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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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, 2021
OR | | | | | |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Commission file number: 001-36014
AGIOS PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
| | | | | | | | | | | |
Delaware | 26-0662915 |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
| | | |
88 Sidney Street, Cambridge, Massachusetts | 02139 |
(Address of Principal Executive Offices) | (Zip Code) |
(617) 649-8600
(Registrant’s Telephone Number, Including Area Code)
(Former Name, Former Address and Former Fiscal Year, if Changed Since Last Report)
Securities registered pursuant to Section 12(b) of the Act: | | | | | | | | |
Title of each class | Trading symbol(s) | Name of each exchange on which registered |
Common Stock, Par Value $0.001 per share | AGIO | Nasdaq Global Select Market |
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 ☒
Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on July 23, 2021: 58,951,469
AGIOS PHARMACEUTICALS, INC.
FORM 10-Q
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2021
TABLE OF CONTENTS
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| | Page No. |
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Item 1. | | |
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Item 2. | | |
Item 3. | | |
Item 4. | | |
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Item 1A. | | |
Item 2. | | |
Item 6. | | |
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PART I. FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(Unaudited) | | | | | | | | | | | |
(In thousands, except share and per share data) | June 30, 2021 | | December 31, 2020 |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 969,124 | | | $ | 127,436 | |
Marketable securities | 703,864 | | | 445,493 | |
| | | |
| | | |
| | | |
Other receivable | 8,131 | | | — | |
| | | |
Prepaid expenses and other current assets | 21,443 | | | 15,889 | |
Current assets of discontinued operations | — | | | 47,859 | |
Total current assets | 1,702,562 | | | 636,677 | |
Marketable securities | 61,313 | | | 97,608 | |
Operating lease assets | 79,901 | | | 84,661 | |
Property and equipment, net | 27,056 | | | 30,815 | |
Financing lease assets | 871 | | | 590 | |
Other non-current assets | 2,900 | | | — | |
Non-current assets of discontinued operations | — | | | 2,601 | |
Total assets | $ | 1,874,603 | | | $ | 852,952 | |
Liabilities and stockholders’ equity | | | |
Current liabilities: | | | |
| | | |
Accounts payable | $ | 7,654 | | | $ | 17,724 | |
Accrued expenses | 36,054 | | | 30,801 | |
| | | |
Operating lease liabilities | 8,932 | | | 7,093 | |
Financing lease liabilities | 839 | | | 317 | |
Taxes payable | 7,170 | | | — | |
Current liabilities of discontinued operations | — | | | 38,459 | |
| | | |
Total current liabilities | 60,649 | | | 94,394 | |
| | | |
Operating lease liabilities, net of current portion | 91,971 | | | 97,458 | |
Financing lease liabilities, net of current portion | 167 | | | 331 | |
| | | |
Non-current liabilities of discontinued operations | — | | | 261,269 | |
Total liabilities | 152,787 | | | 453,452 | |
Stockholders’ equity: | | | |
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at June 30, 2021 and December 31, 2020 | — | | | — | |
Common stock, $0.001 par value; 125,000,000 shares authorized; 70,404,782 shares issued and 59,910,814 outstanding at June 30, 2021, and 69,293,920 shares issued and outstanding at December 31, 2020 | 70 | | | 69 | |
Additional paid-in capital | 2,306,304 | | | 2,242,801 | |
Accumulated other comprehensive (loss) income | (144) | | | 105 | |
Accumulated deficit | (55,367) | | | (1,843,475) | |
Treasury stock, at cost (10,493,968 shares at June 30, 2021 and no shares at December 31, 2020) | (529,047) | | | — | |
Total stockholders’ equity | 1,721,816 | | | 399,500 | |
Total liabilities and stockholders’ equity | $ | 1,874,603 | | | $ | 852,952 | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(In thousands, except share and per share data) | 2021 | | 2020 | | 2021 | | 2020 |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Cost and expenses: | | | | | | | |
| | | | | | | |
Research and development | $ | 62,007 | | | $ | 54,086 | | | $ | 119,674 | | | $ | 109,445 | |
Selling, general and administrative | 29,215 | | | 29,178 | | | 62,765 | | | 60,849 | |
Total cost and expenses | 91,222 | | | 83,264 | | | 182,439 | | | 170,294 | |
Loss from operations | (91,222) | | | (83,264) | | | (182,439) | | | (170,294) | |
Gain on sale of oncology business | 2,000 | | | — | | | 2,000 | | | — | |
Interest (expense) income, net | (92) | | | 1,769 | | | 248 | | | 4,705 | |
Other income, net | 6,524 | | | — | | | 6,524 | | | — | |
Net loss from continuing operations | (82,790) | | | (81,495) | | | (173,667) | | | (165,589) | |
Net income (loss) from discontinued operations, net of tax | (3,427) | | | (8,983) | | | 1,961,775 | | | 34,855 | |
Net income (loss) | $ | (86,217) | | | $ | (90,478) | | | $ | 1,788,108 | | | $ | (130,734) | |
Net loss from continuing operations per share - basic and diluted | $ | (1.36) | | | $ | (1.18) | | | $ | (2.66) | | | $ | (2.41) | |
Net income (loss) from discontinued operations per share - basic and diluted | $ | (0.06) | | | $ | (0.13) | | | $ | 30.05 | | | $ | 0.51 | |
| | | | | | | |
Net income (loss) per share - basic and diluted | $ | (1.41) | | | $ | (1.31) | | | $ | 27.39 | | | $ | (1.90) | |
| | | | | | | |
Weighted-average number of common shares used in computing net loss per share from continuing operations, net income (loss) per share from discontinued operations and net income (loss) per share – basic and diluted | 61,066,977 | | | 68,958,091 | | | 65,281,827 | | | 68,784,109 | |
| | | | | | | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Comprehensive (Loss) Income
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(In thousands) | 2021 | | 2020 | | 2021 | | 2020 |
Net income (loss) | $ | (86,217) | | | $ | (90,478) | | | $ | 1,788,108 | | | $ | (130,734) | |
Other comprehensive (loss) income | | | | | | | |
Unrealized (loss) gain on available-for-sale securities | (141) | | | 1,562 | | | (249) | | | 1,434 | |
Comprehensive income (loss) | $ | (86,358) | | | $ | (88,916) | | | $ | 1,787,859 | | | $ | (129,300) | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Stockholders' Equity
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive (Loss) Income | | Accumulated Deficit | | Treasury Stock | | Total Stockholders’ Equity |
(in thousands, except share amounts) | Shares | | Amount | | | Shares | | Amount | |
Balance at December 31, 2020 | 69,293,920 | | | $ | 69 | | | $ | 2,242,801 | | | $ | 105 | | | $ | (1,843,475) | | | — | | | $ | — | | | $ | 399,500 | |
| | | | | | | | | | | | | | | |
Common stock issued under stock incentive plan and ESPP | 518,285 | | | 1 | | | 7,346 | | | — | | | — | | | — | | | — | | | 7,347 | |
Stock-based compensation expense | — | | | — | | | 14,854 | | | — | | | — | | | — | | | — | | | 14,854 | |
Other comprehensive loss | — | | | — | | | — | | | (108) | | | — | | | — | | | — | | | (108) | |
Net income | — | | | — | | | — | | | — | | | 1,874,325 | | | — | | | — | | | 1,874,325 | |
Disposition of oncology business | — | | | — | | | 712 | | | — | | | — | | | — | | | — | | | 712 | |
Balance at March 31, 2021 | 69,812,205 | | | $ | 70 | | | $ | 2,265,713 | | | $ | (3) | | | $ | 30,850 | | | — | | | $ | — | | | $ | 2,296,630 | |
| | | | | | | | | | | | | | | |
Common stock issued under stock incentive plan and ESPP | 592,577 | | | $ | — | | | $ | 25,673 | | | $ | — | | | $ | — | | | — | | | $ | — | | | $ | 25,673 | |
Stock-based compensation expense | — | | | — | | | 14,885 | | | — | | | — | | | — | | | — | | | 14,885 | |
Repurchase of common stock | — | | | — | | | — | | | — | | | — | | | (10,493,968) | | | (529,047) | | | (529,047) | |
Other comprehensive loss | — | | | — | | | — | | | (141) | | | — | | | — | | | — | | | (141) | |
Net loss | — | | | — | | | — | | | — | | | (86,217) | | | — | | | — | | | (86,217) | |
Disposition of oncology business | — | | | — | | | 33 | | | — | | | — | | | — | | | — | | | 33 | |
Balance at June 30, 2021 | 70,404,782 | | | $ | 70 | | | $ | 2,306,304 | | | $ | (144) | | | $ | (55,367) | | | (10,493,968) | | | $ | (529,047) | | | $ | 1,721,816 | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Stockholders' Equity
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Common Stock | | Additional Paid-In Capital | | Accumulated Other Comprehensive (Loss) Income | | Accumulated Deficit | | Total Stockholders’ Equity |
(in thousands, except share amounts) | Shares | | Amount | |
Balance at December 31, 2019 | 68,401,105 | | | $ | 68 | | | $ | 2,156,363 | | | $ | 202 | | | $ | (1,516,105) | | | $ | 640,528 | |
| | | | | | | | | | | |
Common stock issued under stock incentive plan and ESPP | 388,820 | | | 1 | | | 5,464 | | | — | | | — | | | 5,465 | |
Stock-based compensation expense | — | | | — | | | 15,670 | | | — | | | — | | | 15,670 | |
Other comprehensive loss | — | | | — | | | — | | | (128) | | | — | | | (128) | |
Net loss | — | | | — | | | — | | | — | | | (40,256) | | | (40,256) | |
Disposition of oncology business | — | | | — | | | 4,020 | | | — | | | — | | | 4,020 | |
Balance at March 31, 2020 | 68,789,925 | | | $ | 69 | | | $ | 2,181,517 | | | $ | 74 | | | $ | (1,556,361) | | | $ | 625,299 | |
| | | | | | | | | | | |
Common stock issued under stock incentive plan and ESPP | 268,771 | | | $ | — | | | $ | 1,652 | | | $ | — | | | $ | — | | | $ | 1,652 | |
Stock-based compensation expense | — | | | — | | | 17,614 | | | — | | | — | | | 17,614 | |
Other comprehensive income | — | | | — | | | — | | | 1,562 | | | — | | | 1,562 | |
Net loss | — | | | — | | | — | | | — | | | (90,478) | | | (90,478) | |
Disposition of oncology business | — | | | — | | | 2,816 | | | — | | | — | | | 2,816 | |
Balance at June 30, 2020 | 69,058,696 | | | $ | 69 | | | $ | 2,203,599 | | | $ | 1,636 | | | $ | (1,646,839) | | | $ | 558,465 | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
| | | | | | | | | | | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited) | | | | | | | | | | | |
| Six Months Ended June 30, |
(In thousands) | 2021 | | 2020 |
Operating activities | | | |
Net income (loss) | $ | 1,788,108 | | | $ | (130,734) | |
Less: Net Income from discontinued operations | 1,961,775 | | | 34,855 | |
Net loss from continuing operations | (173,667) | | | (165,589) | |
Adjustments to reconcile net loss from continuing operations to net cash used in operating activities: | | | |
Depreciation and amortization | 4,829 | | | 4,887 | |
Stock-based compensation expense | 29,739 | | | 33,284 | |
Net amortization of premium (accretion of discount) on marketable securities | 3,422 | | | 473 | |
Loss on disposal of property and equipment | 12 | | | — | |
Non-cash operating lease expense | 4,760 | | | 4,435 | |
| | | |
| | | |
| | | |
| | | |
| | | |
Changes in operating assets and liabilities: | | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
Other receivables | (8,131) | | | — | |
Prepaid expenses and other current and non-current assets | (8,454) | | | 1,295 | |
Accounts payable | (5,561) | | | (2,562) | |
Accrued expenses and other current liabilities | (2,547) | | | (8,265) | |
| | | |
Operating lease liabilities | (3,631) | | | (4,149) | |
| | | |
Net cash used in operating activities - continuing operations | (159,229) | | | (136,191) | |
Net cash used in operating activities - discontinued operations | (78,814) | | | (36,964) | |
Net cash used in operating activities | (238,043) | | | (173,155) | |
Investing activities | | | |
Purchases of marketable securities | (498,896) | | | (189,601) | |
Proceeds from maturities and sales of marketable securities | 273,149 | | | 328,883 | |
| | | |
Purchases of property and equipment | (1,261) | | | (8,340) | |
Net cash (used in) provided by investing activities - continuing operations | (227,008) | | | 130,942 | |
Net cash provided by (used in) investing activities - discontinued operations | 1,802,936 | | | (348) | |
Net cash provided by investing activities | 1,575,928 | | | 130,594 | |
Financing activities | | | |
Payments on financing lease obligations | (170) | | | (166) | |
| | | |
| | | |
Purchase of treasury stock | (529,047) | | | — | |
Net proceeds from stock option exercises and employee stock purchase plan | 33,020 | | | 7,117 | |
Net cash (used in) provided by financing activities - continuing operations | (496,197) | | | 6,951 | |
Net cash provided by financing activities - discontinued operations | — | | | 250,537 | |
Net cash (used in) provided by financing activities | (496,197) | | | 257,488 | |
Net change in cash and cash equivalents | 841,688 | | | 214,927 | |
Cash and cash equivalents at beginning of the period | 127,436 | | | 80,931 | |
Cash and cash equivalents at end of the period | $ | 969,124 | | | $ | 295,858 | |
Supplemental disclosure of non-cash investing and financing transactions | | | |
Additions to property and equipment in accounts payable and accrued expenses | $ | 56 | | | $ | 3,621 | |
| | | |
| | | |
Operating lease liabilities arising from obtaining operating lease assets | $ | — | | | $ | — | |
Financing lease liabilities arising from obtaining financing lease assets | $ | 511 | | | $ | — | |
See accompanying Notes to Condensed Consolidated Financial Statements.
AGIOS PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
1. Overview and Basis of Presentation
References to Agios
Throughout this Quarterly Report on Form 10-Q, “we,” “us,” and “our,” and similar expressions, except where the context requires otherwise, refer to Agios Pharmaceuticals, Inc. and its consolidated subsidiaries, and “our Board of Directors” refers to the board of directors of Agios Pharmaceuticals, Inc.
Overview
We are a biopharmaceutical company committed to transforming patients’ lives through scientific leadership in the field of cellular metabolism and adjacent areas of biology, with the goal of creating differentiated, small molecule medicines for genetically defined diseases, or GDDs. To address our focus areas, we take a systems biology approach to deeply understand disease states, drive the discovery and validation of novel therapeutic targets, and define patient selection strategies, thereby increasing the probability that our experimental medicines will have the desired therapeutic effect. We are located in Cambridge, Massachusetts.
Sale of our Oncology Business to Servier
On March 31, 2021, we completed the sale of our oncology business to Servier Pharmaceuticals LLC, or Servier. The transaction included the sale of our oncology business, including TIBSOVO®, our clinical-stage product candidates vorasidenib, AG-270 and AG-636, and our oncology research programs for a payment of approximately $1.8 billion in cash at the closing, subject to certain adjustments, and a payment of $200 million in cash, if, prior to January 1, 2027, vorasidenib is granted new drug application, or NDA, approval from the U.S. Food and Drug Administration, or FDA, with an approved label that permits vorasidenib’s use as a single agent for the adjuvant treatment of patients with Grade 2 glioma that have an isocitrate dehydrogenase 1 or 2 mutation (and, to the extent required by such approval, the vorasidenib companion diagnostic test is granted an FDA premarket approval), as well as a royalty of 5% of U.S. net sales of TIBSOVO® from the close of the transaction through loss of exclusivity, and a royalty of 15% of U.S. net sales of vorasidenib from the first commercial sale of vorasidenib through loss of exclusivity. Servier also acquired our co-commercialization rights for Bristol Myers Squibb’s IDHIFA® and the right to receive a $25.0 million potential milestone payment under our prior collaboration agreement with Celgene Corporation, and following the sale Servier will conduct certain clinical development activities within the IDHIFA® development program.
We recorded income from royalties of approximately $2.0 million on U.S. net sales of TIBSOVO® by Servier in the gain on sale of oncology business line item within the condensed consolidated statements of operations, for the three and six months ended June 30, 2021. We also recorded approximately $3.5 million of cash receipts from customers owed to Servier within the prepaid expenses and other current assets line item within the condensed consolidated balance sheet as of June 30, 2021.
Basis of presentation
The condensed consolidated balance sheet as of June 30, 2021, the condensed consolidated statements of operations, comprehensive income (loss) and stockholders' equity for the three and six months ended June 30, 2021 and 2020, and the condensed consolidated statements of cash flows for the six months ended June 30, 2021 and 2020 are unaudited. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of June 30, 2021, our results of operations and stockholders' equity for the three and six months ended June 30, 2021 and 2020, and cash flows for the six months ended June 30, 2021 and 2020. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and six-month periods are also unaudited. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2020 was derived from our audited financial statements, but does not include all disclosures required by U.S. generally accepted accounting principles, or U.S. GAAP. The condensed consolidated interim financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2020 that was filed with the Securities and Exchange Commission, or the SEC, on February 25, 2021.
In late March 2021, our oncology business met all the conditions to be classified as held for sale and, because we consider the disposal of the oncology business to be a strategic shift that had a major effect on our operations and financial results,
represented a discontinued operation. All assets and liabilities associated with our oncology business were therefore classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets for the periods presented. Further, all historical operating results for our oncology business are reflected within discontinued operations in the condensed consolidated statements of operations for all periods presented. For additional information, see Note 3, Discontinued Operations.
Our condensed consolidated financial statements include our accounts and the accounts of our wholly owned subsidiaries. All intercompany transactions have been eliminated in consolidation. The condensed consolidated financial statements have been prepared in conformity with U.S. GAAP.
Reclassifications
Certain amounts in prior periods have been reclassified to reflect the impact of the discontinued operations treatment of the oncology business in order to conform to the current period presentation.
Use of estimates
The preparation of our condensed consolidated financial statements requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. On an ongoing basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including expenses, reserves and allowances, clinical trials, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and any variant strains of the virus and the actions taken to contain the pandemic or treat COVID-19, as well as the economic impact on local, regional, national and international customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results may differ from these estimates.
Liquidity
On March 31, 2021 we completed the sale of our oncology business to Servier, and received approximately $1.8 billion in cash at closing. In connection with the sale, on March 25, 2021, we announced that our board of directors authorized the repurchase of up to $1.2 billion of our outstanding shares of common stock, or the Repurchase Program, using the proceeds from the sale of our oncology business to Servier. On March 31, 2021, in connection with the Repurchase Program, we entered into a definitive share repurchase agreement with Bristol-Myers Squibb Company, or BMS, to repurchase 7,121,658 shares of our common stock held by certain subsidiaries of BMS for an aggregate purchase price of $344.5 million, or $48.3785 per share. This repurchase was completed on April 5, 2021. Further, on April 2, 2021, in connection with the Repurchase Program, we entered into a Rule 10b5-1 repurchase plan pursuant to which we may repurchase up to $600 million of shares of our common stock. As of June 30, 2021, we have repurchased approximately 3.4 million shares for $184.5 million, or $54.71 per share, under the plan with approximately $415.5 million remaining under the plan for additional repurchases. In total, as of June 30, 2021, we have repurchased 10.5 million common shares for $529.0 million under the Repurchase Program.
As of June 30, 2021, we had cash, cash equivalents and marketable securities of $1.7 billion. Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and marketable securities will be sufficient to fund current operations for at least the next twelve months from the issuance date of these financial statements.
2. Summary of Significant Accounting Policies
Discontinued Operations
We accounted for the sale of our oncology business in accordance with Accounting Standards Codification, ASC, 205 Discontinued Operations and Accounting Standards Update, ASU, No. 2014-08, Reporting of Discontinued Operations and Disclosures of Disposals of Components of an Entity. We followed the held-for-sale criteria as defined in ASC 306 and ASC 205. ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale and has operations and cash flows that can be clearly distinguished from the rest of the entity be reported as assets held for sale and discontinued operations. In the period a component of an entity has been disposed of or classified as held for sale, the results of operations for the periods presented are reclassified into separate line items in the unaudited condensed consolidated statements of operations. Assets and liabilities are also reclassified into separate line items on the related condensed consolidated balance sheets for the periods presented. The statements of cash flows for the periods presented are also reclassified to reflect the results of discontinued operations as separate line items. ASU 2014-08 requires that only a disposal of a component of an entity, or a
group of components of an entity, that represents a strategic shift that has, or will have, a major effect on the reporting entity’s operations and financial results be reported in the financial statements as discontinued operations. ASU 2014-08 also provides guidance on the financial statement presentations and disclosures of discontinued operations.
Due to the sale of the oncology business during the first quarter of 2021, see Note 3, Discontinued Operations, in accordance with ASC 205, Discontinued Operations, we have classified the results of the oncology business as discontinued operations in our unaudited condensed consolidated statements of operations and cash flows for all periods presented. All assets and liabilities associated with our oncology business were therefore classified as assets and liabilities of discontinued operations in our condensed consolidated balance sheets for the periods presented. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted.
Treasury Stock
Treasury stock purchases are accounted for under the cost method whereby the entire cost of the acquired stock is recorded as treasury stock.
There have been no other material changes to the significant accounting policies previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2020.
Recent accounting pronouncements
Other accounting standards that have been issued by the Financial Accounting Standards Board or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on our financial statements upon adoption.
3. Discontinued Operations
On March 31, 2021, we completed the sale of our oncology business to Servier. We have determined the sale of the oncology business represents a strategic shift that had a major effect on our business and therefore met the criteria for classification as discontinued operations at March 31, 2021. Accordingly, the oncology business is reported as discontinued operations in accordance with ASC 205-20, Discontinued Operations. The related assets and liabilities of the oncology business are classified as assets and liabilities of discontinued operations in the condensed consolidated balance sheets and the results of operations from the oncology business as discontinued operations in the condensed consolidated statements of operations. Applicable amounts in prior years have been recast to conform to this discontinued operations presentation. We recognized a gain on the sale of the oncology business upon closing.
The following table presents the assets and liabilities of the discontinued operations as of December 31, 2020: | | | | | |
(in thousands) | December 31, 2020 |
Assets | |
Current assets: | |
Accounts receivable, net | $ | 21,328 | |
Collaboration receivable – related party | 2,123 | |
Collaboration receivable – other | 1,948 | |
Inventory | 14,698 | |
Prepaid expenses and other current assets | 7,762 | |
Total current assets of discontinued operations | 47,859 | |
Other non-current assets | 2,601 | |
Total assets of discontinued operations | $ | 50,460 | |
Liabilities | |
Current liabilities: | |
Accounts payable | $ | 9,120 | |
Accrued expenses | 29,339 | |
Total current liabilities of discontinued operations | 38,459 | |
Liability related to the sale of future revenue, net of debt issuance costs | 261,269 | |
Total liabilities of discontinued operations | $ | 299,728 | |
The following table presents the net liabilities transferred for the sale oncology business for the quarter ended March 31, 2021:
| | | | | |
(in thousands) | March 31, 2021 |
Assets | |
Current assets: | |
Accounts receivable, net | $ | 25,386 | |
Collaboration receivable – related party | 2,253 | |
Collaboration receivable – other | 2,438 | |
Inventory | 16,190 | |
Prepaid expenses and other current assets | 7,125 | |
Total current assets of discontinued operations | 53,392 | |
Other non-current assets | 2,234 | |
Total assets of discontinued operations | $ | 55,626 | |
| |
Liabilities | |
Current liabilities: | |
Accounts payable | $ | 4,245 | |
Accrued expenses | 30,288 | |
Total current liabilities of discontinued operations | 34,533 | |
Liability related to the sale of future revenue, net of debt issuance costs | 264,281 | |
Total liabilities of discontinued operations | 298,814 | |
Net liabilities distributed to Servier | $ | (243,188) | |
The following table presents the gain on the sale for the quarter ended March 31, 2021: | | | | | |
(in thousands) | March 31, 2021 |
Cash proceeds | $ | 1,802,936 | |
Less: transaction and insurance costs | (53,573) | |
Less: net liabilities distributed | (243,188) | |
Gain on sale, pre-tax | 1,992,551 | |
Income tax | (12,867) | |
Gain on sale, net of tax | $ | 1,979,684 | |
As of June 30, 2021, there were no assets or liabilities classified as discontinued operations.
The following table presents the financial results of the discontinued operations:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(in thousands) | 2021 | | 2020 | | 2021 | | 2020 |
Revenues: | | | | | | | |
Product revenue, net | $ | — | | | $ | 27,581 | | | $ | 36,909 | | | $ | 50,255 | |
Collaboration revenue – related party | — | | | 5,735 | | | 1,350 | | | 65,832 | |
Collaboration revenue – other | — | | | 692 | | | 491 | | | 1,685 | |
Royalty revenue – related party | — | | | 3,339 | | | 2,659 | | | 6,673 | |
Total revenue | — | | | 37,347 | | | 41,409 | | | 124,445 | |
Cost and expenses: | | | | | | | |
Cost of sales | — | | | 675 | | | 706 | | | 1,208 | |
Research and development | 207 | | | 36,831 | | | 41,564 | | | 72,728 | |
Selling, general and administrative | 420 | | | 6,773 | | | 8,551 | | | 13,603 | |
Total cost and expenses | 627 | | | 44,279 | | | 50,821 | | | 87,539 | |
(Loss) income from discontinued operations | (627) | | | (6,932) | | | (9,412) | | | 36,906 | |
Non-cash interest expense for the sale of future revenue | — | | | (2,051) | | | (5,697) | | | (2,051) | |
Gain on the sale of the oncology business | (2,800) | | | — | | | 1,989,751 | | | — | |
Income from discontinued operations, pre-tax | (3,427) | | | (8,983) | | | 1,974,642 | | | 34,855 | |
Income tax expense | — | | | — | | | (12,867) | | | — | |
Net income from discontinued operations | $ | (3,427) | | | $ | (8,983) | | | $ | 1,961,775 | | | $ | 34,855 | |
In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations. As such, the research and development, marketing, selling and general and administrative expenses in discontinued operations include corporate costs incurred directly to solely support our oncology business.
We have also entered into a Transition Services Agreement with Servier, through which we will provide transitional services related to discovery, clinical development, technical operations, commercial and general and administrative related activities for periods ranging from one month to approximately one year after March 31, 2021.
The milestone payment for approval of vorasidenib and royalty payments related to vorasidenib and TIBSOVO® represent contingent consideration. Contingent consideration has been accounted for as a gain contingency in accordance with ASC 450, Contingencies, and will be recognized in earnings in the period when realizable.
4. Fair Value Measurements
We record cash equivalents and marketable securities at fair value. ASC 820, Fair Value Measurements and Disclosures, establishes a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). The hierarchy consists of three levels:
Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability.
Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date.
The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of June 30, 2021: | | | | | | | | | | | | | | | | | | | | | | | |
(In thousands) | Level 1 | | Level 2 | | Level 3 | | Total |
Cash equivalents | $ | 834,786 | | | $ | 70,898 | | | $ | — | | | $ | 905,684 | |
Total cash equivalents | 834,786 | | | 70,898 | | | — | | | 905,684 | |
| | | | | | | |
Marketable securities: | | | | | | | |
| | | | | | | |
U.S. Treasuries | — | | | 85,251 | | | — | | | 85,251 | |
Government securities | — | | | 101,976 | | | — | | | 101,976 | |
Corporate debt securities | — | | | 577,950 | | | — | | | 577,950 | |
Total marketable securities | — | | | 765,177 | | | — | | | 765,177 | |
Total cash equivalents and marketable securities | $ | 834,786 | | | $ | 836,075 | | | $ | — | | | $ | 1,670,861 | |
Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently, at the end of each reporting period, valued utilizing third-party pricing services or other observable market data. The pricing services utilize industry standard valuation models, including both income and market-based approaches, and observable market inputs to determine value. After completing our validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of June 30, 2021.
There have been no changes to the valuation methods during the six months ended June 30, 2021. We have no financial assets or liabilities that were classified as Level 3 at any point during the six months ended June 30, 2021.
5. Marketable Securities
Our marketable securities are classified as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities, and are recorded at fair value. Unrealized gains are included as a component of accumulated other comprehensive (loss) income in the condensed consolidated balance sheets and statements of stockholders’ equity and a component of total comprehensive loss in the condensed consolidated statements of comprehensive (loss) income, until realized. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses, to determine if the impairment is credit-related or noncredit-related. Credit-related impairment is recognized as an allowance on the balance sheet with a corresponding adjustment to earnings, and noncredit-related impairment is recognized in other comprehensive income, net of taxes. Realized gains and losses are included in investment income on a specific-identification basis. There were no material realized gains or losses on marketable securities for the three and six months ended June 30, 2021 or 2020.
Marketable securities at June 30, 2021 consisted of the following:
| | | | | | | | | | | | | | | | | | | | | | | |
(In thousands) | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Fair Value |
Current: | | | | | | | |
| | | | | | | |
U.S. Treasuries | $ | 85,256 | | | $ | 2 | | | $ | (7) | | | $ | 85,251 | |
Government securities | 76,980 | | | 16 | | | — | | | 76,996 | |
Corporate debt securities | 541,713 | | | 11 | | | (107) | | | 541,617 | |
Total Current | 703,949 | | | 29 | | | (114) | | | 703,864 | |
| | | | | | | |
Non-current: | | | | | | | |
| | | | | | | |
| | | | | | | |
| | | | | | | |
Government securities | 25,000 | | | — | | | (20) | | | 24,980 | |
Corporate debt securities | 36,372 | | | — | | | (39) | | | 36,333 | |
Total Non-current | 61,372 | | | — | | | (59) | | | 61,313 | |
Total marketable securities | $ | 765,321 | | | $ | 29 | | | $ | (173) | | | $ | 765,177 | |
Marketable securities at December 31, 2020 consisted of the following: | | | | | | | | | | | | | | | | | | | | | | | |
(In thousands) | Amortized Cost | | Unrealized Gains | | Unrealized Losses | | Fair Value |
Current: | | | | | | | |
U.S. Treasuries | $ | 113,559 | | | $ | 134 | | | $ | (21) | | | $ | 113,672 | |
Government securities | 108,263 | | | 37 | | | (8) | | | 108,292 | |
Corporate debt securities | 223,461 | | | 140 | | | (72) | | | 223,529 | |
Total Current | 445,283 | | | 311 | | | (101) | | | 445,493 | |
| | | | | | | |
Non-current: | | | | | | | |
| | | | | | | |
U.S. Treasuries | 15,147 | | | — | | | (10) | | | 15,137 | |
Government securities | 26,831 | | | 8 | | | — | | | 26,839 | |
Corporate debt securities | 55,735 | | | 2 | | | (105) | | | 55,632 | |
Total Non-current | 97,713 | | | 10 | | | (115) | | | 97,608 | |
Total marketable securities | $ | 542,996 | | | $ | 321 | | | $ | (216) | | | $ | 543,101 | |
As of June 30, 2021 and December 31, 2020, we held both current and non-current investments. Investments classified as current have maturities of less than one year. Investments classified as non-current are those that: (i) have a maturity of greater than one year, and (ii) we do not intend to liquidate within the next twelve months, although these funds are available for use and, therefore, are classified as available-for-sale.
As of June 30, 2021 and December 31, 2020, we held 113 and 87 debt securities, respectively, that were in an unrealized loss position for less than one year. We did not record an allowance for credit losses as of June 30, 2021 and December 31, 2020 related to these securities. The aggregate fair value of debt securities in an unrealized loss position at June 30, 2021 and December 31, 2020 was $559.3 million and $299.0 million, respectively. There were no individual securities that were in a significant unrealized loss position as of June 30, 2021 and December 31, 2020. We regularly review the securities in an unrealized loss position and evaluate the current expected credit loss by considering factors such as historical experience, market data, issuer-specific factors, and current economic conditions. We do not consider these marketable securities to be impaired as of June 30, 2021 and December 31, 2020.
6. Leases
Our building leases are comprised of office and laboratory space under non-cancelable operating leases. These lease agreements have remaining lease terms of seven years and contain various clauses for renewal at our option. The renewal options were not included in the calculation of the operating lease assets and the operating lease liabilities as the renewal options are not reasonably certain of being exercised. The lease agreements do not contain residual value guarantees.
The components of lease expense and other information related to leases were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(In millions) | 2021 | | 2020 | | 2021 | | 2020 |
Operating lease costs | $ | 3.8 | | | $ | 3.8 | | | $ | 7.6 | | | $ | 7.6 | |
Cash paid for amounts included in the measurement of operating lease liabilities | $ | 3.6 | | | $ | 3.5 | | | $ | 7.2 | | | $ | 7.4 | |
We have not entered into any material short-term leases or financing leases as of June 30, 2021.
As of June 30, 2021, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows:
| | | | | |
(In thousands) | |
Remaining 2021 | $ | 6,039 | |
2022 | 16,773 | |
2023 | 18,126 | |
2024 | 18,660 | |
2025 | 19,507 | |
Thereafter | 44,385 | |
Undiscounted minimum rental commitments | $ | 123,490 | |
Interest | (22,587) | |
Operating lease liabilities | $ | 100,903 | |
In arriving at the operating lease liabilities as of June 30, 2021 and December 31, 2020, we applied the weighted-average incremental borrowing rate of 5.7% for both periods over a weighted-average remaining lease term of 6.7 years and 7.2 years, respectively.
7. Accrued Expenses
Accrued expenses consist of the following: | | | | | | | | | | | |
(In thousands) | June 30, 2021 | | December 31, 2020 |
Accrued compensation | $ | 10,559 | | | $ | 20,345 | |
Accrued research and development costs | 7,627 | | | 5,444 | |
Accrued professional fees | 3,075 | | | 2,897 | |
Accrued other | 14,793 | | | 2,115 | |
Total accrued expenses | $ | 36,054 | | | $ | 30,801 | |
8. Share-Based Payments
2013 Stock Incentive Plan
In June 2013, our Board of Directors adopted and, in July 2013 our stockholders approved, the 2013 Stock Incentive Plan, or the 2013 Plan. The 2013 Plan became effective upon the closing of our initial public offering and provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, or RSUs, performance-based share units, or PSUs, and other stock-based awards to employees, non-employees and non-employee directors. Following the adoption of the 2013 Plan, we granted no further stock options or other awards under the 2007 Stock Incentive Plan, or the 2007 Plan. Any options or awards outstanding under the 2007 Plan at the time of adoption of the 2013 Plan remain outstanding and effective. As of June 30, 2021, the total number of shares reserved under the 2007 Plan and the 2013 Plan was 11,532,771, and we had 4,814,051 shares available for future issuance under the 2013 Plan.
Stock options
The following table presents stock option activity for the six months ended June 30, 2021: | | | | | | | | | | | |
| Number of Stock Options | | Weighted-Average Exercise Price |
Outstanding at December 31, 2020 | 6,143,046 | | | $ | 58.46 | |
Granted | 999,488 | | | 56.17 | |
Exercised | (677,154) | | | 45.79 | |
Forfeited/Expired | (1,213,538) | | | 61.89 | |
Outstanding at June 30, 2021 | 5,251,842 | | | $ | 58.87 | |
Exercisable at June 30, 2021 | 3,412,161 | | | $ | 61.00 | |
Vested and expected to vest at June 30, 2021 | 5,251,842 | | | $ | 58.87 | |
At June 30, 2021, there was approximately $58.8 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.6 years.
Restricted stock units
The following table presents RSU activity for the six months ended June 30, 2021:
| | | | | | | | | | | |
| Number of Stock Units | | Weighted-Average Grant Date Fair Value |
Unvested shares at December 31, 2020 | 1,284,378 | | | $ | 50.78 | |
Granted | 785,094 | | | 56.02 | |
Vested | (374,307) | | | 57.74 | |
Forfeited | (510,152) | | | 51.84 | |
Unvested shares at June 30, 2021 | 1,185,013 | | | $ | 51.60 | |
As of June 30, 2021, there was approximately $47.2 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 2.1 years.
Performance-based stock units
The following table presents PSU activity for the six months ended June 30, 2021:
| | | | | | | | | | | |
| Number of Stock Units | | Weighted-Average Grant Date Fair Value |
Unvested shares at December 31, 2020 | 142,229 | | | $ | 54.28 | |
Granted | 121,000 | | | 56.68 | |
Vested | — | | | — | |
Forfeited | (24,059) | | | 49.49 | |
Unvested shares at June 30, 2021 | 239,170 | | | $ | 55.98 | |
Stock-based compensation expense associated with these PSUs is recognized if the underlying performance condition is considered probable of achievement using our management’s best estimates.
As of June 30, 2021, there was no unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, and $13.4 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered not probable of achievement.
Market-based stock units
The following table presents market-based stock unit, or MSU, activity for the six months ended June 30, 2021:
| | | | | | | | | | | |
| Number of Stock Units | | Weighted-Average Grant Date Fair Value |
Unvested shares at December 31, 2020 | 42,695 | | | $ | 41.50 | |
Granted | — | | | — | |
| | | |
| | | |
Unvested shares at June 30, 2021 | 42,695 | | | $ | 41.50 | |
The fair value of MSUs are estimated using a Monte Carlo simulation model. Assumptions and estimates utilized in the model include the risk-free interest rate, dividend yield, expected stock volatility and the estimated period to achievement of the market condition. As of June 30, 2021, there was no remaining unrecognized compensation expense related to MSUs.
2013 Employee Stock Purchase Plan
In June 2013, our Board of Directors adopted, and in July 2013 our stockholders approved, the 2013 Employee Stock Purchase Plan, or the 2013 ESPP. We issued and sold 59,401 and 62,694 shares of common stock during the six months ended June 30, 2021 and 2020, respectively, under the 2013 ESPP. The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 1,345,454 shares of our common stock. As of June 30, 2021, we had 921,043 shares of common stock available for future issuance under the 2013 ESPP.
Stock-based compensation expense
Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended June 30, | | Six Months Ended June 30, |
(In thousands) | 2021 | | 2020 | | 2021 | | 2020 |
Stock options | $ | 8,789 | | | $ | 10,143 | | | $ | |