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 Governance 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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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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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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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share
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BGNE
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The NASDAQ Global Select Market
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Ordinary Shares, par value $0.0001 per share*
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06160
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The Stock Exchange of Hong Kong Limited
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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 May 9, 2019
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Exhibit No.
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Description
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99.1
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BEIGENE, LTD.
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Date: May 9, 2019
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By:
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/s/ Scott A. Samuels
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Name:
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Scott A. Samuels
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Title:
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Senior Vice President, General Counsel
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Exhibit 99.1
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•
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Receive approvals in China for the treatment of patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL);
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•
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Submit an initial New Drug Application (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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Achieve first patient dosing in a Phase 1b trial conducted by MEI Pharma of zanubrutinib in combination with ME-401, an investigational selective oral phosphatidylinositol 3-kinase (PI3K) delta inhibitor;
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•
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Complete enrollment of the Phase 3 trial of zanubrutinib compared to bendamustine plus rituximab in patients with previously untreated CLL or SLL;
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•
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Present data from the non-randomized MYD88WT cohort of the Phase 3 trial in WM;
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•
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Announce top-line results from the randomized cohort of 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 R/R CLL/SLL; data from Phase 1 obinutuzumab combination data in CLL/SLL; 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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•
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Announced Phase 1 long-term exposure data and results from the structural and mechanistic analyses at the American Association for Cancer Research (AACR) Annual Meeting in April 2019; and
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•
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Initiated a Phase 3 front-line trial in China of tislelizumab combined with chemotherapy compared to placebo with chemotherapy in patients with recurrent or metastatic nasopharyngeal cancer.
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•
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Receive NDA approval in China for treatment of patients with R/R classical Hodgkin's lymphoma (cHL);
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•
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Present preliminary results of tislelizumab in Chinese patients with nasopharyngeal cancer at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago May 31 - June 4;
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Exhibit 99.1
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•
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Announce top-line results from the pivotal Phase 2 trial in Asian patients with urothelial carcinoma (UC) and file an NDA for UC in China;
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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 hepatocellular carcinoma (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; and
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•
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Complete or nearly complete enrollment in all four ongoing Phase 3 trials in lung and liver cancers.
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•
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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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•
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Present data from the global Phase 1 trial in patients with ovarian cancer and Phase 1 combination data in patients with solid tumors or glioblastoma multiforme.
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•
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In collaboration with SpringWorks Therapeutics, Inc., initiated a Phase 1b combination trial of lifirafenib in combination with PD-0325901, an investigational MEK inhibitor in patients with advanced or refractory solid tumors that harbor RAS mutations, RAF mutations, and other MAPK pathway aberrations.
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•
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Substantially completed equipment installation and validation of GE Healthcare's KUBio
TM
technology-based biologics manufacturing facility in Guangzhou, China.
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•
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Generated
$57.42 million
in product revenue in the three months ended March 31, 2019, from sales in China of ABRAXANE
®
, REVLIMID
®
and VIDAZA
®
, which represents a
147%
increase
compared to the same period in 2018 and a 52% sequential growth compared to the previous quarter; and
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•
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Received supplementary medical insurance coverage for REVLIMID from Zhuhai, Guangdong province, China.
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•
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Announced a global collaboration agreement with BioAtla, LLC, for the development, manufacturing, and commercialization of BioAtla’s investigational Conditionally Active Biologic (CAB) CTLA-4 antibody (BA3071). BA3071 is a novel, CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors. Subject to regulatory clearance of the Investigational New Drug (IND) application, a Phase 1/2 multi-center, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of BA3071 alone and in combination with tislelizumab is anticipated to start in the second half of 2019; and
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Announced a global research and development collaboration with Ambrx, Inc. to develop next-generation biologics utilizing Ambrx's proprietary Expanded Genetic Code technology platforms designed to allow the efficient incorporation of non-natural amino acids into proteins in both E. Coli (ReCODE
TM
) and CHO cells (EuCODE
TM
) for precision protein engineering.
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•
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The
decrease
of
$171.67 million
in the first quarter of 2019 was primarily due to
$171.98 million
of cash
used in
operating activities,
$29.00 million
of upfront payments made under collaboration agreements, and
$21.83 million
for investments in property, plant and equipment primarily attributable to the build-out of the Guangzhou biologic
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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
$57.42 million
for the
first
quarter ended
March 31, 2019
, compared to
$23.25 million
for the same period in 2018.
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•
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Collaboration revenue totaled
$20.41 million
for the
first
quarter ended
March 31, 2019
, compared to
$9.29 million
for the same period in
2018
.
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•
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Cost of Sales
for the
first
quarter ended
March 31, 2019
were
$15.26 million
, compared to
$4.55 million
in the same period in
2018
. 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
first
quarter ended
March 31, 2019
were
$178.35 million
, compared to
$109.70 million
in the same period in
2018
. 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, and manufacturing costs related to pre-commercial activities and supply. Employee share-based compensation expense also contributed to the overall increase in R&D expenses, and was
$15.77 million
for the
first
quarter ended
March 31, 2019
, compared to
$12.05 million
for the same period in
2018
, due to increased headcount.
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•
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SG&A Expenses
for the
first
quarter ended
March 31, 2019
were
$57.65 million
, compared to
$28.92 million
in the same period in
2018
. 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
$10.62 million
for the
first
quarter ended
March 31, 2019
, compared to
$5.34 million
for the same period in
2018
, due to increased headcount.
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•
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Net Loss
for the
first
quarter ended
March 31, 2019
was
$167.64 million
, or
$0.22
per share, or
$2.81
per American Depositary Share (ADS), compared to
$104.60 million
, or
$0.16
per share, or
$2.03
per ADS in the same period in
2018
.
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Exhibit 99.1
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As of
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March 31,
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December 31,
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2019
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2018
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(unaudited)
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(audited)
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Assets:
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Cash, cash equivalents, restricted cash, and short-term investments
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$
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1,637,550
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$
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1,809,222
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Accounts receivable
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58,976
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41,056
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Unbilled receivables
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6,114
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8,612
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Working capital
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1,557,921
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1,697,390
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Property and equipment, net
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197,806
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157,061
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Total assets
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2,172,232
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2,249,684
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Liabilities and equity:
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Accounts payable
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105,320
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113,283
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Accrued expenses and other payables
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90,737
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100,414
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Bank loan [1]
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86,420
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49,512
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Shareholder loan [2]
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155,174
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148,888
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Total liabilities
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549,553
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496,037
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Noncontrolling interest
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13,910
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14,445
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Total equity
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$
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1,622,679
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$
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1,753,647
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Exhibit 99.1
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Three Months Ended
March 31,
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2019
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2018
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(unaudited)
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Revenue:
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Product revenue, net
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$
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57,421
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$
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23,250
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Collaboration revenue
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20,412
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9,294
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Total revenues
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77,833
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32,544
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Expenses:
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Cost of sales - products
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(15,261
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)
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(4,550
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)
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Research and development
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(178,351
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)
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(109,700
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)
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Selling, general and administrative
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(57,645
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)
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(28,915
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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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(188
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)
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Total expenses
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(251,588
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)
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(143,353
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)
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Loss from operations
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(173,755
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)
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(110,809
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)
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Interest income, net
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4,477
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1,552
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Other income, net
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1,728
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729
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Loss before income taxes
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(167,550
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)
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(108,528
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)
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Income tax (expense) benefit
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(519
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)
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3,412
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Net loss
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(168,069
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)
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(105,116
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)
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Less: Net loss attributable to noncontrolling interest
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(429
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)
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(520
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)
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Net loss attributable to BeiGene, Ltd.
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$
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(167,640
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)
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$
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(104,596
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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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(0.22
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)
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$
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(0.16
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)
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Weighted-average shares outstanding, basic and diluted
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774,750,255
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670,510,605
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Net loss per ADS attributable to BeiGene, Ltd., basic and diluted
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$
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(2.81
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)
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$
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(2.03
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)
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Weighted-average ADSs outstanding, basic and diluted
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59,596,173
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51,577,739
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Exhibit 99.1
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