AKESO(HK:09926)2023-03-15 23:15Financial Performance - For the year ended December 31, 2022, the product market sales amounted to RMB 1,104.4 million, a significant increase of 422% compared to RMB 211.6 million for the year ended December 31, 2021[2]. - The sales revenue from the product "Kantian® (Cadonilimab)" was RMB 546.3 million, while "Anike® (Piananpuli)" generated RMB 558.1 million, reflecting a 164% increase from RMB 211.6 million in 2021[3]. - The company reported a net loss of RMB 1,422.2 million for the year ended December 31, 2022, compared to a net loss of RMB 1,258.1 million in 2021[48]. - Total revenue for 2022 reached RMB 1,104.4 million, a 422% increase compared to RMB 211.6 million in 2021[51]. - Gross profit for 2022 was RMB 743.5 million, reflecting a 283% increase from RMB 194.4 million in 2021[53]. - Research and development expenses for 2022 amounted to RMB 1,323.1 million, an 18% increase from RMB 1,123.0 million in 2021[55]. - Selling and marketing expenses for 2022 were RMB 552.7 million, a 209% increase compared to RMB 179.1 million in 2021[57]. - Other income and net gains for 2022 totaled RMB 158.6 million, a 36% increase from RMB 116.3 million in 2021[54]. - The company reported a total of RMB 1,108,305 thousand in sales revenue, with distribution costs of RMB 270,649 thousand, leading to a net revenue of RMB 837,656 thousand[102]. - The group reported a loss attributable to ordinary equity holders of the parent company of RMB 1,168,393,000 for the year 2022, compared to a loss of RMB 1,074,933,000 in 2021[112][114]. Research and Development - Research and development expenses for the year ended December 31, 2022, were RMB 1,323.1 million, an 18% increase from RMB 1,123.0 million in 2021, mainly due to more products advancing to late-stage clinical trials[6]. - The company has over 30 innovative projects in development, with 17 in clinical trials, including 6 potential first-in-class or best-in-class bispecific antibodies[13]. - The company is focused on accelerating the global development of AK112 in collaboration with Summit Therapeutics, enhancing its international market presence[11]. - The company is committed to advancing its research in immuno-oncology, focusing on innovative therapies targeting various cancer types[17]. - The company is actively pursuing global clinical trials for its products, aiming for broader market access and regulatory approvals[18]. - The company is developing multiple combination therapies, including Kadinili with lenvatinib for 1L liver cancer and AK104 with chemotherapy for advanced solid tumors[17]. - The company has established clinical research partnerships to enhance the development of its oncology pipeline, particularly with Cadonilimab[21]. - The company is focusing on expanding its product offerings and market presence through strategic approvals and partnerships in the oncology sector[20][26]. Product Launches and Approvals - The company has launched two drugs: Kadinili® (Kadinili) and Anike® (Piananpili) as of the announcement date[17]. - Anike has been approved for 1L squamous non-small cell lung cancer in January 2023 and is under submission in China for ≥3L nasopharyngeal carcinoma[18]. - The approval of Kantoni® fills a gap in immunotherapy for advanced cervical cancer in China, marking a significant milestone in the company's product offerings[7]. - Cadonilimab received NMPA approval for the treatment of recurrent or metastatic cervical cancer, marking it as the first dual immune checkpoint inhibitor approved globally[20]. - Significant clinical advancements for Cadonilimab include multiple Phase II and III studies approved in 2022, targeting various cancers such as NSCLC and HCC[21][22]. - AK112 has completed patient enrollment for its Phase III trial in treating EGFR-TKI resistant advanced non-squamous NSCLC[24]. - AK117 has been approved for clinical trials in combination with AK112 for treating advanced malignancies, indicating a strategic focus on combination therapies[26]. - Anike® was included in the CSCO guidelines for first-line treatment of advanced or metastatic squamous NSCLC, enhancing its market positioning[27]. Financial Position and Cash Flow - As of December 31, 2022, the company had approximately RMB 2.09 billion in cash on hand[39]. - The company completed a placement in Hong Kong on July 15, 2022, raising approximately $73.46 million net[39]. - The net cash flow from operating activities for the year ended December 31, 2022, was RMB (1,240,413) thousand, compared to RMB (1,001,238) thousand in 2021, indicating a decline of approximately 23.9%[90]. - The cash and cash equivalents at the beginning of the year were RMB 2,641,625 thousand, which decreased to RMB 2,092,388 thousand by the end of the year, reflecting a reduction of about 20.8%[90]. - The company reported a total cash and cash equivalents decrease of RMB 644,310 thousand for the year, compared to an increase of RMB 5,732 thousand in 2021[90]. - The company’s total non-current assets increased to RMB 2,437,477 thousand in 2022 from RMB 1,653,533 thousand in 2021, marking a growth of about 47%[87]. - The total current assets decreased slightly to RMB 3,058,471 thousand in 2022 from RMB 3,152,256 thousand in 2021[87]. - The company’s total liabilities increased to RMB 1,586,798 thousand in 2022 from RMB 869,828 thousand in 2021, reflecting a rise of approximately 82%[88]. Corporate Governance and Compliance - The company has maintained compliance with corporate governance codes throughout the reporting period, except for one specific provision[75]. - The company has established an audit committee in compliance with listing rules, enhancing corporate governance[80]. - The company confirmed that all directors adhered to the standard rules regarding the trading of the company's securities during the reporting period[77]. - The company emphasizes compliance with international financial reporting standards in its financial disclosures[121]. - The company adopted revised International Financial Reporting Standards for the financial statements, which may affect future reporting and compliance[94]. Market Presence and Strategic Partnerships - The company aims to expand its market presence through strategic partnerships and collaborations in the oncology sector[123]. - The company received a milestone payment of USD 500 million and up to USD 5 billion in total deal value from Summit Therapeutics for the exclusive rights to develop and commercialize AK112 in multiple regions[11]. - The company was included in the MSCI China All Shares Index on February 28, 2023, enhancing its market visibility[83]. - The company is exploring potential mergers and acquisitions to strengthen its market position and R&D capabilities[122].