Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2020 | Apr. 24, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-36014 | |
Entity Registrant Name | AGIOS PHARMACEUTICALS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 26-0662915 | |
Entity Address, Address Line One | 88 Sidney Street | |
Entity Address, City or Town | Cambridge | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02139 | |
City Area Code | 617 | |
Local Phone Number | 649-8600 | |
Title of 12(b) Security | Common Stock, Par Value $0.001 per share | |
Trading Symbol | AGIO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 68,889,380 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false | |
Entity Central Index Key | 0001439222 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 89,093 | $ 80,931 |
Marketable securities | 439,528 | 483,946 |
Accounts receivable, net | 11,813 | 8,952 |
Collaboration receivable – related party | 2,577 | 1,539 |
Collaboration receivable – other | 2,033 | 1,928 |
Royalty receivable – related party | 3,300 | 2,900 |
Inventory | 9,778 | 7,331 |
Prepaid expenses and other current assets | 29,152 | 24,177 |
Total current assets | 587,274 | 611,704 |
Marketable securities | 84,503 | 152,929 |
Operating lease assets | 91,440 | 93,643 |
Property and equipment, net | 33,840 | 31,472 |
Financing lease assets | 881 | 993 |
Other assets | 1,800 | 0 |
Total assets | 799,738 | 890,741 |
Current liabilities: | ||
Accounts payable | 18,707 | 21,896 |
Accrued expenses | 39,631 | 53,142 |
Deferred revenue – related party | 4,748 | 10,933 |
Operating lease liabilities | 6,466 | 6,642 |
Financing lease liabilities | 306 | 273 |
Total current liabilities | 69,858 | 92,886 |
Deferred revenue, net of current portion – related party | 0 | 50,580 |
Operating lease liabilities, net of current portion | 104,010 | 106,074 |
Financing lease liabilities, net of current portion | 571 | 673 |
Total liabilities | 174,439 | 250,213 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value; 25,000,000 shares authorized; no shares issued or outstanding at March 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.001 par value; 125,000,000 shares authorized; 68,789,925 and 68,401,105 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 69 | 68 |
Additional paid-in capital | 2,181,517 | 2,156,363 |
Accumulated other comprehensive income | 74 | 202 |
Accumulated deficit | (1,556,361) | (1,516,105) |
Total stockholders’ equity | 625,299 | 640,528 |
Total liabilities and stockholders’ equity | $ 799,738 | $ 890,741 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 25,000,000 | 25,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 125,000,000 | 125,000,000 |
Common stock, shares issued (in shares) | 68,789,925 | 68,401,105 |
Common stock, shares outstanding (in shares) | 68,789,925 | 68,401,105 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenues: | ||
Total revenue | $ 87,098 | $ 30,227 |
Cost and expenses: | ||
Cost of sales | 533 | 334 |
Research and development | 91,256 | 95,585 |
Selling, general and administrative | 38,501 | 31,791 |
Total cost and expenses | 130,290 | 127,710 |
Loss from operations | (43,192) | (97,483) |
Interest income, net | 2,936 | 4,405 |
Net loss | $ (40,256) | $ (93,078) |
Net loss per share – basic and diluted (in usd per share) | $ (0.59) | $ (1.59) |
Weighted-average number of common shares used in computing net loss per share – basic and diluted (in usd per share) | 68,608,279 | 58,453,918 |
Product revenue, net | ||
Revenues: | ||
Total revenue | $ 22,674 | $ 9,138 |
Collaboration revenue – related party | ||
Revenues: | ||
Total revenue | 60,097 | 17,919 |
Collaboration revenue – other | ||
Revenues: | ||
Total revenue | 993 | 970 |
Royalty revenue – related party | ||
Revenues: | ||
Total revenue | $ 3,334 | $ 2,200 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (40,256) | $ (93,078) |
Other comprehensive (loss) income | ||
Unrealized (loss) gain on available-for-sale securities | (128) | 1,687 |
Comprehensive loss | $ (40,384) | $ (91,391) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2018 | 58,218,653 | ||||
Beginning balance at Dec. 31, 2018 | $ 687,537 | $ 58 | $ 1,794,283 | $ (2,171) | $ (1,104,633) |
Common stock issued under stock incentive plan and ESPP (in shares) | 441,168 | ||||
Common stock issued under stock incentive plan and ESPP | 6,003 | $ 1 | 6,002 | ||
Stock-based compensation expense | 18,108 | 18,108 | |||
Other comprehensive income (loss) | 1,687 | 1,687 | |||
Net loss | (93,078) | (93,078) | |||
Ending balance (in shares) at Mar. 31, 2019 | 58,659,821 | ||||
Ending balance at Mar. 31, 2019 | 620,257 | $ 59 | 1,818,393 | (484) | (1,197,711) |
Beginning balance (in shares) at Dec. 31, 2019 | 68,401,105 | ||||
Beginning balance at Dec. 31, 2019 | $ 640,528 | $ 68 | 2,156,363 | 202 | (1,516,105) |
Common stock issued under stock incentive plan and ESPP (in shares) | 133,256 | 388,820 | |||
Common stock issued under stock incentive plan and ESPP | $ 5,465 | $ 1 | 5,464 | ||
Stock-based compensation expense | 19,690 | 19,690 | |||
Other comprehensive income (loss) | (128) | (128) | |||
Net loss | (40,256) | (40,256) | |||
Ending balance (in shares) at Mar. 31, 2020 | 68,789,925 | ||||
Ending balance at Mar. 31, 2020 | $ 625,299 | $ 69 | $ 2,181,517 | $ 74 | $ (1,556,361) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating activities | ||
Net loss | $ (40,256) | $ (93,078) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 2,474 | 2,005 |
Stock-based compensation expense | 19,690 | 18,108 |
Net accretion of premium and discounts on investments | 126 | (1,131) |
Non-cash operating lease expense | 2,203 | 2,085 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (2,861) | 721 |
Collaboration receivable – related party | (1,038) | 143 |
Collaboration receivable – other | (105) | (970) |
Royalty receivable – related party | (400) | 34 |
Inventory | (2,447) | (1,459) |
Prepaid expenses and other current and non-current assets | (6,774) | (2,173) |
Accounts payable | (2,009) | (4,939) |
Accrued expenses | (14,967) | (5,097) |
Deferred revenue – related party | (56,765) | (15,391) |
Operating lease liabilities | (2,229) | (2,129) |
Net cash used in operating activities | (105,358) | (103,271) |
Investing activities | ||
Purchases of marketable securities | (54,911) | (77,421) |
Proceeds from maturities and sales of marketable securities | 167,501 | 210,811 |
Purchases of property and equipment | (4,455) | (2,038) |
Net cash provided by investing activities | 108,135 | 131,352 |
Financing activities | ||
Payments on financing lease obligations | (80) | 0 |
Net proceeds from stock option exercises and employee stock purchase plan | 5,465 | 4,860 |
Net cash provided by financing activities | 5,385 | 4,860 |
Net change in cash and cash equivalents | 8,162 | 32,941 |
Cash and cash equivalents at beginning of the period | 80,931 | 70,502 |
Cash and cash equivalents at end of the period | 89,093 | 103,443 |
Supplemental disclosure of non-cash investing and financing transactions | ||
Additions to property and equipment in accounts payable and accrued expenses | 5,444 | 727 |
Proceeds from stock option exercises in other current assets | 0 | 1,149 |
Operating lease liabilities arising from obtaining operating lease assets | 0 | 0 |
Financing lease liabilities arising from obtaining financing lease assets | $ 0 | $ 0 |
Overview and Basis of Presentat
Overview and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Overview and Basis of Presentation | 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 the fundamental transformation of 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 patients in the areas of hematologic malignancies, solid tumors and rare genetic diseases, or RGDs. To address these 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. Basis of presentation The condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three months ended March 31, 2020 and 2019, and the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 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 March 31, 2020, our results of operations and stockholders' equity for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three-month periods are also unaudited. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2019 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, 2019 that was filed with the Securities and Exchange Commission, or the SEC, on February 19, 2020. 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. 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 sales, 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 the actions taken to contain it 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 As of March 31, 2020, we had cash, cash equivalents and marketable securities of $613.1 million. Although we have incurred recurring losses and expect to continue to incur losses for the foreseeable future, we expect our cash, cash equivalents and |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Significant accounting policies In June 2016, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update, or ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), which introduces new guidance for the accounting for credit losses on instruments within its scope. The new guidance introduces an approach based on expected losses to estimate credit losses on certain types of financial instruments. Credit losses relating to available-for-sale debt securities will also be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. The guidance is effective for fiscal years beginning after December 31, 2019, including interim periods within those years. In the quarter ended March 31, 2020, we adopted ASU 2016-13, which eliminated the concept of other-than-temporary impairments and required credit losses on debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. Application of the amendments is through a cumulative-effect adjustment to retained earnings as of the effective date. Based upon our analysis, the adoption of this final rule did not have a material impact on the financial statements. 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, 2019. Recent accounting pronouncements Other accounting standards that have been issued by the FASB 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. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements We record cash equivalents and marketable securities at fair value. Accounting Standards Codification, or 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 March 31, 2020: (In thousands) Level 1 Level 2 Level 3 Total Cash equivalents $ 54,853 $ 19,979 $ — $ 74,832 Total cash equivalents 54,853 19,979 — 74,832 Marketable securities: U.S. Treasuries — 163,878 — 163,878 Government securities — 100,492 — 100,492 Corporate debt securities — 259,661 — 259,661 Total marketable securities — 524,031 — 524,031 Total cash equivalents and marketable securities $ 54,853 $ 544,010 $ — $ 598,863 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 market observable 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 March 31, 2020. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 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 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, 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 months ended March 31, 2020 and 2019. Marketable securities at March 31, 2020 consisted of the following: (In thousands) Amortized Unrealized Unrealized Fair Current: U.S. Treasuries $ 141,490 $ 835 $ — $ 142,325 Government securities 89,008 256 (21) 89,243 Corporate debt securities 208,596 82 (718) 207,960 Total Current 439,094 1,173 (739) 439,528 Non-current: U.S. Treasuries 21,282 271 — 21,553 Government securities 11,260 4 (15) 11,249 Corporate debt securities 52,329 72 (700) 51,701 Total Non-current 84,871 347 (715) 84,503 Total marketable securities $ 523,965 $ 1,520 $ (1,454) $ 524,031 Marketable securities at December 31, 2019 consisted of the following: (In thousands) Amortized Unrealized Unrealized Fair Current: U.S. Treasuries 178,721 58 (38) 178,741 Government securities 80,228 17 (16) 80,229 Corporate debt securities 224,928 139 (91) 224,976 Total Current 483,877 214 (145) 483,946 Non-current: U.S. Treasuries 35,296 3 (13) 35,286 Government securities 17,587 14 (10) 17,591 Corporate debt securities 99,913 239 (100) 100,052 Total Non-current 152,796 256 (123) 152,929 Total marketable securities $ 636,673 $ 470 $ (268) $ 636,875 As of March 31, 2020 and December 31, 2019, 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. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory, which consists of commercial supply of TIBSOVO®, consists of the following: (In thousands) March 31, December 31, Raw materials $ 180 $ 180 Work-in-process 8,589 6,808 Finished goods 1,009 343 Total inventory $ 9,778 $ 7,331 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | Leases Our building leases are comprised of office and laboratory space under non-cancelable operating leases. These lease agreements have remaining lease terms of eight 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 option is not reasonably certain of being exercised. The lease agreements do not contain residual value guarantees. Operating lease costs for the three months ended March 31, 2020 and 2019 were $3.8 million and $3.1 million, respectively, and cash paid for amounts included in the measurement of operating lease liabilities for the three months ended March 31, 2020 and 2019 were $3.9 million and $3.1 million, respectively. We have not entered into any material short-term leases or financing leases as of March 31, 2020. As of March 31, 2020, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows: (In thousands) Remaining 2020 $ 9,395 2021 14,380 2022 16,773 2023 18,126 2024 18,660 2025 19,507 Thereafter 44,385 Undiscounted minimum rental commitments $ 141,226 Interest (30,750) Operating lease liabilities $ 110,476 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following: (In thousands) March 31, December 31, Accrued compensation $ 7,006 $ 18,982 Accrued research and development costs 18,661 21,777 Accrued professional fees 9,238 8,335 Accrued other 4,726 4,048 Total accrued expenses $ 39,631 $ 53,142 |
Product Revenue
Product Revenue | 3 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Product Revenue | Product Revenue We sell TIBSOVO®, our wholly owned product, to a limited number of specialty distributors and specialty pharmacy providers in the U.S., or collectively, the Customers. The Customers subsequently resell TIBSOVO® to pharmacies or dispense directly to patients. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of TIBSOVO®. The performance obligation related to the sale of TIBSOVO® is satisfied and revenue is recognized when the Customer obtains control of the product, which occurs at a point in time, typically upon delivery to the Customer. Three Months Ended March 31, (In thousands) 2020 2019 Product revenue, net $ 22,674 $ 9,138 Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established and result from contractual adjustments, government rebates, returns and other allowances that are offered within the contracts with our Customers, healthcare providers, payors and other indirect customers relating to the sale of our products. Contractual Adjustments We generally provide Customers with discounts, including prompt pay discounts, and allowances that are explicitly stated in the contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from certain Customers. Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are estimated using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated channel mix and are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue. Government Rebates Government rebates consist of Medicare, TriCare, and Medicaid rebates, which we estimate using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Returns We estimate the amount of product sales that may be returned by Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We currently estimate product return liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel. The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the three months ended March 31, 2020: (In thousands) Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2019 $ 874 $ 1,124 $ 1,798 $ 3,796 Current provisions relating to sales in the current year 3,000 1,338 537 4,875 Adjustments relating to prior years (3) 76 — 73 Payments/returns relating to sales in the current year (2,072) — — (2,072) Payments/returns relating to sales in the prior years (653) (677) — (1,330) Balance at March 31, 2020 $ 1,146 $ 1,861 $ 2,335 $ 5,342 Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows: (In thousands) March 31, December 31, Reduction of accounts receivable $ 707 $ 540 Component of accrued expenses 4,635 3,256 Total revenue-related reserves $ 5,342 $ 3,796 The following table presents changes in our contract assets during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets (1) Accounts receivable, net $ 8,952 $ 27,624 $ (24,763) $ 11,813 |
Collaboration and License Agree
Collaboration and License Agreements | 3 Months Ended |
Mar. 31, 2020 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Collaboration and License Agreements | Collaboration and License Agreements Accounting analysis and revenue recognition Our collaboration and license agreements typically involve us granting licenses of our intellectual property and performing research and development services in exchange of upfront fees, milestone payments and royalty payments. Since December 31, 2019, there have been no material changes to the key terms of our collaboration or license agreements. For further information on the terms and conditions of our existing collaboration and license agreements, please see the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2019. Collaboration revenue We recognize revenue when the customer obtains control of promised goods or services, in an amount that reflects the consideration that we expect to receive in exchange for those goods or services . In determining the appropriate amount of revenue to be recognized, we performed the following steps: (i) identified the promised goods or services in the contract; (ii) determined whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measured the transaction price, including the constraint on variable consideration; (iv) allocated the transaction price to the performance obligations; and (v) recognized revenue when (or as) we satisfied each performance obligation. Royalty revenue For arrangements that include sales-based royalties and sales-based milestones and in which the license is deemed to be the predominant item to which the royalties relate, we recognize royalty revenue upon the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Milestone revenue At each reporting period we evaluate whether milestones are considered probable of being reached and, to the extent that a significant reversal would not occur in future periods, estimate the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within our control, such as regulatory approvals, are considered constrained and are excluded from the transaction price until those approvals are received. Celgene Corporation We have entered into the following collaboration agreements, or collectively, the Collaboration Agreements, with Celgene, a wholly-owned subsidiary of Bristol-Myers Squibb Company, or BMS, which is a related party through ownership of our common stock: • In April 2010, we entered into a discovery and development collaboration and license agreement focused on cancer metabolism, or the 2010 Agreement, which was amended in October 2011 and July 2014. The discovery phase of the 2010 Agreement expired in April 2016. On August 15, 2016, we terminated the 2010 Agreement as to the program directed to the isocitrate dehydrogenase 1, or IDH1, target, for which ivosidenib was the lead development candidate. Accordingly, the sole program remaining under the 2010 Agreement is IDHIFA® (enasidenib), a co-commercialized licensed program for which Celgene leads and funds global development and commercialization activities. Under the remaining terms of the 2010 Agreement, we are eligible to receive up to $80.0 million in potential milestone payments for the enasidenib program. The potential milestone payments are comprised of: (i) up to $55.0 million in milestone payments upon achievement of specified ex-U.S. regulatory milestone events, and (ii) a $25.0 million milestone payment upon achievement of a specified ex-U.S. commercial milestone event, as well as royalties at tiered, low-double digit to mid-teen percentage rates on net sales of IDHIFA®. • In April 2015, we entered into a joint worldwide development and profit share collaboration and license agreement with Celgene, and our wholly owned subsidiary, Agios International Sarl, entered into a collaboration and license agreement with Celgene International II Sarl, or collectively, the AG-881 Agreements, to establish a worldwide collaboration focused on the development and commercialization of vorasidenib products. Under the AG-881 Agreements, we and Celgene split all worldwide development costs for vorasidenib, subject to specified exceptions. The AG-881 Agreements were terminated effective September 4, 2018, upon which we received sole global rights to vorasidenib. In connection with the termination of the AG-881 Agreements, Celgene will be eligible to receive royalties from us at a low single-digit percentage rate on worldwide net sales of products containing vorasidenib. • In May 2016, we entered into a master research and collaboration agreement with Celgene, or the 2016 Agreement, focused on metabolic immuno-oncology, or MIO. The initial four one Collaboration revenue During the three months ended March 31, 2020 and 2019, we recognized the following collaboration revenue: Three Months Ended March 31, (In thousands) 2020 2019 Services performed that were considered performance obligations as of the modification dates Licenses $ — $ — On-going research and development services 59,220 17,065 Services performed that were not considered performance obligations as of the modification dates Commercialization activities 877 854 Total collaboration revenue - related party $ 60,097 $ 17,919 The following table presents changes in our contract assets and liabilities during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets Collaboration receivable – related party (1) $ 1,539 $ 3,332 $ (2,294) $ 2,577 Royalty receivable – related party (2) 2,900 3,334 (2,934) 3,300 Contract liabilities Deferred revenue – related party, current and net of current portions (3) 61,513 579 (57,344) 4,748 (1) Additions to collaboration receivables - related party relate to amounts billed to Celgene for reimbursable costs incurred by us during the reporting period and unbilled amounts related to future reimbursable costs. Deductions to receivables relate to collection of receivables during the reporting period. (2) Additions to royalty receivables - related party relate to amounts billed to Celgene during the reporting period. Deductions to receivables relate to collection of receivables during the reporting period. (3) Additions to deferred revenue - related party relate to consideration from Celgene during the reporting period. Deductions relate to deferred revenue recognized as revenue during the reporting period. The increase in collaboration revenue from on-going research and development services during the three months ended March 31, 2020 is primarily due to the fact that subsequent to Celgene’s decision to decline extending the research term, the Company updated its estimate of the future costs that will be incurred to complete one of its performance obligations under the 2016 collaboration Agreement that is recognized overtime using an input method. During the three months ended March 31, 2020 and 2019, we recognized the following as revenue due to changes in the contract liability balances: Three Months Ended March 31, (In thousands) 2020 2019 Amounts included in the contract liability at the beginning of the period $ 59,248 $ 16,410 Performance obligations satisfied in previous periods — 21 As of March 31, 2020, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $10.5 million. This amount is expected to be recognized as performance obligations are satisfied through September 2023. Royalty revenue As the underlying performance obligation, or delivery of the enasidenib license, had been satisfied as of June 2014, royalty revenue is recognized as the related sales occur. During the three months ended March 31, 2020 and 2019, we recognized the following as royalty revenue: Three Months Ended March 31, (In thousands) 2020 2019 Royalty revenue – related party $ 3,334 $ 2,200 Milestone revenue No milestones were achieved during the three months ended March 31, 2020 or 2019. The next potential milestone expected to be achieved under our Collaboration Agreements is the first regulatory approval of enasidenib in any of China, Japan or a major European country, which would result in a milestone payment of $35.0 million under the 2010 Agreement. CStone Pharmaceuticals In June 2018, we and CStone Pharmaceuticals, or CStone, entered into an exclusive license agreement, or the CStone Agreement, to grant CStone specified intellectual property licenses to enable CStone to develop and commercialize certain products containing ivosidenib in mainland China, Hong Kong, Macau and Taiwan, or the CStone Territory. We retain development and commercialization rights for the rest of the world. On March 2, 2020, we amended the CStone Agreement to include Singapore as part of the CStone Territory. Pursuant to the CStone Agreement, CStone will initially be responsible for the development and commercialization of ivosidenib in acute myeloid leukemia, or AML, cholangiocarcinoma, and, at our discretion, brain cancer indications. CStone is responsible for all costs it incurs in developing, obtaining regulatory approval of, and commercializing ivosidenib in the CStone Territory, as well as certain costs incurred by us. Pursuant to the CStone Agreement, we received an initial upfront payment in the amount of $12.0 million and are entitled to receive up to an additional $407.0 million in milestone payments upon the achievement of certain development, regulatory and sales milestone events. We will also be entitled to receive tiered royalties, ranging from 15% to 19% percent, on annual net sales, if any, of ivosidenib in the CStone Territory. Collaboration revenue During the three months ended March 31, 2020 and 2019, we recognized the following collaboration revenue -other: Three Months Ended March 31, (In thousands) 2020 2019 Services performed that were considered performance obligations as of the inception date License and other services $ 192 $ — Services performed that were not considered performance obligations as of the inception date Other services 801 970 Total collaboration revenue - other $ 993 $ 970 The following table presents changes in our contract assets during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets (1) Collaboration receivable - other $ 1,928 $ 993 $ (888) $ 2,033 (1) Additions to contract assets relate to amounts receivable from CStone. Deductions to contract assets relate to collection of receivables during the reporting period. As of March 31, 2020, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $0.5 million. Royalty revenue The license was determined to be the predominant item to which sales-based royalties and sales-based milestones relate. As the license was delivered in June 2018, we will recognize royalty revenue when the related sales occur. To date, no royalties have been received under the CStone Agreement. Milestone revenue No milestones were earned during the three months ended March 31, 2020 and 2019. The next potential milestone expected to be achieved under the CStone Agreement is the dosing of the first patient in a local study in a solid tumor indication in mainland China. Achievement of this event will result in a milestone payment of $5.0 million. |
Share-Based Payments
Share-Based Payments | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payments | 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 stock 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 March 31, 2020, the total number of shares reserved under the 2007 Plan and the 2013 Plan was 11,030,628, and we had 2,708,920 shares available for future issuance under the 2013 Plan. Stock options The following table presents stock option activity for the three months ended March 31, 2020: Number of Weighted-Average Exercise Price Outstanding at December 31, 2019 6,201,485 $ 58.61 Granted 792,048 51.09 Exercised (133,256) 25.84 Forfeited/Expired (110,904) 69.00 Outstanding at March 31, 2020 6,749,373 $ 58.20 Exercisable at March 31, 2020 3,874,135 $ 59.71 Vested and expected to vest at March 31, 2020 6,749,373 $ 58.20 At March 31, 2020, there was approximately $104.0 million of total unrecognized compensation expense related to unvested stock option awards, which we expect to recognize over a weighted-average period of approximately 2.7 years. Restricted stock units The following table presents RSU activity for the three months ended March 31, 2020: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2019 766,953 $ 63.44 Granted 744,447 51.38 Vested (192,870) 70.54 Forfeited (27,655) 66.70 Unvested shares at March 31, 2020 1,290,875 $ 55.36 As of March 31, 2020, there was approximately $58.3 million of total unrecognized compensation expense related to RSUs, which we expect to recognize over a weighted-average period of approximately 2.2 years. Performance-based stock units The following table presents PSU activity for the three months ended March 31, 2020: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2019 218,143 $ 55.64 Granted 20,622 48.49 Vested — — Unvested shares at March 31, 2020 238,765 $ 55.03 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 March 31, 2020, there was approximately $0.5 million of total unrecognized compensation expense related to PSUs with performance-based vesting criteria that are considered probable of achievement, which we expect to recognize over a weighted-average period of 0.1 years, and $11.3 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 three months ended March 31, 2020: Number of Weighted-Average Unvested shares at December 31, 2019 42,695 $ 41.50 Granted — — Unvested shares at March 31, 2020 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 March 31, 2020, there was approximately $0.5 million of total unrecognized compensation expense related to MSUs, which we expect to recognize over the remaining derived service period of 0.5 years. 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 62,694 and 32,410 shares of common stock during the three months ended March 31, 2020 and 2019, respectively, under the 2013 ESPP. The 2013 ESPP provides participating employees with the opportunity to purchase up to an aggregate of 836,363 shares of our common stock. As of March 31, 2020, we had 528,952 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 (In thousands) 2020 2019 Stock options $ 11,603 $ 13,046 Restricted stock units 6,132 4,548 Performance-based stock units 1,388 186 Employee stock purchase plan 297 328 Other stock awards 270 — Total stock-based compensation expense $ 19,690 $ 18,108 Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations: Three Months Ended (In thousands) 2020 2019 Research and development expense $ 9,564 $ 10,042 Selling, general and administrative expense 10,126 8,066 Total stock-based compensation expense $ 19,690 $ 18,108 |
Loss per Share
Loss per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Loss per Share | Loss per Share Basic net loss per share is calculated by dividing net loss by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury stock method. For purposes of the dilutive net loss per share calculation, stock options, RSUs, PSUs and MSUs for which the performance and market vesting conditions, respectively, have been deemed probable, and 2013 ESPP shares are considered to be common stock equivalents, while PSUs and MSUs with performance and market vesting conditions, respectively, that were not deemed probable as of March 31, 2020 are not considered to be common stock equivalents. Since we had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per share was the same for all periods presented. The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended March 31, 2020 2019 Stock options 6,749,373 6,482,873 Restricted stock units 1,290,875 709,162 Performance-based stock units 78,920 — Employee stock purchase plan shares 13,430 6,778 Total common stock equivalents 8,132,598 7,198,813 |
Organization, Consolidation and
Organization, Consolidation and Presentation of Financial Statements (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Basis of Presentation | The condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three months ended March 31, 2020 and 2019, and the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 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 March 31, 2020, our results of operations and stockholders' equity for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three-month periods are also unaudited. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2019 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, 2019 that was filed with the Securities and Exchange Commission, or the SEC, on February 19, 2020. 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. |
Use of Estimates | 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 sales, 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 the actions taken to contain it 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The condensed consolidated balance sheet as of March 31, 2020, the condensed consolidated statements of operations, comprehensive loss and stockholders' equity for the three months ended March 31, 2020 and 2019, and the condensed consolidated statements of cash flows for the three months ended March 31, 2020 and 2019 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 March 31, 2020, our results of operations and stockholders' equity for the three months ended March 31, 2020 and 2019, and cash flows for the three months ended March 31, 2020 and 2019. The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three-month periods are also unaudited. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The condensed consolidated balance sheet data as of December 31, 2019 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, 2019 that was filed with the Securities and Exchange Commission, or the SEC, on February 19, 2020. 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. |
Significant and Recent Accounting Pronouncements | Significant accounting policies In June 2016, the Financial Accounting Standards Board, or FASB issued Accounting Standards Update, or ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), which introduces new guidance for the accounting for credit losses on instruments within its scope. The new guidance introduces an approach based on expected losses to estimate credit losses on certain types of financial instruments. Credit losses relating to available-for-sale debt securities will also be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. The guidance is effective for fiscal years beginning after December 31, 2019, including interim periods within those years. In the quarter ended March 31, 2020, we adopted ASU 2016-13, which eliminated the concept of other-than-temporary impairments and required credit losses on debt securities to be recorded through an allowance for credit losses instead of as a reduction in the amortized cost basis of the securities. Application of the amendments is through a cumulative-effect adjustment to retained earnings as of the effective date. Based upon our analysis, the adoption of this final rule did not have a material impact on the financial statements. 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, 2019. Recent accounting pronouncements Other accounting standards that have been issued by the FASB 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. |
Fair Value Measurements | We record cash equivalents and marketable securities at fair value. Accounting Standards Codification, or 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. |
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 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, until realized. Unrealized losses are evaluated for impairment under ASC 326, Financial Instruments - Credit Losses |
Product Revenue | We sell TIBSOVO®, our wholly owned product, to a limited number of specialty distributors and specialty pharmacy providers in the U.S., or collectively, the Customers. The Customers subsequently resell TIBSOVO® to pharmacies or dispense directly to patients. In addition to distribution agreements with Customers, we enter into arrangements with healthcare providers and payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of TIBSOVO®. The performance obligation related to the sale of TIBSOVO® is satisfied and revenue is recognized when the Customer obtains control of the product, which occurs at a point in time, typically upon delivery to the Customer. Three Months Ended March 31, (In thousands) 2020 2019 Product revenue, net $ 22,674 $ 9,138 Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established and result from contractual adjustments, government rebates, returns and other allowances that are offered within the contracts with our Customers, healthcare providers, payors and other indirect customers relating to the sale of our products. Contractual Adjustments We generally provide Customers with discounts, including prompt pay discounts, and allowances that are explicitly stated in the contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from certain Customers. Chargebacks for fees and discounts represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from us. Customers charge us for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are estimated using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated channel mix and are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue. Government Rebates Government rebates consist of Medicare, TriCare, and Medicaid rebates, which we estimate using the expected value method, based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue. For Medicare, we also estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Returns We estimate the amount of product sales that may be returned by Customers and record this estimate as a reduction of revenue in the period the related product revenue is recognized. We currently estimate product return liabilities using the expected value method, based on available industry data, including our visibility into the inventory remaining in the distribution channel. |
Loss per Share | March 31, 2020 are not considered to be common stock equivalents. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis | The following table summarizes our cash equivalents and marketable securities measured at fair value on a recurring basis as of March 31, 2020: (In thousands) Level 1 Level 2 Level 3 Total Cash equivalents $ 54,853 $ 19,979 $ — $ 74,832 Total cash equivalents 54,853 19,979 — 74,832 Marketable securities: U.S. Treasuries — 163,878 — 163,878 Government securities — 100,492 — 100,492 Corporate debt securities — 259,661 — 259,661 Total marketable securities — 524,031 — 524,031 Total cash equivalents and marketable securities $ 54,853 $ 544,010 $ — $ 598,863 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | Marketable securities at March 31, 2020 consisted of the following: (In thousands) Amortized Unrealized Unrealized Fair Current: U.S. Treasuries $ 141,490 $ 835 $ — $ 142,325 Government securities 89,008 256 (21) 89,243 Corporate debt securities 208,596 82 (718) 207,960 Total Current 439,094 1,173 (739) 439,528 Non-current: U.S. Treasuries 21,282 271 — 21,553 Government securities 11,260 4 (15) 11,249 Corporate debt securities 52,329 72 (700) 51,701 Total Non-current 84,871 347 (715) 84,503 Total marketable securities $ 523,965 $ 1,520 $ (1,454) $ 524,031 Marketable securities at December 31, 2019 consisted of the following: (In thousands) Amortized Unrealized Unrealized Fair Current: U.S. Treasuries 178,721 58 (38) 178,741 Government securities 80,228 17 (16) 80,229 Corporate debt securities 224,928 139 (91) 224,976 Total Current 483,877 214 (145) 483,946 Non-current: U.S. Treasuries 35,296 3 (13) 35,286 Government securities 17,587 14 (10) 17,591 Corporate debt securities 99,913 239 (100) 100,052 Total Non-current 152,796 256 (123) 152,929 Total marketable securities $ 636,673 $ 470 $ (268) $ 636,875 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, which consists of commercial supply of TIBSOVO®, consists of the following: (In thousands) March 31, December 31, Raw materials $ 180 $ 180 Work-in-process 8,589 6,808 Finished goods 1,009 343 Total inventory $ 9,778 $ 7,331 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Schedule of Undiscounted Minimum Rental Commitments Under Uncancelable Leases | As of March 31, 2020, undiscounted minimum rental commitments under non-cancelable leases, for each of the next five years and total thereafter were as follows: (In thousands) Remaining 2020 $ 9,395 2021 14,380 2022 16,773 2023 18,126 2024 18,660 2025 19,507 Thereafter 44,385 Undiscounted minimum rental commitments $ 141,226 Interest (30,750) Operating lease liabilities $ 110,476 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: (In thousands) March 31, December 31, Accrued compensation $ 7,006 $ 18,982 Accrued research and development costs 18,661 21,777 Accrued professional fees 9,238 8,335 Accrued other 4,726 4,048 Total accrued expenses $ 39,631 $ 53,142 |
Product Revenue (Tables)
Product Revenue (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Product Revenue | Three Months Ended March 31, (In thousands) 2020 2019 Product revenue, net $ 22,674 $ 9,138 |
Schedule of Product Revenue Allowance and Reserves | The following table summarizes balances and activity in each of the product revenue allowance and reserve categories for the three months ended March 31, 2020: (In thousands) Contractual Adjustments Government Rebates Returns Total Balance at December 31, 2019 $ 874 $ 1,124 $ 1,798 $ 3,796 Current provisions relating to sales in the current year 3,000 1,338 537 4,875 Adjustments relating to prior years (3) 76 — 73 Payments/returns relating to sales in the current year (2,072) — — (2,072) Payments/returns relating to sales in the prior years (653) (677) — (1,330) Balance at March 31, 2020 $ 1,146 $ 1,861 $ 2,335 $ 5,342 |
Schedule of Revenue Related Reserves | Total revenue-related reserves above, included in our condensed consolidated balance sheets, are summarized as follows: (In thousands) March 31, December 31, Reduction of accounts receivable $ 707 $ 540 Component of accrued expenses 4,635 3,256 Total revenue-related reserves $ 5,342 $ 3,796 |
Schedule of Changes in Contract Assets and Liabilities, Product Revenue | The following table presents changes in our contract assets during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets (1) Accounts receivable, net $ 8,952 $ 27,624 $ (24,763) $ 11,813 |
Collaboration and License Agr_2
Collaboration and License Agreements (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Revenue Recognition and Deferred Revenue [Abstract] | |
Schedule of Collaboration Revenue | During the three months ended March 31, 2020 and 2019, we recognized the following collaboration revenue: Three Months Ended March 31, (In thousands) 2020 2019 Services performed that were considered performance obligations as of the modification dates Licenses $ — $ — On-going research and development services 59,220 17,065 Services performed that were not considered performance obligations as of the modification dates Commercialization activities 877 854 Total collaboration revenue - related party $ 60,097 $ 17,919 |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in our contract assets and liabilities during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets Collaboration receivable – related party (1) $ 1,539 $ 3,332 $ (2,294) $ 2,577 Royalty receivable – related party (2) 2,900 3,334 (2,934) 3,300 Contract liabilities Deferred revenue – related party, current and net of current portions (3) 61,513 579 (57,344) 4,748 (1) Additions to collaboration receivables - related party relate to amounts billed to Celgene for reimbursable costs incurred by us during the reporting period and unbilled amounts related to future reimbursable costs. Deductions to receivables relate to collection of receivables during the reporting period. (2) Additions to royalty receivables - related party relate to amounts billed to Celgene during the reporting period. Deductions to receivables relate to collection of receivables during the reporting period. (3) Additions to deferred revenue - related party relate to consideration from Celgene during the reporting period. Deductions relate to deferred revenue recognized as revenue during the reporting period. The increase in collaboration revenue from on-going research and development services during the three months ended March 31, 2020 is primarily due to the fact that subsequent to Celgene’s decision to decline extending the research term, the Company updated its estimate of the future costs that will be incurred to complete one of its performance obligations under the 2016 collaboration Agreement that is recognized overtime using an input method. During the three months ended March 31, 2020 and 2019, we recognized the following as revenue due to changes in the contract liability balances: Three Months Ended March 31, (In thousands) 2020 2019 Amounts included in the contract liability at the beginning of the period $ 59,248 $ 16,410 Performance obligations satisfied in previous periods — 21 |
Schedule of Royalty Revenue | During the three months ended March 31, 2020 and 2019, we recognized the following as royalty revenue: Three Months Ended March 31, (In thousands) 2020 2019 Royalty revenue – related party $ 3,334 $ 2,200 |
Schedule of Collaboration Revenue Under CStone Agreement | During the three months ended March 31, 2020 and 2019, we recognized the following collaboration revenue -other: Three Months Ended March 31, (In thousands) 2020 2019 Services performed that were considered performance obligations as of the inception date License and other services $ 192 $ — Services performed that were not considered performance obligations as of the inception date Other services 801 970 Total collaboration revenue - other $ 993 $ 970 |
Schedule of Changes in Contract Assets and Liabilities, CStone Agreement | The following table presents changes in our contract assets during the three months ended March 31, 2020: (In thousands) December 31, Additions Deductions March 31, Contract assets (1) Collaboration receivable - other $ 1,928 $ 993 $ (888) $ 2,033 (1) Additions to contract assets relate to amounts receivable from CStone. Deductions to contract assets relate to collection of receivables during the reporting period. |
Share-Based Payments (Tables)
Share-Based Payments (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Schedule of Company's Stock Option Activity | The following table presents stock option activity for the three months ended March 31, 2020: Number of Weighted-Average Exercise Price Outstanding at December 31, 2019 6,201,485 $ 58.61 Granted 792,048 51.09 Exercised (133,256) 25.84 Forfeited/Expired (110,904) 69.00 Outstanding at March 31, 2020 6,749,373 $ 58.20 Exercisable at March 31, 2020 3,874,135 $ 59.71 Vested and expected to vest at March 31, 2020 6,749,373 $ 58.20 |
Unvested Stock Unit Activity | The following table presents RSU activity for the three months ended March 31, 2020: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2019 766,953 $ 63.44 Granted 744,447 51.38 Vested (192,870) 70.54 Forfeited (27,655) 66.70 Unvested shares at March 31, 2020 1,290,875 $ 55.36 |
Schedule of Performance-Based Units | The following table presents PSU activity for the three months ended March 31, 2020: Number of Weighted-Average Grant Date Fair Value Unvested shares at December 31, 2019 218,143 $ 55.64 Granted 20,622 48.49 Vested — — Unvested shares at March 31, 2020 238,765 $ 55.03 |
Schedule of Market-Based Units Activity | The following table presents market-based stock unit, or MSU, activity for the three months ended March 31, 2020: Number of Weighted-Average Unvested shares at December 31, 2019 42,695 $ 41.50 Granted — — Unvested shares at March 31, 2020 42,695 $ 41.50 |
Schedule of Stock-Based Compensation Expense by Award Type Included Within the Condensed Consolidated Statements of Operations | Stock-based compensation expense by award type included within the condensed consolidated statements of operations is as follows: Three Months Ended (In thousands) 2020 2019 Stock options $ 11,603 $ 13,046 Restricted stock units 6,132 4,548 Performance-based stock units 1,388 186 Employee stock purchase plan 297 328 Other stock awards 270 — Total stock-based compensation expense $ 19,690 $ 18,108 |
Schedule of Allocated Stock-Based Compensation Expense | Expenses related to stock options and stock-based awards were allocated as follows in the condensed consolidated statements of operations: Three Months Ended (In thousands) 2020 2019 Research and development expense $ 9,564 $ 10,042 Selling, general and administrative expense 10,126 8,066 Total stock-based compensation expense $ 19,690 $ 18,108 |
Loss per Share (Tables)
Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Common Stock Excluded from Calculation of Diluted Earnings Per Share | The following common stock equivalents were excluded from the calculation of diluted net loss per share applicable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: Three Months Ended March 31, 2020 2019 Stock options 6,749,373 6,482,873 Restricted stock units 1,290,875 709,162 Performance-based stock units 78,920 — Employee stock purchase plan shares 13,430 6,778 Total common stock equivalents 8,132,598 7,198,813 |
Overview and Basis of Present_2
Overview and Basis of Presentation - Additional Information (Details) $ in Millions | Mar. 31, 2020USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash, cash equivalents, and short-term investments | $ 613.1 |
Fair Value Measurements - Cash
Fair Value Measurements - Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | $ 524,031 | $ 636,875 |
Fair Value, Measurements, Recurring | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 74,832 | |
Total marketable securities | 524,031 | |
Total cash equivalents and marketable securities | 598,863 | |
Fair Value, Measurements, Recurring | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 74,832 | |
Fair Value, Measurements, Recurring | U.S. Treasuries | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 163,878 | |
Fair Value, Measurements, Recurring | Government securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 100,492 | |
Fair Value, Measurements, Recurring | Corporate debt securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 259,661 | |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 54,853 | |
Total marketable securities | 0 | |
Total cash equivalents and marketable securities | 54,853 | |
Fair Value, Measurements, Recurring | Level 1 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 54,853 | |
Fair Value, Measurements, Recurring | Level 1 | U.S. Treasuries | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 1 | Government securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 1 | Corporate debt securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 19,979 | |
Total marketable securities | 524,031 | |
Total cash equivalents and marketable securities | 544,010 | |
Fair Value, Measurements, Recurring | Level 2 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 19,979 | |
Fair Value, Measurements, Recurring | Level 2 | U.S. Treasuries | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 163,878 | |
Fair Value, Measurements, Recurring | Level 2 | Government securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 100,492 | |
Fair Value, Measurements, Recurring | Level 2 | Corporate debt securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 259,661 | |
Fair Value, Measurements, Recurring | Level 3 | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 0 | |
Total marketable securities | 0 | |
Total cash equivalents and marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 3 | Cash equivalents | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total cash equivalents | 0 | |
Fair Value, Measurements, Recurring | Level 3 | U.S. Treasuries | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 3 | Government securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | 0 | |
Fair Value, Measurements, Recurring | Level 3 | Corporate debt securities | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Total marketable securities | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) | Mar. 31, 2020USD ($) |
Fair Value, Measurements, Recurring | Level 3 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Fair value of assets (liabilities) | $ 0 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | 3 Months Ended | ||
Mar. 31, 2020USD ($)security | Mar. 31, 2019USD ($) | Dec. 31, 2019USD ($)security | |
Investments, Debt and Equity Securities [Abstract] | |||
Realized gain (loss) on marketable securities | $ 0 | $ 0 | |
Debt securities in an unrealized loss position | security | 92 | 113 | |
Allowance for credit loss | $ 0 | $ 0 | |
Aggregate fair value of debt securities in an unrealized loss position | $ 224,000,000 | $ 345,700,000 |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 523,965 | $ 636,673 |
Unrealized Gains | 1,520 | 470 |
Unrealized Losses | (1,454) | (268) |
Fair Value | 524,031 | 636,875 |
Current | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 439,094 | 483,877 |
Unrealized Gains | 1,173 | 214 |
Unrealized Losses | (739) | (145) |
Fair Value | 439,528 | 483,946 |
Current | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 141,490 | 178,721 |
Unrealized Gains | 835 | 58 |
Unrealized Losses | 0 | (38) |
Fair Value | 142,325 | 178,741 |
Current | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 89,008 | 80,228 |
Unrealized Gains | 256 | 17 |
Unrealized Losses | (21) | (16) |
Fair Value | 89,243 | 80,229 |
Current | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 208,596 | 224,928 |
Unrealized Gains | 82 | 139 |
Unrealized Losses | (718) | (91) |
Fair Value | 207,960 | 224,976 |
Non-current | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 84,871 | 152,796 |
Unrealized Gains | 347 | 256 |
Unrealized Losses | (715) | (123) |
Fair Value | 84,503 | 152,929 |
Non-current | U.S. Treasuries | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 21,282 | 35,296 |
Unrealized Gains | 271 | 3 |
Unrealized Losses | 0 | (13) |
Fair Value | 21,553 | 35,286 |
Non-current | Government securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 11,260 | 17,587 |
Unrealized Gains | 4 | 14 |
Unrealized Losses | (15) | (10) |
Fair Value | 11,249 | 17,591 |
Non-current | Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 52,329 | 99,913 |
Unrealized Gains | 72 | 239 |
Unrealized Losses | (700) | (100) |
Fair Value | $ 51,701 | $ 100,052 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 180 | $ 180 |
Work-in-process | 8,589 | 6,808 |
Finished goods | 1,009 | 343 |
Total inventory | $ 9,778 | $ 7,331 |
Leases - Additional Information
Leases - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Remaining lease terms | 8 years | ||
Operating lease cost | $ 3.8 | $ 3.1 | |
Cash paid for amounts included in measurement of lease liabilities | $ 3.9 | $ 3.1 | |
Weighted-average incremental borrowing rate | 5.70% | 5.70% | |
Weighted-average remaining lease term | 7 years 10 months 24 days | 8 years 2 months 12 days |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Minimum Rental Commitments Under Non-Cancelable Leases (Details) $ in Thousands | Mar. 31, 2020USD ($) |
Leases [Abstract] | |
Remaining 2020 | $ 9,395 |
2021 | 14,380 |
2022 | 16,773 |
2023 | 18,126 |
2024 | 18,660 |
2025 | 19,507 |
Thereafter | 44,385 |
Undiscounted minimum rental commitments | 141,226 |
Interest | (30,750) |
Operating lease liabilities | $ 110,476 |
Accrued Expenses - Summary of A
Accrued Expenses - Summary of Accrued Expenses (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 7,006 | $ 18,982 |
Accrued research and development costs | 18,661 | 21,777 |
Accrued professional fees | 9,238 | 8,335 |
Accrued other | 4,726 | 4,048 |
Total accrued expenses | $ 39,631 | $ 53,142 |
Product Revenue - Schedule of P
Product Revenue - Schedule of Product Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 87,098 | $ 30,227 |
Product revenue, net | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 22,674 | $ 9,138 |
Product Revenue - Schedule of_2
Product Revenue - Schedule of Product Revenue Allowance and Reserves (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Dec. 31, 2019 | |
Contractual Adjustments [Roll Forward] | ||
Contract adjustments, beginning balance | $ 874 | |
Contractual adjustments, current provisions relating to sales in the current year | 3,000 | |
Contractual adjustments, adjustments relating to prior year | (3) | |
Contractual adjustments, payments/returns relating to sales in the current year | (2,072) | |
Contractual adjustments, payments/returns relating to sales in the prior year | (653) | |
Contract adjustments, ending balance | 1,146 | |
Government Rebates [Roll Forward] | ||
Government rebates, beginning balance | 1,124 | |
Government rebates, current provisions relating to sales in the current year | 1,338 | |
Government rebates, adjustments relating to prior years | 76 | |
Government rebates, payments/returns relating to sales in the current year | 0 | |
Government rebates, payments/returns relating to sales in the prior years | (677) | |
Government rebates, ending balance | 1,861 | |
Product Returns [Roll Forward] | ||
Returns, beginning balance | 1,798 | |
Returns, current provisions relating to sales in the current year | 537 | |
Returns, adjustments relating to prior years | 0 | |
Returns, payments/returns relating to sales in the current year | 0 | |
Returns, payments/returns relating to sales in the prior years | 0 | |
Returns, ending balance | 2,335 | |
Allowance for Doubtful Accounts Receivable [Roll Forward] | ||
Total revenue-related reserves | 5,342 | $ 3,796 |
Total allowances and reserves, current provisions relating to sales in the current year | 4,875 | |
Total allowances and reserves, adjustments relating to prior years | 73 | |
Total allowances and reserves, payments/returns relating to sales in the current year | (2,072) | |
Total allowances and reserves, payments/returns relating to sales in the prior years | $ (1,330) |
Product Revenue - Schedule of R
Product Revenue - Schedule of Revenue-Related Reserves (Details) - USD ($) $ in Thousands | Mar. 31, 2020 | Dec. 31, 2019 |
Revenue from Contract with Customer [Abstract] | ||
Reduction of accounts receivable | $ 707 | $ 540 |
Component of accrued expenses | 4,635 | 3,256 |
Total revenue-related reserves | $ 5,342 | $ 3,796 |
Product Revenue - Schedule of C
Product Revenue - Schedule of Changes in Contract Assets and Liabilities, Product Revenue (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 8,952 |
Additions | 27,624 |
Deductions | (24,763) |
Contract assets, ending balance | $ 11,813 |
Collaboration and License Agr_3
Collaboration and License Agreements - Celegene Purchase Agreements (Details) | 1 Months Ended | ||
May 31, 2016USD ($)extension | Mar. 31, 2020USD ($) | May 17, 2016USD ($) | |
2010 Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Milestone-based receivable payments, eligible to be received | $ 80,000,000 | ||
Milestone payments upon achievement of specified regulatory milestone events | 55,000,000 | ||
Milestone payment upon achievement of a specified commercial milestone event | $ 25,000,000 | ||
2016 Agreement | Celgene | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Term of agreements | 4 years | ||
Extension period | extension | 2 | ||
Number of allowable special case extensions | extension | 4 | ||
Special case extension term | 1 year | ||
Upfront payment agreement extension fee receivable | $ 40,000,000 | ||
Option exercise fee receivable | $ 30,000,000 |
Collaboration and License Agr_4
Collaboration and License Agreements - Collaboration Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 87,098 | $ 30,227 |
Licenses | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 0 | 0 |
On-going research and development services | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 59,220 | 17,065 |
Commercialization activities | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 877 | 854 |
Collaboration revenue – related party | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 60,097 | $ 17,919 |
Collaboration and License Agr_5
Collaboration and License Agreements - Schedule of Changes in Contract Assets and Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Contract assets | ||
Contract assets, beginning balance | $ 8,952 | |
Additions | 27,624 | |
Deductions | (24,763) | |
Contract assets, ending balance | 11,813 | |
Contract liabilities | ||
Additions | 59,248 | $ 16,410 |
Collaboration receivable – related party | ||
Contract assets | ||
Contract assets, beginning balance | 1,539 | |
Additions | 3,332 | |
Deductions | (2,294) | |
Contract assets, ending balance | 2,577 | |
Royalty receivable – related party | ||
Contract assets | ||
Contract assets, beginning balance | 2,900 | |
Additions | 3,334 | |
Deductions | (2,934) | |
Contract assets, ending balance | 3,300 | |
Deferred revenue – related party, current and net of current portions | ||
Contract liabilities | ||
Contract liabilities, beginning balance | 61,513 | |
Additions | 579 | |
Deductions | (57,344) | |
Contract liabilities, ending balance | $ 4,748 |
Collaboration and License Agr_6
Collaboration and License Agreements - Schedule of Revenues as a Result of Changes in Contract Liabilities (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Revenue Recognition and Deferred Revenue [Abstract] | ||
Amounts included in the contract liability at the beginning of the period | $ 59,248 | $ 16,410 |
Performance obligations satisfied in previous periods | $ 0 | $ 21 |
Collaboration and License Agr_7
Collaboration and License Agreements - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Remaining unsatisfied performance obligation | $ 10,500,000 | |
Milestones achieved | 0 | $ 0 |
2010 Agreement | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||
Potential milestone payment | $ 35,000,000 |
Collaboration and License Agr_8
Collaboration and License Agreements - CStone Pharmaceuticals Purchase Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2018 | Mar. 31, 2020 | Mar. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Remaining unsatisfied performance obligation | $ 10,500,000 | ||
Revenue | 87,098,000 | $ 30,227,000 | |
Milestones achieved | 0 | 0 | |
Collaboration revenue – related party | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Revenue | 60,097,000 | 17,919,000 | |
Royalty revenue – related party | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Revenue | 3,334,000 | $ 2,200,000 | |
CStone Pharmaceuticals | CStone Agreement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Initial payment received | $ 12,000,000 | ||
Potential future milestone payments | 5,000,000 | ||
Remaining unsatisfied performance obligation | 500,000 | ||
Milestones achieved | 0 | ||
CStone Pharmaceuticals | CStone Agreement | Minimum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Royalty percentage | 15.00% | ||
CStone Pharmaceuticals | CStone Agreement | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Potential future milestone payments | 407,000,000 | ||
Royalty percentage | 19.00% | ||
CStone Pharmaceuticals | CStone Agreement | Royalty revenue – related party | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Revenue | $ 0 |
Collaboration and License Agr_9
Collaboration and License Agreements - Schedule of Collaboration Revenue from CStone Agreement (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 87,098 | $ 30,227 |
License and other services | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 0 | 0 |
License and other services | CStone Agreement | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 192 | 0 |
Other services | CStone Agreement | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 801 | 970 |
Collaboration revenue – other | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | 993 | 970 |
Collaboration revenue – other | CStone Agreement | ||
Disaggregation of Revenue [Line Items] | ||
Revenue | $ 993 | $ 970 |
Collaboration and License Ag_10
Collaboration and License Agreements - Changes in Contract Assets and Liabilities Under CStone Agreement (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2020USD ($) | |
Contract assets | |
Contract assets, beginning balance | $ 8,952 |
Deductions | (24,763) |
Contract assets, ending balance | 11,813 |
Collaboration receivable - other | CStone Agreement | |
Contract assets | |
Contract assets, beginning balance | 1,928 |
Additions | 993 |
Deductions | (888) |
Contract assets, ending balance | $ 2,033 |
Share-Based Payments - Addition
Share-Based Payments - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense for options | $ 58,300 | |
Weighted-average period to recognize compensation expense (in years) | 2 years 2 months 12 days | |
Performance Stock Unit, Probable of Meeting Vesting Criteria | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted-average period to recognize compensation expense (in years) | 1 month 6 days | |
Unrecognized stock based compensation expense | $ 500 | |
Market-Based Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense for options | $ 500 | |
Weighted-average period to recognize compensation expense (in years) | 6 months | |
2007 Plan and 2013 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Common stock reserved for issuance (in shares) | 11,030,628 | |
2013 Stock Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future issuance (in shares) | 2,708,920 | |
Unrecognized compensation expense for options | $ 104,000 | |
Weighted-average period to recognize compensation expense (in years) | 2 years 8 months 12 days | |
2013 Stock Incentive Plan | Performance Stock Unit, Not Probable of Meeting Vesting Criteria | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized stock based compensation expense | $ 11,300 | |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future issuance (in shares) | 528,952 | |
Shares issued under 2013 ESPP (in shares) | 62,694 | 32,410 |
Opportunity to purchase of common stock (in shares) | 836,363 |
Share-Based Payments - Summary
Share-Based Payments - Summary of Stock Option Activity (Details) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Number of stock options, outstanding, beginning balance (in shares) | shares | 6,201,485 |
Number of stock options, granted (in shares) | shares | 792,048 |
Number of stock options, exercised (in shares) | shares | (133,256) |
Number of stock options, forfeited/expired (in shares) | shares | (110,904) |
Number of stock options, outstanding, ending balance (in shares) | shares | 6,749,373 |
Number of stock options, exercisable (in shares) | shares | 3,874,135 |
Number of stock options, vested and expected to vest (in shares) | shares | 6,749,373 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Weighted-average exercise price, outstanding, beginning balance (in usd per share) | $ / shares | $ 58.61 |
Weighted-average exercise price, granted (in usd per share) | $ / shares | 51.09 |
Weighted-average exercise price, exercised (in usd per share) | $ / shares | 25.84 |
Weighted-average exercise price, forfeited/expired (in usd per share) | $ / shares | 69 |
Weighted-average exercise price, outstanding, ending balance (in usd per share) | $ / shares | 58.20 |
Weighted-average exercise price, exercisable (in usd per share) | $ / shares | 59.71 |
Weighted-average exercise price, vested and expected to vest (in usd per share) | $ / shares | $ 58.20 |
Share-Based Payments - Summar_2
Share-Based Payments - Summary of Unvested RSUs Activity (Details) - Restricted Stock Units | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 766,953 |
Granted (in shares) | shares | 744,447 |
Vested (in shares) | shares | (192,870) |
Forfeited (in shares) | shares | (27,655) |
Unvested shares end of period (in shares) | shares | 1,290,875 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 63.44 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 51.38 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 70.54 |
Weighted-average grant date fair value, Forfeited (in usd per share) | $ / shares | 66.70 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 55.36 |
Share-Based Payments - Schedule
Share-Based Payments - Schedule of Performance-Based and Market- Based Units (Details) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Performance-Based Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 218,143 |
Granted (in shares) | shares | 20,622 |
Vested (in shares) | shares | 0 |
Unvested shares end of period (in shares) | shares | 238,765 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 55.64 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 48.49 |
Weighted-average grant date fair value, Vested (in usd per share) | $ / shares | 0 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 55.03 |
Market-Based Stock Units | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |
Unvested shares beginning of period (in shares) | shares | 42,695 |
Granted (in shares) | shares | 0 |
Unvested shares end of period (in shares) | shares | 42,695 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |
Weighted-average grant date fair value, Unvested shares beginning of period (in usd per share) | $ / shares | $ 41.50 |
Weighted-average grant date fair value, Granted (in usd per share) | $ / shares | 0 |
Weighted-average grant date fair value, Unvested shares end of period (in usd per share) | $ / shares | $ 41.50 |
Share-Based Payments - Schedu_2
Share-Based Payments - Schedule of Stock-Based Compensation Expense by Award Type Included Within the Condensed Consolidated Statements of Operations (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 19,690 | $ 18,108 |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 11,603 | 13,046 |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 6,132 | 4,548 |
Performance-Based Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 1,388 | 186 |
Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 297 | 328 |
Other Stock Awards | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 270 | $ 0 |
Share-Based Payments - Expenses
Share-Based Payments - Expenses Related to Equity-Based Awards (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 19,690 | $ 18,108 |
Research and development expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | 9,564 | 10,042 |
Selling, general and administrative expense | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total stock-based compensation expense | $ 10,126 | $ 8,066 |
Loss per Share - Common Stock E
Loss per Share - Common Stock Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 8,132,598 | 7,198,813 |
Stock Options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 6,749,373 | 6,482,873 |
Restricted Stock Units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 1,290,875 | 709,162 |
Performance-based stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 78,920 | 0 |
Employee stock purchase plan shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total common stock equivalents excluded from computation of earnings per share (in shares) | 13,430 | 6,778 |