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.
The integrated R&D and manufacturing facility is expecting more products to go into commercial production post approval
SHANGHAI, May 7, 2018 /PRNewswire/ — STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from the U.S. Food and Drug Administration (FDA) — with no Form 483s issued. This is the first time that WuXi STA’s Changzhou facility has been inspected by the FDA.
WuXi STA Changzhou Site Passes First U.S. FDA Inspection
WuXi STA has already passed several inspections from the FDA at its API and advanced intermediate manufacturing facility in Shanghai, Jinshan and at its drug product manufacturing facility in Shanghai, Waigaoqiao free trade zone. As a global leading Contract Development and Manufacturing Organization (CDMO), WuXi STA is the first CMC platform (including both APIs and drug product) in China to have passed FDA inspection for new chemical entities. It is also the first CDMO in China that is approved to supply APIs and GMP intermediates for branded commercial drugs by regulatory agencies in the USA, China, EU, Canada, Switzerland, Australia, and New Zealand.
The Changzhou facility — which opened in early 2016 and is situated on a site of 39 acres — has been designed to keep pace with the increasing demand WuXi STA is seeing from customers, as more products move into commercial production.
Currently, the facility employs more than 1000 people including 200 scientists and has three plants in operation. However, the company will continue to add more than 300 scientists and seven multi-functional plants within the next five years. As a purpose-built facility, Changzhou offers an integrated one-site solution for partners to accelerate innovative APIs and advanced intermediates — from preclinical and clinical development through to global commercial launch.
“Quality is ingrained throughout our culture here at WuXi STA and one of our core competency. The Changzhou facility passing its first FDA inspection, with no observations, even with no written or verbal recommendations, is yet further proof of our commitment to the highest possible quality standards. It’s a point of great pride that we have an exemplary regulatory record, and evidence of the company’s ability to supply the U.S. market with innovative commercial APIs from Changzhou site,”said Dr. Minzhang Chen, CEO of WuXi STA.
“We are very proud of successfully passing FDA inspection once more,” commented Ms. Mei Hao, Vice President of Quality at WuXi STA.“We will continue to strengthen our global quality systems to meet and surpass even the most stringent regulatory requirements. This ensures we provide the highest standard of quality services to our partners worldwide.”
-ENDS-
Notes to editors
About WuXi STA
STA Pharmaceutical Co., Ltd., a subsidiary of WuXi AppTec (WuXi STA), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), WuXi STA offers our worldwide partners efficient, flexible and high-quality solutions for Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For more information, please visit: http://www.STApharma.com
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
-By strengthening the wireless X-ray flat panel detector lineup, Vieworks is expecting to revamp sales in China
ANYANG, South Korea and BEIJING, May 7, 2018 /PRNewswire/ — China Food and Drug Administration (CFDA) has cleared two of Vieworks‘ X-ray flat panel detectors, VIVIX-S 1012N and VIVIX-S 1717N, for use in clinical care. “By adding a 10-inch by 12-inch wireless detector and a 17-inch by 17-inch wireless detector to its lineup, Vieworks offers more choice, value, and flexibility to customers,” said Henry Cha, the sales manager at Vieworks.
VIVIX-S 1717N and VIVIX-S 1012N
Key features:
Stable AED (Anytime™): Vieworks’ superior automatic exposure detection (AED) function is known for high reliability and high sensitivity without compromising image quality compared to a DR line trigger.
Advanced Wireless Communication (Inside AP™): Dual band wireless communication supports direct communication with smart devices (2.4GHz, 5GHz).
Built-in Memory up to 200 Images: If a Wi-Fi connection is not stable, the detector automatically saves up to 200 captured images, securing the stability of Wi-Fi usage.
Easy Upgrade to Digital (Cassette Size): The size of detectors is the same as a film or a CR cassette, making it easy to upgrade a conventional X-ray system to digital X-ray system.
Powerful Software (VXvue): Digital radiography image acquisition viewer for VIVIX-S Series, VXvue enables easy management for simple workflow at medical facilities. With the advanced image processing, PureImpact™, VXvue provides powerful post image processing for efficient diagnosis.
About Vieworks Co., Ltd.
Vieworks offers the most advanced flat panel detectors for digital radiography and digital fluoroscopy. Since 1999, Vieworks has been one of the leading manufacturers of X-ray detectors with advanced digital medical imaging processing, robust hardware design, and excellent usability. The in-house R&D team at Vieworks designs, develops, and manufactures to provide the best solution for your needs. Vieworks software, including the image acquisition application and streamlined PACS system, has various tools that will enhance the daily workflow at medical facilities. For more information, please visit www.vieworks.com.
– Mundipharma licenses Starpharma’s VivaGel® BV for Asia, Middle East, Africa and the majority of Latin America, to be marketed as part of the popular BETADINE® Feminine Care portfolio
– Mundipharma is a leading global pharmaceutical company and owns the successful international brand – BETADINE®
– BETADINE® has a market leading position in Feminine Care, trusted by women globally
– Mundipharma will commence regulatory activities in their licensed territory immediately to secure expedited launch of VivaGel® BV
– Deal terms include milestones of ~A$12.2 million and a revenue share
SYDNEY, May 3, 2018 /PRNewswire/ — Starpharma (ASX: SPL, OTCQX: SPHRY) and Mundipharma today announced they have signed a multi-region licence for the sales and marketing rights to VivaGel® BV in Asia (including China, Japan and Korea), the Middle East, Africa and the majority of Latin America.
Mundipharma is one of the largest privately-owned pharmaceutical companies in the world and has a presence in over 120 countries, employing over 8,600 people.
Mundipharma will register and launch VivaGel® BV as part of the popular BETADINE® range, which is sold in more than 120 countries. BETADINE® has a market leading position in Feminine Care and this licence enables Mundipharma to develop the consumer market for VivaGel® BV in rapidly developing markets across Asia, the Middle East, Africa and Latin America, where demand for trusted intimate health and hygiene products is growing.
Under the licence, Starpharma will receive returns via a revenue share on VivaGel® BV sales. In addition, Starpharma is eligible to receive signing, regulatory and commercial milestones totaling up to A$12.2 million (US$9.2 million) including a A$1.3 million (US$1 million) upfront payment. The term of the agreement is 15 years and incorporates commercial performance obligations, including minimum annual purchases by Mundipharma. Other commercial terms of the agreement remain confidential.
Mundipharma is responsible for regulatory activities, market pricing and marketing and promotion of the product. Mundipharma will commence regulatory activities immediately with initial approvals anticipated towards the end of 2018. Under the agreement, Starpharma retains ownership of the VivaGel® BV trademark and will supply Mundipharma with product.
VivaGel® BV already has regulatory approval in both Europe and Australia. In addition, Starpharma has lodged its New Drug Application (NDA) with the US FDA under a Fast Track designation. The NDA submission provide a comprehensive clinical and regulatory package to support rapid approval in many of Mundipharma’s licensed countries.
Starpharma is also in advanced commercial negotiations for marketing rights to VivaGel® BV in the rest of world, including North America and Europe, and expects to announce further licensing arrangements in the coming months.
Commenting on the licence, Dr Jackie Fairley, CEO of Starpharma said: “We are delighted to have licensed VivaGel® BV to Mundipharma, a global leader in healthcare. Mundipharma’s market leading position and extensive sales, marketing and regulatory network make them the ideal partner for VivaGel® BV in this expansive territory. The licence represents a financially attractive deal for Starpharma. Over the coming months, we’ll be working closely with Mundipharma to secure market access for VivaGel® BV as quickly as possible throughout their territory.”
Raman Singh, Mundipharma CEO, commented: “The VivaGel® BV product represents a true innovation in the management of bacterial vaginosis (BV). It sits well under the BETADINE® brand, which has emerged as a powerful brand platform for consumer healthcare products, trusted by women globally.”
About VivaGel® BV
VivaGel® BV is a patented, water-based vaginal gel for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV. VivaGel® BV is a breakthrough product which specifically targets the organisms that cause BV, rapidly relieves symptoms and has a novel mechanism of action affecting biofilm. VivaGel® BV is a non-antibiotic therapy and is not absorbed into the bloodstream.
About Bacterial Vaginosis (BV)
Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age and affects around 30% of women in the US. It is a highly recurrent condition with 50 60% of sufferers having it recurrently. BV is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman’s vagina). Smoking, the use of some hygiene products and several other risk factors are linked to a higher risk of developing BV. Current therapies for BV are inadequate and have many unpleasant side-effects, there are also no approved products in the US for rBV making VivaGel® BV a first-in-class therapy supported by large, randomised clinical studies.
About Mundipharma
Mundipharma and its network of privately owned Independent Associated Companies (IACs) is dedicated to alleviating human suffering and improving quality of life for the human race. The Mundipharma story, spanning over six decades brings together a visionary approach and a pioneering spirit — what is best told through its patients, employees and the communities across six continents in which they serve. Mundipharma is focused on business transformation by leveraging global leadership in pain and, through a shared spirit of innovation, building a growing presence in antisepsis, respiratory, oncology, ophthalmology, consumer healthcare and other specialty areas.
Starpharma Holdings Limited (ASX: SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma’s underlying technology is built around dendrimers – a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has two core development programs: VivaGel® portfolio and DEP® drug delivery with the Company developing several products internally and others via commercial partnerships.
VivaGel®: Starpharma’s women’s health product – VivaGel® BV is based on SPL7013, astodrimer sodium, a proprietary dendrimer. VivaGel® BV is approved for marketing in the EU and Australia for bacterial vaginosis (BV) and a new drug application is under Fast Track review by the US FDA. Starpharma has licensed the sales and marketing of VivaGel® BV to Mundipharma for 120+ countries in Asia, the Middle East, Africa and majority of Latin America; and to Aspen Pharmacare for Australia and New Zealand. Starpharma has licence agreements to market the VivaGel® condom (an antiviral condom which includes VivaGel® in the lubricant) in several regions, including Australia, Europe, Canada, China and Japan (Okamoto). The VivaGel® condom has been launched in Australia and Canada under the Lifestyles® Dual Protect™ brand.
DEP® – Dendrimer Enhanced Product®: Starpharma’s DEP® drug delivery platform has demonstrated reproducible preclinical benefits across multiple internal and partnered DEP® programs, including improved efficacy, safety and survival. Starpharma has two internal DEP® products – DEP® docetaxel and DEP® cabazitaxel – in clinical development in patients with solid tumours, and further DEP® products approaching clinical development. Starpharma’s partnered DEP® programs include a multiproduct DEP® licence with AstraZeneca, which involves the development and commercialisation of two novel oncology compounds, with potential to add more.
This document contains certain forward-looking statements, relating to Starpharma’s business, which can be identified by the use of forward-looking terminology such as “promising”, “plans”, “anticipated”, “will”, “project”, “believe”, “forecast”, “expected”, “estimated”, “targeting”, “aiming”, “set to”, “potential”, “seeking to”, “goal”, “could provide”, “intends”, “is being developed”, “could be”, “on track”, or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA’s and other authorities’ requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management’s expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
SUZHOU, China, May 4, 2018 /PRNewswire/ — CStone Pharmaceuticals (Suzhou) Co., Ltd., (CStone) today announced dosing of the first patient of a Phase I clinical trial in Australia for CS1002, an investigational drug targeting cytotoxic T-lymphocyte-associated protein-4 (CTLA-4). CS1002 is CStone’s first drug candidate that has entered clinical trials outside of China.
“The successful initiation of this study is an important milestone for CStone. We have several immunotherapy drug candidates set to enter clinical-stage development in Australia along with CS1002,” CStone’s Chief Executive Officer (CEO) Dr. Frank Jiang commented. “Meanwhile, we are also progressing CS1002 into clinical trials in China, where our IND filing was accepted by the China Food and Drug Administration (CFDA) in March 2018. We plan to assess CS1002 as both monotherapy and an important part of combination therapy in the near future.”
The Phase I study is being led by Professor Dusan Kotasek of the Ashford Cancer Centre Researchand will assess CS1002’s safety, tolerability, pharmacokinetics, and initial efficacy in patients with advanced solid tumors.
“CS1002 has produced highly promising results in pre-clinical studies, and this clinical trial will help us determine the appropriate dose for the molecule in preparation for later-stage development,” commented Dr. Jason Yang, Chief Medical Officer (CMO) of CStone.
CS1002 is an immunoglobulin G1 (IgG1), fully-human monoclonal antibody against CTLA-4. CStone owns all global rights to CS1002 and intends to develop it for the treatment of melanoma, non-small cell lung cancer, renal carcinoma and other solid tumors.
About the CTLA-4 pathway
CTLA-4 is a transmembrane surface protein found on the surface of T cells that under normal conditions helps to maintain homeostasis in the immune system by down-regulating the activity of T cells. The CTLA-4 pathway takes effect during the early stage of immune response prior to the PD-1 checkpoint, occurring principally in the lymph nodes when CTLA-4 on activated T cells binds to its ligands B7-1 (CD80) or B7-2 (CD86) on antigen presenting cells or tumor cells. CTLA-4/B7 interaction out-competes the stimulatory receptor CD28 on T cells and leads to attenuated T cell activity. A blockade of immune checkpoints using antibody drugs has been shown to promote T cell activation and proliferation, as well as stimulate the generation of memory T cells leading to durable anti-tumor response.
Presently, Bristol-Myers Squibb’s Yervoy® (ipilimumab) is the only anti-CTLA-4 antibody on the market, but it has not yet been approved in China. Pre-clinical tests have shown that CS1002 has high affinity to CTLA-4 and is expected to match Yervoy® clinical activity and safety in cancer patients.
About CStone Pharmaceuticals Co., Ltd
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. In July 2016, CStone announced the completion of its $150 million Series A financing, led by three prestigious VC/PE funds: Oriza Seed Venture Capital, Boyu Capital, and WuXi Healthcare Ventures. 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 funding and 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.
Conference call to take place Friday, May 11, 2018 at 8:30 am Eastern time
ISNES, Belgium, May 4, 2018 /PRNewswire/ — VolitionRx Limited (NYSE AMERICAN: VNRX) (“Volition”) today announced it will host a conference call on Friday, May 11 at 8:30 a.m. Eastern time to discuss its financial and operating results from the first quarter of 2018, in conjunction with the filing of its quarterly report on Form 10-Q for the first quarter ended March 31, 2018.
Event: VolitionRx Limited First Quarter 2018 Earnings and Business Update Conference Call Date:Friday, May 11, 2018 Time:8:30 a.m. Eastern time U.S. & Canada Dial-in: 1-877-407-9716 (toll free) U.K. Dial-in: 0 800 756 3429 (toll free) Toll/International: 1-201-493-6779 Conference ID: 13679703
Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President. The call will provide an update on recent developments and Volition’s international activities, including details of new and ongoing clinical trials, important events which have taken place in this quarter, and milestones for 2018 and beyond.
A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at http://ir.volitionrx.com. In addition, a telephone replay of the call will be available until May 25, 2018. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13679703.
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.
Nucleosomics® is a trademark of VolitionRx Limited and its subsidiaries.
For more information about Volition, visit Volition’s website https://volitionrx.com/ or connect with us via:
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.
–1Q18 Total Sales Up 13.7% YoY and Non-GAAP Adjusted Net Income Up 2.1% YoY in RMB terms, or
Total Sales Up 23.0% YoY to $112.5 Million and Net Income Up 5.3% YoY to $31.6 Million in USD terms–
BEIJING, May 5, 2018 /PRNewswire/ — China Biologic Products Holdings, Inc. (NASDAQ: CBPO, “China Biologic” or the “Company”), a leading fully integrated plasma-based biopharmaceutical company in China, today announced its unaudited financial results for the first quarter of 2018.
First Quarter 2018 Financial Highlights
Total sales in the first quarter of 2018 increased by 13.7% in RMB terms and 23.0% in USD terms to $112.5 million from $91.5 million in the same quarter of 2017.
Gross profit increased by 33.1% to $78.8 million from $59.2 million in the same quarter of 2017. Gross margin increased to 70.0% from 64.8% in the same quarter of 2017.
Income from operations increased by 0.5% to $39.0 million from $38.8 million in the same quarter of 2017. Operating margin decreased to 34.7% from 42.4% in the same quarter of 2017.
Netincomeattributable to the Company increased by 5.3% to $31.6 million from $30.0 million in the same quarter of 2017. Fullydilutedearningsper share decreased to $0.92 compared to $1.06 in the same quarter of 2017.
Non-GAAP adjusted net income attributable to the Company increased by 2.1% in RMB terms and 10.4% in USD terms to $41.3 million from $37.4 million in the same quarter of 2017. Non-GAAP adjustedearningsper share decreased to $1.21 from $1.32 in the same quarter of 2017.
Certain income statement and balance sheet items impacted by the TianXinFu acquisition are presented for comparison purposes.
Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, “We began 2018 with a challenging first quarter of 2018 was worse than we anticipated due to the ongoing impact of government reform measures on China’s healthcare market. The trend of many regional hospitals reducing purchases on certain high-unit-price plasma products at the end of 2017 to comply with the strict policy of capping the revenue from drug sales to 30% of the total revenue of a hospital continued in the first quarter of 2018, which resulted in a high double digit sales revenue decline in our direct sales channel. Our prices in the distribution channel also face increased pressure with more intensified competition among all major plasma products. To offset the deceleration of volume growth associated with ongoing healthcare reform, we continued to enhance marketing and promotional activities to pursue new sales channels and strategic partners, including new distributors and retail pharmacy chains which together achieved 20% year over year growth. The revenue contribution from placenta polypeptide continued to grow approximately 45% in RMB terms in the first quarter, reflecting an increased proportion of higher-invoiced shipments due to the wider implementation of the two-invoice policy. While the TianXinFu business demonstrated softer performance as anticipated in the first quarter of 2018, we expect the business will experience greater levels of growth in the remaining quarters of the year.”
“Despite our first quarter challenges, we achieved notable operational progress in our business. We began full operations at the new Shandong facility in late February, received the long-awaited operating permit at the Daming plasma collection station in early March and commenced commercial plasma collection immediately thereafter, and construction of our Feicheng branch plasma collection facility remains on track for completion by the middle of this year. In addition, the construction of our new Wenchang station in Hainan Province remains on track, and the station is expected to obtain the operating permit to begin commercial operations before the end of this year.”
“We remain focused on solidifying our leading market position by broadening our sales channels, exploring new growth opportunities to offset the impact of ongoing healthcare reform, and further investing in medical marketing with our internal sales force as well as utilizing TianXinFu’s team to support our newly launched products. In addition, we remain committed to managing public tenders in local markets to secure optimized pricing and increasing our profitability by accelerating the commercial launch time of our various pipeline products. Despite the challenges we are facing, we remain optimistic about the long-term development of China’s plasma industry,” concluded Mr. Gao.
First Quarter 2018 Financial Performance
Total sales in the first quarter of 2018 increased by 13.7% in RMB terms, or 23.0% in USD terms due to favorable exchange rate benefit, to $112.5 million from $91.5 million in the same quarter of 2017, primarily attributable to $11.4 million contribution from TianXinFu, accounting for approximately 10.1% of total sales for the quarter. Excluding TianXinFu, total sales in the first quarter of 2018 increased by 2.2% in RMB terms, as a combined result of an increase in the sales of placenta polypeptide products and certain immunoglobulin products, which was partly offset by the decrease in the sales of human albumin and IVIG products.
During the first quarter of 2018, human albumin and IVIG products remained the Company’s two largest sales contributors. As a percentage of total sales, sales from human albumin and IVIG products were 30.1% and 28.3%, respectively, in the first quarter of 2018. Excluding the contribution from TianXinFu, human albumin and IVIG products were 33.4% and 31.4% of total sales, respectively, which was a decrease from 40.3% and 34.8% respectively in the first quarter of 2017, mainly reflecting the combined effects of decreased sales volume and sales prices year-over-year.
The sales volume of human albumin and IVIG products decreased by 12.0% and 6.2%, respectively, for the first quarter of 2018 compared to the same quarter of 2017, reflecting the decreased purchase volumes at various hospitals due to government healthcare reform measures.
The average price for human albumin and IVIG products decreased by 3.7% and 1.3%, respectively, in RMB terms in the first quarter of 2018 compared to the same quarter of 2017, mainly due to further price discounts to certain distributors, which reflected intensified market competition for major plasma products. In USD terms, the average price for human albumin and IVIG products increased by 4.2% and 6.7% year-over-year, respectively.
Revenue from human hyper-immunoglobulin products increased by 56.4% in the first quarter of 2018 compared to the same quarter of 2017, reaching 11.5% of total sales, mainly due to the increase in sales volume of human rabies immunoglobulin products.
Revenue from coagulation factor products, including human coagulation factor VIII, human prothrombin complex concentrate and newly launched human fibrinogen products, increased by 48.2% in the first quarter of 2018 compared to the same quarter of 2017, representing 5.7% of total sales. The growth mainly came from the human fibrinogen products launched by the Company from the beginning of 2018, as well as an increase in sales volume of human prothrombin complex concentrate products, reflective of the Company’s ongoing medical marketing activities.
Revenue from placenta polypeptide products increased by 45.2% in RMB terms, or 57.1% in USD terms, in the first quarter of 2018 compared to the same quarter of 2017, reaching 14.3% of total sales, supported by higher unit selling prices due to wider implementation of the two-invoice policy, partially offset by lower sales volume due to the government’s control on medical insurance spending.
Cost of sales increased by 4.3% to $33.7 million in the first quarter of 2018 compared to the same quarter of 2017. As a percentage of total sales, cost of sales decreased to 30.0% from 35.2% in the same quarter of 2017. The decrease in cost of sales as a percentage of total sales mainly reflected a higher gross margin of TianXinFu. Excluding TianXinFu, cost of sales was 32.2% of total sales, also lower than the first quarter of 2017, mainly due to the higher sales price of placenta polypeptide product.
Gross profit increased by 33.1% to $78.8 million in the first quarter of 2018 from $59.2 million in the same quarter of 2017. Gross margin was 70.0% and 64.8% in the first quarters of 2018 and 2017, respectively.
Total operating expenses in the first quarter of 2018 was $39.8 million, compared to $20.4 million in the same quarter of 2017. As a percentage of total sales, total operating expenses increased to 35.4% in the first quarter of 2018 from 22.4% in the same quarter of 2017. Excluding TianXinFu, total operating expenses increased by $14.3 million, or 70.1%, to $34.7 million in the first quarter of 2018. This increase mainly consisted of an increase of $13.1 million in selling expenses.
Selling expenses in the first quarter of 2018 was $20.7 million, compared to $3.8 million in the same quarter of 2017. More than half of the increase was related to the sales of placenta polypeptide products, with the remainder related to the sales of plasma products and TianXinFu’s sales of its dura mater products. For placenta polypeptide products and certain hyper-immune products, as certain previous multiple layers of distribution channels were disqualified due to the two-invoice regulation, the Company implemented new sales strategies including using an internal sales force or engaging third party contract service organizations to promote its placenta polypeptide products. For other plasma products, in order to solidify its competitiveness within distribution channel customers, the Company incurred additional promotion and marketing costs. TianXinFu’s selling expenses included a $2.0 million amortization expense for the intangible asset of customer relationships associated with the Company’s acquisition of TianXinFu. Excluding this intangible asset amortization expense, selling expenses accounted for 16.7% of total sales of the Company in the first quarter of 2018 compared to 4.2% in the same quarter of 2017.
General and administrative expenses in the first quarter of 2018 was $17.4 million, compared to $15.2 million in the same quarter of 2017. As a percentage of total sales, general and administrative expenses were 15.5% and 16.7% in the first quarter of 2018 and the same quarter of 2017, respectively. The increase in general and administrative expenses was mainly due to a $0.9 million increase of share-based compensation expenses. Excluding the impact of share-based compensation expenses, non-GAAP general and administrative expenses would have been 7.4% and 7.9% of total sales in the first quarter of 2018 and the same quarter of 2017, respectively.
Research and development expenses in the first quarter of 2018 was $1.7 million, compared to $1.4 million in the same quarter of 2017. As a percentage of total sales, research and development expenses remained stable at 1.5% in the first quarter of 2018 compared to the same quarter of 2017.
Income from operations for the first quarter of 2018 increased by 0.5% to $39.0 million from $38.8 million in the same period of 2017. Operating margin decreased to 34.7% in the first quarter of 2018 from 42.4% in the same quarter of 2017.
Income tax expense was $6.7 million for the first quarter of 2018 compared to $7.0 million in the same period of 2017. The effective income tax rate was 15.1% and 16.8% for the first quarter of 2018 and 2017, respectively. The decrease of the effective income tax was mainly due to excess tax benefits from stock-based compensation as a deduction from income tax expense in the first quarter of 2018.
Net incomeattributable to the Company increased by 5.3% to $31.6 million in the first quarter of 2018 from $30.0 million in the same quarter of 2017. Net margin decreased to 28.1% in the first quarter of 2018 from 32.8% in the same quarter of 2017. Diluted net earnings per share decreased to $0.92 in the first quarter of 2018 compared to $1.06 in the same quarter of 2017.
Non-GAAP adjusted net income attributable to the Company increased by 2.1% in RMB terms, or 10.4% in USD terms, to $41.3 million in the first quarter of 2018 from $37.4 million in the same quarter of 2017. Non-GAAP net margin decreased to 36.7% in the first quarter of 2018 from 40.9% in the same quarter of 2017. Non-GAAP adjusted net income per diluted share decreased to $1.21 in the first quarter of 2018 from $1.32 in the same quarter of 2017. Excluding TianXinFu, Non-GAAP adjusted net income attributable to the Company decreased by 12.1% in RMB terms, or 4.8% in USD terms in the first quarter of 2018 compared to the same quarter of 2017.
Non-GAAP adjusted net income and diluted earnings per share for the first quarter of 2018 exclude $8.3 million in non-cash employee share-based compensation expenses and $1.5 million in intangible assets amortization expense related to the acquisition of TianXinFu.
As of March 31, 2018, the Company had $118.2 million in cash and cash equivalents, primarily consisting of cash on hand and demand deposits, $106.6 million in time deposits and $141.9 million in financial instruments.
Net cash provided by operating activities for the first quarter of 2018 was $23.3 million, including a $4.5 million contribution from TianXinFu, compared to $13.0 million for the same quarter of 2017. Excluding TianXinFu, the $5.8 million increase in net cash provided by operating activities was a combined result of 1) the benefit from an increase of other payables and accrued liabilities, an increase of advance from customers, and a slowdown of increase in account receivable, and 2) the negative impact from a decrease in net income, a decrease in accounts payable, an increase in prepayments and deferred expenses as well as inventory compared to the first quarter of 2017.
Excluding TianXinFu, the other payables and accrued liabilities increased by $8.5 million in the first quarter of 2018, compared to a decrease of $5.4 million in the first quarter of 2017. The increase mainly reflected more marketing activities carried out by third party contract service organizations that the Company engaged to promote placenta polypeptide and certain plasma products in complying with the two-invoice policy.
Excluding TianXinFu, accounts receivable increased by $15.5 million during the first quarter of 2018 compared to $17.6 million in the same quarter of 2017. The accounts receivable turnover days for plasma products increased to 84 days during the first quarter of 2018 from 46 days in the same quarter of 2017, reflecting longer credit terms to hospitals as a result of the nationwide implementation of healthcare reform measures and intensified competition in the distribution channel.
Excluding TianXinFu, inventories increased by $10.6 million in the first quarter of 2018 compared to $9.1 million in the same quarter of 2017. This increase was a result of an increase in raw materials due to downwardly adjusted plasma throughput, reflecting weaker market demand due to a more aggressive-than-expected implementation of certain government healthcare reform policies.
Net cash used in investing activities for the first quarter of 2018 was $135.5 million compared to $9.1 million for the same quarter of 2017. Net cash used in investing activities in the first quarter of 2018 mainly consisted of $264.7 million payment for purchase of time deposits and financial instruments, $11.3 million for the acquisition of property, plant and equipment, intangible assets, and land use rights, which was partly offset by $97.7 million cash received upon acquisition of TianXinFu and the maturity of $42.8 million time deposits and financial instruments. In the same quarter of 2017, the Company paid $9.1 million for the acquisition of property, plant and equipment and land use rights for Shandong Taibang and Guizhou Taibang.
Net cash provided by financing activities for the first quarter of 2018 was $0.3 million compared to $8.8 million for the same quarter of 2017. Net cash provided by financing activities in the first quarter of 2018 represented proceeds of $0.3 million from stock options exercised. The net cash provided by financing activities in the first quarter of 2017 mainly consisted of an $8.7 million short-term loan.
Financial Outlook Update for 2018
For the full year of 2018, the Company previously published a guidance of total sales growth of 18% to 20% in RMB terms and non-GAAP adjusted net income growth of 16% to 18% in RMB terms over 2017 financial results. Excluding TianXinFu, sales for 2018 are expected to grow 6% to 8% in RMB terms, and non-GAAP adjusted net income is expected to grow 3% to 4% in RMB terms over 2017 financial results. The 2018 non-GAAP adjusted net income projection excludes non-cash employee share-based compensation expenses and non-cash intangible assets amortization expense associated with the TianXinFu acquisition.
However, given the worse-than-expected first quarter results due to ongoing impact of regulatory changes, the Company expects that it will be challenging to meet its previously published full year guidance. The Company is actively evaluating the evolving regulatory environment and competition dynamics and may lower its full year guidance should there be no significant improvement in the business operating conditions for the remainder of the year.
Conference Call
The Company will host a conference call at 7:30 am Eastern Time on May 7, 2018, which is 7:30 pm Beijing Time on May 7, 2018, to discuss its first quarter 2018 results and answer questions from investors. Listeners may access the call by dialing:
US:
1 888 346 8982
International:
1 412 902 4272
Hong Kong:
800 905 945
China:
400 120 1203
A telephone replay will be available one hour after the conclusion of the conference all through May 14, 2018. The dial-in details are:
US:
1 877 344 7529
International:
1 412 317 0088
Passcode:
10119614
A live and archived webcast of the conference call will be available through the Company’s investor relations website at http://chinabiologic.investorroom.com.
About China Biologic Products Holdings, Inc.
China Biologic Products Holdings, Inc. (NASDAQ: CBPO) is a leading fully integrated plasma-based biopharmaceutical company in China. The Company’s products are used as critical therapies during medical emergencies and for the prevention and treatment of life-threatening diseases and immune-deficiency related diseases. China Biologic is headquartered in Beijing and manufactures over 20 different dosage forms of plasma products through its indirect majority-owned subsidiary, Shandong Taibang Biological Products Co., Ltd. and its wholly owned subsidiary, Guizhou Taibang Biological Products Co., Ltd. The Company also has an equity investment in Xi’an Huitian Blood Products Co., Ltd. The Company sells its products to hospitals, distributors and other healthcare facilities in China. For additional information, please see the Company’s website www.chinabiologic.com.
Non-GAAP Disclosure
This news release contains non-GAAP financial measures that exclude non-cash compensation expenses related to options and restricted shares granted to employees and directors under the Company’s 2008 Equity Incentive Plan, and amortization of acquired intangible assets. To supplement the Company’s unaudited consolidated financial statements presented on a GAAP basis, the Company has provided non-GAAP financial information excluding the impact of these items in this release. The Company’s management believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. A reconciliation of the adjustments to GAAP results appears in the table accompanying this news release. This additional non-GAAP information is not meant to be considered in isolation or as a substitute for GAAP financials. The non-GAAP financial information that the Company provides also may differ from the non-GAAP information provided by other companies.
In addition, as the Company evaluates certain key items of its financial results on a local currency basis (i.e., in RMB) in addition to the reporting currency (i.e., in USD), this news release contains local currency information that eliminates the impact of fluctuations in foreign currency exchange rates. The Company believes that, given its operations primarily based in China, providing local currency information on such key items enhances the understanding of its financial results and evaluation of performance in comparison to prior periods. Changes in local currency percentages are calculated by comparing financial results denominated in RMB from period to period.
Safe Harbor Statement
This news release may contain certain “forward-looking statements” relating to the business of China Biologic Products Holdings, Inc. and its subsidiaries. All statements, other than statements of historical fact included herein, are “forward-looking statements.” These forward-looking statements are often identified by the use of forward-looking terminology such as “intend,” “believe,” “expect,” “are expected to,” “will,” or similar expressions, and involve known and unknown risks and uncertainties. Among other things, the Company’s plans regarding the construction and operation of plasma collection stations, the commercial launch of pipeline products and the integration with TianXinFu, as well as the management’s quotations and forecast of the Company’s financial performance in this news release contain forward-looking statements. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they involve assumptions, risks, and uncertainties, and these expectations may prove to be incorrect.
Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this news release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including, without limitation, quality of purchased source plasma, potential delay or failure to complete construction of new collection facilities, potential inability to pass government inspection and certification process for existing and new facilities, potential inability to achieve the designed collection capacities at the new collection facilities, potential inability to achieve the expected operating and financial performance, potential inability to find alternative sources of plasma, potential inability to increase production at permitted sites, potential inability to mitigate the financial consequences of a temporarily reduced raw plasma supply through cost cutting or other efficiencies, and potential additional regulatory restrictions on its operations and those additional risks and uncertainties discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.
Contact:
China Biologic Products Holdings, Inc. Mr. Ming Yin Senior Vice President Phone: +86-10-6598-3099 Email: ir@chinabiologic.com
ICR Inc. Mr. Bill Zima Phone: +86-10-6583-7511 or +1-646-405-5191 E-mail: bill.zima@icrinc.com
(Financial statements on the following pages)
CHINA BIOLOGIC PRODUCTS HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
March 31, 2018
December 31, 2017
USD
USD
ASSETS
Current Assets
Cash and cash equivalents
118,205,213
219,336,848
Time deposits
106,550,100
22,895,200
Financial instruments
141,883,453
–
Accounts receivable, net of allowance for doubtful accounts
96,279,290
77,267,275
Loan receivable – current
47,709,000
45,912,000
Inventories
231,526,133
209,570,835
Prepayments and other current assets, net of allowance for doubtful accounts
23,824,618
18,139,453
Total Current Assets
765,977,807
593,121,611
Property, plant and equipment, net
192,320,783
166,812,749
Intangible assets,net
62,050,423
536,338
Land use rights, net
30,040,442
24,853,163
Equity method investment
16,568,483
14,903,908
Goodwill
329,364,009
–
Other non-current assets
10,165,068
8,829,648
Total Assets
1,406,487,015
809,057,417
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable
5,898,781
7,548,909
Income tax payable
17,302,336
14,258,544
Other payables and accrued expenses
94,374,626
75,827,864
Total Current Liabilities
117,575,743
97,635,317
Deferred income
3,480,372
3,476,877
Non-current income tax payable
37,067,138
37,067,138
Other liabilities
16,580,741
6,553,088
Total Liabilities
174,703,994
144,732,420
Shareholders’ Equity
Ordinary share:
par value $0.0001;
100,000,000 shares authorized;
35,457,718 and 29,866,545 shares issued at March 31, 2018 and December 31, 2017, respectively;
33,203,014 and 27,611,841 shares outstanding at March 31, 2018 and December 31, 2017, respectively
3,546
2,987
Additional paid-in capital
584,467,652
140,230,395
Treasury share: 2,254,704 shares at March 31, 2018 and December31, 2017, respectively, at cost
(56,425,094)
(56,425,094)
Retained earnings
538,011,513
506,426,436
Accumulated other comprehensive income
36,357,739
7,957,304
Total equity attributable to China Biologic Products Holdings, Inc.
1,102,415,356
598,192,028
Noncontrolling interest
129,367,665
66,132,969
Total Shareholders’ Equity
1,231,783,021
664,324,997
Commitments and contingencies
–
–
Total Liabilities and Shareholders’ Equity
1,406,487,015
809,057,417
CHINA BIOLOGIC PRODUCTS HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
For the Three Months Ended
March 31, 2018
March 31, 2017
USD
USD
Sales:
112,464,890
91,453,112
Human Albumin
33,795,961
36,858,291
Human Immunoglobulin for Intravenous Injection
31,785,221
31,752,986
Other Immunoglobulin products
13,019,557
8,293,667
Placenta Polypeptide
16,094,645
10,246,969
Artificial Dura Mater
9,943,983
–
Others
7,825,523
4,301,199
Cost of sales
33,691,683
32,215,473
Gross profit
78,773,207
59,237,639
Operating expenses
Selling expenses
20,695,215
3,807,552
General and administrative expenses
17,387,075
15,256,766
Research and development expenses
1,716,954
1,357,363
Income from operations
38,973,963
38,815,958
Other income (expenses)
Equity in income of an equity method investee
1,068,045
911,743
Interest expense
(67,564)
(62,510)
Interest income
3,003,929
1,623,839
Fair value changes of financial instruments
1,285,063
–
Total other income, net
5,289,473
2,473,072
Income before income tax expense
44,263,436
41,289,030
Income tax expense
6,707,455
6,950,539
Net income
37,555,981
34,338,491
Less: Net income attributable to noncontrolling interest
5,970,904
4,346,642
Net income attributable to China Biologic Products Holdings, Inc.
31,585,077
29,991,849
Earnings per share of ordinary share:
Basic
0.93
1.07
Diluted
0.92
1.06
Weighted average shares used in computation:
Basic
33,150,695
27,183,733
Diluted
33,338,470
27,465,414
Net income
37,555,981
34,338,491
Other comprehensive income:
Foreign currency translation adjustment, net of nil income taxes
31,793,225
2,720,968
Comprehensive income
69,349,206
37,059,459
Less: Comprehensive income attributable to noncontrolling interest
9,363,694
4,650,562
Comprehensive income attributable to China Biologic Products Holdings, Inc.
59,985,512
32,408,897
CHINA BIOLOGIC PRODUCTS HOLDINGS, INC. AND SUBSIDIARIES
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Three Months Ended
March 31,
March 31,
2018
2017
USD
USD
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income
37,555,981
34,338,491
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation
2,325,609
3,052,133
Amortization
2,404,758
428,028
Loss on sale of property, plant and equipment
44,142
63,425
Fair value changes of financial instruments
(1,285,063)
–
Allowance (reversal) for doubtful accounts – accounts receivable, net
–
(10,168)
Deferred tax expense (benefit)
(846,255)
266,804
Share-based compensation
9,009,234
8,072,065
Equity in income of an equity method investee
(1,068,045)
(911,743)
Change in operating assets and liabilities:
Accounts receivable
(15,505,930)
(17,570,606)
Inventories
(10,766,490)
(9,130,101)
Prepayments and other current assets
(4,582,769)
(2,281,491)
Accounts payable
(1,942,878)
378,931
Income tax payable
1,504,625
1,869,988
Other payables and accrued expenses
6,618,643
(5,411,627)
Deferred income
(130,974)
(121,102)
Net cash provided by operating activities
23,334,588
13,033,027
CASH FLOWS FROM INVESTING ACTIVITIES:
Cash acquired from acquisition of Tianxinfu
97,702,278
–
Purchase of time deposit
(84,828,600)
–
Maturity of time deposit
3,000,000
–
Purchase of financial instruments
(179,855,473)
–
Maturity of financial instruments
39,772,069
–
Payment for property, plant and equipment
(11,048,396)
(8,936,981)
Payment for intangible assets and land use rights
(255,664)
(151,326)
Proceeds from sale of property, plant and equipment
10,722
3,626
Net cash used in investing activities
(135,503,064)
(9,084,681)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from stock option exercised
339,411
98,500
Proceeds from short-term bank loans
–
8,715,000
Net cash provided by financing activities
339,411
8,813,500
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH
10,697,430
829,989
NET INCREASE IN CASH AND CASH EQUIVALENTS
(101,131,635)
13,591,835
Cash and cash equivalents at beginning of period
219,336,848
183,765,533
Cash and cash equivalents at end of period
118,205,213
197,357,368
Supplemental cash flow information
Cash paid for income taxes
6,352,407
4,969,712
Noncash investing and financing activities:
Acquisition of property, plant and equipment included in payables
5,389,336
1,863,464
Issuance of ordinary shares in connection with the Tianxinfu acquisition
434,889,170
–
CHINA BIOLOGIC PRODUCTS HOLDINGS, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
For the Three Months Ended
March 31,
March 31,
2018
2017
USD
USD
Adjusted Net Income Attributable to the Company – Non GAAP
41,314,679
37,430,088
Diluted EPS – Non GAAP
1.21
1.32
Non-cash employee stock compensation
(8,262,637)
(7,438,239)
Amortization of acquired intangible assets
(1,466,965)
–
Net Income Attributable to the Company
31,585,077
29,991,849
Weighted average number of shares used in computation of Non GAAP diluted EPS
From Heber-principle to digital systems, thoracic surgery has significantly changed and improved over the course of time – so has chest drainage. Ten years ago, chest drainage therapy as we knew it was completely overhauled with the introduction of digital drainage systems. An onboard motor creating vacuum in a closed system consisting of tubings and fluid collection container opened a whole new way of how to manage chest drainage patients. In addition to the option to mobilize all patients with a chest drain, digital drainage systems also allowed the general reduction of complications [1]. These systems monitor the patient and alert if the measured data are out of range. Due to the digital control of the negative pressure, the system is able to objectively quantify the presence of parenchymal leakage.
Based on science and innovative research, Medela has continuously proven to be the technology leader in this area. In 2007, Thopaz™ was introduced as the first truly portable, digital drainage system. In 2014, Thopaz+was launched, the first digital drainage monitoring system with electronic measurement of air-leak and drained fluid. Vast amounts of clinical and global experience show how 10 years of digital drainage have truly impacted the medical field:
1’000’000 patients on chest drains worldwide have experienced the benefits of Medela’s digital systems in the past 10 years
Patients benefit from a significantly shorter chest tube duration (study results show 1.1 days shorter chest tube placement on average with Thopaz™) [2]
Thopaz +is cost saving compared with conventional chest drains for people who need drainage after a pulmonary resection or because of a collapsed lung. Healthcare systems and hospitals benefit from shorter length of hospital stay. NICEresource impact assessmentconcluded that, at a national level, adopting Thopaz +is expected to save around GBP 8.5 million per year in England (a study from Italy showed EUR 751 saved per patient with Thopaz™) [3] [4]
Medela Healthcare is working with various leading clinicians, researchers and healthcare institutions to bring innovation in thoracic surgery to hospitals and to help revolutionize post-operative patient care. Through a publication matrix, the latest research findings in the field of modern chest drainage systems can be easily filtered through a number of keywords on theMedela website.
Marcel Hohl, Vice President of Global Marketing at Medela Healthcare, says: “We are very proud to announce the 10-year anniversary of digital chest drainage. During these past 10 years, thoracic drainage research has become a key element of our success and, with the help of our partners; we have reached many milestones that are proof to us that this innovation is here to stay. The previous launches of Thopaz™ and Thopaz+only mark the beginning of this exciting journey. Medela takes great effort to take a modern role in medicine exploring the power of data to eventually allow for better health profiles and predictive models for patient with a chest drain.”
Citations
Frank Detterbeck,Professor of Surgery, Chief of Thoracic Surgery at Yale University and Associate Director of the Yale Cancer Center: “Scientific data from 381 patients proving shorter duration of chest tube placement, shorter hospital stays and a higher patient satisfaction for digital drainage compared to traditional drainage systems was remarkable for me.In practice, Thopaz™ allows complete patient mobility and independence while the chest drain is still in situ, thereby realizing the full potential of the minimally invasive surgery we are performing.”
Konstantinos Papagiannopoulos,MMED Thorax MD at St. James’ University Hospital: “I have collaborated with Medela since 2007 and became actively involved in modifications and improvements of their suction and drainage portable pumps. We quickly embraced the benefits of a technologically advanced device like Thopaz™. Our patients became extremely satisfied. They are now free, mobile and experience modern treatment with a modern device. They feel safe and comfortable with our fast-tracked discharge service facilitated by data recorded from the Thopaz™ electronic suction pump.”
Thomas Kiefer,MD, Chief of Thoracic Surgery, Lungenzentrum Bodensee: “Early digital systems were flawed in various ways, but the introduction of Thopaz™ gave us a product with every quality that we had been looking for. We gradually understood the predictive value of the digital air leak readings, allowing earlier, effective interventions for air leak post-operatively, which in turn further minimized the harm of prolonged air leakage. Thopaz™ has also proven to deliver highly reliable and effective outcome measurements for our clinical research into intra- and post-operative air leak interventions. Thus, we have redesigned our chest drain management protocols to take advantage of the benefits of digital drainage.”
Phillip Antippa,MBBS FRACS, Head, Thoracic Surgical Services, The Royal Melbourne Hospital: “After seeing Thopaz™ hard at work whilst on Sabbatical Leave in the U.K., I was very keen to introduce this technology to –Australia and New Zealand. Not having any experience with electronic drainage systems, our institution was reluctant at first and we conducted a feasibility study confirming the international results that drain tubes could be removed at least a day earlier. This quickly led to the seamless implementation of Thopaz™ into our service and into other parts of our Hospital. Our surgeons easily adopted its use and we have continued to collect data from Thopaz™. Our ongoing research projects in close collaboration with Thopaz™ design engineers and scientists will continue to cement Thopaz™ as an important sophisticated clinical diagnostic and therapeutic tool.
The greatest enthusiasm however has come from our nursing staff. After a simple education process, Thopaz™ has become an integral part of Thoracic Surgical management for our patients. It has definitely made patient care easier and our staff feels more engaged – the only complaints we receive is when a patient returns to the ward with an analogue system!
Many of our patients understand the benefits of Thopaz™. Certainly they are pleased that they are receiving best possible care and enjoy the freedom that the device allows.”
About Medela
Medela concentrates on two business units: “Human Milk”, with basic research recognised globally and leading in the development and manufacture of breastfeeding products and solutions, and “Healthcare”, engineering and manufacturing highly innovative medical vacuum technology solutions. In 2007, Medela Healthcare launched the Thopaz™ cardiothoracic drainage system, followed by the launch of Thopaz +in 2014. Follow this linkto screen all the research studies according to keywords.
References
Read Miller, DL. et al., Digital Drainage System Reduces Hospitalization After Video-Assisted Thoracoscopic Surgery Lung Resection.Ann Thorac Surg.2016 Sep;102(3):955-961, Leo, F. et al.,Ann Thorac Surg.2013 Oct;96(4):1234-9
Pompili, C. et al., 2014: Multicenter International Randomized Comparison of Objective and Subjective Outcomes Between Electronic and Traditional Chest Drainage Systems.Ann Thorac Surg.98: 490-497.
Pompili, C. et al., 2011 Nov: Impact of the learning curve in the use of a novel electronic chest drainage system after pulmonary lobectomy: a case-matched analysis on the duration of chest tube usage.Interact Thorac Surg.13(5): 490-3
Brunelli, A. et al., 2011: Consensus definitions to promote an evidence-based approach to management of the pleural space. A collaborative proposal by ESTS, AATS, STS, and GTSC.Eur J Cardiothorac Surg.: 40(2):291-7.
Manufacture ofteprotumumabfor treatment of thyroid eye disease
COPENHAGEN, Denmark, May 3, 2018 /PRNewswire/ — AGC Biologics, a global leader in clinical and commercial manufacturing of therapeutic proteins, announced today it has entered into an agreement with Horizon Pharma plc for commercial supply of teprotumumab, a monoclonal antibody biologic for the treatment of moderate-to-severe active thyroid eye disease (TED).
TED, also known as Graves’ opthalmopathy or orbitopathy, is a rare condition in which the eye muscles and fatty tissue behind the eye become inflamed. This can cause proptosis, where the eyes are pushed forward (resulting in “staring” or “bulging” eyes), and the eyes and eyelids become red and swollen. In certain cases, swelling and stiffness of the muscles occur, shifting the eyes so they are no longer in line with each other and/or unable to close.
The teprotumumab antibody works by targeting the Insulin-like Growth Factor-1 Receptor (IGF-1R), a well-validated target.
“Thyroid eye disease can be an incapacitating disease, having a significant effect on a patient’s daily quality of life,” said Gustavo Mahler, Ph.D., President and Chief Executive Officer of AGC Biologics. “We’re proud to partner with Horizon Pharma in the manufacturing of teprotumumab, a potentially life-changing therapy.”
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
First-of-its-kind hematology-based test intended to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis as part of a routine CBC with differential test
BREA, California, May 3, 2018 /PRNewswire/ —Beckman Coulter announced today European CE Mark of its Early Sepsis Indicator, a hematology-based solution designed to alert emergency department clinicians to the possibility of sepsis or risk of developing sepsis. The first early sepsis warning solution to be offered as part of a routine CBC with differential test, the Early Sepsis Indicator gives physicians a rapid and simple tool that can aid in the fight against sepsis. The new marker will be commercially available on the recently launched DxH 900 hematology analyzer.
Sepsis is an often-deadly condition that affects 26 million people worldwide every year1 and is increasing at a rate of 1.5% annually.2 Timely and accurate detection solutions in the acute-care setting are key components to stopping the progression of sepsis, as patients with less severe sepsis can progress to severe sepsis or septic shock within 72 hours.3 Up to half of patients with sepsis die.2,4 In addition to the human toll, this global crisis places a significant clinical and economic burden on the healthcare system.5 A clear link exists between the timeliness of treatment and the possibility of death. When antibiotics are administered early to patients with septic shock, the likelihood of death is decreased by 7.6% per hour.6
“Because emergency department personnel are often on the front line of care for people facing critical conditions, giving them a simple and easy tool for detecting sepsis can help us make significant strides against this prevailing threat,” said Peter Soltani, Ph.D., senior vice president and general manager of the hematology business at Beckman Coulter. “The fact that this early warning indicator is part of a routine blood test means that clinicians receive results rapidly, with no additional workflow burden to the laboratory or emergency department.”
The Early Sepsis Indicator uses the DxH 900 hematology analyzer’s unique Coulter technology, which characterizes cells in their near-native states. The system’s powerful VCS 360 technology can uniquely detect morphological changes in monocytes—cells of the innate immune system that provide a first line of defense against infections. Monocytes play a role in the dysregulated immune response to sepsis, and identifying morphological changes provides insight into possible sepsis earlier than other indicators.
The company plans to submit a 510(k) for the Early Sepsis Indicator to the U.S. FDA in the near future. After receiving 510(k) clearance, the Early Sepsis Indicator will be released to the U.S. market.
About Beckman Coulter Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. For over 80 years, Beckman Coulter has been the partner of choice for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers’ mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.
1. Sepsis Alliance. “Critical Fact Sheet.” Sepsis.org. Accessed January 15, 2018. 2. Angus DC, van der Poll T. “Severe Sepsis and Septic Shock.” N Engl J Med, vol. 369. 2013, pp. 840–51. 3. Glickman SW et al. “Disease Progression in Hemodynamically Stable Patients Presenting to the Emergency Department with Sepsis.” Acad Emerg Med, vol. 17. 2010, pp. 383–90. 4. Engel C, Brunkhorst FM, Bone HG et al. “Epidemiology of Sepsis in Germany: Results from a National Prospective Multicenter Study.” Intensive Care Med, vol. 33. 2007, pp. 606–18. 5. Torio C, Moore B. “National Inpatient Hospital Costs: The Most Expensive Conditions by Payer.” http://www.hcup-us.ahrq.gov/reports/statbriefs/sb204-Most-Expensive-Hospital-Conditions.pdf, May 2016. Accessed January 15, 2018. 6. Kumar A, Roberts D, Wood KE et al. “Duration of Hypotension Before Initiation of Effective Antimicrobial Therapy is the Critical Determinant of Survival in Human Septic Shock.” Crit Care Med, vol. 34. 2006, pp. 1589–96.
Disclaimer:The Early Sepsis Indicator is CE Marked and is pending 510(k) clearance by the U.S. FDA. Not yet available for in vitro diagnostic use in the U.S.
The DxH 900 analyzer is not available in all countries. The Early Sepsis Indicator is not available in all countries.
