BioCryst Pharmaceuticals Announces Full Exercise of Underwriters’ Option to Purchase Additional Shares and Completion of Public Offering of Common Stock

On August 6, 2018 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported the completion of an underwritten public offering of 10,454,546 shares of its common stock, including 1,363,636 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares (Press release, BioCryst Pharmaceuticalsa, AUG 6, 2018, View Source [SID1234528782]). The gross proceeds from this offering to BioCryst, including from the shares sold pursuant to the underwriters’ option to purchase additional shares, were approximately $57.5 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by BioCryst. BioCryst expects to use the net proceeds of this offering for general corporate purposes, which may include, but are not limited to, funding worldwide development, manufacturing, regulatory and commercial activities for the prophylactic and acute BCX7353 programs, focusing primarily on the United States, European Union and Japan; the advancement of development activities of our fibrodysplasia ossificans progressiva ("FOP") and other preclinical rare disease program; post-approval commitments for RAPIVAB/ALPIVAB; and capital expenditures and general working capital needs.

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J.P. Morgan and Jefferies acted as joint book-running managers for the offering. JMP Securities acted as lead manager for the offering.

A shelf registration statement on Form S-3 relating to the shares of common stock described above has been previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC"). This press release does not constitute an offer to sell, or the solicitation of an offer to buy, these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale is not permitted.

This offering was made by means of a prospectus supplement and related prospectus. A prospectus supplement relating to the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: 1-866-803-9204 or from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

Fate Therapeutics Reports Second Quarter 2018 Financial Results and Highlights Operational Progress

On August 6, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the second quarter ended June 30, 2018 (Press release, Fate Therapeutics, AUG 6, 2018, View Source [SID1234528450]).

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"Our submission to the FDA of an IND application for FT500, a universal, off-the-shelf NK cell cancer immunotherapy derived from a master iPSC line, is a significant milestone for the Company and the field of cell therapy," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We are excited to be working with the FDA to allow the first U.S. clinical investigation of an iPSC-derived cell therapy and usher in a new era enabling the development, manufacture and delivery of off-the-shelf cell products for the treatment of cancer. I am very pleased with our execution over the first six months of 2018 across the business, as we have also accelerated enrollment in our Phase 2 PROTECT study of ProTmune and expanded our clinical investigation of NK100 to a second leading cancer research center."

Clinical Programs

Treated 20th Subject in Phase 2 PROTECT Study of ProTmune. During the second quarter of 2018, 14 subjects were treated in the randomized, controlled and double-blinded Phase 2 PROTECT study, which is intended to enroll a total of 60 adult subjects with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation (HCT). Subjects in the Phase 2 PROTECT study are being randomized, in a 1:1 ratio, to receive either ProTmune, the Company’s next-generation hematopoietic cell graft, or a conventional matched unrelated donor cell graft. The Company has submitted an abstract to present clinical data from the seven subjects that were administered ProTmune in the Phase 1 stage of PROTECT, including data on a key secondary endpoint assessing freedom from chronic graft-versus-host disease (GvHD), cancer relapse and death at 1-year following HCT, at the 2018 ASH (Free ASH Whitepaper) Annual Meeting.
Expanded Enrollment of FATE-NK100 Dimension Study to Baylor University Medical Center. The Company has now enrolled subjects in the Phase 1 DIMENSION study at two of the nation’s leading cancer research centers, Baylor Charles A. Sammons Cancer Center in Dallas and the Masonic Cancer Center, University of Minnesota. The DIMENSION study is assessing the safety and efficacy of NK100 when administered as a monotherapy and in combination with trastuzumab or cetuximab, two FDA-approved monoclonal antibodies that are widely used today to treat various solid tumor malignancies. Three Phase 1 clinical trials of NK100 are currently being conducted in subjects with advanced liquid and solid tumors, and the Company plans to present additional clinical data for NK100 in the second half of 2018.
Universal Off-the-Shelf Cancer Immunotherapy Preclinical Pipeline

Submitted First-of-Kind IND Application to FDA for FT500. Within the last thirty days, the Company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for FT500, a universal, off-the-shelf NK cell product. FT500 is the first product candidate emerging from the Company’s industry-leading induced pluripotent stem cell (iPSC) product platform, which uses clonal master iPSC lines as a renewable source for producing off-the-shelf cellular immunotherapies. The Company plans to clinically investigate FT500 in combination with FDA-approved checkpoint inhibitors as a rescue therapy.
Gained Rights to Novel CAR Constructs and CRISPR Gene-Editing from MSK. In May, the Company expanded its existing license agreement with Memorial Sloan Kettering Cancer Center (MSK) to further enable the development of off-the-shelf CAR T-cell immunotherapies, including the Company’s universal, off-the-shelf CAR19 T-cell product candidate FT819. The newly-licensed portfolio of intellectual property covers certain patents and patent applications relating to novel chimeric antigen receptor (CAR) constructs and off-the-shelf CAR T cells, including the use of CRISPR and other innovative technologies for their production. In connection with amending the license agreement, Fate Therapeutics paid an upfront fee of $500,000 and issued 500,000 shares of the Company’s common stock valued at $4.8 million to MSK, and MSK returned its entire interest in Tfinity Therapeutics, Inc. to the Company.
Organization

Promoted Bob Valamehr, Ph.D. to Chief Development Officer. Dr. Valamehr joined Fate Therapeutics in 2009 and oversees the Company’s iPSC product platform, including the development of the Company’s off-the-shelf NK cell and T-cell cancer immunotherapy pipeline. He is first author on the Company’s 2014 seminal publication in Stem Cell Reports describing the Company’s ground-breaking approach to the footprint-free generation, clonal selection and master cell banking of human iPSCs (View Source).
Appointed Michael Lee to Board of Directors. Mr. Lee is co-founder of and has served as a portfolio manager at Redmile Group, LLC, a health care-focused investment firm based in San Francisco and New York, since 2007.
Second Quarter 2018 Financial Results

Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of June 30, 2018 were $78.0 million compared to $100.9 million as of December 31, 2017. The decrease was primarily driven by the Company’s use of cash to fund operating activities.
Total Revenue: Revenue was $1.0 million for the second quarter of 2018 as well as for the same period in 2017. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.
R&D Expenses: Research and development expenses were $16.8 million for the second quarter of 2018, compared to $7.9 million for the same period in 2017. In the second quarter of 2018, the Company incurred a one-time $5.3 million expense associated with the in-license of additional intellectual property from MSK. The remaining increase in R&D expenses was primarily attributable to an increase in expenses associated with the clinical development of FATE-NK100 and with regulatory and manufacturing activities to support the submission of the FT500 IND application.
G&A Expenses: General and administrative expenses were $3.8 million for the second quarter of 2018, compared to $2.7 million for the same period in 2017. The increase in G&A expenses was primarily attributable to an increase in employee compensation associated with growth in headcount and in intellectual property-related expenses.
Shares Outstanding: Common shares outstanding were 53.4 million as of June 30, 2018 and 52.6 million as of December 31, 2017. Preferred shares outstanding as of June 30, 2018 and December 31, 2017 were 2.8 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Monday, August 6th, 2018 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 2018. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 2383816. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

About FATE-NK100
FATE-NK100 is an investigational, first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research. Three clinical trials of FATE-NK100 are currently being conducted: VOYAGE for the treatment of refractory or relapsed acute myelogenous leukemia; APOLLO for the treatment of recurrent ovarian cancer; and DIMENSION for the treatment of advanced solid tumors, including in combination with monoclonal antibody therapy.

About ProTmune
ProTmune is an investigational next-generation hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT). ProTmune is manufactured by pharmacologically modulating a donor-sourced, mobilized peripheral blood graft ex vivo with two small molecules (FT1050 and FT4145) to decrease the incidence and severity of acute GvHD while maintaining the anti-leukemia activity of the graft. ProTmune has been granted Orphan Drug and Fast Track Designations by the U.S. Food and Drug Administration, and Orphan Medicinal Product Designation by the European Commission. ProTmune is currently being investigated in a randomized, controlled and double-blinded Phase 2 clinical trial in adult subjects with hematologic malignancies undergoing matched unrelated donor HCT.

About Fate Therapeutics’ iPSC Product Platform
The Company’s proprietary iPSC product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered in repeat doses to mediate more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event, and selecting a single iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for consistently and repeatedly manufacturing homogeneous cell products in quantities that support the treatment of patients in an off-the-shelf manner. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 100 issued patents and 100 pending patent applications.

Almac Discovery, Elasmogen and Innovate UK Collaborate to Develop VNAR Based Oncology Platform

On August 6, 2018 Almac Discovery, a biopharmaceutical company focused on discovering and identifying innovative therapeutics for the treatment of cancer, and Elasmogen, an SME focused on the development of next generation biologics, reported that they have been awarded a grant from Innovate UK through its Innovation in Health and Life Sciences funding programme (Press release, Elasmogen, AUG 6, 2018, View Source [SID1234637763]).

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The £2M peer reviewed collaborative project entitled ‘A Technology Platform for Next Generation VNAR based Oncology Medicines’, plans to utilise the highly selective, high affinity and yet low molecular weight non-antibody VNAR protein scaffold and build a versatile platform to facilitate the discovery and development of targeted oncology therapeutics.

The VNAR structure allows ready access for protein engineering of multiple formats. These VNAR formats can be optimised, with or without conjugation of a cytotoxic payload, with further conversion to soloMER format, to become a first-in-class or best-in-class targeted therapeutic. The two year project optimises both target binding and selectivity, via the identification of novel epitopes and formats, approaches to linker design and payload attachments, and further builds upon the experimental data supporting the unique attributes of VNARs.

Almac first entered into an agreement with Elasmogen for the treatment of solid tumours in 2015. This new joint research programme broadens the collaborative work by combining Almac Discovery’s expertise in protein engineering and oncology drug discovery with Elasmogen’s expertise in the generation, screening and formatting of VNAR proteins.

Stephen Barr, President & Managing Director, Almac Discovery commented: "We are delighted to have secured this highly sought after funding from Innovate UK to support this novel field of research which is testament to the novelty of the proposed approach and the quality of the underlying technologies involved. It is heartening to be able to continue and also broaden our successful collaboration with Elasmogen so that we may remain at the forefront of oncology discovery and ultimately benefit patients."

"Given the devastating and wide-ranging impact of cancer on the lives of so many people, there is a continual need to bring new innovative therapies into the clinic" said Caroline Barelle, Chief Executive Officer, Elasmogen. "I have no doubt that by combining the oncology expertise of Almac with the advantages of our soloMER platform that we can deliver a new class of drugs to patients".

Innovate UK is the UK’s innovation agency working with people, companies and partner organisations to find and drive science and technology innovations that will grow the UK economy.

Future research of next generation VNAR-based oncology medicines, as a result of this investment, will be co-funded by the UK’s innovation agency, Innovation UK, Elasmogen and Almac Group.

Intrexon to Present at the Jefferies 2018 Global Industrials Conference

On August 3, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported Robert Walsh, Senior Vice President, Energy and Fine Chemicals Platforms, will present at the Jefferies 2018 Global Industrials Conference in New York City on Tuesday, August 7, 2018 at 8:00 am Eastern (Press release, Intrexon, AUG 3, 2018, View Source [SID1234528378]). Mr. Walsh’s presentations will highlight Intrexon’s proprietary methane bioconversion platform to convert natural gas into high-value fuels and chemicals through microbial fermentation.

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China Biologic Reports Financial Results for the Second Quarter of 2018

On August 3, 2018 China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, reported its unaudited financial results for the second quarter of 2018 (Press release, China Biologic Products, AUG 3, 2018, View Source [SID1234528424]).

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Second Quarter 2018 Financial Highlights

Total sales in the second quarter of 2018 increased by 25.5% in RMB terms and 34.8% in USD terms to $120.4 million from $89.3 million in the same quarter of 2017.
Gross profit increased by 39.7% to $82.7 million from $59.2 million in the same quarter of 2017. Gross margin increased to 68.7% from 66.3% in the same quarter of 2017.
Income from operations decreased by 15.3% in RMB terms, and 8.9% in USD terms to $35.9 million from $39.4 million in the same quarter of 2017. Operating margin decreased to 29.8% from 44.1% in the same quarter of 2017. Excluding TianXinFu, income from operations decreased by 30.3% in RMB terms and 25.1% in USD terms in the second quarter of 2018 compared to the same quarter of 2017, and operating margin decreased to 27.5% from 44.1% in the same quarter of 2017.
Non-GAAP adjusted income from operations decreased by 3.7% in RMB terms and increased by 3.6% in USD terms to $49.2 million from $47.5 million in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 21.0% in RMB terms and 15.1% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Net income attributable to the Company decreased by 14.1% in RMB terms and 7.7% in USD terms to $28.6 million from $31.0 million in the same quarter of 2017. Fully diluted earnings per share decreased by 23.9% to $0.83 compared to $1.09 in the same quarter of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 29.7% in RMB terms and 24.2% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Non-GAAP adjusted net income attributable to the Company decreased by 2.8% in RMB terms and increased by 4.4% in USD terms to $40.2 million from $38.5 million in the same quarter of 2017. Non-GAAP adjusted earnings per share decreased to $1.17 from $1.35 in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 19.4% in RMB terms and 13.2% in USD terms in the second quarter of 2018 compared to the same quarter of 2017.
Certain income statement and balance sheet items impacted by the TianXinFu acquisition are presented for comparison purposes.
Mr. David Hui Li, Chairman of the Company, commented, " Our second quarter of 2018 continued to be challenging due to the ongoing impact of regulatory changes and intensified competition in China’s healthcare market. Because of spending controls by regional government-sponsored medical insurance programs, an increasing number of hospitals across various provinces are implementing stricter drug purchase budgets by capping drug revenue to no more than 30% of a hospital’s total revenue. This has led to another high-double-digit decline in our direct sales channel revenue in the second quarter. To offset this negative impact, the Company pursued new distributor and pharmacy channels. However, the intensified competition in the distribution market has caused over 10% year-over-year price declines across all major plasma products, deteriorated payment terms, and increased marketing expenditures. In addition, although our placenta polypeptide product experienced a 70% sales revenue growth in RMB terms, its sales volume declined over 30% due to the implementation of the two-invoice policy and the exclusion of it as a supplemental drug from the reimbursement lists of certain provinces. Our TianXinFu business performance met our expectations, and we remain conservatively optimistic about its growth in the second half of the year."

"Recently, the Board of Directors implemented certain important personnel changes. As previously disclosed, the Board removed David Gao as Chairman and director of the Board, and CEO and President of the Company. Subsequently, the Board also terminated David Gao’s employment for cause based on the Board’s review of the facts and circumstances of his removal. Concurrent to Mr. Gao’s removal, two other directors stepped down from the Board. The Board elected me as Chairman, and elected two industry veterans Mr. Qi Ning and Mr. Bing Li to the Board as independent directors. While the Board is conducting search for a new CEO, the Board has appointed Mr. Zhijun Tong as the acting CEO. Mr. Tong is an experienced entrepreneur and executive, and has been a director of the Company since 2012. The Board believes that the overhaul of the senior management and the changes at the Board level will greatly improve the Company’s governance and management and rejuvenate our business, particularly in today’s challenging environment."

Mr. Li continued, "In July, we received the operating permit for our new Feicheng branch plasma collection facility and commenced commercial operations immediately. We also recently extended our strategic collaboration agreement with Xinjiang Deyuan for another 3 years to purchase at least an additional 500 tonnes of plasma. We believe this extended collaboration is mutually beneficial, as it secures plasma supply to enhance our Guizhou facility’s utilization efficiency."

"For the second half of the year, we expect the regulatory headwinds and market competitive dynamics to persist, which will impact our guidance for the year. However, we remain optimistic about the mid- to long-term prospects of our industry, which we believe will continue to transit from a market of demand serving to demand creation in the next three to five years. Specifically, the industry growth engine will shift from albumin to IVIG and coagulation products, which have much higher margins and greater market potential. This transition will open many new opportunities for us and will take China’s plasma industry into the next development stage to replicate what happened in the U.S and Europe decades ago. Currently, due to limited awareness among Chinese doctors and medical practitioners, the growth of immunoglobulin products and high-end premium coagulation products have lagged behind that of albumin, and under-penetration of these products will persist in China’s markets. Our new Board leadership will support the executive management team to upgrade our commercial capabilities and to solidify our leading market position by expanding into new sales channels and by promoting our immunoglobulin and coagulation products. We will remain focused on improving per liter economics by leveraging our leading R&D capabilities to expedite the launch of new pipeline products. As always, we remain focused on pursuing long-term, sustainable growth and maximizing long-term shareholder value," concluded Mr. Li.

Second Quarter 2018 Financial Performance

Total sales in the second quarter of 2018 increased by 25.5% in RMB terms, or 34.8% in USD terms due to the benefit of favorable exchange rates, to $120.4 million from $89.3 million in the same quarter of 2017. The increase in total sales was partly attributable to a $13.0 million contribution from TianXinFu, which accounted for approximately 10.8% of total sales for the quarter. Excluding TianXinFu, total sales in the second quarter of 2018 increased by 11.9% in RMB terms, attributable to the sales increases in placenta polypeptide products, human albumin products, coagulation factor products, and certain immunoglobulin products, which was partly offset by the decrease in the sales of IVIG products. For plasma products, total sales in the second quarter of 2018 increased by 5.0% in RMB terms, or 12.7% in USD terms, to $90.3 million from $80.1 million in the same quarter of 2017.

During the second quarter of 2018, human albumin and IVIG products remained the Company’s two largest sales contributors. Revenue from human albumin increased by 9.6% in RMB terms, or 17.6% in USD terms, from $32.4 million in the second quarter of 2017 to $38.1 million in the second quarter of 2018. Revenue from IVIG products decreased by 11.8% in RMB terms, or 5.4% in USD terms, from $29.7 million in the second quarter of 2017 to $28.1 million in the second quarter of 2018. As a percentage of total sales, sales from human albumin and IVIG products were 31.7% and 23.4%, respectively, in the second quarter of 2018. Excluding the contribution from TianXinFu, human albumin and IVIG products represented 35.5% and 26.2% of total sales, respectively, compared to 36.3% and 33.3%, respectively, in the second quarter of 2017. The large decrease of IVIG sales’ percentage mainly reflected the combined effects of decreased sales volume and sales prices year over year.

The sales volume of human albumin products increased by 15.6% for the second quarter of 2018 compared to the same quarter of 2017, primarily due to increased sales volumes in the distributor and pharmacy channels, which was partly offset by decreased prescription volumes at various hospitals due to the ongoing healthcare regulatory changes in China. The sales volume of IVIG products decreased by 9.0% for the second quarter of 2018 compared to the same quarter of 2017, mainly reflecting decreased prescription volumes at various hospitals with the same effect of policy headwinds to human albumin.

The average prices for human albumin and IVIG products decreased by 5.2% and 3.1%, respectively, in RMB terms in the second quarter of 2018 compared to the same quarter of 2017 because of greater sales volume in the distributor channel and further price discounts to certain distributors reflecting intensified market competition for major plasma products. In USD terms, due to favorable exchange rates, the average price for human albumin and IVIG products increased by 1.9% and 4.1% year over year, respectively.

Revenue from specialty immunoglobulin products increased by 12.8% in RMB terms, or 21.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, reaching 12.8% of total sales. This increase was mainly due to higher sales volumes of human rabies immunoglobulin products and human tetanus immunoglobulin products.

Revenue from coagulation factor products, including human coagulation factor VIII, human prothrombin complex concentrate, and the newly launched human fibrinogen products, increased by 50.9% in RMB terms, or 62.3% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, representing 7.1% of total sales. The growth mainly came from the launch of our human fibrinogen products in the beginning of 2018 and the increased sales volumes of the Company’s human coagulation factor VIII and human prothrombin complex concentrate products, which is reflective of the Company’s ongoing medical marketing activities.

Revenue from placenta polypeptide products increased by 71.6% in RMB terms, or 84.4% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, reaching 14.1% of total sales, which was supported by higher unit selling prices in connection with the wider implementation of the two-invoice policy. However, the sales volume of placenta polypeptide products continued to decline as a result of their inclusion in regional supplemental drug lists, which put pressure on their prescription volume.

Cost of sales increased by 24.9% to $37.6 million in the second quarter of 2018 compared to the same quarter of 2017. As a percentage of total sales, cost of sales decreased to 31.2% from 33.7% in the same quarter of 2017. The decrease in cost of sales as a percentage of total sales mainly reflected the higher gross margin of TianXinFu. Excluding TianXinFu, cost of sales was 33.6% of total sales, remaining stable year over year, a net impact of a higher sales price for the Company’s placenta polypeptide product and lower sales prices for its human albumin and IVIG products.

Gross profit increased by 39.7% to $82.7 million in the second quarter of 2018 from $59.2 million in the same quarter of 2017. Gross margin was 68.7% and 66.3% in the second quarters of 2018 and 2017, respectively.

Total operating expenses in the second quarter of 2018 was $46.9 million compared to $19.8 million in the same quarter of 2017. As a percentage of total sales, total operating expenses increased to 39.0% in the second quarter of 2018 from 22.2% in the same quarter of 2017. Excluding TianXinFu, total operating expenses increased by $22.0 million, or 111.1%, to $41.8 million in the second quarter of 2018. This increase mainly consisted of an increase of $16.7 million in selling expenses and an increase of $5.6 million in general and administrative expenses.

Selling expenses in the second quarter of 2018 was $24.4 million compared to $3.6 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, because certain previous multi-layer distributor channels were disqualified due to the two-invoice regulation, the Company implemented new sales strategies including using an internal sales force and engaging third party contract service organizations to promote its placenta polypeptide products. For other plasma products, in order to solidify its competitiveness within distributor 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 18.6% of total sales in the second quarter of 2018 compared to 4.0% in the same quarter of 2017.

General and administrative expenses in the second quarter of 2018 was $20.6 million compared to $14.3 million in the same quarter of 2017. As a percentage of total sales, general and administrative expenses were 17.1% and 16.0% in the second quarter of 2018 and the same quarter of 2017, respectively. The increase in general and administrative expenses mainly included a $2.7 million increase of share-based compensation expenses and a $1.0 million increase of Shandong Taibang’s depreciation expense and property tax for its new facility. Excluding the impact of share-based compensation expenses, non-GAAP general and administrative expenses would have been 8.1% and 6.9% of total sales in the second quarter of 2018 and the same quarter of 2017, respectively.

Research and development expenses in the second quarter of 2018 remained at $1.9 million compared to the same quarter of 2017. As a percentage of total sales, research and development expenses decreased to 1.6% in the second quarter of 2018 from 2.1% in the same quarter of 2017.

Income from operations for the second quarter of 2018 decreased by 15.3% in RMB terms, or 8.9% in USD terms, to $35.9 million from $39.4 million in the same quarter of 2017. Operating margin decreased to 29.8% in the second quarter of 2018 from 44.1% in the same quarter of 2017. Excluding TianXinFu, income from operations for the second quarter of 2018 decreased by 30.3% in RMB terms, or 25.1% in USD terms, to $29.5 million from $39.4 million in the same quarter of 2017.

Income tax expense was $6.7 million for the second quarter of 2018 compared to $6.9 million in the same quarter of 2017. The effective income tax rate was 16.4% and 16.5% for the second quarters of 2018 and 2017, respectively.

Net income attributable to the Company decreased by 14.1% in RMB terms, or 7.7% in USD terms, to $28.6 million in the second quarter of 2018 from $31.0 million in the same quarter of 2017. Net margin decreased to 23.8% in the second quarter of 2018 from 34.7% in the same quarter of 2017. Diluted net earnings per share decreased to $0.83 in the second quarter of 2018 compared to $1.09 in the same quarter of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 29.7% in RMB terms, or 24.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017, and net margin decreased to 21.9% in the second quarter of 2018 from 34.8% in the same quarter of 2017.

Non-GAAP adjusted income from operations decreased by 3.7% in RMB terms, or increased by 3.6% in USD terms, to $49.2 million in the second quarter of 2018 from $47.5 million in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 21.0% in RMB terms, or 15.1% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017.

Non-GAAP adjusted net income attributable to the Company decreased by 2.8% in RMB terms, or increased by 4.4% in USD terms, to $40.2 million in the second quarter of 2018 from $38.5 million in the same quarter of 2017. Non-GAAP net margin decreased to 33.4% in the second quarter of 2018 from 43.1% in the same quarter of 2017. Non-GAAP adjusted net income per diluted share decreased to $1.17 in the second quarter of 2018 from $1.35 in the same quarter of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 19.4% in RMB terms, or 13.2% in USD terms, in the second quarter of 2018 compared to the same quarter of 2017.

Non-GAAP adjusted income from operations for the second quarter of 2018 excludes $10.8 million in non-cash employee share-based compensation expenses and $2.5 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the second quarter of 2018 exclude $9.9 million in non-cash employee share-based compensation expenses and $1.7 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

First Half 2018 Financial Performance

Total sales in the first half of 2018 increased by 19.5% in RMB terms, or 28.8% in USD terms, to $232.8 million from $180.7 million in the same period of 2017. This includes a $24.4 million contribution from TianXinFu, which accounts for approximately 10.5% of total sales for the first half of 2018. Excluding TianXinFu, total sales in the first half of 2018 increased by 7.0% in RMB terms as a result of increases in the sales of placenta polypeptide products and certain immunoglobulin products, which was partly offset by decreases in the sales of human albumin and IVIG products. For plasma products, total sales in the first half of 2018 increased by 0.8% in RMB terms, or 8.7% in USD terms, to $175.3 million from $161.3 million in the same period of 2017. As a percentage of total sales, sales from human albumin products and IVIG products accounted for 30.9% and 25.7%, respectively, for the first half of 2018. Excluding the contribution from TianXinFu, human albumin and IVIG products were 34.5% and 28.7% of total sales, respectively.

Cost of sales increased by 14.4% to $71.3 million in the first half of 2018 compared to $62.3 million in the same period of 2017. As a percentage of total sales, cost of sales decreased to 30.6% from 34.5% in the same period of 2017. The decrease in cost of sales as a percentage of total sales mainly reflected the higher gross margin of TianXinFu. Excluding TianXinFu, cost of sales decreased to 32.9% of total sales, mainly due to the higher sales price of the Company’s placenta polypeptide product.

Gross profit increased by 36.4% to $161.5 million in the first half of 2018 from $118.4 million in the same period of 2017. Gross margin was 69.4% and 65.5% in the first half of 2018 and 2017, respectively.

Total operating expenses in the first half of 2018 was $86.7 million compared to $40.2 million in the same period of 2017. As a percentage of total sales, total operating expenses increased to 37.2% in the first half of 2018 from 22.2% in the same period of 2017. Excluding TianXinFu, total operating expenses increased by $36.3 million, or 90.3%, to $76.5 million in the first half of 2018. This increase mainly consisted of an increase of $29.8 million in selling expenses and an increase of $7.2 million in general and administrative expenses.

Income from operations for the first half of 2018 decreased by 11.3% in RMB terms, or 4.3% in USD terms, to $74.8 million from $78.2 million in the same period of 2017. Excluding TianXinFu, income from operations for the first half of 2018 decreased by 24.9% in RMB terms, or 19.1% in USD terms, in the first half of 2018 compared to the same period of 2017.

Income tax expense in the first half of 2018 was $13.5 million compared to $13.8 million in the same period of 2017. The effective income tax rate was 15.9% and 16.6% for the first halves of 2018 and 2017, respectively.

Net income attributable to the Company decreased by 8.5% in RMB terms, or 1.3% in USD terms, to $60.2 million in the first half of 2018 from $61.0 million in the same period of 2017. Net margin decreased to 25.9% in the first half of 2018 from 33.8% in the same period of 2017. Diluted earnings per share for the first half of 2018 decreased to $1.75 from $2.15 for the same period of 2017. Excluding TianXinFu, net income attributable to the Company decreased by 22.8% in RMB terms, or 16.8% in USD terms, in the first half of 2018 compared to the same period of 2017, and net margin decreased to 24.4% in the first half of 2018 from 33.8% in the same period of 2017.

Non-GAAP adjusted income from operations decreased by 2.4% in RMB terms, or increased by 5.2% in USD terms, to $99.3 million in the first half of 2018 from $94.4 million in the same period of 2017. Excluding TianXinFu, non-GAAP adjusted income from operations decreased by 18.3% in RMB terms, or 11.9% in USD terms in the first half of 2018 compared to the same period of 2017.

Non-GAAP adjusted net income attributable to the Company decreased by 0.4% in RMB terms, or increased by 7.5% in USD terms, to $81.6 million in the first half of 2018 from $75.9 million in the same period of 2017. Non-GAAP adjusted net income per diluted share decreased to $2.37 in the first half of 2018 from $2.67 in the same period of 2017. Excluding TianXinFu, non-GAAP adjusted net income attributable to the Company decreased by 15.8% in RMB terms, or 9.1% in USD terms, in the first half of 2018 compared to the same period of 2017.

Non-GAAP adjusted income from operations for the first half of 2018 excludes $19.8 million in non-cash employee share-based compensation expenses and $4.6 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

Non-GAAP adjusted net income and diluted earnings per share for the first half of 2018 exclude $18.2 million in non-cash employee share-based compensation expenses and $3.1 million in amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu.

As of June 30, 2018, the Company had $103.3 million in cash on hand and demand deposits, $118.3 million in time deposits, and $144.6 million in financial instruments.

Net cash provided by operating activities for the first half of 2018 was $45.5 million, including an $11.6 million contribution from TianXinFu, compared to $36.9 million for the same period of 2017. Excluding TianXinFu, the $3.0 million decrease in net cash provided by operating activities was a combined result of: 1) the negative impact from a decrease in net income, an increase in accounts receivable, an increase in prepayments and deferred expenses, and decreases in accounts payable and tax payable; and 2) the positive impact from an increase of other payables and accrued liabilities, and a slowdown of increase in inventory compared to the first half of 2017.

Excluding TianXinFu, accounts receivable increased by $30.3 million during the first half of 2018 compared to $26.1 million in the same period of 2017. The accounts receivable turnover days for plasma products increased to 88 days during the first half of 2018 from 51 days in the same period of 2017, reflecting longer credit terms to hospitals as a result of the nationwide healthcare regulation changes and intensified competition in the distributor channel.

Excluding TianXinFu, inventories increased by $20.3 million in the first half of 2018. This is lower than a $22.8 million inventory increase in the same period of 2017, when Shandong Taibang stockpiled inventory to prepare for the planned temporary production suspension.

Excluding TianXinFu, other payables and accrued liabilities increased by $17.9 million in the first half of 2018 compared to a decrease of $2.9 million in the first half of 2017. The increase mainly reflected more marketing activities carried out by third party contract service organizations that the Company engaged to promote its placenta polypeptide and certain plasma products in compliance with the two-invoice policy.

Net cash used in investing activities for the first half of 2018 was $168.9 million compared to $16.6 million for the same period of 2017. Net cash used in investing activities in the first half of 2018 mainly consisted of a $529.6 million payment for the purchase of time deposits and financial instruments and a $19.1 million payment for the acquisition of property, plant, and equipment, intangible assets, and land use rights. This was partly offset by $97.7 million in cash received upon acquisition of TianXinFu and the maturity of $282.1 million in time deposits and financial instruments. In the same period of 2017, the Company paid $16.6 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 half of 2018 was $0.8 million compared to $14.8 million for the same period of 2017. Net cash provided by financing activities in the first half of 2018 represented proceeds of $0.8 million from stock options exercised. Net cash provided by financing activities in the first half of 2017 mainly consisted of $14.3 million in short-term loan net proceeds.

Financial Outlook

The Company is making a downward revision to its full year 2018 forecast. The company expects non-GAAP adjusted income from operations to increase by 0% to 2% in RMB terms and non-GAAP adjusted net income to decrease by 2% to 4% in RMB terms over full year 2017 financial results. Excluding TianXinFu, full year 2018 non-GAAP adjusted income from operations is expected to decrease by 16% to 18% in RMB terms and non-GAAP adjusted net income to decrease by 19% to 21% in RMB terms over full year 2017 financial results.

The full year 2018 forecast was lowered to account for worse-than-expected results for the first half of 2018 and an ongoing challenging outlook in the second half of the year due to the following factors:

persisting regulatory headwinds, which places downward pressure on sales growth;
intensified competition in China’s plasma industry, which continues to drive costs higher and prices lower among plasma product providers in China;
investments in long-term improvements and upgrades to the marketing and sales capabilities, which places additional downward pressure on the bottom line; and
a one-time provision in connection with the new facility project in Guizhou and certain fixed assets among certain non-operating collection stations.
In the interest of increasing transparency, the Company intends to provide future financial outlook using non-GAAP adjusted income from operations and non-GAAP adjusted net income instead of sales. The Company believes that providing a financial outlook using income from operations, while excluding non-GAAP factors such as non-cash employee share-based compensation expenses and amortization expense of intangible assets and land use rights related to the acquisition of TianXinFu, provides greater clarity and understanding of the Company’s operations, especially in light of price surges for polypeptide products and certain hyper-immune products under the two-invoice policy accompanied by proportionately increased selling expenses.

This guidance does not factor in any potential foreign currency translation impact. Having previously adopted an exchange rate of approximately RMB6.76 = $1.00 based on weighted average quarterly exchange rates in 2017 in translating 2017 financial results, the Company expects that the non-GAAP adjusted income from operations and non-GAAP adjusted net income in USD terms in 2018 could be affected by the foreign currency translation impact.

This guidance excludes potential acquisitions, and necessarily assumes no significant adverse product price changes during 2018. This forecast reflects the Company’s current and preliminary views, which are subject to change.

Conference Call

The Company will host a conference call at 7:30 am Eastern Time on August 6, 2018, which is 7:30 pm Beijing Time on August 6, 2018, to discuss its second 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:

852 301 84992

China:

4001 201203

A telephone replay will be available one hour after the conclusion of the conference all through August 13, 2018. The dial-in details are:

US:

1 877 344 7529

International:

1 412 317 0088

Passcode:

10122849

A live and archived webcast of the conference call will be available through the Company’s investor relations website at View Source