[三季报]华东医药(000963):2022年第三季度报告（英文版）
原标题:华东医药:2022年第三季度报告（英文版） The Third Quarterly Report 2022 The Company and all members of the Board of Directors hereby guarantee that the information presented in this report is authentic, accurate and complete and free of any false records, misleading statements or material omissions.Important Declaration: 1. The Board of Directors, Board of Supervisors, directors, supervisors, and senior management of Huadong Medicine Co., Ltd. (hereinafter referred to as the “Company”) hereby guarantee that the information presented in this report is authentic, accurate, and complete and free of any false records, misleading statements or material omissions, and shall undertake individual and joint legal liabilities. 2. The Company’s legal representative and the officer in charge of accounting, and head of accounting department (accounting supervisor) hereby declare and guarantee that the financial statements in this quarterly report are authentic, accurate, and complete. 3. Has the third quarterly report been audited? □ Yes ?No This report is prepared both in Chinese and English. Should there be any discrepancy between the Chinese and English versions, the Chinese version shall prevail. I. Key financial data (I) Key accounting data and financial indicators Whether the Company needs to perform retroactive adjustment or restatement of previous accounting data □ Yes ?No
(II) Items and amounts of non-recurring gains/losses ?Applicable □Inapplicable
There are no other gain/loss items in line with the definition of non-recurring gains/losses in the Company. Explanation for recognizing an item listed as a non-recurring gain/loss in the “Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies – Non-Recurring Gains/Losses” as a recurring gain/loss □Applicable ?Inapplicable There is no circumstance in which the Company recognizes an item listed as a non-recurring gain/loss in the “Interpretative Announcement No. 1 on Information Disclosure Criteria for Public Companies – Non-Recurring Gains/Losses” as a recurring gain/loss. (III) Changes in key accounting data and financial indicators and their reasons ?Applicable □Inapplicable
II. Shareholder information (I) Total number of common shareholders, number of shareholders of preferred shares with voting rights restored, and information about top 10 shareholders Unit: share
□Applicable ?Inapplicable III. Other important matters ?Applicable □Inapplicable (I) Overview of operations 1. The Company’s overall operations during the reporting period During the reporting period, the Company continued to overcome the challenges brought about by the COVID-19 resurgence and the fierce market competition. With the core objective of restoring growth, it accelerated operation and innovation in various fields, so its key operational indicators continued to recover growth amid the effective response to various pressures and uncertainties. In the first nine months of 2022, the Company realized operating income of RMB27.86 billion, up 7.4% year on year (up 0.4% in the first quarter and 5.9% in the first half year on year). Meanwhile, it produced net profit attributable to listed-company shareholders after deduction of non-recurring gains or losses of RMB1.9 billion, up 7.9% (up 0.4% in the first quarter and 6.5% in the first half year on year). Calculated by the same standard in the previous annual report after excluding the controlling subsidiary Huadong Ningbo, operating income in the first nine months of 2022 increased by 11.2% year on year, and net profit attributable to listed-company shareholders after deduction of non-recurring gains or losses went up by 9.3% year on year. The Company saw its overall operations growing steadily. In the third quarter of 2022, the Company posted total operating income of RMB9.66 billion, an increase of 10.4% compared with the same period last year and 4.3% from the second quarter of the year as well as net profit attributable to listed-company shareholders after deduction of non-recurring gains or losses of RMB630 million, an increase of 10.8% compared with the same period last year and 9.8% from the second quarter of the year. Calculated by the same standard in the previousannual report after excluding the controlling subsidiary Huadong Ningbo, the Company’s operating income in the third quarter of 2022 increased by 14.4% year on year, and its net profit attributable to listed- company shareholders after deduction of non-recurring gains or losses rose by 11.2% year on year. The pharmaceutical industry segment (including CSO business) recorded operating income of RMB8.22 billion in the first nine months of 2022, up 5.3% year on year (down 13.4% in the first shareholders after deduction of non-recurring gains or losses of RMB1.62 billion, up 0.9% year on year (down 4.3% in the first quarter and down 3.7% in the first half year on year). In the third quarter of 2022, the segment achieved operating income of RMB2.71 billion and net profit attributable to listed-company shareholders after deduction of non-recurring gains or losses of RMB550 million, up 14.0% and 11.1% year on year. The industrial microbiology business grew slower in the third quarter of 2022 compared with the first half of the year, due to the decline in demand for nucleoside raw materials in the downstream international market and the delayed delivery of the Company’s production in pursuit of overseas certification. However, the overall business is expected to gradually recover in the fourth quarter. From a full-year perspective, the Company continued to implement its industrial microbiology strategy, to enrich product pipelines with high innovation, technical barriers, and value-added in various business areas, and to optimize the product structure. At the same time, it got products registered overseas and launched international business actively. All of these steps aimed to promote the steady growth of the industrial microbiology business. During the reporting period, the Company’s pharmaceutical commerce maintained steady growth, achieving operating income of RMB18.97 billion, up 9.8% year on year, and total net profit of RMB300 million, up 5.0% year on year. During the reporting period, the Company’s aesthetic medicine segment maintained rapid growth as a whole. In the period, the segment achieved total operating income of RMB1.37 billion (excluding internal offsetting factors), representing the highest level of the same period in the Company’s history, and a year-on-year increase of 113.7% on a comparable basis (excluding Huadong Ningbo). Sinclair, a wholly-owned subsidiary in the United Kingdom (the UK), continued to grow fast, making strides in overseas market expansion and international sales. During the reporting period, Sinclair registered consolidated operating income of GBP95.37 million (approximately RMB790 million), an increase of 79.7% year on year, and earnings before interest, taxes, depreciation, and amortization (EBITDA) of GBP17.36 million, an increase of 254.9% year on year. In the third quarter alone, the subsidiary posted operating income of over GBP32 million in spite of the mounting pressures from inflation and rising costs overseas. The Préime DermaFacial, a multi-functional facial skin management platform that Sinclair exclusively introduced from Ireland-based EMA Aesthetics Limited, become available for commercial sales in major global aesthetic medicine markets such as Europe and the United States from September 2022. The energy-based device is scheduled to be launched in China in 2023. As for domestic aesthetic medicine business, Sinclair (Shanghai), the wholly-owned subsidiary of the Company, tapped deep into the core target markets, on the premise of ensuring operational ? the subsidiary continued to lead high-end regenerative filler market in China. Thanks to the constantly enhanced attention and penetration, the domestic aesthetic medicine business saw its sales proceeds in the third quarter of 2022 rebounding significantly compared with the second quarter. Sinclair (Shanghai) racked up total operating income of RMB440 million in the first nine months of 2022. ? China hence become the largest market for Ellansé worldwide. In the fourth quarter, which is a peak season for medical aesthetics sales, Sinclair (Shanghai) is expected to continue its good performance in the third quarter, thus beating the full-year business target smoothly. 2. R&D progress of the Company during the reporting period (1) Progress of clinical studies on major innovative drugs, innovative medical equipment and biosimilars From January to September 2022, the Company continued to accelerate the R&D work. The R&D expenditure in the pharmaceutical industry was RMB870 million, with a year-on-year increase of 21.5% among which RMB760 million was for R&D expenses. As at the date of issuance of this Report, the Company’s main R&D progress of innovative drugs, innovative medical equipment and biosimilars is as follows: Endocrine HDM1002: A GLP-1 receptor agonist formed from small molecules which is independently researched and developed by the Company. It is projected that Pre-IND applications will be delivered both in China and the United States by the end of 2022. Liraglutide Injection: A GLP-1 receptor agonist. The marketing authorization application for diabetes indication was accepted in September 2021 and the submission of materials for supplementary studies was completed in August 2022. The marketing authorization application for obesity or overweight indication was accepted in July 2022. Semaglutide Injection: A GLP-1 receptor agonist. The administration and follow-up visits to all subjects for Phase I clinical trials have been completed. Insulin Degludec Injection: Its IND approval received in September 2022. HDM7003 (D-4517.2): This product is under development jointly by the Company and Ashvattha Therapeutic, Inc., the joint-stock company in the United States. In September 2022, Ashvattha announced that the first subject enrollment for the Phase II clinical trial in the United States of the product, which is utilized for treating wet age-related macular degeneration and diabetic macular edema, had been completed. Oncology HDM2002 (Mirvetuximab Soravtansine): The first investigational ADC targeting positive resistant ovarian cancer with high expression of FRα. In terms of its Phase I clinical trials in China for pharmacokinetics, the enrollment of all subjects was completed in July 2022. In August 2022, the first subject enrollment was completed for its Phase III single-arm clinical trial in China. Autoimmunity ? ARCALYST (Rilonacept): A recombinant dimer fusion protein that can block the transmission of IL-1α and IL-1β signals. In February 2022, the Company signed a cooperative agreement with ? Kiniksa on introducing this product. Continually, ARCALYST was approved in the United States in 2008, 2020 and 2021 for treating cryopyrin-associated periodic syndromes (“CAPS”), deficiency ? of IL-1 receptor antagonist (“DIRA”) and recurrent pericarditis. Also, ARCALYST was included by the CDE in the List of Overseas New Drugs for Urgent Clinical Needs (Group 1) for CAPS. The Company filed a Pre-BLA to the CDE for the product’s CAPS indication in July 2022 and feedback has been procured. It is expected that the BLA application will be delivered domestically in the fourth quarter of 2022. HDM5001 (OP-101): This product is under development jointly by the Company and Ashvattha Therapeutic, Inc., the joint-stock company in the United States. On the basis of its original function of treating severe COVID-19 indications, the possibility of new indication development is currently under assessment. An IND application will be delivered domestically after a conclusion is formed. Innovative medical equipment HD-NP-102 (Transdermal Glomerular Filtration Rate Measurement System and MB102): This product is jointly developed by the Company and MediBeacon, Inc. in the United States. Based on the changes in fluorescence over time emitted by exogenous tracers for non-invasive monitoring, this system can continuously measure the glomerular filtration rate (“GFR”) of patients with normal or impaired renal functions. In July 2022, the registration application for medical equipment of this system was accepted by the NMPA and will enter the review phase. MB-102 Injection (Relmapirazin) which works together with this system is a global innovative drug. The first domestic subject enrollment for the Phase III multi-regional clinical trial (MRCT) was completed in September 2022. (2) R&D and registration of domestic aesthetic medicine products
? ? Lanluma and Ellansé series products in Hainan Boao Lecheng Pilot Zone of International Medical Tourism. 3. External investment and cooperation progress of the Company during the reporting period (1) During the reporting period, the Company completed the delivery of the additional stocks issued publicly and shares transferred by agreement by the listing company in Germany Heidelberg Pharma (please refer to the relevant announcements disclosed by the Company on the website of cninfo.com.cn for details; announcement No.: 2022-060 and 2022-065). After the completion of the delivery, the Company’s equity investment in Heidelberg Pharma was successfully completed. Ultimately, the Company’s wholly owned subsidiary Huadong Medicine Investment Holding (Hong Kong) Limited holds a total of 16,304,560 shares in Heidelberg Pharma, with the corresponding percentage of equity interest held being 35.00%. For this percentage, the Company becomes the second largest shareholder. In terms of the ADC field, the Company further expanded its differentiated layout. It invested in Qyuns Therapeutics, an antibody R&D and production company, and Nuoling Bio, a company specializing in ADC linkers and conjugate techniques, and incubated Huida Biotech which owns the whole product line of ADC payloads. It also controls Doer Biologics, a multi-antibody platform R&D company, and has strong ADC R&D technological accumulations. By carrying out equity investment and product cooperation with Heidelberg Pharma, a global emerging technology company in the ADC field, and introducing a number of ADC innovative products, the Company further enriched its innovative pipeline for oncology products and realized a differentiated layout in the ADC field. In the future, the Company will fully integrate its ADC R&D technological accumulations with the advanced and proprietary ATAC technological platform of Heidelberg Pharma to form a unique ADC global R&D ecosystem, gradually build a differentiating ADC independent R&D platform, and strengthen and improve the antineoplastic product innovation chain and the ADC ecological chain. The Company has established an independent ADC R&D center which will, driven by clinical needs that have not been satisfied, actively cooperate with international leading technical teams and integrate advantageous ecosystem resources. In the next three years, it plans to develop at least ten ADC innovative products and actively promote the registration work and clinical studies. (2) On August 8, 2022, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmei Huadong”), the Company’s wholly owned subsidiary, signed the Agreement on Capital Injection to and Transfer of Equity Interest in Wuhu Huaren Science and Technology Co., Ltd. with Wuhu Huaren Science and Technology Co., Ltd. (hereinafter referred to as “Huaren Science and Technology”), natural persons Shi Ping and Zhao Huijiao, and Wuhu Huaxuan Enterprise Management Partnership (Limited Partnership). Zhongmei Huadong will contribute no more than RMB396 million in total, in the form of capital injection and share acceptance, to acquire a 60% equity interest in Huaren Science and Technology and become its controlling shareholder (please refer to the relevant announcement disclosed by the Company on the website of cninfo.com.cn for details; announcement No.: 2022-056). Up to now, the Company has completed the formalities for changing registration with the administration for industry and commerce related to this transaction, the payment of all the capital injection funds and part of the equity transfer consideration, and the closing of the capital injection to and acceptance of the equity interest in Huaren Science and Technology. In the future, in the nucleoside business layout of the Company’s industrial microbial segment, Huaren Science and Technology will mainly focus on the markets of nucleoside raw materials for small nucleic acid drugs and diagnostic reagents, with modified nucleosides, phosphoramidite monomers and dNTPs, among others, as the main products. The Company’s wholly owned subsidiary, Anhui Meihua Hi-Tech Pharmaceutical Co., Ltd. (hereinafter referred to as “Meihua Hi-Tech”), will assist Huaren Science and Technology with its large-scale production and undertake the function of producing modified nucleosides, monomers and upstream raw materials. Through a series of R&D and integration of industry resources, the Company has formed a complete technological layout necessary for the nucleoside business in fields such as synthetic biology technology, enzyme catalysis, chemical synthesis and modification, and separation and purification. Meanwhile, leveraging Huaren Science and Technology, Meihua Hi-Tech and other production bases, a comprehensive production layout of nucleic acid drugs and upstream raw materials for diagnosis has been formed. In the future, the Company will continue to expand and strengthen the production of nucleic acid drugs and upstream raw materials for diagnosis, and dedicate itself to becoming an international leading supplier in the field of nucleoside raw materials. (3) Meihua Hi-Tech (formerly Anhui Huachang Hi-Tech Pharmaceutical Co., Ltd.), all of whose equity has been acquired by the Company, has started the production of existing nucleoside product projects in an orderly manner and has formed industry linkage and resource integration with Zhongmei Huadong and Huaren Science and Technology within the Company. Currently, the trial production of the Phase I project of Meihua Hi-Tech is undergoing acceptance inspection and at the same time Phase II project planning is being actively promoted. (4) In July 2022, the Company’s wholly owned subsidiary, Zhongmei Huadong, and Gongshu District Government in Hangzhou and Zhejiang University of Technology jointly established the Huadong Institute of Synthetic Biology Industry Technology (hereinafter referred to as the “Institute”), which will focus on the four fields of nutrition and pharmaceutical chemicals, aesthetic medical biology, biomaterials and health substitutes based on synthetic biology technology. Meanwhile, the Institute insists on serving the strategic needs of the national “bio-economy”, and takes as breakthroughs the new mechanism of intelligent biological manufacturing and industrial revolutionary technical issues, while carrying out technological innovation research and industrial transformation research around intelligent biological manufacturing with the help of artificial intelligence, big data and intelligent automation equipment. The Institute is in the Huadong Medical of the Chinese Academy of Engineering, is the president. Synthetic biology is one of the core technologies that the Company relies on for industrial microbial development. Through linkage, sharing and integration, the pioneer cooperation between “government, industry and university in research and application” will accelerate the transformation of innovative projects, which is expected to help build a new cluster of biological manufacturing industry and give the Company a new impetus for industrial microbial innovation. 4. Other work matters During the reporting period, the Company launched the equity incentive plan for the first time since its listing. To further establish and improve the long-term incentive mechanisms, attract and retain outstanding talents, fully mobilize the initiative of the senior management members, managers, and core technical (business) personnel, effectively combine the interests of shareholders, the Company, core teams, and employees together, and rally all parties around the long-term development of the Company, the Restricted Share Incentive Plan 2022 (Draft) (hereinafter referred to as “the Plan”) was formulated on the premise of fully safeguarding the interests of shareholders, as per the principle of matching earnings and contributions, and in accordance with the pertinent laws, regulations, and normative documents of China, such as the Company Law, the Securities Law, the Administrative Measures for Equity Incentives of Listed Companies as well as the Articles of Association of the Company. The Plan would grant restricted shares to the incentive recipients. The second session of the 10th Meeting of the Board of Directors and the second session of the 10th Meeting of the Board of Supervisors were held on August 8, 2022, to review and adopt the Proposal on the Company’s Restricted Share Incentive Plan 2022 (Draft) and Its Summary (details can be seen in the announcement disclosed by the Company on cninfo.com.cn on August 10, 2022). According to the Plan, the Company would grant 5 million restricted shares, at the price of RMB25.00 per share, which represented approximately 0.286% of 1,749,809,548 shares, the total share capital of the Company at the time of the announcement of the Plan. These restricted shares would go to 117 persons in total, including directors, senior management, middle management, and core technical (business) personnel who were working for the Company (including its subsidiaries) at the time of the announcement of the Plan. The Company released the list of first incentive recipients of the Restricted Share Incentive Plan through its intranet for 10 days, that is, August 15-25, 2022. By the end of the public announcement period on August 25, 2022, the Board of Supervisors did not receive any objection from anyone to the incentive recipients. On August 25, 2022, the Board of Supervisors meeting was convened to review and adopt the Verification Opinions and Public Announcement on the List of First Incentive Recipients under the Restricted Share Incentive Plan 2022 (details can be seen in the relevant announcement disclosed on by the Company on cninfo.com.cn on the same day). The Company held the first extraordinary general meeting of 2022 on August 31, 2022 to review and adopt the Proposal on the Company’s Restricted Share Incentive Plan 2022 (Draft) and Its Summary (details can be seen in the relevant announcement disclosed by the Company on cninfo.com.cn on the same day). The work related to equity incentive is now continuing as scheduled. （未完）  |