Expanding Portfolio with New Drug Innovations and Strategic R&D Partnerships
HONG KONG SAR - EQS Newswire - 27 March 2023 - 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 2022 (the "Year").
Key Accomplishments in 2022
During the Year, the Group achieved a spectrum of accomplishments, for both of its marketed products and innovative biologics. The key highlights include:
- During the Year, the Group achieved a record high turnover of HK$440.3 million, representing a noticeable increase of 24.6% year-on-year ("YoY"). Sales of Pinup® and Boshutai® performed exceptionally well, registering an increase of 51.2% and 292.5% YoY respectively.
- The Group made a remarkable turnaround, posting a profit of HK$38.5 million with a significant increase of 296.6% YoY, marking an important milestone for a research-oriented biopharmaceutical company.
- The Group's Acarbose Tablets (Boshutai®) was successfully awarded the drug alliance procurement bid for the second and fourth batches of medicines for two years in the 13-provinces Alliance Procurement. To meet the growing demand for Boshutai®, the Group had already expanded its production capacity at its strategic partner's Suzhou production site to ensure supply stability.
- New Drug Application ("NDA") of the Group's Bogutai® (teriparatide injection) had been accepted by the China National Medical Products Administration ("NMPA") and completed the China Center for Food and Drug Inspections ("CFDI") registration site verification. Bogutai® will be the Group's fifth marketed drug and the first domestically manufactured PTH Liquid in China to use a disposable injection pen.
- The Group has continuously improved EGF process technology and increased the production capacity of the drug substance to 4 times the original amount, further enhancing production efficiency, reducing costs, while opening up new formulation opportunities.
- The formulation development of oral form Uni-GLP-1 was completed, and the results showed that its bioavailability was superior to the positive control oral semaglutide. Currently, formal animal studies in beagle dogs are under preparation to further validate the bioavailability and pharmacokinetics of the oral form Uni-GLP-1 in animals. The clinical work of Uni-GLP-1 injection pen is on schedule for related pharmacological studies.
- The Group's fibronectin products are shown to be as effective as natural fibronectin derived from human blood. During the Year, the Group had completed the development of fibronectin raw material, which have high yield and high activity. It will be the first advanced skincare raw material of the Group to be launched.
In 2022, the Group recorded a record-breaking revenue of approximately HK$440.3 million, representing a significant increase of 24.6% year-on-year (2021: HK$353.4 million). The increase in revenue was mainly attributable to the impressive sales growth of Pinup® and Boshutai®. Pinup® saw a remarkable increase of 51.2% in revenue, jumping from approximately HK$142.2 million to approximately HK$215.1 million for the Year. The increase was attributable to Pinup®'s inclusion in the national centralized procurement in 2021, which has secured the Group with substantial hospital orders. During the Year, revenue of Boshutai® increased substantially from approximately HK$4.5 million to approximately HK$17.4 million, representing a significant increase of 292.5%. GeneSoft® recorded an increase in revenue from approximately HK$36.3 million to approximately HK$38.4 million, representing an increase of 6.0%. Revenue generated from GeneTime® was approximately HK$169.4 million, representing a decrease of 0.6% from approximately HK$170.5 million in 2021. Despite the pandemic-related production interruptions in the first quarter of 2022, the Group quickly resumed and upgraded production of GeneTime®. As a result, sales of GeneTime® resumed growth in the second half of the Year, offsetting the earlier shortfall.
Gross profit was approximately HK$334.9 million, representing an increase of 20.9% as compared with approximately HK$277.0 million in 2021, whereas gross profit margin was 76.1% (2021: 78.4%). Thanks to the Group's diligent internal control, general and administrative expenses accounted for merely 10.7% of revenue in 2022 as compared with 13.3% in 2021. The selling and distribution expense for the Year also decreased to 48.0% of revenue from 52.5% in 2021. The R&D expenses decreased by 28.8% to approximately HK$35.8 million due to the completion of several clinical tests and the capitalization of development expenses.
The Group's commitment to cost control and profitability resulted in earnings before interest, tax, depreciation and amortization ("EBITDA") for the Year of HK$65.8 million as compared to HK$13.7 million in 2021. Net cash flow of HK$48.7 million from operating activities for the Year was recorded, representing the second consecutive year of positive cash flow for the Group. The Group recorded a profit of approximately HK$38.5 million for the Year, a remarkable increase of 296.6% year-on-year (2021: loss of HK$19.6 million). Basic earnings per share was approximately HK$0.61 cents (2021 basic loss per share HK$0.31 cents).
Despite the reopening of borders, global economic headwinds are expected to continue in 2023 due to rising interest rates, inflation, and geopolitical trends. These factors will create economic shifts and challenges for businesses in areas such as trade, investment, and labor. Yet, with the implementation of the "Healthy China" strategy and the support of favorable factors such as supportive policies, industry efforts, and capital investments, the pharmaceutical and healthcare sector is expected to remain one of the most dynamic and promising fields in China over the longer term.
Despite the unpredictable headwinds, the Group has consistently maintained a healthy financial position with a positive cash flow and a manageable debt load. Our innovative "four-wheel drive" business model, which includes high-value generic drugs, bio-innovative drugs, new skincare raw materials, and CMO business, enables us to diversify our income streams and adapt to changing market conditions. This approach fosters sustainable growth while positioning us as a leader in the competitive biopharmaceutical landscape.
Looking forward, Mr. Kingsley Leung, Chairman of Uni-Bio Science said, "We are well-equipped to navigate challenges and capitalize on emerging opportunities, remaining dedicated to product innovations. We have enhanced production capacity four-fold to meet the growing demand of our signature EGF products. We have also been exploring different applications of the EGF products while developing different dosage forms of the EGF products, such as gel form, film form, and VSD foam dressings. The single-dose form of GeneSoft® (no preservatives) utilizing the Blowing Filling and Sealing packaging technology has also been under development, which can reduce the risk of cross-infection as well as is safer and more convenient to use. This technology will also be used to develop Diquafosol Sodium Eye Drops, which is complementary to GeneSoft®.
Besides product innovation, our product development has also come to fruition. Bogutai®, the first domestically manufacturing PTH Liquid in China to use a disposable injection pen, will be approved for product launch by September 2023. It will become our fifth marketed and self-developed drug. We believe that Bogutai® will become another signature product. Meanwhile, our first advanced raw skincare material, fibronectin, is also ready for market launch in 2023. We believe with these products will further diversify our revenue stream and will ride on the growing market opportunities. At the same time, we have been preparing for the new round of national centralized procurement for Pinup®, which will be launched as soon as in April 2023. As Pinup® was among the first to be selected in the fourth batch of the national centralized procurement, the Group will enjoy the advantage and is confident to be selected in the upcoming procurement.
Uni-Bio is steadfast in its efforts to strengthen its comprehensive R&D capabilities and broaden its portfolio of best-in-class products. We have been partnering with Alephoson Biopharmaceuticals Ltd. and DotBio Pte. Ltd. to investigate the potential application of Cell Penetration Protein Alternation Technology (CePPA) and co-develop next-generation best-in-class compounds in ophthalmology and other potential therapeutic areas since late 2021. We have also committed to the research of innovative delivery technology for oral drugs of peptide drugs to solve many pain points caused by traditional single drug delivery. Some of which under development include 3rd generation oral form of Uni-PTH, oral dosage form of Uni-GLP-1, as well as Uni-GLP-1 injection pen. Through these efforts, we aim to further diversify the formulation choices of the Group's marketed and future products, providing better solutions that meet the evolving needs of patients."
The issuer is solely responsible for the content of this announcement.
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 also has a highly efficient commercialization platform and marketing network. The Group focuses on the development of novel treatments and innovative drugs addressing the therapeutic areas of endocrine such as diabetes and osteoporosis, 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.