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| Achieves Major Clinical and Manufacturing Milestones and Strengthens Internal Organizational Structure |
HONG KONG, Mar 28, 2015 - (ACN Newswire) - Uni-Bio Science Group Limited ("Uni-Bio" or the "Group;" HKEx code: 0690) has announced its results for the nine months ended 31 December 2014 (the "Period"), subsequent to its announcement of changing the end date for its financial year from 31 March to 31 December earlier in 2014.
Highlights:
- Sales and Marketing capabilities broadened to realize strong China growth opportunities, Medical Function established to support commercialization of proprietary products
- First commercial partnership agreed following launch of new partnering and commercialization strategy
- Positive results announced from Phase III trial of Uni-PTH, Uni-Bio's novel biologic for the treatment of osteoporosis; filing with CFDA now underway
- Investments made in Uni-Bio's manufacturing facilities to meet cGMP guidelines in preparation of new commercial launches
- China healthcare industry reforms shift focus towards high value-added patented drugs; next generation drugs in Uni-Bio's pipeline positioned well to tap greater opportunities
- Healthy cash position amounting to HK$138.1 million as at 31 December 2014
Under the guidance of a strengthened management team, the Group has advanced across a broad front in the review period, including the consolidation and bolstering of the sales and marketing teams and the Medical Function, while realizing synergies in operations. During the Period, the Group achieved major clinical and manufacturing milestones and successfully launched its new partnership model, completing its first collaboration with a Korean pharmaceutical company - all important advances which will contribute to the Group's future success.
For the nine months ended 31 December 2014, the Group recorded consolidated turnover of approximately HK$91,793,000, representing an increase of 11.8% compared with the corresponding period last year. The growth was mainly driven by the strong 14% rise in the sales of biologic products, in line with industry performance. Gross profit during the period also grew 17.4% to approximately HK$76.7 million, while the gross margin improved further by four percentage points to 84%, representing the fifth consecutive year of growth.
Net loss narrowed to approximately HK$42,434,000 as a result of the sales growth of the Group's core products. A net loss was recorded during the period under review due to large depreciation and amortization expenses, which reflect the Group's previous investments made to develop and commercialize its next generation biologics and to upgrade its manufacturing facilities to meet the latest cGMP standards. The Group maintained a healthy financial position with bank deposits, bank balances and cash amounting to HK$138.1 million as at 31 December 2014.
Mr. KOH Phee Wah, CEO of the China Operations said, "2014 was a transformational year for the healthcare landscape in China. Regulators have attempted to lessen top-down state guidance in favor of market-driven dynamics creating growth opportunities for healthcare companies, as evidenced through a number of new policy measures: easing the one-child family planning policy, beginning the process of liberalizing drug pricing, permitting private and foreign investment in the hospital and elderly care subsectors, and loosening regulations for online prescription drug sales. As an innovative biopharmaceutical company, Uni-Bio has been successful in strategically strengthening its operations during the Period, positioning the Group well to capture growth opportunities and continue to build upon our commercial successes."
To better prepare for the more market-driven environment and to fully capture the value from the upcoming drug launches, the Group has implemented measures to strengthen specific functions in the Period. Firstly, it has completed the consolidation of the sales and marketing teams into one, which realizes synergies, reduces administration cost and, most importantly, creates a focused senior management function well-positioned to seize market opportunities. In addition, during the Period, the Group established a dedicated Government Affairs team and formalized its Medical Function team, encompassing medical affairs and clinical development, which provides valuable input into the Business Development team. Led by the strengthened Board of Directors and senior management team bolstered by the appointment of new members in the first half of 2014, the new and expanded teams will support the ambition to accelerate the Group's growth through strategic business development initiatives.
Secondly, the Group continues to invest in its manufacturing facilities to ensure compliance with global standards across all plants. With the upgrade works to the Group's Shenzhen facilities successfully completed to meet the new cGMP Standards, the Group has focused on upgrades to its Beijing plant and expects the plant to comply with the new standards within the second half of 2015, ahead of the deadline. The investments made in the Group's manufacturing facilities will support its commercialization strategy as more proprietary products reach late-stage development.
Under the new policies launched by the Central Government, one of the goals of the regulators is to reward innovation by providing premium pricing for patented drugs. With its focus on R&D and developing high-value, patented drugs, the Group should greatly benefit from these new mechanisms as all of its drugs except for one product are innovative under these criteria in China.
During the period under review, the Group announced positive Phase III clinical trial results of its anabolic (bone growth) agent, Uni-PTH, for the treatment of osteoporosis. Uni-PTH met its primary endpoint, demonstrating significant superiority over current treatments at improving bone quality after 12 months of treatment. The Group is expected to submit a regulatory filing to the Chinese Food and Drug Administration in the second quarter of 2015. The Group is expected also to complete the investigator meeting for Uni-E4, which is within the GLP-1 agonist class of anti-diabetic treatments, in the first half of 2015. Both Uni-PTH and Uni-E4 are expected to be launched as early as mid-2017.
In view of the Central Government's policy of increasing healthcare expenditure and reimbursement coverage, the Group has set up a market access function that focused on the inclusion of GeneSoft(R) on the National Reimbursement Drug List as it is the Group's only marketed product which is not yet included on the list. With a broader reimbursement coverage, the Group expects GeneSoft(R) to enjoy significant volume expansion. In addition, the Group has also successfully increased the shelf life of Pinapu(R), its voriconazole tablet, from two to three years, significantly improving the competitive profile of Pinapu(R).
As announced earlier, the Group launched a new partnership model during the Period, focusing on partnering innovative late-stage and commercialized drugs which complement its portfolio of approved treatments and candidate drugs for diabetes, ophthalmology and dermatology in China. The first new partnership agreement was completed with an established Korean ophthalmology company, Samil Pharmaceuticals, in September 2014, just four months after embarking on the strategy. Under the terms of the agreement, the Group has gained exclusive rights to one novel anti-allergy and three novel ophthalmology treatments in China, Hong Kong and Macau, and will be the sole distributor of the products for eight years. The agreement is a clear example of the Group's vision to establish a large and growing portfolio of clearly differentiated treatment options for patients in China.
Mr. Kingsley LEUNG, Executive Director of Uni-Bio Science said, "In 2015, the Group will remain focused on implementing its new, focused business development strategy, launch next-generation treatments and establish new partnerships. To accelerate growth of the Group's topline, we plan to aggressively expand the number of sales representatives in key locations. We are also evaluating collaboration opportunities with other sizable pharmaceutical companies in China to proactively expand the market share of our commercialized products. 2015 marks an important year in relation to several major tenders and we believe the Group is in a strong position to realize strong commercial growth opportunities as a result of the increasing prevalence of tendering."
Contact:
Strategic Financial Relations Limited
Veron Ng, +852 2864 4831, veron.ng@sprg.com.hk
Angelus Lau, +852 2864 4805, angelus.lau@sprg.com.hk
Caley Chan, +852 2114 4950, caley.chan@sprg.com.hk
Fax +852 2527 1196
Topic: Earnings
Source: Uni-Bio Science Group Limited
Sectors: Daily Finance, BioTech
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From the Asia Corporate News Network
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