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和黄医药(00013) - 2022 - 中期财报
2022-08-17 08:32
Revenue Growth - Total revenue for the first half of 2022 increased by 28% to $202 million, driven by the commercialization of three self-developed oncology drugs[10]. - Oncology/immunology business revenue grew by 113% to $91.1 million compared to $42.9 million in the first half of 2021[10]. - The sales of ELUNATE® (fruquintinib) in the first half of 2022 reached $50.4 million, a 26% increase from $40.1 million in the same period last year[10]. - Sales of SULANDA® (surufatinib) amounted to $13.6 million in the first half of 2022, up from $8 million in the first half of 2021[10]. - ORPATHYS® (savolitinib) generated sales of $23.3 million in the first half of 2022, marking its first revenue since its launch in late 2021[10]. - The combined revenue from tumor/immunology business was $9,110 million, reflecting a 113% increase from $4,290 million year-over-year[11]. - The sales of Aiyoute® reached $5,040 million, up 26% from $4,010 million in the first half of 2021[11]. - The sales of Sutai Da® increased by 69% to $1,360 million from $800 million in the same period last year[11]. - Revenue from the oncology/immunology business for marketed products was $63.517 million, up from $37.795 million in 2021, representing a 68.2% increase[31]. Clinical Trials and Research Development - The company is advancing multiple key early-stage studies and ongoing late-stage clinical trials, including the SAVANNAH study, which is expected to report encouraging data in August[8]. - The company initiated the SAFFRON global Phase III study for the combination therapy of Saiwo Tini and Tagrisso®[15]. - The FRESCO-2 global Phase III study is set to announce top-line results after reaching the predefined number of OS events, involving 691 patients across 14 countries[16]. - The company plans to submit the marketing application for Aiyoute® to the FDA, EMA, and PMDA in the second half of 2022[16]. - The company has advanced 13 oncology candidates into clinical trials in China, with seven also undergoing clinical development in the US and Europe[34]. - The ongoing global phase III SAFFRON study is currently recruiting patients, focusing on the efficacy of Savolitinib in combination with other therapies[41]. - The company has initiated a Phase I clinical trial for HMPL-760 in China for advanced hematological malignancies[18]. - The company has started a Phase I clinical trial for HMPL-295 in China for advanced solid tumors[18]. - The company has launched a Phase I clinical trial for HMPL-653 in China for advanced malignant solid tumors and tenosynovial giant cell tumors[18]. Financial Performance - The net loss attributable to the company for the first half of 2022 was $162.9 million, compared to a net loss of $102.4 million for the same period in 2021[28]. - The company reported a net cash outflow from operating activities of $110.9 million for the first half of 2022, compared to a cash outflow of $63.1 million in the first half of 2021[27]. - The company reported a 3% decrease in comprehensive income from other businesses to $110.9 million in the first half of 2022, compared to $114.5 million in the same period of 2021[22]. - The company reported a total comprehensive loss of $(167,047) thousand for the six months ended June 30, 2022, compared to $(98,256) thousand in 2021, an increase of 69.9%[169]. - The net cash used in operating activities was $(89.9) million for the six months ended June 30, 2022, compared to $(71.3) million in the same period of 2021[101]. - The company reported a net loss of approximately $5,000 for other joint ventures in the first half of 2022, compared to a net profit of $79,000 in the same period of 2021[189]. Regulatory Approvals and Milestones - The company received approval for Aiyoute® and Sutai Da® in Macau, marking a significant regulatory milestone[12]. - The FDA requested a new international multi-center clinical trial for Sovantib, indicating the need for more representative data for the U.S. patient population[13]. - The company received fast track designation from the FDA for fuquintinib, indicating potential expedited review for market approval[61]. - The company plans to conduct a Phase II clinical trial for severe COVID-19 patients, targeting approximately 80 patients to assess the treatment's effectiveness[76]. Market Expansion and Strategic Initiatives - The company expanded its commercial team in China to approximately 820 employees, covering about 3,000 oncology hospitals and 30,000 oncologists[10]. - The company remains optimistic about future growth opportunities, particularly with the expected revenue increase from ORPATHYS®, SULANDA®, and ELUNATE® in the Chinese market[9]. - The company is constructing a new flagship production facility in Shanghai, aiming to increase production capacity for innovative drug products by over five times, with equipment installation planned for completion by the end of 2022[21]. - The company is exploring the potential for accelerated approval in the U.S. based on the results from the SAVANNAH study[42]. Corporate Governance and Sustainability - The company has established a sustainability committee at the board level to support its sustainability initiatives and has published its second sustainability report in May 2022[124]. - The company emphasizes the importance of high-quality human resources to maintain market leadership and offers competitive salaries and benefits[123]. - The company has complied with all provisions of the Corporate Governance Code as set out in Appendix 14 of the Hong Kong Listing Rules for the six months ended June 30, 2022[126]. - The company is committed to continuous improvement of governance standards and practices across its operations[161].
HUTCHMED(HCM) - 2022 Q2 - Earnings Call Transcript
2022-08-03 15:53
HUTCHMED (China) Limited (NASDAQ:HCM) Q2 2022 Earnings Conference Call August 2, 2022 8:00 AM ET Company Participants Weiguo Su - Executive Director, Chief Executive Officer and Chief Scientific Officer Johnny Cheng - Executive Director and Chief Financial Officer Marek Kania - Executive Vice President, Managing Director and Chief Medical Officer, International Karen Atkin - Executive Vice President and Chief Operating Officer Hong Chen - Chief Commercial Officer of China, Senior Vice President and Chief Co ...
HUTCHMED(HCM) - 2022 Q2 - Quarterly Report
2022-07-31 16:00
Exhibit 99.1 HUTCHMED Reports 2022 Interim Results and Provides Business Updates Oncology/Immunology revenues up 113% to $91.1 million, due to ELUNATE®, SULANDA ® and ORPATHYS® growth First presentation of SAVANNAH data showing 52% response rate and 9.6 month duration of response in 2L+ post-TAGRISSO® NSCLC1 patients with high MET 2levels and no prior chemotherapy Initiated six new trials thus far in 2022 with a further six starting, including with five new drug candidates FRESCO-2 Phase III, our first glob ...
和黄医药(00013) - 2021 - 年度财报
2022-03-23 08:53
Revenue Growth - The comprehensive revenue from the oncology/immunology business increased nearly 4 times to $119.6 million in 2021, with this trend continuing into 2022 [15]. - Total revenue for 2021 increased by 56% to $356.1 million, driven by the commercialization of three self-developed oncology drugs [18]. - Other business revenue grew by 20% (CER: 13%) to $236.5 million in 2021, compared to $197.8 million in 2020 [31]. - The oncology/immunology business revenue for 2021 reached $119.6 million, a 296% increase compared to $30.2 million in 2020, aligning with the revenue guidance of $110 million to $130 million [18]. - The sales of Aiyoute® (Fruquintinib) in China grew by 111% to $71 million in 2021, reflecting strong management performance in medical communication and marketing [18]. - The sales of Vorasatinib® (Savolitinib) reached $15.9 million in 2021, as it became the first selective MET inhibitor in China, quickly gaining market recognition [18]. - The sales of Sunitinib® (Sofitinib) was launched in 2021 for treating neuroendocrine tumors, generating sales of $11.6 million, marking a promising start in the self-pay market [18]. Clinical Development - There are currently over 45 clinical studies ongoing globally, with seven innovative drug candidates undergoing clinical development outside of China [12][15]. - The company has initiated four Phase III studies and one Phase II study for the drug Vorasertib, which received its first approval in 2021, triggering a milestone payment of $40 million [15]. - The NDA application for Surufatinib for the treatment of advanced neuroendocrine tumors is in the late stages of registration review in the EU [15]. - The company has a pipeline of 12 innovative molecular drugs, with three already approved and successfully launched [11][13]. - In 2021, the company initiated several key clinical studies for its drug Savolitinib, including a global Phase III study (NCT05043090) in October for treating MET-driven unresectable and locally advanced or metastatic papillary renal cell carcinoma [23]. - The company plans to initiate a Phase III study (SURTORI-02) in China for the combination therapy of Savolitinib and Tuoyi® for esophageal cancer in the second half of 2022 [24]. - The company has initiated multiple Phase II studies for Furmonertinib in combination with other therapies for advanced or metastatic cancers, including colorectal and gastric cancers [24]. Financial Position - The company has over $1 billion in cash and plans to divest non-core assets to support its strategic initiatives [16]. - Cash and cash equivalents and short-term investments totaled $1.0117 billion as of December 31, 2021, compared to $435.2 million at the end of 2020 [38]. - The company reported a net loss attributable to shareholders of $194.6 million in 2021, compared to a net loss of $125.7 million in 2020, reflecting a 55.0% increase in losses [42]. - The total operating expenses for 2021 were $684.4 million, up from $424.6 million in 2020, indicating a 61.1% increase [42]. - The company’s total assets grew to $1.373 billion in 2021, compared to $724.1 million in 2020, a 89.8% increase [41]. Leadership Changes - The new CEO, Dr. Su Weiguo, has been appointed as part of the succession planning following the retirement of the previous CEO, Mr. He Jun [13][14]. - The company is expanding its leadership team with experienced professionals from the pharmaceutical industry, including former executives from Gilead Sciences and Takeda Pharmaceuticals [142][143]. Research and Development - R&D expenses increased to $299.1 million in 2021 from $174.8 million in 2020, marking a 70.9% growth due to the expansion of innovative oncology drug candidates [39]. - The company continues to prioritize employee development and community engagement through various training programs and initiatives [131]. - The company is focused on enhancing its corporate governance practices, with members holding senior positions in professional accounting and governance bodies [144]. Strategic Partnerships - The company has established a partnership with Hain Celestial for the marketing, distribution, and sales of its products, with pricing based on standard costs plus a profit margin [172]. - The company collaborates with Eli Lilly for fuzuloparib's rights outside of China, enhancing its market reach [64]. Sustainability and Governance - The company aims to enhance its sustainability practices and has established a sustainability committee at the board level [35]. - The company is committed to sustainable development, as indicated by the presence of a dedicated committee chaired by a board member [141]. - The company has a strong emphasis on research and development, particularly in innovative therapies for cancer [143][145]. Shareholder Information - The company reported a total shareholding of 332,574,650 shares, representing approximately 38.46% ownership by CK Hutchison Global Investments Limited [180]. - The company has adopted a share trading code for directors to disclose their interests and holdings [148]. - The company has a stock option plan adopted in 2015, which remains in effect [184].
HUTCHMED(HCM) - 2021 Q4 - Earnings Call Transcript
2022-03-04 01:07
HUTCHMED (China) Limited (NASDAQ:HCM) Q4 2021 Earnings Conference Call March 3, 2022 8:00 AM ET Company Participants Christian Hogg - Chief Executive Officer Hong Chen - Senior Vice President and Chief Commercial Officer, China Weiguo Su - Executive Director and Chief Scientific Officer Marek Kania - Executive Vice President, Managing Director and Chief Medical Officer, International Mark Lee - Senior Vice President, Corporate Finance & Development Johnny Cheng - Executive Director and Chief Financial Offic ...
HUTCHMED(HCM) - 2021 Q4 - Annual Report
2022-03-02 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark one) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 co ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR Date of event requiring this shell comp ...