Uni-Bio Science Group: 2020 Annual Results

Successful Expansion into Pharmaceutical E-commerce

Driving Sales Growth of GeneTime�

Achived Significant Progress towards Pipeline Products and Boshutai® was Granted Approval for Marketing in China

HONG KONG SAR – EQS Newswire – 30 March 2021 – 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 2020 (the “Year”), as well as its comparative figures for the year ended 31 December 2019 (“2019”).

Key Accomplishments in 2020

During the Year, the Group achieved a spectrum of accomplishments, for both of its marketed products and innovative biologics. The key highlights include:

1. GeneTime® (EGF spray indicated for wound healing) generated remarkable results. Sales of GeneTime® reached HK$137.2 million, representing an increase of 9.5% YoY. The Group’s newly-developed digital marketing and pharmaceutical e-commerce platform will continue to be a strong sales driver of GeneTime®.

2. The Group’s Pinup® (Voriconazole Tablets) had been successfully approved by the National Medical Products Administration (“NMPA”) for Bioequivalence (“BE”) certification in December 2020, and had been included in the national procurement tender on 8 December 2020. The approval would facilitate Pinup®’s hospital tenders and listings, especially in national procurement, to achieve a larger market share in the anti-fungal infection drug market.

3. Durning the Year, the Group’s Uni-PTH (pre-filled injection pen) or 2nd Generation Uni-PTH was successfully approved by NMPA for clinical trial. The Group will begin conducting bridging clinical trial for 2nd Generation Uni-PTH. In May 2020, the Group started a partnership with Swiss self-care giant Ypsomed to co-develop 2nd Generation Uni-PTH alongside YpsoPen®, a state-of-the-art pen injector with unparalleled dosing accuracy which minimized injection pain.

4. The application for clinical trial of Recombinant GLP-1 Injection (“Uni-GLP”) has been approved by NMPA on 14 July 2020. Currently, the Group’s professional and technical teams are making great efforts in preparing for clinical trial-related work. Supported by recent data, Uni-GLP has proven its developmental potential in treatment of COVID-19 and other high value indications.

5. The Group’s Boshutai® (Acarbose Tablets) was granted approval for marketing in China by NMPA on 10 November 2020 and the Group also passed GMP manufacturing inspection and was approved to manufacture Boshutai® from 10 December 2020. To ensure Boshutai® would be manufactured at the most competitive cost, the Group formed a strategic partnership with Sinopharm Weiqida Pharmaceutical Company Limited and Suzhou Yingli Medical Technology Company Limited during the Year to lower the production cost, increase manufacturing efficiency and streamline the overall supply chain.

6. During the Year, the Group partnered with Chengdu Medlinker Technology Company Limited to co-develop digital marketing and pharmaceutical e-commerce platform for the Group’s products. Aiming at creating an integrated healthcare system, this corporation is expected to deliver much better service for patients and clinical practitioners, expanding its available marketing channels, and enhancing brand awareness. In addition, the Group is also proactively exploring partners such as Haodaifu (?????) and other respective platforms to address the unmet needs for online drug sales.

Annual Results

In 2020, the Group recorded a turnover of HK$208.8 million, representing a slight decrease of approximately 0.3% YoY (2019: HK$209.4 million). The decrease in turnover was mainly attribute to the significant sales drop in the first quarter of 2020 during the outbreak of COVID 19. The turnover in the second half exceeded expectation, and was able to offset most of the shortfall in the first half of 2020. Among all the products, GeneTime® was particularly favoured by the market, with an increase of 9.5% in turnover from approximately HK$125.3 million in 2019 to HK$137.2 million in 2020. The remarkable turnover growth was mainly attributable to the strong recovery from hospital sales due to efforts of the Group’s broad market team, as well as the additional turnover from the newly-developed digital marketing and pharmaceutical e-commerce platform since May 2020. During the Year, GeneSoft® recorded a decrease in turnover from approximately HK$33 million in 2019 to HK$31.6 million, representing a decrease of4.2%. The decrease was mainly attributable to the serious reduction in patients’ hospital visits since the outbreak of COVID-19, despite there was a gradual recovery in the second half of the Year. Market competition was keen as Pinup® did not received its BE Certification from the NMPA until December 2020. Pinup® recorded a decrease of 21.9% in turnover from approximately HK$48.0 million to approximately HK$37.5 million during the Year. The decrease was also attributed to the reduction in patients’ hospital visits due to the COVID-19 outbreak.

Gross profit slightly decreased 0.2% from approximately HK$181.5 million in 2019 to HK$181.1 million in 2020, whereas gross profit margin remained stable at 86.7% (2019: 86.7%). Alongside the ongoing internal control and business optimization by digitalization, as well as the restructuring of the Group’s sales force and the building of its direct sales team, general and administrative expenses (“G&A Expenses”) decreased for three consecutive years. G&A Expenses decreased 39.7% yoy from HK$ 59.4 million in 2019 to HK$ 35.8 million in 2020, accounted for 17.2% of turnover as compared with 28.4% in 2019. The percentage of selling and distribution expense over turnover improved to around 70.0% in 2020 from 71.3% in 2019 because of the Group’s cautious salesforce optimization. R&D expenses slightly decreased by 4.6% to HK$ 40.7 million due to the completion of several clinical tests, of which the development expenses have been capitalized. Operating loss for the Year was HK$ 70.9 million due to an impairment of intangible assets from certain old technologies of previous version products (Uni-PTH and Uni-GLP) and an impairment of intangible assets from the unsatisfied BE result and the suspended BE process of Boshutai®. Excluding the impact of write-off intangible assets and impairment loss on deposit paid for the acquisition of intangible assets in 2020 together with one off gains from disposal of property and subsidiary in 2019, the normalised operating loss was significantly reduced from HK$62.7 million in 2019 to HK$ 34.8 million in 2020. For 2020, the Group recorded a loss of HK$ 71.3 million (2019: profit of HK$2.5 million), with a basic loss per share of HK 1.11 cents (2019 basic earnings per share: HK0.04 cents).

Prospects

The COVID-19 pandemic has not only driven the growth of the pharmaceutical industry, but also boosted the online healthcare sector, especially in China. Regulatory reforms have been introduced to support the digitalization of the healthcare industry. The Group believes that the favorable online market environment and government policies would benefit its business operation and promotebusiness growth in the future.

Focusing on the Sales of EGF Products

The Group’s signature products, GeneTime® and GeneSoft®, have been well-received by the market. The collaboration with Medlink to develop digital marketing channels has proved to be successful, as GeneTime® recorded a tremendous increase in turnover in the second half of 2020. The Group will continue to utilize the online resources to promote GeneTime®. To accommodate the increasing demand, the Group is planning to expand the production capacity for its EGF products. New technologies will also be integrated to this new plant to further increase efficiency and decrease production costs. The new site is expected to commence operations in 2023.

Awaiting for Results of Pinup® in National Drug Volume-based Procurement Which Will Help Secure Future Growth

The Group submitted the tender application of Pinup® for the National Drug Volume-based Procurement and has been waiting for the results announcement. Pinup® is a voriconazole tablet that is tailored to treat severe fungal infection, and the Group is one of the only two manufactures that has passed BE certification for the 50mg formulation of voriconazole at the end of 2020. The Group is confident that Pinup® will be included in the procurement and believes that the successful inclusion will help meeting the rising demand of anti-fungal medicine in the both public as well as private hospitals, and will deliver positive impact to the Group’s top and bottom line in the future.

Focusing on the Commercialization of Acarbose Tablet

In 2021, the Group will focus on the commercialization of Boshutai®, and expects immediate sales contribution from the product. Meanwhile, the Group will promote Boshutai® through third-party channels, including online platforms, retail pharmacies, as well as private hospitals, to further expand its distribution coverage at a competitive pricing.

Accelerating the Clinical Research Progress

The Group is optimistic about the potential of Uni-GLP in new therapeutic areas, and will continue to collaborate with several universities in China to conduct preclinical research of Uni-GLP in obesity, as well as to formulate a new innovative oral or 3rd generation Uni-GLP. In 2021, the Group will begin conducting bridging clinical trials for liquid form Uni-PTH, and wishes to submit the New Drug Application within 2021. If the process goes smoothly, it is expected that the powder form Uni-PTH will be launched in 2021 and liquid form Uni-PTH can be launched in as soon as 2022.

Mr. Kingsley Leung, Chairman of Uni-Bio Science, added, “In a longer term, we aim to establish a leading drug commercialization platform in expanding its business scale in both upstream and downstream markets. In terms of upstream operations, the Group is looking for collaborations with innovative research and technology companies that are equipped with pharmaceutical development capabilities. While the partner company focuses on developing novel drugs, the Group will conduct clinical research and be responsible for commercialization in China by leveraging its extensive distribution network. In March 2021, the Group has formed a partnership with DotBio Pte. Ltd. (“DotBio”), a highly innovative biopharmaceutical company in Singapore, to co-develop next generation, best-in-class therapeutics for patients with retinal diseases. Leveraging on DotBio’s unparalleled technology capability in the ophthalmology space, together with the Group’s extensive experience in fermentation, purification, quality assurance and quality control of E.coli-expressed proteins, the Group believes that the partnership is able to diversify the Group’s pipeline and capture the rising needs of the age-related macular degeneration treatment market.The Group will also expand its distribution channels by tapping into pharmaceutical e-commerce. The online platforms not only allow patients to access services including online healthcare consultation, e-prescription and drug purchase at any time anywhere, but also expand doctors’ coverage and exposure by solving their bottleneck of being in one hospital at a time. The pharmaceutical e-commerce arena would definitely provide doctors and patients with higher degree of convenience and cost-efficiency, and that would in turn, drive more direct sales of the Group’s drugs. With our strategies to accelerate its product pipeline, enhance its operational efficiency and strengthen its sales network. These would in turn, promote its rapid growth and generate fruitful returns for its shareholders.”

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 centre 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.