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| Strengthens Sales Force and Commercial Platform to Boost Market Penetration |
HONG KONG, June 14, 2016 - (ACN Newswire) - Uni-Bio Science Group Limited ("Uni-Bio Science" or the "Group"; HKEx code: 690) has announced its audited annual results for the year ended 31 December 2015. The Group has achieved its strong financial and operational performance as a result of a number of strategic initiatives including success in managing tenders by the new Market Access department, strengthening its commercial platform, and successful product penetration of new provinces.
Highlights:
- Normalized period (adjusted for forex fluctuations) of sales grew 11.8%, significantly beating industry growth of 5.0%
- Loss from operations narrowed by 30.5% as a result of increase in sales and reduction of general and administrative expenses
- Gross profit margin remained at a high level of around 83.0%
- Healthy balance sheet with HK$110.0 million in bank deposits, bank balances and cash
- Direct sales force expanded by approximately 30% and regional distributor network by 20%
- Reimbursement secured in three new provinces for GeneSoft
- Uni-PTH's New Drug Application accepted for review by the CFDA
- Uni-E4 meets primary and other secondary endpoints in phase III clinical study
- Beijing chemical manufacturing line awarded new cGMP certification
- Completion of first domestic partnership with Jiangsu Hansoh for the commercialization of Mitiglinide, a new oral anti-diabetes drug
For the year ended 31 December 2015, the Group recorded a consolidated turnover of approximately HK$123.4 million, representing an increase of 9.6% year-on-year. Sales growth adjusted for forex fluctuations was 11.8%, which compares very favorably to the overall PRC hospital drug sales growth of approximately 5.0%, according to IMS. Gross profit for the year was approximately HK$102.8 million, representing an increase of 9.7% as compared to the previous year. Gross profit margin remained constant at around 83.0%.
Loss from operations narrowed by 30.5% to HK$42.2 million from HK$60.7 million in FY2014. This year's loss from operations was for the most part due to depreciation on fixed assets and amortization of intangible assets and prepaid lease payment totaling HK$32.6 million due to the heavy investment previously made in plant and machinery to adhere to the new China Good Manufacturing Practice (cGMP) standards, and development in advance of the commercialization of its pipeline products (Uni-PTH and Uni-E4). In addition, the Group continues to invest heavily in R&D as its mission is to enable access of new and effective drugs to Chinese patients, which is otherwise too expensive or not avalaible in the PRC. Over the period, the Group invested a total of HK$36.3 million into R&D (including capitalization to intangible assets), which represents 29.4% of total revenue of the corresponding year. The Group maintained a healthy financial position with bank deposits, bank balances and cash amounting to HK$110.0 million as at 31 December 2015.
Mr. KOH Phee Wah, CEO of the China Operations, said, "2015 marked another year of significant change for the pharmaceuticals industry in China. Regulators have taken more fundamental steps towards upgrading the domestic pharmaceutical industry in order to compete internationally. Their objective is to consolidate the industry, cluster innovators, and improve the quality of pharmaceutical products whilst lowering costs across the overall healthcare system. Therefore, industry growth has slowed significantly from over 20% growth two years ago to 5% this year. While all players across the industry face significant pressure, those who adapt quickly and successfully cope with the changes will emerge stronger. The Group is ensuring we are well positioned to be successful and our business sustainable in light of these priorities. Based on our new international management team, our portfolio strategy focused on new drugs, and significant achievements in 2015, we are confident that Uni-Bio Science can navigate the fast-changing industry environment and emerge as an industry leader."
The Group's core elements for its overall business strategy focus on a two pronged approach of international execution and accelerating growth. The former refers to human capital investment, compliance with cGMP manufacturing standards and upgrading the IT infrastructure to meet international standards of operation. On the other hand, the latter includes the expansion of the commercialization platform and implementation of its new partnership model, in order to accelerate the growth of the Group's business. For example, one of the Group's priorities in 2015 was to expand its commercial platform in preparation for the launch of two new next-generation products. During the year, it increased the in-house team of sales representatives by approximately 30% and expanded its regional distributor network by 20%. The Group continues to be in discussions with large sales organizations exploring partnerships for its currently marketed products.
During the year, Uni-Bio Science has established a new Market Access team which has successfully secured GeneSoft reimbursement, the only product in its marketed portfolio not reimbursed under the National Reimbursement Drug List (NRDL), in Jilin and Yunnan provinces and Tianjin municipality. While 2015 marked a watershed for the industry as it became mandatory for all provinces in China to open up for tender before the end of the year, the Group is glad to see its strategy realizing a very positive result. The Group has set up a dedicated multi-functional task force, including its Market Access team and senior management, to ensure that tendering process for its three marketed products, namely Pinapu GeneTime and GeneSoft is effectively managed, whilst holding drug prices at a sustainable level. The satisfactory outcome is one of the key factors why Pinapu has grown over 30% in 2015.
For the past decade, the Group has focused on creating innovative and proprietary products with the potential to deliver significant commercial value to its business. During the year, substantial progress has been made in Uni-PTH and Uni-E4, two of its leading development products. Uni-PTH was officially accepted by the China Food and Drug Administration (CFDA) for review and Uni-E4 has successfully met the primary effacacy and safety endpoints in phase III study. These progresses mark a significant advance and achievements by Uni-Bio Science's clinical team, enhancing the Group's commercial prospects and attaining key milestones in accordance with the strategic schedule. Post year-end, the Group has also advanced forward with Uni-EPO-Fc by completing phase I single ascending dose (SAD) trial. This trial demonstrated that Uni-EPO-Fc was well tolerated in all dose groups and enables the Group to progress the development of a product with the potential to be the first long-acting EPO formulation to be launched in China.
In order to solidify its foundation, the Group has upgraded its manufacturing facilities during the year to support its commercialization strategy. At the beginning of 2015, the Group's manufacturing entity in Shenzhen has already received new GMP status. Furthermore, its manufacturing facility in Beijing successfully upgraded its chemical manufacturing line to comply with the latest GMP standards in August 2015. In the end of 2015, all of the Group's manufacturing lines thus attained the latest GMP standards. This has bolstered the Group's position as a high-quality and reliable manufacturer, which meets both local and international standards.
Mr. Kingsley LEUNG, Executive Director of Uni-Bio Science, said, "For a small company, we have made very big advances in our business. We have strengthened the Group's capability and track record at every point of the value chain. The Group is well on the way to realizing our vision of becoming China's expert in diabetes management. One of the major milestones this year is completing our first domestic deal with Jiangsu Hansoh, partnering to commercialize our new oral anti-diabetes drug Mitiglinide. Strategically, the deal gives our commercialization platform immediate access to our core therapeutic focus in diabetes, meaning our sales team will be ready to commercialize our future innovative products, Uni-E4 and Uni-PTH, when they are launched. Our business development team is also exploring other exciting opportunities to fortify our portfolio. Overall, we gained good momentum in 2015 which we will channel towards 2016. We hope to achieve even more in the coming year and continue 'Leading Genuine Innovation' in China."
Contact:
Strategic Financial Relations Limited
Veron Ng Phone: +852 2864 4831 Email: veron.ng@sprg.com.hk
Angelus Lau Phone: +852 2864 4805 Email: angelus.lau@sprg.com.hk
Phoebe Li Phone: +852 2864 4862 Email: phoebe.li@sprg.com.hk
Fax: +852 2527 1196
Topic: Press release summary
Source: Uni-Bio Science Group Limited
Sectors: Daily Finance, Daily News, BioTech
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