Cayman Islands
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001-37686
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98-1209416
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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification Number)
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c/o Mourant Ozannes Corporate Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
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(Address of Principal Executive Offices) (Zip Code)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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[ ]
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Exhibit No.
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Description
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99.1
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Press release issued by BeiGene, Ltd. on February 27, 2019
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99.2
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BeiGene, Ltd. presentation dated February 27-28, 2019
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Exhibit No.
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Description
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99.1
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99.2
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BEIGENE, LTD.
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Date: February 27, 2019
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By:
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/s/ Scott A. Samuels
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Scott A. Samuels
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Senior Vice President, General Counsel
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Exhibit 99.1
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•
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Received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy;
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•
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Granted priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA, formerly known as CFDA) to new drug applications (NDAs) for the treatment of patients with relapsed or refractory (R/R) MCL and with R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL);
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•
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Presented full results of the pivotal Phase 2 trial in Chinese patients with R/R MCL in an oral presentation at the 60th American Society of Hematology (ASH) Annual Meeting;
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•
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Presented updated data from a global Phase 1 trial in patients with MCL at the ASH Annual Meeting;
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•
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Completed enrollment of a significantly expanded cohort 2, of 110 previously untreated patients with 17p deletion in the Phase 3 trial in first-line CLL/SLL; and
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•
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Initiated a global Phase 2 trial in patients with R/R marginal zone lymphoma (MZL).
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•
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Receive approvals in China for the treatment of patients with R/R MCL and R/R CLL/SLL;
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•
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Submit an initial NDA for zanubrutinib in the U.S. in 2019 or early 2020;
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•
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Announce top-line results from the pivotal Phase 2 trial in Chinese patients with Waldenström macroglobulinemia (WM) and submit an NDA in China for WM;
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•
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Announce top-line results from the Phase 3 trial comparing zanubrutinib to ibrutinib in patients with WM; and
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•
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Present updated data from the global Phase 1 trial in WM and MCL; pivotal data from the China Phase 2 trials in R/R MCL and CLL/SLL; Phase 1 obinutuzumab combination data in CLL/SLL; data from the MYD88WT cohort of the Phase 3 WM trial; updated data from the Phase 1 obinutuzumab combination trial in non-Hodgkin’s lymphoma (NHL); and updated data from the global Phase 1 trial in CLL/SLL.
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Exhibit 99.1
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•
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Granted priority review by the CDE of NMPA to our NDA for the treatment of patients with R/R classical Hodgkin’s lymphoma (cHL);
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•
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Presented data from the pivotal Phase 2 trial of tislelizumab in Chinese patients with R/R cHL in an oral session at the ASH Annual Meeting;
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•
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Presented updated data from Phase 1 trial expansion cohorts in patients with urothelial carcinoma, esophageal, gastric, hepatocellular, and non-small cell lung cancers at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) congress;
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•
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Presented Phase 2 clinical results in esophageal squamous cell carcinoma (ESCC) and gastric cancer (GC) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI);
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•
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Completed enrollment of the global Phase 2 trial in second- or third-line patients with hepatocellular carcinoma (HCC); and
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•
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Initiated the following clinical trials:
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◦
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A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line advanced gastric or gastroesophageal junction adenocarcinoma; and
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◦
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A global Phase 3 trial of tislelizumab in combination with chemotherapy in patients with front-line, locally advanced recurrent or metastatic ESCC.
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•
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Receive NDA approval in China for treatment of patients with R/R cHL;
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•
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Announce top-line results from the pivotal Phase 2 trial in Chinese and Korean patients with PD-L1 positive urothelial bladder cancer (UBC) and submit an NDA in China for UBC;
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•
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Announce top-line results from the global Phase 2 trial in second- or third-line patients with HCC and have regulatory discussions;
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•
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Present updated China pivotal Phase 2 data in R/R cHL; updated Phase 2 chemotherapy combination data; and Phase 1 data from China trials;
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•
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Complete or close to completing enrollment in all four ongoing Phase 3 trials in lung and liver cancers; and
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•
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Initiate additional pivotal solid tumor trials.
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•
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Presented preliminary Phase 1/2 trial data of pamiparib in combination with radiation therapy and/or temozolomide in patients with newly diagnosed or R/R glioblastoma in an oral presentation at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO); and
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•
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Initiated a global Phase 2 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination deficiency (HRD).
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Announce top-line results from the pivotal Phase 2 trial in Chinese patients with previously treated ovarian cancer in late 2019 or early 2020; and
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Present data in patients with ovarian cancer from the global Phase 1 trial and updated Phase 1 combination data.
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Exhibit 99.1
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•
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Expanded Phase 1 combination trial with tislelizumab in China and Australia to a total of five advanced solid tumors including non-small cell lung cancer, renal cell carcinoma, ovarian cancer, HCC, and GC.
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•
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Initiated a global Phase 1 trial in combination with tislelizumab.
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•
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Substantially completed physical construction of the commercial-scale biologics manufacturing facility in Guangzhou, China, with four 2,000 liter KUBio bioreactors installed.
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•
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Complete Phase 1 construction of the Guangzhou manufacturing facility, with expanded capacity to follow, to support the manufacturing of tislelizumab and other potential drug candidates in the pipeline.
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•
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Generated
$37.76 million
and
$130.89 million
in product revenue in the fourth quarter and year ended December 31, 2018, respectively, from sales in China of ABRAXANE
®
, REVLIMID
®
and VIDAZA
®
, which represents a
142%
increase
and a
436%
increase
, respectively, compared to the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgene transaction closed on August 31, 2017); and
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•
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In support of the planned commercial launch of zanubrutinib in the United States, the Company made key hires in sales and marketing, market access, commercial operations, and business analytics. In China, the Company more than quadrupled the size of its commercial team since September 2017.
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•
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Announced license and collaboration agreements with Zymeworks Inc., under which BeiGene acquired exclusive development and commercial rights in Asia-Pacific for Zymeworks’ HER2-targeted therapeutic candidates ZW25 and ZW49, and a research and license agreement under which BeiGene acquired rights to internally develop and commercialize globally up to three other bispecific antibodies using Zymeworks’ Azymetric™ and EFECT™ platforms; and
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•
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Appointed Dr. Yong (Ben) Ben as Chief Medical Officer, Immuno-Oncology. Dr. Ben has extensive experience in immuno-oncology and early- to late-stage drug development, with multiple successful NDAs and biologics license applications (BLAs), including most recently the approval of PD-L1 immunotherapy IMFINZI
®
(durvalumab) for the treatment of certain patients with locally advanced or metastatic urothelial cancer. Prior to joining BeiGene, he served most recently as chief medical officer of BioAtla, and previously worked at other pharmaceutical companies, including AstraZeneca, Millennium Pharmaceuticals, and Pfizer.
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•
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The
decrease
of
$291.85 million
in the fourth quarter of 2018 was primarily due to
$193.89 million
of cash
used in
operating activities, a $60 million upfront payment made to Zymeworks under our collaboration agreement,
$23.25 million
for investments in property, plant and equipment, and the payment of the remaining
$30.35 million
acquisition cost for our research, development, and office facility in Changping, Beijing, China.
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•
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The
increase
of
$971.71 million
from the prior year period was primarily due to net proceeds received from our global follow-on offering and initial listing on the Hong Kong Stock Exchange of
$869.71 million
in August 2018 and net proceeds from our follow-on offering on the NASDAQ of
$757.59 million
in January 2018. These net proceeds were partially offset by
$547.72 million
of cash
used in
operating activities, $70 million in upfront payments related to the Zymeworks and Mirati collaboration agreements, investments in property, plant and equipment totaling
$70.28 million
and primarily attributable to the build-out of our Guangzhou biologics manufacturing facility, and
$38.30 million
of
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Exhibit 99.1
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•
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Product revenue from sales of ABRAXANE
®
, REVLIMID
®
and VIDAZA
®
in China totaled
$37.76 million
and
$130.89 million
for the fourth quarter and year ended December 31, 2018, respectively, compared to $15.61 million and $24.43 million for the same periods in 2017 (2017 revenue was from the last four months of the year after the Celgene transaction closed on August 31, 2017).
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•
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Collaboration revenue totaled
$20.91 million
and
$67.34 million
for the fourth quarter and year ended December 31, 2018, respectively, compared to $2.57 million and $213.96 million for the same periods in 2017.
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•
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Cost of sales
for the fourth quarter and year ended December 31, 2018 were
$9.19 million
and
$28.71 million
, respectively, compared to $3.03 million and $4.97 million in the same periods in 2017 (the full year period in 2017 included only the last four months of the year after the Celgene deal closed on August 31, 2017). Cost of sales related to the cost of acquiring ABRAXANE
®
, REVLIMID
®
and VIDAZA
®
for distribution in China.
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•
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R&D Expenses
for the fourth quarter and year ended December 31, 2018 were
$257.46 million
and
$679.01 million
, respectively, compared to $91.34 million and $269.02 million in the same periods in 2017. The increase in R&D expenses was primarily attributable to increased spending on our ongoing and newly initiated late-stage pivotal clinical trials, preparation for regulatory submissions and commercial launch of our late-stage drug candidates, manufacturing costs related to pre-commercial activities and supply, as well as increases in spending related to our preclinical-stage programs. Also contributing to the fourth quarter and year-over-year increases were expenses for in-process research and development collaborations, which totaled $79 million in the fourth quarter of 2018 (including $60 million related to the Zymeworks collaboration and $19 million related to the termination of the Merck pamiparib collaboration) and $89 million (inclusive of the $10 million related to the Mirati collaboration) for the year ended December 31, 2018. We did not have any in-process research and development expense from collaborations in the fourth quarter or year ended December 31, 2017. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was
$16.09 million
and
$54.38 million
for the fourth quarter and year ended December 31, 2018, respectively, compared to $10.95 million and $30.61 million for the same periods in 2017, due to increased headcount and a higher share price.
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•
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SG&A Expenses
for the fourth quarter and year ended December 31, 2018 were
$72.49 million
and
$195.39 million
, respectively, compared to $27.42 million and $62.60 million in the same periods in 2017. The increase in SG&A expenses was primarily attributable to increased headcount, including the expansion of our commercial team to support the distribution of our commercial products in China and the potential launches of our late-stage drug candidates, as well as higher professional service fees and costs to support our growing operations. The overall increase in SG&A expenses was also attributable to higher SG&A-related share-based compensation expense, which was
$9.87 million
and
$32.74 million
for the fourth quarter and year ended December 31, 2018, respectively, compared to $5.51 million and $12.25 million for the same periods in 2017, due to increased headcount and a higher share price.
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•
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Net Loss
for the fourth quarter and year ended December 31, 2018 was
$268.26 million
and
$673.77 million
, or
$0.35
and
$0.93
per share, or
$4.52
and
$12.15
per American Depositary Share (ADS), respectively, compared to $99.32 million and $93.11 million, or $0.17 and $0.17 per share, or $2.19 and $2.23 per ADS, respectively, in the same periods in 2017.
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Exhibit 99.1
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Exhibit 99.1
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As of
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December 31,
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December 31,
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2018
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2017
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Assets:
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Cash, cash equivalents, restricted cash and short-term investments
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$
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1,809,222
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$ 837,516
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Accounts receivable
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41,056
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29,428
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Unbilled receivables
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8,612
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—
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Working capital
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1,697,390
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763,509
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Property and equipment, net
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157,061
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62,568
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Total assets
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2,249,684
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1,046,479
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Liabilities and equity:
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Accounts payable
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113,283
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69,779
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Accrued expenses and other payables
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100,414
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49,598
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Bank loan [1]
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49,512
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18,444
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Shareholder loan [2]
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148,888
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146,271
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Total liabilities
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496,037
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362,248
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Noncontrolling interest
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14,445
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14,422
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Total equity
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$
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1,753,647
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$ 684,231
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Exhibit 99.1
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Three Months Ended
December 31,
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Twelve Months Ended
December 31,
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2018
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2017
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2018
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2017
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(unaudited)
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(audited)
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Revenue:
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Product revenue, net
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$
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37,762
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$
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15,606
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$
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130,885
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$
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24,428
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Collaboration revenue
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20,908
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2,568
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67,335
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213,959
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Total revenues
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58,670
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18,174
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198,220
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238,387
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Expenses:
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||||||||
Cost of sales - products
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(9,193
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)
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(3,030
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)
|
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(28,705
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)
|
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(4,974
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)
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||||
Research and development [1]
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(257,464
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)
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(91,340
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)
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(679,005
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)
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(269,018
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)
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Selling, general and administrative
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(72,490
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)
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(27,415
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)
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(195,385
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)
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(62,602
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)
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Amortization of intangible assets
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(331
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)
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(187
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)
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(894
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)
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(250
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)
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Total expenses
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(339,478
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)
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(121,972
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)
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(903,989
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)
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(336,844
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)
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||||
Loss from operations
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(280,808
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)
|
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(103,798
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)
|
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(705,769
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)
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(98,457
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)
|
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Interest income (expense), net
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5,950
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(527
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)
|
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13,947
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(4,108
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)
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||||
Other (expense) income, net
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(396
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)
|
|
9,960
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|
1,993
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|
|
11,501
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||||
Loss before income taxes
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(275,254
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)
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(94,365
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)
|
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(689,829
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)
|
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(91,064
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)
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Income tax benefit (expense)
|
8,544
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(4,915
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)
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15,796
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(2,235
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)
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||||
Net loss
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(266,710
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)
|
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(99,280
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)
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(674,033
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)
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(93,299
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)
|
||||
Less: Net income (loss) attributable to noncontrolling interest
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1,545
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|
43
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(264
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)
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(194
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)
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Net loss attributable to BeiGene, Ltd.
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$
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(268,255
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)
|
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$
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(99,323
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)
|
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$
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(673,769
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)
|
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$
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(93,105
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)
|
|
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|
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||||||||
Net loss per share attributable to BeiGene, Ltd., basic and diluted
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$
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(0.35
|
)
|
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$
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(0.17
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)
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$
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(0.93
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)
|
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$
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(0.17
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)
|
Weighted-average shares outstanding, basic and diluted
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771,982,215
|
|
|
590,234,853
|
|
|
720,753,819
|
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543,185,460
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||||
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||||||||
Net loss per ADS attributable to BeiGene, Ltd., basic and diluted
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$
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(4.52
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)
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$
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(2.19
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)
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$
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(12.15
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)
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$
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(2.23
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)
|
Weighted-average ADSs outstanding, basic and diluted
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59,383,247
|
|
|
45,402,681
|
|
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55,442,601
|
|
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41,783,497
|
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Exhibit 99.1
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