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HONG KONG, Mar 22, 2022 - (ACN Newswire) - Essex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.
Highlights -- The group's turnover surged 67.4% to HK$1,637.7 million, Profit-After-Tax lifted 58% to HK$346.0 million;
-- Sales coverage increased to around 10,500 hospitals and 2,110 pharmaceutical stores in the PRC;
-- Obtained an approval for the registration and commercialisation of the preservative-free unit-dose Moxifloxacin Hydrochloride Eye Drops in the PRC;
-- Significant progress in R&D program, 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage as the below: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021; Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC); Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC);
-- Holds a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents;
-- Completed the acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules.
Significant progression in Financial Performances
Essex achieved significant progression and encouraging performances amid the COVID-19 pandemic and macro uncertainties. For the year ended 31 December 2021, the Group recorded a turnover growth of 67.4% to approximately HK$1,637.7 million as compared to approximately HK$978.1 million in 2020, indicating a strong recovery to the pre-COVID-19 operating level. In tandem with the increase of turnover, the Group achieved an increase of 58% in after-tax profit to approximately HK$346.0 million as compared to approximately HK$218.9 million in 2020.
Turnover of Ophthalmology and Surgical Segments Surged 60.6% and 72.6% respectively The Group's turnover is primarily made up from the segments of Ophthalmology and Surgical (wound care and healing). The core products that are of current growth driver under each segment are:
1. Ophthalmology - Beifushu series (Beifushu eye drops, Beifushu eye gel and Beifushu unit-dose eye drops), Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops and Shilishun(Iodized Lecithin Capsules); and
2. Surgical (Wound care and healing) - Beifuji series (Beifuji spray, Beifuji lyophilised powder and Beifuxin gel), Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules.
The sectoral turnover of Ophthalmology and Surgical is approximately 41.1% and 58.9% of the Group's turnover, respectively. The combined turnover of the Group's flagship biologics, Beifushu series and Beifuji series, the basic fibroblast growth factor (bFGF) based biologic drugs, represented about 84.3% of the Group's total turnover, of which Beifushu series and Beifuji series accounted for 26.1% and 58.2% of the Group's turnover, respectively. The remaining 15.7% of the Group's turnover is mainly contributed from sales of Tobramycin Eye Drops, Levofloxacin Eye Drops, Sodium Hyaluronate Eye Drops, Moxifloxacin Hydrochloride Eye Drops, Shilishun Iodized Lecithin Capsules, Carisolv dental caries removal gel, Dr. YaDian mouth wash and Yi Xue An Granules, collectively. Ophthalmology segment contributed approximately HK$673.3 million to the Group's turnover for the year ended 31 December 2021, representing an increase of 60.6% as compared to approximately HK$419.2 million in 2020. Surgical segment recorded a total turnover of approximately HK$964.4 million for the year ended 31 December 2021, representing an increase of 72.6% as compared to approximately HK$558.9 million in 2020. The increase was attributable to the resumption of clinical operations in hospitals to normalcy in the PRC and the expansion of sales.
The selling of Xalatan Eye Drops and Xalacom Eye Drops would be discontinued in 2022 that contributed approximately 2% to the Group's gross profit for the year ended 31 December 2021.
The Board proposed a final dividend of HK$0.055 (2020: HK$0.05) per ordinary share to be approved at the upcoming annual general meeting of the Company.
Mr. Patrick Ngiam, Chairman of Essex, said, "2021 has been a year full of diverse challenges. Our part of the world has been affected by extended lockdowns and border closures under COVID zero regime, even as other regions begun to reopen. Despite yet another difficult year inflicted by the pandemic of COVID-19 on us all, the tenacity, drive and leadership in our DNA was able to deliver greater stakeholder value. The Group has achieved significantly improved financial performances in the financial year ended 31 December 2021. This is a testament that the Group's business is resilient and was able to recover swiftly to the pre-COVID-19 level after the normalcy of the clinical operations of hospitals resumed in the PRC since September 2020."
Significant Business Development Activities
The Group is committed to pragmatically investing in new products and technologies to strengthen the Group's product and R&D pipeline as near to mid-term growth driver in ophthalmology and long-term plan for new therapeutics in oncology. During the year under review, major investments in ophthalmic products are outlined as follows:
Investment in Ophthalmology
Significant progress for SkQ1's second phase 3 clinical trial In 2018, the Group entered into a co-development agreement with Mitotech S.A. ("Mitotech") and Mitotech LLC for the United States Food and Drug Administration (the "US FDA") phase 3 clinical trial of an ophthalmic solution containing SkQ1 for dry eye disease. As disclosed in the announcement of the Company dated 24 February 2021, positive outcome was achieved during second phase 3 clinical trial (VISTA-2). The clinical trial study repeated statistically significant positive results on key predefined secondary end-point (Central Corneal Fluorescein Staining). The Board is enthusiastic about the read-out of clearing of central staining of the cornea (defined as zero staining in central cornea), which reveals the potential of SkQ1 in addressing oxidative stress in dry eye diseases. Following the positive trial outcome of VISTA-2, Mitotech has planned a pivotal trial (VISTA-3), which will commence once Mitotech's management team has fully assessed there is no potential disruption to trial centres and patient recruitment during the ongoing COVID-19 pandemic. However, recent developments in Ukraine have led to governments and industries reacting to business relationships with Russia in a way that could potentially induce delays in Mitotech's VISTA clinical trial program.
HLX04-O approved for phase 3 clinical trial In 2020, the Group entered into a co-development and exclusive license agreement with Shanghai Henlius Biotech, Inc. to co-develop a pharmaceutical product that contains an anti-vascular endothelial growth factor ("anti-VEGF") as a drug substance, which is intended for the treatment of exudative (wet) age-related macular degeneration ("wet-AMD"). As at the date of 22 March 2022, the recombinant anti-VEGF humanised monoclonal antibody injection HLX04-O ("HLX04-O") for the treatment of wet-AMD has been approved to commence the phase 3 clinical trial in Australia, the United States, Singapore, Russia, Serbia and European Union countries such as Hungary, Spain, Latvia, the Czech Republic and Poland. Also, the first patient has been dosed in a phase 3 clinical study for HLX04-O for the treatment of wet-AMD in the PRC.
Ophthalmology business is expected to be further strengthened by the acquisition of Shilishun Iodized Lecithin Capsules
The successful acquisition of IP rights relating to R&D, production and MAH of Shilishun Iodized Lecithin Capsules will enable the Group to strengthen its ophthalmology business.
Robust Market Access Capability Over the years, the Group has been relentlessly investing in establishing and strengthening its market access capability. As at 31 December 2021, the Group maintains a network of 43 regional sales offices in the PRC and a total number of about 1,265 sales and marketing representatives, out of which 64% are full-time employees and 36% are on contract basis or from appointed agents.
More Extensive Healthcare Network for Product Prescription During the year under review, the Group's therapeutic products are being prescribed in more than 10,500 hospitals and medical providers, coupled with approximately 2,110 pharmaceutical stores, which are mainly located in the major cities, provinces and county cities in the PRC.
Further Investments to Strengthen Competitiveness and Customer Base For achieving a sustainable traction on growth for currently marketed products as well as for near-term to mid-term new products being commercialised, the Group initiated investments to improve its competitiveness and widen its customer base under the following plans:
-- Investing in clinical observation programs for affirming additional clinical indications of its commercialised products; -- Reaching out to market in lower-tier cities; -- Cultivating pharmaceutical stores, where possible, as complementary sales channel; and -- Building on-line platform for medical consultation and e-prescription for patients with chronic diseases under its healthtech initiative.
The Group has initiated its market access expansion to Southeast Asian countries by setting up a base and expanded its presence in Singapore since 2020.
Research and Development
The Group renewed its R&D's vision, emphasising the dedication to science and innovation, with a mission to develop therapeutics that would meet unmet clinical and/or commercial needs. The Group concurrently kick-started a 5-year (2021 to 2025) R&D's development plan to further strengthen its R&D capability and its position in Ophthalmology.
As at 31 December 2021, there are 15 R&D programs in the pre-clinical to clinical stage, out of which 3 ophthalmology programs are in clinical stage. The 3 ophthalmology programs listed below are targeted as mid-term growth driver.
1. EB11-18136P: SkQ1 eye drops, second phase 3 clinical trial (US FDA) (VISTA-2) topline data released on 24 February 2021
2. EB11-15120P: Azithromycin eye drops, ongoing review by external key opinion leaders (National Medical Products Administration ("NMPA") in the PRC)
3. EB12-20145P: Bevacizumab intravitreal injection for wet-AMD, phase 3 clinical trial (US FDA, European Medicines Agency, Therapeutic Goods Administration and NMPA in the PRC)
As at the date of this announcement, the Group has obtained a total of 44 patent certificates or authorisation letters: 35 invention patents, 4 utility model patents and 5 design patents.
The Group currently has diversified its R&D resources to multiple research sites in Zhuhai (PRC), Boston (United States), London (United Kingdom) and Singapore which supports not only our pursuit for new therapeutics but also our acquisition of global talent.
Looking ahead, the Group will continue to monitor the circumstances under the uncertainty of COVID-19 in 2022. Its strong team spirit and dynamic leadership have provided it with the capacity to navigate these turbulent times, and capture any opportunities in the ever changing world. The Group remains highly dynamic in delivering positive results in the coming year.
"COVID-19 remains a major concern in 2022 globally. We continue to monitor the situation and will take appropriate actions to overcome any unforeseen challenges. Barring the unforeseen circumstance, the Group remains focus on executing its plans and delivering progressive results. I would like to take this opportunity to express my sincere gratitude to all stakeholders, business associates and valued customers for the trust, support and cooperation accorded to us, and each and every member of the Group for their relentless efforts rendered in shaping the Group into being a progressive and promising pharmaceutical player.", said Mr. Patrick Ngiam.
About Essex Bio-Technology Limited (Stock Code: 1061.HK) Essex Bio-Technology Limited is a bio-pharmaceutical company that develops, manufactures and commercialises genetically engineered therapeutic rb-bFGF (FGF-2), having six commercialised biologics marketed in China since 1998. Additionally, it has a portfolio of commercialised products of preservative-free unit-dose eye drops and Shilishun Iodized Lecithin Capsules etc.. The products of the Company are principally prescribed for the treatment of wounds healing and diseases in Ophthalmology and Dermatology, which are marketed and sold through approximately 10,500 hospitals and managed directly by its 43 regional sales offices in China. Leveraging on its in-house R&D platform in growth factor and antibody, the Company maintains a pipeline of projects in various clinical stages, covering a wide range of fields and indications.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comEssex Bio-Technology Ltd ("Essex" or the "Group", Stock Code: 1061.HK) today announced the annual results for the year ended 31 December 2021.
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HONG KONG, Mar 17, 2022 - (ACN Newswire) - Sisram Medical Ltd (the "Company" or "Sisram", stock code: 1696.HK; together with its subsidiaries referred as the "Group"), a global consumer wellness group, featuring a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding, ranging from medical aesthetics capital equipment, via injectables therapy, aesthetic dentistry, personal care and more, today announced its audited consolidated annual results for the year ended December 31, 2021 (the "Reporting Period").
FINANCIAL HIGHLIGHTS -- Revenue for the year ended December 31, 2021 was US$294.3 million, increased by 81.6% as compared to the revenue for the previous year. -- Profit for the year ended December 31, 2021 was US$32.5 million, increased by 121.5% as compared to that for the previous year. -- Net cash flows from operating activities for the year ended December 31, 2021 was US$32.4 million, increased by 25.8% as compared to that for the previous year. -- Significant growth in all regions, mainly in North America and APAC. Revenue in North America for the year ended December 31, 2021 was US$112.0 million, increased by 105.8% as compared to that for the previous year. Revenue in APAC for the year ended December 31, 2021 was US$85.2 million, increased by 95.3% as compared to that for the previous year.
BUSINESS HIGHLIGHTS -- R&D investments increased by 42.3% YoY to US$15.6 million with 2 new products launched: "Alma Duo" and "Alma PrimeX". -- Continued the development of two new business lines - (i) Copulla - a new, innovative digital dentistry service; (ii) LMNT, a personal care brand, now launching a light-based skin rejuvenation home use device. -- The Group entered into a sub-license agreement with Fosun Industrial for the commercialization of "RT002" Injectable, the new generation of neurotoxins for medical aesthetics use. The Group's existing injectables distribution operation, registered a revenue growth of 50.1% year over year. -- The Group entered into an investment agreement at the amount of RMB 2.6 million for the establishment of Tianjin Xingsiyi, a research & development, technical services and supply operation for silk fibroin-sodium injectables and facial implant thread products. -- The Group has acquired the entire share capital of Shanghai Foshion Medical System to further enhance its dental business line. -- The Group purchased the remaining 40% equity interest in its Israeli distributor, Nova Medical. Upon completion, Nova Medical is a wholly-owned subsidiary of the Company, rebranded as Alma Israel.
FINAL DIVIDEND -- The Board has resolved to declare a final dividend of HK$0.157 (inclusive of tax) per Share for the year ended December 31, 2021.
Business Growth Projection for 2022 Based on an increase in the demand for the Company's products and the backlog of orders as of December 31, 2021, barring any unforeseen circumstances or material change in market conditions, the Group expects to record a significant growth in revenue of over 35.0% in the first half of 2022 as compared to the revenue recorded in the corresponding period in 2021.
Record results, strong subsidiaries performance, overall geographic performance uptake, continued investments in R&D and strong business development momentum In 2021, Sisram's established global sales and distribution network recorded a total revenue of US$294.3 million for the Reporting Period, representing an increase of 81.6% when compared to 2020. All regions revenue increased substantially during the Reporting Period with North America demonstrating an increase of 105.8%, Asia Pacific with an increase of 95.3%, Latin America with an increase of 76.3%, Europe with an increase of 49.7% and Middle East & Africa with an increase of 45.2%.
The gross profit increased from US$90.3 million in 2020 to US$166.9 million in 2021, representing an increase of US$76.6 million. The gross profit margin in 2021 amounted to 56.7%, representing an increase of 1% compared to 55.7% in 2020. The establishment of direct operation offices in chosen territories has enabled the Company to shorten the supply chain, increase the average selling price, gain a higher brand visibility and ensure consistency among the communications with the target clientele. During 2021, revenue derived from direct sales has surpassed revenue derived from distributors with 62.0% attributed to the former and 38.0% to the latter.
For the Reporting Period, the Group recorded an adjusted net profit of US$40.3 million representing an increase of 100.0% when compared with the corresponding period of 2020. The adjusted net profit margin for the Reporting Period was 13.7%. The net cash flow from operating activities amounted to US$32.4 million, representing an increase of 25.8% when compared to 2020.
In 2021, Sisram continued its substantial R&D efforts, with 13% of corporate employees being R&D specialists. During the Reporting Period, R&D expense increased by 42.3% to US$15.6 million from US$11.0 million for the corresponding period in 2020. During the Reporting Period, the Group launched 2 new products, "Alma Duo" and "Alma PrimeX", as well as expanded two business lines, "Copulla" - a new, innovative digital dentistry service, and "LMNT", a personal care brand, now launching a light-based skin rejuvenation home use device.
Continued Investments in Digital Transformation and Production Ramp-up In 2021, Sisram continued the development of its digital core architecture with vast investments in Information Systems and Digitalization, encompassing traditional ERP and CRM modules, IoT solutions for professional capital equipment, marketing automation and consumer access. Over the past 3 years (2019-2021), Sisram invested more than US$6.5 million in information systems, upgrading its ERP and CRM infrastructure, migrating to cloud-based systems to serve the entire growing and diverse eco-system and implementing new digital tools for Internal organization management, external engagement mechanisms between the organization and the market and cyber security.
On the operational front, Sisram focused on addressing the pandemic effect by investing in production ramp-up to accommodate the growing global demand and improve quality performances KPI's such as FPY (First Pass Yield) and new platforms critical failure.
A Never-before-seen Synergistic Ecosystem Composed of 4 Pillars Sisram's Wellness Group is a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding, ranging from medical aesthetics capital equipment, via injectables therapy, aesthetic dentistry, personal care and more.
As of 2021 Sisram is operating 4 business lines. The Medical Aesthetics business line, led by Alma, registered a revenue increase of 73.4%. The Injectables business line registered a revenue increase of 50.1% year over year. In 2021, Sisram integrated the activity of Shanghai Foshion Medical System into Sisram, while developing Copulla's digital dentistry service. The Personal Care business line, LMNT by Sisram Medical, is a home-use brand, immersing the essence of wellness into consumers' daily routine.
Looking forward, Mr. Liu Yi, Chairman and Executive Director of Sisram, said: "As a core member of Fosun Pharma's medical device sector, as well as the core platform of Fosun's ecosystem, we have always insisted on customer-centric philosophy and focused on technology and innovation, to continuously improve our product power and competitiveness to respond to the rapid development of the industry. In 2022, based on our charted strategy, we will continue to promote Sisram's ecosystem, and steadily expand the product portfolio and ecological interoperability between Sisram's ecosystem, Fosun Pharma's medical device sector, and even Fosun's greater ecosystem, so as to provide customers with advanced technologies and products through the enhancement of technological applications. We will also promote the sustainable and sound development of the industry by improving clinical applications. In addition, we shall meet the market demand of the aesthetic industry through our diversified product portfolio and market strategy."
Mr. Lior Dayan, CEO of Sisram and Alma, said: "The Group's efforts during 2022 will strategically focus on expanding direct operation in strategic markets to secure market access for both professional and consumer clientele, improve digital infrastructure and tools, drive awareness and preference to our global consumer brand and leverage it to globally introduce new products and services."
About Sisram Medical Ltd Sisram Medical Ltd (1696.HK) is a global consumer wellness group, featuring a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding, ranging from medical aesthetics capital equipment, via injectables therapy, aesthetic dentistry, personal care and more. The company is majority held by Fosun Pharma, a leading healthcare group in China. Sisram Medical successfully went public on September 19, 2017, as the first Israeli company listed on the Hong Kong Exchange Main Board.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSisram Medical Ltd (the "Company" or "Sisram", stock code: 1696.HK; together with its subsidiaries referred as the "Group"), a global consumer wellness group, featuring a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding