-Enhanced Market Penetration of Core Marketed Products
-Pipeline Products Witnessed a Steady Progress to Launch
-Commencement of CMO Service to Fully Harness Asset Values
HONG KONG, March 30, 2019 /PRNewswire/ — A fully integrated biopharmaceutical company – Uni-Bio Science Group Limited (“Uni-Bio Science”, together with its subsidiaries referred to as the “Group”, stock code: 0690.HK), is pleased to announce its annual results for the year ended 31 December 2018 (the “Year”), as well as its comparatively figures for the year ended 31 December 2017 (“2017”).
Key Accomplishments in 2018
During the Year, the Group has recorded a spectrum of accomplishments, either in terms of marketed products, or consolidation of the Group’s assets. The key highlights include:
- During the Year, the Group’s investments and efforts in marketing team’s integration and optimization, especially expanding the sales capacity for its biologic drugs, notably GeneTime® and GeneSoft®, have begun to bear fruit. The extended coverage into tier-3 hospitals, primary healthcare centres, and community hospitals has greatly fuelled the revenue growth of the Group. These two products have seen growth both in their average selling price and sales volume, totaled at HK$72.5 million and HK$31.3 million, representing an increase of 9.2% and 49.4% respectively.
- During the Year, Pinup® (commonly known as voriconazole tablets) successfully tapped into the Guizhou, Xinjiang, Shaanxi and Hainan market and expanded its coverage to 26 provinces. The Group also entered into a cooperation agreement for Pinup® National Promotion Project with Shanghai Loymed Pharma Technology Co., Ltd. (“Loymed Pharma”). Under the Agreement, Loymed Pharma was granted the exclusive agency right to market, promote, distribute and sell the contract product in the PRC. The Group believes that partnering with Loymed Pharma, who enjoys extensive distribution network in the PRC market, it will continue to expand the market coverage of Pinup® in order to fully realize its market potential.
- The Group has completed the BE study of Acarbose tablet and is in the view that BE results are robust. The abbreviated new drug application (“ANDA”) together with related BE study results were submitted and accepted by the NMPA in December, 2018. In addition, the Group’s another self-developed biologic drug tailored for patients living with Type 2 diabetes, Recombinant Exendin-4 Injection (“2nd Generation Uni-E4”), has been accepted by the CDE of NMPA for Phase III clinical trial during the Year.
- The Group’s newly launched product Bokangtai (Mitiglinide tablets) also concentrates on the treatment of Type 2 diabetes. During the Year, Bokangtai added ten more provinces into its distribution network, namely Shandong, Guangxi, Xinjiang, Qinghai, Ningxia, Hainan, Sichuan, Guizhou, Yunnan and Guangdong. Currently, the Group is collaborating with Jiangsu Hansoh Pharmaceutical Group Co., Ltd. to jointly conduct the BE study on Bokangtai. The preparation work was commenced and the BE online registration will be submitted in the second half of 2019. Approval is expected to be obtained in 2020.
- To fully harness asset values, the Group set up two state-of-the-art aseptic production lines to support the development of the 2nd Generation Uni-PTH and Uni-E4 injection-form products, and currently the production lines are put into operation of Contract Manufacturing Organization (“CMO”) services. The Group has also launched the 3-in-1 CMO customizing services solution, which could collaborate strategically with client base on the distinctiveness of R&D of new drugs and the respective production process, hence to offer quality and efficient CMO production services.
- During the Year, the Group strategically completed a series of non-core asset disposal and asset structure optimization, including the divestiture of non-core R&D projects by offloading the chemistry, manufacturing, and controls (“CMC”) platform with its related facilities and joint management of fixed assets, thereby improving management efficiency, revitalizing asset portfolios, streamlining business operations, and focusing on core businesses. The Group believes that such disposal will benefit more on developing, manufacturing and distribution of innovative biological pharmaceutical products.
- Uni-PTH, namely its powder famulation, the only anabolic agent effective in improving bone density, is marching towards its official launch. The Group has been taking proactive actions to proceed with the launch timetable of Uni-PTH and actively preparing for its NMPA’s on-site inspection. Meanwhile, through constructive communication with CDE, both sides came to a conclusion that the clinical trial of the liquid form of Uni-PTH is to be exempted, thus, it will proceed into BE study in the near term.
In 2018, the Group recorded a turnover of HK$135.3 million, representing a decrease of 13.6% YoY. The decrease in turnover was mainly attributable to the consistent R&D investment and weaker sales situation for one of the Group’s marketed drugs, namely Pinup®. R&D costs proportionate to revenue increase from 27.2% for 2017 to 32.7% for the Year to progressing our Biological innovation projects as EGF products, Uni-E4 and Uni-PTH, meanwhile, Pinup® faced keener price competitions across the marketplace where other market players lowered the product price, hence the sales was temporarily affected. However, sales of Pinup® had begun to pick up towards the end of the Year, thanks to its increased coverage to the total 26 provinces in PRC. Given that the Group’s major competitors who are engaged with price war in the market have not conducted BE study, obtaining the approval will allow the Group to enjoy numerous policy benefits during tendering and purchasing.
Gross profit decreased by 12.0% to approximately HK$117.6 million (2017: HK$133.6 million), on the contrary, gross profit margin improved slightly from 85.4% in 2017 to 86.9% in 2018, led mainly by the increase of overall unit sales price of GeneTime®. Alongside our efforts for restructuring and reorganizing our sales team in order to achieve greater efficiency, the Group also expanded the number of sales team members. Hence the sales and distribution cost recorded an increase over the Year.
In 2018, the Group recorded a loss of HK$120.6 million with a basic loss per share of HK$2.24 cents for the Year. The increase in loss was mainly caused by this reason: we have seen mounting pressure on the pricing of Pinup®, hence the Group has been optimizing its salesforce since last year in an effort to achieve maximum sales efficiency. The sales team has been expanding rapidly, and the distribution channels have also expanded significantly leading to a higher cost in the short term. By the time the Group secure the threshold of drug consistency evaluation, which should be by 2020, more resources will be deployed on marketing and distributing Pinup®. This should bring promising revenue in the near future.
Looking forward to 2019, in the face of rising pressure on tendering price cut, as well as the escalating trade tension between the United States and China, the Group remains in the view that innovation, business diversification and efficient resource allocation could promise stability despite regulatory pressure and political risks. The expanding aging population, along with the increasing health awareness of people, should also lay a foundation for pharmaceutical companies with expertise in specific diseases to thrive. Diabetes has become increasingly prevailing during the past decade. According to the International Diabetes Federation, there was a total of 425 million adults with diabetes worldwide last year. It is predicted that the population of diabetes patients will grow rapidly in the next 30 years. Within which PRC is expected to be accounted for approximately 48% of the population. Under such favourable factors, The Group is of the belief that market sentiment over healthcare sector will recover in the near future, and hence creating to a stable development environment for the Group.
Mr. Kingsley Leung, Chairman of Uni-Bio Science, commented “In 2018, our Group witnessed a series of policy rollouts with the pharmaceutical peers in China – capacity upgrade and optimization, reshuffling of business channels, new regulations in the capital market that have reshaped the wider marketplace. Faced with these uncertainties, the Group still strived to enhancing our revenues, albeit yet to reach a turnaround in profit, we have laid a solid foundation to harvest the fruits we cultivated previously. Our chemical products, including antifungal and Type II diabetes drugs, would likely to obtain BE approval as scheduled. Innovative biologic drugs in the pipeline and clinical trials have received positive feedback from the CDE and assured of our launch schedule. We partnered two capable parties to deeply explore market potentials, and more investment institutions and investors have come to realized that the Group’s values have been underestimated. Our new production lines can support mass production of injection products apart from taking up more CMO tasks. Going forward, we will continue to push the launch of new drugs and exercise efficient control on costs. We will continue with our business philosophy, to offer more pharmaceutical solutions to the China market with regard of endocrinology and related fields.”
About Uni-Bio Science Group Limited
Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of pharmaceutical products. The research and development center is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with NMPA requirements. The Group also has two GMP manufacturing bases in Beijing and Shenzhen. The Group is focused on the development of novel treatments and innovative drugs addressing the therapeutic areas of diabetes, ophthalmology and dermatology.
Uni-Bio Science Group Limited was listed on the Main Board of the Hong Kong Stock Exchange on November 12, 2001. Stock code: 0690.
This press release is issued by DLK Advisory Limited for and on behalf of Uni-Bio Science Group Limited.
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