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): February 28, 2018  

BEIGENE, LTD.
(Exact Name of Registrant as Specified in Charter)

Cayman Islands001-3768698-1209416
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)

 

c/o Mourant Ozannes Corporate 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))

 

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. [   ]

 
 

Item 2.02. Results of Operations and Financial Condition.

On February 28, 2018, BeiGene, Ltd. (the “Company”) announced its financial results for the three months and year ended December 31, 2017. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K.

Item 8.01. Other Events.

In its press release dated February 28, 2018, the Company also provided an update on fourth quarter 2017 and recent business highlights and expected milestones for 2018. The information in the press release set forth under the headings “Fourth Quarter 2017 and Recent Business Highlights,” “Expected 2018 Milestones” and “Forward-Looking Statements” is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. Description
99.1 Press release issued by BeiGene, Ltd. on February 28, 2018

The portions of the press release incorporated by reference into Item 8.01 of this Current Report on Form 8-K are being filed pursuant to such item. The remaining portions of the press release are being furnished pursuant to Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.


Exhibit Index

 

Exhibit No. Description
99.1 Press release issued by BeiGene, Ltd. on February 28, 2018


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: February 28, 2018By: /s/ Scott A. Samuels        
  Scott A. Samuels
  Senior Vice President, General Counsel
  
EdgarFiling

EXHIBIT 99.1

BeiGene Reports Fourth Quarter and Full Year 2017 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, Feb. 28, 2018 (GLOBE NEWSWIRE) -- BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today reported recent business highlights, anticipated 2018 milestones and financial results for the fourth quarter and full year of 2017.

“We had a transformative year in 2017, highlighted by the collaboration with Celgene Corporation for our anti-PD1 antibody, tislelizumab, expansion of the commercial team in China, and execution on the development plans that we believe will be critical to realizing the potential of our portfolio compounds in China and globally,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. “We have now enrolled more than 2,300 patients and healthy subjects worldwide in clinical trials of our investigational agents as of the end of January 2018 and are on target for our first NDA filings in China later this year.”   

“We also strengthened our balance sheet with an $800 million offering this January. This successful financing will support our efforts to further develop our near-term clinical and pipeline programs, as well as continue to build our  development and commercial capabilities to help maximize our opportunities in the rapidly evolving Chinese oncology market,” continued Mr. Oyler.

Fourth Quarter 2017 and Recent Business Highlights

Clinical Programs:

Zanubrutinib (BGB-3111), an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

Tislelizumab (BGB-A317), an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1 under the collaboration with Celgene Corporation

Pamiparib (BGB-290), an investigational small molecule PARP inhibitor

BGB-A333, an investigational humanized monoclonal antibody against the immune checkpoint receptor ligand PD-L1

Commercial Products

Corporate Development:

Expected 2018 Milestones

Zanubrutinib

Tislelizumab

Pamiparib

Commercial Products

Fourth Quarter and Full Year 2017 Financial Results

Cash, Cash Equivalents, and Short-Term Investments were $837.52 million as of December 31, 2017, compared to $757.44 million at September 30, 2017 and $368.17 million at December 31, 2016. This includes approximately $139.50 million of cash, cash equivalents and short-term investments at December 31, 2017, held by our joint venture, BeiGene Biologics, to build a commercial biologics facility in Guangzhou, China and to fund research and development of biologics drug candidates in China. Cash and cash equivalents as of December 31, 2017 do not include the net proceeds raised in the January 2018 public offering.

Revenue for the fourth quarter and year ended December 31, 2017 was $18.17 million and $238.39 million, respectively, compared to nil and $1.07 million in the same periods in 2016, attributable to product and collaboration revenue under the Celgene collaboration.

Expenses for the fourth quarter and year ended December 31, 2017 were $121.97 million and $336.84 million, respectively, compared to $37.27 million and $118.13 million in the same periods in 2016.

Net Loss for the fourth quarter and year ended December 31, 2017 was $99.28 million and $93.30 million, respectively, compared to a net loss of $37.60 million and $119.22 million in the same periods in 2016.

Financial Summary

Select Consolidated Balance Sheet Data (U.S. GAAP)     
(Amounts in thousands of U.S. Dollars)
(Audited)
     
      
  December 31, 2017 December 31, 2016
Cash, cash equivalents and short‑term investments$837,516$368,174
Working capital 763,509 339,341
Property and equipment, net  62,568 25,977
Total assets  1,046,479 405,813
Total liabilities 362,248 52,906
Noncontrolling interest 14,422 
Total equity$684,231$352,907


Consolidated Statements of Operations (U.S. GAAP)
(Amounts in thousands of U.S. Dollars, except for number of American Depositary Shares (ADSs) and per ADS data)
  
  Three Months Ended
December 31,
(Unaudited)
 Twelve Months Ended
December 31,
(Audited)
  2017 2016 2017 2016
Revenue        
Product revenue, net$15,606$$24,428$
Collaboration revenue 2,568  213,959 1,070
Total revenues 18,174  238,387 1,070
Expenses        
Cost of sales – products (3,030)  (4,974) 
Research and development  (91,340) (28,933) (269,018) (98,033)
Selling, general and administrative  (27,415) (8,337) (62,602) (20,097)
Amortization of intangible assets (187)  (250) 
Total expenses  (121,972) (37,270) (336,844) (118,130)
Loss from operations  (103,798) (37,270) (98,457) (117,060)
Interest (expense) income, net (527) 47 (4,108) 383
Changes in fair value of financial instruments    (1,514)
Gain (loss) on sale of available-for-sale securities 34 (338) 44 (1,415)
Other income (expense), net  9,926 (289) 11,457 443
Loss before income taxes (94,365) (37,850) (91,064) (119,163)
Income tax (expense) benefit (4,915) 252 (2,235) (54)
Net loss$(99,280)$(37,598)$(93,299)$(119,217)
Less: Net loss attributable to noncontrolling interest 43  (194) 
Net loss attributable to BeiGene, Ltd.$(99,323)$(37,598)$(93,105) (119,217)
Net Loss per ADS, basic and diluted$(2.19)$(1.05)$(2.23)$(3.84)
Weighted-average number of ADSs outstanding – basic and diluted 45,402,681 35,663,284 41,783,497 31,047,650
         

 

Consolidated Statements of Comprehensive Income (Loss) (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)
  
  Three Months Ended
December 31,
 (Unaudited)
 Twelve Months Ended
December 31,
 (Audited)
  2017 2016 2017 2016
Net loss$(99,280)$(37,598)$(93,299)$(119,217)
Other comprehensive (loss) income, net of tax of nil:        
Foreign currency translation adjustments (134) (232) 851 (245)
Unrealized holding gain, net (354) 251 (296) 1,108
Comprehensive loss (99,768) (37,579) (92,744) (118,354)
Less: Comprehensive loss attributable to noncontrolling interests 73  (105) 
Comprehensive loss attributable to BeiGene, Ltd.$(99,841)$(37,579)$(92,639)$(118,354)
         

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 900 employees in China, the United States, and Australia, 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. BeiGene markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.i

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 advancement of, and anticipated clinical development, regulatory milestones and commercialization of its drugs and drug candidates, the potential for the Company’s drugs and drug candidates, and the expected milestones under the caption “Expected 2018 Milestones”. 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 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, 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 Contact                         
Lucy Li, Ph.D.
+1 781-801-1800
ir@beigene.com

Media Contact
Liza Heapes 
+ 1 857-302-5663 
media@beigene.com


i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation. GAZYVA® is a registered trademark of Genentech.