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): May 9, 2018  

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 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 May 9, 2018, BeiGene, Ltd. (the “Company”) announced its financial results for the three months ended March 31, 2018. 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 May 9, 2018, the Company also provided an update on first quarter 2018 and recent business highlights and expected milestones for the remainder of 2018. The information in the press release set forth under the headings “Recent Business Highlights,” “Expected Upcoming Milestones in 2018” 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 May 9, 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 May 9, 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: May 9, 2018 By:  /s/ Scott A. Samuels        
    Scott A. Samuels
    Senior Vice President, General Counsel
   

EXHIBIT 99.1

BeiGene Reports First Quarter 2018 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, May 09, 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 and financial results for the first quarter of 2018.

“We continue to make great progress launching new clinical trials on a global scale for patients with a wide variety of cancers, where we believe our investigational treatments can have a profound impact,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene. “We have now enrolled more than 2,300 patients worldwide in more than 30 clinical trials of our investigational agents as of the end of March 2018 and remain on target for our first NDA filings in China later this year.”

“Given the significantly reformed regulatory environment in China, as well as important additions to our senior leadership team highlighted by the appointment of Dr. Xiaobin Wu as our General Manager of China and President of BeiGene, Ltd., we are excited about our China and global prospects,” continued Mr. Oyler.

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

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

Commercial Products:

Corporate Development:

Expected Upcoming Milestones in 2018

Zanubrutinib

Tislelizumab

         
Pamiparib

Commercial Products

First Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash  and Short-Term Investments  were $1,481.48 million as of March 31, 2018, compared to $837.52 million as of December 31, 2017. The increase was primarily due to net proceeds of $757.59 million raised in a public offering in January 2018. Cash, cash equivalents, restricted cash and short-term investments include approximately $131.04 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics facility under construction in Guangzhou, China. Restricted cash of $17.46 million relates to BeiGene Guangzhou Factory’s secured deposits that are held in designated bank accounts for the issuance of a letter of credit.

Cash used in operations for the quarter ended March 31, 2018 was $104.50 million, compared to $35.71 million for the same period in 2017. The increase was primarily attributable to higher operating expenses in support of our clinical programs and organizational growth. Capital expenditures for the quarter ended March 31, 2018 were $9.70 million, compared to $7.39 million for the same period in 2017. The increase was primarily attributable to the construction of our manufacturing facilities in Guangzhou.

Revenues  for the three months ended March 31, 2018 were $32.54 million, compared to nil in the same period in 2017, attributable to product and collaboration revenue under our collaboration with Celgene.

Expenses for the quarter ended March 31, 2018 were $143.35 million, compared to $51.54 million in the same period 2017, consisting primarily of the following:

Financial Summary

Select Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)

         
    As of
    March 31,    December 31, 
    2018   2017
    (unaudited)   (audited)
             
Cash, cash equivalents, restricted cash and short-term investments   $   1,481,475   $    837,516
Accounts receivable     23,485     29,428
Unbilled receivables     23,862    
Working capital     1,443,806     763,509
Property and equipment, net     76,990     62,568
Total assets     1,708,927     1,046,479
         
Accounts payable     52,719     69,779
Accrued expenses and other payables     55,712     49,598
Shareholder loan     154,551     146,271
Total liabilities     350,205     362,248
Noncontrolling interest     14,341     14,422
Total equity   $   1,358,722   $   684,231
             

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) (unaudited)

           
      Three Months Ended 
      March 31, 
        2018       2017  
                   
Revenues                  
Product revenue, net     $   23,250     $   —  
Collaboration revenue        9,294        —  
Total revenues        32,544        —  
Expenses                  
Cost of sales - product        (4,550 )      —  
Research and development        (109,700 )      (42,773 )
Selling, general and administrative        (28,915 )      (8,769 )
Amortization of intangible assets        (188 )      —  
Total expenses        (143,353 )      (51,542 )
Loss from operations        (110,809 )      (51,542 )
Interest income, net        1,552        186  
Other income, net        729        913  
Loss before income tax expense        (108,528 )      (50,443 )
Income tax benefit (expense)        3,412        (180 )
Net loss        (105,116 )      (50,623 )
Less: net loss attributable to noncontrolling interests        (520 )      —  
Net loss attributable to BeiGene, Ltd.     $   (104,596 )   $   (50,623 )
           
Net loss per ADS, basic and diluted     $   (2.03 )   $   (1.27 )
Weighted-average number of ADSs outstanding – basic and diluted       51,577,739       39,725,977  
                   

Consolidated Statements of Comprehensive Loss (U.S. GAAP)
(Amounts in thousands of U.S. Dollars) (unaudited)

         
    Three Months Ended 
    March 31, 
      2018       2017  
                 
Net loss   $   (105,116 )   $   (50,623 )
Other comprehensive loss, net of tax of nil:        
Foreign currency translation adjustments      272        90  
Unrealized holding gain (loss), net      329        (12 )
Comprehensive loss      (104,515 )      (50,545 )
Less: comprehensive loss attributable to noncontrolling interests      (456 )      —  
Comprehensive loss attributable to BeiGene, Ltd.   $   (104,059 )   $   (50,545 )

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 1,100 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 Upcoming Milestones in 2018”. 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 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.

       
Investor Contact      Media Contact
Lucy Li, Ph.D.     Liza Heapes
+1 781-801-1800     + 1 857-302-5663
ir@beigene.com      media@beigene.com 
       

________________________
i ABRAXANE ® , REVLIMID ® , and VIDAZA ® are registered trademarks of Celgene Corporation.