Uni-Bio Science Group Limited: 2018 Annual Results
March 29, 2019Enhanced 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–(BUSINESS WIRE)–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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
Annual Results
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.
Prospects
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.”
–END–
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.
Contacts
DLK Advisory
Michelle Shi ([email protected])
Linda
Liang ([email protected])
Cathy
Wu ([email protected])
Max
Lau ([email protected])
Tel:
+852 2857 7101
Fax: +852 2857 7103