HANSOH PHARMA(03692)2023-04-27 08:17Innovative Drug Development and Approvals - Hansoh Pharmaceutical's innovative drug sales revenue reached approximately RMB 5.006 billion, a year-on-year increase of 19.1%, accounting for 53.4% of the company's total revenue, up from 42.3% in the same period last year[4] - The company has successfully transformed into an innovative biopharmaceutical company, with five Class 1 innovative drugs and one imported innovative drug approved for marketing in China, all included in the National Medical Insurance Directory[4] - In 2022, the company obtained 19 clinical approvals, all related to innovative drugs, and submitted six marketing applications, including one for an innovative drug[4] - The company's Class 1 innovative drug, Ameile (Aumolertinib), was approved for first-line treatment of EGFR-mutated non-small cell lung cancer in December 2021[6] - In 2022, the company received clinical trial approvals for three new Class 1 drugs targeting chronic myeloid leukemia, advanced solid tumors, and schizophrenia[6] - The company's innovative drug Hengmu (Tenofovir Alafenamide Fumarate Tablets) was included in the 2021 National Medical Insurance Directory[6] - The company's innovative drug "Xinyue" (Inebilizumab Injection) received drug registration approval from the National Medical Products Administration in March 2022[7] - The company presented Phase I trial data for its self-developed PI3Kα inhibitor HS-10352 at the 2022 AACR Annual Meeting, showing promising anti-tumor activity in HR+HER2- advanced breast cancer patients with PIK3CA mutations[7] - The company obtained clinical trial approvals for two self-developed Class 1 new drugs: HS-10386 for advanced solid tumors and HS-10384 for menopausal vasomotor syndrome in April 2022[7] - The company's partner EQRx submitted the first MAA for Aumolertinib (a third-generation EGFR-TKI) outside China to the MHRA in June 2022[7] - The company received drug registration approval for Palbociclib Capsules, an anti-tumor drug for HR+HER2- advanced breast cancer, in July 2022[7] - The company's self-developed Class 1 new drug HS-10390 tablets received clinical trial approval from the National Medical Products Administration in January 2023, intended for the treatment of focal segmental glomerulosclerosis and IgA nephropathy[100] - The company's Class 1 new drug HS-10517 tablets, a 3CL protease inhibitor for COVID-19, also received clinical trial approval in January 2023, targeting mild to moderate adult COVID-19 patients[100] - Four innovative drugs (including new indications) were included in the 2022 edition of the National Reimbursement Drug List in January 2023: Ameile®, Xinyue®, Haosen Xinfu®, and Fulaimi®[100] - Ameile® was newly included in the National Reimbursement Drug List for the first-line treatment of NSCLC patients with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations[100] - Xinyue® was newly included in the National Reimbursement Drug List for the treatment of AQP4 antibody-positive NMOSD in adults[100] Financial Performance - Revenue for 2022 was approximately RMB 9.382 billion, a decrease of 5.6% year-over-year[19][21] - Net profit for 2022 was approximately RMB 2.584 billion, a decrease of 4.8% year-over-year[19][21] - Net profit margin remained stable at 27.5%, maintaining a high level in the industry[19] - Sales revenue from innovative drugs reached approximately RMB 5.006 billion, accounting for 53.4% of total revenue, up from 42.3% in the previous year[19][21] - Revenue for 2022 was RMB 9,382,410 thousand, a decrease of 5.6% compared to RMB 9,935,141 thousand in 2021[143] - Gross profit for 2022 was RMB 8,515,400 thousand, a decrease of 6.1% compared to RMB 9,065,099 thousand in 2021[143] - Net profit for 2022 was RMB 2,583,747 thousand, a decrease of 4.8% compared to RMB 2,712,902 thousand in 2021[143] - Total comprehensive income for 2022 was RMB 3,216,633 thousand, an increase of 28.1% compared to RMB 2,511,499 thousand in 2021[144] - Cash and bank balances increased to RMB 17,615,274 thousand in 2022, up from RMB 14,702,056 thousand in 2021[145] - Total assets less current liabilities increased to RMB 27,382,377 thousand in 2022, up from RMB 24,136,441 thousand in 2021[145] - Total equity attributable to owners of the parent company increased to RMB 22,646,944 thousand in 2022, up from RMB 20,028,845 thousand in 2021[146] - R&D expenses for 2022 were RMB 1,693,314 thousand, a decrease of 5.8% compared to RMB 1,797,012 thousand in 2021[143] - Other comprehensive income for 2022 was RMB 632,886 thousand, compared to a loss of RMB 201,403 thousand in 2021[144] - Non-current assets increased to RMB 4,170,259 thousand in 2022, up from RMB 3,980,803 thousand in 2021[145] - Total equity increased from RMB 17,875,598 thousand in 2021 to RMB 22,646,944 thousand in 2022, reflecting a growth of 26.7%[147] - Net profit for the year 2022 was RMB 2,583,747 thousand, compared to RMB 2,712,902 thousand in 2021, a decrease of 4.8%[147] - Foreign exchange translation differences resulted in a gain of RMB 632,886 thousand in 2022, compared to a loss of RMB 201,403 thousand in 2021[147] - Share-based payment reserves increased from RMB 134,062 thousand in 2021 to RMB 313,478 thousand in 2022, a growth of 133.8%[147] - Cash flow from operating activities in 2022 was RMB 2,741,205 thousand, up 6.4% from RMB 2,577,062 thousand in 2021[148] - Depreciation of right-of-use assets increased to RMB 315,538 thousand in 2022 from RMB 257,165 thousand in 2021, a rise of 22.7%[148] - Trade receivables and bills decreased by RMB 90,446 thousand in 2022, compared to an increase of RMB 549,347 thousand in 2021[148] - Inventory increased by RMB 40,943 thousand in 2022, a significant reduction from the RMB 111,747 thousand increase in 2021[148] - Contract liabilities increased by RMB 2,896 thousand in 2022, compared to a decrease of RMB 173,487 thousand in 2021[148] - Income tax paid in 2022 was RMB 324,033 thousand, slightly higher than the RMB 319,439 thousand paid in 2021[148] - Investment activities resulted in a net cash outflow of RMB 5,935,073 thousand in 2022, compared to RMB 2,259,157 thousand in 2021[149] - The company purchased equity investments measured at fair value through profit or loss for RMB 186,205 thousand in 2022, a decrease from RMB 357,266 thousand in 2021[149] - The company received interest income from bank deposits with initial deposit periods exceeding three months of RMB 111,172 thousand in 2022, down from RMB 150,170 thousand in 2021[149] - The company's cash and cash equivalents decreased by RMB 4,012,012 thousand in 2022, compared to an increase of RMB 3,734,681 thousand in 2021[149] - The company's year-end cash and cash equivalents stood at RMB 2,666,132 thousand in 2022, down from RMB 6,718,709 thousand in 2021[149] - The company's unrestricted cash and bank balances were RMB 2,464,318 thousand in 2022, slightly down from RMB 2,503,263 thousand in 2021[149] - The company's short-term unsecured time deposits with initial deposit periods of less than three months decreased to RMB 201,814 thousand in 2022 from RMB 4,215,446 thousand in 2021[149] - The company's financing activities resulted in a net cash outflow of RMB 818,144 thousand in 2022, compared to a net cash inflow of RMB 3,416,776 thousand in 2021[149] - The company paid dividends of RMB 712,184 thousand in 2022, up from RMB 380,866 thousand in 2021[149] ESG and Sustainability - The company's ESG performance was recognized with an MSCI ESG rating of 'A' and a score of 63 in the S&P Global Corporate Sustainability Assessment, surpassing 95% of global peers[4] - The company maintained an MSCI ESG rating of 'A' and scored 63 in the S&P Global Corporate Sustainability Assessment, ranking in the top 5% of global pharmaceutical peers[19] - The company scored 63 in S&P Global's Corporate Sustainability Assessment (CSA), ranking above 95% of global peers and earning multiple ESG awards, including being the only Chinese pharmaceutical company listed in the 2023 Sustainability Yearbook[40] Licensing and Partnerships - The company entered into an exclusive licensing agreement with NiKang Therapeutics in May 2022 to develop and commercialize NKT2152 in China (including Hong Kong, Macau, and Taiwan)[7] - The company signed an exclusive licensing agreement with TiumBio in August 2022 to develop and commercialize TU2670 for endometriosis and uterine fibroids in China (including Hong Kong, Macau, and Taiwan)[8] - The company secured global rights to develop, produce, and commercialize the anti-SARS-CoV-2 candidate drug GDI-4405 through an exclusive licensing agreement with GHDDI in August 2022[8] - The company entered into an exclusive licensing agreement with KiOmed in September 2022 to develop and commercialize KiOmedinevsOne for osteoarthritis in Mainland China, Macau, and Taiwan[9] - The company obtained exclusive rights to develop, produce, and commercialize the EGFR/cMet bispecific antibody drug PM1080 in China (including Hong Kong, Macau, and Taiwan) through a licensing agreement with Primus in November 2022[9] - The company entered into an exclusive licensing agreement with TiumBio in August 2022, securing rights to develop and commercialize TU2670 for endometriosis and uterine fibroids in China (including Hong Kong, Macau, and Taiwan)[36] - The company signed an exclusive licensing and co-development agreement with GHDDI in August 2022, gaining global rights to develop, produce, and commercialize the anti-SARS-CoV-2 candidate drug GDI-4405 series, which shows strong antiviral activity against Delta and Omicron variants[37] - The company partnered with KiOmed in September 2022, obtaining exclusive rights to develop and commercialize KiOmedinevsOne for osteoarthritis treatment in China (including Macau and Taiwan)[38] - The company signed a licensing agreement with Pu-Mu-Si in November 2022, securing exclusive rights to develop and commercialize PM1080, an EGFR/cMet bispecific antibody drug, in China (including Hong Kong, Macau, and Taiwan)[39] R&D and Innovation - The company's global headquarters and R&D center officially opened in December 2021, marking a new phase of innovation and internationalization[6] - The company has six innovative drugs approved in China, all included in the National Reimbursement Drug List[19][21] - Over 30 innovative drug projects are in various clinical stages, covering multiple therapeutic areas[19][21] - R&D personnel increased to 1,521 by the end of 2022[21] - The company completed the introduction of three clinical-stage products through licensing and collaboration[21] - The company's R&D investment totaled RMB 1.693 billion, accounting for 18.0% of total revenue[23] - The company's R&D team consists of 1,521 researchers across four R&D centers in Shanghai, Lianyungang, Changzhou, and the United States[30] - In 2022, Hengrui obtained 82 authorized patents in China (including 18 in Hong Kong, Macao, and Taiwan) and 10 foreign authorized patents[30] - Hengrui launched 11 new products in 2022, including the innovative drug Inebilizumab Injection (brand name: Xinyue®) for treating AQP4 antibody-positive NMOSD in adults[30] - The company submitted 6 new drug applications in 2022, including one innovative drug application (with new indications) for Pemostimotide Injection[30] - Hengrui received 19 clinical trial approvals in 2022, covering treatments for chronic myeloid leukemia, advanced solid tumors, schizophrenia, and menopausal vasomotor syndrome[32] - The company spent approximately RMB 292 million on BD projects (including upfront and milestone payments) in 2022[33] - The company will increase investment in R&D activities, leveraging internal and external cutting-edge technologies such as antibody-drug conjugates, small interfering RNA, and bispecific antibodies to expand its innovative therapy pipeline[44] Corporate Governance and Leadership - The Board of Directors consists of three executive directors (including the Chairman and CEO) and three independent non-executive directors as of December 31, 2022[47] - The Board has established five specialized committees, including Audit, Remuneration, Strategy and Development, ESG, and Nomination Committees, to oversee specific aspects of the company's operations[46] - The company has appointed three independent non-executive directors, with one possessing appropriate professional qualifications or expertise in accounting or financial management[48] - The Chairman and CEO roles are currently held by the same individual, Zhong Huijuan, due to her extensive knowledge and experience in the Chinese pharmaceutical industry, though the Board will consider separating the roles in the future[52] - Directors are required to retire and be re-elected at least once every three years, with one-third of the Board subject to re-election at each annual general meeting[53] - New directors receive comprehensive onboarding training, and the company encourages ongoing professional development to ensure informed contributions to the Board[55] - The company's audit committee reviewed the consolidated financial statements for the year ended December 31, 2022, and confirmed compliance with applicable accounting standards and listing rules[59] - The audit committee held two meetings in 2022 to review financial statements and internal audit effectiveness[60] - The remuneration committee held four meetings in 2022 to review executive and senior management compensation and restricted share unit grants[61] - The company granted restricted share units to certain employees, including two directors, with some units vesting in less than 12 months[61] - The strategy and development committee held one meeting in 2022 to assess development progress and future strategies, including exploring major investments and new market expansion[62] - The environmental, social, and governance (ESG) committee held two meetings in 2022 to review ESG initiatives and identify key ESG issues and climate change risks[63] - The Nomination Committee consists of three members, including one executive director and two independent non-executive directors, and held one meeting in 2022 to review the board's structure and independence[64] - The company has adopted a Board Diversity Policy, aiming to achieve diversity in professional experience, skills, knowledge, gender, age, cultural and educational background, race, and tenure[66] - As of December 31, 2022, the board includes six directors with an equal gender split, and the company's full-time employees consist of 64.2% male and 35.8% female[66] - The board held four meetings in 2022, and the chairman held one meeting with independent non-executive directors without other directors present[67] - All directors attended 100% of the board meetings, and the attendance rates for committee meetings and the annual general meeting were also 100%[68] - The company has five senior management employees, all of whom received compensation exceeding RMB 1.5 million in 2022[70] - The board confirms its responsibility for preparing financial statements that provide a true and fair view of the company's financial position, with no significant uncertainties affecting the group's ability to continue as a going concern[71] - The company has established a three-tier organizational framework (business units, functional departments, and internal control and audit departments) to identify, analyze, classify, control, and monitor risks related to strategy, operations, market development, financial matters, legal matters, investment and financing, information security, anti-bribery, and anti-money laundering[72] - The company paid a total of RMB 3,700 thousand to its external auditor, Ernst & Young, during the reporting period, including RMB 3,150 thousand for audit services and RMB 550 thousand for non-audit services[74] - The company has adopted a shareholder communication policy to ensure timely, comprehensive, and easily understandable information is provided to shareholders and investors through various channels, including market disclosures, the company's website, interim and annual reports, and shareholder meetings[75] - Shareholders holding at least one-tenth of the voting rights can request a general meeting, and if the board does not convene a meeting within 21 days, the requesting shareholders can convene the meeting themselves[76] - The company has not made any changes to its articles of association during the reporting period, and the latest version is available on the company's website and the Hong Kong Stock Exchange website[78] - The company's board has proposed a final dividend of 5 HK cents per share for the year ended December 31, 2022, bringing the total annual dividend to 10 HK cents per share, including the interim dividend[80] - The company's annual general meeting will be held on June 1, 2023, and the notice will be sent to shareholders at least 21 days before the meeting[82] - The company has 5,922,350,070 issued ordinary shares as of December 31, 2022[85] - The net proceeds from the placement in 2020 amounted to approximately HKD 3.4772 billion, with HKD 4.0027 billion utilized by December 31, 2022, and HKD 3.07693 billion remaining unused[86] - The net proceeds from the issuance of zero-coupon convertible bonds in 2021 amounted to approximately USD 595.