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): August 8, 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 August 9, 2018, BeiGene, Ltd. (the “Company”) announced its financial results for the three and six months ended June 30, 2018. A copy of the press release is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K.

Item 8.01. Other Events.

Closing of Underwritten Global Offering

On August 8, 2018, the Company issued a press release announcing the closing of its previously announced underwritten global offering of 65,600,000 of its ordinary shares, par value US$0.0001 per share. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Business Updates

In its press release dated August 9, 2018, the Company also provided an update on second quarter 2018 and recent business highlights and expected milestones for the remainder of 2018. The information in the press release attached hereto as Exhibit 99.2 set forth under the headings “Recent Business Highlights and Upcoming 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 August 8, 2018
99.2   Press release issued by BeiGene, Ltd. on August 9, 2018

The portions of Exhibit 99.2 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 Exhibit 99.2 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 August 8, 2018
99.2   Press release issued by BeiGene, Ltd. on August 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: August 9, 2018 By:  /s/ Scott A. Samuels        
    Scott A. Samuels
    Senior Vice President, General Counsel
   

EXHIBIT 99.1

BeiGene Announces Closing of Its HK$7.08 billion (US$903 million) Hong Kong Initial Public Offering and Global Offering

BEIJING, China and CAMBRIDGE, Mass., Aug. 08, 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 announced the closing of its previously announced Hong Kong initial public offering and global offering (the “Offering”) of 65,600,000 ordinary shares, par value $0.0001 per share (the “Shares”), at a public offering price of HK$108.00 per Share.  Based on an assumed exchange rate of HK$7.8478 to US$1.00, the public offering price equates to US$13.76 per Share, or US$178.90 per American Depositary Share (“ADS”).  BeiGene’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol “BGNE” and each ADS represents 13 ordinary shares. The Shares began trading today on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code "06160".

The gross proceeds to BeiGene from the Offering, before deducting underwriting discounts and commissions and other offering expenses, are approximately HK$7.08 billion, or approximately US$903 million.   In addition, BeiGene has granted the joint global coordinators a 30-day option to purchase up to an additional 9,840,000 Shares at the public offering price, less underwriting discounts and commissions.

BeiGene intends to use net proceeds from the Offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates (zanubrutinib, tislelizumab, and pamiparib), as well as to fund continued expansion of its product portfolio in cancer and potentially other therapeutic areas, and for working capital, expanding internal capabilities, and general corporate purposes.

Morgan Stanley & Co. International plc, Goldman Sachs (Asia) L.L.C., Credit Suisse (Hong Kong) Limited and CLSA Limited acted as joint global coordinators, joint bookrunners and joint lead managers for the Global Offering.  China International Capital Corporation Hong Kong Securities Limited, Deutsche Bank AG, Hong Kong Branch, UBS AG Hong Kong Branch acted as joint bookrunners and joint lead managers. China Renaissance Securities (Hong Kong) Limited acted as joint lead manager.

Sales of Shares outside of Hong Kong, initially offered in the United States and sold outside the United States that may be resold from time to time in the United States, are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the “SEC”). The final prospectus supplement relating to and describing the terms of the Offering was filed with the SEC on August 3, 2018 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from the offices of Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, or email:prospectus-ny@ny.email.gs.com; and Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, New York 10010, or by email at newyork.prospectus@credit-suisse.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

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 1,300 employees in China, the United States, Australia, and Switzerland, 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 ® (azaciditine) in China under a license from Celgene Corporation. 1

Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to BeiGene’s expectations regarding the use of proceeds from the Offering and its research and development activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by BeiGene is contained or incorporated by reference in the final prospectus supplement related to the Offering filed with the SEC. BeiGene disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Investor Contact
Lucy Li, Ph.D.
+1 781-801-1800 
ir@beigene.com 

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

_______________________________

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

Exhibit 99.2

BeiGene Reports Second Quarter 2018 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, Aug. 09, 2018 (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 reported recent business highlights and financial results for the second quarter and first half of 2018.

“We continued to make excellent progress with encouraging new clinical data, including initial topline data from pivotal trials for our lead drug candidates, zanubrutinib and tislelizumab,” said John V. Oyler, Founder, Chief Executive Officer and Chairman of BeiGene. “We have also continued to expand our clinical programs and have now enrolled more than 3,000 patients worldwide in over 50 ongoing or planned clinical trials, including 17 pivotal or potentially registration-enabling trials of our drug candidates, with two new Phase 3 trials in China of tislelizumab in first-line non-small cell lung cancer having recently initiated. We are on track to submit new drug applications for zanubrutinib and tislelizumab in China this year and are planning to accelerate the U.S. NDA filing of zanubrutinib by seeking accelerated approval.”

“Our commercial organization in China is expanding its footprint to prepare for potential new product launches, and we have seen good growth of our commercial product revenue in China since the transition of these products to BeiGene since last September,” said Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd.

Recent Business Highlights and Upcoming Milestones

Clinical Programs

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

Expected Upcoming Milestones in 2018

Tislelizumab (BGB-A317) ,   an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

Expected Upcoming Milestones in 2018

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

Expected Upcoming Milestones in 2018

Sitravatinib, an investigational tyrosine kinase inhibitor of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET; licensed from Mirati Therapeutics in Asia (excluding Japan), Australia, and New Zealand

Expected Upcoming Milestones

BGB-A425, an investigational humanized monoclonal antibody against T-cell immunoglobulin and mucin-domain containing-3 (TIM-3)

Expected Upcoming Milestones in 2018

Commercial Programs

Corporate Developments

Second Quarter 2018 Financial Results

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments  were $1,401.22 million as of June 30, 2018, compared to $1,481.48 million as of March 31, 2018 and $837.52 million at December 31, 2017. Cash, cash equivalents, restricted cash and short-term investments as of June 30, 2018 include approximately $145.28 million held by our 95%-owned joint venture, BeiGene Biologics, to build a commercial biologics manufacturing facility under construction in Guangzhou, China, and restricted cash of $31.59 million related to BeiGene Biologics’ secured deposits. In the quarter, BeiGene Biologics received $42.32 million in proceeds from a new long-term loan with China Construction Bank for the continued construction of the manufacturing facility.

Cash used by operations for the three months ended June 30, 2018 was $117.14 million, compared to $51.89 million for the same period in 2017. The increase in the use of cash was primarily attributable to the continued ramp-up in operating expenses in support of our ongoing and newly initiated late-stage pivotal clinical programs, preparation for regulatory filings and commercial launch of our late-stage drug candidates, and organizational growth. Capital expenditures for the three months ended June 30, 2018 were $10.61 million, compared to $13.62 million for the same period in 2017. The decrease was primarily attributable to the purchase in the prior year period of the land use right in Guangzhou.

Revenue  for the three months ended June 30, 2018 were $52.80 million, compared to nil in the same period in 2017, primarily attributable to product and collaboration revenue under our collaboration with Celgene.

Expenses for the three months ended June 30, 2018 were $215.85 million, compared to $58.02 million in the same period in 2017, consisting primarily of the following:

Financial Summary

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

           
    As of  
    June 30,    December 31,   
      2018     2017  
    (unaudited)   (audited)  
       
Cash, cash equivalents, restricted cash and short-term investments   $   1,401,219   $   837,516  
Accounts receivable     33,171     29,428  
Unbilled receivables     12,702      
Working capital     1,330,272     763,509  
Property and equipment, net     90,510     62,568  
Total assets     1,653,856     1,046,479  
           
Accounts payable     85,878     69,779  
Accrued expenses and other payables     75,037     49,598  
Bank loan [1]     60,534     18,444  
Shareholder loan [1]     149,217     146,271  
Total liabilities     427,188     362,248  
Noncontrolling interest     13,471     14,422  
Total equity   $   1,226,668   $   684,231  

[1]     The bank loan and shareholder loan balances attributable to BeiGene Biologics, a joint venture that is 95% owned by BeiGene, Ltd, totaled $42.40 million and $149.22 million, respectively, as of June 30, 2018.

Condensed 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
June 30,
  Six Months Ended
June 30,
    2018     2017     2018     2017  
Revenue                
Product revenue, net $ 31,426   $   $ 54,676   $  
Collaboration revenue   21,378         30,672      
Total revenues   52,804         85,348      
Expenses:                
Cost of sales – products   (6,256 )       (10,806 )    
Research and development   (164,251 )   (47,245 )   (273,951 )   (90,018 )
Selling, general and administrative   (45,160 )   (10,777 )   (74,075 )   (19,546 )
Amortization of intangible assets   (187 )       (375 )    
Total expenses   (215,854 )   (58,022 )   (359,207 )   (109,564 )
Loss from operations   (163,050 )   (58,022 )   (273,859 )   (109,564 )
Interest income (expense), net   1,892     (1,982 )   3,444     (1,796 )
Other income (expense), net   75     (475 )   804     438  
Loss before income taxes   (161,083 )   (60,479 )   (269,611 )   (110,922 )
Income tax (expense) benefit   3,368     (201 )   6,780     (381 )
Net loss $ (157,715 ) $ (60,680 ) $ (262,831 ) $ (111,303 )
Less: Net loss attributable to noncontrolling interest   (828 )   (135 )   (1,348 )   (135 )
Net loss attributable to BeiGene, Ltd. $ (156,887 ) $ (60,545 ) $ (261,483 ) $ (111,168 )
Net loss attributable to BeiGene, Ltd. per ADS, basic and diluted $ (2.92 ) $ (1.52 ) $ (4.97 ) $ (2.80 )
Weighted-average ADSs outstanding, basic and diluted   53,731,299     39,820,287     52,660,468     39,773,393  
Net loss per share attributable to BeiGene, Ltd.                
basic and diluted   (0.22 )   (0.12 )   (0.38 )   (0.22 )
Weighted-average ordinary shares outstanding, basic and diluted   698,506,891     517,663,736     684,586,086     517,054,109  


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

   
  Three Months Ended
June 30,
Six Months Ended
June 30,
    2018     2017     2018     2017  
Net loss $ (157,715 ) $ (60,680 ) $ (262,831 ) $ (111,303 )
Other comprehensive loss, net of tax of nil:                
Foreign currency translation adjustments   2,033     554     2,305     644  
Unrealized holding gain, net   719     19     1,048     7  
Comprehensive loss   (154,963 )   (60,107 )   (259,478 )   (110,652 )
Less: Comprehensive loss attributable to noncontrolling interests   (870 )   (108 )   (1,326 )   (108 )
Comprehensive loss $ (154,093 ) $ (59,999 ) $ (258,152 ) $ (110,544 )

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 1,300 employees in China, the United States, Australia and Switzerland, 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 the encouraging clinical data for BeiGene’s product candidates and product revenue for its products; the advancement of and anticipated clinical development and regulatory milestones for its product candidates; and the expected milestones under the caption “Recent Business Highlights and Upcoming 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.