Baiji Shenzhou announces its financial results for the first quarter of 2018

BGNE, a biomedical company in the commercial stage, focuses on the development and commercialization of innovative molecular targeting and tumor immune drugs for cancer treatment The company today announced its recent business highlights and financial results for the first quarter of 2018 Mr Ou Lei Qiang, founder, CEO and chairman of Baiji Shenzhou, said: "we continue to carry out new clinical trials for all kinds of cancer patients on a global scale, with significant progress We believe that our in-process treatment program can have a profound impact By the end of March 2018, more than 2300 patients worldwide have been enrolled in more than 30 clinical trials of our drugs under research, and we will submit new drug listing applications in China later this year " Mr oreqiang further commented: "as we look to 2018, we are excited by the current opportunities We hope to be a global leader in the context of major changes in China's regulatory environment In addition, we are also excited by the important addition of the senior leadership team, especially the appointment of Dr Wu Xiaobin as the general manager of China and the president of Baiji Shenzhou " Recent business highlights clinical project: zanubrutinib (bgb-3111), in the research of small molecule Breton tyrosine kinase (Btk) inhibitor, the group of patients who have completed the key phase 2 clinical trial in Chinese patients with Fahrenheit megaglobulinemia (WM) Tislelizumab(BGB-A317), The following clinical trials have been initiated by humanized monoclonal antibody against PD-1 at the immunocheckpoint under study: tislilizumab for global phase 2 clinical trials in patients with relapsed or refractory mature T cell and natural killer (NK) cell lymphoma; and Tislilizumab is used in the global phase 2 clinical trial of previously treated liver cell carcinoma (HCC or liver cancer), which is a solid tumor project cooperated with new base company Pamiparib (bgb-290) presented the preliminary phase 1 clinical data of pamiparib for Chinese ovarian cancer or triple negative breast cancer patients at the 2018 annual meeting of the American Association for cancer research (AACR) held in Chicago Listed products: continue to expand the opportunities for potential Chinese patients to receive Abraxane (nanoparticle albumin combined with paclitaxel) treatment through being included in Jiangsu medical insurance reimbursement drug catalog and Zhejiang major disease insurance; In addition, the market of rimex for first-line adaptation was launched in China after rimex was approved by China food and Drug Administration (CFDA) for the treatment of previously untreated adult multiple myeloma patients who were not suitable for transplantation in combination with dexamethasone Company development: appoint Mr Su Jingshi, former vice chairman of the board of directors and chairman and chief executive officer of Yum! China as the board of directors; appoint Dr Wu Xiaobin as general manager and President of Baiji Shenzhou China; appoint Zhu Yifei as the head of China's joint business operation, sales and market access; and Dr Guillaume Vignon was appointed senior vice president and head of business development It is expected that zanubrutinib, the 2018 milestone event, will publish the updated data of phase 1 clinical trials of WM patients and the safety summary analysis of B-cell lymphoid cancer patients at the annual meeting of European hematology Association (EHA) in Stockholm, Sweden, from June 14 to 17; Publish other clinical phase 1 update data and key clinical trial data in China; submit the first new drug listing application for the indication of mantle cell lymphoma in China; complete the enrollment of global phase 3 clinical trial patients for WM patients in the third quarter of 2018; and To initiate a global phase 3 clinical trial in patients with recurrent / refractory chronic lymphoblastic leukemia (CLL) with ibotinib head to head Tislilizumab publishes the updated data of phase I clinical trials and the data of key clinical trials in China; submits the first new drug application for Hodgkin's lymphoma indications in China; completes the enrollment of phase II critical clinical trials in Chinese patients with urothelial carcinoma; and starts other key clinical trials Pamiparib publishes updated data on Phase 1 clinical trials; launches a global phase 3 clinical trial in the second or third quarter of 2018 in patients with gastric cancer; and launches a phase 3 clinical trial as maintenance treatment in platinum sensitive recurrent ovarian cancer patients in China Listed products continue to expand the coverage of Abraxane ® reimbursement at the local level in China Financial data for the first quarter of 2018 cash, cash equivalents, restricted cash and short-term investments as of March 31, 2018, the company's cash, cash equivalents and short-term investments were $1481.48 million, compared with $837.52 million as of December 31, 2017 This increase is mainly due to the net income of $757.59 million from the public offering in January 2018 Baiji Shenzhou biopharmaceutical Co., Ltd., a 95% joint venture owned by us, holds about US $131.04 million in cash, cash equivalents, restricted cash and short-term investment, which is used for the ongoing construction of a commercial scale biopharmaceutical production base in Guangzhou, China The restricted cash of USD 17.46 million is related to the Guangzhou production base of Baiji Shenzhou, and is deposited in the designated bank account as the guarantee deposit for issuing the letter of credit Operating cash expenditure for the quarter ended March 31, 2018 was $104.5 million, compared with $35.71 million for the same period in 2017 The increase is mainly due to the increase in operating expenses supporting the growth of clinical projects and organizations Capex for the quarter ended March 31, 2018 was $9.7 million, compared with $7.39 million for the same period in 2017 The increase is mainly due to the construction of Guangzhou production base Revenue revenue for the first quarter ended March 31, 2018 was $32.54 million, with no revenue for the same period in 2017 The revenue comes from the product revenue and cooperation revenue brought by the cooperation with NSMC The product revenue comes from the sales of Abraxane ®, Rimage ®, and vaisar ® in China, with the sales revenue of 23.25 million US dollars in the first quarter of 2018 In the first quarter of 2018, the cooperation revenue was 9.29 million US dollars, of which 7.55 million US dollars came from the R & D reimbursement revenue recognized by Xinji and 1.74 million US dollars was the deferred down payment recognized in the first quarter of 2018 In addition, the unsettled receivables of $23.86 million on the balance sheet reflect the R & D reimbursement expenses incurred in the first quarter of 2018 in cooperation with NSMC Expenses as of March 31, 2018, the first quarter expenses were US $143350000, and the same period expenses in 2017 were US $51.54 million, mainly including the following: the first quarter cost of sales was US $4.55 million, and the first quarter of 2017 was zero The cost of sales is related to the cost of acquiring Abraxane ®, Rimage ®, and vaisar ® for distribution in China R & D expenses as of March 31, 2018, the first quarter R & D expenses were $109.7 million and the same period in 2017 was $42.77 million The increase in R & D expenses is mainly due to the increase in the expenditure for the ongoing and later clinical trials and the increase in the staff's remuneration expenditure due to the increase in the number of personnel supporting our clinical projects The increase also includes an advance payment of $10 million to miratitiherapeutics for the authorization of sitravatinib in Asia (excluding Japan), Australia and New Zealand As of March 31, 2018, the first quarter of R & D related share option expense was $12.05 million, compared with $4.53 million in the same period of 2017 The increase is mainly due to the increase in the number of employees and the rise in the stock price SG & A expenses were $28.92 million for the first quarter ended March 31, 2018, compared with $8.77 million for the same period in 2017 The increase in sales, general and administrative expenses is mainly due to the increase in the number of employees, including the inclusion of new base's employees in China after the signing of new base's commercial product license agreement in China, as well as the increase in higher professional service fees and the increasing cost of our growing operational activities As of March 31, 2018, the share option fee related to selling, general and administrative expenses in the first quarter was $5.34 million, compared with $1.46 million in the same period in 2017 The increase is mainly due to the increase in the number of employees and the rise in the stock price Net loss the net loss for the first quarter of 2018 was $105.12 million, or $2.03 per ads, and the net loss for the same period of 2017 was $50.62 million, or $1.27 per ads Financial summary [1] Abraxane ®, rifeme ® and vaisar ® are registered trademarks of new base Pharmaceutical Co., Ltd Source: Baiji Shenzhou