Uni-Bio Science Group Limited 2019 Announces Annual Results

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  • Turnover Increased by 54.9% YoY to HK$209.4 million
  • Recording EBITDA of HK$28.4 million
  • Achieved Significant Progress towards Pipeline Product with 2
    Product Launches Expected in 2020

HONG KONG, CHINA
– EQS Newswire – 1 April 2020 – 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 2019 (the “Year”), as well as its comparatively figures for the year ended 31 December
2018 (“2018”).

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Key Accomplishments in 2019

During the Year, the Group has recorded
a spectrum of accomplishments both in terms of marketed products, and consolidation of the Group’s assets. The
key highlights include:

1.    GeneTime® (EGF spray indicated for wound
healing) recorded significant growth with turnover increase by 103.2%
year-on-year (“YoY”) to approximately HK$128.0 million in 2019. This was mainly
attributed to the effective adjustment in marketing strategy. The Group has
initiated two new research projects in November 2019 on this product line,
aiming to expand its application to new patient groups.

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2.    The Group signed a letter of intent with Kai
Ping Shi Jian Bao Zhen Tourism Development Company Limited (開平時間寶鎮旅遊發展有限公司) to co-construct and co-operate the healthcare facilities used for
chronic disease management in the Greater Bay Area. The agreement is expected
to directly benefit the long-term sales of the Group’s chronic disease
products, especially the soon-to-be-launched rhExendin-4 (“Uni-E4”)
and rhPTH (1-34) (“Uni-PTH”) used in the treatment of diabetes and
osteoporosis, respectively. 

 

3.    The Group’s Uni-PTH (Teriparatide) high-precision industrialization
project was approved by Zhongguancun Science Park Management Committee,
showcasing its clinical significance and commercial potential. Upon approval,
the Group has received the first installment of government support funds (RMB
10 million) in April 2019, which will be used to support the optimization and
upgrades of the production line, the protection of independent intellectual
property rights and major core technologies, as well as market promotion in
order to prepare for its official launch.

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4.    The Group had successfully completed a private placement of HK$30
million of new shares to a new strategic investor – CHMT Peaceful Development
Fund Management Limited, which is a multi-strategy fund with worldwide
investments in both private and public markets with an asset under management
(AUM) of more than USD 5 billion. The proceeds from the placement will be used
as the initial capital to progress three new corporate development projects
towards the next stage, with hopes to further strengthen the Group’s portfolio
coverage.

 

5.    Triazole, recombinant human epidermal growth factor,
along with glinides class products of the Group, were once again included in
the National Medical Insurance Catalogue in 2019. This has further demonstrated
that the market potential of the major products sold by the Group, namely
GeneTime® (a patented biopharmaceutical recombinant human epidermal growth
factor external solution (I)), Pinup® (Voriconazole Tablet, a patented
chemical) and Bokangtai® (Mitiglinide calcium tablets). The Group is expecting
a significant and sustainable growth of the above products in the near future.

 

6.    The Group has completed all consistency assessment
experiences for Pinup® (Voriconazole oral tablet), a major drug for the
treatment of severe fungal infections. Documents has been submitted to the
National Medical Products Administration (“NMPA”) in August 2019. The Group
expects to obtain the consistency assessment certification in the second half
of 2020. By completing the consistency assessment, the Group will be in a good
position to enter into the centralized drug procurement list and compete against
peers who have also passed the consistency assessment.

7.    Uni-PTH, the only anabolic agent effective
in improving bone density and reducing the chance of vertebral and hip fractures,
is getting a step closer towards its official launch. In December 2019, the
Group submitted supplementary drug information to the Center for Drug
Evaluation (“CDE”), and the Uni-PTH lyophilized powder injection was expected
to be launched in the second half of 2020 after obtaining the drug registration
approval.

 

8.    The NMPA has
officially accepted the Group’s application for registering Boshutai® (Acarbose
tablet) as a Category IV chemical drugs in January 2019. The Group is now
preparing the submission of supplementary information and expects to obtain the
drug registration approval number in the second half of 2020. To enhance
competitive advantages, the Group further optimize its cost structure through
internal control and external partnership, as the leaner cost structure should
in turn offer the Group better positions in market penetration to boost
marketing share with limited marketing input.

 

9.    Uni-E4, an innovative biologic drug self-developed by
the Group, is a class of anti-diabetic treatments called GLP-1 agonists and a
non-insulin treatment candidate that stimulates the incretin pathway. It is the
first fully biologically expressed GLP-1 agent in the world. With its unique
biological expression manufacturing process along with its advantages in costs
and price, Uni-E4 has the potential of becoming a leading competitor of the
GLP1 drugs in the blue ocean market of China. The project is currently under
development as scheduled. The CDE has accepted the Group’s application for
bridging trial of the new Uni-E4 pen injection formulation in December 2019.
The Group expects the bridging clinical research of the Uni-E4 injection to
begin in 2020, and the drug will be launched after the completion of
registration with the NMPA as soon as 2022.

 

Annual Results

In 2019, the Group recorded a turnover of HK$209.4 million, representing a surge of approximately 54.9% YoY (2018: HK$135.3 million). The increase in turnover was mainly
attributable to the significant sales growth of GeneTime® and the rebound in
sales of Pinup®. Among all the products, GeneTime® was particularly favoured by
the market, with an increase of 103.2% from approximately HK$63.0 million in
2018 to HK$128 million in 2019. GeneSoft® recorded a stable revenue growth from
approximately HK$27.1 million to HK$30 million, representing an increase of
10.7%. The growth was mainly attributable to our strategic cooperation with CR
Zizhu to broaden our distribution channels. With new strategy in place and good
progress of the bioequivalent (“BE”) study, Pinup® revenue surged by 58.2% from
approximately HK$29.4 million to approximately HK$46.5 million in 2019. The
Group expects that Pinup® will be the second BE approved voriconazole in the
market.

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Cost of sales
for the Year increased proportionally by 58.2% from HK$17.7 million in 2018 to
HK$27.9 million in 2019. Gross profit increased 54.3% from approximately
HK$117.6 million in 2018 to HK$181.5 million in 2019, mainly driven by the
increase in revenue. On the contrary, gross profit margin remained stable at 86.7%
(2018: 86.9%). Alongside our efforts of restructuring and reorganizing our
direct sales team to achieve greater efficiency, selling and distribution costs
as a percentage to revenue decreased from 85.8% in 2018 to 71.3% in 2019,
representing a decrease of 14.5 percentage points. The Group’s structure has
changed from a divisional organization structure to a functional organization
structure with specific business units, which led to additional savings and
efficiencies by combining supporting functions into one. Substantial saving has
been seen from such restructuring with general and administrative expenses
decreased by 20.6% from HK$74.8 million in 2018 to HK$59.4 million in 2019. The
Group continued to focus on research and development by investing HK$42.7
million in 2019, which was approximately the same as HK$44.2 million in 2018.
With the strong revenue growth and stringent cost and expenses control
measures, the Group achieved profitability this year, demonstrating the
effectiveness of the our strategies. As compared with the loss of approximately
HK$107.9 million for the year ended 31 December 2018, the Group recorded an
earnings before interest, tax, depreciation and amortization of approximately
HK$28.4 million as at 31 December 2019. Profit for the year amounted to HK$2.5
million with basic earnings per share of HK$0.04 cents, marking a turnaround
from a loss of HK$138.6 million or a basic loss per share of HK2.24 cents in
2018.

Prospects

China’s pharmaceutical market has been growing in recent years and is estimated to
reach $161.8 billion in size by 2023, or 30% of the global market. The
industry has slowly shifted its focus from generic drugs to the development of
original and innovative treatment. To reduce the reliance on imports, the
Central Government has introduced a series of policies, some of which included
developing multinational clinical centres, sharing clinical data globally,
accelerating the approval process of innovative medicine, and enhancing the
protection of clinical data. The drug approval speed has since increased by
62%, while the newly approved biologicals in 2018 have also surged by 450% YoY.

The State Council introduced a new arrangement for the state-organized,
centralized procurement reform (“4+7 pilot programme”). This included expanding
the pilot area for the centralized procurement and use of generic drugs to
almost the entire mainland, covering 11 major cities including Shanghai and
Beijing, as well as increasing the drug varieties. It is expected that in the
next 3 years, 80% of the top selling drugs (oral intake) will be included in
the 4+7 pilot programme. Acarbose has already been included in the list and there is a
possibility that Pinup® may also be included within the next 3
years.

Mr. Kingsley Leung, Chairman of Uni-Bio Science, commented,
“Adhering to our strategic plan, in 2019, the
Group has invested heavily on the research and development of medicines in
areas of chronic metabolic disorder, such as diabetes and osteoporosis, as well
as epidermal growth factors. In
face of the growing ageing population, we collaborated with Kai Ping Shi Jian
Bao Zhen Tourism Development Company Limited to co-construct healthcare
facilities to treat the increasing needs of patients with chronic disease. We
believe that this cooperation will greatly benefit our Uni-E4 and Uni-PTH
development and further enhance our technical knowledge in the field of
diabetes and osteoporosis. The positive feedback received from CDE and NMPA has
ensured our pipeline products will be launched as scheduled and has solidified our
competition advantages in the market. In response to the 4+7 pilot programme,
we are actively looking for strategic partners, particularly on our generic
product line in order to optimize manufacturing cost and yield a higher
competitive advantage for our products. In the short term, we remain razor
focused in pushing forward our drug application process, establishing strategic
partnerships, as well as further optimizing our sales and marketing structure. In
the mid-to-long term, we will leverage on our core strength of innovative
biologic R&D, in particular look towards building a pipeline of
best-in-class candidates, and less focused on generics, in hope to create a
fruitful return for our 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.

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