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BeiGene Reports Fourth Quarter and Full Year 2016 Financial ResultsCAMBRIDGE, Mass., March 22, 2017 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE) a clinical-stage biopharmaceutical company developing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today reported business highlights and financial results for the fourth quarter and full year of 2016. “2016 was a year of substantial progress and growth for our company,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene, “We significantly advanced our portfolio of four clinical-stage assets, and our clinical trials together have enrolled nearly 1,000 patients. We have initiated three global combination studies, and, in China, all four of our compounds have entered the clinic. We recently reached a significant milestone—the initiation of pivotal programs with our BTK inhibitor BGB-3111 both globally and in China.” “In 2016, we made key executive hires and significantly expanded our global clinical development capabilities. We strengthened our balance sheet with a $199 million follow-on public offering in November. We recently entered into a joint venture agreement with the Guangzhou Development District that provides more than RMB2 billion ($300 million) for building a commercial biologics manufacturing facility as well as for funding research and development of our biologic drug candidates in China. In 2017, we look forward to sharing updated data from multiple clinical programs, including more mature data from our monotherapy studies and initial data from our combination studies, and initiating additional registrational trials of our portfolio compounds,” commented Mr. Oyler. 2016 and Recent Business Highlights Clinical Programs: In total, over 980 patients were enrolled as of March 20, 2017 across four clinical programs, including combination trials. BGB-3111, a potent and highly selective small molecule inhibitor of Bruton’s tyrosine kinase (BTK)
BGB-A317, an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1
BGB-290, a potent and highly selective PARP inhibitor
BGB-283, a novel RAF dimer inhibitor that targets both BRAF- and RAS-mutated cancers
Corporate Development:
Expected Upcoming Milestones BGB-3111 (BTK Inhibitor)
BGB-A317 (PD-1 Antibody)
BGB-290 (PARP Inhibitor)
BGB-283 (RAF Dimer Inhibitor)
Fourth Quarter and Full Year 2016 Financial Results Cash, Cash Equivalents, and Short-term Investments were $368.17 million as of December 31, 2016, compared to $100.49 million as of December 31, 2015. The increase reflects proceeds received from our initial public offering (IPO) in the first quarter of 2016 and a follow-on public offering in the fourth quarter of 2016 partially offset by cash used in operating activities for the twelve months ended December 31, 2016. The cash used in operations for the quarter and year ended December 31, 2016 was $26.14 million and $89.51 million, respectively, as compared to $16.76 million and $39.84 million, respectively, for the same periods in 2015. The increase was primarily attributable to higher operating expense. Capital expenditure for the quarter and year ended December 31, 2016 was $8.06 million and $23.50 million, respectively, as compared to $3.42 million and $5.31 million, respectively, for the same periods in 2015. The increase was primarily attributable to the construction of the manufacturing facility in Suzhou. In February 2016, BeiGene completed its IPO of 7,590,000 American Depositary Shares (“ADSs”) at $24.00 per ADS on the NASDAQ stock exchange. Net proceeds were $166.20 million after underwriting discounts and offering expenses. In addition, Merck Sharp & Dohme Research GmBH, an affiliate of Merck & Co., elected to exchange a senior promissory note of $14.69 million including principle and accrued interest for BeiGene’s ordinary shares at the per share IPO price. In November 2016, BeiGene completed a follow-on public offering of 6,250,000 ADSs plus an over-allotment of 850,000 ADSs, including 6,631,250 ADSs offered by BeiGene and 468,750 ADSs offered by certain selling shareholders, at a price of $32.00 per ADS. Net proceeds were $198.63 million after underwriting discounts and offering expenses. Revenue for the three and twelve months ended December 31, 2016 was nil and $1.07 million, respectively, compared to $4.68 million and $8.82 million in the same periods in 2015. Changes in revenue are primarily attributable to a decrease of revenue recognized for BGB-283 and revenue that was no longer being recognized for BGB-290 in 2016 after we repurchased the ex-PRC rights from Merck KGaA, Darmstadt Germany in October 2015. Research & Development (R&D) Expenses for the three and twelve months ended December 31, 2016 were $28.93 million and $98.03 million, respectively, compared to $28.10 million and $58.25 million in the same periods in 2015. The increase in R&D expenses was primarily attributable to increased spending on clinical activities for BGB-3111, BGB-A317, and BGB-283, due to expansion of ongoing clinical programs, start-up activities for registration trials and increased employee compensation as a result of increased headcount to support growing clinical studies. In addition, R&D-associated stock option expenses were $2.90 million and $8.08 million for the three and twelve months ended December 31, 2016, respectively, compared to $1.83 million and $9.59 million for the same periods in 2015. General & Administrative (G&A) Expenses for the three and twelve months ended December 31, 2016 were $8.34 million and $20.10 million, respectively, compared to $2.95 million and $7.31 million in the same periods in 2015. The increase in G&A expenses was primarily attributable to increased employee compensation including share-based compensation as a result of increased headcount and higher professional service fees to support growing operations. In addition, G&A-associated stock option expenses were $1.05 million and $2.55 million for the three and twelve months ended December 31, 2016, respectively, compared to $0.34 million and $0.62 million for the same periods in 2015. Net Loss for the three and twelve months ended December 31, 2016 were $37.60 million and $119.22 million, respectively, compared to $27.25 million and $57.10 million in the same periods in 2015. Financial Summary:
About BeiGene BeiGene is a global, clinical-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 300 scientists, clinicians and staff in mainland China, the United States, Australia and Taiwan, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s financial condition; results of operations and business outlook; the sufficiency of its cash, cash equivalents and short-term investments; the joint venture with the Guangzhou Development District and any related anticipated funding for building a manufacturing facility and clinical development; momentum of its product pipeline as well as the advancement of, and anticipated clinical development and regulatory milestones and plans related to BeiGene’s drug candidates and clinical trials, including commencing registration and combination trials and providing data readouts and updates for its clinical candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. Investor/Media Contact Lucy Li, Ph.D. +1 781-801-1800 [email protected] [email protected] |