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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________________________
FORM 10-Q
___________________________________________________________
(Mark One)
| | | | | |
☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2020
OR
| | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number: 001-37686
___________________________________________________________
BEIGENE, LTD.
(Exact name of registrant as specified in its charter)
___________________________________________________________
| | | | | |
Cayman Islands | 98-1209416 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| |
c/o Mourant Governance Services (Cayman) Limited | |
94 Solaris Avenue, Camana Bay | |
Grand Cayman | |
Cayman Islands | KY1-1108 |
(Address of principal executive offices) | (Zip Code) |
+1 (345) 949-4123
(Registrant's telephone number, including area code)
| | | | | | | | | | | | | | |
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.
As of July 31, 2020, 1,176,415,671 ordinary shares, par value $0.0001 per share, were outstanding, of which 965,069,391 ordinary shares were held in the form of 74,236,107 American Depositary Shares, each representing 13 ordinary shares.
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports); and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| | | | | | | | | | | | | | |
Large accelerated filer | ☒ | | Accelerated filer | ☐ |
Non-accelerated filer | ☐ | | Smaller reporting company | ☐ |
| | | Emerging growth company | ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
BeiGene, Ltd.
Quarterly Report on Form 10-Q
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
BEIGENE, LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
| | | | | | | | | | | | | | | | | | | | |
| | | | As of | | |
| | | | June 30, | | December 31, |
| | Note | | 2020 | | 2019 |
| | | | $ | | $ |
| | | | (unaudited) | | (audited) |
Assets | | | | | | |
Current assets: | | | | | | |
Cash and cash equivalents | | | | 1,345,014 | | | 618,011 | |
Short-term restricted cash | | 4 | | 283 | | | 288 | |
Short-term investments | | 4 | | 1,807,744 | | | 364,728 | |
Accounts receivable, net | | 10 | | 61,663 | | | 70,878 | |
Inventories | | 5 | | 33,234 | | | 28,553 | |
Prepaid expenses and other current assets | | 10 | | 144,466 | | | 90,238 | |
Total current assets | | | | 3,392,404 | | | 1,172,696 | |
Long-term restricted cash | | 4 | | 4,602 | | | 2,476 | |
Property, plant and equipment, net | | 6 | | 258,106 | | | 242,402 | |
Operating lease right-of-use assets | | | | 90,620 | | | 82,520 | |
Intangible assets, net | | 8 | | 5,375 | | | 5,846 | |
Deferred tax assets | | 9 | | 39,801 | | | 37,894 | |
Other non-current assets | | 10 | | 112,382 | | | 68,455 | |
Total non-current assets | | | | 510,886 | | | 439,593 | |
Total assets | | | | 3,903,290 | | | 1,612,289 | |
Liabilities and shareholders' equity | | | | | | |
Current liabilities: | | | | | | |
Accounts payable | | | | 157,173 | | | 122,488 | |
Accrued expenses and other payables | | 10 | | 207,921 | | | 163,556 | |
Tax payable | | 9 | | 10,448 | | | 13,454 | |
Operating lease liabilities, current portion | | | | 12,888 | | | 10,814 | |
Research and development cost share liability, current portion | | 3 | | 136,704 | | | — | |
Short-term bank loans | | 11 | | 26,061 | | | — | |
Total current liabilities | | | | 551,195 | | | 310,312 | |
Non-current liabilities: | | | | | | |
Long-term bank loan | | 11 | | 131,491 | | | 83,311 | |
Shareholder loan | | 12 | | 160,164 | | | 157,384 | |
Operating lease liabilities, non-current portion | | | | 31,165 | | | 25,833 | |
Deferred tax liabilities | | | | 11,379 | | | 10,532 | |
Research and development cost share liability, non-current portion | | 3 | | 424,890 | | | — | |
Other long-term liabilities | | 10 | | 46,514 | | | 46,562 | |
Total non-current liabilities | | | | 805,603 | | | 323,622 | |
Total liabilities | | | | 1,356,798 | | | 633,934 | |
Commitments and contingencies | | 19 | | | | |
Equity: | | | | | | |
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,014,976,692 and 801,340,698 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively | | | | 102 | | | 79 | |
Additional paid-in capital | | | | 5,200,275 | | | 2,925,970 | |
Accumulated other comprehensive loss | | 16 | | (9,299) | | | (8,001) | |
Accumulated deficit | | | | (2,654,780) | | | (1,955,843) | |
Total BeiGene, Ltd. shareholders’ equity | | | | 2,536,298 | | | 962,205 | |
Noncontrolling interest | | | | 10,194 | | | 16,150 | |
Total equity | | | | 2,546,492 | | | 978,355 | |
Total liabilities and equity | | | | 3,903,290 | | | 1,612,289 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BEIGENE, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three Months Ended | | | | Six Months Ended | | |
| | | | June 30, | | | | June 30, | | |
| | Note | | 2020 | | 2019 | | 2020 | | 2019 |
| | | | $ | | $ | | $ | | $ |
Revenues | | | | | | | | | | |
Product revenue, net | | 13 | | 65,635 | | | 58,142 | | | 117,694 | | | 115,563 | |
Collaboration revenue | | 3 | | — | | | 185,204 | | | — | | | 205,616 | |
Total revenues | | | | 65,635 | | | 243,346 | | | 117,694 | | | 321,179 | |
Expenses | | | | | | | | | | |
Cost of sales - product | | | | 14,307 | | | 17,839 | | | 28,456 | | | 33,100 | |
Research and development | | | | 285,968 | | | 228,760 | | | 590,270 | | | 407,111 | |
Selling, general and administrative | | | | 124,049 | | | 82,248 | | | 231,130 | | | 139,893 | |
Amortization of intangible assets | | | | 188 | | | 332 | | | 471 | | | 663 | |
Total expenses | | | | 424,512 | | | 329,179 | | | 850,327 | | | 580,767 | |
Loss from operations | | | | (358,877) | | | (85,833) | | | (732,633) | | | (259,588) | |
Interest income, net | | | | 1,108 | | | 2,886 | | | 7,798 | | | 7,363 | |
Other income, net | | | | 19,976 | | | (878) | | | 23,657 | | | 850 | |
Loss before income taxes | | | | (337,793) | | | (83,825) | | | (701,178) | | | (251,375) | |
Income tax (benefit) expense | | 9 | | (1,475) | | | 2,129 | | | 79 | | | 2,648 | |
Net loss | | | | (336,318) | | | (85,954) | | | (701,257) | | | (254,023) | |
Less: net loss attributable to noncontrolling interests | | | | (1,116) | | | (384) | | | (2,320) | | | (813) | |
Net loss attributable to BeiGene, Ltd. | | | | (335,202) | | | (85,570) | | | (698,937) | | | (253,210) | |
| | | | | | | | | | |
Net loss per share attributable to BeiGene, Ltd., basic and diluted | | 14 | | (0.33) | | | (0.11) | | | (0.69) | | | (0.33) | |
Weighted-average shares outstanding, basic and diluted | | 14 | | 1,010,230,470 | | | 777,509,102 | | | 1,007,967,904 | | | 776,137,299 | |
| | | | | | | | | | |
Net loss per American Depositary Share (“ADS”), basic and diluted | | | | (4.31) | | | (1.43) | | | (9.01) | | | (4.24) | |
Weighted-average ADSs outstanding, basic and diluted
| | | | 77,710,036 | | | 59,808,392 | | | 77,535,993 | | | 59,702,869 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BEIGENE, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended | | | | Six Months Ended | | |
| | June 30, | | | | June 30, | | |
| | 2020 | | 2019 | | 2020 | | 2019 |
| | $ | | $ | | $ | | $ |
Net loss | | (336,318) | | | (85,954) | | | (701,257) | | | (254,023) | |
Other comprehensive (loss)/ income, net of tax of nil: | | | | | | | | |
Foreign currency translation adjustments | | 1,732 | | | (7,337) | | | (2,617) | | | (3,582) | |
Unrealized holding gain, net | | (4,470) | | | 901 | | | 1,228 | | | 1,586 | |
Comprehensive loss | | (339,056) | | | (92,390) | | | (702,646) | | | (256,019) | |
Less: comprehensive loss attributable to noncontrolling interests | | (1,103) | | | (523) | | | (2,411) | | | (1,058) | |
Comprehensive loss attributable to BeiGene, Ltd. | | (337,953) | | | (91,867) | | | (700,235) | | | (254,961) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BEIGENE, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | |
| | | | Six months ended June 30, | | |
| | Note | | 2020 | | 2019 |
| | | | $ | | $ |
Operating activities: | | | | | | |
Net loss | | | | (701,257) | | | (254,023) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | | |
Depreciation and amortization expense | | | | 15,617 | | | 7,111 | |
Share-based compensation expenses | | 15 | | 83,723 | | | 58,994 | |
| | | | | | |
Unrealized gains on equity method investments | | 4 | | (11,264) | | | — | |
Gain on deconsolidation of entity | | 4 | | (11,307) | | | — | |
Acquired in-process research and development | | | | 43,000 | | | 49,000 | |
Amortization of research and development cost share liability | | | | (55,240) | | | — | |
| | | | | | |
Non-cash interest expense | | | | 5,106 | | | 3,759 | |
Deferred income tax benefits | | | | (1,060) | | | (1,456) | |
Other items, net | | | | (863) | | | (5,458) | |
Changes in operating assets and liabilities: | | | | | | |
Accounts receivable | | | | 9,094 | | | (17,052) | |
Inventories | | | | (4,681) | | | (32,806) | |
Prepaid expenses and other current assets | | | | (54,590) | | | (5,923) | |
Operating lease right-of-use assets | | | | (7,465) | | | (3,604) | |
Other non-current assets | | | | 2,628 | | | (10,293) | |
Accounts payable | | | | 34,851 | | | 21,431 | |
Accrued expenses and other payables | | | | 44,471 | | | 3,535 | |
Tax payable | | | | (3,006) | | | (3,713) | |
Deferred revenue | | | | — | | | (27,982) | |
Operating lease liabilities | | | | 7,406 | | | 383 | |
Other long-term liabilities | | | | (49) | | | 21 | |
Net cash used in operating activities | | | | (604,886) | | | (218,076) | |
Investing activities: | | | | | | |
Purchases of property, plant and equipment | | | | (54,138) | | | (43,275) | |
Deconsolidation of entity | | | | (2,025) | | | — | |
Purchases of investments | | | | (2,442,943) | | | (710,791) | |
Proceeds from sale or maturity of investments | | | | 997,242 | | | 1,167,491 | |
Purchase of in-process research and development | | | | (43,000) | | | (49,000) | |
Net cash (used in) provided by investing activities | | | | (1,544,864) | | | 364,425 | |
Financing activities: | | | | | | |
Proceeds from sale of ordinary shares, net of cost | | | | 2,162,407 | | | — | |
Proceeds from research and development cost share liability | | | | 616,834 | | | — | |
Capital contribution from noncontrolling interest | | | | — | | | 4,000 | |
Proceeds from long-term bank loan | | 11 | | 49,525 | | | 43,704 | |
| | | | | | |
Proceeds from short-term bank loan | | 11 | | 26,197 | | | — | |
Proceeds from option exercises and employee share purchase plan | | | | 28,198 | | | 10,642 | |
Net cash provided by financing activities | | | | 2,883,161 | | | 58,346 | |
Effect of foreign exchange rate changes, net | | | | (4,287) | | | (2,732) | |
Net increase in cash, cash equivalents, and restricted cash | | | | 729,124 | | | 201,963 | |
Cash, cash equivalents, and restricted cash at beginning of period | | | | 620,775 | | | 740,713 | |
Cash, cash equivalents, and restricted cash at end of period | | | | 1,349,899 | | | 942,676 | |
Supplemental cash flow information: | | | | | | |
Cash and cash equivalents | | | | 1,345,014 | | | 918,948 | |
Short-term restricted cash | | | | 283 | | | 14,567 | |
Long-term restricted cash | | | | 4,602 | | | 9,161 | |
Income taxes paid | | | | 9,250 | | | 7,874 | |
Interest paid | | | | 3,354 | | | 2,090 | |
Supplemental non-cash information: | | | | | | |
Acquisitions of equipment included in accounts payable | | | | 28,962 | | | 35,927 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BEIGENE, LTD.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Attributable to BeiGene, Ltd. | | | | | | | | | | | | | | |
| Ordinary Shares | | | | Additional Paid-In Capital | | Accumulated Other Comprehensive Income | | Accumulated Deficit | | Total | | Noncontrolling Interests | | |
| Shares | | Amount | | | | | | | | | | | | Total |
| | | $ | | $ | | $ | | $ | | $ | | $ | | $ |
Balance at December 31, 2019 | 801,340,698 | | | 79 | | | 2,925,970 | | | (8,001) | | | (1,955,843) | | | 962,205 | | | 16,150 | | | 978,355 | |
Issuance of ordinary shares in connection with collaboration | 206,635,013 | | | 21 | | | 2,162,386 | | | — | | | — | | | 2,162,407 | | | — | | | 2,162,407 | |
Use of shares reserved for share option exercises | (3,705,468) | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
Exercise of options, ESPP and release of Restricted Share Units ("RSUs") | 3,706,573 | | | 1 | | | 11,628 | | | — | | | — | | | 11,629 | | | — | | | 11,629 | |
Share-based compensation | — | | | — | | | 38,255 | | | — | | | — | | | 38,255 | | | — | | | 38,255 | |
Other comprehensive income | — | | | — | | | — | | | 1,453 | | | — | | | 1,453 | | | (104) | | | 1,349 | |
Net loss | — | | | — | | | — | | | — | | | (363,735) | | | (363,735) | | | (1,204) | | | (364,939) | |
Balance at March 31, 2020 | 1,007,976,816 | | | 101 | | | 5,138,239 | | | (6,548) | | | (2,319,578) | | | 2,812,214 | | | 14,842 | | | 2,827,056 | |
Exercise of options, ESPP issuances and release of RSUs | 10,493,392 | | | 1 | | | 16,568 | | | — | | | — | | | 16,569 | | | — | | | 16,569 | |
Issuance of shares reserved for share option exercises and RSU releases | (3,493,516) | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
Share-based compensation | — | | | — | | | 45,468 | | | — | | | — | | | 45,468 | | | — | | | 45,468 | |
Deconsolidation of entity | — | | | — | | | — | | | — | | | — | | | — | | | (3,545) | | | (3,545) | |
Other comprehensive loss | — | | | — | | | — | | | (2,751) | | | — | | | (2,751) | | | 13 | | | (2,738) | |
Net loss | — | | | — | | | — | | | — | | | (335,202) | | | (335,202) | | | (1,116) | | | (336,318) | |
Balance at June 30, 2020 | 1,014,976,692 | | | 102 | | | 5,200,275 | | | (9,299) | | | (2,654,780) | | | 2,536,298 | | | 10,194 | | | 2,546,492 | |
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Balance at December 31, 2018 | 776,263,184 | | | 77 | | | 2,744,814 | | | 1,526 | | | (1,007,215) | | | 1,739,202 | | | 14,445 | | | 1,753,647 | |
Use of shares reserved for share option exercises | (916,383) | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
Exercise of options, ESPP and release of RSUs | 2,066,383 | | | 1 | | | 6,268 | | | — | | | — | | | 6,269 | | | — | | | 6,269 | |
Share-based compensation | — | | | — | | | 26,392 | | | — | | | — | | | 26,392 | | | — | | | 26,392 | |
Other comprehensive income | — | | | — | | | — | | | 4,546 | | | — | | | 4,546 | | | (106) | | | 4,440 | |
Net loss | — | | | — | | | — | | | — | | | (167,640) | | | (167,640) | | | (429) | | | (168,069) | |
Balance at March 31, 2019 | 777,413,184 | | | 78 | | | 2,777,474 | | | 6,072 | | | (1,174,855) | | | 1,608,769 | | | 13,910 | | | 1,622,679 | |
Contributions from shareholders | — | | | — | | | — | | | — | | | — | | | — | | | 4,000 | | | 4,000 | |
Exercise of options, ESPP and release of RSUs | 3,802,747 | | | — | | | 4,373 | | | — | | | — | | | 4,373 | | | — | | | 4,373 | |
Issuance of shares reserved for share option exercises | 3,223,701 | | | — | | | — | | | — | | | — | | | — | | | — | | | — | |
Share-based compensation | — | | | — | | | 32,602 | | | — | | | — | | | 32,602 | | | — | | | 32,602 | |
Other comprehensive income | — | | | — | | | — | | | (6,297) | | | — | | | (6,297) | | | (139) | | | (6,436) | |
Net loss | — | |