HONG KONG, Mar 30, 2020 – (ACN Newswire) – Sino Biopharmaceutical Limited ("Sino Biopharm" or the "Company", together with its subsidiaries, the "Group") (HKEX: 1177), a leading, innovative research and development driven pharmaceutical conglomerate in the PRC, has announced its financial results for the year ended 31 December 2019 ("the year"). The Group's overall results for the year continued to show considerable growth. The share of revenue contributed by new products in the Group's total revenue also increased notably, demonstrating its mature integrated capability in launching and promoting innovative products.
Results Highlights
– A total of 28 products including Lenalidomide capsules, Abiraterone Acetate tablet and several indications of Anlotinib capsules obtained the approval for drug registration granted by the National Medical Products Administration. Over 40% of these products are oncology drugs and the competitive edge of our oncology product line has been substantially enhanced. Some 19 products have passed (or are deemed to have passed) the Consistency Evaluation.
– Commanding a total investment of RMB3 billion and occupying an area of 520 mu, CT Tianqing's new drug R&D and production base opened, significantly boosting the Group's integrated strength in the biopharmaceutical area.
– Sino Biopharm ranked 42nd in U.S. magazine Pharm Exec's "Top 50 Companies 2019", as one of the only two Chinese companies on the list.
– Sino Biopharm garnered several awards at "The All-Asia-Executive Team 2019" held by Institutional Investor, and ranked 3rd among the "Honored Companies".
– Sino Biopharm was the only Chinese pharmaceutical company named among Forbes' "Asia 200 Best Over a Billion 2019".
– The quality control study "Shortening the Lyophilization Cycle of Product 'F'" presented by CT Tianqing, a subsidiary of the Company, won the International Quality Gold Award at the 44th International Convention on Quality Control Circles (ICQCC) held in Tokyo, Japan.
– At the "China ChemPharm Annual Summit 2019", Sino Biopharm's subsidiaries, namely CT Tianqing, Beijing Tide, NJCTT, Jiangsu CT Fenghai and CP Qingdao, were included in the Top 100 List of "Outstanding Enterprises and Outstanding Product Brands in China's Chemical Pharmaceutical Industry 2019". CT Tianqing again led the "Ranking of Top 100 R&D Capabilities of Chinese Chemicals Enterprises in 2019" and ranked 2nd in the "2019 Top 100 Enterprises in the PRC Pharmaceutical Industry – Comprehensive R&D Strength".
– CT Tianqing ranked 16th and Beijing Tide ranked 41st in the list of the "2018 Top 100 Pharmaceutical Companies in China" released at the "2019 (36th session) National Pharmaceutical Industry Annual Information Conference".
– Sino Biopharm ranked 1st among the "Top 20 Most Competitive Listed Chinese Pharmaceutical Companies" released at the "2019 China Healthcare Summit of Entrepreneurs, Scientists and Investors", and at the same time also ranked 2nd in the first-tier category of "Top 100 Innovative Pharmaceutical Enterprises in China".
– Eight new drug studies conducted by CT Tianqing were recognised as "National Major Innovative Drug Projects". The number of drug studies approved was among the highest in the country.
– Chia Tai Tianqing Akeso (Shanghai) Biomedical Technology Company Limited, a joint-venture company invested jointly by CT Tianqing and Akeso Biopharma, was officially set up in Shanghai. The joint venture is engaged in the development of the differentiated tumor immunotherapy PD-1 antibody drugs.
Results
During the year, the Group recorded revenue of approximately RMB24.23 billion, representing an increase of approximately 16.0% over the last year. Profit attributable to the owners of the parent was approximately RMB2.71 billion, approximately 70.1% lower than that of the last year. Such year-on year decrease was only due to the absence of a substantial one-off gain on step acquisition recorded last year. Excluding the impact of the one-off gain on step acquisition and the annual amortization expenses of new identifiable intangible assets arising from the acquisition of 24% interests in Beijing Tide, as well as the unrealized net fair value losses on equity investments and financials assets, underlying profit attributable to owners of the parent amounted to approximately RMB3.13 billion, increased by approximately 10.2% as compared with the last year. Based on underlying profit attributable to the owners of the parent, the earnings per share were approximately RMB24.97 cents, 8.7% higher than the last year. The Group has maintained a strong financial position with cash and bank balances reaching approximately RMB11.91 billion at the year end.
The Board of Directors recommended a final dividend payment of HK2.0 cents per share. Together with the dividend of HK2.0 cents already paid in each of the first three quarters, the total dividends for the year amounted to HK8.0 cents (2018: HK8.0 cents).
Business Highlights
During the year, the Group has re-located more resources in strengthening R&D and focused its academic promotion on oncology drugs and other new products with less competition. Two new indications of Anlotinib capsules have been approved and subsequently achieved great sales success. Other oncology drugs including Yinishu, Yigu, Shoufu, Qianping, Saiweijian and a recently approved product, Yijiu, analgesic medicines including Flurbiprofen cataplasm, cardio-cerebral medicines including Kaina and Xijia, digestive system medicines including Aisuping, Getai and Deyou and anti-infectious medicines including Tianjie and Tianli all enjoyed rapid growth. Markets for infusion solution products including Fenghaina, Qingkeping and the newly-launched contrast agent product Qingliming also expanded, leading to fast growth in sales.
During the year, the Group achieved an outstanding research and development ("R&D") performance and the Group obtained 28 production approvals and had 19 products passed Consistency Evaluation. Also, 23 products obtained clinical approval. The Group has made 25 new production applications and filed 19 new clinical trial applications. In addition, some 26 new applications for Consistency Evaluation have been accepted. The Group has obtained 83 invention patent approvals and filed 341 applications for invention patents. In addition, Tenofovir Disoproxil Fumarate tablet (Qingzhong) has obtained Marketing Authorization (MA) from the EU, marking a milestone for the Group to officially enter into the international mainstream market.
During the year, the sales performance of the Group's major medicine categories are outlined below:
Hepatitis medicines
The sales of hepatitis medicines amounted to approximately RMB5,739.72 million, representing approximately 23.7% of the Group's revenue.
— Tianqingganping enteric capsules sales amounted to approximately RMB525.04 million, an increase of approximately 22.5% against the last year.
— Tianqingganmei injections recorded sales of approximately RMB1,803.57 million, an increase of approximately 5.5% against the last year.
Oncology medicines
The sales of oncology medicines amounted to approximately RMB5,427.88 million, representing approximately 22.4% of the Group's revenue.
— Sales of Saiweijian injections amounted to approximately RMB704.52 million during the review period, an increase of approximately 37.5% as compared with the last year.
— Sales of Yinishu tablets amounted to approximately RMB224.90 million, a significant increase of approximately 36.8% as compared with the last year.
— Sales of Shoufu tablets amounted to approximately RMB214.16 million, an increase of 26.6% as compared with the last year.
— Sales of new product Anxian capsules amounted to approximately RMB176.06 million.
— Sales of another new product Qianping injections amounted to approximately RMB166.75 million, a sharp increase of 125.7% as compared with the last year.
Cardio-cerebral medicines
The sales of cardio-cerebral medicines amounted to approximately RMB3,116.29 million, representing approximately 12.9% of the Group's revenue.
— Sales of Yilunping tablets amounted to approximately RMB910.34 million, a year-on-year increase of approximately 16.2%.
— Sales of Tuotuo calcium tablets amounted to approximately RMB753.55 million, a year-on-year increase of approximately 14.8%.
— Sales of Kaina tablets amounted to approximately RMB513.07 million, an increase of approximately 25.1% as compared with the last year.
Orthopedic medicines
The sales of orthopedic medicines amounted to approximately RMB1,809.36 million, representing approximately 7.5% of the Group's revenue.
— Sales of Gaisanchun capsules amounted to approximately RMB1,047.15 million, rising by approximately 4.6% as compared with the last year.
— Sales of Yigu injections amounted to approximately RMB315.05 million, a remarkable increase of approximately 68.8% against the last year.
Digestive system medicines
The sales of digestive system medicines amounted to approximately RMB1,529.55 million, representing approximately 6.3% of the Group's revenue.
— Sales of Aisuping injection amounted to approximately RMB949.25 million, a significant increase of approximately 26.5% as compared with the last year.
— Sales of Getai tablets amounted to approximately RMB327.29 million, an increase of approximately 37.6% as compared with the last year.
— Sales of Deyou granule amounted to approximately RMB176.84 million, a remarkable increase of approximately 66.8% as compared with the last year.
Respiratory system medicines
The sales of respiratory medicines amounted to approximately RMB1,084.61 million, representing approximately 4.5% of the Group's revenue.
— Sales of Tianqingsule inhalation powder amounted to approximately RMB627.43 million, an increase of approximately 24.3% as compared with the last year.
Anti-infectious medicines
The sales of anti-infectious medicines amounted to approximately RMB1,032.19 million, representing approximately 4.3% of the Group's revenue.
— Sales of Tiance injections amounted to approximately RMB564.49 million.
— Sales of Tianjie injections amounted to approximately RMB308.10 million, an increase of approximately 37.5% against the last year.
— Sales of Tianli (Linezolid and Glucose) injections amounted to approximately RMB98.78 million, a significant increase of approximately 101.1% against the last year.
Others
The sales of others amounted to approximately RMB4,494.43 million, representing approximately 18.4% of the Group's revenue.
— Sales of Debaian Cataplasm amounted to approximately RMB1,066.98 million, increased by approximately 42.4% against the last year.
R&D
During the year, the total R&D expenditure (including expensed off in the statement of profit or loss and recorded as development costs in the statement of financial position) amounted to approximately RMB2,651.53 million, which accounted for approximately 10.9% of the Group's revenue.
The Group has continued to focus its R&D efforts on new hepatitis, oncology, respiratory system and cardio-cerebral medicines. During the fourth quarter, the Group was granted 9 clinical trial approvals, 9 production approvals, and 6 approvals for Consistency Evaluation, and made 6 clinical trial applications, 4 applications for Consistency Evaluation and 11 production applications. Cumulatively, a total of 486 pharmaceutical products had obtained clinical trial approval, or were under clinical trial or applying for production approval. Out of these, 34 were for hepatitis medicines, 204 for oncology medicines, 27 for respiratory system medicines, 27 for endocrine, 50 for cardio-cerebral medicines and 144 for other medicines.
The Group also emphasizes on the protection of intellectual property rights. It encourages its subsidiaries to apply for patent applications as a means to enhance the Group's core competitiveness. During the fourth quarter, the Group has received 23 authorized patent notices (all were invention patents) and filed 83 new patent applications (77 invention patents, 1 utility model patents and 5 apparel design patents). Cumulatively, the Group has obtained 766 invention patent approvals, 23 utility model patents and 90 apparel design patents.
Prospects
Looking ahead to 2020, the implementation of measures including the launch of and adjustments to the New National Medical Reimbursement Drug List, realization of payment categorized under DRG, the Key Monitoring Drug List and performance evaluation of hospitals will speed up the adjustments to the products and overall industry landscapes, hence the turning point of the survival of the fittest gradually emerged in the industry. The implementation of new measures encouraging innovation will accelerate the approval and launch of innovative products. Leading local enterprises in the country will be confronted with more intense competition from multinational companies in terms of innovative products. Those companies like Sino Biopharm, which have strong innovative and R&D capabilities and continuously launch new products in the market, highlight their advantages. In addition to marketing more new products and consolidating its dominant position in the hepatitis and oncology small molecular drug sectors, the Group also places high value on the increasingly important treatment and market value of biopharmaceutical medicines and thus has adopted a comprehensive roadmap covering different facets from R&D to the production.
Also, in order to cope with the spread of the novel coronavirus around the world, the Group has maintained ample liquidity. As of 31 December 2019, its cash and bank balances amounted to approximately RMB11.91 billion, which is sufficient for withstanding any shocks that may result from abrupt changes in the economic and industry environments. Facing the fierce outbreak, the Group promptly made the decision in late January 2020 to issue zero coupon convertible bonds with a principal amount of EURO750 million. This move consequently generated more abundant funds for the Group. The Group will make good use of its capital and competitive advantages, to actively seek for high-quality acquisitions, investments and cooperation projects, to expand its core pharmaceutical business, as well as to comprehensively promote its greater healthcare development strategy, so as to lay the foundation for the Group's rapid development in the next decade.
Stepping into 2020, 5G network and devices have become more popular in Mainland China. As such, the Group will continue to step up its investment in big data, digitalization and artificial intelligence, as well as increase the use of related advanced technologies. These strategies will allow Group not only to further enhance its efficiency in management, R&D, production and sales, but also create greater value for the industry and patients and promote the development of "patient-oriented" pharmaceutical services, pharmaceutical care services and chronic disease management systems, providing full course disease management solutions from which patients can benefit.
Some newly approved products
New indication of Anlotinib Capsules( FOCUS V): Anlotinib has obtained the approval for a new indication for soft tissue sarcoma, becoming the first such targeted drug approved in China. It has also been included in the guidelines for the diagnosis and treatment of soft tissue sarcoma by the Chinese Society of Clinical Oncology.
Gadoxetic Acid Disodium Injection (Xian'ai): This liver-specific magnetic resonance contrast agent is the first generic drug of its type in China. The product is able to increase the detection rate of small liver tumors, facilitating early diagnosis and treatment of liver lesions. It is also expected to replace invasive examinations and has piqued the widespread interest of the industry.
Iodixanol Injection: Iodixanol is the only X-ray diagnostic contrast agent that is isotonic with blood. It is recognized and recommended by numerous domestic and international clinical guidelines and expert consensus for enhancing the lesion detection rate and functioning as diagnostic identification in the examinations of organ disease in the nervous and cardiovascular systems, chest, abdomen, pelvis, etc. As the third generic drug of its type in China, this product is expected to complement Xian'ai in the area of marketing.
Rivaroxaban Tablet: Rivaroxaban is an important product for preventing vein thrombosis after orthopedic operations. The Group has succeeded in producing and launching the first generic drug for this medicine.
Apixaban Tablet: Apixaban is applicable to adult patients who have undergone hip joint or knee joint elective replacement to prevent venous thromboembolism. Apixaban has a wider therapeutic window and broader market prospects. Apixaban tablets has been included in the New National Medical Reimbursement Drug List and is expected to become the major new product in the portfolio of the Group.
Abiraterone Acetate Tablet (Qingkeshu): Abiraterone Acetate Tablet is a drug for prostate cancer treatment of new mechanism of action. It has been designated as a first-line or second-line treatment option for prostate cancer by European and American clinical guidelines. Prostate cancer is the second most common type of tumor in men worldwide. In China, prostate cancer is the most common genitourinary cancer in men.
Fosaprepitant Dimeglumine for Injection: This neurokinin-1 (NK-1) antiemetic drug is recommended in numerous domestic and overseas guidelines. The Group is one of the first batch of domestic enterprises successfully producing a generic drug of this kind. This product can perfectly complement the Group's oncology medicine product line, which has already enjoyed the advantage, and is expected to become a heavyweight product in its oncology product line.
Caspofungin Acetate for Injection: This first new echinocandin antifungal drug has broad-spectrum antifungal activity. It has become the market's star product among the antifungal drugs for systemic use.
Tofacitinib Citrate Tablet (Tai'yan): This oral small molecule inhibitor of JAK1/JAK3. Tofacitinib has promising efficacy for treating rheumatoid arthritis, ulcerative colitis, active psoriatic arthritis, moderate-to-severe active ulcerative colitis. The Group is the first in the country to produce generic drugs of this kind. The Group has also obtained approval for Celecoxib Capsule, a classic osteoarthritis medicine with wide indications and a mature market. With the approval of Taiyan, the value of the osteoarthritis drug product lines has also surged substantially.
About Sino Biopharmaceutical Limited (HKEX:1177)
Sino Biopharm Limited is a leading, innovative research and development driven pharmaceutical conglomerate in the PRC. Its business encompasses a fully-integrated chain which spans from R&D to the manufacture and sales of pharmaceutical products. The Group's products have gained a competitive foothold across various therapeutic categories with promising potential, covering a vast array of biopharmaceutical and chemical medicines for treating tumors, liver diseases, respiratory system diseases, cardio-cerebral diseases and orthopedic diseases.
Sino Biopharm is a constituent stock of the following indices: MSCI Global Standard Indices – MSCI China Index, Hang Seng Index, Hang Seng Index – Commerce & Industry, Hang Seng Composite Index, Hang Seng Composite Industry Index – Consumer Goods, Hang Seng Composite LargeCap Index, Hang Seng Composite LargeCap & MidCap Index, Hang Seng China (Hong Kong-listed) 100 Index and Hang Seng Stock Connect Hong Kong Index. Sino Biopharm was ranked as one of "Asia's Fab 50 Companies" by Forbes Asia for three consecutive years in 2016, 2017 and 2018.
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