0001651308-20-000034.txt : 20200325 0001651308-20-000034.hdr.sgml : 20200325 20200325172741 ACCESSION NUMBER: 0001651308-20-000034 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20200325 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200325 DATE AS OF CHANGE: 20200325 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BeiGene, Ltd. CENTRAL INDEX KEY: 0001651308 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 981209416 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37686 FILM NUMBER: 20743290 BUSINESS ADDRESS: STREET 1: C/O MOURANT GOVERNANCE SERVICES (CAYMAN) STREET 2: 94 SOLARIS AVENUE, CAMANA BAY CITY: GRAND CAYMAN STATE: E9 ZIP: KY1-1108 BUSINESS PHONE: 13459494123 MAIL ADDRESS: STREET 1: C/O MOURANT GOVERNANCE SERVICES (CAYMAN) STREET 2: 94 SOLARIS AVENUE, CAMANA BAY CITY: GRAND CAYMAN STATE: E9 ZIP: KY1-1108 8-K 1 a8-kx25mar20.htm 8-K Document
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form 8-K
_________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): March 25, 2020

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)
Cayman Islands
001-37686
98-1209416
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification Number)
c/o Mourant Governance Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of Principal Executive Offices) (Zip Code)
+1 (345) 949-4123
(Registrant's telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)

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:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share
 
BGNE
 
The NASDAQ Global Select Market
Ordinary Shares, par value $0.0001 per share*
 
06160
 
The Stock Exchange of Hong Kong Limited
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o






Item 7.01. Regulation FD Disclosure.

On March 25, 2020, the China National Healthcare Security Administration removed ABRAXANE® from the volume-based procurement list due to the China National Medical Products Administration’s decision to suspend the importation, sales and use of ABRAXANE.

Item 8.01 Other Events.

On March 25, 2020, BeiGene, Ltd. (“BeiGene”) issued a press release announcing that, on March 25, 2020, the China National Medical Products Administration suspended the importation, sales and use of ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene Corporation, a Bristol-Myers Squibb (BMS) company. This suspension is based on inspection findings at BMS’s contract manufacturing facility in the United States. As a result, BeiGene expects a disruption in ABRAXANE supply in China and is working closely with BMS to restore supply as soon as possible, including through BMS’s remediation efforts at the current manufacturing site and application to qualify an alternative manufacturing site for China supply. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.
 
 
 
 
Exhibit No.
 
Description
99.1
 
Press Release titled “BeiGene Announces Supply Update for ABRAXANE® in China,” issued on March 25, 2020
104
 
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL










Exhibit Index
 
 
 
 
Exhibit No.
 
Description
99.1
 
104
 
The cover page from this Current Report on Form 8-K, formatted in Inline XBRL

 



 

 








SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
 
BEIGENE, LTD.
 
 
 
Date: March 25, 2020
By: 
/s/ Scott A. Samuels        
 
Name:
Scott A. Samuels
 
Title:
Senior Vice President, General Counsel













 EX-99.1 2 exhibit991.htm EXHIBIT 99.1 Exhibit

exhibit991image1.jpg


BeiGene Announces Supply Update for ABRAXANE® in China
•
NMPA has suspended the importation, sales and use of ABRAXANE in China supplied by Celgene Corporation, a Bristol-Myers Squibb (BMS) company
•
As the marketing agent for ABRAXANE in China, BeiGene is working with BMS to restore supply in China
BEIJING, China, and CAMBRIDGE, Mass., March 25, 2020 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced that, on March 25, 2020, the China National Medical Products Administration (NMPA) suspended the importation, sales and use of ABRAXANE® (nanoparticle albumin-bound paclitaxel) in China supplied to BeiGene by Celgene Corporation, a Bristol-Myers Squibb (BMS) company. This suspension is based on inspection findings at BMS’s contract manufacturing facility in the United States. As a result, BeiGene expects a disruption in ABRAXANE supply in China and is working closely with BMS to restore supply as soon as possible, including through BMS’s remediation efforts at the current manufacturing site and application to qualify an alternative manufacturing site for China supply.
“As the marketing agent for ABRAXANE in China, we are extremely disappointed by this interruption in drug supply,” said John V. Oyler, Chairman, Co-Founder, and Chief Executive Officer of BeiGene. “At BeiGene, the quality of our medicines is of the utmost importance, and we hold ourselves and our partners to the highest global industry standards. We are working with BMS to determine corrective actions for this situation as quickly as possible. We remain focused on the ongoing launches of our other products in China and the United States and the development of potential new treatments for patients worldwide.”
BeiGene and Celgene, now a BMS company, entered into an exclusive license and supply agreement for ABRAXANE and two other cancer medicines in China in 2017 as part of a broader strategic collaboration. Under the terms of the agreement, BeiGene is responsible for promoting and distributing ABRAXANE in China and BMS is responsible for manufacturing the drug in compliance with regulatory requirements, maintaining the drug registration and import license, and supplying packaged drug product for the China market.
In addition to the ongoing remediation efforts at the current manufacturing site with the contract manufacturer, BMS has applied for NMPA approval to source its supply for the China market from an alternative BMS manufacturing facility for ABRAXANE, which is currently under review.
The NMPA’s findings concerning BMS’s contract manufacturing site do not impact any other products marketed by BeiGene. No other BeiGene products are manufactured at this site.
For information on the manufacturing of ABRAXANE or other BMS inquiries, please contact: media@bms.com or +1 609-252-3345.


exhibit991image1.jpg



About BeiGene
BeiGene is a global, commercial-stage research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 3,500 employees in the United States, China, Australia, and Europe, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. In the United States, BeiGene markets and distributes BRUKINSA™ (zanubrutinib) and in China, the Company markets its anti-PD-1 antibody tislelizumab and markets ABRAXANE® (nanoparticle albumin-bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) under a license from Celgene Logistics Sàrl, a Bristol-Myers Squibb company,1 and plans to market XGEVA® (denosumab) in collaboration with Amgen.2 For more information please visit www.beigene.com.
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 the disruption of ABRAXANE supply in China and efforts to restore supply as soon as possible; and BeiGene’s plans to the continue development and launches of its other products. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the ability of BMS and its contract manufacturer to successfully remediate the existing manufacturing site or of BMS to obtain approval for an alternative site; the NMPA’s inspection of the manufacturing site to be used by BMS; the NMPA’s withdrawal of its suspension or reinstatement of approval to import, sell and use ABRAXANE in China; 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 or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; 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; the impact of the coronavirus on the Company’s clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent annual report on Form 10-K, 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.
1 ABRAXANE® is a registered trademark of Abraxis Bioscience LLC, a Bristol-Myers Squibb company; REVLIMID® and VIDAZA® are registered trademarks of Celgene Corporation, a Bristol-Myers Squibb company.
2 XGEVA® is a registered trademark of Amgen.


exhibit991image1.jpg






Investor Contact
Craig West
+1 857-302-5189
ir@beigene.com
Media Contact
Liza Heapes or Vivian Ni
+1 857-302-5663 or +1 857-302-7596
media@beigene.com



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Cover Document
Mar. 25, 2020
Cover page.  
Document Type 8-K
Document Period End Date Mar. 25, 2020
Entity Registrant Name BEIGENE, LTD.
Entity Incorporation, State or Country Code E9
Entity File Number 001-37686
Entity Tax Identification Number 98-1209416
Entity Address, Street Address c/o Mourant Governance Services (Cayman) Limited
Entity Address, Street Address 2 94 Solaris Avenue, Camana Bay
Entity Address, City or Town Grand Cayman
Entity Address, Postal Zip Code KY1-1108
Entity Address, Country KY
City Area Code 345
Local Phone Number 949-4123
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of each class American Depositary Shares, each representing 13 Ordinary Shares, par value $0.0001 per share
Trading Symbol BGNE
Name of each exchange on which registered NASDAQ
Entity Emerging Growth Company false
Entity Central Index Key 0001651308
Amendment Flag false
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