GREENVILLE, N.C., Nov. 13, 2018 /PRNewswire/ — Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, is pleased to announce successful qualification of two commercial bottling lines for serialization at its new US$80 million oral solid dose commercial manufacturing site in Greenville, North Carolina, USA. This marks the culmination of several years of preparation and investment to comply with the new requirements associated with the US Drug Supply Chain Security Act (DSCSA), which are subject to enforcement starting November 2018.
As part of the Greenville site expansion, packaging capacity has more than doubled. One bottling line is dedicated for clinical packaging, and two commercial bottling lines have been qualified for serialization. The newly installed equipment includes a New Jersey Machine with an IMA automated case packer and palletizer. The new commercial facility has space available to add a third commercial packaging line as needed to support future growth.
Mayne Pharma has implemented Optel systems on the packaging lines and is using TraceLink as its level 4 and 5 provider to manage the enterprise and network connectivity. Qualification of both commercial packaging lines includes aggregation capabilities in anticipation of the next regulation enforcement deadlines.
Metrics’ Executive Vice President Kimberly McClintock said, “We are pleased to provide serialized bottling services to our Metrics’ clients to complete our concept to commercialization offering. Our ability to offer testing, manufacturing, and packaging all at one site in North Carolina offers an efficient and convenient supply chain solution. While this is a new service offering for Metrics, the Greenville site has substantial firsthand experience supporting more than 30 Mayne Pharma products across 90 product SKUs through the serialization transition. Metrics’ clients have access to a seasoned team with direct experience ensuring successful serialization interactions with 3PLs, wholesalers and retailers.”
About Metrics Contract Services
Metrics Contract Services is a full-service pharmaceutical development and manufacturing organization serving clients worldwide delivering proven scientific and operational excellence for oral dosage forms.
Metrics’ areas of expertise include quality pharmaceutical formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial scale manufacturing.
Technical capabilities include highly potent, cytotoxic and unstable compounds; Schedule II-V controlled substances; and products with poor bioequivalence, for which we offer an impressive proprietary portfolio of advanced delivery methods. Located in Greenville, N.C., Metrics is a proud member of Mayne Pharma. Learn more at www.metricscontractservices.com
About Mayne Pharma
Mayne Pharma is a specialty pharmaceutical company listed on the Australian Securities Exchange (ASX: MYX) focused on the application of drug delivery expertise to commercialize branded and generic pharmaceuticals, providing patients with access to better and more affordable medicines.
Mayne Pharma has a 30-year track record of innovation and success in developing new oral drug delivery systems, and these technologies have been successfully commercialized in numerous products that have been marketed around the world. Mayne Pharma has two drug development and manufacturing facilities based in in Salisbury, Australia and Greenville, USA, with expertise in the formulation of complex oral and topical dose forms including potent compounds, modified-release products and inherently unstable compounds. For further information, visit www.maynepharma.com.
Neurent Medical’s rhinitis device delivers radio frequency energy in a focused and controllable zone of effect, causing minimal collateral damage to surrounding tissues
LONDON, Nov. 13, 2018 /PRNewswire/ — Based on its recent analysis of the European rhinitis therapy market, Frost & Sullivan recognises Neurent Medical with the 2018 European New Product Innovation Award for developing a non-surgical, minimally invasive device that uses radio frequency (RF) to modulate a nerve group to offer relief from nasal obstruction and rhinorrhea. With the total annual avoidable expenditure on the European allergy market, not limited to rhinitis, amounting between $50 billion and $150 billion, even back in 2014, Neurent Medical’s out-patient device can help customers achieve significant savings by using RF in a highly targeted manner.
The current clinical gold standard approaches to treating chronic ear, nose, and throat infections range from avoiding various environmental triggers, which provides only temporary relief, to invasive surgery, which often requires lengthy recovery periods. Medications such as antihistamines, decongestants, and topical or systemic corticosteroids have limited patient and physician acceptance because of side effects, such as drowsiness, bleeding, drying, and crusting. In more severe cases, surface cautery of enlarged turbinates is performed as an out-patient procedure; however, side effects include edema and crusting in the nose that can last three weeks or longer. In such a scenario, Neurent Medical’s single-use device presents exceptional value as it can be used in office settings, and patients can resume normal activity almost immediately after implantation.
“Neurent Medical has based its rhinitis device on its extensive research on neuronal activity in the nasal cavity and the cellular makeup of the nasal mucosa. These guiding principles have enabled the product to stand out as a low-powered RF treatment that targets the autonomic supply to the nasal turbinates, positively impacting both allergic and non-allergic rhinitis,” said Arjunvasun, Industry Analyst at Frost & Sullivan. “The device uses a microelectrode array that is designed to deliver targeted energy to interrupt the autonomic function within mucosal structures of the nasal cavities to reverse inflammatory cascade. The device incorporates an intelligent RF generator to maximize the energy delivery to the intended target, while minimizing collateral damage to the sub-mucosal tissues.”
Additionally, the device offers substantial cost savings by eliminating patients’ dependence on pharmacotherapies and by requiring only a single out-patient procedure.
“Although the application of RF to treat rhinitis has been evaluated through clinical studies, Neurent Medical has pioneered its application in treating inflammation caused by rhinitis,” noted Arjunvasun. “Research conducted at the National University of Ireland, Galway supports the claim that Neurent Medical’s solution is truly a game-changing technology for allergy patients worldwide.”
Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognises the product’s value-added features/benefits and the increased return on investment (ROI) it provides to customers, which, in turn, raises customer acquisition and overall market penetration potential.
Frost & Sullivan Best Practices Awards recognise companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.
About Neurent Medical
Neurent Medical Ltd is a privately held, venture backed, Galway (Ireland) based medical device company in the Ear, Nose and Throat market. The company designs and develops products for treating inflammatory diseases of the nasal cavities. The initial product offering reduces the primary symptoms of rhinitis, congestion and rhinorrhoea. www.neurentmedical.com/
About Frost & Sullivan Frost & Sullivan, the Growth Partnership Company, collaborates with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, Frost & Sullivan has been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community. Contact us: Start the discussion.
New US$26.35 Million Collaboration Seeks Prevention and Treatment Solutions to Address Rising Burden of Condition
SINGAPORE, Nov. 12, 2018 /PRNewswire/ — The Singapore National Eye Centre (SNEC), the Singapore Eye Research Institute (SERI) and Johnson & Johnson Vision today announced a US$26.35 million (S$36.35 million) research collaboration to tackle myopia, or nearsighted vision, the largest threat to eye health this century.1,2,3 By 2050, half of the world’s population are projected to be myopic, with one billion expected to have high myopia, a severe state of the condition that can lead to retinal disease with an increased risk of blindness.1
The first-of-its-kind public-private strategic partnership in Asia focused on myopia will create a deeper understanding of how the condition develops, how it progresses and how it may be intercepted. It will focus on developing predictive tools to identify those who may be at risk to develop high myopia, conduct research on the underlying mechanisms of myopia, progress novel therapies, and discover and validate methods to prevent the onset and progression of the condition.
“The incidence of myopia is increasing at an alarming rate around the world and if left unchecked, the human and financial toll could skyrocket in the coming decades, especially in Asia,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
“We are delighted to be collaborating with SERI and SNEC to better understand the underpinnings of this condition and identify ways to halt this global public health threat,” he said. “Together, we hope to bring important progress to individuals and families throughout the Asia Pacific region and ultimately, around the world.”
“Documented increases in myopia, especially among young people, are a serious concern and if we can understand the underlying mechanisms that are contributing to its rapid rise, we can work to tackle the problem at its roots,” said Professor Aung Tin, Executive Director of SERI. “SERI is strongly committed to collaborating with leading companies to address eye diseases, and we are excited to be embarking on this research collaboration to break new ground against the epidemic.”
According to Professor Wong Tien Yin, Medical Director at the SNEC, the collaboration will bring together the right mix of resources, clinical and scientific experience, and intellect to create a leading centre for myopia research, clinical care and education practices designed to contribute substantially to regional and global efforts to fight the condition. “SNEC is honored to be working with collaborators coming together to address the growing burden of myopia,” Professor Wong said. “By leveraging the diverse strengths of our clinicians, clinician scientists and strategic partners to establish new disease frameworks and share this knowledge across world communities to help eradicate myopia.”
Myopia is the number one eye defect in the world.1,2 Myopia increases risk of retinal degeneration and detachment, cataracts and glaucoma. Unchecked, it will become the leading cause of irreversible vision impairment and blindness.1 The condition occurs when the eyeball becomes elongated due to environmental and genetic factors.4 Few modalities are currently approved by regulatory bodies to control myopia.
Significant Burden Projected Worldwide, With Biggest Impact in Asia
Five billion people globally are expected to have myopia by 2050.1
East Asia and Singapore will shoulder the greatest impact, with current prevalence rates among young people as high as 80 to 97 percent concentrated in urban areas.5
Children are most vulnerable. For example, in China, among children ages six to 18, myopia prevalence rises from less than 10 to 80 percent.6 Children who go on to develop high myopia are at a high risk for a lifetime of severe eye disease and permanent vision loss.7
In Singapore, one in two children develop myopia by the age of 128, and 75 percent of teenagers are myopic and rely on glasses.9
Uncorrected distance refractive errors, largely caused by myopia, are already estimated to cost global healthcare systems US$202 billion annually1 and this cost will rise exponentially with increased prevalence and severity of myopia in coming decades.
In Singapore alone, the annual direct cost of optical correction of myopia for Singaporeans has been estimated at US$755 million (S$1.04 billion).10
Due to the complexity and scale of myopia, halting the epidemic will require a multidisciplinary approach that encompasses novel clinical research as well as innovations in education and clinical care. SNEC, SERI and Johnson & Johnson Vision intend to build on these efforts and convene other stakeholders to support broad-based strategies.
Johnson & Johnson Vision brings to this initiative deep expertise in optometry and ophthalmology backed by the strength, capabilities and reach of the Johnson & Johnson Family of Companies, which are committed to solving complex global public health challenges. SERI and SNEC have a strong track record of high-impact eye research and excellence in clinical care that has paved the way for improvements in how eye diseases are detected, prevented and treated in Singapore, across Asia and on a global scale.
About the Strategic Partnership The US$26.35 million (S$36.35 million) program is a collaboration between Johnson & Johnson Vision and the Singapore Eye Research Institute (SERI), which is the research arm of the Singapore National Eye Centre (SNEC), over three years. Johnson & Johnson Vision is making a US$15.78 million (S$21.77 million) investment, comprising cash and in-kind contributions, while SERI’s investment is US$10.57 million (S$14.58 million) in cash and in-kind contributions.
Johnson & Johnson Vision At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health around the world. Through our operating companies, we deliver innovation that enables eye care professionals to create better outcomes for patients throughout their lives, with products and technologies that address unmet needs including refractive error, cataracts and dry eye. In communities with greatest need, we work in collaboration to expand access to quality eye care, and we are committed to helping people see better, connect better and live better. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
Singapore Eye Research Institute (SERI) Established in 1997, SERI is Singapore’s national research institute for ophthalmic and vision research. SERI’s mission is to conduct high impact eye research with the aim to prevent blindness, low vision and major eye diseases common to Singaporeans and Asians. SERI has grown from a founding team of five in 1997 to a faculty of 194, encompassing clinician scientists, scientists, research fellows, PhD students and support staff. This makes SERI one of the largest research institutes in Singapore and the largest eye research institute in Asia-Pacific. In addition, SERI has over 218 adjunct faculties from various eye departments, biomedical institutes and tertiary centres in Singapore.
SERI has amassed an impressive array of more than 3,295 scientific papers as of September 2018, and has secured more than S$307.9 million in external peer-reviewed competitive grants. To date, SERI’s faculty has been awarded more than 493 national and international prizes and filed more than 121 patents. Serving as the research institute of the Singapore National Eye Centre and affiliated to the Duke-NUS Medical School, National University of Singapore, SERI undertakes vision research in collaboration with local clinical ophthalmic centres and biomedical research institutions, as well as major eye centres and research institutes throughout the world. Today, SERI is recognized as a pioneering center for high quality eye research in Asia, with breakthrough discoveries that has translated to significant paradigm shift in eye care delivery. Visit us at www.seri.com.sg.
Singapore National Eye Centre (SNEC) Singapore National Eye Centre was incorporated in 1989 and commenced operations in 1990. It is the designated national centre within the public sector healthcare network, and spearheads and coordinates the provision of specialised ophthalmological services with emphasis on quality education and research. Since its opening in 1990, SNEC has achieved rapid growth and currently manages an annual workload of 330,000 outpatient visits, 34,000 major eye surgeries and laser procedures.
Ten subspecialties in Cataract, Cataract and Comprehensive Ophthalmology, Corneal and External Eye Disease, Glaucoma, Neuro-Ophthalmology, Oculoplastic and Aesthetic Eyeplastic, Pediatric Ophthalmology and Strabismus, Refractive Surgery, Ocular Inflammation and Immunology and Retina (Medical & Surgical) have been established to provide a full range of eye treatment from comprehensive to tertiary levels for the entire spectrum of eye conditions.
SNEC was accorded the Excellence for Singapore Award in 2003 for achieving excellence in the area of Ophthalmology, thrusting Singapore into international prominence. In 2006, SNEC received the first Minister for Health Award for public health. Three clinician scientists from Singapore National Eye Centre and Singapore Eye Research Institute were awarded the prestigious President’s Science and Technology Award in 2009, 2010 and 2014 for their outstanding contributions in translational, clinical and epidemiological research in cornea, retina and glaucoma. Visit us at www.snec.com.sg.
1 Holden et al Ophthalmol 2016; 123: 1036 2 Fricke et al Ophthalmol 2018; 125(10):1492-1499 3 Internal data on file 4 Fredrick, D. R. (2002). Myopia. BMJ, 324(7347), 1195-1199. doi:10.1136/bmj.324.7347.1195 5 Ding et al Survey of Ophthalmol 2015. 6Taiwan, Lin et al 2000 Ann Acad Med Singapore 2004; 33:27-33 7 Chua et al Ophthalmic Physiol Opt 2016; 36 388–394 8 SingHealth, Eye Check A look at common eye conditions 9 HealthXchange, Common Eye Problems by Age Group, Stats and Care Tips 10 The Impact of Myopia and High Myopia: report of the Joint World Health Organization – Brien Holden Vision Institute Global Scientific Meeting on Myopia, University of New South Wales, Sydney, Australia, 16–18 March 2015 Pages 10-11
SEONGNAM, South Korea, Nov. 12, 2018 /PRNewswire/ — Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea, announced that BBT-401, the first anti-Pellino-1 compound currently under development for ulcerative colitis (UC) treatment, proved its safety and tolerability from phase I study.
BBT-401, a GI-tract restricted small molecule inhibitor of Pellino-1, was proved to be well tolerated and safe from Phase 1 Study, which is a randomized, double-blind study with 80 healthy volunteers. The most common adverse events were mild and recoverable diarrhea and mild headache. In addition, the PK data 1 demonstrated its key feature of no or minimal systemic exposure.
Bridge Biotherapeutics plans to initiate Phase II study in US within this year with patients with active UC diseases to see safety and efficacy at patients.
BBT-401 was discovered by SKKU (Sungkyunkwan University) and KRICT (Korea Research Institute of Chemical Technology) and was licensed the exclusive worldwide right to Bridge Biotherapeutics in 2015.
Product: BBT-401
Business: Inflammatory Disease
Molecular target: Pellino-1
Description: Oral small molecule inhibitor of Pellino-1
Indication: Ulcerative Colitis
Primary Endpoint: To assess the safety and tolerability of single and multiple ascending oral doses of BBT-401-1S in healthy adult subjects
Status: Phase I data
Milestone: Expected to begin Phase II study in December 2018
For more information
1. Bridge Biotherapeutics, Inc.
Bridge Biotherapeutics is a virtually-operated, venture-backed clinical stage biotech engaged in the development of novel therapeutics in the therapeutic areas of high unmet needs such as ulcerative colitis, fibrotic diseases and cancers. Following its first compound BBT-401, BBT-877, a potent and selective Autotaxin (ENPP) inhibitor is being developed potentially for the treatment of various fibrotic diseases such as idiopathic pulmonary fibrosis (IPF) and non-alcoholic steatohepatitis (NASH). Bridge Biotherapeutics is a JLABS tenant company at JLABS@TMC, Houston, TX.
2. About Pellino Proteins
Pellino proteins are a family of E3 ubiquitin ligases which are highly conserved across species in mammal. Pellinos also serve as scaffold proteins that bind to proteins in inflammatory signaling pathways, including IRAK4, MyD88 (myeloid differentiation primary response gene 88) and to RIPK1 in various physio-pathological conditions.
BEIJING, Nov. 8, 2018 /PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced today its unaudited financial results for the six months ended June 30, 2018.
Financial highlights
Sales revenue for the first six months of 2018 was $122.5 million, compared to $66.9 million in the prior year period, an increase of 83.1%. Sales increased primarily due to revenue generated by the Company’s EV71 vaccine.
Net income attributable to shareholders was $14.1 million, or $0.24 per basic and diluted share, compared to net income attributable to shareholders of $10.9 million, or $0.19 per basic and diluted share, in the prior year period.
Business Highlights
Sales and Marketing
In the first half of 2018, sales were mainly generated from the EV71 vaccine. The increase of EV71 vaccine sales was primarily attributable to government advocacy regarding the benefits of this vaccine to the public. In March 2018, the National Health Commission of the People’s Republic of China (“NHFPC”) issued a notice to encourage vaccination to prevent hand, foot and mouth disease due to the expected high prevalence of this disease in 2018. In addition, since late 2017, Sinovac has been collaborating with third party companies to improve market coverage and penetration in the private sector of the Chinese market. As a result, the number of customers increased over 30% in the first half of 2018 compared to the same period in 2017. Also in the first half of 2018, the marketing team of Sinovac expanded its activities, including academic promotion activities at the national, provincial, district, and county levels, which largely improved the awareness of Sinovac’s EV71 vaccine among professionals and consumers.
The Company does not expect any sales of seasonal influenza vaccine during the 2018-2019 flu season. As was announced in April 2018, production at the Company’s hepatitis A vaccine and flu vaccine bulk production site was suspended when a minority shareholder of Sinovac Beijing forcibly entered Sinovac Beijing’s corporate offices along with dozens of unnamed individuals in an attempt to wrongfully take control of Sinovac Beijing’s operations. As it was determined that the quality and safety of the vaccines could not be sufficiently verified to the Company’s high standards following the disruption, the vaccines in production at the time of the attack were destroyed. Since the attacks, the Company has verified the safety and quality of the vaccine production process, and is ready to resume production in anticipation of next year’s market demand. Sales of flu vaccine for the 2017-2018 flu season were $13.5 million.
Research and Development
Varicella Vaccine – Sinovac filed a production license application with the CFDA in November 2017; the CFDA’s Center of Drug Evaluation completed its review and provided comments to the Company. The Company is preparing supplementary documents as requested by the CFDA.
Sabin Inactivated Polio Vaccine (sIPV) – In April 2018, the phase III trial of the sIPV candidate developed by Sinovac was unblinded. The preliminary results showed that it was not inferior to the control vaccine group. In June 2018, a sequential vaccination schedule consisting of sIPV and two doses of bOPV was conducted. Dosing and blood sampling have been completed recently, and the Company is awaiting the results.
Quandrivalent Flu vaccine (QIV) – Sinovac is conducting a phase III clinical study of its QIV and expects to complete this study by the end of 2018.
Unaudited Financial Results for the First Six Months of 2018
2018 1H
% of Sales
2017 1H
% of Sales
(In thousands except percentage data)
Hepatitis A – Healive
25,853
21.1%
12,879
19.2%
Hepatitis A&B – Bilive
10,344
8.4%
4,928
7.4%
Hepatitis vaccines subtotal
36,197
29.5%
17,807
26.6%
Influenza vaccine
2,063
1.7%
(6)
0.0%
Enterovirus 71 vaccine
84,113
68.7%
48,751
72.9%
Mumps vaccine
117
0.1%
356
0.5%
Total sales
122,490
100.0%
66,908
100.0%
Cost of sales
13,337
10.9%
7,735
11.6%
Gross profit
109,153
89.1%
59,173
88.4%
Sales in the first half of 2018 were $122.5 million, compared to $66.9 million in the prior year period. Sales increased primarily due to additional revenue generated by the Company’s EV71 vaccine.
Gross profit was $109.2 million, compared to gross profit of $59.2 million in the prior year period. The increase was primarily due to the contribution of EV71 vaccine sales in the first half of 2018. Gross margin was 89.1%, compared to 88.4% in the prior year period.
Selling, general and administrative expenses in the first half of 2018 were $67.8 million, compared to $36.7 million in the same period of 2017. The Company’s selling, general and administrative expenses increased with the higher level of sales activity. The Company incurred $3.4 million in legal expenses related to the facility disruption and litigation regarding the Company’s annual meeting and related matters.
R&D expenses in the first half of 2018 were $10.1 million, compared to $8.8 million in the same period of 2017.
Net income was $22.6 million, compared to net income of $15.8 million in the prior year period.
Net income attributable to shareholders was $14.1 million, or $0.24 per basic and diluted share, compared to net income attributable to shareholders of $10.9 million, or $0.19 per basic and diluted share, in the prior year period.
Non-GAAP EBITDA was $34.2 million in the first half of 2018, compared to $15.9 million in the prior year period. Non-GAAP net income from continuing operations in the first half of 2018 was $24.0 million, compared to $16.2 million in the prior year period. Non-GAAP diluted earnings per share from continuing operations in the first half of 2018 were $0.26, compared to $0.20 per share in the prior year period. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement.
As of June 30, 2018, cash and cash equivalents totaled $88.1 million, compared to $114.4 million as of December 31, 2017. For the six months ended June 30, 2018, net cash used in operating activities was $11.3 million. Net cash used in investing activities was $2.9 million, which was for the purchase of equipment. Net cash used in financing activities was $8.0 million, including loan proceeds of $13.4 million and loan repayment of $23.8 million. As of June 30, 2018, the Company had $9.8 million of bank loans due within one year. The Company expects that its current cash position will be able to support its operations for at least the next 12 months.
About Sinovac
Sinovac Biotech Ltd. is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases. Sinovac’s product portfolio includes vaccines against enterovirus71, or EV71, hepatitis A and B, seasonal influenza, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), and mumps. The EV71 vaccine, an innovative vaccine developed by Sinovac against hand foot and mouth disease caused by EV71, was commercialized in China in 2016. In 2009, Sinovac was the first company worldwide to receive approval for its H1N1 influenza vaccine, which it has supplied to the Chinese Government’s vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine to the government stockpiling program. The Company is developing a number of new products including a Sabin-strain inactivated polio vaccine, pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and varicella vaccine. Sinovac primarily sells its vaccines in China, while also exploring growth opportunities in international markets. The Company has exported select vaccines to over 10 countries in Asia and South America. For more information, please visit the Company’s website at www.sinovacbio.com.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the United States federal securities laws. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Factors that might cause such a difference include our inability to compete successfully in the competitive and rapidly changing marketplace in which we operate, failure to retain key employees, cancellation or delay of projects, disruptions to our operations, the results of any pending litigation, and adverse general economic conditions in China, the United States and elsewhere. These risks and other factors include those listed under “Risk Factors” and elsewhere in our Annual Report on Form 20-F as filed with the Securities and Exchange Commission. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. The Company assumes no obligation to update the forward-looking information contained in this release.
Non-GAAP Financial Measures
To supplement its consolidated financial statements, which are prepared and presented in accordance with generally accepted accounting principles in the United States (“GAAP”), Sinovac uses the following non-GAAP financial measures: non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations. For more information on these non-GAAP financial measures, please refer to the table captioned “Reconciliations of non-GAAP Measures to the Nearest Comparable GAAP Measures” in this release.
Sinovac believes that non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations help identify underlying trends in its business that could otherwise be distorted by the effect of certain income or expenses that Sinovac includes in income from operations from continuing operations, net income from continuing operations and diluted EPS from continuing operations. Sinovac believes that non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations provide useful information about its core operating results, enhance the overall understanding of its past performance and future prospects and allow for greater visibility with respect to key metrics used by our management in its financial and operational decision-making. Non-GAAP EBITDA, non-GAAP net income from continuing operations and non-GAAP diluted EPS from continuing operations should not be considered in isolation or construed as an alternative to income from operations from continuing operations, net income from continuing operations, diluted EPS from continuing operations, or any other measure of performance or as an indicator of Sinovac’s operating performance. These non-GAAP financial measures presented here may not be comparable to similarly titled measures presented by other companies. Other companies may calculate similarly titled measures differently, limiting their usefulness as comparative measures to our data.
Non-GAAP EBITDA represents income (loss) from continuing operations, excludes interest and financing expenses, interest income, net other income (expenses) and income tax benefit (expenses), and certain non-cash expenses, consisting of share-based compensation expenses, amortization and depreciation that Sinovac does not believe are reflective of the core operating performance during the periods presented.
Non-GAAP net incomefrom continuing operations represents net income from continuing operations before share-based compensation expenses, and foreign exchange gain or loss.
Non-GAAP diluted EPSfrom continuing operations represents non-GAAP net income attributable to ordinary shareholders from continuing operations divided by the weighted average number of shares outstanding during the periods on a diluted basis, including accounting for the effect of the assumed conversion of options.
Contact
Sinovac Biotech Ltd.
Helen Yang Tel: +86-10-8279-9871 Fax: +86-10-6296-6910 Email: ir@sinovac.com
SHANGHAI, Nov. 9, 2018 /PRNewswire/ — With the rapid development of the internet and artificial intelligence (AI) technology, new technologies, new formats, new products, and new services are constantly changing, and this has really changed people’s lives. However, there are still problems when it comes to seeing a doctor, long lines, and poor experiences at hospitals and clinics, which affect the quality of life of Chinese people. On November 8, at the Fifth World Internet Conference held in Wuzhen, Mr. Wang Tao, the Chairman and CEO of Ping An Good Doctor (the “Company”, stock code: 1833.HK) presented his “prescription solution.” According to Wang: “‘Internet + AI’ will reinvent medical services and provide every Chinese people with family doctor services.”
Mr. Wang Tao, the Chairman and CEO of Ping An Good Doctor
“We now feel that it is generally difficult and expensive to see a doctor. The most important factor behind this is Class III Grade A hospitals account for only 8% of the total number of hospitals in the country but must accept more than 50% of the patients. Everyone wants to see a good doctor, so the major Class III Grade A hospitals are overcrowded. One data set shows that at present, the average queuing time for domestic medical treatment is as high as three hours, and the average consultation time is less than eight minutes,” Wang said.
When talking about the current medical services market in China, Wang summed up two major pain points: quality medical resources are scarce and unevenly distributed; experiences with medical services are poor. Wang believes the only way to address the pain points of medical services is to fully apply “Internet + AI” technology to improve the efficiency and service level of the entire industry, and thereby reshape the entire medical services market.
“Everyone wants to enjoy the best doctors, but where do they come from? It is certainly not possible in the traditional way, and it is impossible to have enough finances, material, and time to solve the problem. We will use artificial intelligence to find a solution to the problem of the shortage of good doctors in China.” Wang believes that with the big data of more than 300 million online consultations accumulated by an in-house medical team of over 1000, plus more than 200 of the world’s top AI experts, Ping An Good Doctor has developed the most advanced AI Doctor in the medical profession. It can reduce the misdiagnosis rate of traditional medical care, improve the efficiency of medical resources, accurately match the needs of doctors and patients, and simplify the doctor’s workflow.
At present, AI Doctor has already entered The People’s Liberation Army No. 303 Hospital, Qingdao Eye Hospital, The First Affiliated Hospital of Jinan University, The Third Affiliated Hospital of Southern Medical University, and over 100 Class III Grade A hospitals nationwide, multiplying the efficiency and accuracy of hospitals and reducing operating costs.
In addition, AI Doctor technology has entered Traditional Chinese Medicine (TCM), corresponding to the Chinese medicine consultation process of “observation, listen to breathing, ask about symptoms and pulse-taking”. Ping An Good Doctor successively launched Smart TCM Diagnosis by Tongue Observation, Smart TCM Diagnosis by Listening, Smart consultation, and Smart TCM Diagnosis by Pulse-taking. It can simulate TCM medicine practitioners to conduct inquiries before diagnosis, and through comprehensive analysis and inferential diagnosis, generate a structured medical history that conforms to the case specification, transmit the analysis results to the doctor’s workbench, intelligently recommend Chinese medicine prescriptions for doctors to choose, and effectively improve the patient experience.
Wang Tao believes that in traditional medical treatment, the patient is tied to the hospital and doctor, but “Internet + AI” can open up all aspects of the medical industry, integrated resources can “revolve around the patient” and provide the patient with an efficient service. “Now that internet health-tech companies like Ping An Good Doctor have been able to provide incredibly convenient and efficient quality medical services, the average consultation time of our platform is only 26 seconds. Patients can complete a one-stop online consultation and purchase medicine without leaving their home. It takes only one hour to deliver medicines to the home, and individualized electronic health records can also be generated. Ping An Good Doctor now has more than 200 million registered users, and there are more than 500,000 consultations every day,” Wang said.
“Big data and artificial intelligence can greatly improve industry efficiency and medical security, reduce the burden on hospitals, doctors and patients, and at the same time reduce the burden on our government and generate great social value,” Wang added.
Looking to the future, Wang Tao believes that as more and more people experience the changes brought by “Internet + AI” to medical services, every Chinese person can have access to family doctor services and enjoy outstanding quality of medical and health services. “Looking forward, we will enter the era of the Internet of Things (IOT) where a cup or a pair of glasses can become an IOT smart device, directly transmit health data to us and truly achieve health management and disease prediction,” Wang added.
About Ping An Good Doctor (1833.HK)
Ping An Good Doctor is the leading one-stop healthcare ecosystem platform in China. By combining “mobile health + AI technology”, the Company strives to provide every family with a family doctor, every person with an e-health profile and everyone with a healthcare management plan. Ping An Good Doctor has established a comprehensive, one-stop healthcare ecosystem covering family doctor services, consumer healthcare services, a health mall as well as health management and wellness interaction.
As of the end of June 2018, there were 228 million registered users and the Company’s MAU reached 48.6 million. Ping An Good Doctor is today the largest mobile medical application in China in terms of user scale. Ping An Good Doctor employs more than a thousand medical personnel (Assistant Supervisor Level or above from Class III Grade A Hospitals) in its in-house medical team and contracts with 4,650 renowned external doctors. This in-house medical team, empowered by our proprietary AI technology, provides users with 24 x 7 online consultation services. In our offline partnership network, Ping An Good Doctor collaborates with approximately 3,100 hospitals (including more than 1,200 Class III Grade A hospitals) to provide services such as hospital referral, appointment and inpatient arrangements. Ping An Good Doctor also partners with more than 2,000 healthcare institutions, including physical examination centers, dental clinics, cosmetic surgery institutions and more than 10,000 pharmacy outlets, to provide relevant health and wellness services to our users. By integrating our AI-empowered medical team, external doctors and offline network, Ping An Good Doctor has established a closed-loop healthcare ecosystem which enables our users to enjoy online consultations and online drug purchases, as well as online consultations and offline follow-up treatment, thereby providing convenient, high-quality and efficient family doctor services.
In April 2015, the App “Ping An Good Doctor” was officially launched. In May 2016, the Company completed an A round financing and raised US$500 million. In December 2017, the Company completed the pre-IPO financing from Softbank Vision Fund, during which it raised US$400 million. On 4 May 2018, Ping An Good Doctor became the No.1 listed internet health-tech company in the world when it joined the Hong Kong Stock Exchange, stock code 01833.HK. Our IPO cornerstone investors include Blackrock, Capital Group, GIC, Canada Pension Plan Investment Board, Khazanah Nasional Berhad, Swiss Re and CP Group.
Inceptua Group today announces that Clive Whitcher joins Inceptua as Vice President, Head of Global Patient Access.
“Clive joining the teamto focus on patient access strengthensourcommercializationcapabilities, offering even greatersupport toour partnercompanies as they try to reach patients in need,“ says Alan Raffensperger, CEO, Inceptua Group.
Clive will be working to provide strategic and tactical support and guidance to companies preparing to launch products into new markets.
“I‘m very excited to be joining Inceptua at this time.Patient access activities are critical in preparing for the successful launch of new therapies, and continued post launch with ongoing community engagement and data generation.Inceptuaiswell placed to support companies with theircommercializationapproach and helpensure that sustainable access solutions are developedtoenablepatientstoaccess new therapiesas quickly as possible,“ says Clive Whitcher.
Clive brings patient access experience from both Pharma and consulting across a wide range of therapeutic areas. Clive joins Inceptua from Sobi, where he held the role of Vice President, Head of Global Patient Access & Community Engagement. He was responsible for developing and delivering patient access launch strategies, including launch sequencing and innovative pricing and contracting strategies to secure sustainable access for rare, specialty, and orphan therapies.
About Inceptua
Inceptua is a pharmaceutical company, and the next generation partner to pharma, biotech and healthcare. We provide clinical trial services, deliver early access to medicines, and commercialize specialty care and rare disease products. Inceptua is headquartered in Luxembourg and has global operations with offices in Europe, the USA, and Asia.
For further information, please contact:
Inceptua Group Communications Miranda McLaughlan, Communications Manager Phone: +49-30-1202-1353 E-Mail: miranda.mclaughlan@inceptua.com
HANGZHOU, China, Nov. 9, 2018 /PRNewswire/ — China Jo-Jo Drugstores, Inc. (NASDAQ: CJJD) (“Jo-Jo Drugstores” or the “Company”), a leading online and offline retailer and wholesale distributor of pharmaceutical and other healthcare products and a healthcare provider in China, today announced that Mr. Wei Hu was nominated and approved by the Company’s Board of Directors to serve as the Company’s Chief Operating Officer effective November 7, 2018.
Mr. Hu has an extensive track record of innovation and business success in key roles in various institutions in the healthcare industry. His areas of expertise include hospital management, strategic planning and deployment, performance management, lean management, medical quality management, operational analysis, information management, and external cooperation and exchange. His career highlights include:
Served as Vice President of Taizhou Central Hospital (Taizhou College Affiliated Hospital) since September 2016. He is also the Vice President of Taizhou Medical Association, the Vice Chairman of the Special Committee of Nasopharyngeal Carcinoma and Tumor Causes of Zhejiang Anti-Cancer Association, a Standing Committee Member of the Cancer Radiotherapy Professional Committee of Zhejiang Medical Association, a member of the Provincial Clinical Epidemiology and Evidence-Based Medicine Branch, member of the Cancer Pain Professional Committee, and leader of the Cancer Chemotherapy and Chemotherapy Group of Taizhou Medical Association.
Served as Executive Vice President, Vice President and Dean of Enze Medical Center of Taizhou Central Hospital from February 2011 to September 2016. Under his leadership, Taizhou Central Hospital was named Class 3 Grade A hospital in 2011.
Successively served as Director of Radiotherapy Department and Assistant Dean of Taizhou Hospital.
Deputy Chairman of the Fourth Committee of Taizhou Municipality as well as Standing Committee of the Fifth Taizhou Municipal Committee of the Chinese People’s Political Consultative Conference (“CPPCC”.)
Earned a Bachelor of Science in Clinical Medicine and is currently a Ph.D. candidate at the Medicine School of Zhejiang University.
Mr. Wei Hu, Chief Operating Officer of Jo-Jo Drugstores, Inc., stated, “It is a great honor to join Jo-Jo Drugstores. This is an exceptionally important time for Jo-Jo Drugstores and the health industry as a whole in China as the retail pharmacy industry adapts to trends in digital technology, demographics, and medical science. At Jo-Jo Drugstores our ambition is to help lead the transformation of health care services to adapt to these trends. I am proud to join an innovative executive team as we attempt to drive forward our business and create a uniquely satisfying experience for our customers.”
Mr. Lei Liu, Chief Executive Officer and Chairman of Jo-Jo Drugstores, Inc., commented, “Mr. Hu is an accomplished executive of the health industry with a long track record of success and accomplishments. Mr. Hu’s dynamic accomplishments and his depth of knowledge and deep industry connections make him an exceptional addition to our team as our Chief Operating Officer as we advance our growth strategy. We are very confident in Mr. Hu’s vision for this critical role in our organization.”
About China Jo-Jo Drugstores, Inc.
China Jo-Jo Drugstores, Inc. (“Jo-Jo Drugstores” or the “Company”), is a leading online and offline retailer and wholesale distributor of pharmaceutical and other healthcare products in China. Jo-Jo Drugstores currently operates retail drugstores and an online pharmacy. It is also a wholesale distributor of products similar to those carried in its pharmacies and it cultivates and sells herbs used for traditional Chinese medicine. For more information about the Company, please visit http://www.chinajojodrugstores.com/. The Company routinely posts important information on its website.
Forward-Looking Statements
This press release contains information about the Company’s view of its future expectations, plans and prospects that constitute forward-looking statements. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets into its portfolio of products and services, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the technical skills and experience necessary to meet the requirements of its clients, and its ability to protect its intellectual property. The Company’s encourages you to review other factors that may affect its future results in the Company’s annual reports and in its other filings with the Securities and Exchange Commission.
– Global genetics testing market expected to be worth USD 50-billion per annum by 2026 [1]
BEIJING and HONG KONG, Nov. 9, 2018 /PRNewswire/ — China’s leading clinical genomics testing company, Berry Genomics (SHE: 000710), and Prenetics Limited — the leading consumer digital health and genetics testing company in Southeast Asia and Europe — today announce that both parties will establish a joint venture company that will deliver transformative consumer digital health and genetics testing services in mainland China.
The joint venture, the first of its kind to operate in China, will provide an array of integrated digital health and genetics testing services aimed at helping millions of consumers in mainland China understand their genes and how it relates back to their health.
The joint venture will work on a direct-to-consumer model, allowing consumers the ability to purchase its suite of genetics enabled health services directly online. The joint venture will also seek collaborations with insurers, governments and other key stakeholders to ensure local market needs are met. The services will launch in the first quarter of next year.
Daixing Zhou, CEO and Co-Founder, Berry Genomics, says: “We are extremely excited about the potential of the direct-to-consumer testing market in mainland China. Consumer genetics can provide a genetic reference for people’s health and promote people’s wellness. By joining forces with Prenetics, we believe that we can effectively complement one another and ultimately provide valuable benefits to millions of people across mainland China. This has the potential to make a huge impact in the lives of many families across the country.”
Danny Yeung, CEO and Co-Founder, Prenetics says, “We are thrilled to partner with Berry Genomics. Berry is an industry leader in NIPT and has developed a proven business model in genomics around a complex challenge in mainland China. Prenetics was founded on the principle of giving everyone the power to be in control of their own health. We believe everyone should have access to high-quality and affordable genetic testing and digital health services. Together with Berry, we will create awareness on health and the power of prevention through genetic understanding.”
About Berry Genomics:
Founded in May 2010, Berry Genomics (SHE: 000710) is a pioneer in China’s genomics industry, dedicated to transforming gene testing technologies from lab only into clinical applications. Berry Genomics has successfully spread genomics testing as a valuable disease screening technology, and built a strong network with academics and doctors. Berry Genomics keeps continuous investment in R&D, and exploring more solutions of detecting more diseases. Berry’s mission is to serve society to improve the genetic health of all peoples for the benefit of humankind.
Berry Genomics is headquartered in Beijing and has set up 8 medical testing laboratories in 8 cities. It has a production base in Hangzhou, and set up Xcelom Limited in Hong Kong. The company serves over 2,000 hospitals in more than 30 provinces. In August 2017, Berry Genomics was successfully listed on the main board of China A shares. For more information, please visit the company’s official website: http://www.berrygenomics.com/
About Prenetics
Prenetics is one of the leading global genetics testing and digital health companies. The Company has a team of over 120 people, and is spread across eight offices in Asia, Europe and South Africa.
Prenetics’ mission is to help people lead healthier, more active lives by empowering them with personalized, predictive, and preventive measures in the form of the latest, proven innovations in DNA and mobile technology. With backing of over US$50mn strategic investments from powerhouses such as Alibaba and Ping An, Prenetics is helping millions of people live healthier lives. Learn more at www.prenetics.com
-Growing number of GCAM centers on track to more than double nationwide in years
YONGIN, South Korea, Nov. 9, 2018 /PRNewswire/ — GCAM, Inc., a U.S. based plasma collection company, announced that it has added two additional plasma collection centers; one located in Indianapolis, Indiana, and another in Pasco, Washington. With the two newest additions, GCAM now runs 10 plasma donation centers nationwide.
GCAM Pasco Center
“The centers are part of a GCAM mid-term plan to bring the number of plasma centers so that more patients ultimately may have access to a variety of live saving and life sustaining therapies from the collected plasma,” said Jay Bae, GCAM President. “We are bringing job opportunities to these areas and also upping local economies through compensation to residents for their plasma donations.”
Human plasma is the essential source for products to treating patients suffering from many different life-threatening disease and conditions, including immune deficiencies, hemophilia and other blood disorders.
GCAM, is a member of GC, the parent company of GC Pharma, one of the largest protein therapies makers in the world. GCAM collects high quality source plasma for GC Pharma and other plasma fractionators. A plasma center can collect up to 50,000 liters of source plasma annually.
About GCAM
GCAM, Inc., headquartered in Fullerton, CA, was established in 2009 and a member of South Korea’s GC group of companies. GCAM runs source plasma centers in the United States. Its sister company, GC Pharma operates biopharmaceutical businesses on a global scale and GCBT, its immediate parent company owns state-of-art plasma fractionation facility in Montreal, Quebec.
This release includes forward-looking statements, which express the current beliefs and expectations of GCAM’s management. Such statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
