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, 2022
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 listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited (HKEX).
As of July 31, 2022, 1,349,639,439 ordinary shares, par value $0.0001 per share, were outstanding, of which 949,028,496 ordinary shares were held in the form of 73,002,192 American Depositary Shares, each representing 13 ordinary shares, and 115,055,260 were RMB 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
TABLE OF CONTENTS
| Page | ||||||||
2
Summary of Risk Factors
Below is a summary of the principal factors that make an investment in our American Depositary Shares ("ADSs") listed on Nasdaq, our ordinary shares listed on The Stock Exchange of Hong Kong Limited ("HKEX"), and our ordinary shares issued to permitted investors in China and listed and traded on the Science and Technology Innovation Board ("STAR") of the Shanghai Stock Exchange ("SSE") in Renminbi ("RMB Shares") speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, are summarized in “Part II – Item 1A – Risk Factors” and should be carefully considered, together with other information in this Form 10-Q and our other filings with the Securities and Exchange Commission (“SEC”), before making an investment decision regarding our ADSs, ordinary shares or RMB Shares.
•Our medicines may fail to achieve and maintain the degree of market acceptance by physicians, patients, third-party payors, and others in the medical community necessary for commercial success.
•We have limited experience in launching and marketing our internally developed and in-licensed medicines. If we are unable to further develop marketing and sales capabilities or enter into agreements with third parties to market and sell our medicines, we may not be able to generate substantial product sales revenue.
•If we are not able to continue to obtain, or experience delays in obtaining, required regulatory approvals, we will not be able to commercialize our medicines and drug candidates, and our ability to generate revenue will be materially impaired.
•We face substantial competition, which may result in others discovering, developing, or commercializing competing medicines before or more successfully than we do.
•We have limited manufacturing capability and must rely on third-party manufacturers to manufacture some of our commercial products and clinical supplies, and if they fail to meet their obligations, the development and commercialization of our medicines and drug candidates could be adversely affected.
•We depend substantially on the success of the clinical development of our medicines and drug candidates. If we are unable to successfully complete clinical development, obtain regulatory approvals and commercialize our medicines and drug candidates, or experience significant delays in doing so, our business will be materially harmed.
•Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results.
•If clinical trials of our drug candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our drug candidates.
•All material aspects of the research, development, manufacturing and commercialization of pharmaceutical products are heavily regulated, and we may face difficulties in complying with or be unable to comply with such regulations, which could have a material adverse effect on our business.
•The approval processes of regulatory authorities in the United States, China, Europe and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.
•Even if we are able to commercialize our medicines and any approved drug candidates, the medicines may become subject to unfavorable pricing regulations or third-party reimbursement practices or healthcare reform initiatives, which could harm our business.
•We have incurred significant net losses since our inception and anticipate that we will continue to incur net losses for the foreseeable future and may not become profitable.
•We have limited experience in obtaining regulatory approvals and commercializing pharmaceutical products, which may make it difficult to evaluate our current business and predict our future performance.
•We may need to obtain additional financing to fund our operations, and if we are unable to obtain such financing, we may be unable to complete the development of our drug candidates or achieve profitability.
3
•If we are unable to obtain and maintain patent protection for our medicines and drug candidates through intellectual property rights, or if the scope of such intellectual property rights is not sufficiently broad, third parties may compete against us.
•We rely on third parties to manufacture some of our commercial and clinical drug supplies. Our business could be harmed if those third parties fail to provide us with sufficient quantities of product or fail to do so at acceptable quality levels or prices.
•We have entered into licensing and collaboration arrangements and may enter into additional collaborations, licensing arrangements, or strategic alliances in the future, and we may not realize the benefits of such arrangements.
•We have significantly increased and expect to continue to increase our research, development, manufacturing, and commercial capabilities, and we may experience difficulties in managing our growth.
•Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.
•Our business is subject to complex and evolving industry-specific laws and regulations regarding the collection and transfer of personal data. These laws and regulations can be complex and stringent, and many are subject to change and uncertain interpretation, which could result in claims, changes to our data and other business practices, significant penalties, increased cost of operations, or otherwise adversely impact our business.
•We manufacture some of our medicines and intend to manufacture some of our drug candidates, if approved. Delays in completing and receiving regulatory approvals for our manufacturing facilities, or damage to, destruction of or interruption of production at such facilities, could delay our development plans or commercialization efforts.
•Changes in the political and economic policies of the PRC government or in relations between China and the United States or other governments may materially and adversely affect our business, financial condition, and results of operations and may result in our inability to sustain our growth and expansion strategies.
•The PRC government has significant oversight and discretion over the conduct of the business operations of our PRC subsidiaries or to exert control over any offering of securities conducted overseas and/or foreign investment in China-based issuers, and may intervene with or influence our operations, may limit or completely hinder our ability to offer or continue to offer securities to investors, and may cause the value of such securities to significantly decline or be worthless, as the government deems appropriate to further regulatory, political and societal goals.
•The audit reports included in our Annual Report on Form 10-K filed with the SEC have historically been prepared by auditors who are not inspected fully by the Public Company Accounting Oversight Board (the "PCAOB"), and as such, investors have previously been deprived of the benefits of such inspections.
•Our ADSs may be delisted and our ADSs and ordinary shares prohibited from trading in the over-the-counter market under the Holding Foreign Companies Accountable Act, or the HFCAA. On December 16, 2021, PCAOB issued the HFCAA Determination Report, according to which our previous auditor is subject to the determinations that the PCAOB is unable to inspect or investigate it completely. Under current law, delisting and prohibition from over-the-counter trading in the U.S. could take place in 2024. The delisting of our ADSs, or the threat of their being delisted, may materially and adversely affect the value of your investment.
•The trading prices of our ordinary shares, ADSs and/or RMB Shares can be volatile, which could result in substantial losses to you.
4
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 | 2022 | 2021 | ||||||||||||||||||
| $ | $ | |||||||||||||||||||
| (unaudited) | (audited) | |||||||||||||||||||
| Assets | ||||||||||||||||||||
| Current assets: | ||||||||||||||||||||
| Cash and cash equivalents | 4,531,137 | 4,375,678 | ||||||||||||||||||
| Short-term restricted cash | 4 | 333 | 328 | |||||||||||||||||
| Short-term investments | 4 | 1,172,554 | 2,241,962 | |||||||||||||||||
| Accounts receivable, net | 9 | 172,259 | 483,113 | |||||||||||||||||
| Inventories | 5 | 262,210 | 242,626 | |||||||||||||||||
| Prepaid expenses and other current assets | 9 | 207,383 | 270,173 | |||||||||||||||||
| Total current assets | 6,345,876 | 7,613,880 | ||||||||||||||||||
| Long-term restricted cash | 4 | 3,939 | 6,881 | |||||||||||||||||
| Property, plant and equipment, net | 6 | 633,100 | 587,605 | |||||||||||||||||
| Operating lease right-of-use assets | 117,583 | 117,431 | ||||||||||||||||||
| Intangible assets, net | 7 | 43,325 | 46,679 | |||||||||||||||||
| Deferred tax assets | 8 | 103,429 | 110,424 | |||||||||||||||||
| Other non-current assets | 9 | 130,955 | 163,049 | |||||||||||||||||
| Total non-current assets | 1,032,331 | 1,032,069 | ||||||||||||||||||
| Total assets | 7,378,207 | 8,645,949 | ||||||||||||||||||
| Liabilities and shareholders' equity | ||||||||||||||||||||
| Current liabilities: | ||||||||||||||||||||
| Accounts payable | 234,355 | 262,400 | ||||||||||||||||||
| Accrued expenses and other payables | 9 | 454,183 | 558,055 | |||||||||||||||||
| Deferred revenue, current portion | 3 | 163,396 | 187,414 | |||||||||||||||||
| Tax payable | 8 | 15,564 | 21,395 | |||||||||||||||||
| Operating lease liabilities, current portion | 24,788 | 21,925 | ||||||||||||||||||
| Research and development cost share liability, current portion | 3 | 125,394 | 120,801 | |||||||||||||||||
| Short-term debt | 10 | 380,729 | 427,565 | |||||||||||||||||
| Total current liabilities | 1,398,409 | 1,599,555 | ||||||||||||||||||
| Non-current liabilities: | ||||||||||||||||||||
| Long-term bank loans | 10 | 185,207 | 202,113 | |||||||||||||||||
| Deferred revenue, non-current portion | 3 | 167,570 | 220,289 | |||||||||||||||||
| Operating lease liabilities, non-current portion | 41,921 | 43,041 | ||||||||||||||||||
| Deferred tax liabilities | 8 | 14,739 | 14,169 | |||||||||||||||||
| Research and development cost share liability, non-current portion | 3 | 219,385 | 269,561 | |||||||||||||||||
| Other long-term liabilities | 9 | 48,432 | 54,234 | |||||||||||||||||
| Total non-current liabilities | 677,254 | 803,407 | ||||||||||||||||||
| Total liabilities | 2,075,663 | 2,402,962 | ||||||||||||||||||
| Commitments and contingencies | 18 | |||||||||||||||||||
| Equity: | ||||||||||||||||||||
Ordinary shares, US$0.0001 par value per share; 9,500,000,000 shares authorized; 1,349,639,439 and 1,334,804,281 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 134 | 133 | ||||||||||||||||||
| Additional paid-in capital | 11,356,686 | 11,191,007 | ||||||||||||||||||
| Accumulated other comprehensive income (loss) | 14 | (82,450) | 17,950 | |||||||||||||||||
| Accumulated deficit | (5,971,826) | (4,966,103) | ||||||||||||||||||
| Total equity | 5,302,544 | 6,242,987 | ||||||||||||||||||
| Total liabilities and equity | 7,378,207 | 8,645,949 | ||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
BEIGENE, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||||||||
| Note | 2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||||||||
| Revenues | ||||||||||||||||||||||||||||||||
| Product revenue, net | 11 | 304,511 | 138,624 | 566,084 | 244,741 | |||||||||||||||||||||||||||
| Collaboration revenue | 3 | 37,061 | 11,368 | 82,114 | 511,123 | |||||||||||||||||||||||||||
| Total revenues | 341,572 | 149,992 | 648,198 | 755,864 | ||||||||||||||||||||||||||||
| Expenses | ||||||||||||||||||||||||||||||||
| Cost of sales - product | 71,173 | 36,263 | 136,410 | 68,948 | ||||||||||||||||||||||||||||
| Research and development | 378,207 | 356,091 | 768,122 | 676,817 | ||||||||||||||||||||||||||||
| Selling, general and administrative | 331,403 | 232,289 | 625,976 | 414,395 | ||||||||||||||||||||||||||||
| Amortization of intangible assets | 188 | 187 | 376 | 375 | ||||||||||||||||||||||||||||
| Total expenses | 780,971 | 624,830 | 1,530,884 | 1,160,535 | ||||||||||||||||||||||||||||
| Loss from operations | (439,399) | (474,838) | (882,686) | (404,671) | ||||||||||||||||||||||||||||
| Interest income (expense), net | 11,431 | (4,866) | 21,502 | (9,045) | ||||||||||||||||||||||||||||
| Other expense, net | (129,617) | (867) | (117,650) | (4,990) | ||||||||||||||||||||||||||||
| Loss before income taxes | (557,585) | (480,571) | (978,834) | (418,706) | ||||||||||||||||||||||||||||
| Income tax expense (benefit) | 8 | 13,864 | (230) | 26,889 | (4,860) | |||||||||||||||||||||||||||
| Net loss | (571,449) | (480,341) | (1,005,723) | (413,846) | ||||||||||||||||||||||||||||
| Net loss per share | (0.43) | (0.40) | (0.75) | (0.35) | ||||||||||||||||||||||||||||
| Weighted-average shares outstanding—basic and diluted | 1,336,463,026 | 1,194,071,476 | 1,334,252,648 | 1,191,521,766 | ||||||||||||||||||||||||||||
| Net loss per American Depositary Share ("ADS") | (5.56) | (5.23) | (9.80) | (4.52) | ||||||||||||||||||||||||||||
| Weighted-average ADSs outstanding—basic and diluted | 102,804,848 | 91,851,652 | 102,634,819 | 91,655,520 | ||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
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, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Net loss | (571,449) | (480,341) | (1,005,723) | (413,846) | ||||||||||||||||||||||
| Other comprehensive income (loss), net of tax of nil: | ||||||||||||||||||||||||||
| Foreign currency translation adjustments | (97,459) | 9,626 | (88,085) | 5,864 | ||||||||||||||||||||||
| Pension liability adjustments | — | (136) | — | 361 | ||||||||||||||||||||||
| Unrealized holding loss, net | (2,445) | (599) | (12,315) | (1,072) | ||||||||||||||||||||||
| Comprehensive loss | (671,353) | (471,450) | (1,106,123) | (408,693) | ||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
7
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 | 2022 | 2021 | ||||||||||||||||||
| $ | $ | |||||||||||||||||||
| Operating activities: | ||||||||||||||||||||
| Net loss | (1,005,723) | (413,846) | ||||||||||||||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||
| Depreciation and amortization expense | 32,061 | 21,159 | ||||||||||||||||||
| Share-based compensation expenses | 13 | 146,860 | 110,624 | |||||||||||||||||
| Unrealized losses on equity investments | 4 | 23,529 | 6,033 | |||||||||||||||||
| Acquired in-process research and development | — | 53,500 | ||||||||||||||||||
| Amortization of research and development cost share liability | 3 | (45,583) | (53,902) | |||||||||||||||||
| Deferred income tax benefits | 7,550 | (12,311) | ||||||||||||||||||
| Other items, net | 6,360 | 11,212 | ||||||||||||||||||
| Changes in operating assets and liabilities: | ||||||||||||||||||||
| Accounts receivable | 307,430 | (13,338) | ||||||||||||||||||
| Inventories | (31,633) | (28,294) | ||||||||||||||||||
| Other assets | 32,315 | (77,204) | ||||||||||||||||||
| Accounts payable | (30,362) | (42,558) | ||||||||||||||||||
| Accrued expenses and other payables | 19,525 | 1,688 | ||||||||||||||||||
| Deferred revenue | (76,737) | 138,877 | ||||||||||||||||||
| Other liabilities | (2,114) | 3,189 | ||||||||||||||||||
| Net cash used in operating activities | (616,522) | (295,171) | ||||||||||||||||||
| Investing activities: | ||||||||||||||||||||
| Purchases of property, plant and equipment | (95,421) | (80,920) | ||||||||||||||||||
| Purchases of investments | (11,504) | (1,357,051) | ||||||||||||||||||
| Proceeds from sale or maturity of investments | 1,051,028 | 1,997,515 | ||||||||||||||||||
| Purchase of in-process research and development | (75,000) | (8,500) | ||||||||||||||||||
| Other investing activities | — | (7,500) | ||||||||||||||||||
| Net cash provided by investing activities | 869,103 | 543,544 | ||||||||||||||||||
| Financing activities: | ||||||||||||||||||||
| Proceeds from long-term loan | 10 | — | 10,819 | |||||||||||||||||
| Proceeds from short-term loans | 10 | 67,586 | 112,589 | |||||||||||||||||
| Repayment of short-term loans | 10 | (115,405) | (15,959) | |||||||||||||||||
| Proceeds from option exercises and employee share purchase plan | 18,972 | 35,601 | ||||||||||||||||||
| Net cash (used in) provided by financing activities | (28,847) | 143,050 | ||||||||||||||||||
| Effect of foreign exchange rate changes, net | (71,212) | 5,257 | ||||||||||||||||||
| Net increase in cash, cash equivalents, and restricted cash | 152,522 | 396,680 | ||||||||||||||||||
| Cash, cash equivalents, and restricted cash at beginning of period | 4,382,887 | 1,390,005 | ||||||||||||||||||
| Cash, cash equivalents, and restricted cash at end of period | 4,535,409 | 1,786,685 | ||||||||||||||||||
| Supplemental cash flow information: | ||||||||||||||||||||
| Cash and cash equivalents | 4,531,137 | 1,776,448 | ||||||||||||||||||
| Short-term restricted cash | 333 | 310 | ||||||||||||||||||
| Long-term restricted cash | 3,939 | 9,927 | ||||||||||||||||||
| Income taxes paid | 24,436 | 14,527 | ||||||||||||||||||
| Interest paid | 12,899 | 14,267 | ||||||||||||||||||
| Supplemental non-cash information: | ||||||||||||||||||||
| Acquisitions of equipment included in accounts payable | 58,676 | 28,885 | ||||||||||||||||||
| Acquired in-process research and development included in accrued expenses | — | 45,000 | ||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
8
BEIGENE, LTD.
CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY
(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data)
(Unaudited)
| Ordinary Shares | Additional Paid-In Capital | Accumulated Other Comprehensive Income (loss) | Accumulated Deficit | Total | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | 1,334,804,281 | 133 | 11,191,007 | 17,950 | (4,966,103) | 6,242,987 | |||||||||||||||||||||||||||||
| Cost from issuance of ordinary shares | — | — | (152) | — | — | (152) | |||||||||||||||||||||||||||||
| Use of shares reserved for share option exercises | (2,850,328) | — | — | — | — | — | |||||||||||||||||||||||||||||
| Exercise of options, ESPP and release of Restricted Share Units ("RSUs") | 2,851,316 | — | 11,880 | — | — | 11,880 | |||||||||||||||||||||||||||||
| Share-based compensation | — | — | 65,555 | — | — | 65,555 | |||||||||||||||||||||||||||||
| Other comprehensive loss | — | — | — | (496) | — | (496) | |||||||||||||||||||||||||||||
| Net loss | — | — | — | — | (434,274) | (434,274) | |||||||||||||||||||||||||||||
| Balance at March 31, 2022 | 1,334,805,269 | 133 | 11,268,290 | 17,454 | (5,400,377) | 5,885,500 | |||||||||||||||||||||||||||||
| Use of shares reserved for share option exercises | 5,016,232 | — | — | — | — | — | |||||||||||||||||||||||||||||
| Exercise of options, ESPP and release of Restricted Share Units ("RSUs") | 9,817,938 | 1 | 7,091 | — | — | 7,092 | |||||||||||||||||||||||||||||
| Share-based compensation | — | — | 81,305 | — | — | 81,305 | |||||||||||||||||||||||||||||
| Other comprehensive loss | — | — | — | (99,904) | — | (99,904) | |||||||||||||||||||||||||||||
| Net loss | — | — | — | — | (571,449) | (571,449) | |||||||||||||||||||||||||||||
| Balance at June 30, 2022 | 1,349,639,439 | 134 | 11,356,686 | (82,450) | (5,971,826) | 5,302,544 | |||||||||||||||||||||||||||||
| Balance at December 31, 2020 | 1,190,821,941 | 118 | 7,414,932 | 6,942 | (3,552,749) | 3,869,243 | |||||||||||||||||||||||||||||
| Use of shares reserved for share option exercises | (123,097) | — | — | — | — | — | |||||||||||||||||||||||||||||
| Exercise of options, ESPP and release of Restricted Share Units ("RSUs") | 6,623,773 | 1 | 25,753 | — | — | 25,754 | |||||||||||||||||||||||||||||
| Share-based compensation | — | — | 45,833 | — | — | 45,833 | |||||||||||||||||||||||||||||
| Other comprehensive loss | — | — | — | (3,738) | — | (3,738) | |||||||||||||||||||||||||||||
| Net income | — | — | — | — | 66,495 | 66,495 | |||||||||||||||||||||||||||||
| Balance at March 31, 2021 | 1,197,322,617 | 119 | 7,486,518 | 3,204 | (3,486,254) | 4,003,587 | |||||||||||||||||||||||||||||
| Use of shares reserved for share option exercises | (1,599,676) | — | — | — | — | — | |||||||||||||||||||||||||||||
| Exercise of options, ESPP and release of Restricted Share Units ("RSUs") | 8,844,082 | 1 | 9,846 | — | — | 9,847 | |||||||||||||||||||||||||||||
| Share-based compensation | — | — | 64,791 | — | — | 64,791 | |||||||||||||||||||||||||||||
| Other comprehensive income | — | — | — | 8,891 | — | 8,891 | |||||||||||||||||||||||||||||
| Net loss | — | — | — | — | (480,341) | (480,341) | |||||||||||||||||||||||||||||
| Balance at June 30, 2021 | 1,204,567,023 | 120 | 7,561,155 | 12,095 | (3,966,595) | 3,606,775 | |||||||||||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
9
BEIGENE, LTD.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands of U.S. Dollar (“$”) and Renminbi (“RMB”), except for number of shares and per share data)
(Unaudited)
1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies
Description of business
BeiGene, Ltd. (the "Company", "BeiGene", "it", "its") is a global biotechnology company focused on developing and commercializing innovative affordable oncology medicines to improve treatment outcomes and expand access for patients worldwide.
The Company currently has three approved medicines that were discovered and developed in its own labs, including BRUKINSA®, a small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) for the treatment of various blood cancers, tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers, and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2. The Company has obtained approvals to market BRUKINSA® in the United States, the People's Republic of China (China or the PRC), the European Union (EU), the United Kingdom ("UK"), Canada, Australia and additional international markets, and tislelizumab and pamiparib in China. By leveraging its China commercial capabilities, the Company has in-licensed the rights to distribute 13 approved medicines for the China market. Supported by its global clinical development and commercial capabilities, the Company has entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc. ("Amgen") and Novartis Pharma AG ("Novartis") to develop and commercialize innovative medicines.
The Company is committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. Its internal clinical development capabilities are deep, including a more than 2,500-person global clinical development and medical affairs team that is running close to 80 ongoing or planned clinical trials in over 40 medicines and drug candidates. This includes more than 30 pivotal or potentially registration-enabling trials across its portfolio, including three internally discovered, approved medicines. The Company has enrolled in its clinical trials more than 16,000 subjects, of which approximately one-half have been outside of China.
The Company has built, and is expanding, its internal manufacturing capabilities, through its state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of its medicines, and is building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey. The Company also works with high quality contract manufacturing organizations ("CMOs") to manufacture its internally developed clinical and commercial products.
Since its inception in 2010, the Company has become a fully integrated global organization of over 8,600 employees in 29 countries and regions, including the United States, China, Europe and Australia.
Basis of presentation and consolidation
The accompanying condensed consolidated balance sheet as of June 30, 2022, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021, the condensed consolidated statements of cash flows for the six months ended June 30, 2022 and 2021, and the condensed consolidated statements of shareholders' equity for the three and six months ended June 30, 2022 and 2021, and the related footnote disclosures are unaudited. The accompanying unaudited interim condensed financial statements were prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), including guidance with respect to interim financial information and in conformity with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for annual financial statements. These financial statements should be read in conjunction with the consolidated financial statements and related footnotes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 (the "Annual Report").
The unaudited interim condensed consolidated interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all normal recurring adjustments, necessary to present a fair statement of the results for the interim periods presented. Results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results expected for the full fiscal year or for any future annual or interim period.
10
The unaudited interim condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All significant intercompany transactions and balances between the Company and its subsidiaries are eliminated upon consolidation.
Use of estimates
The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating variable consideration in product sales and collaboration revenue arrangements, identifying separate accounting units and determining the standalone selling price of each performance obligation in the Company’s revenue arrangements, assessing the impairment of long-lived assets, valuation and recognition of share-based compensation expenses, realizability of deferred tax assets, estimating uncertain tax positions, valuation of inventory, estimating the allowance for credit losses, determining defined benefit pension plan obligations, measurement of right-of-use assets and lease liabilities and the fair value of financial instruments. Management bases the estimates on historical experience, known trends and various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities and reported amounts of revenues and expenses. Actual results could differ from these estimates.
Recent accounting pronouncements
New accounting standards which have not yet been adopted
In November 2021, the FASB issued ASU 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance. This update requires certain annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model by analogy. This update is effective for annual periods beginning after December 15, 2021, and early application is permitted. This guidance should be applied either prospectively to all transactions that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or retrospectively to those transactions. The Company does not expect the adoption of this guidance to have a material impact on the Company’s consolidated financial statements.
Significant accounting policies
For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited interim condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report for the year ended December 31, 2021.
There have been no material changes to the Company’s significant accounting policies as of and for the six months ended June 30, 2022, as compared to the significant accounting policies described in the Annual Report.
2. Fair Value Measurements
The Company measures certain financial assets and liabilities at fair value. Fair value is determined based upon the exit price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as determined by either the principal market or the most advantageous market. Inputs used in the valuation techniques to derive fair values are classified based on a three-level hierarchy, as follows:
Level 1 – Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 – Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which all significant inputs are observable or can be derived principally from or corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the asset or liability.
The Company considers an active market to be one in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis, and considers an inactive market to be one in which there are infrequent or few transactions for the asset or liability, the prices are not current, or price quotations vary substantially either over time or among market makers.
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The following tables present the Company’s financial assets and liabilities measured and recorded at fair value on a recurring basis using the above input categories as of June 30, 2022 and December 31, 2021:
| Quoted Price in Active Market for Identical Assets | Significant Other Observable Inputs | Significant Unobservable Inputs | ||||||||||||||||||
| As of June 30, 2022 | (Level 1) | (Level 2) | (Level 3) | |||||||||||||||||
| $ | $ | $ | ||||||||||||||||||
| Cash equivalents | ||||||||||||||||||||
| U.S. Treasury securities | 384,121 | — | — | |||||||||||||||||
| Money market funds | 257,614 | — | — | |||||||||||||||||
| Short-term investments (Note 4): | ||||||||||||||||||||
| U.S. Treasury securities | 1,172,554 | — | — | |||||||||||||||||
| Other non-current assets (Note 4): | ||||||||||||||||||||
| Equity securities with readily determinable fair values | 8,451 | 3,003 | — | |||||||||||||||||
| Convertible debt instrument | — | — | 5,000 | |||||||||||||||||
| Total | 1,822,740 | 3,003 | 5,000 | |||||||||||||||||
| Quoted Price in Active Market for Identical Assets | Significant Other Observable Inputs | Significant Unobservable Inputs | ||||||||||||||||||
| As of December 31, 2021 | (Level 1) | (Level 2) | (Level 3) | |||||||||||||||||
| $ | $ | $ | ||||||||||||||||||
| Cash equivalents | ||||||||||||||||||||
| U.S. Treasury securities | 107,855 | — | — | |||||||||||||||||
| Money market funds | 315,564 | — | — | |||||||||||||||||
| Short-term investments (Note 4): | ||||||||||||||||||||
| U.S. Treasury securities | 2,241,962 | — | — | |||||||||||||||||
| Other non-current assets (Note 4): | ||||||||||||||||||||
| Equity securities with readily determinable fair values | 23,809 | 10,306 | — | |||||||||||||||||
| Total | 2,689,190 | 10,306 | — | |||||||||||||||||
The Company's cash equivalents are highly liquid investments with original maturities of 3 months or less. Short-term investments represent the Company's investments in available-for-sale debt securities. The Company determines the fair value of cash equivalents and available-for-sale debt securities using a market approach based on quoted prices in active markets.
The Company's equity securities carried at fair value consist of holdings in common stock and warrants to purchase additional shares of common stock of Leap Therapeutics, Inc. ("Leap"), which were acquired in connection with a collaboration and license agreement entered into in January 2020 and in Leap's underwritten public offering in September 2021. The common stock investment in Leap, a publicly-traded biotechnology company, is measured and carried at fair value and classified as Level 1. The warrants to purchase additional shares of common stock in Leap are classified as a Level 2 investment and are measured using the Black-Scholes option-pricing valuation model, which utilizes a constant maturity risk-free rate and reflects the term of the warrants, dividend yield and stock price volatility, that is based on the historical volatility of similar companies. Refer to Note 4, Restricted Cash and Investments for details of the determination of the carrying amount of private equity investments without readily determinable fair values and equity method investments.
The Company holds a convertible note of a private biotech company. The Company has elected the fair value option method of accounting for the convertible note. Accordingly, the convertible note is remeasured at fair value on a recurring basis using Level 3 inputs, with any changes in the fair value option recorded in other income (loss).
As of June 30, 2022 and December 31, 2021, the fair values of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and short-term debt approximated their carrying values due to their short-term nature. Long-term bank loans approximate their fair value due to the fact that the related interest rates approximate the rates currently offered by financial institutions for similar debt instrument of comparable maturities.
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3. Collaborative and Licensing Arrangements
The Company has entered into collaborative arrangements for the research and development, manufacture and/or commercialization of medicines and drug candidates. To date, these collaborative arrangements have included out-licenses of and options to out-license internally developed products and drug candidates to other parties, in-licenses of products and drug candidates from other parties, and profit- and cost-sharing arrangements. These arrangements may include non-refundable upfront payments, contingent obligations for potential development, regulatory and commercial performance milestone payments, cost-sharing and reimbursement arrangements, royalty payments, and profit sharing.
Out-Licensing Arrangements
For the three and six months ended June 30, 2022 and 2021, the Company’s collaboration revenue consisted entirely of upfront license fees, research and development services revenue and right to access intellectual property revenue from its collaboration agreements with Novartis for tislelizumab and ociperlimab.
The following table summarizes total collaboration revenue recognized for the three and six months ended June 30, 2022 and 2021:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| Revenue from Collaborators | $ | $ | $ | $ | ||||||||||||||||||||||
| License revenue | — | — | — | 484,646 | ||||||||||||||||||||||
| Research and development service revenue | 10,813 | 11,368 | 24,240 | 26,477 | ||||||||||||||||||||||
| Right to access intellectual property revenue | 26,248 | — | 52,497 | — | ||||||||||||||||||||||
| Other | — | — | 5,377 | — | ||||||||||||||||||||||
| Total | 37,061 | 11,368 | 82,114 | 511,123 | ||||||||||||||||||||||
Novartis
Tislelizumab Collaboration and License
In January 2021, the Company entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in North America, Europe, and Japan ("Novartis Territory"). The Company and Novartis have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and the Company has an option to co-detail the product in North America, funded in part by Novartis.
Under the agreement the Company received an upfront cash payment of $650,000 from Novartis. The Company is eligible to receive up to $1,300,000 upon the achievement of regulatory milestones, $250,000 upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. Under the terms of the agreement, the Company is responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.
The Company evaluated the Novartis agreement under ASC 606 as all the material units of account within the agreement represented transactions with a customer. The Company identified the following material components under the agreement: (1) exclusive license for Novartis to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark; (2) conducting and completing ongoing trials of tislelizumab (“tislelizumab R&D services”); and (3) supplying Novartis with required quantities of the tislelizumab drug product, or drug substance, upon receipt of an order from Novartis.
The Company determined that the license, transfer of know-how and use of trademarks are not distinct from each other and represent a single performance obligation. The tislelizumab R&D services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis. The Company evaluated the supply component of the contract and noted the supply will not be provided at a significant incremental discount to Novartis. The Company concluded that, for the purpose of ASC 606, the provision related to providing clinical and commercial supply of tislelizumab in the Novartis Territory was an option but not a performance
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obligation of the Company at the outset of the Novartis collaboration agreement. A performance obligation for the clinical and commercial supply will be established as quantities of drug product or drug substance are ordered by Novartis.
The Company determined that the transaction price as of the outset of the arrangement was the upfront payment of $650,000. The potential milestone payments that the Company is eligible to receive were excluded from the transaction price, as all milestone amounts were fully constrained due to uncertainty of achievement. The transaction price was allocated to the two identified performance obligations based on a relative fair value basis. The standalone selling price of the license, transfer of know-how and use of trademarks performance obligation was determined using the adjusted market assessment approach. Based on the valuation performed by the Company, the standalone selling price of the license, transfer of know-how and use of trademarks was valued at $1,231,000. The standalone selling price of the tislelizumab R&D services was valued at $420,000 using a cost plus margin valuation approach. Based on the relative standalone selling prices of the two performance obligations, $484,646 of the total transaction price was allocated to the license and $165,354 was allocated to the tislelizumab R&D services.
The Company satisfied the license performance obligation at a point in time when the license was delivered and the transfer of know-how completed which occurred during the six months ended June 30, 2021. As such, the Company recognized the entire amount of the transaction price allocated to the license as collaboration revenue during the six months ended June 30, 2021. The portion of the transaction price allocated to the tislelizumab R&D services was deferred and is being recognized as collaboration revenue as the tislelizumab R&D services are performed using a percentage-of-completion method. Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis. The Company recognized R&D service revenue of $9,021 and $20,656 during the three and six months ended June 30, 2022, respectively, and $11,368 and $26,477 during the three and six months ended June 30, 2021, respectively. The Company also recognized other collaboration revenue of nil and $5,377 related to the sale of tislelizumab clinical supply to Novartis in conjunction with the collaboration during the three and six months ended June 30, 2022, respectively.
Ociperlimab Option, Collaboration and License Agreement and China Broad Market Development Agreement
In December 2021, the Company expanded its collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize the Company's investigational TIGIT inhibitor ociperlimab in the Novartis Territory. In addition, the Company and Novartis entered into an agreement granting the Company rights to market, promote and detail five approved Novartis oncology products, TAFINLAR® (dabrafenib), MEKINIST® (trametinib), VOTRIENT® (pazopanib), AFINITOR® (everolimus), and ZYKADIA® (ceritinib), across designated regions of China referred to as “broad markets.” In the first quarter of 2022, the Company initiated marketing and promotion of these five products.
Under the terms of the option, collaboration and license agreement, the Company received an upfront cash payment of $300,000 in January 2022 from Novartis and will receive an additional payment of $600,000 or $700,000 in the event Novartis exercises its exclusive time-based option prior to mid-2023 or between then and late-2023, respectively. Following option exercise, the Company is eligible to receive up to $745,000 upon the achievement of regulatory approval milestones, $1,150,000 upon the achievement of sales milestones, and royalties on future sales of ociperlimab in the Novartis Territory. Subject to the terms of the option, collaboration and license agreement, during the option period, Novartis has agreed to initiate and fund additional global clinical trials with ociperlimab and the Company has agreed to expand enrollment in two ongoing trials. Following the option exercise, Novartis has agreed to share development costs of global trials. Following approval, the Company has agreed to provide 50 percent of the co-detailing and co-field medical efforts in the United States, and has an option to co-detail up to 25 percent in Canada and Mexico, funded in part by Novartis. Each party retains the worldwide right to commercialize its propriety products in combination with ociperlimab, as is the case with tislelizumab under the tislelizumab collaboration and license agreement. The existing tislelizumab collaboration and license agreement was not modified as a result of the ociperlimab option, collaboration and license agreement.
The Company evaluated the Novartis agreements under ASC 606 as the units of account within the agreement represented transactions with a customer. The Company identified the following material promises under the agreement: (1) exclusive option for Novartis to license the rights to develop, manufacture, and commercialize ociperlimab in the Novartis Territory; (2) Novartis' right to access ociperlimab in its own clinical trials during the option period; (3) initial transfer of BeiGene know-how; and (4) conducting and completing ongoing trials of ociperlimab during the option period ("ociperlimab R&D Services", together with "tislelizumab R&D services", "R&D services"). The market development activities are considered immaterial in the context of the contracts.
The Company concluded that, at the inception of the agreement, the option for the exclusive product license constitutes a material right as it represents a significant and incremental discount to the fair value of the exclusive product license that Novartis would not have received without entering into the agreement and is therefore considered a distinct performance
14
obligation. The Company determined that Novartis' right to access ociperlimab in its own trials over the option period and the initial transfer of know-how were not distinct from each other, as the right to access ociperlimab has limited value without the corresponding know-how transfer, and therefore should be combined into one distinct performance obligation. The ociperlimab R&D Services represent a material promise and were determined to be a separate performance obligation at the outset of the agreement as the promise is distinct and has standalone value to Novartis.
The Company determined the transaction price at the outset of the arrangement as the upfront payment of $300,000. The option exercise fee is contingent upon Novartis exercising its right and is considered fully constrained until the option is exercised. Additionally, the milestone and royalty payments are not applicable until after the option is exercised, at which point the likelihood of meeting milestones, regulatory approval and meeting certain sales thresholds will be assessed. The transaction price was allocated to the three identified performance obligations based on a relative fair value basis. The standalone selling price of the material right for the option to the exclusive product license was calculated as the incremental discount between (i) the value of the license determined using a discounted cash flow method adjusted for probability of the option being exercised and (ii) the expected option exercise fee using the most-likely-amount method at option exercise. The standalone selling price of the combined performance obligation for Novartis' right to access ociperlimab for its own clinical trials during the option period and the initial transfer of BeiGene know-how was determined using a discounted cash flow method. The standalone selling price of the ociperlimab R&D Services was determined using an expected cost plus margin approach. Based on the relative standalone selling prices of the three performance obligations, $71,980 of the total transaction price was allocated to the material right, $213,450 was allocated to Novartis' right to use ociperlimab in its own clinical trials during the option period and the transfer of BeiGene know-how, and $14,570 was allocated to the ociperlimab R&D Services.
The Company will satisfy the material right performance obligation at a point in time at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period. As such, the entire amount of the transaction price allocated to the material right was deferred. The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period. The portion of the transaction price allocated to the ociperlimab R&D Services was deferred and is being recognized as collaboration revenue as the ociperlimab R&D Services are performed over the expected option period. The Company recognized collaboration revenue of $26,248 and $52,497 related to Novartis right to access ociperlimab in clinical trials and the transfer of know how performance obligation during the three and six months ended June 30, 2022, respectively, and R&D service revenue of $1,792 and $3,584 during the three and six months ended June 30, 2022, respectively.
In-Licensing Arrangements
Amgen
In October 2019, the Company entered into a global strategic oncology collaboration with Amgen ("Amgen Collaboration Agreement") for the commercialization and development in China, excluding Hong Kong, Taiwan and Macau, of Amgen’s XGEVA®, KYPROLIS®, and BLINCYTO®, and the joint global development of a portfolio of oncology assets in Amgen’s pipeline, with BeiGene responsible for development and commercialization in China. The agreement became effective on January 2, 2020, following approval by the Company's shareholders and satisfaction of other closing conditions.
Under the agreement, the Company is responsible for the commercialization of XGEVA®, KYPROLIS® and BLINCYTO® in China for or seven years. Amgen is responsible for manufacturing the products globally and will supply the products to the Company at an agreed upon price. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. Following the commercialization period, the Company has the right to retain one product and is entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA® was approved in China in 2019 for patients with giant cell tumor of the bone and in November 2020 for the prevention of skeletal-related events in cancer patients with bone metastases. In July 2020, the Company began commercializing XGEVA® in China. In December 2020, BLINCYTO® was approved in China for injection for the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL). In July 2021, KYPROLIS® was conditionally approved in China for injection in combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma. In April 2022, BLINCYTO® was conditionally approved for injection for the treatment of pediatric patients with R/R CD19-positive B-cell precursor ALL.
Amgen and the Company are also jointly developing a portfolio of Amgen oncology pipeline assets under the collaboration. The Company is responsible for conducting clinical development activities in China and co-funding global development costs by contributing cash and development services up to a total cap of $1,250,000. Amgen is responsible for all development, regulatory and commercial activities outside of China. For each pipeline asset that is approved in China, the Company will receive commercial rights for seven years from approval. The Company has the right to retain approximately one
15
out of every three approved pipeline assets, other than LUMAKRAS™ (sotorasib), Amgen's KRAS G12C inhibitor, for commercialization in China. The Company and Amgen will share equally in the China commercial profits and losses during the commercialization period. The Company is entitled to receive royalties from sales in China for pipeline assets returned to Amgen for five years after the seven-year commercialization period. The Company is also entitled to receive royalties from global sales of each product outside of China (with the exception of LUMAKRAS™).
The Amgen Collaboration Agreement is within the scope of ASC 808, as both parties are active participants and are exposed to the risks and rewards dependent on the commercial success of the activities performed under the agreement. The Company is the principal for product sales to customers in China during the commercialization period and recognizes 100% of net product revenue on these sales. Amounts due to Amgen for its portion of net product sales will be recorded as cost of sales. Cost reimbursements due to or from Amgen under the profit share will be recognized as incurred and recorded to cost of sales; selling, general and administrative expense; or research and development expense, based on the underlying nature of the related activity subject to reimbursement. Costs incurred for the Company's portion of the global co-development funding are recorded to research and development expense as incurred.
On April 20, 2022, the parties entered into the First Amendment to Amgen Collaboration Agreement, which amends certain terms and conditions relating to the financial responsibilities of the parties in connections with the development and commercialization of certain Amgen proprietary products for the treatment of oncology-related diseases and conditions.
In connection with the Amgen Collaboration Agreement, a Share Purchase Agreement ("SPA") was entered into by the parties in October 2019. On January 2, 2020, the closing date of the transaction, Amgen purchased 15,895,001 of the Company's ADSs for $174.85 per ADS, representing a 20.5% ownership stake in the Company. Per the SPA, the cash proceeds shall be used as necessary to fund the Company's development obligations under the Amgen Collaboration Agreement. Pursuant to the SPA, Amgen also received the right to designate one member of the Company's board of directors, and Anthony Hooper joined the Company's board of directors as the Amgen designee in January 2020.
In determining the fair value of the common stock at closing, the Company considered the closing price of the common stock on the closing date of the transaction and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $132.74 per ADS, or $2,109,902 in the aggregate. The Company determined that the premium paid by Amgen on the share purchase represents a cost share liability due to the Company's co-development obligations. The fair value of the cost share liability on the closing date was determined to be $601,857 based on the Company's discounted estimated future cash flows related to the pipeline assets. The total cash proceeds of $2,779,241 were allocated based on the relative fair value method, with $2,162,407 recorded to equity and $616,834 recorded as a research and development cost share liability. The cost share liability is being amortized proportionately as the Company contributes cash and development services to its total co-development funding cap.
Amounts recorded related to the Company's portion of the co-development funding on the pipeline assets for the three and six months ended June 30, 2022 and 2021 were as follows:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Research and development expense | 24,393 | 27,687 | 46,789 | 55,330 | ||||||||||||||||||||||
| Amortization of research and development cost share liability | 23,764 | 26,973 | 45,583 | 53,903 | ||||||||||||||||||||||
| Total amount due to Amgen for BeiGene's portion of the development funding | 48,157 | 54,660 | 92,372 | 109,233 | ||||||||||||||||||||||
| As of | ||||||||||||||||||||||||||
| June 30, | ||||||||||||||||||||||||||
| 2022 | ||||||||||||||||||||||||||
| Remaining portion of development funding cap | 698,687 | |||||||||||||||||||||||||
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As of June 30, 2022 and December 31, 2021, the research and development cost share liability recorded in the Company's balance sheet was as follows:
| As of | |||||||||||
| June 30, | December 31, | ||||||||||
| 2022 | 2021 | ||||||||||
| $ | $ | ||||||||||
| Research and development cost share liability, current portion | 125,394 | 120,801 | |||||||||
| Research and development cost share liability, non-current portion | 219,385 | 269,561 | |||||||||
| Total research and development cost share liability | 344,779 | 390,362 | |||||||||
The total reimbursement due under the commercial profit-sharing agreement for product sales is classified in the income statement for the three and six months ended June 30, 2022 and 2021 as follows:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Cost of sales - product | 2,449 | (32) | 3,478 | 678 | ||||||||||||||||||||||
| Research and development | 657 | 898 | 898 | 63 | ||||||||||||||||||||||
| Selling, general and administrative | (13,661) | (9,218) | (26,642) | (15,917) | ||||||||||||||||||||||
| Total | (10,555) | (8,352) | (22,266) | (15,176) | ||||||||||||||||||||||
The Company purchases commercial inventory from Amgen to distribute in China. Inventory purchases amounted to $22,462 and $30,061 during the three and six months ended June 30, 2022, respectively. Inventory purchases amounted to $12,138 and $18,854 during the three and six months ended June 30, 2021, respectively. Net amounts payable to Amgen as of June 30, 2022 and December 31, 2021 were $101,580 and $106,790, respectively.
4. Restricted Cash and Investments
Restricted Cash
The Company’s restricted cash balance of $4,272 and $7,209 as of June 30, 2022 and December 31, 2021, respectively, primarily consists of RMB-denominated cash deposits held in designated bank accounts for collateral for letters of credit. The Company classifies restricted cash as current or non-current based on the term of the restriction.
Short-Term Investments
Short-term investments as of June 30, 2022 consisted of the following available-for-sale debt securities:
| Gross | Gross | Fair Value | ||||||||||||||||||||||||
| Amortized | Unrealized | Unrealized | (Net Carrying | |||||||||||||||||||||||
| Cost | Gains | Losses | Amount) | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| U.S. Treasury securities | 1,184,869 | — | 12,315 | 1,172,554 | ||||||||||||||||||||||
| Total | 1,184,869 | — | 12,315 | 1,172,554 | ||||||||||||||||||||||
Short-term investments as of December 31, 2021 consisted of the following available-for-sale debt securities:
| Gross | Gross | Fair Value | ||||||||||||||||||||||||
| Amortized | Unrealized | Unrealized | (Net Carrying | |||||||||||||||||||||||
| Cost | Gains | Losses | Amount) | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| U.S. Treasury securities | 2,245,662 | — | 3,700 | 2,241,962 | ||||||||||||||||||||||
| Total | 2,245,662 | — | 3,700 | 2,241,962 | ||||||||||||||||||||||
As of June 30, 2022, the Company's available-for-sale debt securities consisted entirely of short-term U.S. treasury securities, which were determined to have zero risk of expected credit loss. Accordingly, no allowance for credit loss was recorded as of June 30, 2022.
17
Equity Securities with Readily Determinable Fair Values
Leap Therapeutics, Inc. (Leap)
In January 2020, the Company purchased $5,000 of Series B mandatorily convertible, non-voting preferred stock of Leap in connection with a strategic collaboration and license agreement the Company entered into with Leap. The Series B shares were subsequently converted into shares of Leap common stock and warrants to purchase additional shares of common stock upon approval of Leap's shareholders in March 2020. In September 2021, the Company purchased $7,250 of common stock in Leap's underwritten public offering. As of June 30, 2022, the Company's ownership interest in the outstanding common stock of Leap was 8.3% based on information from Leap. Inclusive of the shares of common stock issuable upon the exercise of the currently exercisable warrants, the Company's interest is approximately 13.1% based on information from Leap. The Company measures the investment in the common stock and warrants at fair value, with changes in fair value recorded to other income (expense), net. The Company recorded unrealized losses of $5,908 and $22,661 for the three and six months ended June 30, 2022, respectively, and $2,325 and $5,376 for the three and six months ended June 30, 2021, respectively, in the consolidated statements of operations. As of June 30, 2022 and December 31, 2021, the fair value of the common stock and warrants was as follows:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Fair value of Leap common stock | 8,451 | 23,809 | ||||||||||||
| Fair value of Leap warrants | 3,003 | 10,306 | ||||||||||||
Private Equity Securities without Readily Determinable Fair Values
The Company invests in equity securities of certain companies whose securities are not publicly traded and fair value is not readily determinable and where the Company has concluded it does not have significant influence based on its ownership percentage and other factors. These investments are recorded at cost minus impairment, if any, plus or minus changes resulting from observable price changes in orderly transactions for the identical or a similar investment of the same issuer. The Company held investments of $44,033 and $43,722 in equity securities without readily determinable fair values as of June 30, 2022 and December 31, 2021, respectively. The Company recorded a gain of $366 related to an observable price change in an orderly transaction for a similar investment of the same issuer for the three and six months ended June 30, 2022, respectively, to other income (expense), net in the consolidated statements of operations.
Equity-Method Investments
The Company records equity-method investments at cost and subsequently adjusts the basis based on the Company's ownership percentage in the investee's income and expenses, as well as dividends, if any. The Company holds equity-method investments totaling $27,100 and $22,955 as of June 30, 2022 and December 31, 2021, respectively, that it does not consider to be individually significant to its financial statements. The Company recorded unrealized losses of $647 and $1,234 for the three and six months ended June 30, 2022, respectively, and $381 and $657 for the three and six months ended June 30, 2021, respectively, to other income (expense), net in the consolidated statements of operations.
5. Inventories
The Company’s inventory balance consisted of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Raw materials | 82,848 | 78,140 | ||||||||||||
| Work in process | 37,992 | 9,397 | ||||||||||||
| Finished goods | 141,370 | 155,089 | ||||||||||||
| Total inventories | 262,210 | 242,626 | ||||||||||||
18
6. Property, plant and equipment
Property, plant and equipment are recorded at cost and consisted of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Land | 65,485 | 65,485 | ||||||||||||
| Laboratory equipment | 131,885 | 118,203 | ||||||||||||
| Leasehold improvements | 50,878 | 50,288 | ||||||||||||
| Building | 179,495 | 144,083 | ||||||||||||
| Manufacturing equipment | 138,478 | 119,585 | ||||||||||||
| Software, electronics and office equipment | 36,473 | 27,404 | ||||||||||||
| Property, plant and equipment, at cost | 602,694 | 525,048 | ||||||||||||
| Less: accumulated depreciation | (142,561) | (124,286) | ||||||||||||
| Construction in progress | 172,967 | 186,843 | ||||||||||||
| Property, plant and equipment, net | 633,100 | 587,605 | ||||||||||||
In November 2021, the Company purchased a 42-acre site located in Hopewell, NJ for $75,197. The total purchase price was allocated between the land and an existing building on the property based on their relative fair values. The Company is constructing a biologics manufacturing facility and research and development center on the land.
Depreciation expense was $14,461 and $30,041 for the three and six months ended June 30, 2022, respectively, and $11,223 and $20,667 for the three and six months ended June 30, 2021, respectively.
7. Intangible Assets
Intangible assets as of June 30, 2022 and December 31, 2021 are summarized as follows:
| As of | ||||||||||||||||||||||||||||||||||||||
| June 30, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||
| Gross | Gross | |||||||||||||||||||||||||||||||||||||
| carrying | Accumulated | Intangible | carrying | Accumulated | Intangible | |||||||||||||||||||||||||||||||||
| amount | amortization | assets, net | amount | amortization | assets, net | |||||||||||||||||||||||||||||||||
| $ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||||||||
| Finite-lived intangible assets: | ||||||||||||||||||||||||||||||||||||||
| Product distribution rights | 7,500 | (3,625) | 3,875 | 7,500 | (3,250) | 4,250 | ||||||||||||||||||||||||||||||||
| Developed product | 42,016 | (2,566) | 39,450 | 43,394 | (965) | 42,429 | ||||||||||||||||||||||||||||||||
| Trading license | 816 | (816) | — | 816 | (816) | — | ||||||||||||||||||||||||||||||||
| Total finite-lived intangible assets | 50,332 | (7,007) | 43,325 | 51,710 | (5,031) | 46,679 | ||||||||||||||||||||||||||||||||
Product distribution rights consist of distribution rights on the approved cancer therapies licensed from Bristol Myers Squibb ("BMS") as part of the BMS collaboration. The Company is amortizing the product distribution rights, as a single identified asset, over a period of 10 years from the date of acquisition. Developed products represent the post-approval milestone payments under license and commercialization agreements. The Company is amortizing the developed products over the remainder of the respective product patent or the term of the commercialization agreements. Trading license represents the Guangzhou drug distribution license acquired in September 2018. The Company amortized the drug distribution trading license over the remainder of the initial license term through February 2020. The trading license has been renewed through February 2024.
Amortization expense for developed product is included in cost of sales - product in the accompanying consolidated statements of operations. Amortization expense for product distribution rights and the trading licenses is included in operating expenses in the accompanying consolidated statements of operations.
19
The weighted-average life for each finite-lived intangible assets is approximately 12 years. Amortization expense was as follows:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
Amortization expense - Cost of sales - product | 812 | 117 | 1,644 | 117 | ||||||||||||||||||||||
Amortization expense - Operating expense | 188 | 187 | 376 | 375 | ||||||||||||||||||||||
| 1,000 | 304 | 2,020 | 492 | |||||||||||||||||||||||
Estimated amortization expense for each of the five succeeding years and thereafter, as of June 30, 2022 is as follows:
| Year Ending December 31, | Cost of Sales - Product | Operating Expenses | Total | |||||||||||||||||
| $ | $ | $ | ||||||||||||||||||
2022 (remainder of year) | 1,614 | 375 | 1,989 | |||||||||||||||||
| 2023 | 3,222 | 750 | 3,972 | |||||||||||||||||
| 2024 | 3,222 | 750 | 3,972 | |||||||||||||||||
| 2025 | 3,222 | 750 | 3,972 | |||||||||||||||||
| 2026 | 3,222 | 750 | 3,972 | |||||||||||||||||
| 2027 and thereafter | 24,948 | 500 | 25,448 | |||||||||||||||||
| Total | 39,450 | 3,875 | 43,325 | |||||||||||||||||
8. Income Taxes
Income tax expense was $13,864 and $26,889 for the three and six months ended June 30, 2022, respectively. Income tax benefit was $230 and $4,860 for the three and six months ended June 30, 2021, respectively. The income tax expense for the three and six months ended June 30, 2022 relating to income reported by certain subsidiaries was primarily attributable to China tax expense determined after certain non-deductible expenses and U.S. tax expense determined after research and development tax credits, other special tax deductions and non-deductible U.S. stock compensation. The income tax benefit for the three and six months ended June 30, 2021 was primarily attributable to the deferred tax benefit of U.S. stock-based compensation deductions in excess of tax expense on income reported in certain China subsidiaries as adjusted for certain non-deductible expenses.
On a quarterly basis, the Company evaluates the realizability of deferred tax assets by jurisdiction and assesses the need for a valuation allowance. In assessing the realizability of deferred tax assets, the Company considers historical profitability, evaluation of scheduled reversals of deferred tax liabilities, projected future taxable income and tax-planning strategies. Valuation allowances have been provided on deferred tax assets where, based on all available evidence, it was considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. After consideration of all positive and negative evidence, the Company believes that as of June 30, 2022, it is more likely than not that deferred tax assets will not be realized for the Company’s subsidiaries in Australia and Switzerland, in certain subsidiaries in China and for all U.S. tax credit carryforwards.
As of June 30, 2022, the Company had gross unrecognized tax benefits of $11,765. The Company does not anticipate that the amount of existing unrecognized tax benefits will significantly change within the next 12 months. The Company’s reserve for uncertain tax positions increased by $951 and $1,840, respectively, in the three and six months ended June 30, 2022 primarily due to U.S. federal and state tax credits and incentives.
The Company has elected to record interest and penalties related to income taxes as a component of income tax expense. As of June 30, 2022 and December 31, 2021, the Company's accrued interest and penalties, where applicable, related to uncertain tax positions were not material.
The Company conducts business in a number of tax jurisdictions and, as such, is required to file income tax returns in multiple jurisdictions globally. As of June 30, 2022, Australia tax matters are open to examination for the years 2013 through 2022, China tax matters are open to examination for the years 2012 through 2022, Switzerland tax matters are open to examination for the years 2018 through 2022, and U.S. federal tax matters are open to examination for years 2015 through
20
2022. Various U.S. states and other non-US tax jurisdictions in which the Company files tax returns remain open to examination for 2011 through 2022.
9. Supplemental Balance Sheet Information
The roll-forward of the allowance for credit losses related to trade accounts receivable for the six months ended June 30, 2022 and 2021 consists of the following activity:
| Six Months Ended | ||||||||||||||
| June 30, | ||||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Balance at beginning of the period | 415 | 112 | ||||||||||||
| Current period provision for expected credit losses | (210) | (46) | ||||||||||||
| Amounts written-off | — | — | ||||||||||||
| Exchange rate changes | 3 | 1 | ||||||||||||
| Balance at end of the period | 208 | 67 | ||||||||||||
Prepaid expenses and other current assets consist of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Prepaid research and development costs | 72,474 | 87,239 | ||||||||||||
| Prepaid manufacturing cost | 59,291 | 78,538 | ||||||||||||
| Prepaid taxes | 18,627 | 58,579 | ||||||||||||
| Other receivables | 17,409 | 12,010 | ||||||||||||
| Interest receivable | 2,611 | 5,052 | ||||||||||||
| Prepaid insurance | 8,462 | 1,695 | ||||||||||||
| Other current assets | 28,509 | 27,060 | ||||||||||||
| Total | 207,383 | 270,173 | ||||||||||||
Other non-current assets consist of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Goodwill | 109 | 109 | ||||||||||||
| Prepayment of property and equipment | 14,412 | 14,140 | ||||||||||||
| Prepayment of facility capacity expansion activities (1) | 21,473 | 24,237 | ||||||||||||
| Prepaid VAT | 29 | 17,162 | ||||||||||||
| Rental deposits and other | 7,345 | 6,609 | ||||||||||||
| Long-term investments (Note 4) | 87,587 | 100,792 | ||||||||||||
| Total | 130,955 | 163,049 | ||||||||||||
(1) Represents payments for facility expansions under commercial supply agreements. The payments are providing future benefit to the Company through credits on commercial supply purchases.
21
Accrued expenses and other payables consist of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Compensation related | 124,565 | 139,966 | ||||||||||||
| External research and development activities related | 151,321 | 213,922 | ||||||||||||
| Commercial activities | 55,366 | 71,560 | ||||||||||||
| Employee tax withholdings | 23,525 | 45,661 | ||||||||||||
| Sales rebates and returns related | 71,512 | 59,639 | ||||||||||||
| Professional fees and other | 27,894 | 27,307 | ||||||||||||
| Total | 454,183 | 558,055 | ||||||||||||
Other long-term liabilities consist of the following:
| As of | ||||||||||||||
| June 30, | December 31, | |||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Deferred government grant income | 40,835 | 46,352 | ||||||||||||
| Pension liability | 7,484 | 7,814 | ||||||||||||
| Other | 113 | 68 | ||||||||||||
| Total | 48,432 | 54,234 | ||||||||||||
10. Debt
The following table summarizes the Company's short-term and long-term debt obligations as of June 30, 2022 and December 31, 2021:
| Lender | Agreement Date | Line of Credit | Term | Maturity Date | Interest Rate | As of | ||||||||||||||||||||||||||||||||||||||||||||||||||
| June 30, 2022 | December 31, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| $ | RMB | $ | RMB | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| China Construction Bank | April 4, 2018 | RMB580,000 | 9-year | April 4, 2027 | (1) | 4,330 | 29,000 | 1,255 | 8,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| China Merchants Bank | January 22, 2020 | (2) | 9-year | January 20, 2029 | (2) | 1,493 | 10,000 | 1,569 | 10,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| China Merchants Bank | November 9, 2020 | RMB378,000 | 9-year | November 8, 2029 | (3) | 2,613 | 17,500 | — | — | |||||||||||||||||||||||||||||||||||||||||||||||
| China Minsheng Bank (the "Senior Loan") | September 24, 2020 | $200,000 | (4) | 4.5 | % | 200,000 | 1,339,585 | 200,000 | 1,274,535 | |||||||||||||||||||||||||||||||||||||||||||||||
| Zhuhai Hillhouse (the "Related Party Loan") | September 24, 2020 | RMB500,000 | (5) | 4.5 | % | 14,930 | 100,000 | 15,693 | 100,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| Shanghai Pudong Development Bank | February 25, 2022 | $50,000 | 1-year | February 25, 2023 | 2.2 | % | 50,000 | 334,896 | — | — | ||||||||||||||||||||||||||||||||||||||||||||||
| Other short-term debt (6) | 107,363 | 719,115 | 209,048 | 1,332,197 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total short-term debt | 380,729 | 2,550,096 | 427,565 | 2,724,732 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| China Construction Bank | April 4, 2018 | RMB580,000 | 9-year | April 4, 2027 | (1) | 81,368 | 545,000 | 89,444 | 570,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| China Merchants Bank | January 22, 2020 | (2) | 9-year | January 20, 2029 | (2) | 50,016 | 335,000 | 53,353 | 340,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| China Merchants Bank | November 9, 2020 | RMB378,000 | 9-year | November 8, 2029 | (3) | 53,823 | 360,500 | 59,316 | 378,000 | |||||||||||||||||||||||||||||||||||||||||||||||
| Total long-term bank loans | 185,207 | 1,240,500 | 202,113 | 1,288,000 | ||||||||||||||||||||||||||||||||||||||||||||||||||||
1.The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.9% as of June 30, 2022. The loan is secured by BeiGene Guangzhou Factory's land use right and certain Guangzhou Factory fixed assets in the first phase of the Guangzhou manufacturing facility's build out. The Company repaid $598(RMB4,000) during the six months ended June 30, 2022.
2.On January 22, 2020, BeiGene Guangzhou Biologics Manufacturing Co., Ltd.("BeiGene Guangzhou Factory") entered into a nine-year bank loan with China Merchants Bank to borrow up to RMB1,100,000 at a floating interest rate benchmarked against prevailing interest rates of certain PRC financial
22
institutions. The loan is secured by Guangzhou Factory's second land use right and fixed assets placed into service upon completion of the second phase of the Guangzhou manufacturing facility's build out. In connection with the Company's short-term loan agreements with China Merchants Bank entered into during the year ended December 31, 2020, the borrowing capacity was reduced from RMB1,100,000 to RMB350,000. The loan interest rate was 4.4% as of June 30, 2022. The Company repaid $771(RMB5,000) during the six months ended June 30, 2022. BeiGene Guangzhou Biologics Manufacturing Co., Ltd. is a company incorporated under the laws of the PRC on March 3, 2017 and a wholly owned subsidiary of BeiGene Biologics.
3.The outstanding borrowings bear floating interest rates benchmarking RMB loan interest rates of financial institutions in the PRC. The loan interest rate was 4.3% as of June 30, 2022. The loan is secured by fixed assets placed into service upon completion of the third phase of the Guangzhou manufacturing facility's build out.
4.In September 2020, the Company entered into a loan agreement with China Minsheng Bank for a total loan facility of up to $200,000 ("Senior Loan"), of which $120,000 was designated to fund the purchase of noncontrolling equity interest in BeiGene Biologics Co., Ltd. ("BeiGene Biologics") from Guangzhou GET Technology Development Co., Ltd. (now Guangzhou High-tech Zone Technology Holding Group Co., Ltd.) ("GET") and repayment of the loan provided by GET ("Shareholder Loan") and $80,000 was designated for general working capital purposes. The Senior Loan had an original maturity date of October 8, 2021, which was the first anniversary of the first date of utilization of the loan. The Company may extend the original maturity date for up to two additional 12 month periods. On October 8, 2021, the Company extended the maturity date for twelve months to October 8, 2022 and repurposed the Senior Loan for general working capital purposes. BeiGene Biologics Co., Ltd. is a company incorporated under the laws of the PRC on January 25, 2017 and an indirectly wholly owned subsidiary of the Company.
5.In September 2020, the Company entered into a loan agreement with Zhuhai Hillhouse Zhaohui Equity Investment Partnership (Zhuhai Hillhouse) for a total loan facility of $73,640 (RMB500,000) ("Related Party Loan"), of which $14,728 (RMB100,000) can be used for general corporate purposes and $58,912 (RMB400,000) can only be applied towards the repayment of the Senior Loan facility, including principal, interest and fees. The loan maturity was the earlier of: (i) November 9, 2021, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. On October 8, 2021, the Company extended the maturity date of the Related Party Loan to the earlier of: (i) November 9, 2022, which is one month after the Senior Loan maturity date, if not extended, or (ii) 10 business days after the Senior Loan is fully repaid. Zhuhai Hillhouse is a related party of the Company, as it is an affiliate of Hillhouse Capital. Hillhouse Capital is a shareholder of the Company, and a Hillhouse Capital employee is a member of the Company's board of directors.
6.During the year ended December 31, 2021 and 2020, the Company entered into additional short-term working capital loans with China Industrial Bank and China Merchants Bank to borrow up to RMB1,760,000 in aggregate, with maturity dates ranging from April 19, 2021 to May 24, 2023. The Company drew down $17,586 (RMB117,000) and repaid $114,036 (RMB730,082) of the short-term loans in the six months ended June 30, 2022. The weighted average interest rate for the short-term working capital loans was approximately 4.1% as of June 30, 2022.
Interest Expense
Interest expense recognized for the three and six months ended June 30, 2022 was $5,456 and $10,984, respectively, among which, $654 and $1,935 was capitalized, respectively. Interest expense recognized for the three and six months ended June 30, 2021 was $7,627 and $14,577, respectively, among which, $147 and $251 was capitalized, respectively.
11. Product Revenue
The Company’s product revenue is primarily derived from the sale of its internally developed products BRUKINSA® in the United States and China, and tislelizumab and pamiparib in China; REVLIMID® and VIDAZA® in China under a license from BMS; XGEVA®, BLINCYTO® and KYPROLIS® in China under a license from Amgen; and POBEVCY® in China under a license from Bio-Thera.
The table below presents the Company’s net product sales for the three and six months ended June 30, 2022 and 2021.
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Product revenue – gross | 342,885 | 148,312 | 638,273 | 291,794 | ||||||||||||||||||||||
| Less: Rebates and sales returns | (38,374) | (9,688) | (72,189) | (47,053) | ||||||||||||||||||||||
| Product revenue – net | 304,511 | 138,624 | 566,084 | 244,741 | ||||||||||||||||||||||
23
The following table disaggregates net product sales by product for the three and six months ended June 30, 2022 and 2021:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
BRUKINSA® | 128,747 | 42,423 | 233,072 | 64,513 | ||||||||||||||||||||||
| Tislelizumab | 104,879 | 74,879 | 192,522 | 123,758 | ||||||||||||||||||||||
REVLIMID® | 19,916 | 10,146 | 41,576 | 26,775 | ||||||||||||||||||||||
XGEVA® | 15,509 | 3,338 | 29,008 | 17,792 | ||||||||||||||||||||||
POBEVCY® | 12,983 | — | 19,798 | — | ||||||||||||||||||||||
BLINCYTO® | 9,530 | — | 21,396 | — | ||||||||||||||||||||||
KYPROLIS® | 4,092 | — | 8,405 | — | ||||||||||||||||||||||
VIDAZA® | 3,434 | 3,255 | 8,946 | 6,961 | ||||||||||||||||||||||
| Pamiparib | 2,022 | 2,221 | 4,577 | 2,221 | ||||||||||||||||||||||
| Other | 3,399 | 2,362 | 6,784 | 2,721 | ||||||||||||||||||||||
| Total product revenue – net | 304,511 | 138,624 | 566,084 | 244,741 | ||||||||||||||||||||||
The following table presents the roll-forward of accrued sales rebates and returns for the six months ended June 30, 2022 and 2021:
| Six Months Ended | ||||||||||||||
| June 30, | ||||||||||||||
| 2022 | 2021 | |||||||||||||
| $ | $ | |||||||||||||
| Balance at beginning of the period | 59,639 | 11,874 | ||||||||||||
| Accrual | 72,189 | 47,053 | ||||||||||||
| Payments | (60,316) | (33,355) | ||||||||||||
| Balance at end of the period | 71,512 | 25,572 | ||||||||||||
12. Loss Per Share
The following table reconciles the numerator and denominator in the computations of basic and diluted loss per share:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Numerator: | ||||||||||||||||||||||||||
| Net loss | (571,449) | (480,341) | (1,005,723) | (413,846) | ||||||||||||||||||||||
| Denominator: | ||||||||||||||||||||||||||
| Weighted average shares outstanding—basic and diluted | 1,336,463,026 | 1,194,071,476 | 1,334,252,648 | 1,191,521,766 | ||||||||||||||||||||||
For the three and six months ended June 30, 2022 and 2021, the computation of basic loss per share using the two-class method was not applicable as the Company was in a net loss position, and the effects of all share options, restricted shares, restricted share units and ESPP shares were excluded from the calculation of diluted loss per share, as their effect would have been anti-dilutive.
13. Share-Based Compensation Expense
2016 Share Option and Incentive Plan
In January 2016, in connection with the Company's initial public offering ("IPO") on the Nasdaq Stock Market, the board of directors and shareholders of the Company approved the 2016 Share Option and Incentive Plan (the “2016 Plan”), which became effective in February 2016. The Company initially reserved 65,029,595 ordinary shares for the issuance of awards
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under the 2016 Plan, plus any shares available under the 2011 Option Plan (the “2011 Plan”), and not subject to any outstanding options as of the effective date of the 2016 Plan, along with underlying share awards under the 2011 Plan that are cancelled or forfeited without issuance of ordinary shares. As of June 30, 2022, ordinary shares cancelled or forfeited under the 2011 Plan that were carried over to the 2016 Plan totaled 5,166,510. In December 2018, the shareholders approved an amended and restated 2016 Plan to increase the number of shares authorized for issuance by 38,553,159 ordinary shares, as well as amend the cap on annual compensation to independent directors and make other changes. In June 2020, the shareholders approved an Amendment No. 1 to the 2016 Plan to increase the number of shares authorized for issuance by 57,200,000 ordinary shares and to extend the term of the plan through April 13, 2030. The number of shares available for issuance under the 2016 Plan is subject to adjustment in the event of a share split, share dividend or other change in the Company’s capitalization.
During the six months ended June 30, 2022, the Company granted options for 12,159,745 ordinary shares and restricted share units for 33,193,771 ordinary shares under the 2016 Plan. As of June 30, 2022, options and restricted share units for ordinary shares outstanding under the 2016 Plan totaled 63,489,649 and 57,144,906, respectively. As of June 30, 2022, share-based awards to acquire 74,479,333 ordinary shares were available for future grant under the 2016 Plan.
In order to continue to provide incentive opportunities under the 2016 Plan, the Board of Directors and shareholders of the Company approved an amendment to the 2016 Plan (the "Amendment No. 2"), which became effective as of June 22, 2022, to increase the number of authorized shares available for issuance under the 2016 Plan by 66,300,000 ordinary shares, or 5% of the Company's outstanding shares as of March 31, 2022.
2018 Inducement Equity Plan
In June 2018, the board of directors of the Company approved the 2018 Inducement Equity Plan (the "2018 Plan") and reserved 12,000,000 ordinary shares to be used exclusively for grants of awards to individuals that were not previously employees of the Company or its subsidiaries, as a material inducement to the individual’s entry into employment with the Company or its subsidiaries within the meaning of Rule 5635(c)(4) of the Nasdaq Listing Rules. The 2018 Plan was approved by the board of directors upon recommendation of the compensation committee, without shareholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the 2018 Plan, and the forms of award agreements to be used thereunder, are substantially similar to the 2016 Plan and the forms of award agreements thereunder. In August 2018, in connection with the Hong Kong IPO, the board of directors of the Company approved an amended and restated 2018 Plan to implement changes required by the listing rules of the Stock Exchange of Hong Kong Limited ("HKEX").
During the six months ended June 30, 2022, the Company did not grant any options or restricted share units under the 2018 Plan. As of June 30, 2022, options and restricted share units for ordinary shares outstanding under the 2018 Plan totaled 30,901 and 408,408, respectively.
Upon the effectiveness of Amendment No. 2 to the 2016 Plan, on June 22, 2022, the 2018 Plan was terminated to the effect that no new equity awards shall be granted under the plan but the outstanding equity awards under the plan shall continue to vest and/or be exercisable in accordance with their terms.
2018 Employee Share Purchase Plan
In June 2018, the shareholders of the Company approved the 2018 Employee Share Purchase Plan (the “ESPP”). Initially, 3,500,000 ordinary shares of the Company were reserved for issuance under the ESPP. In December 2018, the board of directors of the Company approved an amended and restated ESPP to increase the number of shares authorized for issuance by 3,855,315 ordinary shares to 7,355,315 ordinary shares. In June 2019, the board of directors adopted an amendment to revise the eligibility criteria for enrollment in the plan. In June 2021, the board of directors of the Company adopted the third amended and restated ESPP to include certain technical amendments under U.S. tax rules and to consolidate the changes in the prior amendment, to be effective on September 1, 2021. The ESPP allows eligible employees to purchase the Company’s ordinary shares (including in the form of ADSs) at the end of each offering period, which will generally be six months, at a 15% discount to the market price of the Company’s ADSs at the beginning or the end of each offering period, whichever is lower, using funds deducted from their payroll during the offering period. Eligible employees are able to authorize payroll deductions of up to 10% of their eligible earnings, subject to applicable limitations.
As of June 30, 2022, 4,527,386 ordinary shares were available for future issuance under the ESPP.
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The following tables summarizes the shares issued under the ESPP:
Market Price1 | Purchase Price2 | |||||||||||||||||||||||||||||||||||||
| Issuance Date | Number of Ordinary Shares Issued | ADS | Ordinary | ADS | Ordinary | Proceeds | ||||||||||||||||||||||||||||||||
| February 28, 2022 | 667,160 | $ | 210.52 | $ | 16.19 | $ | 178.94 | $ | 13.76 | $ | 9,183 | |||||||||||||||||||||||||||
| August 31, 2021 | 425,386 | $ | 308.30 | $ | 23.72 | $ | 262.06 | $ | 20.16 | $ | 8,575 | |||||||||||||||||||||||||||
| February 26, 2021 | 436,124 | $ | 236.30 | $ | 18.18 | $ | 200.86 | $ | 15.45 | $ | 6,738 | |||||||||||||||||||||||||||
1 The market price is the lower of the closing price on the Nasdaq Stock Market on the issuance date or the offering date, in accordance with the terms of the ESPP.
2 The purchase price is the price which was discounted from the applicable market price, in accordance with the terms of the ESPP.
The following table summarizes total share-based compensation expense recognized for the three and six months ended June 30, 2022 and 2021:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Research and development | 37,107 | 30,193 | 67,965 | 52,082 | ||||||||||||||||||||||
| Selling, general and administrative | 44,198 | 34,598 | 78,895 | 58,542 | ||||||||||||||||||||||
| Total | 81,305 | 64,791 | 146,860 | 110,624 | ||||||||||||||||||||||
14. Accumulated Other Comprehensive Income (Loss)
The movement of accumulated other comprehensive income (loss) was as follows:
| Unrealized | ||||||||||||||||||||||||||
| Foreign Currency | Gains/(Losses) on | Pension | ||||||||||||||||||||||||
| Translation | Available-for-Sale | Liability | ||||||||||||||||||||||||
| Adjustments | Securities | Adjustments | Total | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| Balance as of December 31, 2021 | 27,898 | (3,700) | (6,248) | 17,950 | ||||||||||||||||||||||
| Other comprehensive loss before reclassifications | (88,085) | (12,315) | — | (100,400) | ||||||||||||||||||||||
| Amounts reclassified from accumulated other comprehensive income (loss) | — | — | — | — | ||||||||||||||||||||||
| Net-current period other comprehensive loss | (88,085) | (12,315) | — | (100,400) | ||||||||||||||||||||||
| Balance as of June 30, 2022 | (60,187) | (16,015) | (6,248) | (82,450) | ||||||||||||||||||||||
15. Shareholders’ Equity
Share Purchase Agreement
In September 2021, the Company issued an aggregate of 165,529 ADSs, representing 2,151,877 ordinary shares, to Amgen for a total consideration of $50,000, in a private placement pursuant to a Share Purchase Agreement dated October 31, 2019, as amended on December 6, 2019 and September 24, 2020 by and between Amgen and Company.
STAR Offering
In December 2021, the Company completed an initial public offering of ("STAR Offering") on the Science and Technology Innovation Board (STAR Market) of the Shanghai Stock Exchange ("SSE"). The shares offered in the STAR Offering were issued to and subscribed for by permitted investors in the People’s Republic of China ("PRC") in Renminbi ("RMB Shares"). The public offering price of the RMB Shares was RMB192.60 per ordinary share, or $391.68 per ADS. In this offering, the Company sold 115,055,260 ordinary shares. Net proceeds after deducting underwriting discounts and commission and offering expenses were $3,392,616. As required by the PRC securities laws, the net proceeds from the STAR Offering must be used in strict compliance with the planned uses as disclosed in the PRC prospectus as well as the Company's proceeds management policy for the STAR Offering approved by the board of directors.
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16. Restricted Net Assets
The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its PRC subsidiaries. Relevant PRC statutory laws and regulations permit payments of dividends by the Company’s PRC subsidiaries only out of the subsidiary's retained earnings, if any, as determined in accordance with PRC accounting standards and regulations. The results of operations reflected in the condensed consolidated financial statements prepared in accordance with GAAP differ from those reflected in the statutory financial statements of the Company’s PRC subsidiaries.
In accordance with the company law of the PRC, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s PRC statutory accounts. A domestic enterprise is also required to provide discretionary surplus reserve, at the discretion of the board of directors, from the profits determined in accordance with the enterprise’s PRC statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s PRC subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits.
As a result of these PRC laws and regulations, including the requirement to make annual appropriations of at least 10% of after-tax income and set aside as general reserve fund prior to payment of dividends, the Company’s PRC subsidiaries are restricted in their ability to transfer a portion of their net assets to the Company.
Foreign exchange and other regulations in the PRC may further restrict the Company's PRC subsidiaries from transferring funds to the Company in the form of dividends, loans and advances. As of June 30, 2022 and December 31, 2021, the net assets of the Company’s PRC subsidiaries amounted to $2,448,530 and $799,574, respectively.
17. Commitments and Contingencies
Purchase Commitments
As of June 30, 2022, the Company had purchase commitments amounting to $109,700, of which $65,020 related to minimum purchase requirements for supply purchased from contract manufacturing organizations and $44,680 related to binding purchase obligations of inventory from BMS and Amgen. The Company does not have any minimum purchase requirements for inventory from BMS or Amgen.
Capital Commitments
The Company had capital commitments amounting to $308,141 for the acquisition of property, plant and equipment as of June 30, 2022, which were mainly for the Company’s manufacturing and clinical R&D campus in Hopewell, NJ, and additional capacity at the Guangzhou and Suzhou manufacturing facilities.
Co-Development Funding Commitment
Under the Amgen Collaboration Agreement, the Company is responsible for co-funding global development costs for the Amgen oncology pipeline assets up to a total cap of $1,250,000. The Company is funding its portion of the co-development costs by contributing cash and development services. As of June 30, 2022, the Company's remaining co-development funding commitment was $698,687.
Research and Development Commitment
The Company entered into a long-term research and development agreement in June 2021, which includes obligations to make an upfront payment and fixed quarterly payments over the next four years. As of June 30, 2022, the total research and development commitment amounted to $25,173.
Funding Commitment
The Company had committed capital related to an equity method investment in the amount of $15,000. As of June 30, 2022, the remaining capital commitment was $12,750 and is expected to be paid from time to time over the investment period.
Pension Commitment
The Company maintains a defined benefit pension plan in Switzerland. Funding obligations under the defined benefit pension plan are equivalent to $1,536 per year based on annual funding contributions in effect as of June 30, 2022 to achieve fully funded status where the market value of plan assets equals the projected benefit obligations. Future funding requirements will be subject to change as a result of future changes in staffing and compensation levels, various actuarial assumptions and actual investment returns on plan assets.
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Other Business Agreements
The Company enters into agreements in the ordinary course of business with contract research organizations ("CROs") to provide research and development services. These contracts are generally cancellable at any time by us with prior written notice.
The Company also enters into collaboration agreements with institutions and companies to license intellectual property. The Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products associated with its collaboration agreements. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. These commitments are not recorded on the Company's balance sheet because the achievement and timing of these milestones are not fixed and determinable. When the achievement of these milestones or sales have occurred, the corresponding amounts are recognized in the Company’s financial statements.
18. Segment and Geographic Information
The Company operates in one segment: pharmaceutical products. Its chief operating decision maker is the Chief Executive Officer, who makes operating decisions, assesses performance and allocates resources on a consolidated basis.
The Company’s long-lived assets are primarily located in the PRC and the U.S.
Net product revenues by geographic area are based upon the location of the customer, and net collaboration revenue is recorded in the jurisdiction in which the related income is expected to be sourced from. Total net revenues by geographic area are presented as follows:
| Three Months Ended | Six Months Ended | |||||||||||||||||||||||||
| June 30, | June 30, | |||||||||||||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
| $ | $ | $ | $ | |||||||||||||||||||||||
| PRC | 212,429 | 122,635 | 403,164 | 218,617 | ||||||||||||||||||||||
| United States | 114,324 | 23,846 | 213,749 | 383,809 | ||||||||||||||||||||||
| Rest of world | 14,819 | 3,511 | 31,285 | 153,438 | ||||||||||||||||||||||
| Total | 341,572 | 149,992 | 648,198 | 755,864 | ||||||||||||||||||||||
PRC revenues consisted entirely of product revenues for the three and six months ended June 30, 2022 and 2021. U.S. revenues for the three and six months ended June 30, 2022 consisted of collaboration revenue of $25,943 and $57,480, respectively, and BRUKINSA® product sales of $88,381 and $156,269, respectively. U.S. revenues for the three and six months ended June 30, 2021 consisted of collaboration revenue of $7,958 and $357,786, respectively, and BRUKINSA® product sales of $15,888 and $26,023, respectively. Rest of world revenues for the three and six months ended June 30, 2022 consisted of collaboration revenue of $11,118 and $24,634, respectively, and BRUKINSA® product sales of $3,701 and $6,651, respectively. Rest of world revenues consisted entirely of collaboration revenues for the three and six months ended June 30, 2021.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our condensed consolidated financial statements (unaudited) and related notes included in the section of this Quarterly Report on Form 10-Q (this “Quarterly Report”), titled “Part I – Item 1 – Financial Statements.” This Quarterly Report contains forward-looking statements that are based on management’s beliefs and assumptions and on information currently available to management. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. These forward-looking statements, include, but are not limited to, statements regarding: our ability to successfully commercialize our approved medicines and to obtain approvals in additional indications and territories for our medicines; our ability to successfully develop and commercialize our in-licensed medicines and drug candidates and any other medicines and drug candidates we may in-license; our ability to successfully develop and commercialize oncology assets licensed from our partners pursuant to our global strategic oncology collaborations; our ability to further develop sales and marketing capabilities and launch and commercialize new medicines, if approved; our ability to maintain and expand regulatory approvals for our medicines and drug candidates, if approved; the pricing and reimbursement of our medicines and drug candidates, if approved; the initiation, timing, progress and results of our preclinical studies and clinical trials and our research and development programs; our ability to advance our drug candidates into, and successfully complete, clinical trials and obtain regulatory approvals; our reliance on the success of our clinical stage drug candidates; our plans, expected milestones and the timing or likelihood of regulatory filings and approvals; the implementation of our business model, strategic plans for our business, medicines, drug candidates and technology; the scope of protection we (or our licensors) are able to establish and maintain for intellectual property rights covering our medicines, drug candidates and technology; the scope of protection we (or our licensors) are able to establish and maintain for intellectual property rights covering our medicines, drug candidates and technology; our ability to operate our business without infringing, misappropriating or otherwise violating the intellectual property rights and proprietary technology of third parties; costs associated with enforcing or defending against intellectual property infringement, misappropriation or violation, product liability and other claims; regulatory environment and regulatory developments in the United States, China, UK, EU and other jurisdictions in which we operate; the accuracy of our estimates regarding expenses, revenues, capital requirements and our need for additional financing; the potential benefits of strategic collaboration and licensing agreements and our ability to enter into strategic arrangements; our ability to maintain and establish collaborations or licensing agreements; our reliance on third parties to conduct drug development, manufacturing and other services; our ability to manufacture and supply, or have manufactured and supplied, drug candidates for clinical development and medicines for commercial sale; the rate and degree of market access and acceptance and the pricing and reimbursement of our medicines and drug candidates, if approved; developments relating to our competitors and industry, including competing therapies; the size of the potential markets for our medicines and drug candidates and our ability to serve those markets; our ability to effectively manage our growth; our ability to attract and retain qualified employees and key personnel; statements regarding future revenue, hiring plans, expenses, capital expenditures, capital requirements and share performance; the future trading price of our ADSs, ordinary shares and RMB Shares, and impact of securities analysts’ reports on these prices; our foreign currency risk exposure due to fluctuations in exchange rates; the impact of the COVID-19 pandemic on our clinical development, commercial, manufacturing, and other operations; and other risks and uncertainties, including those listed under “Part II – Item 1A – Risk Factors” of this Quarterly Report. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those described in “Part II – Item 1A – Risk Factors” of this Quarterly Report. These forward-looking statements speak only as of the date hereof. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Unless the context requires otherwise, in this Quarterly Report, the terms “BeiGene,” the “Company,” “we,” “us” and “our” refer to BeiGene, Ltd., a Cayman Islands holding company with operations conducted by its subsidiaries, and its subsidiaries, on a consolidated basis.
Overview
We are a global biotechnology company focused on developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and expand access for patients worldwide.
We currently have three approved medicines that were discovered and developed in our own labs, including BRUKINSA®, a small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK) for the treatment of various blood cancers; tislelizumab, an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and pamiparib, a selective small molecule inhibitor of PARP1 and PARP2. We have obtained approvals to market BRUKINSA® in the United States, China,
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EU, the UK, Canada, Australia and additional international markets, and tislelizumab and pamiparib in China. By leveraging our China commercial capabilities, we have in-licensed the rights to distribute 13 approved medicines for the China market. Supported by our global clinical development and commercial capabilities, we have entered into collaborations with world-leading biopharmaceutical companies such as Amgen Inc. ("Amgen") and Novartis Pharma AG ("Novartis") to develop and commercialize innovative medicines.
We are committed to advancing best and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. Our internal clinical development capabilities are deep, including a more than 2,500-person global clinical development team that is running close to 80 ongoing or planned clinical trials in over 40 medicines and drug candidates. This includes more than 30 pivotal or potentially registration-enabling trials across our portfolio, including our three internally discovered, approved medicines. We have enrolled in our clinical trials more than 16,000 subjects, of which approximately one-half have been outside of China.
We have built, and are expanding, our internal manufacturing capabilities through our state-of-the-art biologic and small molecule manufacturing facilities in China to support current and potential future demand of our medicines, and are building a commercial-stage biologics manufacturing and clinical R&D center in New Jersey. We also work with high quality contract manufacturing organizations (CMOs) to manufacture our internally developed clinical and commercial products.
Since our inception in 2010, we have become a fully integrated global organization of over 8,600 employees in 29 countries and regions, including the United States, China, Europe, and Australia.
Recent Developments
Recent Business Developments
On July 14, 2022, we announced that the U.S. Food and Drug Administration (FDA) has deferred action on the Biologics License Application (BLA) for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma. In the FDA’s general advice letter communicating the deferral of action, the FDA cited only the inability to complete inspections due to restrictions on travel as the reason for the deferral and did not provide a new anticipated action date as they continue to monitor the public health situation and travel restrictions.
On June 30, 2022, we announced new data from RATIONALE 306, a global Phase 3 trial evaluating tislelizumab plus chemotherapy in adult patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) without prior systemic treatment for advanced disease, presented as a late-breaking oral presentation at the 2022 European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer.
On June 21, 2022, we announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for the our anti-PD-1 inhibitor, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.
On June 13, 2022, we announced that our BTK inhibitor BRUKINSA® (zanubrutinib) has been approved by the Ministry of Health in Kuwait, the National Health Regulatory Authority in Bahrain and the Ministry of Public Health in Qatar for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. We are working with NewBridge Pharmaceuticals, a specialty company in the Middle East and North Africa (MENA) regions established to bridge the access gap by partnering with global pharma and biotech companies, to bring BRUKINSA® to patients in Kuwait, Bahrain, Qatar, Saudi Arabia, United Arab Emirates, and other markets in the MENA region following regulatory approvals.
On June 13, 2022, we announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplementary new drug application (sNDA) for BRUKINSA® as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by three months to January 20, 2023. The FDA extended the PDUFA goal date to allow time to review additional clinical data submitted by us, which was deemed a major amendment to the sNDA. The submission included final response analysis from the global ALPINE clinical trial showing BRUKINSA® demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) CLL or SLL. We announced this final response analysis on April 11, 2022.
On June 10, 2022, we announced that the NMPA approved our anti-PD-1 antibody, tislelizumab, in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC).
Components of Operating Results
Revenue
Product Revenue
We generate product revenue through the sale of our three internally developed products and our in-licensed medicines from our partners.
Revenues from product sales are recognized when there is a transfer of control from the Company to the customer. The Company determines transfer of control based on when the product is delivered, and title passes to the customer. Revenues from product sales are recognized net of variable consideration resulting from rebates, chargebacks, trade discounts and allowances, sales returns allowances and other incentives. Provisions for estimated reductions to revenue are provided for in the same period the related sales are recorded and are based on contractual terms, historical experience and trend analysis.
Collaboration Revenue
We recognize collaboration revenue for amounts earned under collaborative and out-licensing arrangements. In January 2021, we entered into a collaboration and license agreement with Novartis, granting Novartis rights to develop, manufacture and commercialize tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (the Novartis Territory). There were two performance obligations identified at the outset of the agreement: (1) the exclusive license to develop, manufacture, and commercialize tislelizumab in the Novartis Territory, transfer of know-how and use of the tislelizumab trademark and (2) conducting and completing tislelizumab R&D services. Under this agreement, we received an upfront cash payment, which was allocated between the two performance obligations identified in the agreement based on the relative standalone selling prices of the performance obligations. The portion allocated to the license was recognized upon the delivery of the license right and transfer of know-how. The portion of the upfront payment allocated to the tislelizumab R&D services was deferred and is being recognized as collaboration revenue as the tislelizumab R&D services are performed using a percentage of completion method. Estimated costs to complete are reassessed on a periodic basis and any updates to the revenue earned are recognized on a prospective basis.
In December 2021, we expanded our collaboration with Novartis by entering into an option, collaboration and license agreement with Novartis to develop, manufacture and commercialize our investigational TIGIT inhibitor ociperlimab in the Novartis Territory. In addition, we entered into an agreement with Novartis which granted us rights to market, promote and detail five approved Novartis oncology products, TAFINLAR® (dabrafenib), MEKINIST® (trametinib), VOTRIENT® (pazopanib), AFINITOR® (everolimus), and ZYKADIA® (ceritinib), across designated regions of China referred to as “broad markets.” There were three performance obligations identified at the outset of the arrangement: (1) a material right for the option to the exclusive product license, (2) the right to access ociperlimab in clinical trials during the option period provided to Novartis, combined with the initial transfer of BeiGene know-how, and (3) conducting ociperlimab R&D services. The market development activities are considered immaterial in the context of the agreements. Under this agreement, we received an upfront cash payment, which was allocated between the three performance obligations identified in the agreement based on the relative standalone selling prices of the performance obligations. The portion allocated to the material right was deferred and will be recognized at the earlier of when Novartis exercises the option and the license is delivered or the expiration of the option period. The portion of the transaction price allocated to Novartis' right to access ociperlimab in its own clinical trials during the option period and the initial transfer of BeiGene know-how was deferred and is being recognized over the expected option period. The portion of the transaction price allocated to the ociperlimab R&D services was deferred and is being recognized as collaboration revenue as the ociperlimab R&D services are performed over the expected option period.
The option exercise fee under the ociperlimab agreement is contingent upon Novartis exercising its right, and is considered fully constrained until the option is exercised. The potential milestone payments that we are eligible to receive under both of the Novartis collaborations were excluded from the initial transaction prices, as all milestone amounts are variable consideration and were fully constrained due to uncertainty of achievement. Performance-based milestones will be recognized when the milestone event is achieved or when the risk of revenue reversal is remote. Sales-based milestones and royalties will be recognized when the underlying sales occur.
Expenses
Cost of Sales
Cost of sales includes the costs to manufacture our internally developed commercial products, as well as costs to purchase tislelizumab from Boehringer Ingelheim. Additionally, cost of sales included the cost of in-licensed products purchased for sale
in the PRC. Costs to manufacture inventory in preparation for commercial launch of a product incurred prior to regulatory approval are expensed to research and development expense as incurred. Cost of sales for newly launched products will not be recorded until the initial pre-launch inventory is depleted and additional inventory is manufactured. To date, the Company's initial pre-launch inventory for its commercial products has been immaterial and has not had a significant impact on the Company's gross margin.
Research and Development Expenses
Research and development expenses consist of the costs associated with our research and development activities, conducting preclinical studies and clinical trials, and activities related to regulatory filings. Our research and development expenses consist of:
•expenses incurred under agreements with contract research organizations (CROs), CMOs, and consultants that conduct and support clinical trials and preclinical studies;
•costs of comparator drugs in certain of our clinical trials;
•manufacturing costs related to pre-commercial activities;
•costs associated with preclinical activities and development activities;
•costs associated with regulatory operations;
•employee-related expenses, including salaries, benefits, travel and share-based compensation expense for research and development personnel;
•in-process research and development costs expensed as part of collaboration agreements entered into; and
•other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies used in research and development activities.
Our current research and development activities mainly relate to the clinical advancement of our internally developed medicines and drug candidates:
•BRUKINSA® (zanubrutinib), a small molecule inhibitor of BTK;
•tislelizumab, a humanized monoclonal antibody against PD-1;
•ociperlimab, an investigational humanized monoclonal antibody against TIGIT;
•pamiparib, a selective small molecule inhibitor of PARP1 and PARP2;
•BGB-15025, an investigational hematopoietic progenitor kinase 1 (HPK1) inhibitor;
•BGB-11417, an investigational small molecular inhibitor of Bcl-2;
•BGB-A445, an investigational non-ligand competing OX40 monoclonal antibody;
•BGB-16673, an investigational Chimeric Degradation Activating Compound ("CDAC"), targeting BTK; and
•BGB-A425, an investigational humanized monoclonal antibody against TIM-3;
•BGB-10188, an investigational PI3Kδ inhibitor;
•BGB-23339, a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor; and
•LBL-007, a novel investigational antibody targeting the LAG-3 pathway
Research and development activities also include costs associated with in-licensed drug candidates, including:
•R&D expense related to the co-development of pipeline assets under the Amgen collaboration agreement. Our total cost share obligation to Amgen is split between R&D expense and a reduction to the R&D cost share liability;
•sitravatinib, an investigational, spectrum-selective kinase inhibitor, licensed from Mirati Therapeutics, Inc. ("Mirati");
•ZW25 (zanidatamab) and ZW49, two investigational bispecific antibody-based product candidates targeting HER2, licensed from Zymeworks Inc. ("Zymeworks"); and
•POBEVCY® (BAT1706), a biosimilar to Avastin® (bevacizumab), licensed from Bio-Thera Solutions, Ltd. (Bio-Thera).
We expense research and development costs when incurred. We record costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information our vendors provide to us. We expense the manufacturing costs of our internally developed products that are used in clinical trials as they are incurred as research and development expense. We do not allocate employee‑related costs, depreciation, rental and other indirect costs to specific research and development programs because these costs are deployed across multiple product programs under research and development and, as such, are separately classified as unallocated research and development expenses.
At this time, it is difficult to estimate or know for certain, the nature, timing and estimated costs of the efforts that will be necessary to complete the development of our internally developed and in-licensed medicines and drug candidates. This is due to the numerous risks and uncertainties associated with developing such medicines and drug candidates, including the uncertainty of:
•successful enrollment in and completion of clinical trials;
•establishing an appropriate safety and efficacy profile;
•establishing and maintaining commercial manufacturing capabilities or making arrangements with third‑party manufacturers;