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Ye S.,Chinese Academy of Sciences | Lei M.,Chinese Academy of Sciences | Jiang P.,Chinese Academy of Sciences | Liu F.,Chinese Academy of Sciences | And 7 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2017

Intravenous immunoglobulin (IVIg) is produced by pooling plasma from thousands of healthy blood donors, and the diversity of the antibody is critical for the clinical efficacy of IVIg. This study investigated the antibody diversity of Chinese IVIg. Firstly, 2-dimensional gel electrophoresis and immunoblotting with protein extracts of Escherichia coli (E. coli) O157:H7 were used to study IgG antibody repertoire of 8 IVIg preparations from different Chinese manufacturers. This was followed by the identification of the antibody-reactive proteins of E. coli by mass spectrometry and the sequence similarity of the proteins was aligned by bioinformatics analysis. The results showed that all IVIg preparations expressed a large range of antibody reactivities against E. coli proteins. 94-238 antigens were recognized by the 8 IVIg preparations. 33 interesting target antigens were selected and identified as 29 different proteins, mainly including membrane proteins, molecular chaperones, metabolism enzymes, and proteins involved in cell cycle processes. Additionally, these antigens were highly conserved proteins which were found extensively in a variety of other pathogenic microorganisms. Our study indicated that Chinese IVIg preparations recognized a large range of high conserved proteins which play key roles in pathogenic microorganisms, and showed each IVIg had its own distinct antibody repertoire. © 2016 Elsevier B.V.


BEIJING, Feb. 15, 2017 /PRNewswire/ -- China Biologic Products, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release fourth quarter and Fiscal Year 2016 financial results on Thursday, February 23, 2017 after the market closes. The Company's management will hold a conference call at 7:30 a.m. ET on Friday, February 24, 2017, which is 8:30 p.m., Beijing Time on February 24, 2017, to discuss fourth quarter and fiscal year 2016 results. Listeners may access the call by dialing: A telephone replay will be available one hour after the conclusion of the conference call through March 3, 2017. The dial-in details are: A live and archived webcast of the conference call will be available through the Company's investor relations website at http://chinabiologic.investorroom.com/. China Biologic is a leading 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 dosages of plasma-based products through its 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 and inoculation centers, as well as distributors, in China. For additional information, please see the Company's website, www.chinabiologic.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/china-biologic-products-to-report-fourth-quarter-and-fiscal-year-2016-financial-results-300406894.html


News Article | February 23, 2017
Site: en.prnasia.com

-- 4Q16 Total Sales Up 13.6% YoY to $77.6 Million and Net Income Up 19.0% YoY to $19.4 Million in USD terms, orTotal Sales Up 21.7% YoY and Non-GAAP Adjusted Net Income Up 40.7% YoY in RMB terms -- -- FY16 Total Sales Up 15.1% YoY to $341.2 Million and Net Income Up 17.8% YoY to $104.8 Million in USD terms, orTotal Sales Up 22.8% YoY and Non-GAAP Adjusted Net Income Up 35.1% YoY in RMB terms ----Issue Forecast for FY17 --BEIJING, Feb. 24, 2017 /PRNewswire/ -- China Biologic Products, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, today announced its financial results for the fourth quarter and fiscal year of 2016. Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, "We are pleased to maintain strong year-over-year growth, despite the negative impact associated with RMB depreciation throughout 2016. We met our upwardly revised revenue and profit forecast from last quarter, supported by modest product price increases, optimization of our product portfolio mix, continued penetration into tier-one markets, greater financial contribution from Guizhou Taibang due to an increase in equity interest and from a stronger-than-expected minority interest contribution from our Xi'an Huitian facility. We achieved a new milestone in 2016 as plasma collection volume surpassed one thousand metric tonnes for the first time through a combination of internal plasma collection and outsourced plasma growth, and we were pleased to broaden our presence in Shandong Province by receiving approvals to build new collection facilities in the province. We also achieved significant progress on the R&D front in 2016 and received CFDA approvals to commence clinical trials of three new products -- Human Coagulation Factor IX, Human Antithrombin III and Human Cytomegalovirus Immunoglobulin (pH4) for Intravenous Injection ("CMV IVIG") products. Our new fractionation facility under development in Shandong province is expected to complete the GMP certificate inspection process and commence operation at the end of 2017. We are working diligently to stock sufficient inventory to ensure adequate product supply prior to the shutdown of the older facility, and our increased inventory position in the fourth quarter is reflective of such efforts. Looking ahead, we expect to achieve healthy growth in 2017 even with factoring the impact of our plant transition in Shandong and continue to focus on key long-term operational growth strategies. We expect to achieve revenue growth of 13%-15% and adjusted net income growth of 18%-20% in RMB terms in 2017 over 2016." concluded Mr. Gao. Total sales in the fourth quarter of 2016 increased by 21.7% in RMB terms, or increased by 13.6% in USD terms to $77.6 million from $68.3 million in the same quarter of 2015. The increase was primarily attributable to the sales volume increase in human albumin products and the sales price increase in human tetanus immunoglobulin products. Cost of sales was $30.8 million in the fourth quarter of 2016, compared to $27.0 million in the same quarter of 2015. As a percentage of total sales, cost of sales was 39.7%, compared to 39.5% in the same quarter of 2015. Gross profit increased by 13.3% to $46.8 million in the fourth quarter of 2016 from $41.3 million in the same quarter of 2015. Gross margin was 60.3% and 60.5% in the fourth quarter of 2016 and 2015, respectively. Total operating expenses in the fourth quarter of 2016 increased by $4.9 million, or 26.2%, to $23.6 million from $18.7 million in the same quarter of 2015, including $1.7 million, $1.6 million, and $1.6 million increases in selling expenses, general and administrative expenses and research and development expenses, respectively. As a percentage of total sales, total operating expenses increased to 30.4% in the fourth quarter of 2016 from 27.4% in the same quarter of 2015. Income from operations for the fourth quarter of 2016 increased by 2.7% to $23.2 million from $22.6 million in the same period of 2015. Operating margin decreased to 29.9% in the fourth quarter of 2016 from 33.1% in the same quarter of 2015. Net income attributable to the Company increased by 19.0% to $19.4 million in the fourth quarter of 2016 from $16.3 million in the same quarter of 2015. Net margin increased to 25.0% from 23.9% in the same quarter of 2015. Fully diluted net income per share increased to $0.69 in the fourth quarter of 2016 from $0.59 in the same quarter of 2015. Non-GAAP adjusted net income attributable to the Company increased by 40.7% in RMB terms, or 31.9% in USD terms, to $26.9 million in the fourth quarter of 2016 from $20.4 million in the same quarter of 2015. Non-GAAP net margin increased to 34.7% in the fourth quarter of 2016 from 29.9% in the same quarter of 2015. Non-GAAP adjusted net income per diluted share increased to $0.95 in the fourth quarter of 2016 from $0.74 in the same quarter of 2015. Total sales in 2016 increased by 22.8% in RMB terms, or 15.1% in USD terms, to $341.2 million from $296.5 million in 2015. The increase in sales was primarily driven by the increases in sales volume of human albumin products, placenta polypeptide and human tetanus immunoglobulin products and the increase in sales price of human tetanus immunoglobulin products, partially offset by the decrease in sales volume of IVIG products. During 2016, human albumin and IVIG products remained the Company's two largest sales contributors, while the revenue contribution from the Company's other products continued to grow. As a percentage of total sales, sales from human albumin products increased to 39.2% in 2016 compared to 37.6% in 2015, while sales from IVIG products decreased to 34.6%, compared to 42.2% in 2015, and sales from hyper-immune products increased to 11.8% of total sales, compared to 7.6% in 2015. The sales volume of human albumin products increased by 26.2% due to enhanced production volume at Shandong Taibang and Guizhou Taibang as a result of increased plasma supply volume, while the sales volume of IVIG products decreased by 3.6% mainly due to the depletion of previously reserved IVIG pastes in 2015 and the allocation of more production to human tetanus immunoglobulin products, whose sales volume increased by 41.9% in 2016, as compared to 2015. The average price for human albumin products, excluding foreign exchange impact, would have increased by 1.5% in RMB terms, or decreased by 4.9% in USD terms, in 2016 compared to 2015. The average price for IVIG products, excluding foreign exchange impact, would have increased by 4.2% in RMB terms, or decreased by 2.3% in USD terms, in 2016 compared to 2015. Revenue from other plasma products including human coagulation factor VIII and human prothrombin complex concentrate increased by 68.0% in 2016, representing 5.0% of total sales, compared to 2015. Revenue from placenta polypeptide products increased by 18.4% in 2016, representing 9.4% of total sales, compared to 2015. Cost of sales was $124.0 million in 2016, compared to $106.5 million in 2015. Cost of sales as a percentage of total sales was 36.4%, as compared to 35.9% in the same period of 2015. The increase in cost of sales as a percentage of total sales was mainly due to the higher concentration of outsourced raw plasma with higher cost, which was partially offset by the increase in the average sales price of certain plasma products and a more profitable product mix. Gross profit increased by 14.3% to $217.2 million in 2016 from $190.0 million in 2015. Gross margin was 63.6% in 2016, compared to 64.1% in 2015. Total operating expenses in 2016 increased 27.5% to $73.2 million from $57.4 million in 2015. As a percentage of total sales, total operating expenses increased to 21.5% for 2016 from 19.4% in 2015, mainly due to the increase in both selling expenses and general and administrative expenses. Selling expenses in 2016 increased by 17.0% to $11.7 million from $10.0 million in 2015. As a percentage of total sales, selling expenses remained stable at 3.4% compared with 2015. The increase in selling expenses was in line with the sales growth in 2016 as compared to 2015. General and administrative expenses in 2016 increased by 31.6% to $54.5 million from $41.4 million in 2015. As a percentage of total sales, general and administrative expenses were 16.0% and 14.0% in 2016 and 2015, respectively. The increase in general and administrative expenses was mainly due to a $12.3 million increase in share-based compensation expenses. Excluding the impact of share-based compensation expenses, non-GAAP general and administrative expenses would have been 8.8% and 9.9% as a percentage of total sales in 2016 and 2015, respectively. Research and development expenses in 2016 were $7.0 million, or 2.1% of total sales, compared to $6.0 million, or 2.0% of total sales, in 2015. During 2016 and 2015, the Company received government grants totaling $0.8 million and $1.2 million, respectively, and recognized them as a reduction of research and development expenses. Excluding this impact, non-GAAP research and development expenses increased by $0.6 million in 2016 from 2015, and these non-GAAP expenses as a percentage of total sales decreased from 2.4% to 2.3%. Income from operations in 2016 increased by 8.6% to $144.0 million from $132.6 million in 2015. Operating margin was 42.1% in 2016, compared to 44.7% in 2015. Income tax expense in 2016 was $25.1 million, as compared to $21.0 million in 2015. The effective income tax rate was 16.3% and 15.5% for 2016 and 2015, respectively. Net income attributable to the Company increased by 17.8% to $104.8 million for 2016 from $89.0 million in 2015. Net margin was 30.7% and 30.0% for 2016 and 2015, respectively. Fully diluted net income per share for 2016 increased to $3.74 from $3.27 for 2015. Non-GAAP adjusted net income attributable to the Company increased by 35.1% in RMB terms, or 26.7% in USD terms, to $126.8 million for 2016 from $100.1 million in the same period of 2015. Non-GAAP net margin increased to 37.2% from 33.8% in 2015. Non-GAAP adjusted net income per diluted share increased to $4.52 for 2016 from $3.68 in 2015. Non-GAAP adjusted net income and diluted earnings per share for 2016 exclude $22.0 million of non-cash employee share-based compensation expenses. As of December 31, 2016, the Company had $183.8 million in cash and cash equivalents, primarily consisting of cash on hand and demand deposits. Net cash provided by operating activities for 2016 was $123.3 million, as compared to $109.4 million for 2015. The increase in net cash provided by operating activities was largely consistent with the improvements in the results of operations in 2016, as compared to the same period in 2015, partially offset by the increases in accounts receivable and inventories. Accounts receivable increased by $11.0 million during 2016, as compared to $7.1 million in 2015. The accounts receivable turnover days for plasma products increased to 41 days during 2016 from 34 days in 2015. To enhance the business relationship with certain key customers, the Company granted longer credit term to certain qualified hospitals during 2016. Inventories increased by $40.1 million in 2016, as compared to $32.1 million in 2015, mainly due to an increase in the inventory of outsourced raw plasma as well as the increase of finished goods in preparation for Shandong facility transition. Net cash used in investing activities for 2016 was $52.5 million, as compared to $89.8 million for 2015. During 2016 and 2015, the Company paid $51.0 million and $52.3 million, respectively, for the acquisition of property, plant and equipment, intangible assets and land use rights for Shandong Taibang and Guizhou Taibang. During 2016 and 2015, the Company granted a loan of $12.3 million and $40.7 million, respectively, to our plasma outsourcing partner. In addition, the Company received a refund of $10.3 million from the local government of Guiyang with respect to deposits of land use rights in 2016. Net cash used in financing activities for 2016 was $22.1 million, as compared to net cash of $51.6 million provided by financing activities for 2015. The net cash used in financing activities in 2016 mainly consisted of payment of $58.1 million to former minority shareholders of Guizhou Taibang in connection with their capital withdrawal from Guizhou Taibang and a dividend of $7.9 million paid to the minority shareholder by Shandong Taibang, partially offset by the maturity of a $37.8 million time deposit as a security for a bank loan which was fully repaid in June 2015 and the proceeds of $3.6 million from stock options exercised. The net cash provided by financing activities for 2015 mainly consisted of net proceeds of $80.6 million from a follow-on offering of the Company's stock in June 2015, proceeds of $63.2 million from the maturity of deposit used as security for bank loans, proceeds of $15.8 million from a short-term bank loan, and proceeds of $7.7 million from stock options exercised, partially offset by the repayment of bank loans totaling $113.5 million and a dividend payment of $3.7 million held in escrow by a trial court in connection with disputes with a minority shareholder of Guizhou Taibang. For the full year of 2017, factoring into the impact of approximately three months of production suspension at our Shandong facility in connection with plant transition, the Company expects total sales to grow 13% to 15% in RMB terms and non-GAAP adjusted net income to grow 18% to 20% in RMB terms over 2016 financial results. This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.63 = $1.00 based on weighted average quarterly exchange rates in 2016 in translating 2016 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2017 will be adversely affected by the foreign currency translation impact. This guidance assumes only organic growth, excluding potential acquisitions, and necessarily assumes no significant adverse product price changes during 2017. This forecast reflects the Company's current and preliminary views, which are subject to change. The Company will host a conference call at 7:30 am Eastern Time on Friday, February 24, 2017, which is 8:30 pm Beijing Time on February 24, 2017, to discuss its results for the fourth quarter and fiscal year 2016 and answer questions from investors. Listeners may access the call by dialing: A telephone replay will be available one hour after the conclusion of the conference all through March 4, 2017. The dial-in details are: A live and archived webcast of the conference call will be available through the Company's investor relations website at http://chinabiologic.investorroom.com. China Biologic Products, 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 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. 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. To supplement the Company's unaudited condensed 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 these non-GAAP measures provide investors with a better understanding of how the results relate to the Company's performance. 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. This news release may contain certain "forward-looking statements" relating to the business of China Biologic Products, 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 positive impact on the Company's earnings results driven by the acquisition of full ownership in Guizhou Taibang and 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 potential delay or failure to complete the clinical trials for new products, potential delay or failure to complete construction of new collection facilities, potential inability to pass government inspection and certification process for new collection 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/china-biologic-reports-financial-results-for-the-fourth-quarter-and-fiscal-year-2016-300412394.html


News Article | November 2, 2016
Site: en.prnasia.com

BEIJING, Nov 3, 2016 /PRNewswire/ -- China Biologic Products, 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 third quarter of 2016. Mr. David (Xiaoying) Gao, Chairman and Chief Executive Officer of China Biologic, commented, "We are very pleased to achieve another quarter of strong financial results with higher-than-expected gross margin and profit growth. Third quarter revenue increased by 9.8% in USD terms, or 17.3% in RMB terms, and would have been higher were it not for the delay of certain new regional drug tenders. Albumin sales were largely in-line with our expectation, and IVIG production and sales were lower than anticipated, compared to the unusually higher levels in the corresponding period of last year as we continued to allocate more production capacity to tetanus immunoglobulin. We are pleased with the increase in our gross margin, which was primarily attributable to higher pricing for most of our products, a more profitable product mix, and a higher sales contribution from products made from in-house sourced raw plasma at lower cost. The overall earnings contribution from our Guizhou facility continued to increase due to several capital injections made over the past twelve months. Our Huitian facility also began contributing to our earnings growth in the third quarter after a two-year production suspension for facility upgrade." "We are also very pleased to complete the AIC registration of our full equity ownership in our Guizhou facility following a negotiated capital withdrawal by its two former minority shareholders, which will allow us to fully capture the high growth potential and receive the full benefits and earnings accretion of existing and future products produced at this facility. In addition, through the successful execution of our plasma outsourcing arrangements for the first year, our partner delivered more plasma than the contractual volume, and we expect to market more finished products made from such plasma in the fourth quarter and next year. On the R&D front, we are making significant progress with our commitment to serving the broader needs of coagulation-deficient patients. We recently received approval from the CFDA to commence clinical trials of two new 'first-to-market' products in China--Human Coagulation Factor IX and Human Antithrombin III, both of which will further improve our plasma fractionation utilization and contribute to our long-term financial growth." "We anticipate ongoing favorable business momentum heading into the fourth quarter and are pleased to raise our full year sales and adjusted net income forecast," concluded Mr. Gao. Total sales in the third quarter of 2016 increased by 9.8% in USD terms to $86.5 million from $78.8 million in the same quarter of 2015, or increased by 17.3% in RMB terms during the same period. The increase was primarily attributable to the sales price increase in human tetanus immunoglobulin products and the sales volume increase in human albumin products and human tetanus immunoglobulin products, partially offset by the sales volume decrease in IVIG products. During the third quarter of 2016, human albumin and IVIG products remained the Company's two largest sales contributors, while the revenue contribution from the Company's other products continued to grow. As a percentage of total sales, sales from human albumin and IVIG products decreased to 37.0% and 33.1%, respectively, in the third quarter of 2016, compared to 38.7% and 41.4% in the same quarter of 2015, while sales from hyper-immune products increased to 15.5% of total sales, compared to 6.3% in the same quarter of 2015. The sales volume of human albumin products increased by 11.4% due to enhanced production volume, while the sales volume of IVIG products decreased by 10.6% mainly due to the depletion of previously reserved IVIG pastes in 2015 and the allocation of more production to human tetanus immunoglobulin products, whose sales volume increased by 49.3% for the third quarter of 2016, as compared to the same period in 2015. The average price for human albumin products, excluding foreign exchange impact, would have increased by 0.9% in RMB terms, or decreased by 5.5% in USD terms, in the third quarter of 2016 compared to the same quarter of 2015. The average price for IVIG products, excluding foreign exchange impact, would have increased by 4.8% in RMB terms, or decreased by 1.8% in USD terms, in the third quarter of 2016 compared to the same quarter of 2015. Revenue from other plasma products including human coagulation factor VIII and human prothrombin complex concentrate increased by 34.4% in the third quarter of 2016, representing 5.0% of total sales, compared to the same quarter of 2015. Revenue from placenta polypeptide products increased by 6.6% in the third quarter of 2016, representing 9.4% of total sales, compared to the same quarter of 2015. Cost of sales was $27.6 million in the third quarter of 2016, compared to $28.0 million in the same quarter of 2015. As a percentage of total sales, cost of sales decreased to 31.9% from 35.5% in the same quarter of 2015, mainly due to the increase of the average sales price of certain plasma products and a more profitable product mix. Gross profit increased by 15.9% to $58.9 million in the third quarter of 2016 from $50.8 million in the same quarter of 2015. Gross margin was 68.1% and 64.5% in the third quarter of 2016 and 2015, respectively. Total operating expenses in the third quarter of 2016 increased by 20.9% to $19.1 million from $15.8 million in the same quarter of 2015, mainly due to the increases of general and administrative expenses. As a percentage of total sales, total operating expenses increased to 22.2% in the third quarter of 2016 from 20.0% in the same quarter of 2015. Selling expenses in the third quarter of 2016 increased by 11.1% to $3.0 million from $2.7 million in the same quarter of 2015. As a percentage of total sales, selling expenses remained stable at 3.5% compared with 3.4% in the same quarter of 2015. General and administrative expenses in the third quarter of 2016 were $15.1 million compared to $11.5 million in the same quarter of 2015. As a percentage of total sales, general and administrative expenses increased to 17.5% in the third quarter of 2016 from 14.6% in the same quarter of 2015. The increase in general and administrative expenses was mainly due to a $3.4 million increase in share-based compensation expenses. Excluding the impact of share-based compensation expenses, general and administrative expenses would have been 9.4% and 10.0% as a percentage of total sales in the third quarter of 2016 and 2015, respectively. Research and development expenses in the third quarter of 2016 decreased to $1.0 million from $1.6 million in the same quarter of 2015. As a percentage of total sales, research and development expenses decreased to 1.2% in the third quarter of 2016 from 2.0% in the same quarter of 2015. During the third quarter of 2016, the Company received a government grant of $0.5 million and recognized it as a reduction of research and development expenses. Income from operations for the third quarter of 2016 increased by 13.4% to $39.7 million from $35.0 million in the same period of 2015. Operating margin increased to 45.9% in the third quarter of 2016 from 44.5% in the same quarter of 2015. Income tax expense in the third quarter of 2016 was $7.2 million, compared to $6.0 million in the same quarter of 2015, representing an increase of 20.0%. The effective income tax rate remained stable at 16.8% in the third quarters of 2016 compared with the same period of 2015. Net income attributable to the Company increased by 24.0% to $28.4 million in the third quarter of 2016 from $22.9 million in the same quarter of 2015. Net margin increased to 32.8% from 29.0% in the same quarter of 2015. Fully diluted net income per share increased to $1.01 in the third quarter of 2016 from $0.82 in the same quarter of 2015. Non-GAAP adjusted net income attributable to the Company increased by 39.8% in RMB terms, or 30.9% in USD terms, to $34.3 million in the third quarter of 2016 from $26.2 million in the same quarter of 2015. Non-GAAP net margin increased to 39.7% from 33.2% in the same quarter of 2015. Non-GAAP adjusted net income per diluted share increased to $1.22 in the third quarter of 2016 from $0.94 in the same quarter of 2015. Non-GAAP adjusted net income and diluted earnings per share for the third quarter of 2016 exclude $5.9 million of non-cash employee share-based compensation expenses. First Nine Months 2016 Financial Performance Total sales in the first nine months of 2016 increased by 15.5% in USD terms, to $263.5 million from $228.2 million in the same period of 2015, or increased by 23.1% in RMB terms during the same period. The increase in sales was primarily driven by the increase in sales volume of human albumin products, human tetanus immunoglobulin products and placenta polypeptide products, as well as an increase in the sales price of human tetanus immunoglobulin products. As a percentage of total sales, sales from human albumin products and IVIG products accounted for 38.9% and 35.5%, respectively, for the first nine months of 2016. Cost of sales was $93.2 million in the first nine months of 2016, compared to $79.5 million in the same period of 2015. Cost of sales as a percentage of total sales was 35.4%, as compared to 34.8% in the same period of 2015. The increase in cost of sales as a percentage of total sales was mainly due to the higher cost of outsourced raw plasma, which was partially offset by the increase in the average sales price of certain plasma products and a more profitable product mix. Gross profit increased by 14.5% to $170.3 million in the first nine months of 2016 from $148.7 million in the same period of 2015. Gross margin was 64.6% in the first nine months of 2016, compared to 65.2% in the same period of 2015. Total operating expenses in the first nine months of 2016 increased 28.4% to $49.7 million from $38.7 million in the same period of 2015. As a percentage of total sales, total operating expenses increased to 18.9% for the first nine months of 2016 from 17.0% in the same period of 2015, mainly due to $8.7 million increase of share-based compensation expenses. Income from operations in the first nine months of 2016 increased by 9.7% to $120.7 million from $110.0 million in the same period of 2015. Income tax expense in the first nine months of 2016 was $20.8 million, as compared to $17.8 million in the same period of 2015. The effective income tax rate was 16.4% and 15.9% for the first nine months of 2016 and 2015, respectively. Net income attributable to the Company increased by 17.2% to $85.3 million for the first nine months of 2016 from $72.8 million in the same period of 2015. Net margin was 32.4% and 31.9% for the first nine months of 2016 and 2015. Fully diluted net income per share for the first nine months of 2016 increased to $3.05 from $2.68 for the same period of 2015. Non-GAAP adjusted net income attributable to the Company increased by 33.7% in RMB terms, or 25.3% in USD terms, to $99.9 million for the first nine months of 2016 from $79.7 million in the same period of 2015. Non-GAAP net margin increased to 37.9% from 34.9% in the same period of 2015. Non-GAAP adjusted net income per diluted share increased to $3.57 for the first nine months of 2016 from $2.94 in the same period of 2015. Non-GAAP adjusted net income and diluted earnings per share for the first nine months of 2016 exclude $14.6 million of non-cash employee share-based compensation expenses. As of September 30, 2016, the Company had $203.2 million in cash and cash equivalents, primarily consisting of cash on hand and demand deposits. Net cash provided by operating activities for the first nine months of 2016 was $87.3 million, as compared to $72.3 million for the same period in 2015. The increase in net cash provided by operating activities was largely consistent with the improvements in the results of operations and the increase of net non-cash operating expenses for the first nine months of 2016, as compared to the same period in 2015. Our cash inflows from operating activities are negatively affected by increases of accounts receivable and inventory. Accounts receivable increased by $16.1 million during the first nine months of 2016, as compared to $16.2 million during the same period in 2015. The accounts receivable turnover days for plasma products remained stable at 45 days during the first nine months of 2016 compared with the same period in 2015. To enhance the business relationship with certain key customers, the Company granted longer credit term to certain qualified hospitals during the nine months ended September 30, 2016 and granted special credit term extensions to certain distributors of rabies immunoglobulin products in the same period of 2015. Inventories increased by $24.5 million in the first nine months of 2016, as compared to $26.1 million during the same period in 2015. The inventory turnover days increased to 398 days for the nine months ended September 30, 2016 from 387 days for the same period in 2015, mainly due to an increase in the inventory of outsourced raw plasma. Net cash used in investing activities for the first nine months of 2016 was $44.1 million, as compared to $55.8 million for the same period in 2015. During the first nine months of 2016 and 2015, the Company paid $42.5 million and $30.5 million, respectively, for the acquisition of property, plant and equipment, intangible assets and land use rights for Shandong Taibang and Guizhou Taibang. During the first nine months of 2016 and 2015, the Company granted a loan of $12.3 million and $28.5 million, respectively, to our plasma outsourcing partner. In addition, the Company received a refund of $10.3 million from the local government of Guiyang with respect to deposits of land use rights. Net cash provided by financing activities for the first nine months of 2016 was $19.6 million, as compared to $49.7 million for the same period in 2015. The net cash provided by financing activities in the first nine months of 2016 mainly consisted of the proceeds of $3.2 million from stock options exercised and the maturity of a $37.8 million time deposit as a security for a bank loan which was fully repaid in June 2015, partially offset by a dividend of $7.9 million paid to the minority shareholder by Shandong Taibang and payment of $13.5 million to former minority shareholders of Guizhou Taibang in connection with their capital withdrawal from Guizhou Taibang. The net cash provided by financing activities for the first nine months of 2015 mainly consisted of net proceeds of $80.6 million from a follow-on offering of the Company's stock in June 2015 and proceeds of $63.2 million from the maturity of deposit used as security for bank loans, and proceeds of $7.2 million from stock options exercised, partially offset by repayments of bank loans of $97.9 million and a dividend of $3.7 million held in escrow by a trial court in connection with disputes with a former minority shareholder of Guizhou Taibang. For the full year of 2016, due to better-than-expected market price increases for new tenders for certain higher margin products during the first nine months of the year, the Company is raising its full year total sales growth forecast to 22% to 24% from 21% to 23% in RMB terms. Due to favorable pricing for certain products, a higher sales contribution from products made from in-house sourced raw plasma at lower cost and enhanced earnings contribution at our Guizhou facility after acquiring full ownership, the Company is raising its full year forecast of non-GAAP adjusted net income growth to 33% to 35% from 24% to 26% in RMB terms over the Company's 2015 financial results. This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.21 = $1.00 based on weighted average quarterly exchange rates in 2015 in translating 2015 financial results, the Company expects that the total sales and non-GAAP adjusted net income in USD terms in 2016 will be adversely affected by the foreign currency translation impact. This guidance assumes only organic growth, excluding potential acquisitions, and necessarily assumes no significant adverse product price changes during the fourth quarter of 2016. This forecast reflects the Company's current and preliminary views, which are subject to change. The Company will host a conference call at 7:30 am Eastern Time on Thursday, November 3, 2016, which is 7:30 pm Beijing Time on November 3, 2016, to discuss third quarter 2016 results and answer questions from investors. Listeners may access the call by dialing: A telephone replay will be available one hour after the conclusion of the conference all through November 10, 2016. The dial-in details are: A live and archived webcast of the conference call will be available through the Company's investor relations website at http://chinabiologic.investorroom.com. China Biologic Products, 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 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. 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. To supplement the Company's unaudited condensed 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 these non-GAAP measures provide investors with a better understanding of how the results relate to the Company's performance. 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. This news release may contain certain "forward-looking statements" relating to the business of China Biologic Products, 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 positive impact on the Company's earnings results driven by the acquisition of full ownership in Guizhou Taibang 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 potential delay or failure to complete the clinical trials for new products, potential delay or failure to complete construction of new collection facilities, potential inability to pass government inspection and certification process for new collection 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/china-biologic-reports-financial-results-for-the-third-quarter-of-2016-300355826.html


Wang Z.K.,Peking Union Medical College | Du X.,Peking Union Medical College | Wang Y.M.,Guizhou Taibang Biological Products Co. | Li C.Q.,Peking Union Medical College | And 5 more authors.
Genetics and Molecular Research | Year: 2015

Cohn fraction IV (CFIV) is a byproduct of a plasma fractionation process known as the Cohn process. It is an inexpensive source of protein C, retaining about 90% of protein C (PC) in human plasma. We investigated whether PC is affected during the Cohn process and evaluated correlations among coagulant activity, amidolytic activity and PC antigen during the Cohn process. CFIV was redissolved with citrate-buffered saline for 5 h at 4°C, and then centrifuged at 3500 g for 40 min at 4°C. Functional anticoagulant activity was measured with a one-stage coagulation method based on activated partial thromboplastin time. The functional amidolytic activity of PC was determined using chromogenic substrate assay, and measurement of PC antigen was performed by ELISA. In CFIV, anticoagulant activity declined significantly, with a loss of >80%, while amidolytic activity was not significantly altered, compared to PC antigen. Prior to the Cohn process, high-rank correlations were observed in cryosupernatant, with rs = 0.921 for anticoagulant and amidolytic activities (P = 0.009), 0.896 for anticoagulant activity and antigen (P = 0.014) and 0.832 for amidolytic activity and antigen (P = 0.031). After the Cohn process in CFIV, there was also a high correlation between amidolytic activity and antigen (rs = 0.782, P = 0.038). There were no significant correlations between anticoagulant activity and antigen (rs = 0.223, P = 0.653), or anticoagulant and amidolytic activity (rs = 0.236, P = 0.675). We conclude that the Cohn process significantly influences the anticoagulant activity of PC. Compared to the antigen, PC lost greater than 80% of its anticoagulant activity, but retained its amidolytic activity, during the Cohn process. © FUNPEC-RP.


PubMed | Guizhou Taibang Biological Products Co. and Peking Union Medical College
Type: Journal Article | Journal: Genetics and molecular research : GMR | Year: 2015

Cohn fraction IV (CFIV) is a byproduct of a plasma fractionation process known as the Cohn process. It is an inexpensive source of protein C, retaining about 90% of protein C (PC) in human plasma. We investigated whether PC is affected during the Cohn process and evaluated correlations among coagulant activity, amidolytic activity and PC antigen during the Cohn process. CFIV was redissolved with citrate-buffered saline for 5 h at 4C, and then centrifuged at 3500 g for 40 min at 4C. Functional anticoagulant activity was measured with a one-stage coagulation method based on activated partial thromboplastin time. The functional amidolytic activity of PC was determined using chromogenic substrate assay, and measurement of PC antigen was performed by ELISA. In CFIV, anticoagulant activity declined significantly, with a loss of >80%, while amidolytic activity was not significantly altered, compared to PC antigen. Prior to the Cohn process, high-rank correlations were observed in cryosupernatant, with rs = 0.921 for anticoagulant and amidolytic activities (P = 0.009), 0.896 for anticoagulant activity and antigen (P = 0.014) and 0.832 for amidolytic activity and antigen (P = 0.031). After the Cohn process in CFIV, there was also a high correlation between amidolytic activity and antigen (rs = 0.782, P = 0.038). There were no significant correlations between anticoagulant activity and antigen (rs = 0.223, P = 0.653), or anticoagulant and amidolytic activity (rs = 0.236, P = 0.675). We conclude that the Cohn process significantly influences the anticoagulant activity of PC. Compared to the antigen, PC lost greater than 80% of its anticoagulant activity, but retained its amidolytic activity, during the Cohn process.


Yuan J.,Guizhou Taibang Biological Products Co. | Li Y.-X.,Guizhou Taibang Biological Products Co. | Chen Y.-H.,Guizhou Taibang Biological Products Co.
Chinese Journal of New Drugs | Year: 2015

Objective: To analyze strategies and experience sharing on recruiting patients with rare diseases in order to give useful references for clinical study which is being conducted or will be conducted. Methods: The procedures, methods, strategies, factors, outlook and advices for recruiting strategies for patients with rare diseases were summarized and discussed. Results: Recruiting procedures include investigation in advance, making working plan, expanded investigation, implement of recruiting program, screening data bank, making plan for patient-contacting and gaining informed consent. Recruiting can be done in a variety of ways. The main approach for recruiting is hospital. Recruiting by the third part, publishing poster at the site of relevant academic conference, organizing small patient education or expert consultation meeting inside hospital will also be choices. The factors, which may influence the effect of recruiting, may be study protocol, disease and drug, patient, and hospital. Problems will be resolved case by case through adopting positive and practicable measures. Conclusion: The recruiting strategy will be developed according to characteristics of the rare diseases, the principles for guarantee for rights of patients, and quality of clinical trial. Strategy analysis and shared experiences from the author is are worthy for reference. ©, 2015, Chinese Journal of New Drugs Co. Ltd. All right reserved.


Zhao X.,Beijing Institute of Biotechnology | Dong Y.,Beijing Institute of Biotechnology | Zhao Z.,Chinese Academy of Agricultural Sciences | Guo J.,Beijing Institute of Biotechnology | And 11 more authors.
Protein Expression and Purification | Year: 2013

Protein transduction domains (PTDs), such as the TAT peptide derived from HIV Tat protein, may transduce macromolecules into cells. In the present study, the TAT peptide-fused artificial transcription factors (ATFs) were generated by fusion of the N-terminal TAT peptide with SV40 promoter-targeted three-fingered C2H2 zinc finger proteins and the KRAB transcriptional repression domain. The fusion proteins were then expressed in an E.coli system and purified by Ni-NTA affinity chromatography. The purified fusion proteins were tested on mammalian cell lines CHO DG44 and L929. TAT-ATF-S, which contains the zinc fingers that bind to the SV40 promoter with high specificity, exhibited the desired transcriptional repression activity to the reported genes, indicating the successful cellular delivery and desired conformation of TAT-ATF-S. Our study has provided a new strategy for intracellular ATF delivery. © 2013 Elsevier B.V. All rights reserved.


PubMed | Chinese Academy of Sciences and Guizhou Taibang Biological Products Co.
Type: | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2016

Intravenous immunoglobulin (IVIg) is produced by pooling plasma from thousands of healthy blood donors, and the diversity of the antibody is critical for the clinical efficacy of IVIg. This study investigated the antibody diversity of Chinese IVIg. Firstly, 2-dimensional gel electrophoresis and immunoblotting with protein extracts of Escherichia coli (E. coli) O157:H7 were used to study IgG antibody repertoire of 8 IVIg preparations from different Chinese manufacturers. This was followed by the identification of the antibody-reactive proteins of E. coli by mass spectrometry and the sequence similarity of the proteins was aligned by bioinformatics analysis. The results showed that all IVIg preparations expressed a large range of antibody reactivities against E. coli proteins. 94-238 antigens were recognized by the 8 IVIg preparations. 33 interesting target antigens were selected and identified as 29 different proteins, mainly including membrane proteins, molecular chaperones, metabolism enzymes, and proteins involved in cell cycle processes. Additionally, these antigens were highly conserved proteins which were found extensively in a variety of other pathogenic microorganisms. Our study indicated that Chinese IVIg preparations recognized a large range of high conserved proteins which play key roles in pathogenic microorganisms, and showed each IVIg had its own distinct antibody repertoire.

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