ======== ========= ========
Attributable to:
Ordinary equity
holders of the
Company (821,427) (899,378) (398,484) (54,592)
Non-controlling
interests - (75) (247) (34)
-------- -------- --------- --------
(821,427) (899,453) (398,731) (54,625)
================ ======== ======== ========= ========
Ascentage Pharma
Group
International
Consolidated statements of
financial position
(Amounts in thousands of Renminbi and U.S. dollar,
except for number of shares and per share data)
As at December 31
-------------------------------------
2023 2024 2024
------------ ----------- ----------
RMB RMB US$
Unaudited) Unaudited)
NON-CURRENT ASSETS
Property, plant and
equipment 905,815 849,450 116,374
Right-of-use assets 51,252 56,109 7,687
Goodwill 24,694 24,694 3,383
Other intangible
assets 85,446 75,998 10,412
Investment in a
joint venture 16,998 32,717 4,482
Financial assets at
fair value through
profit or loss
("FVTPL") 1,951 1,141 156
Deferred tax assets 59,842 44,236 6,060
Other non-current
assets 10,217 59,303 8,125
---------- ---------- ---------
Total non-current
assets 1,156,215 1,143,648 156,679
---------- ---------- ---------
CURRENT ASSETS
Inventories 16,167 6,597 904
Trade receivables,
net 145,893 83,143 11,390
Prepayments, other
receivables and
other assets 88,285 123,211 16,880
Cash and bank
balances 1,093,833 1,261,211 172,785
---------- ---------- ---------
Total current assets 1,344,178 1,474,162 201,959
---------- ---------- ---------
CURRENT
LIABILITIES
Trade payables 72,445 91,966 12,599
Other payables and
accruals 206,914 258,098 35,360
Contract liabilities 38,410 37,485 5,135
Interest-bearing
bank and other
borrowings 616,404 779,062 106,731
Total current
liabilities 934,173 1,166,611 159,825
---------- ---------- ---------
NET CURRENT ASSETS 410,005 307,551 42,134
========== ========== =========
TOTAL ASSETS LESS
CURRENT
LIABILITIES 1,566,220 1,451,199 198,813
========== ========== =========
NON-CURRENT
LIABILITIES
Contract liabilities 251,189 248,460 34,039
Interest-bearing
bank and other
borrowings 1,179,191 889,435 121,852
Deferred tax
liabilities 10,549 5,368 735
Long-term payables 18,299 - -
Deferred income 36,360 27,500 3,767
Other non-current
liabilities - 6,274 860
---------- ---------- ---------
Total non-current
liabilities 1,495,588 1,177,037 161,253
---------- ---------- ---------
TOTAL LIABILITIES 2,429,761 2,343,648 321,078
========== ========== =========
EQUITY
Equity attributable to ordinary
equity holders of the Company
Ordinary shares (par
value of US$0.0001
per share as of
December 31, 2023
and 2024;
290,196,560 and
315,224,993 shares
authorized, issued
and outstanding as
of December 31,
2023 and 2024,
respectively) 197 214 29
Treasury shares (21,351) (8) (1)
Share premium 5,951,154 6,545,129 896,679
Capital and reserves (371,441) (384,515) (52,678)
Exchange fluctuation
reserve (133,020) (126,071) (17,272)
Accumulated losses (5,365,122) (5,770,555) (790,563)
---------- ---------- ---------
60,417 264,194 36,194
Non-controlling
interests 10,215 9,968 1,366
---------- ---------- ---------
Total equity 70,632 274,162 37,560
========== ========== =========
(END) Dow Jones Newswires
March 27, 2025 07:00 ET (11:00 GMT)
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