Ascensia Diabetes Care today announced that it has now launched its upgraded version of the CONTOUR®DIABETES app in 24 countries worldwide. This latest version includes the new My Patterns feature, which uses innovative algorithms to more intelligently analyze blood glucose results received from the CONTOUR®NEXT ONE meter, and delivers personalized meaningful feedback to patients. This feedback is designed to help patients improve diabetes self-management and maintain positive lifestyle changes.
The upgraded CONTOUR®DIABETES app has recently been launched in Austria, Belgium, Canada, Cyprus, Czech Republic, Denmark, Finland, France, Greece, India, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Sweden, Slovenia, Spain, Switzerland, and USA, adding to the launches in Germany, UK and Ireland that took place at the end of 2017. This new release is now available in the Apple App Store (iOS) and Google Play (Android).
The CONTOUR®DIABETES app was first launched in 2016 and is designed to seamlessly connect to the CONTOUR®NEXT ONE meter† . The My Patterns feature on the upgraded CONTOUR®DIABETES app analyzes data received from the meter to identify and notify the user of sub-optimal patterns in their blood glucose readings. Once it has notified the user that a pattern has been identified, the CONTOUR®DIABETES app will prompt users about the possible causes of the pattern and provide guidance to help address it. It allows patients to set reminders or use testing plans to help improve their blood glucose patterns, and will track their progress to see if the pattern improves over time*. The latest version of the app includes the ability to recognize 14 different patterns and use 11 different structured testing plans. The app will continue to evolve in the future to include additional patterns and testing plans, as well as adding new features and functionality.
My Patterns has been developed using evidence-based behavioral science concepts from the Information, Motivation and Behavioral Skills (IMB) model of health behavior change, pioneered by health psychologists Dr. William Fisher and Dr. Jeffrey Fisher. This well-researched model shows that people with diabetes need actionable information, motivation to act on that information and a set of specific behavioral skills, in order to make changes to improve the self-management of their diabetes. Studies to assess this model have demonstrated that the presence of all three elements in people with diabetes is associated with more frequent blood glucose testing and improved self-management actions[1]. The My Patterns feature of the CONTOUR®DIABETES app is designed to help the user in these three areas and support more effective self-management, enabled by technology.
Dr. William Fisher, Professor of Psychology and health psychologist at Western University, London, Canada, commented: “Self-management is essential in diabetes, and three decades of research concerning the Information-Motivation-Behavioral Skills model of health behavior show that well informed and well-motivated individuals who have the skills needed to initiate and maintain health behaviors can do so effectively and over the long-term. The IMB model–stressing the provision of actionable diabetes self-management information, motivation to act on it, and skills development for acting effectively–helped guide development of this latest version of the CONTOUR®DIABETES app to create an accessible, intuitive tool that employs an evidence-based health behavior model delivered through the latest technology, to enable more effective and personalized diabetes self-management.”
Michael Kloss, Chief Executive Officer, Ascensia Diabetes Care, explained: “The My Patterns feature on the new CONTOUR®DIABETES app represents a real advance in the use of data for diabetes management. It can uncover patterns in blood glucose readings that patients may not have otherwise recognized and provides tailored reminders that can support improved self-management. This can help people with diabetes stay on track between visits to their doctor and can provide meaningful information for more informed consultations.”
Michael added: “We are very excited to be able to bring this new innovation to patients. At Ascensia we are listening to feedback from people with diabetes about their needs, and are continuing to invest in further development of the CONTOUR®DIABETES app, so that we can provide solutions that make diabetes self-management better, easier and smarter.”
The CONTOUR®NEXT ONE BGMS is also the most accurate system that has been developed by Ascensia Diabetes Care to date. Published study data has shown the CONTOUR®NEXT ONE BGMS to be remarkably accurate, meeting EN ISO 15197:2015 accuracy criteria[2] in both the laboratory and clinical setting. A study has shown that 95% of results were within ±8.4 mg/dL or ±8.4% of the laboratory reference values for glucose concentrations < 100 mg/dL or ≥ 100 mg/dL, respectively, when tested via subject obtained fingerstick results[3].
† Please check our device compatibility list at http://compatibility.contourone.com/ to confirm your device will pair with the CONTOUR®DIABETES app.
* Information provided by the CONTOUR®DIABETES app is not considered medical advice and is for informational purposes only. Patients should always speak with their HCP prior to making changes to diet, treatment or exercise.
1. Fisher WA, Kohut T, Schachner H, Stenger P. The Diabetes Educator (2011) 37;1:85-94
2. International Organization for Standardization (2015). In vitro diagnostic test systems-requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (EN ISO 15197:2015)
3. Christiansen et al. Poster presented at the 15th Annual Meeting of the Diabetes Technology Society, October 22-24, 2015, Bethesda, Maryland
For more information, please contact: Joseph Delahunty VP, Global Head of Communications, Ascensia Diabetes Care joseph.delahunty@ascensia.com +41-79-422-9286
SYDNEY, May 10, 2018 /PRNewswire/ — Biopharmaceutical company NeuClone has announced positive preclinical results of its biosimilar to Johnson & Johnson’s Stelara®, including 3-dimensional (3-D) structure confirmation through X-ray crystallography analysis.
X-ray crystallography analysis confirms identity and equal structural integrity of NeuClone’s biosimilar and the reference product Stelara®, in both primary amino acid sequence and 3-D folding (structure).
Stelara® is a monoclonal antibody that targets both interleukin-12 and -23 and is currently approved to treat various diseases including plaque psoriasis and Crohn’s disease.
Dr Noelle Sunstrom, CEO of NeuClone, stated: “These results demonstrate our ability to create biosimilars using our Right from the Start® approach to biosimilarity, confirming each NeuClone product is indistinguishable from its originator at every stage of development. We develop crystals, functional cell-based assays and other tier 1 biosimilarity tests all in the same facility, allowing us to select the right candidate to go into the clinic.”
NeuClone’s Stelara® biosimilar is co-developed with Serum Institute of India and is currently in process scale up to support planned Phase I clinical trials in 2019. This will be the company’s second product to enter clinical studies in Australia following its first product, a biosimilar of Roche / Genentech’s Herceptin®.
In comparison to reference monoclonal antibody products, biosimilar approval requires more extensive analytical data packages to demonstrate structural and functional characterisation of the biosimilar candidate. Analytical studies, such as X-ray crystallography, provide the foundations for determining biosimilarity.
In 2017, Stelara® achieved global sales of USD 4.0 billion. EvaluatePharma has forecast global sales of Stelara® to reach USD 4.9 billion in 2022.
NeuClone representatives will attend the upcoming 2018 BIO International Convention in Boston from 4-7thJune 2018 and look forward to meeting potential commercialisation partners.
Stelara® is marketed by Janssen, a wholly owned subsidiary of Johnson & Johnson.
About NeuClone Pty. Ltd.
NeuClone Pty. Ltd. is a private biopharmaceutical company focused exclusively on developing a pipeline of biosimilar products. Five biosimilar products have been disclosed in NeuClone’s pipeline that reference Herceptin®, Stelara®, Humira®, Synagis® and Prolia®/XGEVA®. NeuClone develops biosimilar products using its proprietary NeuMAX® platform that facilitates low-cost manufacture of biologics, whilst enabling the highest product quality. NeuClone is led by a highly experienced team with state-of-the-art integrated facilities based in Sydney, Australia. For more information, please visit www.neuclone.com.
Contact: John Oksinski, Head of Global Business Development – j.oksinski@neuclone.com, +61429133767
BEIJING, May 11, 2018 /PRNewswire/ — Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, announced today that it has filed its annual report for the year ended December 31 on Form 20-F (the “2017 Annual Report”) with the U.S. Securities and Exchange Commission. The Company also reported its unaudited financial results for the six months ended December 31, 2017, as well as audited financial results for the year ended December 31, 2017.
Filing of 2017 Annual Report
The Company has filed its 2017 Annual Report with the SEC on May 11, 2018. The 2017 Annual Report is available on the SEC’s website www.sec.gov. Sinovac will also post the 2017 Annual Report on its website www.sinovac.com under SEC Filings in the Investor Relations section. The Company will provide a hard copy of the 2017 Annual Report to its shareholders upon request, free of charge. Requests for a hard copy of the 2017 Annual Report can be made by sending a request by email to ir@sinovac.com and submitting the complete mailing details on a request form.
Unaudited Second Half of2017 Financial Highlights
Sales from continuing operations for the second half of 2017 were $107.4 million compared to $60.1 million in the prior year period, an increase of 78.8%. Sales increased primarily due to revenue generated by the Company’s EV71 vaccine.
Net income attributable to common shareholders was $15.0 million, or $0.26 per basic and diluted share, compared to net income attributable to common shareholders of $7.7 million, or $0.13 per basic and diluted share, in the prior year period.
Full Year2017 Financial Highlights
Sales from continuing operations in 2017 were $174.3 million, an increase of 140.7% from $72.4 million in 2016. Sales increased primarily due to revenue generated by the Company’s EV71 vaccine.
Net income attributable to common shareholders was $25.8 million, or $0.45 per basic and diluted share in 2017, compared to net loss attributable to common shareholders of $0.6 million, or ($0.01) per basic and diluted share in 2016.
Business Highlights
Marketing and Sales
In 2017, the vaccine market recovered from the impact caused by the Shandong incident in 2016. The Company’s new product, EV71, made a significant contribution to the revenue. Hepatitis vaccine and flu vaccine sales rebounded compared to 2016.
Research and Development
Varicella – Sinovac obtained clinical research approval for its proprietary Varicella vaccine candidate from the China Food and Drug Administration (CFDA) in September 2015 and completed phase I clinical trials in 2016. The phase III trial was completed in 2017 with preliminary phase III data showing that Sinovac’s varicella vaccine was 87.1% (95% CI: 69.7%, 94.5%) efficacious against chickenpox caused by Varicella-zoster Virus (VZV). The results of the lot consistency study indicated that the immunogenicity of the three vaccine lots was consistent. The Company filed the production license application with the CFDA before the end of 2017.
sIPV – In November 2015, the Company obtained clinical trial licensing for its Sabin IPV. Phase I/II clinical trials were completed in 2017. A phase III trial was commenced in April 2017 and recently unblended. The preliminary results of the trial after unblinding show that the seroconversion rate of poliovirus type II is superior to the control vaccine and seroconversion rates of the other two types of poliovirus are non-inferior to the control vaccine. In addition, the geometric mean titer (“GMT”) of all three poliovirus types were higher than the control vaccine.
23 Valent Pneumococcal Polysaccharide Vaccine – A phase III trial on 23-PPV was completed with results showed that the immunogenicity and safety of Sinovac’s vaccine candidate were not inferior to the controlled vaccine, a 23-PPV already commercialized in China. Furthermore, the results showed that the vaccine candidate could be used by the target age group to control and prevent diseases caused by pneumonia. The New Drug Application was filed to the CFDA in August 2017. Due to the aggressive actions taken by the minority shareholder of Sinovac Biotech Co., Ltd. (Sinovac Beijing), Sinovac Beijing was forced to suspend all preparations for and ultimately postpone the CFDA inspection of the manufacturing site necessary for 23-valent PPV production approval.
Quadrivalent Influenza Vaccine (QIV) – The Company initiated the development of a QIV in May 2013. Following the completion of preclinical studies, the Company applied for the clinical license from the CFDA. The approval to conduct a human clinical trial was issued by the CFDA in November 2016, and the trial was initiated in the fourth quarter of 2017. In contrast to the trivalent influenza vaccine, such as Sinovac’s Anflu product, which includes an influenza A H1N1 virus, an influenza A H3N2 virus, and a B virus, the quadrivalent flu vaccine is designed to protect against four different flu viruses: two influenza A viruses and two influenza B viruses. Adding another B virus to the vaccine is expected to provide broader protection against circulating flu viruses because there are two very different lineages of B viruses that both circulate during most seasons.
Other Legal Matters
A number of legal matters have recently arisen related to the actions of certain shareholders of the Company in connection with 2017 Annual General Meeting of Shareholders (“2017 AGM”) in the United States and Antigua by the Company or 1 Globe. The progress of each litigation was disclosed in the form of 20-F filed by the Company.
On April 9, 2018, the Company received a document request from the SEC requesting all of the Company’s documents concerning 1Globe, the Chiang Li Family, OrbiMed, certain other shareholders, and their affiliates. We have been cooperating with the SEC. We understand the SEC is conducting a fact-finding investigating to determine whether these shareholders and possibly other parties violated the U.S. securities laws. We do not have any information to suggest the SEC is investigating the actions of the Company or its officers and directors. We cannot predict the outcome of the SEC’s investigation.
Unaudited Financial Results for Second Half of 2017
2017 2H
% of Sales
2016 2H
% of Sales
(In $000 except percentage data)
Hepatitis A – Healive
14,542
13.5%
15,520
25.8%
Hepatitis A&B – Bilive
5,502
5.2%
1,695
2.8%
Hepatitis vaccines subtotal
20,044
18.7%
17,215
28.6%
Influenza vaccine
13,550
12.6%
9,119
15.2%
Enterovirus 71 vaccine
72,533
67.5%
33,578
55.9%
Mumps vaccine
1,311
1.2%
191
0.3%
Regular sales
107,438
100.0%
60,103
100.0%
H5N1
–
0.0%
(3)
0.0%
Total sales
107,438
100.0%
60,100
100.0%
Cost of sales
12,505
11.6%
14,030
23.3%
Gross profit
94,933
88.4%
46,070
76.7%
Sales from continuing operations in the second half of 2017 were $107.4 million compared to $60.1 million in the prior year period. Sales increased primarily due to revenue generated by the Company’s EV71 vaccine.
Gross profit from continuing operations was $94.9 million compared to gross profit of $46.1 million in the prior year period. Gross margin was 88.4% compared to 76.7% in the prior year period. Growth margin in the second half of 2016 was lower due to higher idle capacity costs charged to cost of sales and a negative gross profit for the hepatitis A&B vaccine due to higher sales returns provision provided in 2016 as a result of the Shandong incident. Gross profit in the second half of 2017 also increased due to higher gross profit generated by the Company’s EV71 vaccine.
Selling, general and administrative expenses in the second half of 2017 were $50.6 million compared to $27.5 million in the same period of 2016. The Company’s selling, general and administrative expenses increased with higher levels of sales activity. The Company also incurred a cost of $0.6 million relating to the proposed privatization of Sinovac.
R&D expenses in the second half of 2017 were $11.7 million compared to $7.8 million in the same period of 2016. The increase was mainly due to higher R&D expenses on the varicella and sIPV vaccine pipeline products.
Income from continuing operations in the second half of 2017 was $20.9 million compared to $11.1 million in the prior year period.
Net income attributable to common shareholders was $15.0 million, or $0.26 per basic and diluted share, compared to net income attributable to common shareholders of $7.7 million, or $0.13 per basic and diluted share, in the prior year period.
Non-GAAP EBITDA was $35.4 million in the second half year of compared to $20.1 million in the prior year period. Non-GAAP net income from continuing operations in the second half of 2017 was $20.2 million compared to $13.4 million in the prior year period. Non-GAAP diluted earnings per share from continuing operations in the second half of 2017 were $0.25 per share compared to $0.17 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.
Financial Results for the TwelveMonths EndedDecember 31, 2017
2017
% of Sales
2016
% of Sales
(In $000 except percentage data)
Hepatitis A – Healive
27,421
15.7%
20,044
27.7%
Hepatitis A&B – Bilive
10,430
6.0%
552
0.7%
Hepatitis vaccines subtotal
37,851
21.7%
20,596
28.4%
Influenza vaccine
13,544
7.7%
9,829
13.6%
Enterovirus 71 vaccine
121,284
69.6%
35,140
48.5%
Mumps vaccine
1,667
1.0%
477
0.7%
Regular sales
174,346
100.0%
66,042
91.2%
H5N1
–
0.0%
6,389
8.8%
Total sales
174,346
100.0%
72,431
100.0%
Cost of sales
20,240
11.6%
22,393
30.9%
Gross profit
154,106
88.4%
50,038
69.1%
Sales from continuing operations in 2017 were $174.3 million, an increase of 140.7% from $72.4 million in 2016. Sales increased primarily due to revenue generated by the Company’s EV71 vaccine as well as sales recovery in the Company’s other products following the 2016 Shandong vaccine incident.
Gross profit from continuing operations in 2017 was $154.1 million, an increase of 208.0% from $50.0 million in 2016. Gross margin was 88.4% compared to 69.1% in 2016. Gross margin in 2016 was lower due to higher inventory provision provided for the hepatitis A&B and mumps vaccines, higher idle capacity costs charged to cost of sales, and a negative gross profit for the hepatitis A&B vaccine due to a higher sales returns provision provided in 2016 as a result of the Shandong incident. Gross profit in 2017 also increased due to higher gross profit generated by the Company’s EV71 vaccine.
Selling, general and administrative expenses in 2017 were $87.4 million compared to $42.0 million in 2016. The Company’s selling, general and administrative expenses increased with the higher level of sales activity, and the Company also incurred a cost of $1.5 million related to the proposed privatization of Sinovac.
R&D expenses in 2017 were $20.5 million compared to $12.6 million in 2016. The increase was mainly due to higher R&D expenses on the varicella and sIPV vaccine pipeline products.
Net income from continuing operations was $36.7 million in 2017 compared to a net loss of $3.1 million in 2016. Net income from discontinued operations was nil in 2017 compared to $2.3 million in 2016.
Net income attributable to common shareholders was $25.8 million, or $0.45 per basic and diluted share in 2017, compared to net loss attributable to common shareholders of $0.6 million, or ($0.01) per basic and diluted share in 2016.
Non-GAAP EBITDA was $51.3 million in 2017 compared to $8.2 million in 2016. Non-GAAP net income from continuing operations in 2017 was $36.4 million compared to net income of $0.3 million in 2016. Non-GAAP diluted earnings per share from continuing operations in 2017 were $0.45 compared to diluted earnings per share of $0.01 in 2016. Reconciliations of non-GAAP measures to the nearest comparable GAAP measures are included at the end of this earnings announcement.
As of December 31, 2017, cash and cash equivalents totaled $114.4 million compared to $62.4 million as of December 31, 2016. In 2017, net cash provided in operating activities was $61.4 million. Net cash used in investing activities was $11.9 million, which was due to the purchase of equipment. Net cash used by financing activities was $1.3 million, including loan proceeds of $28.6 million and loan repayment of $38.7 million. As of December 31, 2017, the Company had $18.2 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.
Update on “Going Private” Proposals
On June 26, 2017, the Company entered into an amalgamation agreement (the “Amalgamation Agreement”) with Sinovac (Cayman) Limited, (“Parent”) and Sinovac Amalgamation Sub Limited (“Amalgamation Sub”), a wholly owned subsidiary of Parent. Pursuant to the Amalgamation Agreement, Parent will acquire the Company for cash consideration equal to $7.00 per common share. Subject to the terms and conditions of the Amalgamation Agreement, at the effective time of the amalgamation, Amalgamation Sub will be amalgamated with and into the Company, with the Company continuing as the surviving corporation and a wholly owned subsidiary of Parent (the “Amalgamation”). Immediately following the consummation of the transactions contemplated by the Amalgamation Agreement, Parent will be beneficially owned by a consortium comprising Mr. Weidong Yin, SAIF Partners IV L.P., C-Bridge Healthcare Fund II, L.P., Advantech Capital L.P., Vivo Capital Fund VIII, L.P., and Vivo Capital Surplus Fund VIII, L.P.
Our board of directors, acting upon the unanimous recommendation of the special committee formed by the board of directors, or the Special Committee, unanimously approved the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and resolved to recommend that the Company’s shareholders authorize and approve the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation.
The Amalgamation is subject to customary closing conditions, including approval by an affirmative vote of holders of Shares representing at least two-thirds of the Company’s common shares present and voting in person or by proxy as a single class at a meeting of its shareholders, which will be convened to consider the authorization and approval of the Amalgamation Agreement and the transactions contemplated by the Amalgamation Agreement, including the Amalgamation, and the other closing conditions specified in the Amalgamation Agreement. If completed, the Amalgamation will result in Sinovac Biotech Ltd. becoming a privately-held company, and the Company’s common shares will no longer be listed on NASDAQ.
On June 28, 2017, the Company received a written proposal (the “Sinobioway Proposal”) from a consortium comprising (i) PKU V-Ming (Shanghai) Investment Holdings Co., Ltd., (ii) Shandong Sinobioway Biomedicine Co., Ltd., (iii) CICC Qianhai Development (Shenzhen) Fund Management Co., Ltd., (iv) Beijing Sinobioway Group Co., Ltd., (v) CITIC M&A Fund Management Co., Ltd., (vi) Heng Feng Investments (International) Limited, and (vii) Fuerde Global Investment Limited (collectively, the “Sinobioway Consortium”), pursuant to which the Sinobioway Consortium proposed to acquire the Company for cash consideration equal to $8.00 per common share (the “Sinobioway Transaction”).During the course of the following three months, the Special Committee and its advisors sought to clarify the terms of the Sinobioway Proposal, including the financing of the Sinobioway Transaction, and the likelihood of consummating the Sinobioway Transaction, with the Sinobioway Consortium and its advisors. In late October, the Special Committee determined, after consultation with its advisors, that negotiations with respect to the Sinobioway Proposal were not permitted under the Amalgamation Agreement based on the information provided by the Sinobioway Consortium prior to such determination.
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. Healive, the hepatitis A vaccine manufactured by the Company has passed the assessment under WHO Prequalification procedures in 2017. 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.
Safe Harbor Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. 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 and adverse general economic conditions in the United States and internationally. 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 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 results announcement.
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
Media ICR Inc. United States Phil Denning Tel : 1-646 277 1258 Email : Phil.denning@icrinc.com
BOTHELL, Washington, May 10, 2018 /PRNewswire/ — AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today that in late 2017 it entered into a commercial supply agreement with MacroGenics, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, for the manufacture of margetuximab, a clinical-stage, novel immune-optimized monoclonal antibody.
AGC Biologics has provided comprehensive development and validation services for margetuximab since 2014, and plans to implement a transition to commercial supply services.
Margetuximab is an investigational product that targets the human epidermal growth factor receptor 2, or HER2. HER2 is expressed by tumor cells in breast, gastroesophageal, bladder and other forms of solid tumor cancers, making it a key marker for biologic therapy. Margetuximab has an Fc domain, which was engineered to enhance engagement and activation of the immune system.
“Patients with late-stage cancer, such as metastatic breast cancer, often have limited choices and greater uncertainty regarding what drug will be most effective as the next step in their treatment path,” said Gustavo Mahler, Ph.D., President & Chief Executive Officer of AGC Biologics. “We’re thrilled to work alongside MacroGenics in potentially bringing margetuximab to the market — filling a critical need, and delivering a promising new treatment option, if approved, with the chance to meaningfully impact patients’ lives.”
“We’re pleased to have worked with AGC Biologics to bring the development of margetuximab to this point, getting MacroGenics closer to our goal of providing a possibly meaningful advance to patients in need,” said Tom Spitznagel, Ph.D., Sr. Vice President, Biopharmaceutical Development & Manufacturing at MacroGenics. “AGC Biologics has been an important partner throughout the development and validation process, providing the expertise, technology and customized flexibility to facilitate the exciting path of margetuximab from development to pre-commercialization.”
About AGC Biologics AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), with a strong commitment to deliver the highest standard of service to our clients and partners. AGC Biologics is the product of the convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH, and CMC Biologics. The company currently employs more than 850 employees worldwide. Our extensive network spans three continents, with cGMP-compliant facilities in Seattle, WA; Berkeley, CA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba, Japan.
AGC Biologics offers deep industry expertise and unique customized services for the scale-up and cGMP manufacture of protein-based therapeutics; from pre-clinical to commercial production, for mammalian and microbial. Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage, and protein expression — including our proprietary CHEF1® Expression System for mammalian production. Further information can be found at www.agcbio.com
AGC Biologics Media Contact Information: Ms. Kim Yang Director, Global Marketing and Communications Email: kyang@agcbio.com Office: +1 425.415.5438
ISNES, Belgium, May 9, 2018 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) today announced that it has entered into a Global Sales and Distribution Agreement with Active Motif for a range of Research Use Only (“RUO”) kits, that are based on its proprietary Nucleosomics® technology.
Founder and Chairman of Active Motif, Joseph M. Fernandez commented “We are continuously looking for innovative products in the field of epigenetics and believe Nucleosomics® is a breakthrough technology. We are delighted to announce our strategic relationship with Volition and believe their Nucleosomics® technology will complement our current range of products and should sell well. These RUO kits will provide researchers throughout the world with a new way to explore epigenetic modifications in circulating cell-free nucleosomes across different diseases from clinical samples. We aim to have the first kit available for sale by the end of June this year and are working with Volition to develop a broad range of assays focused on important targets.”
The RUO kits are based on the same Nu.Q™ immunoassay technology as Volition’s cancer screening panels and may be used to investigate a variety of clinical questions beyond Volition’s core focus in cancer biomarkers. The range of the RUO kits will allow researchers to explore patterns of epigenetic modifications in circulating nucleosomes in disease models, pre-clinical testing and clinical trials across a broad spectrum of clinical applications including cancer, inflammatory and infectious diseases and trauma. The RUO kits will offer a complete profiling solution from cell to serum.
Chief Executive Officer of Volition, Cameron Reynolds, commented, “We are very happy to be working with Active Motif, who are key players in the field of epigenetics kits. This is a fantastic opportunity for Volition and we expect that it will provide an additional revenue stream beyond that from the expected commercialization of our blood-based tests for cancer. If the assays are developed as a companion diagnostic for another company’s therapeutic, this could also potentially result in further future revenue through a licensing or similar arrangement.”
Dr. Mark Eccleston, Volition’s Business Development Director, commented, “Active Motif is an ideal partner for us, given its great team that has already established relationships with our target customers across the world. Not only will the sale of the RUO kits generate revenue, but such sales will also broaden potential applications of our technology and generate further validation of the Nucleosomics® platform.”
Active Motif is an industry leader in developing and delivering innovative tools to enable epigenetics and gene regulation research for the life science, clinical and pharmaceutical and drug discovery communities. The company has a world leading portfolio of assays, genome wide services and validated antibodies for use in ChIP-Seq. Active Motif operates globally through its corporate headquarters in Carlsbad, California, regional headquarters in Belgium, Japan and China, as well as a worldwide network of sales and support offices. Active Motif applies a multi-disciplinary approach to create new and modify existing technologies to meet the current and future needs of life science researchers. To learn more please visit www.activemotif.com.
About Volition
Volition is a multi-national life sciences company focused on developing simple, easy to use, cost effective blood tests designed to help diagnose a range of cancers. The tests are based on the technology platform of Nucleosomics®, which is the practice of identifying and measuring nucleosomes in the bloodstream or other bodily fluid – an indication that disease is present.
As cancer screening programs become more widespread, Volition’s products aim to help to diagnose a range of cancers quickly, simply, accurately and cost effectively. Early diagnosis has the potential to not only prolong the life of patients, but also to improve their quality of life. Volition’s research and development activities are currently centered in Belgium, with additional offices in London, Texas and Singapore, as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.
The contents found at Volition’s website address, Twitter, LinkedIn, Facebook, and YouTube are not incorporated by reference into this document and should not be considered part of this document. The addresses for Volition’s website, Twitter, LinkedIn, Facebook, and YouTube are included in this document as inactive textual references only.
Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “may,” “will” and similar expressions identify forward-looking statements. These forward-looking statements relate to the effectiveness of Volition’s bodily-fluid-based diagnostic tests as well as Volition’s ability to develop and successfully commercialize such test platforms for early detection of cancer. Volition’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if Volition fails to develop and commercialize diagnostic products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in Volition’s development pipeline or any other diagnostic products Volition might develop; Volition will face fierce competition and Volition’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in Volition’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.
Nucleosomics®, NuQ®, Nu.QTM and HyperGenomics® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners. Additionally, unless otherwise specified, all references to “$” refer to the legal currency of the United States of America.
TOKYO, May 10, 2018 /PRNewswire/ — Kaneka Corporation has been in dispute with Xiamen Kingdomway Group Company since March 2011, when Kaneka instituted a patent infringement action against the company in the United States District Court for the Central District of California alleging infringement of Kaneka’s U.S. Patent No. 7,910,340 relating to coenzyme Q10 (Kaneka Q10™).
Mamoru Kadokura, President of Kaneka Corporation stated, “We are aware of the ruling in Kaneka’s case against Xiamen Kingdomway Group Company for patent infringement and will appeal the decision to the Federal Circuit Court of Appeals. Kaneka will continue to protect our interests and defend our organization against any patent infringement. We have invested heavily in the development of proprietary technology and we intend to continue with our legal efforts to protect our investment.”
Keith Nowak Phone: 212-238-8610 Email: Nowak@clm.com
SUZHOU, China, May 9, 2018 /PRNewswire/ — CStone Pharmaceuticals (“CStone”) announced today the successful completion of a $260 million (about RMB1.65 billion) financing, the largest Series B funding in the history of the China biopharmaceutical industry. The investment was led by GIC Private Limited, Singapore’s sovereign wealth fund, with participation from new investors including Sequoia China, Yunfeng Capital, 6 Dimensions Capital, CITIC PE, Taikang Insurance Group, ARCH Venture Partners, Hillhouse Capital, King Star Capital, 3W Partners, AVICT, and Terra Mafnum Capital Partners. Existing investors also participated in this round, including Oriza Seed Venture Capital , Boyu Capital, and WuXi Healthcare Ventures (currently a 6 Dimensions Capital fund). Together with the $150 million raised in Series A financing in 2016, this most recent round of funding brings the total capital raised to $410 million (about RMB2.63 billion).
Founded in 2016 and headquartered in Suzhou, China, CStone is an innovative biopharmaceutical company led by a management team comprised of seasoned executives from top multinational pharmaceutical companies. Since its founding, CStone has focused on the development of innovative drugs and combination therapies in immuno-oncology, and made significant progress in the establishment and clinical development of its rich pipeline. As of today, CStone has built a portfolio of more than ten assets, including four in various clinical stages. In particular, CS1001, China’s first full-length and fully human anti-PD-L1 monoclonal antibody, is completing Phase I dose escalation study and will soon enter registrational trials. The Suzhou Translational Medicine Research Center, established by CStone at the end of 2017, will further enhance the efficiency of clinical development.
Dr. Frank Jiang, Chief Executive Officer of CStone, commented, “We appreciate the recognition and support from top domestic and overseas investors, which enabled our Series B financing to be completed in merely two months. As a young but pragmatic innovative biopharmaceutical company, we have grown rapidly in less than two years, making significant progress in pipeline development, external collaboration, and establishment of core team. This round of financing is critical for CStone’s current and near-term growth.“
Choo Yong Cheen, Chief Investment Officer of Private Equity at GIC, said, “GIC is pleased to be the lead investor in this financing round by CStone. CStone is one of China’s most innovative pharmaceutical companies, with a strong pipeline, a world-class management team and a team of clinical developers with international calibre. We are confident in the long-term growth potential of China’s biopharmaceutical industry and CStone’s leading position in the field of immuno-oncology.“
All existing investors from Series A participated in this round of financing, continuing their strong support for CStone’s growth. Dr. Wei Li, Managing Partner of 6 Dimensions Capital, said, “Within only a few years, immunotherapies now account for more than half of the oncology development projects in the world. The era of cancer immunotherapy and combination therapy has arrived. As one of the founding investors, we are delighted to see CStone achieving such remarkable results in the advancement of innovative cancer immunotherapies and are convinced of CStone’s potential. We are thrilled to continuing our support of CStone and their quest for the development of high quality immuno-oncology based combination therapies and becoming the leading biotech company in China.”
The funds raised in this round will be primarily used for clinical development of CS1001 and other clinical stage assets, expanding company pipeline through internal R&D and external partnerships, and attracting top industry talents, for delivering breakthrough therapeutic solutions to cancer patients.
About CStone Pharmaceuticals
CStone Pharmaceuticals is a biopharmaceutical company devoted to the development of next-generation innovative drugs. With its broad immuno-oncology pipeline, the firm is pursuing a development strategy focused on combination therapy. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up an industry leading team with clinical development and translational medicine as its core competence. With substantial funding and robust pipeline, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region.
For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com
About GIC
GIC is a leading global investment firm established in 1981 to manage Singapore’s foreign reserves. A disciplined long-term value investor, GIC is uniquely positioned for investments across a wide range of asset classes, including equities, fixed income, private equity, real estate and infrastructure. In private equity, GIC invests through funds as well as directly in companies, partnering with its fund managers and management teams to help world class businesses achieve their objectives. GIC has investments in over 40 countries and has been investing in emerging markets for more than two decades. Headquartered in Singapore, GIC employs over 1,400 people across 10 offices in key financial cities worldwide. For more information, please visit: www.gic.com.sg.
Expanding its Footprint in the Greater China Region and Capitalizing on Life Sciences Innovation and Hi-tech Investment Opportunities
HONG KONG, May 9, 2018 /PRNewswire/ — Cedrus Investments (“Cedrus”), a global boutique investment firm, is pleased to announce that it has obtained approval from the local government to launch a new office in Shenzhen, which will join an array of Cedrus’ offices in Hong Kong, Beijing, Shanghai, Jakarta, and Grand Cayman to better serve its clients globally.
Shenzhen has its unique city portrait, including important geographical location (being near the Pearl River Delta, which is considered an emerging megacity) as well as its vigorous market dynamics. It is one of the fastest-growing cities in China in terms of GDP, and it is the hub for innovation in life sciences and high-tech, which are sectors Cedrus actively focused on making investments. Shenzhen’s proximity to Hong Kong also enhances its strategic importance, as Hong Kong is one of the world’s top financial centers, allowing free flows of capital internationally.
Since Cedrus has been serving as a trusted partner and advisor to companies in the Greater China region in bridging boththeirinbound and outbound investments for more than a decade, the expansion not only demonstrates the strong track record of success Cedrus has established in the Greater China region but also the firm’s commitment to getting further involved in better serving its clients in a more comprehensive and specialized way.
Mr. Rani Jarkas, Chairman of Cedrus Investments, shared his vision towards the blueprint of Cedrus Investments and the group in general and said that “As Shenzhen is now emerging as a new and within the top-three major financial centers in mainland China along with Beijing and Shanghai, we believe it is necessary to form our own local teams to better capture unique business and investment opportunities in addition to enhancing our local connections and trusted partnerships.
We are looking forward to the upcoming investment opportunities and business diversification made possible by deepening our reach to the vibrant city of Shenzhen, in particular, bringing cutting-edge technology and innovative companies in the life sciences and technology sectors overseas to China to advance its technological development and forge collaborative relationships, thus subsequently boosting Cedrus’ ability to create more investment value to our clients from around the world.”
RARITAN, New Jersey and SINGAPORE, May 8, 2018 /PRNewswire/ — Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, will host the Ortho Lab Leader Scientific Summit on May 8 and 9 at the Conrad Hotel in Seoul, South Korea.
The summit, arranged with the support of the College of American Pathologists, will be an opportunity for lab leaders in the Asia-Pacific region to gain insights from some of the brightest minds in the field of diagnostics about the latest innovations in clinical labs and transfusion medicine.
“Ortho is committed to serving as a trusted advisor to the diagnostics community around the world,” said Alex Socarrás, Ortho’s chief commercial officer. “Diagnostics is rapidly evolving to meet increasing challenges and keep pace with medical innovation worldwide, and helping labs thrive despite the increasing pressures they face is important for us.”
Expert speakers from Korea, the U.S. and Europe will cover automation, leadership and quality in the lab, acute kidney injury and cardiac biomarkers, and work practice standardization.
“This year’s Lab Leader Summit continues Ortho’s tradition of bringing together the most innovative thinkers in diagnostics throughout Asia, as we discuss how to address operational challenges and persistent areas of high unmet medical need,” said Anand Pande, head of Ortho’s Asia-Pacific region.
In March, Ortho sponsored asecond annual Transfusion Medicine Summit in China. And in July, Ortho will host its third annual “C-Suite Summit” in Singapore to address key issues of priority to senior hospital leaders.
About Ortho Clinical Diagnostics Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks, and labs in more than 125 countries and territories, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. For the immunohematology community, Ortho’s blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management and interpretation tools to clinical laboratories around the world, helping them run more efficiently and effectively, and improve patient care. Ortho’s purpose is to improve and save lives with diagnostics, and it does that by reimagining what’s possible. This is what has defined Ortho for more than 75 years, and it’s what drives Ortho forward. For more information, visitwww.orthoclinicaldiagnostics.com.
SHANGHAI, May 8, 2018 /PRNewswire/ — WuXi AppTec Co., Ltd. (“WuXi AppTec” or “the Company”; Stock Code: 603259), a leading global pharmaceutical and medical device open-access capability and technology platform company, today announced listing of its initial public offering of 104,198,600 shares of common stock at a public offering price of RMB21.60 per share. Proceeds from the IPO will be used to build and expand its R&D facilities in China, further strengthening its capabilities and capacities to better serve global customers and partners.
WuXi AppTec Announces Listing of Initial Public Offering of Common Stock on Shanghai Stock Exchange
WuXi AppTec, headquartered in Shanghai, is now operating globally with 26 sites and branch offices in China, the United States, Germany, UK, Japan, Korea and Israel. The Company’s integrated R&D, manufacturing and testing platform for small molecules, cell and gene therapies, and medical devices is supporting over 3,000 customers and partners around the world.
WuXi AppTec Announces Listing of Initial Public Offering of Common Stock on Shanghai Stock Exchange
“I’m deeply grateful for the great confidence and support we have received from the investment community,” said Dr. Ge Li, Chairman and CEO of WuXi AppTec. “It allows us to further focus on our mission and accelerate growth of our enabling platform. Our commitment has always remained the same — we want to empower and enable anyone and any company to advance medicines for patients faster. This commitment will underpin everything we do as we build a strong, valuable and socially responsible public company.”
About WuXi AppTec
WuXi AppTec is a leading global pharmaceutical and medical device open-access capability and technology platform company with global operations. As an innovation-driven and customer-focused company, WuXi AppTec provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the cost of drug and medical device R&D through cost-effective and efficient solutions. With its industry-leading capabilities such as small molecule R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, and medical device testing, WuXi platform is enabling nearly 3,000 innovative collaborators from more than 30 countries to bring innovative healthcare products to patients, and to fulfill WuXi’s dream that “every drug can be made and every disease can be treated.” Please visit http://www.wuxiapptec.com.
